Author: "G. De Berardis" - Searchworks@Jio Institute Digital Library Search Results

53 results on '"G. De Berardis"'

1. Use of the Diabetes Risk Score for Opportunistic Screening of Undiagnosed Diabetes and Impaired Glucose Tolerance

Author: M. FRANCIOSI, G. DE BERARDIS, Rossi, Matteo, M. SACCO, M. BELFIGLIO, F. PELLEGRINI, G. TOGNONI, M. VALENTINI, A. NICOLUCCI, GALLUZZO, Aldo, SINAGRA, Domenico, M FRANCIOSI, G DE BERARDIS, MCE ROSSI, M SACCO, M BELFIGLIO, F PELLEGRINI, G TOGNONI, M VALENTINI, A NICOLUCCI, GALLUZZO A, SINAGRA D, and ET AL
Subjects: medicine.medical_specialty, Diabetes risk, Endocrinology, Diabetes and Metabolism, Type 2 diabetes, Impaired glucose tolerance, MELLITUS, NIDDM, PEOPLE, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Risk factor, Prospective cohort study, Advanced and Specialized Nursing, Glucose tolerance test, medicine.diagnostic_test, business.industry, PERFORMANCE, medicine.disease, Impaired fasting glucose, PREVENTION, PREVALENCE, Endocrinology, LIFE-STYLE, HEALTH, business
Abstract: OBJECTIVE—To evaluate an opportunistic screening strategy addressed to individuals with one or more cardiovascular risk factor, based on the Diabetes Risk Score (DRS) as the initial instrument, for the identification of individuals with type 2 diabetes or impaired glucose tolerance (IGT). RESEARCH DESIGN AND METHODS—The DRS, a simple self-administered questionnaire, was completed by individuals identified by general practitioners and presenting with one or more cardiovascular risk factor. All patients underwent a 2-h oral glucose tolerance test (OGTT). The optimal DRS cutoff was calculated by applying the receiver-operating characteristic curve. RESULTS—Overall, 1,377 individuals aged between 55 and 75 years received an OGTT and completed the DRS. Mean DRS values showed a marked variation according to glucose metabolism categories, as follows: 8.7 ± 3.0 in normoglycemic individuals, 9.5 ± 3.1 in individuals with impaired fasting glucose, 9.9 ± 3.3 in individuals with IGT, and 12.0 ± 3.5 in individuals with type 2 diabetes. The receiver-operating characteristic curve showed that, with a cutoff of 9, the sensitivity of DRS in detecting individuals with glucose abnormalities (type 2 diabetes or IGT) was 77% and the specificity 45%. The use of the DRS as an initial screening instrument, followed by the measurement of fasting blood glucose in individuals with a score ≥9 and by the OGTT in individuals with a fasting blood glucose between 5.6 and 6.9 mmol/l, would lead to the identification of 83% of the case subjects with type 2 diabetes and 57% of the case subjects with IGT, at a cost of an OGTT in 38% of the sample and a fasting blood glucose in 64%. CONCLUSIONS—The DRS can represent a valid inexpensive instrument for opportunistic screening and a useful alternative to indiscriminate fasting blood glucose measurement, not readily available in general practice.
Published: 2005

2. The burden of hospitalization related to diabetes mellitus: A population-based study

Author: Simona Cammarota, C.A. Germinario, Giuseppe Lucisano, Enrica Menditto, G. De Berardis, Fabio Pellegrini, Vito Lepore, Antonio Nicolucci, A. Nicolosi, Giusi Graziano, F. Vitullo, Antonio D'Ettorre, Anna Citarella, De Berardis, G, D'Ettorre, A, Graziano, G, Lucisano, G, Pellegrini, F, Cammarota, S, Citarella, A, Germinario, Ca, Lepore, V, Menditto, Enrica, Nicolosi, A, Vitullo, F, and Nicolucci, A.
Subjects: Adult, Male, medicine.medical_specialty, Adolescent, Endocrinology, Diabetes and Metabolism, Administrative data, MEDLINE, Medicine (miscellaneous), Young Adult, Cost of Illness, Diabetes mellitus, Health care, Epidemiology, Diabetes Mellitus, Odds Ratio, Prevalence, medicine, Humans, Hypoglycemic Agents, Insulin, Young adult, Medical prescription, Aged, Nutrition and Dietetics, business.industry, Odds ratio, Middle Aged, medicine.disease, Metformin, Hospitalization, Population based study, Treatment Outcome, Italy, diabete, Benzamides, Emergency medicine, Female, Thiazolidinediones, epidemiology, Medical emergency, Cardiology and Cardiovascular Medicine, business
Abstract: BACKGROUND AND AIMS: To estimate the impact of diabetes and its complications, overall and in different age classes, on the likelihood of hospital admission for specific causes. METHODS AND RESULTS: We carried out a record-linkage analysis of administrative registers including data on 8,940,420 citizens in 21 Local Health Authorities in Italy. Individuals with pharmacologically treated diabetes (???2 prescriptions of antidiabetic agents during the year 2008) were paired in a 1:1 proportion with those who did not receive such drugs (controls) based on propensity-score matching. Odds Ratios (ORs) of hospitalization for macro and microvascular conditions in individuals with diabetes as compared to controls were estimated. The system identified 498,825 individuals with diabetes pharmacologically treated (prevalence of 5.6%). Prevalence of diabetes in people aged
Published: 2012

3. Epidemiology and outcome research in CKD 5D

Author: L. Coentrao, C. Ribeiro, C. Santos-Araujo, R. Neto, M. Pestana, W. Kleophas, A. Karaboyas, Y. LI, J. Bommer, R. Pisoni, B. Robinson, F. Port, G. Celik, B. Burcak Annagur, M. Yilmaz, T. Demir, F. Kara, K. Trigka, P. Dousdampanis, N. Vaitsis, S. Aggelakou-Vaitsi, K. Turkmen, I. Guney, F. Turgut, L. Altintepe, H. Z. Tonbul, E. Abdel-Rahman, P. Sclauzero, G. Galli, G. Barbati, M. Carraro, G. O. Panzetta, M. Van Diepen, M. Schroijen, O. Dekkers, F. Dekker, A. Sikole, G. Severova- Andreevska, L. Trajceska, S. Gelev, V. Amitov, S. Pavleska- Kuzmanovska, H. Rayner, R. Vanholder, M. Hecking, B. Jung, M. Leung, F. Huynh, T. Chung, S. Marchuk, M. Kiaii, L. Er, R. Werb, C. Chan-Yan, M. Beaulieu, P. Malindretos, P. Makri, G. Zagkotsis, G. Koutroumbas, G. Loukas, E. Nikolaou, M. Pavlou, E. Gourgoulianni, M. Paparizou, M. Markou, E. Syrgani, C. Syrganis, J. Raimann, L. A. Usvyat, V. Bhalani, N. W. Levin, P. Kotanko, X. Huang, P. Stenvinkel, A. R. Qureshi, U. Riserus, T. Cederholm, P. Barany, O. Heimburger, B. Lindholm, J. J. Carrero, J. H. Chang, J. Y. Sung, J. Y. Jung, H. H. Lee, W. Chung, S. Kim, J. S. Han, K. Y. Na, A. Fragoso, A. Pinho, A. Malho, A. P. Silva, E. Morgado, P. Leao Neves, N. Joki, Y. Tanaka, M. Iwasaki, S. Kubo, T. Hayashi, Y. Takahashi, K. Hirahata, Y. Imamura, H. Hase, C. Castledine, J. Gilg, C. Rogers, Y. Ben-Shlomo, F. Caskey, J. S. Sandhu, G. S. Bajwa, S. Kansal, J. Sandhu, A. Jayanti, M. Nikam, L. Ebah, A. Summers, S. Mitra, J. Agar, A. Perkins, R. Simmonds, A. Tjipto, S. Amet, V. Launay-Vacher, M. Laville, A. Tricotel, C. Frances, B. Stengel, J.-Y. Gauvrit, N. Grenier, G. Reinhardt, O. Clement, N. Janus, L. Rouillon, G. Choukroun, G. Deray, A. Bernasconi, R. Waisman, A. P. Montoya, A. A. Liste, R. Hermes, G. Muguerza, R. Heguilen, E. L. Iliescu, V. Martina, M. A. Rizzo, P. Magenta, L. Lubatti, G. Rombola, M. Gallieni, C. Loirat, H. Mellerio, M. Labeguerie, B. Andriss, E. Savoye, M. Lassale, C. Jacquelinet, C. Alberti, Y. Aggarwal, J. Baharani, S. Tabrizian, S. Ossareh, M. Zebarjadi, P. Azevedo, F. Travassos, I. Frade, M. Almeida, J. Queiros, F. Silva, A. Cabrita, R. Rodrigues, C. Couchoud, J. Kitty, S. Benedicte, C. Fergus, C. Cecile, B. Sahar, V. Emmanuel, J. Christian, E. Rene, H. Barahimi, M. Mahdavi-Mazdeh, M. Nafar, M. Petruzzi, M. De Benedittis, M. Sciancalepore, L. Gargano, P. Natale, M. C. Vecchio, V. Saglimbene, F. Pellegrini, G. Gentile, P. Stroumza, L. Frantzen, M. Leal, M. Torok, A. Bednarek, J. Dulawa, E. Celia, R. Gelfman, J. Hegbrant, C. Wollheim, S. Palmer, D. W. Johnson, P. J. Ford, J. C. Craig, G. F. Strippoli, M. Ruospo, B. El Hayek, B. Hayek, E. Baamonde, E. Bosch, J. I. Ramirez, G. Perez, A. Ramirez, A. Toledo, M. M. Lago, C. Garcia-Canton, M. D. Checa, B. Canaud, B. Lantz, A. Granger-Vallee, P. Lertdumrongluk, N. Molinari, J. Ethier, M. Jadoul, B. Gillespie, C. Bond, S. Wang, T. Alfieri, P. Braunhofer, B. Newsome, M. Wang, B. Bieber, M. Guidinger, L. Zuo, X. Yu, X. Yang, J. Qian, N. Chen, J. Albert, Y. Yan, S. Ramirez, M. Beresan, A. Lapidus, M. Canteli, A. Tong, B. Manns, J. Craig, G. Strippoli, M. Mortazavi, B. Vahdatpour, S. Shahidi, A. Ghasempour, D. Taheri, S. Dolatkhah, A. Emami Naieni, M. Ghassami, M. Khan, K. Abdulnabi, P. Pai, M. Vecchio, M. A. Muqueet, M. J. Hasan, M. A. Kashem, P. K. Dutta, F. X. Liu, L. Noe, T. Quock, N. Neil, G. Inglese, M. Motamed Najjar, B. Bahmani, A. Shafiabadi, J. Helve, M. Haapio, P.-H. Groop, C. Gronhagen-Riska, P. Finne, R. Sund, M. Cai, S. Baweja, A. Clements, A. Kent, R. Reilly, N. Taylor, S. Holt, L. Mcmahon, M. Carter, F. M. Van der Sande, J. Kooman, R. Malhotra, G. Ouellet, E. L. Penne, S. Thijssen, M. Etter, A. Tashman, A. Guinsburg, A. Grassmann, C. Barth, C. Marelli, D. Marcelli, G. Von Gersdorff, I. Bayh, L. Scatizzi, M. Lam, M. Schaller, T. Toffelmire, Y. Wang, P. Sheppard, L. Neri, V. A. Andreucci, L. A. Rocca-Rey, S. V. Bertoli, D. Brancaccio, G. De Berardis, G. Lucisano, D. Johnson, A. Nicolucci, C. Bonifati, S. D. Navaneethan, V. Montinaro, M. Zsom, A. Bednarek-Skublewska, G. Graziano, J. N. Ferrari, A. Santoro, A. Zucchelli, G. Triolo, S. Maffei, S. De Cosmo, V. M. Manfreda, L. Juillard, A. Rousset, F. Butel, S. Girardot-Seguin, T. Hannedouche, M. Isnard, Y. Berland, P. Vanhille, J.-P. Ortiz, G. Janin, P. Nicoud, M. Touam, E. Bruce, B. Grace, P. Clayton, A. Cass, S. Mcdonald, Y. Furumatsu, T. Kitamura, N. Fujii, S. Ogata, H. Nakamoto, K. Iseki, Y. Tsubakihara, C.-C. Chien, J.-J. Wang, J.-C. Hwang, H.-Y. Wang, W.-C. Kan, N. Kuster, L. Patrier, A.-S. Bargnoux, M. Morena, A.-M. Dupuy, S. Badiou, J.-P. Cristol, J.-M. Desmet, V. Fernandes, F. Collart, N. Spinogatti, J.-M. Pochet, M. Dratwa, E. Goffin, J. Nortier, D. S. Zilisteanu, M. Voiculescu, E. Rusu, C. Achim, R. Bobeica, S. Balanica, T. Atasie, S. Florence, S. Anne-Marie, L. Michel, C. Cyrille, A. Strakosha, N. Pasko, S. Kodra, N. Thereska, A. Lowney, E. Lowney, R. Grant, M. Murphy, L. Casserly, T. O' Brien, W. D. Plant, J. Radic, D. Ljutic, V. Kovacic, M. Radic, K. Dodig-Curkovic, M. Sain, I. Jelicic, T. Hamano, C. Nakano, S. Yonemoto, A. Okuno, M. Katayama, Y. Isaka, M. Nordio, A. Limido, M. Postorino, M. Nichelatti, M. Khil, I. Dudar, V. Khil, I. Shifris, M. Momtaz, A. R. Soliman, M. I. El Lawindi, P. Dzekova-Vidimliski, S. Pavleska-Kuzmanovska, I. Nikolov, G. Selim, T. Shoji, R. Kakiya, N. Tatsumi-Shimomura, Y. Tsujimoto, T. Tabata, H. Shima, K. Mori, S. Fukumoto, H. Tahara, H. Koyama, M. Emoto, E. Ishimura, Y. Nishizawa, and M. Inaba
Subjects: Transplantation, medicine.medical_specialty, Nephrology, business.industry, Epidemiology, Medicine, business, Intensive care medicine, Outcome (game theory)
Published: 2012

