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1. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Mammì, F., Bruzzese, M., Schettino, M., Nuzzo, M.G., Di Blasi, V., Fresa, R., Lambiase, C., Iafusco, D., Zanfardino, A., Confetto, S., Bozzetto, L., Annuzzi, G., Alderisio, A., Riccardi, G., Gentile, S., Marino, G., Guarino, G., Zucchini, S., Maltoni, G., Suprani, T., Graziani, V., Nizzoli, M., Acquati, S., Cavani, R., Romano, S., Michelini, M., Manicardi, E., Bonadonna, R., Dei Cas, A., Dall'aglio, E., Papi, M., Riboni, S., Manicardi, V., Pugni, V., Lasagni, A., Street, M.E., Pagliani, U., Rossi, C., Assaloni, R., Brunato, B., Tortul, C., Zanette, G., Li Volsi, P., Zanatta, M., Tonutti, L., Agus, S., Pellegrini, M.A., Ceccano, P., Pozzilli, G., Anguissola, Beretta, Buzzetti, R., Moretti C, C., Leto, G., Pozzilli, P., Manfrini, S., Maurizi, A.R., Leotta, S., Altomare, M., Abbruzzese, S., Carletti, S., Suraci, C., Filetti, S., Manca Bitti, M.L., Arcano, S., Cavallo, M.G., De Bernardinis, M., Pitocco, D., Caputo, S., Rizzi, A., Manto, A., Schiaffini, R., Cappa, M., Benevento, D., Frontoni, S., Malandrucco, I., Morano, S., Filardi, T., Lauro, D., Marini, M.A., Castaldo, E., Sabato, D., Tuccinardi, F., Forte, E., Viterbori, P., Arnaldi, C., Minuto, N., d'Annunzio, G., Corsi, A., Rota, R., Scaranna, C., Trevisan, R., Valentini, U., Girelli, A., Bonfadini, S., Zarra, E., Plebani, A., Prandi, E., Felappi, B., Rocca, A., Meneghini, E., Galli, P., Ruggeri, P., Carrai, E., Fugazza, L., Baggi, V., Conti, D., Bosi, E., Laurenzi, A., Caretto, A., Molinari, C., Orsi, E., Grancini, V., Resi, V., Bonfanti, R., Favalli, V., Bonura, C., Rigamonti, A., Bonomo, M., Bertuzzi, F., Pintaudi, B., Disoteo, O., Perseghin, G., Perra, S., Chiovato, L., De Cata, P., Zerbini, F., Lovati, E., Laneri, M., Guerraggio, L., Bossi, A.C., De Mori, V., Galetta, M., Meloncelli, I., Aiello A, A., Di Vincenzo, S., Nuzzi, A., Fraticelli, E., Ansaldi, E., Battezzati, M., Lombardi, M., Balbo, M., Lera, R., Secco, A., De Donno, V., Cadario, F., Savastio, S., Ponzani, C., Aimaretti, G., Rabbone, I., Ignaccolo, G., Tinti, D., Cerutti, F., Bari, F., Giorgino, F., Piccinno, E., Zecchino, O., Cignarelli, M., Lamacchia, O., Picca, G., De Cosmo, S., Rauseo, A., Tomaselli, L., Tumminia, A., Egiziano, C., Scarpitta, A.M., Maggio, F., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Scorsone, A., Scatena, A., Gregori, G., Lucchesi, S., Gadducci, F., Di Cianni, S., Pancani, S., Del Prato, S., Aragona, M., Crisci, I., Calianno, A., Fattor, B., Crazzolara, D., Reinstadler, P., Longhi, S., Incelli, G., Rauch, S., Romanelli, T., Orrasch, M., Cauvin, V., Franceschi, R., Lalli, C., Pianta, A., Marangoni, A., Aricò, C.N., Marin, N., Nogara, N., Simioni, N., Filippi, A., Gidoni Guarneri, G.L., Contin M.L, M.L., Decata, A.P., Bondesan, L., Confortin, L., Coracina, A., Lombardi, S., Costa Padova, S., Cipponeri, E., Scotton, R., Galasso, S., Boscari, F., Zanon, M.S., Vinci, C., Lisato, G., Gottardo, L., Bonora, E., Trombetta, M., Negri, C., Brangani, C., Maffeis, C., Sabbion, A., Marigliano, M., Lepore, Giuseppe, Bonfanti, Riccardo, Bozzetto, Lutgarda, Di Blasi, Vincenzo, Girelli, Angela, Grassi, Giorgio, Iafusco, Dario, Laviola, Luigi, Rabbone, Ivana, Schiaffini, Riccardo, and Bruttomesso, Daniela

Published
2018
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2. Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes): A multicenter retrospective nationwide Italian study and crowdsourcing opportunity

Author

Consoli, A., Formoso, G., Antenucci, D., Grossi, G., Pucci, A., Sesti, G., Andreozzi, F., Indrieri, L., Capobianco, G., Gatti, A., Bonadonna, R., Zavaroni, I., Dei Cas, A., Felace, G., Li Volsi, P., Buzzetti, R., Leto, G., D'Angelo, F., Morano, S., Giaccari, A., Sorice, G., Orsi, E., Carlo Bossi, A., Querci, F., Duratorre, E., Malagola, C., Franzetti, I., Silvia Morpurgo, P., Boemi, M., Petrelli, M., Aimaretti, G., Karamouzis, I., Cavalot, F., Saglietti, G., Gruden, G., Devangelio, E., Cazzetta, G., Lamacchia, O., Cervone, S., Frittitta, L., Arena, S., Di Benedetto, A., Piro, S., Giordano, C., Rizzo, M., Chianetta, R., Mannina, C., Solini, A., Natali, A., Anichini, R., Dotta, F., Fattor, B., Avogaro, A., Fadini, G.P., Bonora, E., Cigolini, M., Simioni, N., Frison, V., Poli, M., Lapolla, A., Cristiano Chilelli, N., Vinci, C., and Zatti, G.

Published
2017
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4. Short-term effectiveness of dapagliflozin versus DPP-4 inhibitors in elderly patients with type 2 diabetes: a multicentre retrospective study

Author

Morieri, M. L., Raz, I., Consoli, A., Rigato, M., Lapolla, A., Broglio, F., Bonora, E., Avogaro, A., Fadini, G. P., Ginestra, F., Formoso, G., Andreozzi, F., Sesti, G., Turco, S., Lucibelli, L., Gatti, A., Aldigeri, R., Dei Cas, A., Felace, G., Li Volsi, P., Sorice, G. P., Giaccari, A., Mignogna, C., Buzzetti, R., Filardi, T., Morano, S., Barchetta, I., Gisella Cavallo, M., Malandrucco, I., Frontoni, S., Carletti, S., D'Angelo, P., Leto, G., Leonetti, F., Silvia Morpurgo, P., Fiorina, P., Palmieri, E., Orsi, E., Mantovani, E., Franzetti, I., Querci, F., Bossi, A., Turchi, F., Manfrini, S., Guida, D., Placentino, G., Beccuti, G., Cavalot, F., Nuzzo, A., Aimaretti, G., Lamacchia, O., Cignarelli, A., Laviola, L., Giorgino, F., Devangelio, E., Cazzetta, G., Chianetta, R., Citarrella, R., Tumminia, A., Frittitta, L., Anzaldi, M., Buscema, M., Piro, S., Di Pino, A., Purrello, F., Di Benedetto, A., Russo, G., Anichini, R., Solini, A., Garofolo, M., Del Prato, S., Fattor, B., Paolo Fadini, G., Sartore, G., D'Ambrosio, M., Da Tos, V., Frison, V., Simioni, N., Cigolini, M., Brun, E., Strazzabosco, M., Poli, M., Paccagnella, A., and Vinci, C.

Subjects
Aging, Cardiovascular, Heart failure, Kidney disease, Observational
Published
2023

5. Predictors of early discontinuation of dapagliflozin versus other glucose-lowering medications: a retrospective multicenter real-world study

Author

Fadini, G. P., Li Volsi, P., Devangelio, E., Poli, M., Cazzetta, G., Felace, G., Avogaro, A., Consoli, A., Formoso, G., Grossi, G., Pucci, A., Sesti, G., Andreozzi, F., Capobianco, G., Gatti, A., Bonadonna, R., Zavaroni, I., Cas, A. D., Buzzetti, R., Leto, G., Sorice, G. P., D'Angelo, P., Morano, S., Bossi, A. C., Duratorre, E., Franzetti, I., Morpurgo, P. S., Orsi, E., Querci, F., Boemi, M., D'Angelo, F., Petrelli, M., Aimaretti, G., Karamouzis, I., Cavalot, F., Saglietti, G., Cervone, S., Lamacchia, O., Arena, S., Di Benedetto, A., Frittitta, L., Giordano, C., Piro, S., Rizzo, M., Chianetta, R., Mannina, C., Anichini, R., Penno, G., Solini, A., Fattor, B., Bonora, E., Cigolini, M., Lapolla, A., Chilelli, N. C., Simioni, N., Frison, V., Vinci, C., Fadini G.P., Li Volsi P., Devangelio E., Poli M., Cazzetta G., Felace G., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Buzzetti R., Leto G., Sorice G.P., D'Angelo P., Morano S., Bossi A.C., Duratorre E., Franzetti I., Morpurgo P.S., Orsi E., Querci F., Boemi M., D'Angelo F., Petrelli M., Aimaretti G., Karamouzis I., Cavalot F., Saglietti G., Cervone S., Lamacchia O., Arena S., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Simioni N., Frison V., and Vinci C.

Subjects
Blood Glucose, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Glucosides, Diabetes mellitus, Internal medicine, Adherence, Observational, Pharmacotherapy, Real-world, Aged, Benzhydryl Compounds, Diabetes Mellitus, Type 2, Dipeptidyl-Peptidase IV Inhibitors, Female, Humans, Hypoglycemic Agents, Middle Aged, Retrospective Studies, Withholding Treatment, Diabetes Mellitus, medicine, Outpatient clinic, Dapagliflozin, business.industry, Retrospective cohort study, medicine.disease, Metformin, Discontinuation, chemistry, Tolerability, 030220 oncology & carcinogenesis, business, Type 2, medicine.drug
Abstract

Background and aims: In routine clinical practice, early discontinuation of newly initiated glucose-lowering medications (GLM) is relatively common. We herein evaluated if the clinical characteristics associated with early discontinuation of dapagliflozin were different from those associated with early discontinuation of other GLM. Methods: The DARWIN-T2D was a multicenter retrospective study conducted at diabetes specialist outpatient clinics in Italy. We included 2484 patients who were initiated on dapagliflozin in 2015–2016 and 14,801 patients who were initiated on other GLM (DPP-4 inhibitors, GLP-1 receptor agonists, or gliclazide) in the same period. After excluding patients who had not (yet) returned to follow-up, we compared the characteristics of patients who persisted on drug versus those who were no longer on drug at the first available follow-up after at least 3months. Results: As compared to those who persisted on drug, patients who discontinued dapagliflozin (51.7%) were more often female, had higher baseline fasting plasma glucose (FPG), HbA1c, and eGFR, and less common use of metformin. Upon multiple regression, higher HbA1c, higher eGFR, and lower metformin use remained independently associated with early discontinuation. Among patients who had been initiated on other GLM, 41.7% discontinued. Variables independently associated with discontinuation were older age, longer diabetes duration, higher HbA1c, eGFR, and albumin excretion, more common use of insulin and less metformin. Conclusion: In routine clinical practice, all variables associated with dapagliflozin discontinuation were also associated with discontinuation of other GLM. Thus, despite a distinctive mechanism of action and a peculiar tolerability profile, no specific predictor of dapagliflozin discontinuation was detected.

Published
2019
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6. Physicians’ misperceived cardiovascular risk and therapeutic inertia as determinants of low LDL-cholesterol targets achievement in diabetes

Author

Morieri, M. L., Lamacchia, O., Manzato, E., Giaccari, Andrea, Avogardo, A., Amoresano, L., Angotti, S., Bartone, L., Caraffa, F., Carboni, A., Carro, S., Cervone, S., Clerico, A., Console, I., Conti, D. M., D'Addato, S., De Bellis, Andrea, de Meo, F., di Carlo, A., di Cianni, G., di Giovanni, G., di Lembo, S., Diacono, F., Dolcino, M., Elia, G., Elli, P., Fatone, C., Galli, A., Galluzzo, G., Garzaniti, A., Ghelardi, R., Giacchini, A., Giunta, L., Golia, F., Gregorio, F., Ierna, D., Lampitella, A., Luciano, A., Maffettone, A., Mancini, R., Mangone, I., Mantovani, L. E., Marangoni, A., Marelli, G., Marin, N., Marino, G., Mastromatteo, E., Mazziotti, G., Me, E., Memoli, G., Menicatti, L. S. M., Moffa, Simona, Moise', M., Monaco, F., Morgante, S. N., Pellicano, F., Petraroli, E., Piersanti, D., Pipitone, A., Puglisi, S., Rinaldi, M., Rizzo, M., Rosco, Principia Maria, Scollo, G., Simioni, N., Squadrone, M., Sturniolo, G., Tedeschi, Alessandra, Tizio, B., Ugolotti, D., Valente, L., Vinci, C., Zenoni, L., Zenti, M. G., Giaccari A. (ORCID:0000-0002-7462-7792), de Bellis A., Moffa S., Rosco M., Tedeschi A., Morieri, M. L., Lamacchia, O., Manzato, E., Giaccari, Andrea, Avogardo, A., Amoresano, L., Angotti, S., Bartone, L., Caraffa, F., Carboni, A., Carro, S., Cervone, S., Clerico, A., Console, I., Conti, D. M., D'Addato, S., De Bellis, Andrea, de Meo, F., di Carlo, A., di Cianni, G., di Giovanni, G., di Lembo, S., Diacono, F., Dolcino, M., Elia, G., Elli, P., Fatone, C., Galli, A., Galluzzo, G., Garzaniti, A., Ghelardi, R., Giacchini, A., Giunta, L., Golia, F., Gregorio, F., Ierna, D., Lampitella, A., Luciano, A., Maffettone, A., Mancini, R., Mangone, I., Mantovani, L. E., Marangoni, A., Marelli, G., Marin, N., Marino, G., Mastromatteo, E., Mazziotti, G., Me, E., Memoli, G., Menicatti, L. S. M., Moffa, Simona, Moise', M., Monaco, F., Morgante, S. N., Pellicano, F., Petraroli, E., Piersanti, D., Pipitone, A., Puglisi, S., Rinaldi, M., Rizzo, M., Rosco, Principia Maria, Scollo, G., Simioni, N., Squadrone, M., Sturniolo, G., Tedeschi, Alessandra, Tizio, B., Ugolotti, D., Valente, L., Vinci, C., Zenoni, L., Zenti, M. G., Giaccari A. (ORCID:0000-0002-7462-7792), de Bellis A., Moffa S., Rosco M., and Tedeschi A.

