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29 results on '"Calatola, P"'

1. A different derivation of conservation laws for water waves

Author

Oliveras, Katie L and Calatola-Young, Salvatore

Subjects
Mathematics - Analysis of PDEs, Mathematical Physics
Abstract

We consider a new nonlocal formulation of the water-wave problem for a free surface with an irrotational flow based on the work of Ablowitz, Fokas, and Musslimani and presented in the recent work of Oliveras. The main focus of the short paper is to show how one can systematically derive Olver's eight conservation laws not only for an irrotational fluid, but also for constant vorticity (linear shear flow) without explicitly relying on the underlying Lie symmetries. This allows us to make draw new conclusions about conservation laws and posit the existence of additional, nonlocal, conservation laws for the water-wave problem.

Published
2021

2. Sex-difference of multifactorial intervention on cardiovascular and mortality risk in DKD: post-hoc analysis of a randomised clinical trial.

Author

Minutolo, Roberto, Simeon, Vittorio, De Nicola, Luca, Chiodini, Paolo, Galiero, Raffaele, Rinaldi, Luca, Caturano, Alfredo, Vetrano, Erica, Sardu, Celestino, Marfella, Raffaele, Sasso, Ferdinando Carlo, Amelia, U., Acierno, C., Calatola, P., Carbonara, O., Caturano, A., Conte, G., Corigliano, G., Corigliano, M., and D'Urso, R.

Subjects
TYPE 2 diabetes, CARDIOVASCULAR diseases risk factors, THERAPEUTICS, PHYSICIANS, BLOOD pressure
Abstract

Objective: Women with type 2 diabetes experience higher cardiovascular and mortality risk than men possibly because of a sub-optimal cardio-protective treatment. We evaluated whether an intensive multifactorial therapy (MT) produces similar protective effect on development of adverse outcomes in women and men. Research design and methods: Nephropathy in Diabetes type 2 study is an open-label cluster randomized trial comparing the effect of Usual Care (UC) or MT of main cardiovascular risk factors (blood pressure < 130/80 mmHg, HbA1c < 7%, LDL < 100 mg/dL, and total cholesterol < 175 mg/dL) on cardiovascular and mortality risk in patients with type 2 diabetes. In this post-hoc analysis, we stratified patients by sex to compare the occurrence of MACEs (primary endpoint) and all-cause death (secondary endpoint) between women (104 MT and 105 UC) and men (103 MT and 83 UC). Results: Achievement of therapeutic goals was similar by sex, with 44% and 47% of women and men in MT achieving at least 3 targets vs. 16% and 20% of women and men in UC. During a median follow-up of 13.0 years, we recorded 262 MACE (48.5% in women) and 189 deaths (53.6% in women). Compared to the UC group, the risk of MACE in the MT group was reduced by 52% in women and by 44% in men (P = 0.11). Conversely, the reduction in mortality risk by MT was greater in women (44% versus 12%, P = 0.019). Conclusions: MT similarly reduces the risk of MACEs in either sex. This therapeutic approach is associated with a survival advantage in women as compared with men and it may represent an important rationale to motivate physicians in overcoming their therapeutic inertia often encountered in female patients as well as to encourage patients of both sexes at improving their adherence to multidrug therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Efficacy and durability of multifactorial intervention on mortality and MACEs:a randomized clinical trial in type-2 diabetic kidney disease

Author

Sasso, F. C., Pafundi, Pia Clara, Simeon, Vittorio, De Nicola, L., Chiodini, Paolo, Galiero, Raffaele, Rinaldi, Luca, Nevola, Riccardo, Salvatore, Teresa, Sardu, Celestino, Marfella, Raffaele, Adinolfi, Luigi Elio, Minutolo, R., Amelia, U., Acierno, C., Calatola, P., Carbonara, O., Caturano, A., Conte, G., Corigliano, G., Corigliano, M., D’Urso, R., De Matteo, A., De Rosa, N., Del Vecchio, E., Di Giovanni, G., Gatti, A., Gentile, S., Gesuè, L., Improta, L., Lampitella, A., Lanzilli, A., Lascar, N., Masi, S., Mattei, P., Mastrilli, V., Memoli, P., Nasti, R., Pagano, A., Pentangelo, M., Pisa, E., Rossi, E., Sorrentino, S., Torella, R., Troise, R., Trucillo, P., and NID-2 Study Group Investigators

Abstract

Background: Multiple modifiable risk factors for late complications in patients with diabetic kidney disease (DKD), including hyperglycemia, hypertension and dyslipidemia, increase the risk of a poor outcome. DKD is associated with a very high cardiovascular risk, which requires simultaneous treatment of these risk factors by implementing an intensified multifactorial treatment approach. However, the efficacy of a multifactorial intervention on major fatal/non-fatal cardiovascular events (MACEs) in DKD patients has been poorly investigated. Methods: Nephropathy in Diabetes type 2 (NID-2) study is a multicentre, cluster-randomized, open-label clinical trial enrolling 395 DKD patients with albuminuria, diabetic retinopathy (DR) and negative history of CV events in 14 Italian diabetology clinics. Centres were randomly assigned to either Standard-of-Care (SoC) (n = 188) or multifactorial intensive therapy (MT, n = 207) of main cardiovascular risk factors (blood pressure < 130/80 mmHg, glycated haemoglobin < 7%, LDL, HDL and total cholesterol < 100 mg/dL, > 40/50 mg/dL for men/women and < 175 mg/dL, respectively). Primary endpoint was MACEs occurrence by end of follow-up phase. Secondary endpoints included single components of primary endpoint and all-cause death. Results: At the end of intervention period (median 3.84 and 3.40 years in MT and SoC group, respectively), targets achievement was significantly higher in MT. During 13.0 years (IQR 12.4–13.3) of follow-up, 262 MACEs were recorded (116 in MT vs. 146 in SoC). The adjusted Cox shared-frailty model demonstrated 53% lower risk of MACEs in MT arm (adjusted HR 0.47, 95%CI 0.30–0.74, P = 0.001). Similarly, all-cause death risk was 47% lower (adjusted HR 0.53, 95%CI 0.29–0.93, P = 0.027). Conclusion: MT induces a remarkable benefit on the risk of MACEs and mortality in high-risk DKD patients. Clinical Trial Registration ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT00535925

Published
2021

5. The number of risk factors not at target is associated with cardiovascular risk in a type 2 diabetic population with albuminuria in primary cardiovascular prevention. Post-hoc analysis of the NID-2 trial.

Author

Sasso, Ferdinando Carlo, Simeon, Vittorio, Galiero, Raffaele, Caturano, Alfredo, De Nicola, Luca, Chiodini, Paolo, Rinaldi, Luca, Salvatore, Teresa, Lettieri, Miriam, Nevola, Riccardo, Sardu, Celestino, Docimo, Giovanni, Loffredo, Giuseppe, Marfella, Raffaele, Adinolfi, Luigi Elio, Minutolo, Roberto, NID-2 study group Investigators, Amelia, U, Acierno, C, and Calatola, P

Subjects
DIABETIC nephropathies, MAJOR adverse cardiovascular events, CARDIOVASCULAR diseases risk factors, TYPE 2 diabetes, CLUSTER randomized controlled trials, ALBUMINURIA
Abstract