4. Persistent platelet activation in patients with type 2 diabetes treated with low doses of aspirin

Author: G. Iacuitti, Giuseppe Marelli, G. De Simone, Licia Totani, Elisa Nada, C. Amore, Stefano Manarini, Antonio Nicolucci, G. Levantesi, G Pozzoli, P. Di Summa, L. Brero, G. De Berardis, V. Evangelista, Fausto Avanzini, Ausilia Maione, Carlo Giorda, Giuseppe Dell'Elba, M. Pupillo, R. Pecce, and G. Tognoni
Subjects: Blood Glucose, medicine.medical_specialty, Urinary system, Type 2 diabetes, Thromboxane A2, chemistry.chemical_compound, Internal medicine, Diabetes mellitus, medicine, Humans, Platelet activation, Glycemic, Inflammation, Creatinine, Aspirin, medicine.diagnostic_test, business.industry, Hematology, Platelet Activation, medicine.disease, Endocrinology, Diabetes Mellitus, Type 2, chemistry, Glycemic Index, Case-Control Studies, Lipid profile, business, Biomarkers, medicine.drug
Abstract: Summary. Background: The percentage of diabetic patients who do not benefit from the protective effect of aspirin is larger than in other populations at cardiovascular risk. Objective: We compared the ability of aspirin to suppress TxA2 and platelet activation in vivo, in type-2 diabetics vs. high-risk non-diabetic patients. Methods: Urinary 11-dehydro-TXB2, plasma sCD40 L, and sP-selectin were measured, together with indices of low-grade inflammation, glycemic control, and lipid profile, in 82 patients with type-2 diabetes and 39 without diabetes, treated with low doses of aspirin. Results: Urinary 11-dehydro-TxB2, plasma sCD40L and sP-selectin were significantly higher in diabetics than in controls: [38.9 (27.8–63.3) vs. 28.5 (22.5–43.9) ng mmol−1 of creatinine, P = 0.02], [1.06 (0.42–3.06) vs. 0.35 (0.22–0.95) ng mL−1; P = 0.0001], [37.0 (16.8–85.6) vs. 20.0 (11.2–35.6) ng mL−1, P = 0.0001], respectively. The proportion of individuals with diabetes increased across quartiles of 11-dehydro-TxB2, sCD40L, and sP-selectin, with the highest quartiles of 11-dehydro-TxB2, sCD40L and sP-selectin, including 66%, 93.3%, and 93.3% of individuals with diabetes. Markers of platelet activation positively correlated with indices of glycemic control but not with markers of low-grade inflammation. Conclusions: Platelet dysfunction associated with insufficient glycemic control, may mediate persistent platelet activation under aspirin treatment.
Published: 2007

5. Self-monitoring of blood glucose in non-insulin-treated diabetic patients: a longitudinal evaluation of its impact on metabolic control

Author: G. De Berardis, Maurizio Belfiglio, Sheldon Greenfield, Maria Chiara Rossi, G. Tognoni, Monica Franciosi, Fabio Pellegrini, Sherrie H. Kaplan, Antonio Nicolucci, B. Di Nardo, Michele Sacco, and Miriam Valentini
Subjects: medicine.medical_specialty, endocrine system diseases, business.industry, Endocrinology, Diabetes and Metabolism, Insulin, medicine.medical_treatment, nutritional and metabolic diseases, Type 2 diabetes, medicine.disease, Surgery, Endocrinology, Homogeneous, Diabetes mellitus, Internal medicine, Metabolic control analysis, Internal Medicine, medicine, Self-monitoring, In patient, Outcomes research, business
Abstract: Aims In the framework of a nationwide outcomes research programme, we assessed the impact of self-monitoring of blood glucose (SMBG) on metabolic control over 3 years in patients with Type 2 diabetes mellitus (DM2) not treated with insulin. Methods The study involved 1896 patients who completed, at 6-month intervals for 3 years, a questionnaire investigating SMBG practice. Clinical information was collected by participating clinicians at the same time intervals. The predictive value of SMBG frequency on long-term metabolic control was estimated using multilevel analysis. The impact of SMBG on metabolic control was also evaluated in distinct and homogeneous subgroups of patients showing different likelihood of performing SMBG, identified using a tree-growing technique (RECPAM). Results Overall, 22% of the patients were on diet alone and 78% were treated with oral agents; 41% practiced SMBG ≥ 1/week (10.3%≥ 1/day). The analysis of metabolic control according to the frequency of SMBG failed to show any significant impact of this practice on HbA1c levels over 3 years. Similarly, changes in SMBG frequency during the study were not related to significant changes in HbA1c levels. RECPAM analysis led to the identification of eight classes, characterized by substantial differences in the likelihood of performing SMBG with a frequency of at least 1/week. Nevertheless, in none of the RECPAM classes identified, did SMBG predict a better metabolic control over 3 years of follow-up. In those RECPAM classes indicating that SMBG was mainly performed to avoid hypoglycaemic episodes, SMBG was associated with a decrease in the frequency of hypoglycaemic episodes during the study. Conclusions In a large sample of non-insulin-treated Type 2 diabetic patients, the performance and frequency of SMBG did not predict better metabolic control over 3 years. We could not identify any specific subgroups of patients for whom SMBG practice was associated with lower HbA1c levels during the study.
Published: 2005

6. Randomized Trial of 2 Versus 5 Years of Adjuvant Tamoxifen for Women Aged 50 Years or Older With Early Breast Cancer: Italian Interdisciplinary Group for Cancer Evaluation Study of Adjuvant Treatment in Breast Cancer 01

Author: G. De Berardis, Monica Franciosi, Antonio Nicolucci, Miriam Valentini, Maurizio Belfiglio, Michele Sacco, and Fabio Pellegrini
Subjects: Oncology, Gynecology, Cancer Research, medicine.medical_specialty, business.industry, medicine.medical_treatment, Hazard ratio, Cancer, Hormone replacement therapy (menopause), Antiestrogen, medicine.disease, law.invention, Breast cancer, Randomized controlled trial, law, Internal medicine, medicine, Breast carcinoma, business, Tamoxifen, medicine.drug
Abstract: Purpose: To compare 2 with 5 years of adjuvant tamoxifen therapy in the treatment of early breast cancer. Patients and Methods: Women with breast carcinoma T1–3, N0–3, M0, who were between 50 and 70 years of age, were eligible irrespective of menopausal status, tumor grade, or estrogen receptor (ER) status. Patients who were event-free after 2 years of tamoxifen therapy were randomly assigned to stop or continue tamoxifen therapy for an additional 3 years. The primary end point was length of disease-free survival (DFS). Secondary end points included overall survival (OS) and toxicity. Results: From 1989 through 1996, 1,901 patients were randomly assigned either to stop treatment (n = 958) or to receive tamoxifen for 3 additional years (n = 943). The median duration of postrandomization follow-up was 52 months. We found no statistically significant differences between the 5-year arm and the 2-year arm in terms of DFS (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.76 to 1.08) and OS (HR, 1.16; 95% CI, 0.92 to 1.46). In ER-positive patients, a statistically significant prolongation of DFS related to longer treatment duration was observed (HR, 0.74; 95% CI, 0.59 to 0.93), whereas no difference in OS could be detected (HR, 0.98; 95% CI, 0.72 to 1.32). No differences in terms of endometrial cancers, cardiac or cerebrovascular events, or fractures were detected, whereas a doubling in the risk of thromboembolic events was found in the 5-year arm. Conclusion: Our results confirm previous research that shows that 5 years of tamoxifen decreases recurrence compared to 2 years in patients with ER-positive tumors.
Published: 2003

7. The Relationship Between Physicians’ Self-Reported Target Fasting Blood Glucose Levels and Metabolic Control in Type 2 Diabetes

Author: Maurizio Belfiglio, Sherrie H. Kaplan, Antonio Nicolucci, D. Cavaliere, R Della Vedova, Miriam Valentini, Monica Franciosi, Fabio Capani, G. De Berardis, M. Massi Benedetti, Giacomo Vespasiani, Sheldon Greenfield, Fabio Pellegrini, outcomes in type diabetes, C. Taboga, G. Tognoni, A Corsi, B. Di Nardo, Massimo Tombesi, V. Caimi, and Michele Sacco
Subjects: Advanced and Specialized Nursing, Research design, medicine.medical_specialty, business.industry, Endocrinology, Diabetes and Metabolism, Type 2 diabetes, medicine.disease, Diabetes mellitus, Internal medicine, Metabolic control analysis, Health care, Internal Medicine, medicine, Population study, Medical emergency, Quality of care, business, Body mass index
Abstract: OBJECTIVE—To investigate the relationship between beliefs of physicians relative to intensive metabolic control in type 2 diabetes and levels of HbA1c obtained in a sample of their patients. RESEARCH DESIGN AND METHODS—Physicians’ beliefs were investigated through a questionnaire sent to a sample of self-selected clinicians participating in a nationwide initiative aimed at assessing the relationship between the quality of care delivered to patients with type 2 diabetes and their outcomes. At the same time, physicians were asked to collect clinical data on a random sample of their patients, stratified by age ( RESULTS—Of 456 physicians, 342 (75%) returned the questionnaire. Among the responders, 200 diabetologists and 99 general practitioners (GPs) recruited 3,297 patients; 2,003 of whom were always followed by the same physician and 1,294 of whom were seen by different physicians in the same structure on different occasions. Only 14% of the respondents used target FBG levels ≤6.1 mmol/l, whereas 38% pursued values >7.8 mmol/l, with no statistically significant difference between diabetologists and GPs. The analysis of the relationship between FBG targets and metabolic control, restricted to those patients always seen by the same physician, showed a strong linear association, with mean HbA1c values of 7.0 ± 1.6 for patients in the charge of physicians pursuing FBG levels ≤6.1 mmol/l and 7.8 ± 1.8 for those followed by physicians who used target values >7.8 mmol/l. After adjusting for patients’ and physicians’ characteristics, the risk of having HbA1c values >7.0% was highly correlated with physicians’ beliefs. Patients followed by different physicians in the same unit showed a risk of inadequate metabolic control similar to that of patients followed by physicians adopting a nonaggressive policy. CONCLUSIONS—Doctors adopt extremely heterogeneous target FBG levels in patients with type 2 diabetes, which in turn represent an important independent predictor of metabolic control. To improve patient outcomes, physicians-centered educational activities aimed at increasing the awareness of the potential benefits of a tight metabolic control in patients with type 2 diabetes are urgently needed.
Published: 2001

8. Alternative site blood glucose testing:a multicenter study

Author: A Corsi, Antonio Nicolucci, Monica Franciosi, Dario Iafusco, C Noacco, Francesco Prisco, David A. Fedele, E Torre, R Toniato, G. De Berardis, M K Errico, Lorenzo Neri, and S. Squatrito
Subjects: Adult, Blood Glucose, Male, medicine.medical_specialty, Adolescent, Endocrinology, Diabetes and Metabolism, Type 2 diabetes, Hypoglycemia, Fingers, Endocrinology, Forearm, Reference Values, Diabetes mellitus, Linear regression, Medicine, Humans, Age of Onset, Child, Type 1 diabetes, business.industry, Blood Glucose Self-Monitoring, Glucose Measurement, Reproducibility of Results, Glucose clamp technique, medicine.disease, Surgery, Medical Laboratory Technology, medicine.anatomical_structure, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Patient Satisfaction, Anesthesia, Glucose Clamp Technique, Regression Analysis, Female, business
Abstract: The aim of this study was to compare glucose measurements between fingertip and forearm using the blood glucose (BG) monitoring system One Touch Ultra (LifeScan), an electrochemical sensor that requires only a very small drop of blood (1 microL). Patients with type 1 or type 2 diabetes were identified in five outpatient diabetes clinics. Participants were requested to use the One Touch Ultra at home for 1 week for the measurement of BG levels from both sites. Patients filled in a questionnaire about their experience with testing blood samples from fingertip and forearm. The agreement between the measurements from the two sites was assessed using linear regression analysis, mean absolute relative error (MARE), the Bland-Altman method, and Error Grid Analysis (EGA). Overall, 112 patients were recruited, of whom 58% had type 1 diabetes. Linear regression analysis showed an intercept of 17.7, statistically different from 0 (p
Published: 2004

9. 40(th) EASD Annual Meeting of the European Association for the Study of Diabetes : Munich, Germany, 5-9 September 2004

Author: S. Artigas, A V Dreval, Mark I. McCarthy, C Watson, Peter H. Bennett, M Quint, Y Ikeda, E Alpert, F Schiele, H Sekihara, Erik Gylfe, P Lowe, J Kuhlmann, Alain Golay, V Longo, Shahidul Alam Khan Akm., L G Mantovani, M Zawodniak-Szalapska, G Winkler, T Harrity, L Virág, U Johne, Kuo S-W., Linda C Tapsell, J Rodriguez, Michel Komajda, K Kankova, Carole A. Cull, M Sporna, E Estilles, U Ribel, M C Spruce, E Buzzigoli, T Prazak, J K McLaughlin, M K Lingohr, M Lim, F Calara, A Siebenhofer, G Meregalli, Roberto Anichini, A D Baron, R Kurashvili, P C Butler, G I Fantus, T. E. De Gooyer, Park Y-M., R. Walther, S Heinrich, Agnieszka Zawiejska, S Mukherjee, Nikolaos Papanas, G Wong, Ian D. Caterson, David M. Maahs, Shuichi Kaneko, Alexandra E. Butler, Francisco Javier Ampudia-Blasco, O N Kong, Attali J-R., C A Hedman, K Oshinyemi, Nicolle Müller, I C Cranston, N Okumus, M V Vlaiculescu, Balasubramanian Ravikumar, W W Cheatham, K Mukasa, K B Biswas, Annunziata Lapolla, Phil McEwan, G Mader, Gilles Chassot, Dragi Anevski, Werner A. Scherbaum, M Donath, C Hesselmann, R A Gandhi, David E. Moller, Ezio Bonifacio, C Garcia, V Ifandi, P Hornnes, Nieuwenhoven Fav., C Puech, S Pérez-Del-Pulgar, Kim S-R., G Hines, C Rubio Terrés, Michael Gaster, N. Hosszufalusi, A Scholze, Andrew A. Young, Stavros Liatis, F Hariri, S Tan, Paul Valensi, Allan E. Karlsen, J Kim, E. Moberg, J Kaiser, L Berman, G Nelson, A Altkrüger, P Kothare, D B Cook, S Doran, G. van Dijk, Shahnaz Shahinfar, Kim C-S., P Stahl, M Manousaki, S Sigrist, S K Lim, M. P. Stern, A Guberti, C Rezzani, J McKenney, Karl Thomaseth, Sofia Carlsson, M Julia, R Brillante, I Rubesova, T Darkow, E Matsumoto, Wendy M. Macfarlane, M Di Martino, G Bardini, Rossella Menghini, D Duhot, E Farcasiu, Annalisa Natalicchio, I Lindner, J Buvat, Christian L. Brand, Harry Dorchy, Iwona Pietrzak, Z T Luo, P Home, M Ekelund, Jesper Gromada, Kristine Færch, F Piarulli, H Kim, R Mentel, Zsuzsanna K. Zsengellér, Dullaart Rpf., Anton Luger, Thomas A. Pearson, V Manicardi, P Rösen, Feng Y-M., R Morganti, Lars Hansen, Demuth H-U., Haruo Kasai, A Shostak, Rudi Steffensen, G Taylor, Markolf Hanefeld, C Santini, E Hamaguchi, Roberto Miccoli, F Storms, M Cooper, Y Lee, Allison E. Aiello, P Smith, T Suehiro, K Treece, M Waluś, Timothy A Welborn, Simone Baltrusch, E Kontela, S Chai, J Crean, H Yokoyama, Johan G. Eriksson, Rafael Hernández Hernández, J Rodríguez-Saldaña, M P Tornero, G Formoso, D. Lovell, E Bingham, A Mylonakis, M Manteghetti, D Fedele, Antonio Martín-Duce, Ralph A. DeFronzo, D Salcedo, Kurt Højlund, Antonio Petrone, Sheu Whh., C Gutierrez, Flavia Pricci, S Kurita, Z G Abbas, M M Benedetti, Philippe A. 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D, Torjesen, P, Kilhovd, B, Berg, T, Sandvik, L, Hanssen, K, Mentink, C, Donchenko, G, Stepanenko, S, Maingrette, F, Deng, H, Lindenmair, A, Freudenthaler, A, Baumgartner parzer, S, Nizheradze, K, Khoruzhenko, A, Tronko, N, Sheu, W, Ou, H, Shen, H, Lin, T, Wu, H, Yang, C, Mogylnytska, L, Schmoelzer, I, Davies, J, Band, M, Struthers, A, Prázný, M, Škrha, J, Kasalová, Z, Neelotpol, S, Jahan, P, Kauschke, S, Harrop, C, Schäfer, A, Widder, J, Eigenthaler, M, Walter, U, Uchimura, I, Ikebukuro, M, Kaibara, M, Hirata, M, Helal, R, Pervin, F, Yang, X, Jansson, P, Nagaev, I, Jack, M, Carvalho, E, Sunnerhagen, K, Cam, M, Cushman, S, Smith, U, Creely, S, Farmer, J, Gustafson, B, Kusminski, C, Krusinova, E, Wohl, P, Klementova, M, Lanska, V, Mcdougall, C, Kelly, I, Abbas, Z, Lutale, J, Archibald, L, Karunajeewa, H, Stingemore, N, Stuccio, G, Mcgechie, D, Muller, L, Hak, E, Goudzwaard, W, Montorsi, F, Homering, M, Sprenger, K, Goldstein, I, Asnaghi, V, Ferrari, G, Rastaldi, M, Gabellini, D, Dell'Antonio, G, Maestroni, A, Ruggieri, D, Luzi, L, Piemonti, L, Zerbini, G, Anafaroglu, I, Tutuncu, N, Sultana, M, Siddiqua, N, Iwasaki, T, Nakajima, A, Yoneda, M, Mukasa, K, Tanaka, S, and Sekihara, H
Subjects: 0303 health sciences, medicine.medical_specialty, business.industry, EASD, Endocrinology, Diabetes and Metabolism, Human physiology, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Diabetes mellitus, Family medicine, Internal Medicine, Medicine, business, 030217 neurology & neurosurgery, 030304 developmental biology
Published: 2004