Abstract

Background: Greater efforts are needed to overcome the worldwide reported low achievement of LDL-c targets. This survey aimed to dissect whether and how the physician-based evaluation of patients with diabetes is associated with the achievement of LDL-c targets. Methods: This cross-sectional self-reported survey interviewed physicians working in 67 outpatient services in Italy, collecting records on 2844 patients with diabetes. Each physician reported a median of 47 records (IQR 42–49) and, for each of them, the physician specified its perceived cardiovascular risk, LDL-c targets, and the suggested refinement in lipid-lowering-treatment (LLT). These physician-based evaluations were then compared to recommendations from EAS/EASD guidelines. Results: Collected records were mostly from patients with type 2 diabetes (94%), at very-high (72%) or high-cardiovascular risk (27%). Physician-based assessments of cardiovascular risk and of LDL-c targets, as compared to guidelines recommendation, were misclassified in 34.7% of the records. The misperceived assessment was significantly higher among females and those on primary prevention and was associated with 67% lower odds of achieving guidelines-recommended LDL-c targets (OR 0.33, p < 0.0001). Peripheral artery disease, target organ damage and LLT-initiated by primary-care-physicians were all factors associated with therapeutic-inertia (i.e., lower than expected probability of receiving high-intensity LLT). Physician-suggested LLT refinement was inadequate in 24% of overall records and increased to 38% among subjects on primary prevention and with misclassified cardiovascular risk. Conclusions: This survey highlights the need to improve the physicians’ misperceived cardiovascular risk and therapeutic inertia in patients with diabetes to successfully implement guidelines recommendations into everyday clinical practice.

Published
2022

10. Similar effectiveness of dapagliflozin and GLP-1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospective study

Author

Fadini, G. P., Sciannameo, V., Franzetti, I., Bottigliengo, D., D'Angelo, P., Vinci, C., Berchialla, P., Arena, S., Buzzetti, R., Avogaro, A., Consoli, A., Formoso, G., Grossi, G., Pucci, A., Sesti, G., Andreozzi, F., Capobianco, G., Gatti, A., Bonadonna, R., Zavaroni, I., Cas, A. D., Felace, G., Volsi, P. L., Leto, G., Sorice, G. P., Morano, S., Bossi, A. C., Duratorre, E., Morpurgo, P. S., Orsi, E., Querci, F., Boemi, M., D'Angelo, F., Petrelli, M., Aimaretti, G., Karamouzis, I., Cavalot, F., Saglietti, G., Cazzetta, G., Cervone, S., Devangelio, E., Lamacchia, O., Di Benedetto, A., Frittitta, L., Giordano, C., Piro, S., Rizzo, M., Chianetta, R., Mannina, C., Anichini, R., Penno, G., Solini, A., Fattor, B., Bonora, E., Cigolini, M., Lapolla, A., Chilelli, N. C., Poli, M., Simioni, N., Frison, V., Fadini G.P., Sciannameo V., Franzetti I., Bottigliengo D., D'Angelo P., Vinci C., Berchialla P., Arena S., Buzzetti R., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Felace G., Volsi P.L., Leto G., Sorice G.P., Morano S., Bossi A.C., Duratorre E., Morpurgo P.S., Orsi E., Querci F., Boemi M., D'Angelo F., Petrelli M., Aimaretti G., Karamouzis I., Cavalot F., Saglietti G., Cazzetta G., Cervone S., Devangelio E., Lamacchia O., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Poli M., Simioni N., and Frison V.

Subjects
Blood Glucose, Male, Glycated Hemoglobin A, Endocrinology, Diabetes and Metabolism, Blood Pressure, Type 2 diabetes, 030204 cardiovascular system & hematology, Settore MED/13 - Endocrinologia, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Glucosides, Clinical endpoint, Medicine, Dapagliflozin, GLP-1 analogue, Middle Aged, Treatment Outcome, glycaemic control, antidiabetic drug, dapagliflozin, observational study, Combination, Original Article, Drug Therapy, Combination, Female, Type 2, medicine.drug, Adult, medicine.medical_specialty, 030209 endocrinology & metabolism, Glucagon-Like Peptide-1 Receptor, 03 medical and health sciences, Drug Therapy, GLP‐1 analogue, Internal medicine, Diabetes mellitus, Internal Medicine, Diabetes Mellitus, Humans, Hypoglycemic Agents, Benzhydryl Compounds, Aged, Retrospective Studies, Glycated Hemoglobin, Body Weight, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Exenatide, Liraglutide, business.industry, Retrospective cohort study, Original Articles, medicine.disease, Blood pressure, chemistry, Propensity score matching, business, Antidiabetic drug, dapagliflozin, GLP-1 analogue, glycaemic control, observational study
Abstract

Aims According to cardiovascular outcome trials, some sodium‐glucose contransporter‐2 inhibitors (SGLT2i) and glucagon‐like peptide‐1 receptor agonists (GLP‐1RA) are recommended for secondary cardiovascular prevention in type 2 diabetes (T2D). In this real‐world study, we compared the simultaneous reductions in HbA1c, body weight and systolic blood pressure after initiation of dapagliflozin or GLP‐1RA as second or a more advanced line of therapy. Materials and methods DARWIN‐T2D was a retrospective multi‐centre study conducted at diabetes specialist clinics in Italy that compared T2D patients who initiated dapagliflozin or GLP‐1RA (exenatide once weekly or liraglutide). Data were collected at baseline and at the first follow‐up visit after 3 to 12 months. The primary endpoint was the proportion of patients achieving a simultaneous reduction in HbA1c, body weight and systolic blood pressure. To reduce confounding, we used multivariable adjustment (MVA) or propensity score matching (PSM). Results Totals of 473 patients initiating dapagliflozin and 336 patients initiating GLP‐1RA were included. The two groups differed in age, diabetes duration, HbA1c, weight and concomitant medications. The median follow‐up was 6 months in both groups. Using MVA or PSM, the primary endpoint was observed in 30% to 32% of patients, with no difference between groups. Simultaneous reduction of HbA1c, BP and SBP by specific threshold, as well as achievement of final goals, did not differ between groups. GLP‐1RA reduced HbA1c by 0.3% more than the reduction achieved with dapagliflozin. Conclusion In routine specialist care, initiation of dapagliflozin can be as effective as initiation of a GLP‐1RA for attainment of combined risk factor goals.

Published
2019

11. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, Marigliano, M, Lepore G., Bonfanti R., Bozzetto L., Di Blasi V., Girelli A., Grassi G., Iafusco D., Laviola L., Rabbone I., Schiaffini R., Bruttomesso D., Mammi F., Bruzzese M., Schettino M., Nuzzo M. G., Fresa R., Lambiase C., Zanfardino A., Confetto S., Annuzzi G., Alderisio A., Riccardi G., Gentile S., Marino G., Guarino G., Zucchini S., Maltoni G., Suprani T., Graziani V., Nizzoli M., Acquati S., Cavani R., Romano S., Michelini M., Manicardi E., Bonadonna R., Dei Cas A., Dall'aglio E., Papi M., Riboni S., Manicardi V., Pugni V., Lasagni A., Street M. E., Pagliani U., Rossi C., Assaloni R., Brunato B., Tortul C., Zanette G., Li Volsi P., Zanatta M., Tonutti L., Agus S., Pellegrini M. A., Ceccano P., Pozzilli G., Anguissola B., Buzzetti R., Moretti C C., Leto G., Pozzilli P., Manfrini S., Maurizi A. R., Leotta S., Altomare M., Abbruzzese S., Carletti S., Suraci C., Filetti S., Manca Bitti M. L., Arcano S., Cavallo M. G., De Bernardinis M., Pitocco D., Caputo S., Rizzi A., Manto A., Cappa M., Benevento D., Frontoni S., Malandrucco I., Morano S., Filardi T., Lauro D., Marini M. A., Castaldo E., Sabato D., Tuccinardi F., Forte E., Viterbori P., Arnaldi C., Minuto N., d'Annunzio G., Corsi A., Rota R., Scaranna C., Trevisan R., Valentini U., Bonfadini S., Zarra E., Plebani A., Prandi E., Felappi B., Rocca A., Meneghini E., Galli P., Ruggeri P., Carrai E., Fugazza L., Baggi V., Conti D., Bosi E., Laurenzi A., Caretto A., Molinari C., Orsi E., Grancini V., Resi V., Favalli V., Bonura C., Rigamonti A., Bonomo M., Bertuzzi F., Pintaudi B., Disoteo O., Perseghin G., Perra S., Chiovato L., De Cata P., Zerbini F., Lovati E., Laneri M., Guerraggio L., Bossi A. C., De Mori V., Galetta M., Meloncelli I., Aiello A A., Di Vincenzo S., Nuzzi A., Fraticelli E., Ansaldi E., Battezzati M., Lombardi M., Balbo M., Lera R., Secco A., De Donno V., Cadario F., Savastio S., Ponzani C., Aimaretti G., Ignaccolo G., Tinti D., Cerutti F., Bari F., Giorgino F., Piccinno E., Zecchino O., Cignarelli M., Lamacchia O., Picca G., De Cosmo S., Rauseo A., Tomaselli L., Tumminia A., Egiziano C., Scarpitta A. M., Maggio F., Cardella F., Roppolo R., Provenzano V., Fleres M., Scorsone A., Scatena A., Gregori G., Lucchesi S., Gadducci F., Di Cianni S., Pancani S., Del Prato S., Aragona M., Crisci I., Calianno A., Fattor B., Crazzolara D., Reinstadler P., Longhi S., Incelli G., Rauch S., Romanelli T., Orrasch M., Cauvin V., Franceschi R., Lalli C., Pianta A., Marangoni A., Arico C. N., Marin N., Nogara N., Simioni N., Filippi A., Gidoni Guarneri G. L., Contin M. L M. L., Decata A. P., Bondesan L., Confortin L., Coracina A., Lombardi S., Costa Padova S., Cipponeri E., Scotton R., Galasso S., Boscari F., Zanon M. S., Vinci C., Lisato G., Gottardo L., Bonora E., Trombetta M., Negri C., Brangani C., Maffeis C., Sabbion A., Marigliano M., Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, Marigliano, M, Lepore G., Bonfanti R., Bozzetto L., Di Blasi V., Girelli A., Grassi G., Iafusco D., Laviola L., Rabbone I., Schiaffini R., Bruttomesso D., Mammi F., Bruzzese M., Schettino M., Nuzzo M. G., Fresa R., Lambiase C., Zanfardino A., Confetto S., Annuzzi G., Alderisio A., Riccardi G., Gentile S., Marino G., Guarino G., Zucchini S., Maltoni G., Suprani T., Graziani V., Nizzoli M., Acquati S., Cavani R., Romano S., Michelini M., Manicardi E., Bonadonna R., Dei Cas A., Dall'aglio E., Papi M., Riboni S., Manicardi V., Pugni V., Lasagni A., Street M. E., Pagliani U., Rossi C., Assaloni R., Brunato B., Tortul C., Zanette G., Li Volsi P., Zanatta M., Tonutti L., Agus S., Pellegrini M. A., Ceccano P., Pozzilli G., Anguissola B., Buzzetti R., Moretti C C., Leto G., Pozzilli P., Manfrini S., Maurizi A. R., Leotta S., Altomare M., Abbruzzese S., Carletti S., Suraci C., Filetti S., Manca Bitti M. L., Arcano S., Cavallo M. G., De Bernardinis M., Pitocco D., Caputo S., Rizzi A., Manto A., Cappa M., Benevento D., Frontoni S., Malandrucco I., Morano S., Filardi T., Lauro D., Marini M. A., Castaldo E., Sabato D., Tuccinardi F., Forte E., Viterbori P., Arnaldi C., Minuto N., d'Annunzio G., Corsi A., Rota R., Scaranna C., Trevisan R., Valentini U., Bonfadini S., Zarra E., Plebani A., Prandi E., Felappi B., Rocca A., Meneghini E., Galli P., Ruggeri P., Carrai E., Fugazza L., Baggi V., Conti D., Bosi E., Laurenzi A., Caretto A., Molinari C., Orsi E., Grancini V., Resi V., Favalli V., Bonura C., Rigamonti A., Bonomo M., Bertuzzi F., Pintaudi B., Disoteo O., Perseghin G., Perra S., Chiovato L., De Cata P., Zerbini F., Lovati E., Laneri M., Guerraggio L., Bossi A. C., De Mori V., Galetta M., Meloncelli I., Aiello A A., Di Vincenzo S., Nuzzi A., Fraticelli E., Ansaldi E., Battezzati M., Lombardi M., Balbo M., Lera R., Secco A., De Donno V., Cadario F., Savastio S., Ponzani C., Aimaretti G., Ignaccolo G., Tinti D., Cerutti F., Bari F., Giorgino F., Piccinno E., Zecchino O., Cignarelli M., Lamacchia O., Picca G., De Cosmo S., Rauseo A., Tomaselli L., Tumminia A., Egiziano C., Scarpitta A. M., Maggio F., Cardella F., Roppolo R., Provenzano V., Fleres M., Scorsone A., Scatena A., Gregori G., Lucchesi S., Gadducci F., Di Cianni S., Pancani S., Del Prato S., Aragona M., Crisci I., Calianno A., Fattor B., Crazzolara D., Reinstadler P., Longhi S., Incelli G., Rauch S., Romanelli T., Orrasch M., Cauvin V., Franceschi R., Lalli C., Pianta A., Marangoni A., Arico C. N., Marin N., Nogara N., Simioni N., Filippi A., Gidoni Guarneri G. L., Contin M. L M. L., Decata A. P., Bondesan L., Confortin L., Coracina A., Lombardi S., Costa Padova S., Cipponeri E., Scotton R., Galasso S., Boscari F., Zanon M. S., Vinci C., Lisato G., Gottardo L., Bonora E., Trombetta M., Negri C., Brangani C., Maffeis C., Sabbion A., and Marigliano M.