Background: Nephropathy in Diabetes type 2 (NID-2) study is an open-label cluster randomized clinical trial that demonstrated that multifactorial intensive treatment reduces Major Adverse Cardiac Events (MACEs) and overall mortality versus standard of care in type 2 diabetic subjects with albuminuria and no history of cardiovascular disease. Aim of the present post-hoc analysis of NID- 2 study is to evaluate whether the number of risk factors on target associates with patient outcomes. Methods: Intervention phase lasted four years and subsequent follow up for survival lasted 10 years. To the aim of this post-hoc analysis, the whole population has been divided into 3 risk groups: 0–1 risk factor (absent/low); 2–3 risk factors (intermediate); 4 risk factors (high). Primary endpoint was a composite of fatal and non-fatal MACEs, the secondary endpoint was all-cause death at the end of the follow-up phase. Results: Absent/low risk group included 166 patients (52.4%), intermediate risk group 128 (40.4%) and high-risk group 23 (7.3%). Cox model showed a significant higher risk of MACE and death in the high-risk group after adjustment for confounding variables, including treatment arm (HR 1.91, 95% CI 1.04–3.52, P = 0.038 and 1.96, 95%CI 1.02–3.8, P = 0,045, respectively, vs absent/low risk group). Conclusions: This post-hoc analysis of the NID-2 trial indicates that the increase in the number of risk factors at target correlates with better cardiovascular-free survival in patients with type 2 diabetes at high CV risk. Clinical Trial Registration: ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT00535925 [ABSTRACT FROM AUTHOR]

Published
2022
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6. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study

Author

Vitale, M, Masulli, M, Rivellese, A, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo, P, Giorgino, F, Gnasso, A, Mannucci, E, Mazzotti, A, Nappo, R, Palena, A, Pata, P, Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, A, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, Capuano, G, Vitale M., Masulli M., Rivellese A. A., Bonora E., Cappellini F., Nicolucci A., Squatrito S., Antenucci D., Barrea A., Bianchi C., Bianchini F., Fontana L., Fornengo P., Giorgino F., Gnasso A., Mannucci E., Mazzotti A., Nappo R., Palena A. P., Pata P., Perriello G., Potenziani S., Radin R., Ricci L., Romeo F., Santini C., Scarponi M., Serra R., Timi A., Turco A. A., Vedovato M., Zavaroni D., Grioni S., Riccardi G., Vaccaro O., Cocozza S., Auciello S., Cigolini M., Pichiri I., Brangani C., Tomasetto E., Sinagra T., Longhitano S., Tropea V., Ballardini G., Babini A. C., Ripani R., Gregori G., Dolci M., Bruselli L., Salutini I., Mori M., Baccetti F., Lapolla A., Sartore G., Burlina S., Chilelli N. C., Buzzetti R., Venditti C., Carlone A., Galluzzo A., Giordano C., Torregrossa V., Corsi L., Cuneo G., Corsi S., Tizio B., Galluzzo G., Citro G., Natale M., Salvatore V., Di Cianni G., Lacaria E., Russo L., Iannarelli R., De Gregorio A., Sciarretta F., D'Andrea S., Montani V., Cannarsa E., Dolcetti K., Cordera R., Bonabello L. A., Mazzucchelli C., Giorda C. B., Bonetto C., Baldassarre M. P. A., Iovine C., Ciano O., Dall'Aglio E., Mancastroppa G., Grimaldi F., Tonutti L., Boemi M., D'Angelo F., Leotta S., Lauro D., Rinaldi M. E., Cignarelli M., La Macchia O., Fariello S., Tomasi F., Zamboni C., Dozio N., Trevisan R., Scaranna C., Del Prato S., Miccoli R., Garofolo M., Pugliese G., Salvi L., Rangel G., Anichini R., Tedeschi A., Corsini E., Cucinotta D., Di Benedetto A., Giunta L., Ruffo M. C., Bossi A. C., Carpinter R., Dotta F., Ceccarelli E., Bartolo P. D., Caselli C., Luberto A., Calbucci G., Consoli A., Ginestra F., Calabrese M., Zogheri A., Laviola L., Ippolito C., Tarantino L., Avogaro A., Carallo C., Scicchitano C., Livraga S., Perin P. C., Forrnengo P., Prinzis T., De Cosmo S., Bacci S., Lamanna C., Lettina G., Aiello A., Lalli C., Franzetti I., Petrachi F., Asprino V., Capra C., Forte E., Reggiani G. M., Forlani G., Montesi L., Mazzella N., Piatti P. M., Monti L., Stuccillo M., Auletta P., Petraroli E., Capobianco G., Romano G., Cutolo M., De Simone G., Caiazzo G., Nunziata P., Sorrentino S., Amelia U., Calatola P., Capuano G., Vitale, M, Masulli, M, Rivellese, A, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo, P, Giorgino, F, Gnasso, A, Mannucci, E, Mazzotti, A, Nappo, R, Palena, A, Pata, P, Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, A, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, Capuano, G, Vitale M., Masulli M., Rivellese A. A., Bonora E., Cappellini F., Nicolucci A., Squatrito S., Antenucci D., Barrea A., Bianchi C., Bianchini F., Fontana L., Fornengo P., Giorgino F., Gnasso A., Mannucci E., Mazzotti A., Nappo R., Palena A. P., Pata P., Perriello G., Potenziani S., Radin R., Ricci L., Romeo F., Santini C., Scarponi M., Serra R., Timi A., Turco A. A., Vedovato M., Zavaroni D., Grioni S., Riccardi G., Vaccaro O., Cocozza S., Auciello S., Cigolini M., Pichiri I., Brangani C., Tomasetto E., Sinagra T., Longhitano S., Tropea V., Ballardini G., Babini A. C., Ripani R., Gregori G., Dolci M., Bruselli L., Salutini I., Mori M., Baccetti F., Lapolla A., Sartore G., Burlina S., Chilelli N. C., Buzzetti R., Venditti C., Carlone A., Galluzzo A., Giordano C., Torregrossa V., Corsi L., Cuneo G., Corsi S., Tizio B., Galluzzo G., Citro G., Natale M., Salvatore V., Di Cianni G., Lacaria E., Russo L., Iannarelli R., De Gregorio A., Sciarretta F., D'Andrea S., Montani V., Cannarsa E., Dolcetti K., Cordera R., Bonabello L. A., Mazzucchelli C., Giorda C. B., Bonetto C., Baldassarre M. P. A., Iovine C., Ciano O., Dall'Aglio E., Mancastroppa G., Grimaldi F., Tonutti L., Boemi M., D'Angelo F., Leotta S., Lauro D., Rinaldi M. E., Cignarelli M., La Macchia O., Fariello S., Tomasi F., Zamboni C., Dozio N., Trevisan R., Scaranna C., Del Prato S., Miccoli R., Garofolo M., Pugliese G., Salvi L., Rangel G., Anichini R., Tedeschi A., Corsini E., Cucinotta D., Di Benedetto A., Giunta L., Ruffo M. C., Bossi A. C., Carpinter R., Dotta F., Ceccarelli E., Bartolo P. D., Caselli C., Luberto A., Calbucci G., Consoli A., Ginestra F., Calabrese M., Zogheri A., Laviola L., Ippolito C., Tarantino L., Avogaro A., Carallo C., Scicchitano C., Livraga S., Perin P. C., Forrnengo P., Prinzis T., De Cosmo S., Bacci S., Lamanna C., Lettina G., Aiello A., Lalli C., Franzetti I., Petrachi F., Asprino V., Capra C., Forte E., Reggiani G. M., Forlani G., Montesi L., Mazzella N., Piatti P. M., Monti L., Stuccillo M., Auletta P., Petraroli E., Capobianco G., Romano G., Cutolo M., De Simone G., Caiazzo G., Nunziata P., Sorrentino S., Amelia U., Calatola P., and Capuano G.

Abstract

Purpose: Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. Methods: We studied 2573 men and women aged 50–75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results: The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. Conclusions: The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes.