10. The impact of blood glucose self-monitoring on metabolic control and quality of life in type 2 diabetic patients: an urgent need for better educational strategies

Author: M, Franciosi, F, Pellegrini, G, De Berardis, M, Belfiglio, D, Cavaliere, B, Di Nardo, S, Greenfield, S H, Kaplan, M, Sacco, G, Tognoni, M, Valentini, and A, Nicolucci
Subjects: Glycated Hemoglobin, Male, Quality Assurance, Health Care, Blood Glucose Self-Monitoring, Middle Aged, Ambulatory Care Facilities, Hypoglycemia, Diabetes Mellitus, Type 2, Italy, Patient Education as Topic, Surveys and Questionnaires, Quality of Life, Humans, Hypoglycemic Agents, Insulin, Regression Analysis, Female, Family Practice
Abstract: The role of self-monitoring of blood glucose (SMBG) in type 2 diabetes is still a matter of debate. In the framework of a nationwide outcomes research program, we investigated the frequency of SMBG and its association with metabolic control and quality of life (QoL).The study involved 3,567 patients with type 2 diabetes who were recruited by 101 outpatient diabetes clinics and 103 general practitioners. Patients completed a questionnaire investigating SMBG practice and QoL (diabetes-related stress, diabetes health distress, diabetes-related worries, and Centers for Epidemiologic Studies-Depression scale).Data on SMBG were available for 2,855 subjects (80% of the entire study population). Overall, 471 patients (17%) stated that they tested their blood glucose levels at homeor =1 time per day, 899 patients (31%) tested their blood glucose levelsor =1 time per week, and 414 patients (14%) tested their blood glucose levels1 time per week, whereas 1,071 patients (38%) stated that they never practiced SMBG. A higher frequency of SMBG was associated with better metabolic control among subjects who were able to adjust insulin doses, whereas no relationship was found in all other patients, irrespective of the kind of treatment. Multivariate analyses showed that an SMBG frequencyor =1 time per day was significantly related to higher levels of distress, worries, and depressive symptoms in non-insulin-treated patients.Our findings suggest that SMBG can have an important role in improving metabolic control if it is an integral part of a wider educational strategy devoted to the promotion of patient autonomy. In patients not treated with insulin, self-monitoring is associated with higher HbA(1c) levels and psychological burden. Our data do not support the extension of SMBG to this group.
Published: 2001

11. The relationship between physicians' self-reported target fasting blood glucose levels and metabolic control in type 2 diabetes. The QuED Study Group--quality of care and outcomes in type 2 diabetes

Author: M, Belfiglio, G, De Berardis, M, Franciosi, D, Cavaliere, B, Di Nardo, S, Greenfield, S H, Kaplan, F, Pellegrini, M, Sacco, G, Tognoni, M, Valentini, A, Nicolucci, V, Caimi, F, Capani, A, Corsi, R, Della Vedova, M, Massi Benedetti, C, Taboga, M, Tombesi, and G, Vespasiani
Subjects: Blood Glucose, Glycated Hemoglobin, Male, Quality Assurance, Health Care, Fasting, Middle Aged, Body Mass Index, Diabetes Mellitus, Type 2, Italy, Physicians, Surveys and Questionnaires, Humans, Female, Delivery of Health Care, Aged
Abstract: To investigate the relationship between beliefs of physicians relative to intensive metabolic control in type 2 diabetes and levels of HbA1c obtained in a sample of their patients.Physicians' beliefs were investigated through a questionnaire sent to a sample of self-selected clinicians participating in a nationwide initiative aimed at assessing the relationship between the quality of care delivered to patients with type 2 diabetes and their outcomes. At the same time, physicians were asked to collect clinical data on a random sample of their patients, stratified by age (65 vs.or = 65 years). Mean HbA1c levels in the study population were thus evaluated according to target fasting blood glucose (FBG) used by their physicians.Of 456 physicians, 342 (75%) returned the questionnaire. Among the responders, 200 diabetologists and 99 general practitioners (GPs) recruited 3,297 patients; 2,003 of whom were always followed by the same physician and 1,294 of whom were seen by different physicians in the same structure on different occasions. Only 14% of the respondents used target FBG levelsor = 6.1 mmol/l, whereas 38% pursued values7.8 mmol/l, with no statistically significant difference between diabetologists and GPs. The analysis of the relationship between FBG targets and metabolic control, restricted to those patients always seen by the same physician, showed a strong linear association, with mean HbA1c values of 7.0 +/- 1.6 for patients in the charge of physicians pursuing FBG levelsor = 6.1 mmol/l and 7.8 +/- 1.8 for those followed by physicians who used target values7.8 mmol/l. After adjusting for patients' and physicians' characteristics, the risk of having HbA1c values7.0% was highly correlated with physicians' beliefs. Patients followed by different physicians in the same unit showed a risk of inadequate metabolic control similar to that of patients followed by physicians adopting a nonaggressive policy.Doctors adopt extremely heterogeneous target FBG levels in patients with type 2 diabetes, which in turn represent an important independent predictor of metabolic control. To improve patient outcomes, physicians-centered educational activities aimed at increasing the awareness of the potential benefits of a tight metabolic control in patients with type 2 diabetes are urgently needed.
Published: 2001

12. Alternative Site Blood Glucose Testing: A Multicenter Study.

Author: D. Fedele, A. Corsi, C. Noacco, F. Prisco, S. Squatrito, E. Torre, D. Iafusco, M. K. Errico, R. Toniato, A. Nicolucci, M. Franciosi, G. De Berardis, and L. Neri
Published: 2003

13. Efficacy, safety and acceptability of the new pen needle 34G × 3.5 mm: a crossover randomized non-inferiority trial; AGO 02 study.

Author: De Berardis G, Scardapane M, Lucisano G, Abbruzzese S, Bossi AC, Cipponeri E, D'Angelo P, Fontana L, Lancione R, Marelli G, Sciangula L, and Nicolucci A
Subjects: Adult, Aged, Blood Glucose analysis, Female, Humans, Hypoglycemic Agents administration & dosage, Male, Middle Aged, Patient Compliance, Patient Preference, Treatment Outcome, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 1 psychology, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 psychology, Injections instrumentation, Insulin administration & dosage, Needles, Quality of Life, Syringes
Abstract: Objective: Insulin injection aspects, such as fear of injection and pain, directly affect glycemic control, patient adherence and quality of life. Use of thinner and shorter needles could increase acceptance of injections. The aim of the study is to evaluate the non-inferiority of the new 34G × 3.5 mm needle compared to a 32G × 4 mm in patients with diabetes treated with insulin., Methods: This is an open, randomized, two-period crossover, non-inferiority trial. Every treatment period lasted 3 weeks. Patients with type 1 or type 2 diabetes, treated with multiple daily insulin injections, were randomly assigned to receive a 34G × 3.5 mm or a 32G × 4 mm pen needle. The primary endpoint was the non-inferiority of the 34G × 3.5 mm in comparison with the 32G × 4 mm pen needle in terms of percentage absolute change of blood fructosamine (% |ΔFru|), using a non-inferiority margin of 20%., Results: Overall 77 patients were randomized and 73 completed the study. Patients characteristics were: 52% male, 80.5% affected by type 1 diabetes, mean age 52 years (±14.6), mean BMI 24.5 kg/m 2 (±5.6), HbA1c 8% (±1.1) and baseline fructosamine level 350 µmol/l (±84). Mean fructosamine levels increased by 0.56 µmol/l with the 34G needle, while a reduction of 7.29 μmol/l was documented with the 32G needle. The difference between the two groups (7.84 μmol/l) was not statistically significant (p = .27). The % |ΔFru| between the two groups was 7.55% (95% CI 5.67-9.44), meeting the non-inferiority criterion. Glycemic variability, expressed as standard deviation of fasting blood glucose and post-prandial glucose, was not different between the two treatment groups (p = .63 and p = .77, respectively)., Conclusions: The 34G × 3.5 mm needle was non-inferior to the 32G × 4 mm needle regarding fructosamine levels and glycemic variability supporting the suitability of the 34G × 3.5 mm needle for insulin injection in patients with diabetes., Clinical Trial Registration: NCT02690467.
Published: 2018
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14. Treatment with insulin is associated with worse outcome in patients with chronic heart failure and diabetes.

Author: Cosmi F, Shen L, Magnoli M, Abraham WT, Anand IS, Cleland JG, Cohn JN, Cosmi D, De Berardis G, Dickstein K, Franzosi MG, Gullestad L, Jhund PS, Kjekshus J, Køber L, Lepore V, Lucisano G, Maggioni AP, Masson S, McMurray JJV, Nicolucci A, Petrarolo V, Robusto F, Staszewsky L, Tavazzi L, Teli R, Tognoni G, Wikstrand J, and Latini R
Subjects: Aged, Cause of Death trends, Comorbidity, Diabetes Mellitus, Type 2 epidemiology, Double-Blind Method, Female, Heart Failure diagnosis, Heart Failure physiopathology, Humans, Hypoglycemic Agents therapeutic use, Italy epidemiology, Male, Prognosis, Propensity Score, Risk Factors, Survival Rate trends, Diabetes Mellitus, Type 2 drug therapy, Heart Failure epidemiology, Insulin therapeutic use, Registries
Abstract: Aims: Up to one-third of patients with diabetes mellitus and heart failure (HF) are treated with insulin. As insulin causes sodium retention and hypoglycaemia, its use might be associated with worse outcomes., Methods and Results: We examined two datasets: 24 012 patients with HF from four large randomized trials and an administrative database of 4 million individuals, 103 857 of whom with HF. In the former, survival was examined using Cox proportional hazards models adjusted for baseline variables and separately for propensity scores. Fine-Gray competing risk regression models were used to assess the risk of hospitalization for HF. For the latter, a case-control nested within a population-based cohort study was conducted with propensity score. Prevalence of diabetes mellitus at study entry ranged from 25.5% to 29.5% across trials. Insulin alone or in combination with oral hypoglycaemic drugs was prescribed at randomization to 24.4% to 34.5% of the patients with diabetes. The rates of death from any cause and hospitalization for HF were higher in patients with vs. without diabetes, and highest of all in patients prescribed insulin [propensity score pooled hazard ratio for all-cause mortality 1.27 (1.16-1.38), for HF hospitalization 1.23 (1.13-1.33)]. In the administrative registry, insulin prescription was associated with a higher risk of all-cause death [odds ratio (OR) 2.02, 95% confidence interval (CI) 1.87-2.19] and rehospitalization for HF (OR 1.42, 95% CI 1.32-1.53)., Conclusions: Whether insulin use is associated with poor outcomes in HF should be investigated further with controlled trials, as should the possibility that there may be safer alternative glucose-lowering treatments for patients with HF and type 2 diabetes mellitus., (© 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.)
Published: 2018
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15. Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in Patients With Type 2 Diabetes: A Meta-analysis.