Abstract

Background and aim: The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII). Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals’ clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. <58 mmol/mol for age <18 years and [removed]18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis. Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia. Clinical trial registration number: NCT 02620917 (ClinicalTrials.gov).

Published
2018

13. Comparative Effectiveness of DPP-4 Inhibitors Versus Sulfonylurea for the Treatment of Type 2 Diabetes in Routine Clinical Practice: A Retrospective Multicenter Real-World Study

Author

Fadini, Gian Paolo, Bottigliengo, Daniele, D'Angelo, Federica, Cavalot, Franco, Bossi, Antonio Carlo, Zatti, Giancarlo, Baldi, Ileana, Avogaro, A, Consoli, A, Formoso, G, Grossi, G, Pucci, A, Sesti, G, Andreozzi, F, Capobianco, G, Gatti, A, Bonadonna, R, Zavaroni, I, Cas, Ad, Felace, G, Volsi, Pl, Buzzetti, R, Leto, G, Sorice, Gp, D'Angelo, P, Morano, S, Bossi, Ac, Duratorre, E, Franzetti, I, Morpurgo, Ps, Orsi, E, Querci, F, Boemi, M, D'Angelo, F, Petrelli, M, Aimaretti, G, Karamouzis, I, Cavalot, F, Saglietti, G, Cazzetta, G, Cervone, S, Devangelio, E, Lamacchia, O, Arena, S, Benedetto, Di, A, Frittitta, L, Giordano, C, Piro, S, Rizzo, M, Chianetta, R, Mannina, C, Anichini, R, Penno, G, Solini, A, Fattor, B, Bonora, E, Cigolini, M, Lapolla, A, Chilelli, Nc, Poli, M, Simioni, N, Frison, V, Vinci, C, Fadini G.P., Bottigliengo D., D'Angelo F., Cavalot F., Bossi A.C., Zatti G., Baldi I., Avogaro A., Consoli A., Formoso G., Grossi G., Pucci A., Sesti G., Andreozzi F., Capobianco G., Gatti A., Bonadonna R., Zavaroni I., Cas A.D., Felace G., Volsi P.L., Buzzetti R., Leto G., Sorice G.P., D'Angelo P., Morano S., Duratorre E., Franzetti I., Morpurgo P.S., Orsi E., Querci F., Boemi M., Petrelli M., Aimaretti G., Karamouzis I., Saglietti G., Cazzetta G., Cervone S., Devangelio E., Lamacchia O., Arena S., Di Benedetto A., Frittitta L., Giordano C., Piro S., Rizzo M., Chianetta R., Mannina C., Anichini R., Penno G., Solini A., Fattor B., Bonora E., Cigolini M., Lapolla A., Chilelli N.C., Poli M., Simioni N., Frison V., and Vinci C.

Subjects
endocrine system, medicine.medical_specialty, Epidemiology, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, 030204 cardiovascular system & hematology, Database, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Diabetes mellitus, Internal medicine, medicine, Clinical endpoint, Pharmacotherapy, Internal Medicine, Outpatient clinic, Gliclazide, Original Research, Glycemic, business.industry, nutritional and metabolic diseases, Retrospective cohort study, medicine.disease, Metformin, Diabetes and Metabolism, business, medicine.drug
Abstract

Introduction DPP-4 inhibitors (DPP4i) and sulfonylureas are popular second-line therapies for type 2 diabetes (T2D), but there is a paucity of real-world studies comparing their effectiveness in routine clinical practice. Methods This was a multicenter retrospective study on diabetes outpatient clinics comparing the effectiveness of DPP4i versus gliclazide extended release. The primary endpoint was change from baseline in HbA1c. Secondary endpoints were changes in fasting plasma glucose, body weight, and systolic blood pressure. Automated software extracted data from the same clinical electronic chart system at all centers. Propensity score matching (PSM) was used to generate comparable cohorts to perform outcome analysis. Results We included data on 2410 patients starting DPP4i and 1590 patients starting gliclazide (mainly 30–60 mg/day). At baseline, the two groups differed in disease duration, body weight, blood pressure, HbA1c, fasting glucose, HDL cholesterol, triglycerides, liver enzymes, eGFR, prevalence of microangiopathy, and use of metformin. Among DPP4i molecules, no difference in glycemic effectiveness was detected. In matched cohorts (n = 1316/group), patients starting DPP4i, as compared with patients starting gliclazide, experienced greater reductions in HbA1c (− 0.6% versus − 0.4%; p

Published
2018

14. Changes in the Prescription of Glucose-Lowering Medications in Patients With Type 2 Diabetes Mellitus After a Cardiovascular Event: A Call to Action From the DATAFILE Study

Author

Fadini, G, Frison, V, Simioni, N, Lapolla, A, Gatti, A, Bossi, A, Del Buono, A, Fornengo, P, Gottardo, L, Laudato, M, Perseghin, G, Bonora, E, Avogaro, A, Fadini, Gian Paolo, Frison, Vera, Simioni, Natalino, Lapolla, Annunziata, Gatti, Adriano, Bossi, Antonio Carlo, Del Buono, Andrea, Fornengo, Paolo, Gottardo, Lucia, Laudato, Mario, Perseghin, Gianluca, Bonora, Enzo, Avogaro, Angelo, Fadini, G, Frison, V, Simioni, N, Lapolla, A, Gatti, A, Bossi, A, Del Buono, A, Fornengo, P, Gottardo, L, Laudato, M, Perseghin, G, Bonora, E, Avogaro, A, Fadini, Gian Paolo, Frison, Vera, Simioni, Natalino, Lapolla, Annunziata, Gatti, Adriano, Bossi, Antonio Carlo, Del Buono, Andrea, Fornengo, Paolo, Gottardo, Lucia, Laudato, Mario, Perseghin, Gianluca, Bonora, Enzo, and Avogaro, Angelo

Abstract

Background: Evidence accumulated that some glucose-lowering medications protect against cardiovascular events (CVEs) in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease. The present study evaluated if and how glucose-lowering medication prescription pattern changes in T2DM after a CVE. Methods and Results: DATAFILE (Diabetes Therapy After a Cardiovascular Event) was a retrospective multicenter study conducted at 12 diabetes mellitus specialist outpatient clinics in Italy. We identified T2DM patients with an incident CVE for whom a follow-up visit was available after the event. We selected control T2DM patients without an incident CVE, who were matched with cases for age, sex, known diabetes mellitus duration, baseline hemoglobin A1c, kidney function, and follow-up time. We extracted clinical variables and compared prescribed therapies at baseline and follow-up. We included 563 patients with and 497 matched patients without an incident CVE. As expected, patients with a subsequent CVE had a higher baseline prevalence of ischemic heart disease. After a median of 9.5 months, in patients with versus those without a CVE, there was a significant increase in the prescription of beta-blockers, loop diuretics, dual antiplatelet therapy, and, among glucose-lowering medications, a significant decrease in metformin. Hemoglobin A1c marginally declined only in the control group, whereas low-density lipoprotein cholesterol decreased only in patients with CVE. Conclusions: This study highlights that occurrence of a CVE in T2DM patients did not prime the prescription of glucose-lowering medications provided with cardiovascular protective effects, even though glucose control remained poor. These data emphasize the need to optimize the therapeutic regimen of T2DM patients with established cardiovascular disease, according to updated guidelines.

Published
2019

16. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Lepore, Giuseppe, primary, Bonfanti, Riccardo, additional, Bozzetto, Lutgarda, additional, Di Blasi, Vincenzo, additional, Girelli, Angela, additional, Grassi, Giorgio, additional, Iafusco, Dario, additional, Laviola, Luigi, additional, Rabbone, Ivana, additional, Schiaffini, Riccardo, additional, Bruttomesso, Daniela, additional, Mammì, F., additional, Bruzzese, M., additional, Schettino, M., additional, Nuzzo, M.G., additional, Di Blasi, V., additional, Fresa, R., additional, Lambiase, C., additional, Iafusco, D., additional, Zanfardino, A., additional, Confetto, S., additional, Bozzetto, L., additional, Annuzzi, G., additional, Alderisio, A., additional, Riccardi, G., additional, Gentile, S., additional, Marino, G., additional, Guarino, G., additional, Zucchini, S., additional, Maltoni, G., additional, Suprani, T., additional, Graziani, V., additional, Nizzoli, M., additional, Acquati, S., additional, Cavani, R., additional, Romano, S., additional, Michelini, M., additional, Manicardi, E., additional, Bonadonna, R., additional, Dei Cas, A., additional, Dall'aglio, E., additional, Papi, M., additional, Riboni, S., additional, Manicardi, V., additional, Pugni, V., additional, Lasagni, A., additional, Street, M.E., additional, Pagliani, U., additional, Rossi, C., additional, Assaloni, R., additional, Brunato, B., additional, Tortul, C., additional, Zanette, G., additional, Li Volsi, P., additional, Zanatta, M., additional, Tonutti, L., additional, Agus, S., additional, Pellegrini, M.A., additional, Ceccano, P., additional, Pozzilli, G., additional, Anguissola, Beretta, additional, Buzzetti, R., additional, Moretti C, C., additional, Leto, G., additional, Pozzilli, P., additional, Manfrini, S., additional, Maurizi, A.R., additional, Leotta, S., additional, Altomare, M., additional, Abbruzzese, S., additional, Carletti, S., additional, Suraci, C., additional, Filetti, S., additional, Manca Bitti, M.L., additional, Arcano, S., additional, Cavallo, M.G., additional, De Bernardinis, M., additional, Pitocco, D., additional, Caputo, S., additional, Rizzi, A., additional, Manto, A., additional, Schiaffini, R., additional, Cappa, M., additional, Benevento, D., additional, Frontoni, S., additional, Malandrucco, I., additional, Morano, S., additional, Filardi, T., additional, Lauro, D., additional, Marini, M.A., additional, Castaldo, E., additional, Sabato, D., additional, Tuccinardi, F., additional, Forte, E., additional, Viterbori, P., additional, Arnaldi, C., additional, Minuto, N., additional, d'Annunzio, G., additional, Corsi, A., additional, Rota, R., additional, Scaranna, C., additional, Trevisan, R., additional, Valentini, U., additional, Girelli, A., additional, Bonfadini, S., additional, Zarra, E., additional, Plebani, A., additional, Prandi, E., additional, Felappi, B., additional, Rocca, A., additional, Meneghini, E., additional, Galli, P., additional, Ruggeri, P., additional, Carrai, E., additional, Fugazza, L., additional, Baggi, V., additional, Conti, D., additional, Bosi, E., additional, Laurenzi, A., additional, Caretto, A., additional, Molinari, C., additional, Orsi, E., additional, Grancini, V., additional, Resi, V., additional, Bonfanti, R., additional, Favalli, V., additional, Bonura, C., additional, Rigamonti, A., additional, Bonomo, M., additional, Bertuzzi, F., additional, Pintaudi, B., additional, Disoteo, O., additional, Perseghin, G., additional, Perra, S., additional, Chiovato, L., additional, De Cata, P., additional, Zerbini, F., additional, Lovati, E., additional, Laneri, M., additional, Guerraggio, L., additional, Bossi, A.C., additional, De Mori, V., additional, Galetta, M., additional, Meloncelli, I., additional, Aiello A, A., additional, Di Vincenzo, S., additional, Nuzzi, A., additional, Fraticelli, E., additional, Ansaldi, E., additional, Battezzati, M., additional, Lombardi, M., additional, Balbo, M., additional, Lera, R., additional, Secco, A., additional, De Donno, V., additional, Cadario, F., additional, Savastio, S., additional, Ponzani, C., additional, Aimaretti, G., additional, Rabbone, I., additional, Ignaccolo, G., additional, Tinti, D., additional, Cerutti, F., additional, Bari, F., additional, Giorgino, F., additional, Piccinno, E., additional, Zecchino, O., additional, Cignarelli, M., additional, Lamacchia, O., additional, Picca, G., additional, De Cosmo, S., additional, Rauseo, A., additional, Tomaselli, L., additional, Tumminia, A., additional, Egiziano, C., additional, Scarpitta, A.M., additional, Maggio, F., additional, Cardella, F., additional, Roppolo, R., additional, Provenzano, V., additional, Fleres, M., additional, Scorsone, A., additional, Scatena, A., additional, Gregori, G., additional, Lucchesi, S., additional, Gadducci, F., additional, Di Cianni, S., additional, Pancani, S., additional, Del Prato, S., additional, Aragona, M., additional, Crisci, I., additional, Calianno, A., additional, Fattor, B., additional, Crazzolara, D., additional, Reinstadler, P., additional, Longhi, S., additional, Incelli, G., additional, Rauch, S., additional, Romanelli, T., additional, Orrasch, M., additional, Cauvin, V., additional, Franceschi, R., additional, Lalli, C., additional, Pianta, A., additional, Marangoni, A., additional, Aricò, C.N., additional, Marin, N., additional, Nogara, N., additional, Simioni, N., additional, Filippi, A., additional, Gidoni Guarneri, G.L., additional, Contin M.L, M.L., additional, Decata, A.P., additional, Bondesan, L., additional, Confortin, L., additional, Coracina, A., additional, Lombardi, S., additional, Costa Padova, S., additional, Cipponeri, E., additional, Scotton, R., additional, Galasso, S., additional, Boscari, F., additional, Zanon, M.S., additional, Vinci, C., additional, Lisato, G., additional, Gottardo, L., additional, Bonora, E., additional, Trombetta, M., additional, Negri, C., additional, Brangani, C., additional, Maffeis, C., additional, Sabbion, A., additional, and Marigliano, M., additional