Published
2018

7. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

Author

Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, Vaccaro O., Masulli M., Nicolucci A., Bonora E., Del Prato S., Maggioni A. P., Rivellese A. A., Squatrito S., Giorda C. B., Sesti G., Mocarelli P., Lucisano G., Sacco M., Signorini S., Cappellini F., Perriello G., Babini A. C., Lapolla A., Gregori G., Giordano C., Corsi L., Buzzetti R., Clemente G., Di Cianni G., Iannarelli R., Cordera R., La Macchia O., Zamboni C., Scaranna C., Boemi M., Iovine C., Lauro D., Leotta S., Dall'Aglio E., Cannarsa E., Tonutti L., Pugliese G., Bossi A. C., Anichini R., Dotta F., Di Benedetto A., Citro G., Antenucci D., Ricci L., Giorgino F., Santini C., Gnasso A., De Cosmo S., Zavaroni D., Vedovato M., Consoli A., Calabrese M., di Bartolo P., Fornengo P., Riccardi G., D'Angelo F., Giansanti R., Tanase L., Lanari L., Testa I., Pancani F., Ranchelli A., Vagheggi P., Scatona A., Fontana L., Laviola L., Tarantino L., Ippolito C., Gigantelli V., Manicone M., Conte E., Trevisan R., Rota R., Dodesini A. R., Reggiani G. M., Montesi L., Mazzella N., Forlani G., Caselli C., Di Luzio R., Mazzotti A., Aiello A., Barrea A., Musto A., D'Amico F., Sinagra T., Longhitano S., Trowpea V., Sparti M., Italia S., Lisi E., Grasso G., Pezzino V., Insalaco F., Carallo C., Scicchitano C., De Franceschi M. S., Calbucci G., Ripani R., Cuneo G., Corsi S., Romeo F., Lesina A., Comoglio M., Bonetto C., Robusto A., Nada E., Asprino V., Cetraro R., Impieri M., Lucchese G., Donnarumma G., Tizio B., Lenza L., Paraggio P., Tomasi F., Dozio N., Scalambra E., Mannucci E., Lamanna C., Cignarelli M., Macchia O. L., Fariello S., Sorrentino M. R., Franzetti I., Radin R., Annunziata F., Bonabello L. A., Durante A., Dolcino M., Gallo F., Mazzucchelli C., Aleo A., Melga P., Briatore L., Maggi D., Storace D., Cecoli F., D'Ugo E., Pupillo M., Baldassarre M. P. A., Salvati F., Minnucci A., De Luca A., Zugaro A., Santarelli L., Bosco A., Petrella V., La Verghetta G. G., D'Andrea S., Giuliani A. E., Polidoro W. L., Sperandio A., Sciarretta F., Pezzella A., Carlone A., Potenziani S., Venditti C., Foffi C., Carbone S., Cipolloni L., Moretti C., Leto G., Serra R., Petrachi F., Romano I., Lacaria E., Russo L., Goretti C., Sannino C., Dolci M., Bruselli L., Mori M. L., Baccetti F., Del Freo M., Cucinotta D., Giunta L., Ruffo M. C., Cannizzaro D., Pintaudi B., Perrone G., Pata P., Ragonese F., Lettina G., Mancuso T., Coppolino A., Piatti P. M., Monti L., Stuccillo M., Lucotti P., Setola M., Crippa G. V., Loi C., Oldani M., Bottalico M. L., Pellegata B., Bonomo M., Menicatti L. S. M., Resi V., Bertuzzi F., Disoteo E. O., Pizzi G., Annuzzi G., Capaldo B., Nappo R., Auciello S. M., Turco A. A., Costagliola L., Corte G. D., Vallefuoco P., Nappi F., Vitale M., Cocozza S., Ciano O., Massimino E., Garofalo N., Avogaro A., Guarneri G., Fedele D., Sartore G., Chilelli N. C., Burlina S., Bonsembiante B., Galluzzo A., Torregrossa V., Mancastroppa G., Arsenio L., Cioni F., Caronna S., Papi M., Santeusanio F., Calagreti G., Timi A., Tantucci A., Marino C., Ginestra F., Di Biagio R., Taraborelli M., Miccoli R., Bianchi C., Garofolo M., Politi K. S., Penno G., Livraga S., Calzoni F., Mancastroppa G. L. F., Corsini E., Tedeschi A., Gagliano M. S., Ippolito G., Salutini E., Cervellino F., Natale M., Salvatore V., Zampino A., Sinisi R., Arcangeli A., Zogheri A., Guizzotti S., Longo R., Pellicano F., Scolozzi P., Termine S., Luberto A., Ballardini G., Trojani C., Mazzuca P., Bruglia M., Ciamei M., Genghini S., Zannoni C., Rangel G., Salvi L., Zappaterreno A., Cordone S., Simonelli P., Meggiorini M., Frasheri A., Di Pippo C., Maglio C., Mazzitelli G., Rinaldi M. E., Galli A., Romano M., D'Angelo P., Suraci C., Bacci S., Palena A. P., Genovese S., Mancino M., Rondinelli M., Capone F., Calabretto E., Bulgheroni M., Bucciarelli L., Ceccarelli E., Fondelli C., Santacroce C., Guarino E., Nigi L., Lalli C., Di Vizia G., Scarponi M., Montani V., Di Bernardino P., Romagni P., Dolcetti K., Forte E., Tamburo L., Perin P. C., Prinzis T., Gruden G., Bruno G., Zucco C., Perotta M., Marena S., Monsignore S., Panero F., Ponzi F., Carpinteri R., Casagrande M. L., Coletti M. F., Balini A., Filopanti M., Madaschi S., Pulcina A., Grimaldi F., Venturini G., Agus S., Pagnutti S., Guidotti F., Cavarape A., Cigolini M., Pichiri I., Brangani C., Fainelli G., Tomasetto E., Zoppini G., Galletti A., Perrone D., Capra C., Bianchini F., Ceseri M., Di Nardo B., Sasso E., Bartolomei B., Suliman I., Fabbri G., Romano G., Maturo N., Nunziata G., Capobianco G., De Simone G., Villa V., Rota G., Pentangelo C., Carbonara O., Caiazzo G., Cutolo M., Sorrentino T., Mastrilli V., Amelia U., Masi S., Corigliano G., Gaeta I., Armentano V., Calatola P., Capuano G., Angiulli B., Auletta P., Petraroli E., Iodice C. E., Agrusta M., Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, Vaccaro O., Masulli M., Nicolucci A., Bonora E., Del Prato S., Maggioni A. P., Rivellese A. A., Squatrito S., Giorda C. B., Sesti G., Mocarelli P., Lucisano G., Sacco M., Signorini S., Cappellini F., Perriello G., Babini A. C., Lapolla A., Gregori G., Giordano C., Corsi L., Buzzetti R., Clemente G., Di Cianni G., Iannarelli R., Cordera R., La Macchia O., Zamboni C., Scaranna C., Boemi M., Iovine C., Lauro D., Leotta S., Dall'Aglio E., Cannarsa E., Tonutti L., Pugliese G., Bossi A. C., Anichini R., Dotta F., Di Benedetto A., Citro G., Antenucci D., Ricci L., Giorgino F., Santini C., Gnasso A., De Cosmo S., Zavaroni D., Vedovato M., Consoli A., Calabrese M., di Bartolo P., Fornengo P., Riccardi G., D'Angelo F., Giansanti R., Tanase L., Lanari L., Testa I., Pancani F., Ranchelli A., Vagheggi P., Scatona A., Fontana L., Laviola L., Tarantino L., Ippolito C., Gigantelli V., Manicone M., Conte E., Trevisan R., Rota R., Dodesini A. R., Reggiani G. M., Montesi L., Mazzella N., Forlani G., Caselli C., Di Luzio R., Mazzotti A., Aiello A., Barrea A., Musto A., D'Amico F., Sinagra T., Longhitano S., Trowpea V., Sparti M., Italia S., Lisi E., Grasso G., Pezzino V., Insalaco F., Carallo C., Scicchitano C., De Franceschi M. S., Calbucci G., Ripani R., Cuneo G., Corsi S., Romeo F., Lesina A., Comoglio M., Bonetto C., Robusto A., Nada E., Asprino V., Cetraro R., Impieri M., Lucchese G., Donnarumma G., Tizio B., Lenza L., Paraggio P., Tomasi F., Dozio N., Scalambra E., Mannucci E., Lamanna C., Cignarelli M., Macchia O. L., Fariello S., Sorrentino M. R., Franzetti I., Radin R., Annunziata F., Bonabello L. A., Durante A., Dolcino M., Gallo F., Mazzucchelli C., Aleo A., Melga P., Briatore L., Maggi D., Storace D., Cecoli F., D'Ugo E., Pupillo M., Baldassarre M. P. A., Salvati F., Minnucci A., De Luca A., Zugaro A., Santarelli L., Bosco A., Petrella V., La Verghetta G. G., D'Andrea S., Giuliani A. E., Polidoro W. L., Sperandio A., Sciarretta F., Pezzella A., Carlone A., Potenziani S., Venditti C., Foffi C., Carbone S., Cipolloni L., Moretti C., Leto G., Serra R., Petrachi F., Romano I., Lacaria E., Russo L., Goretti C., Sannino C., Dolci M., Bruselli L., Mori M. L., Baccetti F., Del Freo M., Cucinotta D., Giunta L., Ruffo M. C., Cannizzaro D., Pintaudi B., Perrone G., Pata P., Ragonese F., Lettina G., Mancuso T., Coppolino A., Piatti P. M., Monti L., Stuccillo M., Lucotti P., Setola M., Crippa G. V., Loi C., Oldani M., Bottalico M. L., Pellegata B., Bonomo M., Menicatti L. S. M., Resi V., Bertuzzi F., Disoteo E. O., Pizzi G., Annuzzi G., Capaldo B., Nappo R., Auciello S. M., Turco A. A., Costagliola L., Corte G. D., Vallefuoco P., Nappi F., Vitale M., Cocozza S., Ciano O., Massimino E., Garofalo N., Avogaro A., Guarneri G., Fedele D., Sartore G., Chilelli N. C., Burlina S., Bonsembiante B., Galluzzo A., Torregrossa V., Mancastroppa G., Arsenio L., Cioni F., Caronna S., Papi M., Santeusanio F., Calagreti G., Timi A., Tantucci A., Marino C., Ginestra F., Di Biagio R., Taraborelli M., Miccoli R., Bianchi C., Garofolo M., Politi K. S., Penno G., Livraga S., Calzoni F., Mancastroppa G. L. F., Corsini E., Tedeschi A., Gagliano M. S., Ippolito G., Salutini E., Cervellino F., Natale M., Salvatore V., Zampino A., Sinisi R., Arcangeli A., Zogheri A., Guizzotti S., Longo R., Pellicano F., Scolozzi P., Termine S., Luberto A., Ballardini G., Trojani C., Mazzuca P., Bruglia M., Ciamei M., Genghini S., Zannoni C., Rangel G., Salvi L., Zappaterreno A., Cordone S., Simonelli P., Meggiorini M., Frasheri A., Di Pippo C., Maglio C., Mazzitelli G., Rinaldi M. E., Galli A., Romano M., D'Angelo P., Suraci C., Bacci S., Palena A. P., Genovese S., Mancino M., Rondinelli M., Capone F., Calabretto E., Bulgheroni M., Bucciarelli L., Ceccarelli E., Fondelli C., Santacroce C., Guarino E., Nigi L., Lalli C., Di Vizia G., Scarponi M., Montani V., Di Bernardino P., Romagni P., Dolcetti K., Forte E., Tamburo L., Perin P. C., Prinzis T., Gruden G., Bruno G., Zucco C., Perotta M., Marena S., Monsignore S., Panero F., Ponzi F., Carpinteri R., Casagrande M. L., Coletti M. F., Balini A., Filopanti M., Madaschi S., Pulcina A., Grimaldi F., Venturini G., Agus S., Pagnutti S., Guidotti F., Cavarape A., Cigolini M., Pichiri I., Brangani C., Fainelli G., Tomasetto E., Zoppini G., Galletti A., Perrone D., Capra C., Bianchini F., Ceseri M., Di Nardo B., Sasso E., Bartolomei B., Suliman I., Fabbri G., Romano G., Maturo N., Nunziata G., Capobianco G., De Simone G., Villa V., Rota G., Pentangelo C., Carbonara O., Caiazzo G., Cutolo M., Sorrentino T., Mastrilli V., Amelia U., Masi S., Corigliano G., Gaeta I., Armentano V., Calatola P., Capuano G., Angiulli B., Auletta P., Petraroli E., Iodice C. E., and Agrusta M.