Author: Palmer SC, Mavridis D, Nicolucci A, Johnson DW, Tonelli M, Craig JC, Maggo J, Gray V, De Berardis G, Ruospo M, Natale P, Saglimbene V, Badve SV, Cho Y, Nadeau-Fredette AC, Burke M, Faruque L, Lloyd A, Ahmad N, Liu Y, Tiv S, Wiebe N, and Strippoli GF
Subjects: Cause of Death, Drug Therapy, Combination, Glycated Hemoglobin, Humans, Hypoglycemic Agents adverse effects, Insulin therapeutic use, Metformin therapeutic use, Randomized Controlled Trials as Topic, Risk, Treatment Failure, Cardiovascular Diseases epidemiology, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use
Abstract: Importance: Numerous glucose-lowering drugs are used to treat type 2 diabetes., Objective: To estimate the relative efficacy and safety associated with glucose-lowering drugs including insulin., Data Sources: Cochrane Library Central Register of Controlled Trials, MEDLINE, and EMBASE databases through March 21, 2016., Study Selection: Randomized clinical trials of 24 weeks' or longer duration., Data Extraction and Synthesis: Random-effects network meta-analysis., Main Outcomes and Measures: The primary outcome was cardiovascular mortality. Secondary outcomes included all-cause mortality, serious adverse events, myocardial infarction, stroke, hemoglobin A1c (HbA1C) level, treatment failure (rescue treatment or lack of efficacy), hypoglycemia, and body weight., Results: A total of 301 clinical trials (1,417,367 patient-months) were included; 177 trials (56,598 patients) of drugs given as monotherapy; 109 trials (53,030 patients) of drugs added to metformin (dual therapy); and 29 trials (10,598 patients) of drugs added to metformin and sulfonylurea (triple therapy). There were no significant differences in associations between any drug class as monotherapy, dual therapy, or triple therapy with odds of cardiovascular or all-cause mortality. Compared with metformin, sulfonylurea (standardized mean difference [SMD], 0.18 [95% CI, 0.01 to 0.34]), thiazolidinedione (SMD, 0.16 [95% CI, 0.00 to 0.31]), DPP-4 inhibitor (SMD, 0.33 [95% CI, 0.13 to 0.52]), and α-glucosidase inhibitor (SMD, 0.35 [95% CI, 0.12 to 0.58]) monotherapy were associated with higher HbA1C levels. Sulfonylurea (odds ratio [OR], 3.13 [95% CI, 2.39 to 4.12]; risk difference [RD], 10% [95% CI, 7% to 13%]) and basal insulin (OR, 17.9 [95% CI, 1.97 to 162]; RD, 10% [95% CI, 0.08% to 20%]) were associated with greatest odds of hypoglycemia. When added to metformin, drugs were associated with similar HbA1C levels, while SGLT-2 inhibitors offered the lowest odds of hypoglycemia (OR, 0.12 [95% CI, 0.08 to 0.18]; RD, -22% [-27% to -18%]). When added to metformin and sulfonylurea, GLP-1 receptor agonists were associated with the lowest odds of hypoglycemia (OR, 0.60 [95% CI, 0.39 to 0.94]; RD, -10% [95% CI, -18% to -2%])., Conclusions and Relevance: Among adults with type 2 diabetes, there were no significant differences in the associations between any of 9 available classes of glucose-lowering drugs (alone or in combination) and the risk of cardiovascular or all-cause mortality. Metformin was associated with lower or no significant difference in HbA1C levels compared with any other drug classes. All drugs were estimated to be effective when added to metformin. These findings are consistent with American Diabetes Association recommendations for using metformin monotherapy as initial treatment for patients with type 2 diabetes and selection of additional therapies based on patient-specific considerations.
Published: 2016
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16. [Not Available].

Author: De Berardis G and Nicolucci A
Subjects: Humans, Algorithms, Diabetes Mellitus, Type 2 therapy, Precision Medicine
Published: 2016
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17. The Drug Derived Complexity Index (DDCI) Predicts Mortality, Unplanned Hospitalization and Hospital Readmissions at the Population Level.

Author: Robusto F, Lepore V, D'Ettorre A, Lucisano G, De Berardis G, Bisceglia L, Tognoni G, and Nicolucci A
Subjects: Adult, Aged, Cohort Studies, Comorbidity, Databases, Factual, Female, Humans, Incidence, Italy, Kaplan-Meier Estimate, Male, Middle Aged, Mortality, Proportional Hazards Models, Registries, Risk Factors, Drug Prescriptions, Hospitalization, Models, Statistical, Patient Readmission, Population Surveillance
Abstract: Objective: to develop and validate the Drug Derived Complexity Index (DDCI), a predictive model derived from drug prescriptions able to stratify the general population according to the risk of death, unplanned hospital admission, and readmission, and to compare the new predictive index with the Charlson Comorbidity Index (CCI)., Design: Population-based cohort study, using a record-linkage analysis of prescription databases, hospital discharge records, and the civil registry. The predictive model was developed based on prescription patterns indicative of chronic diseases, using a random sample of 50% of the population. Multivariate Cox proportional hazards regression was used to assess weights of different prescription patterns and drug classes. The predictive properties of the DDCI were confirmed in the validation cohort, represented by the other half of the population. The performance of DDCI was compared to the CCI in terms of calibration, discrimination and reclassification., Setting: 6 local health authorities with 2.0 million citizens aged 40 years or above., Results: One year and overall mortality rates, unplanned hospitalization rates and hospital readmission rates progressively increased with increasing DDCI score. In the overall population, the model including age, gender and DDCI showed a high performance. DDCI predicted 1-year mortality, overall mortality and unplanned hospitalization with an accuracy of 0.851, 0.835, and 0.584, respectively. If compared to CCI, DDCI showed discrimination and reclassification properties very similar to the CCI, and improved prediction when used in combination with the CCI., Conclusions and Relevance: DDCI is a reliable prognostic index, able to stratify the entire population into homogeneous risk groups. DDCI can represent an useful tool for risk-adjustment, policy planning, and the identification of patients needing a focused approach in everyday practice.
Published: 2016
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18. Association of Drug Effects on Serum Parathyroid Hormone, Phosphorus, and Calcium Levels With Mortality in CKD: A Meta-analysis.

Author: Palmer SC, Teixeira-Pinto A, Saglimbene V, Craig JC, Macaskill P, Tonelli M, de Berardis G, Ruospo M, and Strippoli GF
Subjects: Biomarkers blood, Humans, Mortality trends, Renal Agents adverse effects, Renal Insufficiency, Chronic drug therapy, Treatment Outcome, Calcium blood, Parathyroid Hormone blood, Phosphorus blood, Renal Insufficiency, Chronic blood, Renal Insufficiency, Chronic mortality
Abstract: Background: Serum parathyroid hormone (PTH), phosphorus, and calcium levels are surrogate outcomes that are central to the evaluation of drug treatments in chronic kidney disease (CKD). This systematic review evaluates the evidence for the correlation between drug effects on biochemical (PTH, phosphorus, and calcium) and all-cause and cardiovascular mortality end points in adults with CKD., Study Design: Systematic review and meta-analysis., Setting & Population: Adults with CKD., Selection Criteria for Studies: Randomized trials reporting drug effects on biochemical and mortality end points., Intervention: Drug interventions with effects on serum PTH, phosphorus, and calcium levels, including vitamin D compounds, phosphate binders, cinacalcet, bisphosphonates, and calcitonin., Outcomes: Correlation between drug effects on biochemical and all-cause and cardiovascular mortality., Results: 28 studies (6,999 participants) reported both biochemical and mortality outcomes and were eligible for analysis. Associations between drug effects on surrogate biochemical end points and corresponding effects on mortality were weak and imprecise. All correlation coefficients were less than 0.70, and 95% credible intervals were generally wide and overlapped with zero, consistent with the possibility of no association. The exception was an inverse correlation between drug effects on serum PTH levels and all-cause mortality, which was nominally significant (-0.64; 95% credible interval, -0.85 to -0.15), but the strength of this association was very imprecise. Risk of bias within available trials was generally high, further reducing confidence in the summary correlations. Findings were robust to adjustment for age, baseline serum PTH level, allocation concealment, CKD stage, and drug class., Limitations: Low power in analyses and combining evidence from many different drug comparisons with incomplete data across studies., Conclusions: Drug effects on serum PTH, phosphorus, and calcium levels are weakly and imprecisely correlated with all-cause and cardiovascular death in the setting of CKD. Risks of mortality (patient-level outcome) cannot be inferred from treatment-induced changes in biochemical outcomes in people with CKD. Similarly, existing data do not exclude a mortality benefit with treatment. Trials need to address patient-centered outcomes to evaluate drug effectiveness in this setting., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)
Published: 2015
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19. The long-term effects of stillbirth on women with and without gestational diabetes: a population-based cohort study.

Author: Pintaudi B, Lucisano G, Pellegrini F, D'Ettorre A, Lepore V, De Berardis G, Scardapane M, Di Vieste G, Rossi MC, Sacco M, Tognoni G, and Nicolucci A
Subjects: Adult, Cardiovascular Diseases therapy, Case-Control Studies, Cohort Studies, Female, Follow-Up Studies, Hospitalization statistics & numerical data, Humans, Infant, Newborn, Pregnancy, Time Factors, Cardiovascular Diseases epidemiology, Diabetes Mellitus, Type 2 epidemiology, Diabetes, Gestational epidemiology, Stillbirth epidemiology
Abstract: Aims/hypothesis: The aim of this study was to estimate the incidence of type 2 diabetes (primary objective) and hospitalisation for cardiovascular events (secondary objective) in women with previous gestational diabetes mellitus (GDM) and in those with normal glucose tolerance (NGT) in pregnancy, and to evaluate the role of stillbirth in differentiating the risks., Methods: This was a population-based cohort study using administrative data and involving 12 local health authorities. Women with GDM (n = 3,851) during the index period from 2002 to 2010 were propensity matched with women with NGT (n = 11,553). Information was collected on type 2 diabetes development and hospitalisation for cardiovascular events., Results: During a median follow-up of 5.4 years, the incidence rate per 1,000 person-years of type 2 diabetes was 2.1 (95% CI 1.8, 2.5) in women without GDM and 54.0 (95% CI 50.2, 58.0) among women with GDM and pregnancy at term (incidence rate ratio [IRR] 26.9; 95% CI 22.1, 32.7 compared with NGT and pregnancy at term). A history of stillbirth increased the risk of type 2 diabetes development by about twofold, irrespective of GDM status. No significant interaction between stillbirth and GDM on type 2 diabetes risk was found. GDM was associated with a significantly higher risk of cardiovascular events compared with NGT (IRR 2.4; 95% CI 1.5, 3.8)., Conclusions/interpretation: Pregnancy complicated by GDM and ending in stillbirth represents an important contributory factor in determining type 2 diabetes development. Women with GDM are at a high risk of future cardiovascular events. Women with pregnancy complicated by GDM and stillbirth deserve careful follow-up.
Published: 2015
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20. Patient satisfaction with in-centre haemodialysis care: an international survey.

Author: Palmer SC, de Berardis G, Craig JC, Tong A, Tonelli M, Pellegrini F, Ruospo M, Hegbrant J, Wollheim C, Celia E, Gelfman R, Ferrari JN, Törok M, Murgo M, Leal M, Bednarek-Skublewska A, Dulawa J, and Strippoli GF
Subjects: Adolescent, Adult, Aged, Cross-Sectional Studies, Female, Hemodialysis Units, Hospital, Humans, Internationality, Male, Middle Aged, Surveys and Questionnaires, Young Adult, Kidney Failure, Chronic therapy, Patient Satisfaction, Renal Dialysis
Abstract: Objectives: To evaluate patient experiences of specific aspects of haemodialysis care across several countries., Design: Cross-sectional survey using the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) questionnaire., Setting: Haemodialysis clinics within a single provider in Europe and South America., Participants: 2748 adults treated in haemodialysis., Primary and Secondary Outcomes: The primary outcome was patient satisfaction with overall care. Secondary outcomes included patient experiences of individual aspects of dialysis care., Results: 2145 (78.1%) adults responded to the questionnaire. Fewer than half (46.5% (95% CI 44.5% to 48.6%)) rated their overall care as excellent. Global perceptions of care were uninfluenced by most respondent characteristics except age and depressive symptoms; older respondents were less critical of their care (adjusted OR for excellent rating 1.44 (1.01 to 2.04)) and those with depressive symptoms were less satisfied (0.56 (0.44 to 0.71)). Aspects of care that respondents most frequently ranked as excellent were staff attention to dialysis vascular access (54% (52% to 56%)); caring of nurses (53% (51% to 55%)); staff responsiveness to pain or discomfort (51% (49% to 53%)); caring, helpfulness and sensitivity of dialysis staff (50% (48% to 52%)); and ease of reaching dialysis staff by telephone (48% (46% to 50%)). The aspects of care least frequently ranked as excellent were information provided when choosing a dialysis modality (23% (21% to 25%)), ease of seeing a social worker (28% (24% to 32%)), information provided about dialysis (34% (32% to 36%)), accuracy of information from nephrologist (eg, about prognosis or likelihood of a kidney transplant; 37% (35% to 39%)) and accuracy of nephrologists' instructions (39% (36% to 41%))., Conclusions: Haemodialysis patients are least satisfied with the complex aspects of care. Patients' expectations for accurate information, prognosis, the likelihood of kidney transplantation and their options when choosing dialysis treatment need to be considered when planning healthcare research and practices., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)
Published: 2014
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21. Effect of pioglitazone versus metformin on cardiovascular risk markers in type 2 diabetes.

Author: Genovese S, De Berardis G, Nicolucci A, Mannucci E, Evangelista V, Totani L, Pellegrini F, and Ceriello A
Subjects: Aged, Biomarkers metabolism, Cardiovascular Diseases etiology, Cardiovascular Diseases metabolism, Cell Adhesion Molecules metabolism, Diabetes Mellitus, Type 2 complications, Double-Blind Method, Female, Humans, Inflammation metabolism, Male, Middle Aged, Oxidative Stress, Pioglitazone, Platelet Activation, Treatment Outcome, C-Reactive Protein metabolism, Cardiovascular Diseases prevention & control, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use, Metformin therapeutic use, Thiazolidinediones therapeutic use
Abstract: Introduction: Besides its critical role in metabolic homeostasis, peroxisome proliferator-activated receptor (PPAR)-γ modulates several cellular responses involved in atherothrombosis. This multicenter, double-blind, randomized study investigated the effects of two oral hypoglycemic agents on markers of inflammation, platelet activation, thrombogenesis, and oxidative stress in patients with type 2 diabetes., Methods and Results: The primary objective of this study was to evaluate the effect on C-reactive protein (CRP) after a 16-week treatment period with either pioglitazone or metformin. Additionally, markers of vascular inflammatory response, platelet activation, thrombogenesis, oxidative stress, glucose, and lipid metabolism, as well as liver function, were measured. In total, 50 patients completed the study. Pioglitazone-treated patients were found to have statistically significantly larger decreases in mean CRP levels (-0.4 mg/dL) compared to those treated with metformin (-0.2 mg/dL) (P=0.04), as well as greater reductions in levels of mean fasting plasma glucose (-27 vs. -9 mg/dL; P=0.01), serum insulin (-2 vs. -1.9 mU/L; P=0.014), homeostatic model assessment (HOMA) (-1.2 vs. -0.9; P=0.015), and E-selectin (-12.4 vs. +3.4 μg/mL; P=0.01). Mean glycated hemoglobin (HbA1c) levels decreased in both treatment groups from baseline to week 16 (-0.4% in the pioglitazone group, -0.2% in the metformin group; P=0.36). Pioglitazone treatment was also found to be associated with a statistically significant increase in total cholesterol levels (+10 mg/dL in the pioglitazone arm, -3 mg/dL in the metformin arm; P=0.05) and a decrease in liver enzyme levels., Conclusions: The favorable changes in markers of systemic and vascular inflammatory response with pioglitazone suggest that it may positively influence the atherothrombotic process in type 2 diabetes.
Published: 2013
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22. The burden of hospitalization related to diabetes mellitus: a population-based study.