Published
2018
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17. Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes): A multicenter retrospective nationwide Italian study and crowdsourcing opportunity

Author

Fadini, G. P., Zatti, G., Consoli, A., Bonora, E., Sesti, G., Avogaro, Consoli A, A. DARWIN-T2D. Network., Formoso, G, Antenucci, D, Grossi, G, Pucci, A, Sesti, G, Andreozzi, F, Indrieri, L, Capobianco, G, Gatti, A, Bonadonna, R, Zavaroni, I, Dei Cas, A, Felace, G, Li Volsi, P, Buzzetti, R, Leto, G, D'Angelo, F, Morano, S, Giaccari, A, Sorice, G, Orsi, E, Carlo Bossi, A, Querci, F, Duratorre, E, Malagola, C, Franzetti, I, Silvia Morpurgo, P, Boemi, M, Petrelli, M, Aimaretti, G, Karamouzis, I, Cavalot, F, Saglietti, G, Gruden, G, Devangelio, E, Cazzetta, G, Lamacchia, O, Cervone, S, Frittitta, L, Arena, S, Di Benedetto, A, Piro, S, Giordano, C, Rizzo, M, Chianetta, R, Mannina, C, Solini, A, Natali, A, Anichini, R, Dotta, F, Fattor, B, Avogaro, A, Fadini, Gp, Bonora, E, Cigolini, M, Simioni, N, Frison, V, Poli, M, Lapolla, A, Cristiano Chilelli, N, Author information, Vinci C., Fadini, G, Zatti, G, Consoli, A, Bonora, E, Sesti, G, Avogaro, A, and Giordano, C

Subjects
randomized controlled trial, real-life, retrospective study, sodium glucose co-transporter-2 inhibitor, medicine (miscellaneous), endocrinology, diabetes and metabolism, nutrition and dietetics, cardiology and cardiovascular medicine, Blood Glucose, Time Factors, Glucoside, Glycated Hemoglobin A, Time Factor, Medicine (miscellaneous), Settore MED/13 - Endocrinologia, Endocrinology, Glucosides, Sodium-Glucose Transporter 2, Retrospective Studie, Diabetes Mellitus, Humans, Hypoglycemic Agents, Data Mining, Benzhydryl Compounds, Randomized controlled trial, Real-life, Retrospective study, Sodium glucose co-transporter-2 inhibitor, Biomarkers, Diabetes Mellitus, Type 2, Italy, Research Design, Retrospective Studies, Sodium-Glucose Transporter 2 Inhibitors, Treatment Outcome, Crowdsourcing, Evidence-Based Medicine, Endocrinology, Diabetes and Metabolism, Nutrition and Dietetics, Cardiology and Cardiovascular Medicine, Glycated Hemoglobin, Benzhydryl Compound, Hypoglycemic Agent, Sodium-Glucose Transporter 2 Inhibitor, Biomarker, Diabetes and Metabolism, Type 2, Human
Abstract

Background Randomized controlled trials (RCTs) in the field of diabetes have limitations inherent to the fact that design, setting, and patient characteristics may be poorly transferrable to clinical practice. Thus, evidence from studies using routinely accumulated clinical data are increasingly valued. Aims We herein describe rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes), a multicenter retrospective nationwide study conducted at 50 specialist outpatient clinics in Italy and promoted by the Italian Diabetes Society. Data synthesis The primary objective of the study is to describe the baseline clinical characteristics (particularly HbA1c) of patients initiated on dapagliflozin from marketing authorization approval to the end of 2016. Secondary and exploratory objectives will evaluate the changes in glycaemic and extraglycaemic efficacy parameters after initiation of dapagliflozin or after initiation of comparator glucose lowering medications (DPP-4 inhibitors, gliclazide extended release, and long-acting GLP-1 receptor agonists). An automated software will extract relevant data from the same electronic chart system at all centres, thereby minimizing data treatment and human intervention. Conclusion The study is expected to collect an enormous dataset of information on dapagliflozin- and comparator-using patients. After study completion, the Italian Diabetes Society will launch an open crowdsourcing call on the DARWIN-T2D database, challenging diabetes researchers to apply their ideas and approaches to address new unmet needs and knowledge gaps in diabetes. We believe this will move DARWIN-T2D to the next generation of real world studies.

Published
2017

18. Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes)

Author

Fadini, G.P., primary, Zatti, G., additional, Consoli, A., additional, Bonora, E., additional, Sesti, G., additional, Avogaro, A., additional, Formoso, G., additional, Antenucci, D., additional, Grossi, G., additional, Pucci, A., additional, Andreozzi, F., additional, Indrieri, L., additional, Capobianco, G., additional, Gatti, A., additional, Bonadonna, R., additional, Zavaroni, I., additional, Dei Cas, A., additional, Felace, G., additional, Li Volsi, P., additional, Buzzetti, R., additional, Leto, G., additional, D'Angelo, F., additional, Morano, S., additional, Giaccari, A., additional, Sorice, G., additional, Orsi, E., additional, Carlo Bossi, A., additional, Querci, F., additional, Duratorre, E., additional, Malagola, C., additional, Franzetti, I., additional, Silvia Morpurgo, P., additional, Boemi, M., additional, Petrelli, M., additional, Aimaretti, G., additional, Karamouzis, I., additional, Cavalot, F., additional, Saglietti, G., additional, Gruden, G., additional, Devangelio, E., additional, Cazzetta, G., additional, Lamacchia, O., additional, Cervone, S., additional, Frittitta, L., additional, Arena, S., additional, Di Benedetto, A., additional, Piro, S., additional, Giordano, C., additional, Rizzo, M., additional, Chianetta, R., additional, Mannina, C., additional, Solini, A., additional, Natali, A., additional, Anichini, R., additional, Dotta, F., additional, Fattor, B., additional, Fadini, G.P., additional, Cigolini, M., additional, Simioni, N., additional, Frison, V., additional, Poli, M., additional, Lapolla, A., additional, Cristiano Chilelli, N., additional, and Vinci, C., additional

Published
2017
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26. Combined chemotherapy with bleomycin, adriamycin, and platinum in advanced thyroid cancer

Author

Besi, Pietro, Busnardo, B., Toso, S., Girelli, M., Nacamulli, D., Simioni, N., Casara, D., Zorat, P., and Fiorentino, M.

Abstract

Twenty-two advanced consecutive thyroid cancer patients with varying histologies were treated with the so called BAP regime which consisted of bleomycin (B) 30 mg a day for three days, adriamycin (A) 60 mg/m2iv in day 5, and cisplatinum (P) 60 mg/m2iv in day 5. Patients with progressive, symptomatic recurrent or disseminated disease unresponsive to hormonal and/or isotopic treatment were eligible. Nine patients had an objective response: two long-lasting complete and seven partial responses were observed out of 21 evaluable patients. Stable disease was observed in four additional patients. The median duration of response was 12 months (range, 6–29). The total series experienced a median survival of 11 months (range, 1 to 57), with 2 patients actually disease free. Several histologic types of thyroid carcinoma responded, but the best responses were observed in medullary and anaplastic giant-cell carcinomas. Toxicity was reversible in all but one patient. Of the patients failing on BAP chemotherapy three responded to a four drug second line combination containing vincristine, fluorouracil, BCNU and methotrexate. BAP regime can achieve reasonable palliation, and probably increases survival, in poor-prognosis thyroid cancers.