Abstract

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50–75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2–3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15–45 mg) or a sulfonylurea (5–15 mg glibenclamide, 2–6 mg glimepiride, or 30–120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 p

Published
2017

8. Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease.

Author

Sasso, Ferdinando Carlo, Pafundi, Pia Clara, Simeon, Vittorio, De Nicola, Luca, Chiodini, Paolo, Galiero, Raffaele, Rinaldi, Luca, Nevola, Riccardo, Salvatore, Teresa, Sardu, Celestino, Marfella, Raffaele, Adinolfi, Luigi Elio, Minutolo, Roberto, NID-2 Study Group Investigators, Amelia, U., Acierno, C., Calatola, P., Carbonara, O., Caturano, A., and Conte, G.

Subjects
DIABETIC nephropathies, CLINICAL trials, HDL cholesterol, TYPE 2 diabetes, DIABETIC retinopathy, MAJOR adverse cardiovascular events
Abstract

Background: Multiple modifiable risk factors for late complications in patients with diabetic kidney disease (DKD), including hyperglycemia, hypertension and dyslipidemia, increase the risk of a poor outcome. DKD is associated with a very high cardiovascular risk, which requires simultaneous treatment of these risk factors by implementing an intensified multifactorial treatment approach. However, the efficacy of a multifactorial intervention on major fatal/non-fatal cardiovascular events (MACEs) in DKD patients has been poorly investigated. Methods: Nephropathy in Diabetes type 2 (NID-2) study is a multicentre, cluster-randomized, open-label clinical trial enrolling 395 DKD patients with albuminuria, diabetic retinopathy (DR) and negative history of CV events in 14 Italian diabetology clinics. Centres were randomly assigned to either Standard-of-Care (SoC) (n = 188) or multifactorial intensive therapy (MT, n = 207) of main cardiovascular risk factors (blood pressure < 130/80 mmHg, glycated haemoglobin < 7%, LDL, HDL and total cholesterol < 100 mg/dL, > 40/50 mg/dL for men/women and < 175 mg/dL, respectively). Primary endpoint was MACEs occurrence by end of follow-up phase. Secondary endpoints included single components of primary endpoint and all-cause death. Results: At the end of intervention period (median 3.84 and 3.40 years in MT and SoC group, respectively), targets achievement was significantly higher in MT. During 13.0 years (IQR 12.4–13.3) of follow-up, 262 MACEs were recorded (116 in MT vs. 146 in SoC). The adjusted Cox shared-frailty model demonstrated 53% lower risk of MACEs in MT arm (adjusted HR 0.47, 95%CI 0.30–0.74, P = 0.001). Similarly, all-cause death risk was 47% lower (adjusted HR 0.53, 95%CI 0.29–0.93, P = 0.027). Conclusion: MT induces a remarkable benefit on the risk of MACEs and mortality in high-risk DKD patients. Clinical Trial Registration ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT00535925 [ABSTRACT FROM AUTHOR]

Published
2021
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9. The METABOLIC Study: Multidimensional assessment of health and functional status in older patients with type 2 diabetes taking oral antidiabetic treatment

Author

Maggi, S., Noale, M., Pilotto, A., Tiengo, A., Cavallo Perin, P., Crepaldi, G., Metabolic Working Group Collaborators:, Andrea C., Aglioloro, A., Allochis, G., Arico, C. N., Balbo, M., Marangoni, A., Balzano, S., Battisti, B., Testa, I., Brandoni, G., Bruno, A., Degiovanni, M., Buzzetti, Raffaella, Foffi, C., Calatola, P., Cantarella, S. A., Rondena, M., Cimpanelli, M. G., Confortin, L., Consoli, A., Baldassarre, M., Invitti, C., Conti, A., Del Prato, S., Crisci, I., Derosa, G., Maffioli, P., Devangelio, E., Di Bartolo, P., Ruggeri, P., Di Lembo, S., Di Mauro, M., Battiato, R., Farci, F., Fisicaro, M., Pontiroli, A., Folini, L., Gargiulo, A., Vinciguerra, A., Giorgino, F., Laviola, L., Clementina, C., Guerini, S., Tonolo, G., Iwaniszyn, D., Lambiase, C., Leotta, S., Mangeri, F., Mangili, R., Mattiuzzo, C., Mollo, F., Novara, F., Gucciardi, P., Orsi, E., Palmieri, E., Pacifico, A. A., Burruni, A., Pagani, G., Albizzi, M., Pasquini, C., Cavallo, P. P., Perotto, M., Piccolo, P., D'Ambrosio, P., Maolo, G., Polenta, B., Purrello, F., Tomaselli, T., Tardio, M. S., Quarantelli, C., Ragusa, G. S., Borzi, V., Rapisardi, R., Richini, D., Rosco, M., Serra, R., Marchesini, R. G., Soverini, V., Tomasi, F., De Angelis, M., Turco, A., Tolaini, P., Vangucci, S., and Zavaroni, I.