Author: De Berardis G, D'Ettorre A, Graziano G, Lucisano G, Pellegrini F, Cammarota S, Citarella A, Germinario CA, Lepore V, Menditto E, Nicolosi A, Vitullo F, and Nicolucci A
Subjects: Adolescent, Adult, Aged, Benzamides therapeutic use, Female, Hospitalization, Humans, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Italy epidemiology, Male, Metformin therapeutic use, Middle Aged, Odds Ratio, Prevalence, Thiazolidinediones therapeutic use, Treatment Outcome, Young Adult, Cost of Illness, Diabetes Mellitus drug therapy, Diabetes Mellitus epidemiology
Abstract: Background and Aims: To estimate the impact of diabetes and its complications, overall and in different age classes, on the likelihood of hospital admission for specific causes., Methods and Results: We carried out a record-linkage analysis of administrative registers including data on 8,940,420 citizens in 21 Local Health Authorities in Italy. Individuals with pharmacologically treated diabetes (≥2 prescriptions of antidiabetic agents during the year 2008) were paired in a 1:1 proportion with those who did not receive such drugs (controls) based on propensity-score matching. Odds Ratios (ORs) of hospitalization for macro and microvascular conditions in individuals with diabetes as compared to controls were estimated. The system identified 498,825 individuals with diabetes pharmacologically treated (prevalence of 5.6%). Prevalence of diabetes in people aged <14 years, 14-39 years, 40-65 years, and ≥65 years was 0.1%, 0.6%, 6.4%, and 18.2%, respectively. Overall, 23.9% of subjects with diabetes and 11.5% of controls had had at least a hospital admission during 12 months for the causes considered. Diabetes increased the likelihood of hospitalization by two to six times for the different causes examined. In absolute terms, diabetes was responsible for an excess of over 12,000 hospital admissions per 100,000 individuals/year., Conclusion: Despite the availability of effective treatments to prevent or delay major complications, diabetes still places an enormous burden on both patients and the health care system. Given the continuous rise in diabetes prevalence both in middle-aged and elderly individuals, we can expect an additional, hardly sustainable increase in the demand for health care in the near future., (Copyright © 2010 Elsevier B.V. All rights reserved.)
Published: 2012
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23. Association of aspirin use with major bleeding in patients with and without diabetes.

Author: De Berardis G, Lucisano G, D'Ettorre A, Pellegrini F, Lepore V, Tognoni G, and Nicolucci A
Subjects: Adult, Aged, Aged, 80 and over, Aspirin therapeutic use, Cardiovascular Diseases prevention & control, Case-Control Studies, Cohort Studies, Female, Gastrointestinal Hemorrhage epidemiology, Humans, Incidence, Intracranial Hemorrhages epidemiology, Italy epidemiology, Male, Middle Aged, Platelet Aggregation Inhibitors therapeutic use, Risk, Aspirin adverse effects, Diabetes Mellitus, Gastrointestinal Hemorrhage chemically induced, Intracranial Hemorrhages chemically induced, Platelet Aggregation Inhibitors adverse effects
Abstract: Context: The benefit of aspirin for the primary prevention of cardiovascular events is relatively small for individuals with and without diabetes. This benefit could easily be offset by the risk of hemorrhage., Objective: To determine the incidence of major gastrointestinal and intracranial bleeding episodes in individuals with and without diabetes taking aspirin., Design, Setting, and Participants: A population-based cohort study, using administrative data from 4.1 million citizens in 12 local health authorities in Puglia, Italy. Individuals with new prescriptions for low-dose aspirin (≤300 mg) were identified during the index period from January 1, 2003, to December 31, 2008, and were propensity-matched on a 1-to-1 basis with individuals who did not take aspirin during this period., Main Outcome Measures: Hospitalizations for major gastrointestinal bleeding or cerebral hemorrhage occurring after the initiation of antiplatelet therapy., Results: There were 186,425 individuals being treated with low-dose aspirin and 186,425 matched controls without aspirin use. During a median follow-up of 5.7 years, the overall incidence rate of hemorrhagic events was 5.58 (95% CI, 5.39-5.77) per 1000 person-years for aspirin users and 3.60 (95% CI, 3.48-3.72) per 1000 person-years for those without aspirin use (incidence rate ratio [IRR], 1.55; 95% CI, 1.48-1.63). The use of aspirin was associated with a greater risk of major bleeding in most of the subgroups investigated but not in individuals with diabetes (IRR, 1.09; 95% CI, 0.97-1.22). Irrespective of aspirin use, diabetes was independently associated with an increased risk of major bleeding episodes (IRR, 1.36; 95% CI, 1.28-1.44)., Conclusions: In a population-based cohort, aspirin use was significantly associated with an increased risk of major gastrointestinal or cerebral bleeding episodes. Patients with diabetes had a high rate of bleeding that was not independently associated with aspirin use.
Published: 2012
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24. Sexual dysfunction in women with ESRD requiring hemodialysis.

Author: Strippoli GF, Vecchio M, Palmer S, De Berardis G, Craig J, Lucisano G, Johnson D, Pellegrini F, Nicolucci A, Sciancalepore M, Saglimbene V, Gargano L, Bonifati C, Ruospo M, Navaneethan SD, Montinaro V, Stroumza P, Zsom M, Torok M, Celia E, Gelfman R, Bednarek-Skublewska A, Dulawa J, Graziano G, Gentile G, Ferrari JN, Santoro A, Zucchelli A, Triolo G, Maffei S, Hegbrant J, Wollheim C, De Cosmo S, and Manfreda VM
Subjects: Adult, Aged, Chi-Square Distribution, Cross-Sectional Studies, Europe epidemiology, Female, Humans, Kidney Failure, Chronic epidemiology, Logistic Models, Middle Aged, Multivariate Analysis, Odds Ratio, Prevalence, Risk Assessment, Risk Factors, Sexual Dysfunction, Physiological diagnosis, Sexual Dysfunctions, Psychological diagnosis, South America epidemiology, Surveys and Questionnaires, Treatment Outcome, Kidney Failure, Chronic therapy, Renal Dialysis adverse effects, Sexual Dysfunction, Physiological epidemiology, Sexual Dysfunctions, Psychological epidemiology
Abstract: Background and Objectives: The few existing studies of sexual dysfunction in women on hemodialysis are limited by small sample size. This large, cross-sectional study evaluated the prevalence and correlates of female sexual dysfunction in advanced kidney disease. DESIGN, SETTING, PARTICIPANTS, METHODS: A total of 1472 women with ESRD undergoing hemodialysis were recruited to a multinational, cross-sectional study conducted within a collaborative dialysis network in Europe and South America. Sexual dysfunction was identified by the Female Sexual Function Index. Correlates of self-reported sexual dysfunction were identified by regression analyses., Results: Of the 1472 women, 659 completed questionnaires (45%). More than half (362 of 659 [55%]) lived with a partner, and 232 of 659 (35%) reported being sexually active. Of these 659 respondents, 555 (84%) reported sexual dysfunction. Women with a partner (282 of 362 [78%]) were less likely to report sexual dysfunction than those without a partner (273 of 297 [92%]) (P<0.001). Sexual dysfunction was independently associated with age, depressive symptoms, less education, menopause, diabetes, and diuretic therapy. Nearly all women who were not wait-listed for a kidney transplant and were living without a partner (249 of 260 [96%]) reported sexual dysfunction. More than half (128 of 232 [55%]) of sexually active women reported sexual dysfunction, associated with age, depressive symptoms, menopause, low serum albumin, and diuretic therapy., Conclusions: This descriptive study suggests most women on hemodialysis experience sexual problems. Additional research on the relevance of sexual dysfunction to symptom burden and quality of life in these women is needed.
Published: 2012
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25. Prevalence and correlates of erectile dysfunction in men on chronic haemodialysis: a multinational cross-sectional study.

Author: Vecchio M, Palmer S, De Berardis G, Craig J, Johnson D, Pellegrini F, Nicolucci A, Sciancalepore M, Saglimbene V, Gargano L, Bonifati C, Ruospo M, Navaneethan SD, Montinaro V, Stroumza P, Zsom M, Torok M, Celia E, Gelfman R, Bednarek-Skublewska A, Dulawa J, Graziano G, Lucisano G, Gentile G, Ferrari JN, Santoro A, Zucchelli A, Triolo G, Maffei S, Hegbrant J, Wollheim C, De Cosmo S, Manfreda VM, and Strippoli GF
Subjects: Aged, Cross-Sectional Studies, Follow-Up Studies, Humans, International Agencies, Male, Middle Aged, Prevalence, Prognosis, Risk Factors, Surveys and Questionnaires, Erectile Dysfunction epidemiology, Erectile Dysfunction etiology, Renal Dialysis adverse effects
Abstract: Background: Factors associated with erectile dysfunction in men on haemodialysis are incompletely identified due to suboptimal existing studies. We determined the prevalence and correlates of erectile dysfunction and identified combinations of clinical characteristics associated with a higher risk of erectile dysfunction using recursive partitioning and amalgamation (REPCAM) analysis., Methods: We conducted a multinational cross-sectional study in men on haemodialysis within a collaborative network. Erectile dysfunction and depressive symptoms were evaluated using the erectile function domain of the International Index of Erectile Function questionnaire and the Center for Epidemiological Studies-Depression Scale, respectively., Results: Nine hundred and forty-six (59%) of 1611 eligible men provided complete data for erectile dysfunction. Eighty-three per cent reported erectile dysfunction and 47% reported severe erectile dysfunction. Four per cent of those with erectile dysfunction were receiving pharmacological treatment. Depressive symptoms were the strongest correlate of erectile dysfunction [adjusted odds ratio 2.41 (95% confidence interval (CI) 1.57-3.71)]. Erectile dysfunction was also associated with age (1.06, 1.05-1.08), being unemployed (1.80, 1.17-2.79) or receiving a pension (2.05, 1.14-3.69) and interdialytic weight gain (1.9-2.87 kg, 1.92 [CI 1.19-3.09]; >2.87 kg, 1.57 [CI 1.00-2.45]). Married men had a lower risk of erectile dysfunction (0.49, 0.31-0.76). The prevalence of erectile dysfunction was highest (94%) in unmarried and unemployed or retired men who have depressive symptoms., Conclusions: Most men on haemodialysis experience erectile dysfunction and are untreated. Given the prevalence of this condition and the relative lack of efficacy data for pharmacological agents, we suggest that large trials of pharmacological and non-pharmacological interventions for erectile dysfunction and depression are needed.
Published: 2012
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26. Comorbidity affects the relationship between glycemic control and cardiovascular outcomes in diabetes: a cohort study.

Author: Greenfield S, Billimek J, Pellegrini F, Franciosi M, De Berardis G, Nicolucci A, and Kaplan SH
Subjects: Age Factors, Age of Onset, Aged, Comorbidity, Cost of Illness, Female, Humans, Longitudinal Studies, Male, Middle Aged, Risk Factors, Blood Glucose metabolism, Cardiovascular Diseases epidemiology, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 drug therapy, Diabetic Angiopathies epidemiology, Glycated Hemoglobin metabolism
Abstract: Background: Recent studies have shown mixed results regarding the effectiveness of intensive glucose-lowering therapy in reducing risk for cardiovascular events., Objective: To determine whether attaining hemoglobin A(1c) (HbA(1c)) targets of 6.5% or less or 7.0% or less for glycemic control at baseline provides differential benefits for patients with high versus low-to-moderate levels of comorbidity., Design: 5-year longitudinal observational study of patients with type 2 diabetes. Patients were categorized into high and low-to-moderate comorbidity subgroups by using the Total Illness Burden Index (TIBI), a validated patient-reported measure of comorbidity., Setting: 101 diabetes outpatient clinics and 103 general practitioners' clinics in Italy., Patients: 2613 (83%) of 3074 patients with type 2 diabetes, sampled randomly from diabetes outpatient clinic rosters and recruited consecutively from general practitioners' clinics, who completed the baseline questionnaire., Measurements: TIBI score, total mortality, and incident cardiovascular events. Hazard ratios (HRs) were adjusted for age and sex., Results: Attaining an HbA(1c) level of 6.5% or less at baseline was associated with lower 5-year incidence of cardiovascular events in the low-to-moderate comorbidity subgroup (adjusted HR, 0.60 [95% CI, 0.42 to 0.85]; P = 0.005) but not in the high comorbidity subgroup (adjusted HR, 0.92 [CI, 0.68 to 1.25]; P = 0.61; P for subgroup by HbA(1c) interaction = 0.048). Similarly, attaining a baseline HbA(1c) level of 7.0% predicted fewer cardiovascular events in the low-to-moderate comorbidity subgroup (adjusted HR, 0.61 (CI, 0.44 to 0.83; P = 0.001) but not in the high comorbidity subgroup (adjusted HR, 0.88 [CI, 0.66 to 1.17]; P = 0.38; P for subgroup by HbA(1c) interaction = 0.093)., Limitations: The observational nature of the study does not allow causal inference. The length of the data collection period was limited. Information on clinical management was not available., Conclusion: Patients with the high levels of comorbidity common in type 2 diabetes may receive diminished cardiovascular benefit from intensive blood glucose control. Comorbidity should be considered when tailoring glucose-lowering therapy in patients with type 2 diabetes., Primary Funding Source: Pfizer of Italy.
Published: 2009
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27. Aspirin for primary prevention of cardiovascular events in people with diabetes: meta-analysis of randomised controlled trials.

Author: De Berardis G, Sacco M, Strippoli GF, Pellegrini F, Graziano G, Tognoni G, and Nicolucci A
Subjects: Aspirin adverse effects, Cardiovascular Agents adverse effects, Female, Humans, Male, Primary Prevention, Prognosis, Prospective Studies, Randomized Controlled Trials as Topic, Risk Factors, Aspirin administration & dosage, Cardiovascular Agents administration & dosage, Diabetic Angiopathies prevention & control
Abstract: Objective: To evaluate the benefits and harms of low dose aspirin in people with diabetes and no cardiovascular disease., Design: Meta-analysis of randomised controlled trials., Data Sources: Medline (1966-November 2008), the Cochrane central register of controlled trials (Cochrane Library 2008;issue 4), and reference lists of retrieved articles. Review methods Randomised trials of aspirin compared with placebo or no aspirin in people with diabetes and no pre-existing cardiovascular disease were eligible for inclusion. Data on major cardiovascular events (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, and all cause mortality) were extracted and pooled with a random effect model. Results are reported as relative risks with 95% confidence intervals., Results: Of 157 studies in the literature searches, six were eligible (10 117 participants). When aspirin was compared with placebo there was no statistically significant reduction in the risk of major cardiovascular events (five studies, 9584 participants; relative risk 0.90, 95% confidence interval 0.81 to 1.00), cardiovascular mortality (four studies, n=8557, 0.94; 0.72 to 1.23), or all cause mortality (four studies, n=8557; 0.93, 0.82 to 1.05). Significant heterogeneity was found in the analysis for myocardial infarction (I(2)=62.2%; P=0.02) and stroke (I(2)=52.5%; P=0.08). Aspirin significantly reduced the risk of myocardial infarction in men (0.57, 0.34 to 0.94) but not in women (1.08, 0.71 to 1.65; P for interaction=0.056). Evidence relating to harms was inconsistent., Conclusions: A clear benefit of aspirin in the primary prevention of major cardiovascular events in people with diabetes remains unproved. Sex may be an important effect modifier. Toxicity is to be explored further.
Published: 2009
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28. Management of erectile dysfunction in general practice.