Published
1991
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29. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Giuseppe Lepore, Riccardo Bonfanti, Lutgarda Bozzetto, Vincenzo Di Blasi, Angela Girelli, Giorgio Grassi, Dario Iafusco, Luigi Laviola, Ivana Rabbone, Riccardo Schiaffini, Daniela Bruttomesso, F. Mammì, M. Bruzzese, M. Schettino, M.G. Nuzzo, V. Di Blasi, R. Fresa, C. Lambiase, D. Iafusco, A. Zanfardino, S. Confetto, L. Bozzetto, G. Annuzzi, A. Alderisio, G. Riccardi, S. Gentile, G. Marino, G. Guarino, S. Zucchini, G. Maltoni, T. Suprani, V. Graziani, M. Nizzoli, S. Acquati, R. Cavani, S. Romano, M. Michelini, E. Manicardi, R. Bonadonna, A. Dei Cas, E. Dall'aglio, M. Papi, S. Riboni, V. Manicardi, V. Pugni, A. Lasagni, M.E. Street, U. Pagliani, C. Rossi, R. Assaloni, B. Brunato, C. Tortul, G. Zanette, P. Li Volsi, M. Zanatta, L. Tonutti, S. Agus, M.A. Pellegrini, P. Ceccano, G. Pozzilli, Beretta Anguissola, R. Buzzetti, C. Moretti C, G. Leto, P. Pozzilli, S. Manfrini, A.R. Maurizi, S. Leotta, M. Altomare, S. Abbruzzese, S. Carletti, C. Suraci, S. Filetti, M.L. Manca Bitti, S. Arcano, M.G. Cavallo, M. De Bernardinis, D. Pitocco, S. Caputo, A. Rizzi, A. Manto, R. Schiaffini, M. Cappa, D. Benevento, S. Frontoni, I. Malandrucco, S. Morano, T. Filardi, D. Lauro, M.A. Marini, E. Castaldo, D. Sabato, F. Tuccinardi, E. Forte, P. Viterbori, C. Arnaldi, N. Minuto, G. d'Annunzio, A. Corsi, R. Rota, C. Scaranna, R. Trevisan, U. Valentini, A. Girelli, S. Bonfadini, E. Zarra, A. Plebani, E. Prandi, B. Felappi, A. Rocca, E. Meneghini, P. Galli, P. Ruggeri, E. Carrai, L. Fugazza, V. Baggi, D. Conti, E. Bosi, A. Laurenzi, A. Caretto, C. Molinari, E. Orsi, V. Grancini, V. Resi, R. Bonfanti, V. Favalli, C. Bonura, A. Rigamonti, M. Bonomo, F. Bertuzzi, B. Pintaudi, O. Disoteo, G. Perseghin, S. Perra, L. Chiovato, P. De Cata, F. Zerbini, E. Lovati, M. Laneri, L. Guerraggio, A.C. Bossi, V. De Mori, M. Galetta, I. Meloncelli, A. Aiello A, S. Di Vincenzo, A. Nuzzi, E. Fraticelli, E. Ansaldi, M. Battezzati, M. Lombardi, M. Balbo, R. Lera, A. Secco, V. De Donno, F. Cadario, S. Savastio, C. Ponzani, G. Aimaretti, I. Rabbone, G. Ignaccolo, D. Tinti, F. Cerutti, F. Bari, F. Giorgino, E. Piccinno, O. Zecchino, M. Cignarelli, O. Lamacchia, G. Picca, S. De Cosmo, A. Rauseo, L. Tomaselli, A. Tumminia, C. Egiziano, A.M. Scarpitta, F. Maggio, F. Cardella, R. Roppolo, V. Provenzano, M. Fleres, A. Scorsone, A. Scatena, G. Gregori, S. Lucchesi, F. Gadducci, S. Di Cianni, S. Pancani, S. Del Prato, M. Aragona, I. Crisci, A. Calianno, B. Fattor, D. Crazzolara, P. Reinstadler, S. Longhi, G. Incelli, S. Rauch, T. Romanelli, M. Orrasch, V. Cauvin, R. Franceschi, C. Lalli, A. Pianta, A. Marangoni, C.N. Aricò, N. Marin, N. Nogara, N. Simioni, A. Filippi, G.L. Gidoni Guarneri, M.L. Contin M.L, A.P. Decata, L. Bondesan, L. Confortin, A. Coracina, S. Lombardi, S. Costa Padova, E. Cipponeri, R. Scotton, S. Galasso, F. Boscari, M.S. Zanon, C. Vinci, G. Lisato, L. Gottardo, E. Bonora, M. Trombetta, C. Negri, C. Brangani, C. Maffeis, A. Sabbion, M. Marigliano, Lepore, Giuseppe, Bonfanti, Riccardo, Bozzetto, Lutgarda, Di Blasi, Vincenzo, Girelli, Angela, Grassi, Giorgio, Iafusco, Dario, Laviola, Luigi, Rabbone, Ivana, Schiaffini, Riccardo, Bruttomesso, Daniela, Lepore, G., Bonfanti, R., Bozzetto, L., Di Blasi, V., Girelli, A., Grassi, G., Iafusco, D., Laviola, L., Rabbone, I., Schiaffini, R., Bruttomesso, D., Mammi, F., Bruzzese, M., Schettino, M., Nuzzo, M. G., Fresa, R., Lambiase, C., Zanfardino, A., Confetto, S., Annuzzi, G., Alderisio, A., Riccardi, G., Gentile, S., Marino, G., Guarino, G., Zucchini, S., Maltoni, G., Suprani, T., Graziani, V., Nizzoli, M., Acquati, S., Cavani, R., Romano, S., Michelini, M., Manicardi, E., Bonadonna, R., Dei Cas, A., Dall'Aglio, E., Papi, M., Riboni, S., Manicardi, V., Pugni, V., Lasagni, A., Street, M. E., Pagliani, U., Rossi, C., Assaloni, R., Brunato, B., Tortul, C., Zanette, G., Li Volsi, P., Zanatta, M., Tonutti, L., Agus, S., Pellegrini, M. A., Ceccano, P., Pozzilli, G., Anguissola, B., Buzzetti, R., Moretti C, C., Leto, G., Pozzilli, P., Manfrini, S., Maurizi, A. R., Leotta, S., Altomare, M., Abbruzzese, S., Carletti, S., Suraci, C., Filetti, S., Manca Bitti, M. L., Arcano, S., Cavallo, M. G., De Bernardinis, M., Pitocco, D., Caputo, S., Rizzi, A., Manto, A., Cappa, M., Benevento, D., Frontoni, S., Malandrucco, I., Morano, S., Filardi, T., Lauro, D., Marini, M. A., Castaldo, E., Sabato, D., Tuccinardi, F., Forte, E., Viterbori, P., Arnaldi, C., Minuto, N., D'Annunzio, G., Corsi, A., Rota, R., Scaranna, C., Trevisan, R., Valentini, U., Bonfadini, S., Zarra, E., Plebani, A., Prandi, E., Felappi, B., Rocca, A., Meneghini, E., Galli, P., Ruggeri, P., Carrai, E., Fugazza, L., Baggi, V., Conti, D., Bosi, E., Laurenzi, A., Caretto, A., Molinari, C., Orsi, E., Grancini, V., Resi, V., Favalli, V., Bonura, C., Rigamonti, A., Bonomo, M., Bertuzzi, F., Pintaudi, B., Disoteo, O., Perseghin, G., Perra, S., Chiovato, L., De Cata, P., Zerbini, F., Lovati, E., Laneri, M., Guerraggio, L., Bossi, A. C., De Mori, V., Galetta, M., Meloncelli, I., Aiello A, A., Di Vincenzo, S., Nuzzi, A., Fraticelli, E., Ansaldi, E., Battezzati, M., Lombardi, M., Balbo, M., Lera, R., Secco, A., De Donno, V., Cadario, F., Savastio, S., Ponzani, C., Aimaretti, G., Ignaccolo, G., Tinti, D., Cerutti, F., Bari, F., Giorgino, F., Piccinno, E., Zecchino, O., Cignarelli, M., Lamacchia, O., Picca, G., De Cosmo, S., Rauseo, A., Tomaselli, L., Tumminia, A., Egiziano, C., Scarpitta, A. M., Maggio, F., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Scorsone, A., Scatena, A., Gregori, G., Lucchesi, S., Gadducci, F., Di Cianni, S., Pancani, S., Del Prato, S., Aragona, M., Crisci, I., Calianno, A., Fattor, B., Crazzolara, D., Reinstadler, P., Longhi, S., Incelli, G., Rauch, S., Romanelli, T., Orrasch, M., Cauvin, V., Franceschi, R., Lalli, C., Pianta, A., Marangoni, A., Arico, C. N., Marin, N., Nogara, N., Simioni, N., Filippi, A., Gidoni Guarneri, G. L., Contin, M. L M. L., Decata, A. P., Bondesan, L., Confortin, L., Coracina, A., Lombardi, S., Costa Padova, S., Cipponeri, E., Scotton, R., Galasso, S., Boscari, F., Zanon, M. S., Vinci, C., Lisato, G., Gottardo, L., Bonora, E., Trombetta, M., Negri, C., Brangani, C., Maffeis, C., Sabbion, A., Marigliano, M., Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, and Marigliano, M

Subjects
Blood Glucose, Male, Pediatrics, Acute and chronic complication, Glycated Hemoglobin A, Time Factors, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Medicine (miscellaneous), Ketosi, Infusions, Subcutaneous, Settore MED/13 - Endocrinologia, Acute and chronic complications, Continuous subcutaneous insulin infusion (CSII), Diabetes mellitus, Metabolic control, Nutrition and Dietetics, Cardiology and Cardiovascular Medicine, 0302 clinical medicine, Endocrinology, Adolescent, Adult, Albuminuria, Biomarkers, Child, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Diabetic Retinopathy, Female, Health Care Surveys, Humans, Hypertension, Hypoglycemia, Hypoglycemic Agents, Insulin, Italy, Ketosis, Middle Aged, Risk Factors, Treatment Outcome, Young Adult, Insulin Infusion Systems, 030212 general & internal medicine, Subcutaneous, Diabetic retinopathy, Diabetes and Metabolism, medicine.symptom, Type 2, Human, Type 1, Insulin pump, Infusions, medicine.medical_specialty, Diabetes mellitu, Time Factor, 030209 endocrinology & metabolism, 03 medical and health sciences, medicine, Cross-Sectional Studie, Glycated Hemoglobin, Type 1 diabetes, Hypoglycemic Agent, business.industry, Risk Factor, Biomarker, medicine.disease, Ketoacidosis, Infusions, Subcutaneou, Health Care Survey, Diabetic Nephropathie, business
Abstract

Background and aim: The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII). Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals’ clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. 18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis. Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia. Clinical trial registration number: NCT 02620917 (ClinicalTrials.gov).

Published
2018

30. Changes in the Prescription of Glucose‐Lowering Medications in Patients With Type 2 Diabetes Mellitus After a Cardiovascular Event: A Call to Action From the DATAFILE Study

Author

Gianluca Perseghin, Mario Laudato, Annunziata Lapolla, Andrea Del Buono, Lucia Gottardo, Antonio Bossi, A. Gatti, Angelo Avogaro, Vera Frison, Enzo Bonora, Paolo Fornengo, Gian Paolo Fadini, Natalino Simioni, Fadini, G, Frison, V, Simioni, N, Lapolla, A, Gatti, A, Bossi, A, Del Buono, A, Fornengo, P, Gottardo, L, Laudato, M, Perseghin, G, Bonora, E, and Avogaro, A

Subjects
Male, Complications, endocrine system diseases, Epidemiology, Myocardial Infarction, Myocardial Ischemia, Angiotensin-Converting Enzyme Inhibitors, 030204 cardiovascular system & hematology, appropriateness, 0302 clinical medicine, Sodium Potassium Chloride Symporter Inhibitors, Myocardial Revascularization, Secondary Prevention, 030212 general & internal medicine, Practice Patterns, Physicians', Original Research, Quality and Outcomes, diabetes mellitu, Dual Anti-Platelet Therapy, Diabetes, Type 2, Middle Aged, Metformin, Call to action, Italy, Cardiovascular Diseases, diabetes mellitus, appropriatene, Female, Cardiology and Cardiovascular Medicine, Cardiovascular event, medicine.medical_specialty, Adrenergic beta-Antagonists, Glucagon-Like Peptide-1 Receptor, Angiotensin Receptor Antagonists, 03 medical and health sciences, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, In patient, Medical prescription, MED/13 - ENDOCRINOLOGIA, Sodium-Glucose Transporter 2 Inhibitors, Aged, Glycated Hemoglobin, Heart Failure, Glucose lowering, business.industry, nutritional and metabolic diseases, Type 2 Diabetes Mellitus, pharmacology, Cholesterol, LDL, medicine.disease, Diabetes Mellitus, Type 2, Hydroxymethylglutaryl-CoA Reductase Inhibitors, business
Abstract

Background Evidence accumulated that some glucose‐lowering medications protect against cardiovascular events ( CVEs ) in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease. The present study evaluated if and how glucose‐lowering medication prescription pattern changes in T2DM after a CVE. Methods and Results DATAFILE (Diabetes Therapy After a Cardiovascular Event) was a retrospective multicenter study conducted at 12 diabetes mellitus specialist outpatient clinics in Italy. We identified T2DM patients with an incident CVE for whom a follow‐up visit was available after the event. We selected control T2DM patients without an incident CVE , who were matched with cases for age, sex, known diabetes mellitus duration, baseline hemoglobin A 1c , kidney function, and follow‐up time. We extracted clinical variables and compared prescribed therapies at baseline and follow‐up. We included 563 patients with and 497 matched patients without an incident CVE . As expected, patients with a subsequent CVE had a higher baseline prevalence of ischemic heart disease. After a median of 9.5 months, in patients with versus those without a CVE , there was a significant increase in the prescription of beta‐blockers, loop diuretics, dual antiplatelet therapy, and, among glucose‐lowering medications, a significant decrease in metformin. Hemoglobin A 1c marginally declined only in the control group, whereas low‐density lipoprotein cholesterol decreased only in patients with CVE . Conclusions This study highlights that occurrence of a CVE in T2DM patients did not prime the prescription of glucose‐lowering medications provided with cardiovascular protective effects, even though glucose control remained poor. These data emphasize the need to optimize the therapeutic regimen of T2DM patients with established cardiovascular disease, according to updated guidelines.

Published
2019
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31. Changes in markers of hepatic steatosis and fibrosis in patients with type 2 diabetes during treatment with glucagon-like peptide-1 receptor agonists. A multicenter retrospective longitudinal study.

Author

Morieri ML, Targher G, Lapolla A, D'Ambrosio M, Tadiotto F, Rigato M, Frison V, Paccagnella A, Simioni N, Avogaro A, and Fadini GP

Subjects
Biomarkers, Humans, Longitudinal Studies, Retrospective Studies, Diabetes Mellitus, Type 2 drug therapy, Glucagon-Like Peptide-1 Receptor antagonists & inhibitors, Glucagon-Like Peptide-1 Receptor therapeutic use, Liver Cirrhosis diagnosis
Abstract

Aims: Metabolic dysfunction-associated fatty liver disease (MAFLD) is common in people with type 2 diabetes (T2D) and can progress to advanced fibrosis and cirrhosis. In this retrospective study, we explored the longitudinal changes in markers of hepatic steatosis and fibrosis during T2D treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs)., Methods: We analysed observational data from six diabetes outpatient clinics. In the whole T2D population, we calculated the hepatic steatosis index (HSI), which we previously validated against liver ultrasonography, and the Fibrosis (Fib)-4 index. We then identified patients who initiated a GLP-1RA from 2010 to 2018 and for whom data were available to evaluate changes in both HSI and Fib-4 scores over 24 months., Results: From 83,116 outpatients with T2D, 41,302 (49.7%) had complete data for calculating HSI and Fib-4. Most of these T2D patients (∼70%) had MAFLD (defined as HSI>36), 9.7% of whom had advanced fibrosis based on Fib-4 thresholds. Patients with low compared to high risk of advanced fibrosis were 5-times more likely to be treated with GLP-1RA. In 535 patients who initiated a GLP-1RA, the prevalence of MAFLD based on HSI declined significantly at 6 and 24 months, but Fib-4 categories did not. HSI improved significantly only in patients receiving human-based but not exendin-based GLP-1RA, while patients concomitantly receiving metformin had less worsening in Fib-4 categories., Conclusions: MAFLD is very common among outpatients with T2D (∼70%) and the estimated prevalence of advanced fibrosis was ∼10%. Treatment with GLP-1RAs significantly improved MAFLD, but not MAFLD-associated advanced fibrosis., Competing Interests: Declaration of competing interest MLM received grant support, lecture fees, or advisory board fees from Servier, Eli Lilly, Novo Nordisk, Merck Sharp & Dohme, Amryt, and Mylan. MR received lecture and advisory board fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Mundipharma, Novo Nordisk. VF served as consultant for NovoNordisk. NS received lecture or consultancy fees from Astra-Zeneca, Boehringer-Lilly, Novartis, NovoNordisk, Sanofi-Aventis, Takeda, Merck Sharp & Dohme, and Abbott and research support from NovoNordisk. AL received grant support, lecture or advisory board fees from Novo Nordisk, Sanofi, Abbott, and Eli Lilly. AA received research grants, lecture fees, or advisory board fees from Merck Sharp & Dome, AstraZeneca, Novartis, Boehringer Ingelheim, Sanofi, Mediolanum, Janssen, Novo Nordisk, Eli Lilly, Servier, and Takeda. GPF. received grant support, lecture fees, or advisory board fees from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Sanofi, Genzyme, Servier, and Merck Sharp & Dohme. The remaining authors have nothing to disclose., (Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Published
2021
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32. Deintensification of basal-bolus insulin after initiation of GLP-1RA in patients with type 2 diabetes under routine care.