Subjects
Male, Drug, medicine.medical_specialty, Activities of daily living, Health Status, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, media_common.quotation_subject, Administration, Oral, Type 2 diabetes, Cohort Studies, Diabetes Complications, Endocrinology, Surveys and Questionnaires, Internal medicine, Diabetes mellitus, Internal Medicine, Humans, Hypoglycemic Agents, Medicine, Metabolic study, Aged, media_common, Aged, 80 and over, business.industry, Insulin, Age Factors, General Medicine, medicine.disease, Hypoglycemia, Malnutrition, Diabetes Mellitus, Type 2, Physical therapy, Female, business, Cohort study
Abstract

Aim The objective of the METABOLIC Study was to evaluate overall health status, with particular focus on assessment of functional status of older patients taking oral antidiabetic drug (OAD) treatment. Methods The study included 1342 type 2 diabetes patients aged ≥ 65 years treated with OADs, with or without insulin, who had been referred to outpatients clinics across Italy. Information on diabetes (duration, medications taken during the last 3 months, hypoglycaemic events and diabetic complications) was collected by questionnaire, and the patients’ overall health status was assessed using a multidimensional prognostic index. Results The sample recruited (mean age: 73.3 ± 5.5 years) had a mean duration of diabetes of 11.3 ± 8.2 years. Half were taking sulphonylureas alone or together with other medications, 9.7% were taking insulin in combination with other OADs, almost 30% were using biguanides and 6.2% were taking dipeptidyl peptidase-4 (DPP-4) inhibitors. Also, 12% of patients reported hypoglycaemic events, 90% of whom were taking insulin or sulphonylureas. In addition, 81% of the participants were completely independent in their activities of daily living, while 19% were mildly, moderately or severely disabled. Age, female gender, hypoglycaemic events, neuropathy and low diastolic blood pressure were the main variables associated with disability. Conclusion Disability is common in older diabetic patients and some associated factors, such as hypoglycaemia and low diastolic blood pressure, have been identified. Also identified was malnutrition as a specific factor associated with hypoglycaemic events independent of the use of insulin and sulphonylureas.

Published
2013
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10. Sexual dysfunction in type 2 diabetes at diagnosis: Progression over time and drug and non-drug correlated factors

Author

Corona, G., Giorda, Carlo B., Cucinotta, Domenico, Guida, Piero, Nada, Elisa, Aglialoro, A., Albanese, V., Albano, S., Antonangelo, C., Baccetti, F., Bulzomi, R., Calatola, P., Capano, F., Clemente, G., Corigliano, G., Cucinotta, D., De Fazio, C., DE FRANCESCO, Claudia, De Joannon, U., Del Buono, A., Fontana, L., Fornengo, R., Fraticelli, E., Gaviglio, D., Gentile, S., Giorda, C. B., Giorgianni, Letterio, Guarino, G., Iannarelli, R., Improta, L., Improta, M., Leotta, S., Magro, G., Maiani, L., Mastroiacovo, D., Mingardi, R., Morviducci, L., Nada, E., Nosso, G., Nuzzi, A., Ocelli, C., Paciotti, V., Pata, P., Rampini, P. A., Rovere, M., Sabbatini, A., Sciarrafia, M., Sciarretta, F., Sforza, A., Starnone, V., Testori, G., Trevisan, F., Turco, S., Viviani, G., and Zavaroni, D.

Subjects
Male, Cross-sectional study, Aged, Cross-Sectional Studies, Depressive Disorder, Diabetes Mellitus, Type 2, Erectile Dysfunction, Follow-Up Studies, Humans, Hypoglycemic Agents, Interviews as Topic, Life Style, Middle Aged, Phosphodiesterase 5 Inhibitors, Prevalence, Prospective Studies, Severity of Illness Index, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), 030232 urology & nephrology, lcsh:Medicine, Type 2 diabetes, Biochemistry, 0302 clinical medicine, Endocrinology, Drug Metabolism, Medicine and Health Sciences, Testosterone, Lipid Hormones, lcsh:Science, Prospective cohort study, 030219 obstetrics & reproductive medicine, Multidisciplinary, Pharmaceutics, Depression, Obstetrics and Gynecology, Type 2 Diabetes, Androgens, medicine.symptom, sexual disfunction, Research Article, medicine.medical_specialty, Sexual Dysfunction, Endocrine Disorders, Urology, PDE5i, 03 medical and health sciences, Drug Therapy, Internal medicine, Severity of illness, Mental Health and Psychiatry, medicine, Diabetes Mellitus, Pharmacokinetics, Pharmacology, business.industry, Mood Disorders, Hypogonadism, lcsh:R, Type 2 Diabetes Mellitus, Biology and Life Sciences, medicine.disease, Hormones, Surgery, Erectile dysfunction, Sexual dysfunction, Metabolic Disorders, Women's Health, lcsh:Q, Sexual function, business
Abstract

Aims To present the longitudinal data of the SUBITO-DE study, a prospective survey involving male patients with new or recently diagnosed type 2 diabetes mellitus (T2DM) (

Published
2016
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12. The SUBITO-DE study: sexual dysfunction in newly diagnosed type 2 diabetes male patients

Author

Corona G1, Giorda CB, Cucinotta D, Guida P, Nada E, SUBITO DE study g.r.o.u.p. CollaboratorsAglialoro A, Albanese V, Albano S, Antonangelo C, Baccetti F, Bulzomì R, Calatola P, Capano F, Clemente G, Corigliano G, Corona G, De Fazio C, De Francesco C, De Joannon U, Del Buono A, Fontana L, Fornengo R, Fraticelli E, Gaviglio D, GENTILE, Sandro, Giorgianni L, GUARINO, Giuseppina, Iannarelli R, Improta L, Improta M, Leotta S, Magro G, Maiani L, Mingardi R, Morviducci L, Nosso G, Nuzzi A, Ocelli C, Paciotti V, Pata P, Rampini PA, Rovere M, Sabbatini A, Sciarrafia M, Sciarretta F, Sforza A, Starnone V, Testori G, Trevisan F, Turco S, Viviani G, Zavaroni D., Corona, G1, Giorda, Cb, Cucinotta, D, Guida, P, Nada, E, CollaboratorsAglialoro A, SUBITO DE study g. r. o. u. p., Albanese, V, Albano, S, Antonangelo, C, Baccetti, F, Bulzomì, R, Calatola, P, Capano, F, Clemente, G, Corigliano, G, Corona, G, De Fazio, C, De Francesco, C, De Joannon, U, Del Buono, A, Fontana, L, Fornengo, R, Fraticelli, E, Gaviglio, D, Gentile, Sandro, Giorgianni, L, Guarino, Giuseppina, Iannarelli, R, Improta, L, Improta, M, Leotta, S, Magro, G, Maiani, L, Mingardi, R, Morviducci, L, Nosso, G, Nuzzi, A, Ocelli, C, Paciotti, V, Pata, P, Rampini, Pa, Rovere, M, Sabbatini, A, Sciarrafia, M, Sciarretta, F, Sforza, A, Starnone, V, Testori, G, Trevisan, F, Turco, S, Viviani, G, and Zavaroni, D.