Author: De Berardis G, Pellegrini F, Franciosi M, Pamparana F, Morelli P, Tognoni G, and Nicolucci A
Subjects: Carbolines therapeutic use, Cardiovascular Diseases epidemiology, Drug Prescriptions statistics & numerical data, Erectile Dysfunction epidemiology, Humans, Imidazoles therapeutic use, Male, Middle Aged, Phosphodiesterase Inhibitors therapeutic use, Piperazines therapeutic use, Practice Patterns, Physicians' statistics & numerical data, Purines therapeutic use, Sildenafil Citrate, Sulfones therapeutic use, Surveys and Questionnaires, Tadalafil, Triazines therapeutic use, Vardenafil Dihydrochloride, Attitude of Health Personnel, Erectile Dysfunction physiopathology, Erectile Dysfunction therapy, Physician-Patient Relations, Primary Health Care
Abstract: Introduction: In recent years, the availability of effective oral pharmacological treatment for erectile dysfunction (ED) has revolutionized its management; however, it is still unclear how everyday clinical practice has changed in response to this evolving scenario., Aim: The aim of this study is to describe general practitioners' (GPs) beliefs and attitudes toward the management of ED., Methods: Each GP was asked to recruit consecutive men aged >or=18 years and sexually active, with already known erectile problems or with newly diagnosed ED., Main Outcomes Measures: A written questionnaire was used to investigate GPs' sociodemographic characteristics and their beliefs toward the management of ED., Results: Overall, 127 GPs (53.4%) returned the questionnaire and 124 enrolled patients for the study. Only 9.5% of the GPs reported routinely inquiring about ED of patients >40 years of age, whereas 45.7% did it only when the patient raised the problem. GPs' gender and age were associated with their beliefs about ED treatment and referral to specialist care. Overall, 932 patients were enrolled, of whom 38% had newly diagnosed ED. The problem came to light for initiative of patient in 80% of cases, and 84.8% of men were prescribed a treatment. Patients who on their own initiative discussed of their condition had an almost 3-fold increased probability to be treated than those whose GP began the discussion about ED (odds ratio [OR] = 2.6, confidence interval [CI] 95% 1.5-4.5). Patients followed by female physicians were significantly more likely to be referred to a specialist than those followed by male physicians (OR = 3.3, CI 95% 1.4-5.0)., Conclusions: The management of ED has become an integral component of clinical practice in primary care. Nevertheless, barriers in addressing sexual issues still persist. Appropriate training is needed for a proactive approach to ED screening and management in men over 40s.
Published: 2009
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29. Glycated haemoglobin or mean blood glucose as indicators of metabolic control in Type 2 diabetes?

Author: Pupillo M, De Berardis G, Antenucci D, Minnucci A, and Nicolucci A
Subjects: Biomarkers blood, Blood Glucose metabolism, Fasting, Humans, Reference Values, Reproducibility of Results, Blood Glucose analysis, Diabetes Mellitus, Type 2 blood, Environmental Monitoring methods, Glycated Hemoglobin analysis
Abstract: The aim of the study was to assess whether HbA(1c) levels reflected mean blood glucose (MBG) levels in Type 2 diabetes. Despite the good correlation between HbA(1c) and MBG, one-third of the patients had consistently higher HbA(1c) or lower HbA(1c) levels than that expected under the hypothesis that HbA(1c) is solely determined by MBG, suggesting the existence of different haemoglobin glycation phenotypes. The use of HbA(1c) alone for glycemic control monitoring in these patients could be insufficient to clearly trace their risk of complications.
Published: 2008
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30. Quality of diabetes care predicts the development of cardiovascular events: results of the QuED study.

Author: De Berardis G, Pellegrini F, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Aged, Albuminuria etiology, Blood Pressure, Cardiovascular Diseases blood, Cardiovascular Diseases etiology, Cardiovascular Diseases physiopathology, Cholesterol, LDL blood, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 physiopathology, Female, Follow-Up Studies, Glycated Hemoglobin metabolism, Health Status Indicators, Humans, Incidence, Italy, Male, Middle Aged, Odds Ratio, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Cardiovascular Diseases prevention & control, Diabetes Mellitus, Type 2 drug therapy, Outcome and Process Assessment, Health Care, Quality of Health Care
Abstract: Background and Aim: In the context of the QuED Study we assessed whether a quality of care summary score was able to predict the development of cardiovascular (CV) events in patients with type 2 diabetes., Methods and Results: The score was calculated using process and intermediate outcome indicators (HbA1c), blood pressure, low-density lipoprotein cholesterol, microalbuminuria) and ranged from 0 to 40. Overall, 3235 patients were enrolled, of whom 492 developed a CV event after a median follow-up of 5 years. The incidence rate (per 1000 person-years) of CV events was 62.4 in patients with a score < or =10, 54.8 in those with a score between 15 and 20, and 39.8 in those with a score >20. In adjusted multilevel regression models, the risk to develop a CV event was 89% greater in patients with a score of < or =10 (rate ratio [RR]=1.89; 95% confidence interval [CI] 1.43-2.50) and 43% higher in those with a score between 10 and 20 (RR=1.43; 95% CI 1.14-1.79), as compared to those with a score >20. A difference between centers of 5 points in the mean quality score was associated with a difference of 16% in CV event risk (RR=0.84; 95% CI 0.72-0.98)., Conclusion: Our study documented for the first time a close relationship between a score of quality of diabetes care and long-term outcomes.
Published: 2008
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31. Persistent platelet activation in patients with type 2 diabetes treated with low doses of aspirin.

Author: Evangelista V, de Berardis G, Totani L, Avanzini F, Giorda CB, Brero L, Levantesi G, Marelli G, Pupillo M, Iacuitti G, Pozzoli G, di Summa P, Nada E, de Simone G, Dell'Elba G, Amore C, Manarini S, Pecce R, Maione A, Tognoni G, and Nicolucci A
Subjects: Aspirin therapeutic use, Biomarkers blood, Blood Glucose, Case-Control Studies, Diabetes Mellitus, Type 2 drug therapy, Glycemic Index, Humans, Inflammation, Thromboxane A2 antagonists & inhibitors, Aspirin pharmacology, Diabetes Mellitus, Type 2 blood, Platelet Activation drug effects
Abstract: Background: The percentage of diabetic patients who do not benefit from the protective effect of aspirin is larger than in other populations at cardiovascular risk., Objective: We compared the ability of aspirin to suppress TxA2 and platelet activation in vivo, in type-2 diabetics vs. high-risk non-diabetic patients., Methods: Urinary 11-dehydro-TXB2, plasma sCD40 L, and sP-selectin were measured, together with indices of low-grade inflammation, glycemic control, and lipid profile, in 82 patients with type-2 diabetes and 39 without diabetes, treated with low doses of aspirin., Results: Urinary 11-dehydro-TxB2, plasma sCD40L and sP-selectin were significantly higher in diabetics than in controls: [38.9 (27.8-63.3) vs. 28.5 (22.5-43.9) ng mmol(-1) of creatinine, P = 0.02], [1.06 (0.42-3.06) vs. 0.35 (0.22-0.95) ng mL(-1); P = 0.0001], [37.0 (16.8-85.6) vs. 20.0 (11.2-35.6) ng mL(-1), P = 0.0001], respectively. The proportion of individuals with diabetes increased across quartiles of 11-dehydro-TxB2, sCD40L, and sP-selectin, with the highest quartiles of 11-dehydro-TxB2, sCD40L and sP-selectin, including 66%, 93.3%, and 93.3% of individuals with diabetes. Markers of platelet activation positively correlated with indices of glycemic control but not with markers of low-grade inflammation., Conclusions: Platelet dysfunction associated with insufficient glycemic control, may mediate persistent platelet activation under aspirin treatment.
Published: 2007
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32. Identifying patients at risk for microalbuminuria via interaction of the components of the metabolic syndrome: a cross-sectional analytic study.

Author: Franciosi M, Pellegrini F, Sacco M, De Berardis G, Rossi MC, Strippoli GF, Belfiglio M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Aged, Albuminuria complications, Albuminuria epidemiology, Cross-Sectional Studies, Female, Humans, Male, Metabolic Syndrome complications, Metabolic Syndrome diagnosis, Middle Aged, Risk Factors, Albuminuria diagnosis
Abstract: Background and Objectives: The objective of this study was to investigate correlates of risk for having microalbuminuria in individuals with one or more cardiovascular risk factors., Design, Setting, Participants, & Measurements: The study involved 1919 individuals who attended general practice settings, were aged 55 to 75 yr, and did not have a history of cardiovascular events or diabetes but had one or more cardiovascular risk factors. A tree-based regression technique and multivariate analysis were used to identify distinct, homogeneous subgroups of patients with different likelihood of having microalbuminuria; interaction between correlates of microalbuminuria and risk for microalbuminuria was also investigated., Results: The prevalence of microalbuminuria was 5.9%. Patients who did not have hypertension and had postload glycemia < 140 mg/dl showed the lowest prevalence of microalbuminuria (1.9%) and represented the reference class. The likelihood of microalbuminuria was seven times higher in men with hypertension and homeostatic model assessment levels in the upper tertile and four times higher in women with the same characteristics. Individuals with hypertension and lower homeostatic model assessment levels and normotensive individuals with postload glycemia > or = 140 mg/dl had a more than three-fold increased likelihood of having microalbuminuria. Treatment with statins was associated with a 54% reduction in the likelihood of having microalbuminuria, whereas levels of triglycerides > 150 mg/dl and fibrinogen levels in the upper tertile were associated with a significantly higher risk for microalbuminuria., Conclusions: The likelihood of having microalbuminuria in a population-based study of elderly individuals is strongly related to the interaction between the components of the metabolic syndrome, particularly hypertension, insulin resistance, and impaired glucose tolerance.
Published: 2007
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33. Aspirin and Simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes (ACCEPT-D): design of a randomized study of the efficacy of low-dose aspirin in the prevention of cardiovascular events in subjects with diabetes mellitus treated with statins.

Author: De Berardis G, Sacco M, Evangelista V, Filippi A, Giorda CB, Tognoni G, Valentini U, and Nicolucci A
Abstract: Background: Despite the high cardiovascular risk, evidence of efficacy of preventive strategies in individuals with diabetes is scant. In particular, recommendations on the use of aspirin in patients with diabetes mostly reflect an extrapolation from data deriving from other high risk populations. Furthermore, the putative additive effects of aspirin and statins in diabetes remain to be investigated. This aspect is of particular interest in the light of the existing debate regarding the need of multiple interventions to reduce total cardiovascular risk, which has also led to the proposal of a polypill. Aim of the study is to evaluate the efficacy of aspirin in the primary prevention of major cardiovascular events in diabetic patients candidate for treatment with statins. These preventive strategies will be evaluated on the top of the other strategies aimed at optimizing the care of diabetic patients in terms of metabolic control and control of the other cardiovascular risk factors., Methods/design: The ACCEPT-D is an open-label trial assessing whether 100 mg/daily of aspirin prevent cardiovascular events in patients without clinically manifest vascular disease and treated with simvastatin (starting dose 20 mg/die). Eligible patients will be randomly assigned to receive aspirin + simvastatin or simvastatin alone., Eligibility Criteria: male and female individuals aged >=50 years with diagnosis of type 1 or type 2 diabetes, already on treatment with statins or candidate to start the treatment (LDL-cholesterol >=100 mg/dL persisting after 3 months of dietary advise). The primary combined end-point will include cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospital admission for cardiovascular causes (acute coronary syndrome, transient ischemic attack, not planned revascularization procedures, peripheral vascular disease). A total of 515 first events are needed to detect a reduction in the risk of major cardiovascular events of 25% (alpha = 0.05; 1-beta = 0.90). Overall, 5170 patients will be enrolled. The study will be conducted by diabetes specialists and general practitioners., Discussion: The study will provide important information regarding the preventive role of aspirin in diabetes when used on the top of the other strategies aimed to control cardiovascular risk factors., Trial Registration: Current Controlled Trials ISRCTN48110081.
Published: 2007
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34. AHA/ADA vs. ESC/EASD recommendations on aspirin as a primary prevention strategy in people with diabetes: how the same data generate divergent conclusions.

Author: Nicolucci A, De Berardis G, Sacco M, and Tognoni G
Subjects: Adult, Aged, Data Collection, Data Interpretation, Statistical, Europe, Humans, Middle Aged, Randomized Controlled Trials as Topic, Risk Factors, Societies, Medical, United States, Aspirin therapeutic use, Diabetic Angiopathies prevention & control, Platelet Aggregation Inhibitors therapeutic use, Practice Guidelines as Topic
Abstract: Recently, major scientific societies in Europe and USA have issued guidelines on diabetes and cardiovascular (CV) disease. The conclusions of the two panels of experts regarding the use of aspirin for the primary prevention of CV disease in individuals with diabetes are totally divergent. The US statement recommends the use of aspirin for primary prevention in all individuals aged > 40 or with additional risk factors. In contrast, in the European guidelines there is no mention of aspirin for the primary prevention of myocardial infarction or CV death, while it is recommended for the prevention of stroke. Both recommendations seem mainly based on extrapolations from data on other high-risk groups, rather than on a comprehensive review of pertinent data. Actually, a body of evidence suggests that the efficacy of aspirin in patients with diabetes is substantially lower than in individuals without diabetes. Nevertheless, existing knowledge is mainly derived from dated trials, including small numbers of patients, and hardly representing current strategies for the management of CV risk factors. The high level of uncertainty regarding the balance between benefits and risks of aspirin therapy have important implications for clinical practice, auditing activities, and the design and conduct of randomized clinical trials.
Published: 2007
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35. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association: response to Buse et al.

Author: Nicolucci A, De Berardis G, Sacco M, and Tognoni G
Subjects: American Heart Association, Diabetic Angiopathies, Humans, Primary Prevention, Societies, Medical, United States, Cardiovascular Diseases prevention & control
Published: 2007
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36. Clinical and psychological predictors of incidence of self-reported erectile dysfunction in patients with type 2 diabetes.

Author: De Berardis G, Pellegrini F, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Diabetes Complications etiology, Erectile Dysfunction etiology, Humans, Incidence, Male, Middle Aged, Risk Factors, Diabetes Complications epidemiology, Diabetes Complications psychology, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 psychology, Erectile Dysfunction epidemiology, Erectile Dysfunction psychology
Abstract: Purpose: We evaluated the predictors of the incidence of erectile dysfunction in patients with type 2 diabetes mellitus and identified subgroups of patients in whom the interaction between clinical and psychological characteristics determined an increase in the risk of erectile dysfunction., Materials and Methods: The study was based on 670 individuals. The presence of erectile dysfunction and the severity of depressive symptoms were investigated with a questionnaire filled in every 6 months for 3 years. Poisson regression was used to calculate incidence rates. To evaluate interactions among the different variables and identify distinct and homogeneous subgroups in terms of incidence of erectile dysfunction, RECursive Partitioning and AMalgamation method was used., Results: Overall erectile dysfunction developed in 192 men with type 2 diabetes, with an incidence rate of 166.3 per 1,000 person-years. Age, insulin treatment, hemoglobin A1c greater than 8.0%, total cholesterol greater than 3.88 mmol/l and severity of depressive symptoms represented independent predictors of erectile dysfunction. RECursive Partitioning and AMalgamation analysis identified 5 classes with a marked variation in the risk of erectile dysfunction. Patients with low levels of depressive symptoms and hemoglobin A1c 8.0% or less showed the lowest risk of erectile dysfunction. Compared with this subgroup patients with higher levels of depressive symptoms and treated with insulin had a 3-fold risk of erectile dysfunction. Age, smoking, high cholesterol levels and neuropathy were globally predictive variables associated with an increased risk of erectile dysfunction., Conclusions: The incidence of erectile dysfunction is predicted by modifiable risk factors. Even in diabetes, psychological problems can contribute to the pathogenesis of erectile dysfunction, in addition to organic causes.
Published: 2007
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37. Twelve-year mortality results of a randomized trial of 2 versus 5 years of adjuvant tamoxifen for postmenopausal early-stage breast carcinoma patients (SITAM 01).