Author

Bonora BM, Rigato M, Frison V, D'Ambrosio M, Tadiotto F, Lapolla A, Simioni N, Paccagnella A, Avogaro A, and Fadini GP

Subjects
Female, Humans, Hypoglycemic Agents pharmacology, Insulin pharmacology, Male, Middle Aged, Retrospective Studies, Diabetes Mellitus, Type 2 drug therapy, Glucagon-Like Peptide-1 Receptor therapeutic use, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
Abstract

Aims: We evaluated de-intensification of basal-bolus insulin (BBI) after initiation of a GLP-1 receptor agonist (GLP-1RA) under routine care., Research Design and Methods: This retrospective, multicenter study conducted at outpatient clinics in North-East Italy collected data on patients with T2D on BBI who initiated a GLP-1RA. Patients were divided according to whether they de-intensified BBI at the end of observation by stopping prandial insulin., Results: We included 425 patients with mean age of 61.3 years and 13 years of diabetes duration. Baseline HbA1c was 8.6% and BMI was 35.5 kg/m 2 . After 14 months. 58.6% of patients de-intensified BBI after initiating GLP-1RA: they were younger, had a shorter disease duration, lower HbA1c and insulin dose, and less frequent microangiopathy than those who continued BBI. A probability estimation based on these variables was validated in an independent cohort of 40 patients. Body weight improved in both groups, but HbA1c and fasting plasma glucose significantly declined only among patients who de-intensified BBI. Patients who de-intensified BBI and persisted on GLP-1RA at the last observation (80.7%) had greater HbA1c reductions., Conclusion: Under routine care, GLP-1RA initiation frequently allowed discontinuing BBI, especially among patients with shorter disease duration, lower insulin requirement, and better glucose control., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: B.M.B. received lecture or advisory board fees from Astra Zeneca, Eli Lilly, Boehringer Ingelheim, Novo Nordisk and Novartis. M.R. received lecture and advisory board fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Mundipharma, Novo Nordisk. V.F. served as consultant for NovoNordisk. N.S. received lecture or consultancy fees from Astra-Zeneca, Boehringer-Lilly, Novartis, NovoNordisk, Sanofi-Aventis, Takeda, Merck Sharp & Dohme, and Abbott and research support from NovoNordisk. A.L. received grant support, lecture or advisory board fees from Novo Nordisk, Sanofi, Abbott, and Eli Lilly. A.A. received research grants, lecture fees, or advisory board fees from Merck Sharp & Dome, AstraZeneca, Novartis, Boehringer Ingelheim, Sanofi, Mediolanum, Janssen, Novo Nordisk, Eli Lilly, Servier, and Takeda. G.P.F. received grant support, lecture fees, or advisory board fees from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Sanofi, Genzyme, Servier, and Merck Sharp & Dohme. The remaining authors have nothing to disclose., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Published
2021
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33. Real-World Evaluation of Glycemic Outcomes and Extra-Glycemic Parameters in Diabetic Patients Treated with the Combined Formulation Degludec-Liraglutide (Ideglira).

Author

Zenari L, Da Porto A, De Moliner L, Lugli F, Guazzoni V, Groppelli G, Molteni L, Bracaccia M, Frison V, Simioni N, Bonsembiante B, Miranda C, and Lapolla A

Abstract

Introduction: Combination therapy with both basal insulin (BI) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) is an effective treatment in patients with uncontrolled type 2 diabetes mellitus (T2DM). The recent development and release of a fixed-ratio combination of slow-release insulin degludec and the GLP-1RA liraglutide (IDegLira) represents an improvement to this therapy. We have conducted a real-world evidence study in Italian patients with T2DM to evaluate whether the encouraging clinical trial results obtained with IDegLira, which became available in Italy in January 2018, can be confirmed in Italian clinical practice., Methods: This was a multicenter, retrospective, observational study in patients with T2DM treated with IDegLira from January to December 2018. Prior to the initiation of IDegLira therapy, patients were treated with BI with or without one or more concomitant oral antidiabetic drugs (BOT group) or according to the basal bolus protocol (BI and rapid-acting insulin treatment; BB group)., Results: A total of 244 patients were included in the present study, of whom 186 were in the BOT group and 58 in the BB group. Following the switch to IDegLira therapy, glycemic control improved in both groups, with significant reductions in glycated hemoglobin after 6 and 12 months of treatment in the BOT group and after 6 months of treatment in the BB group. No gain in body weight and body mass index and reductions in fasting plasma glucose and number of concomitant diabetic medications (in BOT patients) were observed. All results obtained during the study were achieved at a moderate dose of IDegLira., Conclusion: The findings from this study show that in a real-world setting, the switch to IDegLira treatment is a valid option for patients who are failing to achieve glycemic control targets and/or struggling with the side effects, such as weight gain and hypoglycemia, of other insulin therapies.

Published
2021
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34. Effectiveness of Dulaglutide in the Real World and in Special Populations of Type 2 Diabetic Patients.

Author

Morieri ML, Frison V, Rigato M, D'Ambrosio M, Tadiotto F, Paccagnella A, Simioni N, Lapolla A, Avogaro A, and Fadini GP

Subjects
Aged, Blood Glucose, Diabetes Mellitus, Type 2 blood, Female, Glucagon-Like Peptides administration & dosage, Glucagon-Like Peptides therapeutic use, Glycated Hemoglobin, Humans, Hypoglycemic Agents administration & dosage, Immunoglobulin Fc Fragments administration & dosage, Male, Middle Aged, Recombinant Fusion Proteins administration & dosage, Retrospective Studies, Treatment Outcome, Body Weight drug effects, Diabetes Mellitus, Type 2 drug therapy, Glucagon-Like Peptides analogs & derivatives, Hypoglycemic Agents therapeutic use, Immunoglobulin Fc Fragments therapeutic use, Recombinant Fusion Proteins therapeutic use, Weight Loss drug effects
Abstract

Context: In randomized controlled trials (RCTs) on type 2 diabetes (T2D) patients, the glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-RA) dulaglutide reduced HbA1c and body weight, but generalizability of such findings to real-world T2D patients is challenging., Objective: We evaluated effectiveness of dulaglutide in routine clinical practice, especially in subgroups of patient that are underrepresented in RCTs., Design: Retrospective multicenter study., Setting: Diabetes outpatient clinics., Patients and Intervention: All consecutive patients who initiated dulaglutide between 2015 and 2018., Main Outcome Measures: Changes in HbA1c and body weight were assessed up to 30 months after baseline. Effectiveness was analyzed in patient subgroups according to: prior use of GLP-1RA, persistence on treatment and dose, age, sex, disease duration, renal function, obesity, cardiovascular disease, or concomitant use of insulin or sulphonylurea., Results: From a background population of 83,116 patients, 2084 initiated dulaglutide (15.3% switching from another GLP-1RA), 1307 of whom had at least 1 follow-up visit. Overall, dulaglutide reduced HbA1c by 1.0% and body weight by 2.9 kg at the end of observation. These effects were more pronounced in GLP-1RA-naïve patients and in those with shorter disease duration. Improvement in HbA1c was highly significant and consistent across all subgroups, including those aged ≥ 75 years, nonobese, or with chronic kidney disease. Body weight declined in all subgroups and significantly more with the 1.5-mg versus 0.75-mg dose., Conclusions: In real-world T2D patients, effectiveness of dulaglutide on HbA1c and body weight reduction was highly consistent and significant even in subgroups of patients poorly represented in RCTs., (© Endocrine Society 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2020
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35. Effectiveness of dulaglutide vs liraglutide and exenatide once-weekly. A real-world study and meta-analysis of observational studies.

Author

Morieri ML, Rigato M, Frison V, Simioni N, D'Ambrosio M, Tadiotto F, Paccagnella A, Lapolla A, Avogaro A, and Fadini GP

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Young Adult, Drug Administration Schedule, Drug Therapy, Combination, Follow-Up Studies, Observational Studies as Topic statistics & numerical data, Retrospective Studies, Treatment Outcome, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 epidemiology, Exenatide administration & dosage, Exenatide adverse effects, Glucagon-Like Peptides administration & dosage, Glucagon-Like Peptides adverse effects, Glucagon-Like Peptides analogs & derivatives, Immunoglobulin Fc Fragments administration & dosage, Immunoglobulin Fc Fragments adverse effects, Liraglutide administration & dosage, Liraglutide adverse effects, Recombinant Fusion Proteins administration & dosage, Recombinant Fusion Proteins adverse effects
Abstract

Introduction and Aim: Real-word data on the head-to-head comparisons among glucagon-like peptide-1 receptor agonists (GLP-1RA) are scant. Therefore, we aimed to compare the effectiveness of dulaglutide versus liraglutide and exenatide once weekly (exeOW) in type 2 diabetic (T2D) patients under routine care., Methods: This was a retrospective, multicenter, real-world study on patients with T2D (aged 18-80) initiating a GLP-1RA between 2010 and 2018 at specialist outpatient clinics. We compared the effectiveness of dulaglutide versus liraglutide and exeOW on the changes in HbA1c (primary outcome), body weight, blood pressure and fasting glucose (secondary outcomes). Average follow-up was 5.9 months. Channelling biases were addressed with propensity score matching or multivariable adjustment. Meta-analyses of observational studies, covering the same comparisons, are also presented., Results: 849, 1371 and 198 patients were included in the dulaglutide, liraglutide and exeOW groups, respectively. The reduction of HbA1c was greater with dulaglutide than with liraglutide (-0.24 ± 0.08%; p = 0.003), and was confirmed in the meta-analysis of observational studies. In our study, dulaglutide showed similar effectiveness compared to exeOW. When these results were pooled with other observational studies, dulaglutide showed a greater reduction of HbA1c (-0.19%; p = 0.003) and body weight (-0.8 kg; p = 0.007)., Conclusions: In a real-world scenario, dulaglutide reduced HbA1c more than liraglutide. Conversely, we found similar effect of dulaglutide and exeOW, with statistical differences arising solely when results were meta-analysed with those from other observational studies. Lack of up-titration for liraglutide and higher discontinuation rate for exeOW likely influenced the estimated treatment difference., Competing Interests: Declaration of competing interest MLM received grant support or lecture fees from Servier and Amryt. MR received lecture and advisory board fees from AstraZeneca, Boehringer-Ingelheim, Novonordisk and Sanofi Aventis. VF served as consultant for NovoNordisk. NS received lecture or consultancy fees from Astra-Zeneca, Boehringer-Lilly, Novartis, NovoNordisk, Sanofi-Aventis, Takeda, Merck Sharp & Dohme, Abbott and research support from NovoNordisk. AL received grant support, lectures or advisory board fees from Novo Nordisk, Sanofi, Abbott, Eli Lilly. AA received research grants, lecture or advisory board fees from Merck Sharp & Dome, AstraZeneca, Novartis, Boeringher-Ingelheim, Sanofi, Mediolanum, Janssen, Novo Nordisk. GPF received grant support, lecture or advisory board fees from Abbott, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Mundipharma, NovoNordisk, Novartis, Merck Sharp & Dohme, Sanofi, Genzyme. FT, and MDA declare no conflict of interest., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Published
2020
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36. Trend 2010-2018 in the clinical use of GLP-1 receptor agonists for the treatment of type 2 diabetes in routine clinical practice: an observational study from Northeast Italy.

Author

Fadini GP, Frison V, Rigato M, Morieri ML, Simioni N, Tadiotto F, D'Ambrosio M, Paccagnella A, Lapolla A, and Avogaro A

Subjects
Aged, Blood Glucose metabolism, Blood Pressure, Body Mass Index, Body Weight, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 2 physiopathology, Female, Glycated Hemoglobin metabolism, Humans, Italy epidemiology, Lipids blood, Male, Middle Aged, Prevalence, Retrospective Studies, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents administration & dosage, Glucagon-Like Peptide-1 Receptor Agonists
Abstract

Aims: Several GLP-1 receptor agonists (GLP-1RA) have become available for the treatment of type 2 diabetes (T2D), and evidence on their beneficial effects has evolved. We evaluated how the clinical phenotype of patients initiating GLP-1RA changed from 2010 to 2018., Methods: This was a retrospective study conducted at six diabetes outpatient clinics in Northeast Italy. We collected data of T2D patients who initiated new GLP-1RA between 2010 and 2018. We recorded baseline characteristics, including demographics, anthropometrics, cardiovascular risk factors, glucose control, lipid profile, liver enzymes, renal function and concomitant medications. We recorded updated HbA1c and body weight at follow-up., Results: There were 83,116 T2D patients from a general population of ~ 1,380,000 inhabitants. Among 6167 cases of GLP-1RA initiation, 5408 were analyzed after excluding intra-class switchers. Prescription of GLP-1RA increased exponentially, and the change in the type of GLP-1RA reflected waves of their entering the market. From 2010 to 2018, there were significant increases in baseline age, diabetes duration and prevalence of male sex, of cardiovascular disease and of insulin users. Blood pressure and cholesterol levels decreased concomitantly with increasing use of medications for the control of cardiovascular risk. Baseline average HbA1c (8.3% [67 mmol/mol]) and BMI (34 kg/m 2 ) and their improvement after GLP-1RA initiation did not change over time., Conclusions: Despite the early positioning of GLP-1RA in T2D treatment algorithms, GLP-1RA have been prescribed in patients with progressively more advanced disease stage and especially in the presence of cardiovascular disease. Optimization of GLP-1RA use in routine clinical practice is still needed.