Subjects
Male, Depression, Hypogonadism, Comorbidity, Middle Aged, Prognosis, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Erectile Dysfunction, Risk Factors, Humans, Testosterone, Longitudinal Studies, Prospective Studies, Follow-Up Studies
Abstract

No data on the prevalence of erectile dysfunction (ED) in subjects with newly diagnosed Type 2 diabetes mellitus (T2DM) are currently available.The aim of the present study was to estimate the prevalence of ED and its associated causes in a sample of male patients with recently diagnosed DM (24 months) attending a diabetes care center.The study comprised two phases: a cross-sectional analysis and a longitudinal reassessment of the data collected during the first phase. During the first phase, 1503 subjects (mean age 58.7±8.9 yr) from 27 centers were interviewed: 666 (43.3%) reported experiencing ED, 499 of which (mean age 58.8±8.8 yr) agreed to participate in the study (final enrolment rate, 33.3%). Concurrent morbidities were hypertension (55.3%), dyslipidemia (39.5%), and coronary heart disease (7.8%); chronic complications were neuropathy (8.9%), nephropathy (12.6%) and retinopathy (7.6%) in about one third of the sample at enrolment.Overall, about 20% of the patients reported having used ED drugs, but more than 50% had abandoned therapy because of the drug's ineffectiveness or high cost. The prevalence of hypogonadism was 46.9% (total testosterone level, 3.5 ng/ml). Some 20% of patients reported symptoms suggestive of depression.The present study provides data showing a high prevalence of ED, hypogonadism and depressive symptoms among male patients with newly diagnosed T2DM. Further analysis of the data will elucidate the specific determinants of such conditions and their longitudinal significance.

Published
2013

13. Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial

Author

Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, IT study group, T. O. S. C. A., Sud, Cm, Imbaro, S, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, S, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, G, Rizzo, Mr, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, Francesco, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini, M., Vaccaro, O1, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, Collaborators Riccardi G, T. O. S. C. A. IT study g. r. o. u. p., Sud, Cm, Imbaro, S, Vaccaro, O, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, Sandro, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, Giuseppe, Rizzo, Maria Rosaria, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, F, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini M., Author information, Vaccaro, Olga, Masulli, Maria, Rivellese, ANGELA ALBAROSA, Riccardi, Gabriele, Giorda, C, Maggioni, A, Rivellese, A, Giorda, CB, Maggioni, AP, and Rivellese, AA

Subjects
Blood Glucose, Male, BIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICA, Endocrinology, Diabetes and Metabolism, pioglitazone, sulfonylurea, type 2 diabetes, metformin, cardiovascular events, Medicine (miscellaneous), Type 2 diabetes, Settore MED/13 - Endocrinologia, Body Mass Index, law.invention, Randomized controlled trial, Risk Factors, law, Surveys and Questionnaires, Cardiovascular Disease, pioglitazone, piogllitazone, Stroke, Diabetes, Therapy, Pioglitazone, Nutrition and Dietetics, Diabetes, Thiazolidinedione, cardiovascular events, Type 2 Diabetes Mellitus, sulphonylureas, Middle Aged, Metformin, Sulfonylurea Compound, Treatment Outcome, Tolerability, Cardiovascular Diseases, Drug Therapy, Combination, Female, type 2 diabetes, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Endpoint Determination, sulfonylurea, cardiovascualr event, Sudden death, Follow-Up Studie, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, sulfonylureas, interventio trial, randomized controlled trial, Aged, Hypoglycemic Agent, Questionnaire, business.industry, Risk Factor, medicine.disease, Surgery, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Quality of Life, Thiazolidinediones, Therapy, business, metformin, Pioglitazone, Follow-Up Studies
Abstract

Background and aims Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Methods Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50–75 years, BMI 20–45 Kg/m 2 , on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee. Conclusions TOSCA.IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Registration: Clinicaltrials.gov ID NCT00700856.

Published
2012

14. Sexual dysfunction at the onset of type 2 diabetes: the interplay of depression, hormonal and cardiovascular factors

Author

Corona G., Giorda C.B., Cucinotta D., Guida P., Nada E., Aglialoro A., Albanese V., Albano S., Antonangelo C., Baccetti F., Bulzomi' R., Calatola P., Capano F., Clemente G., Corigliano G., De Fazio C., De Francesco C., De Joannon U., Del Buono A., Fontana L., Fornengo R., Fraticelli E., Gaviglio D., Gentile S., Giorgianni L., Guarino G., Iannarelli R., Improta L., Improta M., Leotta S., Magro G., Maiani L., Mingardi R., Morviducci L., Nosso G., Nuzzi A., Ocelli C., Paciotti V., Pata P., Rampini P.A., Rovere M., Sabbatini A., Sciarrafia M., Sciarretta F., Sforza A., Starnone V., Testori G., Trevisan F., Turco S., Viviani G., Zavaroni D., Gentile, Sandro, Giorda, C. B., Giorgianni, L., and Guarino, Giuseppina

Subjects
Male, medicine.medical_specialty, Urology, Endocrinology, Diabetes and Metabolism, Libido, Type 2 diabetes, Endocrinology, Diabetes mellitus, Erectile Dysfunction, Testosterone, Diabetes Mellitus, Internal medicine, Premature ejaculation, medicine, Prevalence, Humans, Ejaculation, Prospective Studies, Premature Ejaculation, Depression (differential diagnoses), Depressive Disorder, business.industry, Hypogonadism, Delayed ejaculation, Middle Aged, medicine.disease, Psychiatry and Mental health, Sexual desire, Sexual Dysfunction, Physiological, Sexual dysfunction, Erectile dysfunction, Reproductive Medicine, Diabetes Mellitus, Type 2, Italy, medicine.symptom, business, Sexual function
Abstract

Introduction: Several data have emphasized the importance of early diagnosis of erectile dysfunction (ED) and meticulous cardiovascular investigation in the type 2 diabetic mellitus (T2DM) patients. Aim: To estimate the prevalence of ED and its associated determinants in a sample of male patients with new or recently diagnosed T2DM. Methods: The SUBITO-DE study is an observational, multicenter, prospective study involving 27 Italian diabetes centers. Male patients recently diagnosed with T2DM were consecutively interviewed by their attending physician at the diabetes care centers and asked whether they had experienced a change in their sexual function or found it unsatisfactory. Those responding positively were then invited to participate in the study. Main Outcome Measure: Several hormonal and biochemical parameters were studied. Results: A nonselected series of 1,503 patients was interviewed, 499 of which (mean age, 58.8±8.8 years) entered the study, yielding a final enrolment rate of 33.3%. ED was classified as mild in 19.4%, mild-to-moderate in 15.4%, moderate in 10.4%, and severe in 21.6% of patients, respectively. In addition, premature ejaculation, delayed ejaculation, and hypoactive sexual desire (HSD) were comorbid in 28.3%, 32.9%, and 58.4%, respectively. Finally, hypogonadism, showed an estimated prevalence of almost 20%. Both organic (at least one chronic DM-associated complication) and psychological factors (severe depressive symptoms) increased the risk of ED. Severe depressive symptoms were also associated with ejaculatory problems, HSD, and hypogonadism. Conclusions: A high prevalence of sexual dysfunction in men with recently diagnosed T2DM was detected. Early diagnosis of ED could help prevent emotional and physical discomfort in men and aid in identifying reversible cardiovascular risk factors. Screening of sexual dysfunction should become a part of routine care in the management of T2DM patients. Corona G, Giorda CB, Cucinotta D, Guida P, Nada E, and Gruppo di studio SUBITO-DE. Sexual dysfunction at the onset of type 2 diabetes: The interplay of depression, hormonal and cardiovascular factors. J Sex Med 2014;11:2065-2073. © 2014 International Society for Sexual Medicine.