Author: Belfiglio M, Valentini M, Pellegrini F, De Berardis G, Franciosi M, Rossi MC, Sacco M, and Nicolucci A
Subjects: Age Factors, Aged, Antineoplastic Agents, Hormonal therapeutic use, Breast Neoplasms mortality, Breast Neoplasms pathology, Chemotherapy, Adjuvant, Female, Humans, Italy, Middle Aged, Neoplasm Staging, Receptors, Estrogen analysis, Survival Analysis, Breast Neoplasms drug therapy, Postmenopause, Tamoxifen therapeutic use
Abstract: Background: This study evaluated the impact on overall survival (OS) of 2 versus 5 years adjuvant tamoxifen in early breast carcinoma patients after 12 years of follow-up., Methods: Women with breast carcinoma T1-3, N0-3, M0, aged 50-70 years, were eligible for this multicenter randomized Phase III trial. Patients event-free after 2 years of tamoxifen therapy (TAM) were randomly assigned to stop or continue TAM (20 mg/day) for an additional 3 years. The primary endpoint was disease-free survival. Secondary endpoints included OS and toxicity., Results: From 1989 through 1996, 1901 patients were randomly assigned either to stop treatment (n = 958) or to continue TAM (n = 943). Overall, 98% of patients alive at the previous report (n = 1611) had updated information about OS, of whom 549 had died. The median duration of postrandomization follow-up was 115 months (interquartile range, 86-137). No statistically significant differences between the two arms were detected in the whole population (hazard ratio [HR], 1.02; 95% confidence interval [CI], 0.86-1.22) and in estrogen receptor (ER)-positive patients (HR, 0.90; 95% CI, 0.72-1.13). In the latter group, survival curves started to diverge after 90 months, showing a trend in favor of the 5-year arm. In younger (age < or =55 yrs) ER-positive patients longer TAM was associated with a 44% decrease in the risk of death (HR, 0.56; 95% CI, 0.31-1.00), while no clear benefit was documented in women older than 55 years of age (HR, 0.98; 95% CI, 0.77-1.25)., Conclusions: The benefits of longer TAM on OS start to emerge only after 9 years from diagnosis and seem to be more relevant in younger ER-positive women.
Published: 2005
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38. Are Type 2 diabetic patients offered adequate foot care? The role of physician and patient characteristics.

Author: De Berardis G, Pellegrini F, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Aged, Ambulatory Care Facilities, Female, Health Knowledge, Attitudes, Practice, Humans, Insulin therapeutic use, Italy epidemiology, Male, Middle Aged, Patient Education as Topic, Practice Patterns, Physicians', Quality of Health Care, Risk Factors, Diabetes Mellitus, Type 2 complications, Diabetic Foot prevention & control, Family Practice standards, Physician's Role
Abstract: In the context of a nationwide outcomes research program on Type 2 diabetes, we investigated physician and patient practices related to foot care. Patients filled in a questionnaire investigating whether they had received information about foot care, how often they had had their feet examined in the last year, and how often they usually checked their feet. Analyses were adjusted for patient case-mix and physician-level clustering. Overall, 3564 patients were recruited by 125 diabetes outpatient clinics (DOCs) and 103 general practitioners (GPs), of whom 6.8% suffered form lower limb complications. The presence of foot complications was correlated with insulin treatment, cigarette smoking, low levels of school education, and the presence of other diabetic complications. More than 50% of the patients reported that they had not had their feet examined by their physician and 28% referred that they had not received foot education. Patients with lower levels of school education and income, as well as overweight individuals, were less likely to receive foot education. Physicians tended to perform foot examination more often in males, low-income patients, those with foot complications, and those treated with insulin, but not in patients with the highest risk of foot complications, that is, those with diabetic neuropathy or peripheral vascular disease (PVD). GPs tended to perform foot examination less frequently than diabetologists do. Foot self-examination was not performed by 33% of the patients. Those individuals who had received foot education or had had their feet examined were more likely to check their feet regularly. A substantial proportion of Type 2 diabetic patients is not offered adequate foot care, even in the presence of major risk factors for lower limb complications. Patient knowledge and practices are strongly related to physicians' attitudes.
Published: 2005
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39. Longitudinal assessment of quality of life in patients with type 2 diabetes and self-reported erectile dysfunction.

Author: De Berardis G, Pellegrini F, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Aged, Chi-Square Distribution, Health Surveys, Humans, Italy epidemiology, Longitudinal Studies, Male, Middle Aged, Surveys and Questionnaires, Time Factors, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 2 psychology, Erectile Dysfunction epidemiology, Quality of Life psychology
Abstract: Objective: In the context of the QuED (Quality of Care and Outcomes in Type 2 Diabetes) project, we evaluated the longitudinal changes over 3 years in quality of life (QoL) in patients with type 2 diabetes according to the presence or the development of erectile dysfunction (ED)., Research Design and Methods: Patients were requested to fill in a questionnaire investigating the presence of ED and QoL (SF-36 Health Survey, depression symptoms [Center for Epidemiologic Studies-Depression], and quality of sexual life) every 6 months for 3 years. The analyses were based on multilevel models, adjusted for patient clinical and sociodemographic characteristics., Results: The study involved 1,456 patients, of whom 34% reported frequent erectile problems at baseline; 192 developed ED during the follow-up. No changes in QoL measures were detected in patients without ED; in those with ED at baseline, a worsening in all SF-36 scales was observed, reaching statistical significance for physical functioning (P = 0.03). Among patients who developed ED during the study, a deterioration in all SF-36 dimensions and a worsening in depressive symptoms preceded the development of ED. The onset of ED was associated with a further marked worsening in physical functioning (P = 0.0008), general health perception (P = 0.02), and social functioning (P = 0.04) on SF-36 subscales, as well as in the summary physical and mental components scores (P = 0.04 and P = 0.07, respectively). The development of ED was also associated with a highly significant increase in depressive symptoms (P = 0.001) and a marked decrease in quality of sexual life (P < 0.0001)., Conclusions: This longitudinal study documents for the first time the impact of ED onset on several aspects of QoL in patients with type 2 diabetes. The study also shows that QoL tended to further decrease during 3 years in patients with ED at baseline but not in those without this condition.
Published: 2005
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40. Self-monitoring of blood glucose in non-insulin-treated diabetic patients: a longitudinal evaluation of its impact on metabolic control.

Author: Franciosi M, Pellegrini F, De Berardis G, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Algorithms, Blood Glucose analysis, Decision Trees, Diabetes Mellitus, Type 2 diet therapy, Diabetes Mellitus, Type 2 drug therapy, Female, Glycated Hemoglobin analysis, Humans, Hypoglycemic Agents therapeutic use, Longitudinal Studies, Male, Middle Aged, Social Support, Treatment Outcome, Blood Glucose Self-Monitoring methods, Diabetes Mellitus, Type 2 blood
Abstract: Aims: In the framework of a nationwide outcomes research programme, we assessed the impact of self-monitoring of blood glucose (SMBG) on metabolic control over 3 years in patients with Type 2 diabetes mellitus (DM2) not treated with insulin., Methods: The study involved 1896 patients who completed, at 6-month intervals for 3 years, a questionnaire investigating SMBG practice. Clinical information was collected by participating clinicians at the same time intervals. The predictive value of SMBG frequency on long-term metabolic control was estimated using multilevel analysis. The impact of SMBG on metabolic control was also evaluated in distinct and homogeneous subgroups of patients showing different likelihood of performing SMBG, identified using a tree-growing technique (RECPAM)., Results: Overall, 22% of the patients were on diet alone and 78% were treated with oral agents; 41% practiced SMBG > or = 1/week (10.3% > or = 1/day). The analysis of metabolic control according to the frequency of SMBG failed to show any significant impact of this practice on HbA1c levels over 3 years. Similarly, changes in SMBG frequency during the study were not related to significant changes in HbA1c levels. RECPAM analysis led to the identification of eight classes, characterized by substantial differences in the likelihood of performing SMBG with a frequency of at least 1/week. Nevertheless, in none of the RECPAM classes identified, did SMBG predict a better metabolic control over 3 years of follow-up. In those RECPAM classes indicating that SMBG was mainly performed to avoid hypoglycaemic episodes, SMBG was associated with a decrease in the frequency of hypoglycaemic episodes during the study., Conclusions: In a large sample of non-insulin-treated Type 2 diabetic patients, the performance and frequency of SMBG did not predict better metabolic control over 3 years. We could not identify any specific subgroups of patients for whom SMBG practice was associated with lower HbA1c levels during the study.
Published: 2005
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41. Use of the diabetes risk score for opportunistic screening of undiagnosed diabetes and impaired glucose tolerance: the IGLOO (Impaired Glucose Tolerance and Long-Term Outcomes Observational) study.

Author: Franciosi M, De Berardis G, Rossi MC, Sacco M, Belfiglio M, Pellegrini F, Tognoni G, Valentini M, and Nicolucci A
Subjects: Aged, Blood Glucose, Fasting, Female, Glucose Tolerance Test, Humans, Incidence, Male, Middle Aged, Prevalence, Prospective Studies, Risk Assessment, Risk Factors, Surveys and Questionnaires, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 epidemiology, Glucose Intolerance diagnosis, Glucose Intolerance epidemiology, Mass Screening methods
Abstract: Objective: To evaluate an opportunistic screening strategy addressed to individuals with one or more cardiovascular risk factor, based on the Diabetes Risk Score (DRS) as the initial instrument, for the identification of individuals with type 2 diabetes or impaired glucose tolerance (IGT)., Research Design and Methods: The DRS, a simple self-administered questionnaire, was completed by individuals identified by general practitioners and presenting with one or more cardiovascular risk factor. All patients underwent a 2-h oral glucose tolerance test (OGTT). The optimal DRS cutoff was calculated by applying the receiver-operating characteristic curve., Results: Overall, 1,377 individuals aged between 55 and 75 years received an OGTT and completed the DRS. Mean DRS values showed a marked variation according to glucose metabolism categories, as follows: 8.7 +/- 3.0 in normoglycemic individuals, 9.5 +/- 3.1 in individuals with impaired fasting glucose, 9.9 +/- 3.3 in individuals with IGT, and 12.0 +/- 3.5 in individuals with type 2 diabetes. The receiver-operating characteristic curve showed that, with a cutoff of 9, the sensitivity of DRS in detecting individuals with glucose abnormalities (type 2 diabetes or IGT) was 77% and the specificity 45%. The use of the DRS as an initial screening instrument, followed by the measurement of fasting blood glucose in individuals with a score > or =9 and by the OGTT in individuals with a fasting blood glucose between 5.6 and 6.9 mmol/l, would lead to the identification of 83% of the case subjects with type 2 diabetes and 57% of the case subjects with IGT, at a cost of an OGTT in 38% of the sample and a fasting blood glucose in 64%., Conclusions: The DRS can represent a valid inexpensive instrument for opportunistic screening and a useful alternative to indiscriminate fasting blood glucose measurement, not readily available in general practice.
Published: 2005
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42. Impact of physicians' beliefs and practices on cholesterol levels in patients with type 2 diabetes: a longitudinal assessment.

Author: Franciosi M, Pellegrini F, De Berardis G, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Cholesterol, LDL blood, Diabetes Mellitus, Type 2 complications, Female, Humans, Hyperlipidemias complications, Italy, Longitudinal Studies, Male, Middle Aged, Surveys and Questionnaires, Triglycerides blood, Attitude of Health Personnel, Cholesterol blood, Diabetes Mellitus, Type 2 blood, Hyperlipidemias drug therapy, Hypolipidemic Agents therapeutic use, Practice Patterns, Physicians'
Abstract: Background: Clinical trials demonstrate significant benefit from cholesterol management for patients with type 2 diabetes. The aim of this work was to explore the correlates of lipid management in patients with type 2 diabetes, including the subjective beliefs of physicians, setting of care, and patient-related factors., Methods: This longitudinal outcomes research study involved 2359 patients with type 2 diabetes recruited by 111 general practitioners and 214 physicians practicing in diabetes clinics. Physicians' beliefs were assessed through a questionnaire administered when the study started in 1998. Main outcome measures were total cholesterol (TC) and LDL cholesterol (LDL-C) levels over 3 years and the proportion of patients treated with lipid-lowering drugs (LLDs)., Results: Less than one-third of the physicians (27%) stated that they routinely started pharmacologic therapy for TC values > or =200 mg/dL (more aggressive), whereas 46% considered a TC level > or =240 mg/dL as the threshold for the initiation of treatment (less aggressive). During 3 years of observation, mean TC and LDL-C levels decreased from 215 +/- 40 mg/dL to 203 +/- 37 mg/dL and from 135 +/- 36 mg/dL to 126 +/- 35 mg/dL respectively, while the proportion of patients treated with LLDs increased from 13.2% to 24.6%; in particular, among individuals cared for by the more aggressive physicians, 30.0% were taking LLDs after 3 years, while only 17.7% of those followed by the less aggressive physicians and 18.1% of those followed by >1 physician were being treated with LLDs. Multilevel analysis showed that physicians' beliefs were an independent predictor of TC levels over the 3-year period. In patients treated with LLDs, TC levels decreased on average by 14%, and LDL-C levels decreased by 20%., Conclusion: Our data show that physicians' beliefs in more aggressive management strategies will result in better mean TC values over a 3-year period.
Published: 2005
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43. Prevention of cardiovascular disease in type-2 diabetes: how to improve the clinical efficacy of aspirin.