Published
2020
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37. Fixed versus flexible combination of GLP-1 receptor agonists with basal insulin in type 2 diabetes: A retrospective multicentre comparative effectiveness study.

Author

Morieri ML, Rigato M, Frison V, Simioni N, D'Ambrosio M, Tadiotto F, Paccagnella A, Lapolla A, Avogaro A, and Fadini GP

Subjects
Aged, Blood Glucose, Drug Therapy, Combination, Female, Glucagon-Like Peptide-1 Receptor administration & dosage, Glycated Hemoglobin, Humans, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Male, Middle Aged, Retrospective Studies, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Glucagon-Like Peptide-1 Receptor Agonists
Abstract

Background and Aims: The combination of basal insulin (BI) and GLP-1 receptor agonists (GLP-1RAs) is a rational and effective therapy for patients with uncontrolled type 2 diabetes (T2D). We compared the effectiveness of fixed and flexible BI/GLP-1RA combinations using routinely accumulated clinical data., Methods: This was a retrospective, multicentre, real-world study concerning T2D patients initiating a fixed or flexible BI/GLP-1RA combination (NCT03959865). The primary endpoint was change in HbA1c. Secondary endpoints were changes in body weight, fasting plasma glucose (FPG) and systolic blood pressure (SBP). Confounding was addressed by propensity score matching (PSM) or multivariable adjustment (MVA)., Results: A total of 609 patients were included in the study, 131 in the fixed group and 478 in the flexible group. The two groups differed in terms of diabetes duration, body weight and concomitant medications. After 5.7 months, observed HbA1c reductions were 0.6% and 0.8%, and body weight reductions were 2.8 kg and 1.2 kg in the flexible and fixed groups, respectively. Following PSM, HbA1c declined similarly in the two groups, whereas reduction in body weight was significantly in favour of the flexible combination. Findings were robust in sensitivity analyses, with the exception that, with MVA, a significantly higher reduction in HbA1c was detected in the fixed group. Final doses of BI were higher in the fixed group, whereas those of GLP-1RA were higher in the flexible group., Conclusions: In routine specialist care, initiation of the fixed or flexible BI/GLP-1RA combination allowed similar improvement in glycaemic control, but greater weight loss was observed with the flexible combination. This difference reflected dosages of BI and GLP-1RAs., (© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Published
2019
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38. Changes in the Prescription of Glucose-Lowering Medications in Patients With Type 2 Diabetes Mellitus After a Cardiovascular Event: A Call to Action From the DATAFILE Study.

Author

Fadini GP, Frison V, Simioni N, Lapolla A, Gatti A, Bossi AC, Del Buono A, Fornengo P, Gottardo L, Laudato M, Perseghin G, Bonora E, and Avogaro A

Subjects
Adrenergic beta-Antagonists therapeutic use, Aged, Angiotensin Receptor Antagonists therapeutic use, Angiotensin-Converting Enzyme Inhibitors therapeutic use, Cardiovascular Diseases complications, Cholesterol, LDL, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 metabolism, Dual Anti-Platelet Therapy, Female, Glycated Hemoglobin metabolism, Heart Failure complications, Heart Failure drug therapy, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Italy, Male, Metformin therapeutic use, Middle Aged, Myocardial Infarction complications, Myocardial Infarction drug therapy, Myocardial Ischemia complications, Myocardial Ischemia drug therapy, Myocardial Revascularization, Sodium Potassium Chloride Symporter Inhibitors therapeutic use, Cardiovascular Diseases drug therapy, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use, Practice Patterns, Physicians' statistics & numerical data, Sodium-Glucose Transporter 2 Inhibitors therapeutic use, Glucagon-Like Peptide-1 Receptor Agonists
Abstract

Background Evidence accumulated that some glucose-lowering medications protect against cardiovascular events ( CVEs ) in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease. The present study evaluated if and how glucose-lowering medication prescription pattern changes in T2DM after a CVE. Methods and Results DATAFILE (Diabetes Therapy After a Cardiovascular Event) was a retrospective multicenter study conducted at 12 diabetes mellitus specialist outpatient clinics in Italy. We identified T2DM patients with an incident CVE for whom a follow-up visit was available after the event. We selected control T2DM patients without an incident CVE , who were matched with cases for age, sex, known diabetes mellitus duration, baseline hemoglobin A 1c , kidney function, and follow-up time. We extracted clinical variables and compared prescribed therapies at baseline and follow-up. We included 563 patients with and 497 matched patients without an incident CVE . As expected, patients with a subsequent CVE had a higher baseline prevalence of ischemic heart disease. After a median of 9.5 months, in patients with versus those without a CVE , there was a significant increase in the prescription of beta-blockers, loop diuretics, dual antiplatelet therapy, and, among glucose-lowering medications, a significant decrease in metformin. Hemoglobin A 1c marginally declined only in the control group, whereas low-density lipoprotein cholesterol decreased only in patients with CVE . Conclusions This study highlights that occurrence of a CVE in T2DM patients did not prime the prescription of glucose-lowering medications provided with cardiovascular protective effects, even though glucose control remained poor. These data emphasize the need to optimize the therapeutic regimen of T2DM patients with established cardiovascular disease, according to updated guidelines.

Published
2019
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39. Comparative effectiveness of exenatide once-weekly versus liraglutide in routine clinical practice: A retrospective multicentre study and meta-analysis of observational studies.

Author

Fadini GP, Bonora BM, Lapolla A, Fattor B, Morpurgo PS, Simioni N, and Avogaro A

Subjects
Adult, Blood Glucose drug effects, Blood Glucose metabolism, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 epidemiology, Drug Administration Schedule, Female, Glycated Hemoglobin drug effects, Glycated Hemoglobin metabolism, Humans, Hypoglycemic Agents administration & dosage, Male, Observational Studies as Topic statistics & numerical data, Primary Health Care statistics & numerical data, Retrospective Studies, Treatment Outcome, Diabetes Mellitus, Type 2 drug therapy, Exenatide administration & dosage, Liraglutide administration & dosage
Abstract

In this study, we retrospectively compared the effectiveness of exenatide once-weekly (ExeOW) versus liraglutide in non-insulin treated patients with type 2 diabetes followed under routine care. We also present a meta-analysis of similar observational studies available in the literature. In our multicentre retrospective study, patients initiating ExeOW (n = 204) or liraglutide (n = 410) had similar baseline clinical characteristics. Change in HbA1c at 6 months was superimposable in the two groups (-0.7% ± 1.0%), and changes in body weight were also similar (ExeOW -2.2 ± 3.7 kg; liraglutide -2.5 ± 4.3 kg; p = 0.457). Discontinuation rates were numerically but not significantly lower for ExeOW versus liraglutide. Pooling these data with those of observational studies available in the literature yielded superimposable effects between the two groups for the change in HbA1c and body weight, with a higher risk of discontinuation (mainly based on pharmacy refill rates) for ExeOW. We conclude that, in patients under routine care, initiation of ExeOW provides similar benefits on HbA1c and body weight as initiation of liraglutide. These data help view the results of randomized controlled trials from the perspective of their application in routine clinical practice., (© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Published
2019
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40. Clinical Impact of 5 Years of Liraglutide Treatment on Cardiovascular Risk Factors in Patients with Type 2 Diabetes Mellitus in a Real-Life Setting in Italy: An Observational Study.

Author

Frison V, Simioni N, Marangoni A, Balzano S, Vinci C, Zenari L, De Moliner L, Tadiotto F, D'Ambrosio M, Confortin L, Marin N, Lombardi S, Costa S, Prosperini G, and Lapolla A

Abstract

Introduction: Based on existing data regarding the durability of liraglutide in type 2 diabetes, this study aimed to assess its long-term effectiveness at 5 years and its overall impact on cardiovascular (CV) risk., Methods: This was a multicenter retrospective observational study. Liraglutide was used under routine clinical practice conditions. Changes from baseline to 60 months in HbA1c, fasting plasma glucose (FPG), body weight, blood pressure, and lipid profile were assessed. United Kingdom Prospective Diabetes Study (UKPDS) scores were calculated at baseline and after 60 months to assess changes in the estimated 5- and 10-year risk for fatal and nonfatal coronary heart disease (CHD) and fatal and nonfatal stroke., Results: Overall, 103 patients (age 59.0 ± 7.9 years, diabetes duration 10.4 ± 6.8 years) were involved in the study. After 60 months, HbA1c levels were reduced by - 1.0 ± 1.2%, FPG levels by - 24.5 ± 43.4 mg/dl, body weight by - 5.3 ± 6.4 kg, systolic blood pressure by - 6.5 ± 18.5 mmHg, diastolic blood pressure by - 3.6 ± 11.8 mmHg, and total cholesterol by - 16.9 ± 37.4 mg/dl. The proportion of patients achieving HbA1c levels  of < 7% increased from 12.7% to 39.8% (p = 0.02). Based on the UKPDS scores, statistically significant reductions in the 5- and 10-year risk of nonfatal CHD and fatal CHD were found, with no change in the 5- and 10-year risk of fatal and nonfatal stroke., Conclusion: In patients prolonging treatment with liraglutide for 5 years, the benefits in relation to metabolic control and CV risk factors are maintained. The UKPDS risk scores suggest that liraglutide is associated with a reduced CHD risk, but not with a reduced stroke risk.

Published
2018
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41. Prevalence and predictors of no lifetime utilization of mental health treatment among people with mental disorders in France: findings from the 'Mental Health in General Population' (MHGP) survey.

Author

Font H, Roelandt JL, Behal H, Geoffroy PA, Pignon B, Amad A, Simioni N, Vaiva G, Thomas P, Duhamel A, Benradia I, and Rolland B

Subjects
Adult, Aged, Female, France epidemiology, Humans, Male, Mental Disorders therapy, Middle Aged, Prevalence, Prognosis, Young Adult, Mental Disorders epidemiology, Mental Health Services statistics & numerical data, Patient Acceptance of Health Care statistics & numerical data
Abstract

Purpose: No lifetime utilization of mental health treatment (NUMT) is an indicator of the treatment gap among people in need of treatment. Until now, the overall prevalence and predictors of NUMT have never been explored in France., Methods: In a 39,617-respondent survey, participants were assessed for NUMT, i.e., no lifetime psychotherapy, psychopharmacotherapy, or psychiatric hospitalization. Mental disorders were investigated using the Mini International Neuropsychiatric Interview (MINI 5.0.0). MINI diagnoses were grouped into five categories: mood disorders (MDs); anxiety disorders (ADs); alcohol use disorders (AUDs); substance use disorders (SUDs); and psychotic disorders (PDs). Using multivariable logistic regression models, we explored the factors associated with NUMT among the MINI-positive respondents. The odds ratio and 95% confidence interval were calculated for each factor., Results: In total, 12,818 (32.4%) respondents were MINI-positive, 46.5% of them reported NUMT (35.6% for MDs, 39.7% for PDs, 42.8% for ADs, 56.0% for AUDs, and 56.7% for SUDs). NUMT was positively associated with being male [OR 1.75 (1.59-1.91)] and practising religion [OR 1.13 (1.02-1.25)] and negatively associated with ageing [per 10-year increase: OR 0.88 (0.85-0.91)], being single [OR 0.74 (0.66-0.84)], being a French native [OR 0.67 (0.60-0.75)], and experiencing MDs [OR 0.39 (0.36-0.43)], ADs [OR 0.47 (0.43-0.52)], AUDs [OR 0.83 (0.73-0.96)], SUDs [OR 0.77 (0.65-0.91)], or PDs [OR 0.50 (0.43-0.59)]., Conclusions: In France, NUMT rates were the highest for AUDs and SUDs. Additionally, suffering from MDs or ADs increased the lifetime treatment utilization for people having any other mental disorder. This finding emphasizes the need to better screen AUDs and SUDs among people treated for MDs or ADs.

Published
2018
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42. Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study.