Published
2014
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15. Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes: The PRISMA Randomized Trial

Author

Bosi, E, Scavini, M, Ceriello, A, Cucinotta, D, Tiengo, A, Marino, R, Bonizzoni, E, Giorgino, F, on behalf of the PRISMA Study Group, Trevisan, R, Dodesini, Ar, Corsi, A, Sciangula, L, Ciucci, A, Olivo, Es, Tonutti, L, Boscariol, C, Armellini, M, Pozzilli, P, Maurizi, Ar, Manfrini, S, Napoli, N, Tuccinardi, D, Ghirlanda, G, Gagliardi, L, Ranalli, L, Zaccuri, S, Giorgianni, L, Guarnieri, G, Di Bartolo, P, Pellicano, F, Scolozzi, P, Leotta, S, Fontana, L, Tonolo, G, Cherchi, S, Canu, L, Foglini, P, Maricotti, R, Tortato, E, Pianti, C, Madaschi, S, Tortul, C, Da Ros, R, Muraro, R, Ansaldi, E, Cacciola, S, Cignarelli, M, Lamacchia, O, Nizzoli, M, Buci, L, Calatola, P, Clemente, G, Caputo, A, Mollo, F, Friogato, G, Rampini, A, Morpurgo, P, Bonino, G, Vita, Mg, Laviola, L, Gnasso, A, Carallo, C, Calabria, M, Beltramello, G, Marangoni, A, Cattaneo, A, Guido, R, Massidda, A, Meloni, G, Bonomo, Ma, Pizzi, G, Camerini, M, Provenzano, V, Ferrara, L, Provenzano, F, Paccagnella, A, Sambataro, M, Almoto, B, Baroni, Mg, Cossu, E, Zedde, A, Consoli, A, Di Fulvio, P, Dotta, Francesco, Guarino, E, Annuzzi, G, Bozzeto, L, Cicioni, G, Calabrese, M, Guizzotti, S, Cabasino, F, Farci, F, Ghiani, M, Tubili, C, Nardone, Mr, Candido, R, Tommasi, E, Jagodnik, G, Strazzabosco, M, Mesturino, Ca, Santeusanio, F, Torlone, E, and Annone, S.

Published
2013

16. Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: The PRISMA randomized trial

Author

Bosi, E., Scavini, M., Ceriello, A., Cucinotta, D., Tiengo, A., Marino, R., Bonizzoni, E., Giorgino, F., Group Collaborators: Trevisan, Prisma Study R., Dodesini, A. R., Corsi, A., Sciangula, L., Ciucci, A., Olivo, E. S., Tonutti, L., Boscariol, C., Armellini, M., Pozzilli, P., Maurizi, A. R., Manfrini, S., Napoli, N., Tuccinardi, D., Ghirlanda, G., Gagliardi, L., Ranalli, L., Zaccuri, S., Giorgianni, L., Guarnieri, G., Di Bartolo, P., Pellicano, F., Scolozzi, P., Leotta, S., Fontana, L., Tonolo, G., Cherchi, S., Canu, L., Foglini, P., Maricotti, R., Tortato, E., Pianti, C., Madaschi, S., Tortul, C., Da Ros, R., Muraro, R., Ansaldi, E., Cacciola, S., Cignarelli, M., Lamacchia, O., Nizzoli, M., Buci, L., Calatola, P., Clemente, G., Caputo, A., Mollo, F., Friogato, G., Rampini, A., Morpurgo, P., Bonino, G., Vita, M. G., Laviola, L., Gnasso, A., Carallo, C., Calabria, M., Beltramello, G., Marangoni, A., Cattaneo, A., Guido, R., Massidda, A., Meloni, G., Bonomo, M. A., Pizzi, G., Camerini, M., Provenzano, V., Ferrara, L., Provenzano, F., Paccagnella, A., Sambataro, M., Almoto, B., Baroni, Marco Giorgio, Cossu, E., Zedde, A., Consoli, A., Di Fulvio, P., Dotta, Francesco, Guarino, E., Annuzzi, G., Bozzeto, L., Cicioni, G., Calabrese, M., Guizzotti, S., Cabasino, F., Farci, F., Ghiani, M., Tubili, C., Nardone, M. R., Candido, R., Tommasi, E., Jagodnik, G., Strazzabosco, M., Mesturino, C. A., Santeusanio, F., Torlone, E., and Annone, S.