Author: Evangelista V, Totani L, Rotondo S, Lorenzet R, Tognoni G, De Berardis G, and Nicolucci A
Subjects: Angiotensin-Converting Enzyme Inhibitors therapeutic use, Cardiovascular Diseases drug therapy, Cardiovascular Diseases etiology, Diabetes Complications prevention & control, Drug Resistance, Humans, Inflammation drug therapy, Thiazolidinediones therapeutic use, Aspirin therapeutic use, Cardiovascular Diseases prevention & control, Diabetes Mellitus, Type 2 complications
Abstract: Atherosclerotic cardiovascular disease and its thrombotic complications are the principal causes of morbidity and mortality in patients with type-2 diabetes. Aspirin reduces the risk of thrombotic events in a broad range of patients with vascular disease and, in selected individuals, is beneficial for primary prevention. Although recommended by existing guidelines, in secondary and in primary prevention trials the clinical efficacy of low-dose aspirin in patients with diabetes appears to be substantially lower than in individuals without diabetes. In this review, we discuss possible mechanisms that may contribute to reduce the antithrombotic activity of aspirin in diabetes. We also discuss adjuvant therapies used in diabetic patients that may potentially improve the antithrombotic efficacy of aspirin.
Published: 2005
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44. Correlates of satisfaction for the relationship with their physician in type 2 diabetic patients.

Author: Franciosi M, Pellegrini F, De Berardis G, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Aged, Diabetes Mellitus, Type 2 physiopathology, Female, Humans, Male, Middle Aged, Psychometrics, Surveys and Questionnaires, Diabetes Mellitus, Type 2 psychology, Patient Satisfaction, Physician-Patient Relations
Abstract: In the context of an Italian nation-wide outcomes research program on type 2 diabetes, we investigated the contribution of both patient and setting-related factors to patient satisfaction with their relationship with their physicians. The level of patient satisfaction was measured using the American Board of Internal Medicine (ABIM) 14 patient satisfaction questionnaire. The main results were obtained using multilevel analysis, a statistical technique that takes into account the clustered nature of our data. Overall, 3563 patients were recruited by 101 diabetologists and 103 general practitioners (GPs). Information on patients' satisfaction was available for 2515 patients (71% of the whole sample). Patients' satisfaction was related to patient characteristics and attitudes, but not with physician's sex, age, speciality, and setting of care. In particular, patients who were less likely to delegate to physicians responsibility for diabetes management and those perceiving a lower degree of involvement in disease management showed lower levels of satisfaction. Lower satisfaction scores were also related to lower levels of school education, more severe clinical conditions, and lower psychological adaptation to diabetes. However, patients reporting higher levels of diabetes related worries and more frequent encounters with health care providers showed higher levels of satisfaction. In conclusion, patient satisfaction with physicians' humanness and communication skills is strongly related to personal characteristics, attitudes, expectations, and perceived health. In deciding the best decision-making approach to adopt in individual patients, it is of primary importance to measure how the patient perceives and engages in relationships.
Published: 2004
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45. Quality of care and outcomes in type 2 diabetic patients: a comparison between general practice and diabetes clinics.

Author: De Berardis G, Pellegrini F, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Aged, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 physiopathology, Female, Humans, Italy, Male, Middle Aged, Quality Assurance, Health Care, Surveys and Questionnaires, Treatment Outcome, Ambulatory Care Facilities standards, Diabetes Mellitus, Type 2 therapy, Family Practice standards
Abstract: Objective: The role of general practice and diabetes clinics in the management of diabetes is still a matter of debate. Methodological flaws in previous studies may have led to inaccurate conclusions when comparing the care provided in these different settings. We compared the care provided to type 2 diabetic patients attending diabetes outpatient clinics (DOCs) or being treated by a general practitioner (GP) using appropriate statistical methods to adjust for patient case mix and physician-level clustering., Research Design and Methods: We prospectively evaluated the process and intermediate outcome measures over 2 years in a sample of 3,437 patients recruited by 212 physicians with different specialties practicing in 125 DOCs and 103 general practice offices. Process measures included frequency of HbA(1c), lipids, microalbuminuria, and serum creatinine measurements and frequency of foot and eye examinations. Outcome measures included HbA(1c), blood pressure, and total and LDL cholesterol levels., Results: Differences for most process measures were statistically significantly in favor of DOCs. The differences were more marked for patients who were always treated by the same physician within a DOC and if that physician had a specialty in diabetology. Less consistent differences in process measures were detected when patients followed by GPs were compared with those followed by physicians with a specialty other than diabetology. As for the outcomes considered, patients attending DOCs attained better total cholesterol levels, whereas no major differences emerged in terms of metabolic control and blood pressure levels between DOCs and GPs. Physicians' specialties were not independently related to patient outcomes., Conclusions: Being followed always by the same physician in a DOC, particularly if the physician had a specialty in diabetes, ensured better quality of care in terms of process measures. In the short term, care provided by DOCs was also associated with better intermediate outcome measures, such as total cholesterol levels.
Published: 2004
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46. Physician attitudes toward foot care education and foot examination and their correlation with patient practice.

Author: De Berardis G, Pellegrini F, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Diabetic Foot epidemiology, Family Practice standards, Humans, Physical Examination, Attitude of Health Personnel, Diabetes Mellitus, Type 2 rehabilitation, Diabetic Foot prevention & control, Foot, Patient Education as Topic, Physicians psychology
Published: 2004
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47. Randomized trial of 2 versus 5 years of adjuvant tamoxifen for women aged 50 years or older with early breast cancer: Italian Interdisciplinary Group Cancer Evaluation Study of Adjuvant Treatment in Breast Cancer 01.

Author: Sacco M, Valentini M, Belfiglio M, Pellegrini F, De Berardis G, Franciosi M, and Nicolucci A
Subjects: Aged, Breast Neoplasms pathology, Breast Neoplasms therapy, Chemotherapy, Adjuvant, Disease-Free Survival, Female, Humans, Middle Aged, Neoplasm Recurrence, Local, Proportional Hazards Models, Time Factors, Treatment Outcome, Antineoplastic Agents, Hormonal administration & dosage, Breast Neoplasms drug therapy, Tamoxifen administration & dosage
Abstract: Purpose: To compare 2 with 5 years of adjuvant tamoxifen therapy in the treatment of early breast cancer., Patients and Methods: Women with breast carcinoma T1-3, N0-3, M0, who were between 50 and 70 years of age, were eligible irrespective of menopausal status, tumor grade, or estrogen receptor (ER) status. Patients who were event-free after 2 years of tamoxifen therapy were randomly assigned to stop or continue tamoxifen therapy for an additional 3 years. The primary end point was length of disease-free survival (DFS). Secondary end points included overall survival (OS) and toxicity., Results: From 1989 through 1996, 1,901 patients were randomly assigned either to stop treatment (n = 958) or to receive tamoxifen for 3 additional years (n = 943). The median duration of postrandomization follow-up was 52 months. We found no statistically significant differences between the 5-year arm and the 2-year arm in terms of DFS (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.76 to 1.08) and OS (HR, 1.16; 95% CI, 0.92 to 1.46). In ER-positive patients, a statistically significant prolongation of DFS related to longer treatment duration was observed (HR, 0.74; 95% CI, 0.59 to 0.93), whereas no difference in OS could be detected (HR, 0.98; 95% CI, 0.72 to 1.32). No differences in terms of endometrial cancers, cardiac or cerebrovascular events, or fractures were detected, whereas a doubling in the risk of thromboembolic events was found in the 5-year arm., Conclusion: Our results confirm previous research that shows that 5 years of tamoxifen decreases recurrence compared to 2 years in patients with ER-positive tumors.
Published: 2003
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48. Identifying patients with type 2 diabetes with a higher likelihood of erectile dysfunction: the role of the interaction between clinical and psychological factors.

Author: De Berardis G, Pellegrini F, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Rossi MC, Sacco M, Tognoni G, Valentini M, and Nicolucci A
Subjects: Aged, Cross-Sectional Studies, Depression diagnosis, Depression epidemiology, Depression psychology, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 2 psychology, Diabetic Angiopathies diagnosis, Diabetic Angiopathies epidemiology, Diabetic Angiopathies psychology, Diabetic Neuropathies diagnosis, Diabetic Neuropathies epidemiology, Diabetic Neuropathies psychology, Diabetic Retinopathy diagnosis, Diabetic Retinopathy epidemiology, Diabetic Retinopathy psychology, Erectile Dysfunction epidemiology, Erectile Dysfunction psychology, Humans, Impotence, Vasculogenic epidemiology, Impotence, Vasculogenic psychology, Likelihood Functions, Male, Middle Aged, Psychophysiologic Disorders epidemiology, Psychophysiologic Disorders psychology, Risk Factors, Diabetes Mellitus, Type 2 diagnosis, Erectile Dysfunction diagnosis, Impotence, Vasculogenic diagnosis, Psychophysiologic Disorders diagnosis
Abstract: Purpose: We estimated the prevalence of erectile dysfunction in patients with type 2 diabetes and identified subgroups of patients in which the interaction among clinical, psychological and sociodemographic characteristics determined an increased likelihood of erectile dysfunction., Materials and Methods: The presence of erectile dysfunction was based on patient self-reporting. Clinical information was collected by participating physicians. The severity of depressive symptoms was investigated using the Center for Epidemiological Studies Depression scale. To evaluate interactions among the variables investigated and identify distinct, homogeneous subgroups of patients with different odds ratios for erectile dysfunction a tree growing technique was used., Results: In the 1,460 patients studied the prevalence of severe and mild-moderate erectile dysfunction was 34% and 24%, respectively. While severe erectile dysfunction was mainly related to the severity of diabetes, mild-moderate dysfunction was independent of clinical variables and only associated with the severity of depressive symptoms. The tree growing technique led to the identification of 6 classes characterized by a marked difference in the prevalence of severe erectile dysfunction of between 19% and 65%. Patients on diet alone showed the lowest prevalence of erectile dysfunction and were considered the reference category, while patients treated with insulin who had neuropathy represented the subgroup with the highest likelihood of erectile dysfunction (OR = 7.2, 95% CI 3.9 to 13.2). In patients treated with oral agents the odds ratio for erectile dysfunction was 2.7 (95% CI 1.8 to 3.9) for those with severe depressive symptoms and 1.9 (95% CI 1.3 to 2.7) for current/former smokers with low depressive symptoms. Patient age, retinopathy and cardiac-cerebrovascular disease were globally predictive variables associated with an increased likelihood of erectile dysfunction., Conclusions: Our data illustrate the interplay of clinical and psychological factors in determining the risk of erectile dysfunction in type 2 diabetes and can help identify those for whom much greater attention is needed to detect erectile problems.
Published: 2003
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49. Role of organizational factors in poor blood pressure control in patients with type 2 diabetes: the QuED Study Group--quality of care and outcomes in type 2 diabetes.

Author: Pellegrini F, Belfiglio M, De Berardis G, Franciosi M, Di Nardo B, Greenfield S, Kaplan SH, Sacco M, Tognoni G, Valentini M, Corrado D, D'Ettorre A, and Nicolucci A
Subjects: Antihypertensive Agents therapeutic use, Chi-Square Distribution, Female, Humans, Hypertension etiology, Italy, Logistic Models, Male, Middle Aged, Surveys and Questionnaires, Attitude of Health Personnel, Diabetes Mellitus, Type 2 complications, Hypertension prevention & control, Practice Patterns, Physicians' statistics & numerical data, Quality of Health Care
Abstract: Background: A large body of evidence supports the need for reducing the cardiovascular burden of diabetes. Only indirect and occasional data describe the adequacy of routine management of hypertension in patients with diabetes. The aim of this study was to explore the interplay of some potential key determinants of quality of antihypertensive care, including the settings, physicians' beliefs about blood pressure (BP) control, and patient-related factors., Methods: We evaluated physicians' beliefs about BP control using questionnaire responses at study entry. A sample of 3449 patients with type 2 diabetes mellitus, of whom 1782 (52%) were considered to have hypertension, was recruited by 212 physicians practicing in 125 diabetes outpatients clinics (DOCs) and 106 general practitioners (GPs). We evaluated the type and number of antihypertensive agents used and the BP values at study entry and after 1 year of follow-up. We used multilevel analysis to investigate correlates of poor BP control (> or =160/90 mm Hg)., Results: Only 16% of GPs and 14% of DOC physicians targeted BP values of less than 130/85 mm Hg. At study entry, 6% of the patients had values below 130/85 mm Hg, whereas 52% showed values of 160/90 mm Hg or greater. Only 12% of subjects were treated with more than 2 drugs at study entry, compared with 16% at the 1-year follow-up (P =.001). Multilevel analysis showed that patients attending DOCs had a more than 2-fold increased risk for inadequate BP control, compared with those treated by GPs. The risk for poor BP control was 2 times higher for patients treated by male physicians compared with those treated by female physicians, and it was halved when the physician responsible for the diabetes care specialized in diabetology or endocrinology., Conclusion: In a model situation of comorbidity, the overall quality of care depends on structural and organizational factors, which are likely to be more influential than existing guidelines.
Published: 2003
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50. Alternative site blood glucose testing: a multicenter study.

Author: Fedele D, Corsi A, Noacco C, Prisco F, Squatrito S, Torre E, Iafusco D, Errico MK, Toniato R, Nicolucci A, Franciosi M, De Berardis G, and Neri L
Subjects: Adolescent, Adult, Age of Onset, Blood Glucose metabolism, Child, Female, Fingers blood supply, Forearm blood supply, Glucose Clamp Technique, Humans, Male, Patient Satisfaction, Reference Values, Regression Analysis, Reproducibility of Results, Blood Glucose analysis, Blood Glucose Self-Monitoring methods, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 2 blood
Abstract: The aim of this study was to compare glucose measurements between fingertip and forearm using the blood glucose (BG) monitoring system One Touch Ultra (LifeScan), an electrochemical sensor that requires only a very small drop of blood (1 microL). Patients with type 1 or type 2 diabetes were identified in five outpatient diabetes clinics. Participants were requested to use the One Touch Ultra at home for 1 week for the measurement of BG levels from both sites. Patients filled in a questionnaire about their experience with testing blood samples from fingertip and forearm. The agreement between the measurements from the two sites was assessed using linear regression analysis, mean absolute relative error (MARE), the Bland-Altman method, and Error Grid Analysis (EGA). Overall, 112 patients were recruited, of whom 58% had type 1 diabetes. Linear regression analysis showed an intercept of 17.7, statistically different from 0 (p<0.0001). The slope was 0.956, and the Pearson correlation coefficient was 0.95. A MARE of 12.1% (SD=11.8%) was obtained, with a greater deviation of the forearm values from the fingertip ones in the hypoglycemic range (MARE=22.3%; SD=21.7%). The Bland-Altman bias plot showed a mean bias of 10.2 mg/dL (SD=23.1), with no correlation between mean difference and average BG levels (r=0.02). The EGA showed that 89.2% of the values fell in zone A, 10.4% in zone B, and 0.4% in zone C. The vast majority of patients (71%) declared that the collection of blood from the forearm caused no pain or less pain than the traditional site. Only 17% of the patients declared that it was impossible to obtain any blood from the forearm, while 63% reported with satisfaction that the quantity requested was small. At the end of the study period, 32% of the participants indicated the forearm as the preferred test site. Alternative site testing on the arm, with a BG meter that requires only a very small drop of blood, is feasible and reliable under routine clinical conditions. When testing with the express purpose of detecting hypoglycemia, the finger still remains the recommended test site.
Published: 2003
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