Author

Lapolla A, Berra C, Boemi M, Bossi AC, Candido R, Di Cianni G, Frontoni S, Genovese S, Ponzani P, Provenzano V, Russo GT, Sciangula L, Simioni N, Bette C, and Nicolucci A

Subjects
Adult, Aged, Body Weight drug effects, Female, Glycated Hemoglobin analysis, Humans, Italy, Longitudinal Studies, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use, Liraglutide therapeutic use
Abstract

Introduction: The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice., Methods: ReaL was a multicenter, non-interventional, observational, retrospective, longitudinal study on the effectiveness of liraglutide, a human glucagon-like peptide-1 analog, in individuals with T2D treated in daily practice in Italy. Between 26 March and 16 November 2015, data were taken from clinical records of patients aged ≥ 18 years with treatment follow-up data of up to 24 months and who received their first prescription of liraglutide in 2011., Results: A total of 1723 patients were included in the analysis. At baseline, mean age was 58.9 years, duration of diabetes was 9.6 years, and HbA1c was 8.3%. At 12 months, 36.1% of patients were prescribed the maximum 1.8 mg dose; 43.5% [95% confidence interval (CI): 40.9; 46.2] of patients attained the primary outcome of a reduction in HbA1c of ≥ 1% point at 12 months. At 24 months, 40.9% (95% CI 38.1; 43.7) of patients had attained the HbA1c target of ≤ 7%. Additionally, body weight significantly decreased by 3.4 kg (95% CI - 3.6; - 3.1, p < 0.0001)., Conclusion: In this observational study conducted in routine clinical practice for up to 2 years, treatment with liraglutide improved HbA1c and reduced body weight in a similar fashion to that observed under randomized clinical trial conditions. The data support the use of liraglutide as an effective treatment for T2D in clinical practice., Funding: Novo Nordisk S.p.A., Trial Registration: ClinicalTrials.gov identifier, NCT02255266.

Published
2018
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43. Thirty- Versus Ten-Day Diazepam Treatment for Alcohol Detoxification and a Comparison of Drinking Patterns, Craving, and Anxiety for up to 12 Weeks: A "Proof-of-Concept" Open-Label Randomized Controlled Trial.

Author

Simioni N, Labreuche J, Behal H, Cottencin O, and Rolland B

Subjects
Adult, Alcoholism blood, Diazepam administration & dosage, Drug Administration Schedule, Female, GABA Modulators administration & dosage, Humans, Male, Middle Aged, Pilot Projects, Proof of Concept Study, Transferrin analogs & derivatives, Transferrin analysis, Alcohol Abstinence, Alcoholism drug therapy, Anxiety drug therapy, Craving drug effects, Diazepam pharmacology, GABA Modulators pharmacology, Outcome Assessment, Health Care
Abstract

Purpose: The aim of this study was to evaluate whether a prolonged detoxification treatment could decrease the relapse rate at 3 months after alcohol cessation in alcohol-dependent individuals through decreasing the levels of postdetoxification craving and anxiety., Methods: Twenty-six adult patients with alcohol dependence (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) who began an outpatient alcohol cessation program with an initial drinking goal of abstinence were enrolled in a 3-month, parallel, randomized (1:1 ratio), controlled, open-label, pilot trial. Participants were randomized to receive a detoxification treatment of diazepam with a duration of 30 (n = 12) or 10 days (n = 14). All participants received BRENDA-based psychotherapy during follow-up., Results: No significant between-group difference in relapse to any drinking was found at 3 months (P = 0.20). However, relapse to any heavy drinking at 3 months and regular drinking or heavy drinking during follow-up were significantly lower in the 30-day diazepam group (P = 0.009, P = 0.049, and P = 0.004, respectively). These differences were corroborated by significant differences in the alcohol-specific biological marker carbohydrate deficient transferrin at 3 months. Participants in the 30-day diazepam group also displayed significantly lower scores for alcohol craving (P = 0.007), self-reported anxiety (P = 0.024), and clinician-assessed anxiety (P = 0.002) throughout the follow-up. No serious adverse event was reported during the study., Conclusion: This study provides an evidence-based rationale for a double-blind, randomized, placebo-controlled trial to confirm the efficacy of such a procedure on short-term and mid-/long-term drinking outcomes after alcohol cessation in alcohol-dependent individuals.

Published
2017
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44. Efficacy and Safety of Insulin Degludec for Hyperglycemia Management in Noncritical Hospitalized Patients with Diabetes: An Observational Study.

Author

Simioni N, Filippi A, Scardapane M, Nicolucci A, Rossi MC, and Frison V

Abstract

Introduction: To assess the efficacy and safety of insulin degludec administered in a basal-bolus regimen according to the GesTIO protocol in noncritical hospitalized patients with T1DM and T2DM., Methods: Mean blood glucose levels (BG) and their standard deviations (SD) at admission vs. discharge were compared in 52 subjects (48.1% ≥75 years) managed through a basal-bolus scheme including degludec. The percentages of patients with BG at target (140-180 mg/dl) or below at discharge and the incidence rate (and the 95% confidence interval for it) of hypoglycemia were assessed., Results: From admission to discharge, fasting BG decreased from 237 to 153 mg/dl (p < 0.0001) and SD dropped from 125 to 38 mg/dl (p < 0.0001); average BG decreased from 189 to 145 mg/dl (SD dropped from 57 to 32 mg/dl). At discharge, 28.9% had BG at target, while 50.0% had lower levels (average 119.0 ± 14.4 mg/dl). The incidence rate of hypoglycemia was 0.07 (0.05; 0.11) episodes per person-day; 1 out of 27 episodes occurred during the night., Conclusions: Degludec in hospitalized, mainly elderly patients is effective and minimizes glucose variability and nocturnal hypoglycemia.

Published
2017
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45. The dose-effect relationship of baclofen in alcohol dependence: A 1-year cohort study.

Author

Pignon B, Labreuche J, Auffret M, Gautier S, Deheul S, Simioni N, Cottencin O, Bordet R, Duhamel A, and Rolland B

Subjects
Adult, Alcohol Drinking, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Male, Middle Aged, Proportional Hazards Models, Treatment Outcome, Alcohol Deterrents administration & dosage, Alcoholism drug therapy, Baclofen administration & dosage
Abstract

Objective: Our aim is to study the relationship between dose of baclofen and effectiveness in alcohol dependence., Methods: Two hundred two patients with alcohol dependence, who received baclofen treatment for drinking reduction, were followed up for 1 year. For each patient-month of treatment, the maximum daily dose of baclofen (DDB) and average weekly alcohol consumption (AWAC) were calculated. We defined a favorable drinking outcome as an AWAC under 200 g/w for at least 2 consecutive months. We divided the DDB of each patient-month into 3 categories (low dose: <90 mg/d, medium dose: 90-150 mg/d, and high dose: >150 mg/d) and investigated the relationship between reaching a favorable outcome and the concurrent DDB category in a time-varying Cox regression analysis. Hazard ratios (HRs) were adjusted based on age, sex, and initial AWAC., Results: One hundred forty subjects were followed during at least 1 month. Of these patients, 58 (41%) had a favorable drinking outcome. In comparison to low dose, medium dose was associated with a decreased rate of favorable drinking outcome (HR = 0.42; 95% CI [0.20, 0.88]), whereas no difference was found with high dose (HR = 1.31; 95% CI [0.65, 2.64])., Conclusion: The relationship between dose of baclofen and favorable drinking outcome was U-shaped, that is, was increased at low and high doses compared to medium doses., (Copyright © 2017 John Wiley & Sons, Ltd.)

Published
2017
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46. Characteristics of Patients with Alcohol Dependence Seeking Baclofen Treatment in France: A Two-Centre Comparative Cohort Study.

Author

Simioni N, Preda C, Deken V, Bence C, Cottencin O, and Rolland B

Subjects
Female, France, Humans, Male, Middle Aged, Retrospective Studies, Alcoholism drug therapy, Baclofen therapeutic use, GABA-B Receptor Agonists therapeutic use, Patient Acceptance of Health Care statistics & numerical data
Abstract

Aim: To characterize the profile of patients seeking baclofen treatment for alcohol dependence in France., Method: We compared retrospectively baclofen seekers and baclofen non-seekers within a cohort of consecutive outpatients with alcohol dependence who attended a first appointment for alcohol treatment at two French addiction centres between September 2012 and March 2014. We documented socio-demographic characteristics; comorbid psychiatric, addiction, alcohol dependence features; patients' initial drinking goal, and referral status; and treatment retention at 6 and 12 months., Results: Of the 289 patients identified, 107 were baclofen seekers and 182 were baclofen non-seekers. The only parameters significantly associated with baclofen seekers in multivariate analyses were a greater baseline alcohol consumption (β = 15.4, 95% CI: 0.18-30.65, P = 0.05), a controlled-drinking initial goal (OR = 14.9, 95% CI: 7.7-29, P < 0.0001) and self-referral (OR = 6.6, 95% CI: 3.7-12, P < 0.0001), baclofen seekers being eight times more likely to be self-referred and treatment-naïve (OR = 8.8, 95% CI: 4.1-18.9, P < 0.0001). Baclofen seekers were more likely to be retained in treatment at 6 months (OR = 3.5, 95% CI: 1.8-6.7, P < 0.0001) and 12 months (OR = 1.9, 95% CI: 1.1-3.2, P = 0.019)., Conclusion: In France, the perspective of controlled drinking offered by baclofen treatment may have attracted more self-referred patients, including those without previous alcohol treatment, to attend treatment, than the usual treatment options. These findings raise the question as to whether future public health strategies on alcohol should more prominently promote some aspects of alcohol treatment, such as patient's preference and treatment options, in order to reduce the treatment gap in alcohol dependence., (© The Author 2016. Medical Council on Alcohol and Oxford University Press. All rights reserved.)

Published
2016
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48. Interventions for Increasing Alcohol Treatment Utilization Among Patients with Alcohol Use Disorders from Emergency Departments: A Systematic Review.

Author

Simioni N, Rolland B, and Cottencin O

Subjects
Humans, Alcohol-Related Disorders therapy, Emergency Service, Hospital, Patient Acceptance of Health Care
Abstract

Aim: Alcohol use disorders (AUDs) are characterized by low treatment coverage. Emergency departments (EDs) have great potential to increase alcohol treatment coverage. While ED-based brief interventions (BIs) are rarely effective for reducing alcohol use and related consequences in people with AUDs, utilization of formal alcohol treatment has been demonstrated to be useful. Thus we conducted a systematic review to determine efficacious interventions for increasing subsequent alcohol treatment from EDs., Methods: A systematic search of the literature up to 31 December 2013 was undertaken in three electronic databases: PubMed, PsycINFO and The Cochrane Library. Only randomized controlled trials (RCTs), controlled clinical trials (CCTs) and non-randomized controlled trials (NRCTs) were included. A meta-analysis was judged inappropriate because of substantial discrepancies in term of interventions' characteristics across studies., Results: From the 2182 identified records, 7 studies (4RCTs, 2 CCTs, 1NRCT) met inclusion criteria. Onsite brief advice (BA) was found efficacious in comparison to no active control condition, but no evidence of efficacy was found when compared to active control conditions. Referral to post-discharge BIs was not found efficacious either used alone or in addition to onsite BA. There is evidence, albeit limited, suggesting that more intensive interventions, such as referral to extended post-discharge interventions and onsite extended BI, might be useful., Conclusions: Based on the available evidence, onsite BA with leaflets appears to be the minimum level of intervention since it enables to actively intervene while fitting in the time concerns experienced in EDs. Further research is needed to confirm these findings given the limited quantity and quality of existing data and to determine whether more intensive interventions could actually be useful., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Published
2015
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49. Resurgence of anorexic symptoms during smoking cessation in patients with a history of anorexia nervosa: An unseen problem?--Report of two cases.

Author

Simioni N and Cottencin O

Subjects
Adult, Binge-Eating Disorder etiology, Female, Humans, Middle Aged, Recurrence, Weight Gain physiology, Anorexia Nervosa etiology, Smoking Cessation
Abstract

This report describes a resurgence of anorexic symptoms during a smoking cessation program in two patients with a history of anorexia nervosa. These two events were identified among patients lost to follow-up by using a strategy implemented to limit early drop out. In both cases, the resurgence of anorexic symptoms occurred rapidly after having reached abstinence from tobacco and was described as a response to the weight gain they had experienced just after the start of smoking cessation. The smoking cessation process itself was considered as the most plausible explanation for these two events. Given the potential serious consequences, further research is needed to determine whether such events are frequent during smoking cessation but being unseen because of being hidden in the loss to follow-up. This report also suggests that systematic screening for both binge eating and anorexic behaviors during smoking cessation is warranted., (© 2015 Wiley Periodicals, Inc.)

Published
2015
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50. [Temporary recommendation for use on off-label baclofen: viewpoint of Prescribers of the CAMTEA system].

Author

Rolland B, Deheul S, Danel T, Bence C, Blanquart MC, Bonord A, Semal R, Briand T, Sochala M, Dubocage C, Dupriez F, Duquesne D, Gibour B, Loosfeld X, Henebelle D, Henon M, Vernalde E, Matton C, Bacquet JE, Molmy L, Sarasy F, Simioni N, Richez C, Gentil-Spinosi L, Vosgien V, Yguel J, Ledent T, Auffret M, Wilquin M, Ziolkowski D, Sochala M, Gautier S, Bordet R, and Cottencin O

Subjects
Baclofen administration & dosage, Dose-Response Relationship, Drug, France, Humans, Alcoholism drug therapy, Baclofen therapeutic use, Off-Label Use, Practice Patterns, Physicians' statistics & numerical data
Abstract

The use of high dose baclofen for alcohol-dependence emerged in France from 2008 based on empirical findings, and is still off-label. However, due to the rapid increase in this prescribing practice, the French health authorities have decided to frame it using an extraordinary regulatory measure named "temporary recommendation for use" (TRU). Baclofen prescribers from CAMTEA, a regional team-based off-label system for supervising baclofen prescribing, which was developed much prior to the TRU, discuss herein the pros and cons of this measure and the applicability of its different aspects in the daily clinical practice., (© 2014 Société Française de Pharmacologie et de Thérapeutique.)

Published
2015
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