Published
2013

17. Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes

Author

Parving, Hh, Brenner, Bm, Mcmurray, Jj, de Zeeuw, D, Haffner, Sm, Solomon, Sd, Chaturvedi, N, Persson, F, Desai, As, Nicolaides, M, Richard, A, Xiang, Z, Brunel, P, Pfeffer, Ma, Viberti, G, Lachin, Jm, Zinman, B, Pedersen, Tr, Villamil, As, Juncos, L, Prager, R, Verpooten, G, Zanella, Mt, Leiter, L, Pan, C, Wang, H, Botero, R, Cifkova, R, Christiansen, Js, Groop, Ph, Marre, M, Haller, H, Nickenig, G, Siamopoulos, K, Gero, L, Maggioni, A, Remuzzi, G, Katayama, Ss, Kim, Sg, Petrulioniene, Z, Lok, D, Kooy, A, Jorde, R, Medina, F, Polonia, J, Wong, Ks, Dukat, A, Rayner, Bl, Ruilope, L, Weiss, L, Wuethrich, R, Sheu, W, Sritara, P, Comlekci, A, Bilous, R, Toto, R, Jamerson, K, Carillo, E, Orias, M, Kuschnir, E, Rusculleda, M, Garcia, S, Farias, E, Lema, L, Hominal, M, Montaña, O, Sala, J, Diaz, M, Piskorz, D, Vita, N, Litwak, L, Sinay, I, Marin, M, Massari, P, Majul, C, Aizemberg, D, Azize, Gm, Bartolacci, I, Reboredo, A, Vico, M, Milesi, R, Sessa, H, Wassermann, A, Margulis, F, Zangroniz, P, Watschinger, B, Toplak, H, Paulweber, B, Drexel, H, Francesconi, C, Foeger, B, Mayer, G, Braun, Rk, Brath, H, Gaal, Lv, Niepen, Pv, Persu, A, Vercammen, C, Vriese, Ad, Coucke, F, Mathieu, C, Fery, F, Treille, S, Meeus, G, Acker, Kv, Scheen, A, Tits, J, Ruige, J, Krzesinski, Jm, Hollanders, G, Liénart, F, Dendale, P, Quinonez, M, Arnouts, P, Vanuytsel, J, Zanella, M, Mion D., Jr, Forti, A, Almeida, F, Cunha, R, de Paula RB, Brandao, A, Rocha, J, Krieger, E, Feitosa, G, Saraiva, J, Martin, J, Hissa, Mn, Schmid, H, Felicio, J, Sgarbi, J, Oigman, W, Bowering, K, Garceau, C, Berlingieri, Jc, Weisnagel, Sj, Hardin, P, Powell, C, Turcot, R, Muirhead, N, Aronson, R, Barima, Yt, Steele, Aw, Pandey, S, Woo, V, Cha, J, Dattani, D, Godin, C, Gupta, M, Saunders, K, Tellier, G, Ting, R, Tobe, S, Chouinard, G, Schlosser, R, Khandwala, H, Ekoe, Jm, Harris, Sb, Pichette, V, Lachance, P, Ooi, Tc, Tildesley, H, Barrett, B, Cournoyer, S, Lu, J, Zhang, H, Liu, X, Yan, S, Qi, X, Li, Q, Li, H, Lv, X, Yang, J, Sun, N, Xia, W, Wang, N, Tong, N, Mei, C, Gu, S, Zhang, J, Chen, X, Li, L, Su, B, Wang, L, Qiu, M, Wu, X, Liu, Z, Jia, W, Xu, G, Dong, J, Zhu, D, Zhang, M, Yan, J, Liu, B, Chen, J, Fu, J, Yan, L, Zhan, X, Zhong, L, Yang, T, Ma, J, Xu, M, Xu, X, Shi, B, Ji, Q, Zhong, H, He, R, Yuan, Z, Zhou, Z, Lin, H, Yang, W, Ke, Y, Hong, T, Franco, C, Casas, L, Triana, A, Jaramillo, C, Hernandez, E, Barrera, C, Blanco, D, Stipal, R, Widimsky, P, Dohnalova, L, Komroskova, M, Kvapil, M, Belobradkova, J, Tesar, V, Vodnansky, P, Kocourkova, B, Lervang, Hh, Perrild, H, Rossing, P, Oestergaard, O, Juhl, H, Thorsteinsson, B, Snorgaard, O, Urhammer, S, Egstrup, K, Tikkanen, T, Helin, K, Rinne, J, Lahtela, J, Strand, J, Valtonen, E, Saari, M, Kananen, K, Savela, K, Blacher, J, Aldigier, Jc, Zaoui, P, Fauvel, Jp, Gouet, D, Valensi, Pe, Charpentier, G, Marechaud, R, Penfornis, A, Ovize, M, Kovalchuck, Aa, Dellanna, F, Schoen, N, Groeschel, W, Eickhoff, F, Hanefeld, M, Merke, J, Rambausek, M, Zimmermann, U, Stuetz, W, Vosskuehler, A, Hevendehl, G, Schax, U, Lehmann, G, Haack, A, Hilgenberg, J, Klausmann, G, Adelberger, V, Gessner, S, Fiesselmann, A, Oerter, E, Hohenstatt, T, Groeschel, A, Behnke, T, Sisting, Rt, Schoch, D, Bieler, T, Schleyer, S, Altes, U, Klepzig, C, Rudofsky, G, Mueller, G, Burkhardt, F, Reschke, K, Senftleber, I, Wiesweg, Ck, Herrmann, Hj, Brandstetter, R, Segner, A, Schmitt, H, Rippert, R, Goebel, R, Schreibmueller, F, Pencz, I, Ott, P, Migdalis, I, Pappas, S, Pagkalos, E, Yalouris, A, Tsapas, A, Maltezos, E, Tentolouris, N, Papadakis, I, Ioannidis, G, Goumenos, D, Corona, V, Gonzalez, R, Haase, F, Monterroso, V, Sánchez, V, Turcios, E, Wyss, F, Arango, Jl, Bako, B, Deak, L, Dömötör, E, Dudas, M, Fulop, T, Kiss, I, Koranyi, L, Lengyel, Z, Nyirati, G, Oroszlan, T, Aniko, S, Vörös, P, Kapocsi, J, Wittmann, I, Paragh, G, Abraham, G, Tandon, N, Thomas, N, Mohan, V, Sahay, R, Sethi, B, Rao, V, Kumar, S, Chowdhury, S, Dharmalingam, M, Seshiah, V, Bantwal, G, Viswanathan, V, Yajnik, C, Adhikari, P, Krishnan, U, Varthakavi, P, Hiremath, J, Bhattacharyya, A, Dani, S, Modi, Kk, Glorioso, N, Morosetti, M, Veglio, Franco, Perticone, F, Dotta, F, Quarello, F, Sesti, G, Aiello, A, D'Ospina, A, Giordano, C, Novo, S, Santoro, A, Ferri, C, Capuano, V, Trimarco, B, Tonolo, G, Villa, G, De Pellegrin, A, Zanette, G, Federici, M, Aucello, G, Piatti, P, Vinciguerra, A, Mannarino, E, Taddei, S, Filetti, S, Grandaliano, G, Marchionni, N, Lambiase, C, Locatelli, F, Scanferla, F, Lembo, G, Leotta, S, Mos, L, Calatola, P, Fogari, R, David, S, Pedrinelli, R, Pignone, Am, Cozzolino, D, Bevilacqua, Mt, Catena, C, Del Prato, S, Cerasola, G, Frontoni, S, Falcone, C, Porta, A, Bonora, E, Cocchi, R, Fucili, A, Frisinghelli, A, Volpe, M, Carugo, S, Gambardella, S, Spagnuolo, V, Maglia, G, D'Angelo, Ar, Corsi, A, Limone, Pp, Guarnieri, A, Ghigo, Ezio, Ronchi, E, Ravera, M, Scioli, Ga, Sekiguchi, M, Aoki, S, Ogawa, Y, Seino, H, Onishi, Y, Tojo, A, Narimiya, M, Iwaita, Y, Takeda, H, Shimizu, H, Yamada, T, Kojima, S, Zushi, S, Kaneko, S, Matsumoto, A, Kajiyama, S, Fujita, H, Shikata, K, Tone, A, Matsubayashi, S, Tanaka, S, Sekigami, T, Tatsukawa, Y, Abe, N, Kawahara, K, Kasahara, H, Maeda, Y, Suzuki, Y, Okamoto, H, Tachi, K, Yamada, K, Uzu, T, Itou, T, Fukui, T, Kim, S, Kim, Y, Cho, W, Kwak, I, Chae, D, Oh, H, Ha, S, Shin, Y, Cha, D, Kang, S, Lim, C, Song, J, Kwon, Y, Badariene, J, Labutiniene, Ip, Zabuliene, L, Poteliuniene, V, Miglinas, M, van den Meiracker AH, Gregoor, Pj, Luik, Aj, van Loon BJ, Feenstra, Hj, Kaasjager, Ha, Viergever, Pp, Woittiez, Aj, van Bemmel, T, Lieverse, Ag, Simsek, S, Gaillard, Ca, van der Zwaan, C, Lok, Dj, Spiering, W, Nierop, Pr, Baggen, Mg, Leendert, Rj, de Jong, A, Leurs, Pb, Vincent, Hh, Wins, Eh, Voors, Aa, Ronner, E, Heeg, Je, van Hal JM, Boermans, T, Feis, Wl, Mostard, G, Bakker, Rc, Dunselman, Ph, Skeie, S, Istad, H, Skjelvan, G, Gronert, J, Tomala, T, Gudnason, S, Torvik, Dt, Risberg, K, Abedini, S, Cabrera, W, Medina, B, Herrada, B, Saavedra, A, Polonia, Dj, Providencia, Dl, Carvalho, D, Vasconcelos, Mp, da Silva GF, Branco, P, Gil, Dv, da Costa AG, da Silva PM, Arez, L, Martins, L, Birne, R, Dzuponova, J, Surovcikova, M, Culak, J, Filipova, S, Andre, I, Stevlik, J, Uhliar, R, Fabryova, L, Benacka, J, Koleny, D, Szentivanyi, M, Spisak, V, Pella, D, Pastrnakova, E, Martinka, E, Chua, T, Lau, T, Ng, Tg, Yeoh, Ly, Bhana, Sa, Rayner, B, Wellmann, H, Amod, A, Ranjith, N, Ahmed, F, Rheeder, P, Makan, H, Naicker, P, Podgorski, G, De Teresa, E, Olivan, J, Fernandez, Vl, Povedano, St, Terns, M, Ricart, W, Gonzalez, Jm, Fernandez, P, Parreño Lde, T, Redon, J, Parra, J, Calvo, C, Lopez, I, Puig, Jg, Calle, A, Garcia, Jc, Lopez, Jm, Jimenez, Ml, Fraile, B, Perez, Js, Nadal, Jj, Guija, E, Calviño, J, Barrios, V, Iglesias, Jn, Armario, P, Garcia, M, Aranda, P, Brotons, C, Gomez, P, Catelao, Am, Cusachs, Ar, Sarro, M, Martinez, V, dell Valle MH, Trias, F, Comas, A, Salvador, N, Martinez, F, Hernandez, F, Martinez, J, Mateos, C, Peral, Jl, Tolosana, J, Sobrino, J, Isart, J, Vizcaino, J, Vega, Ff, Zamorano, Jl, Bacariza, M, Soubriet, A, Fernández Cruz, A, Querejeta, R, Leira, Vm, Iglesias, Fe, Ibrik, O, Martin, D, Nanclares, Ms, Mediavilla, Jd, Galceran, Jm, Lopez, A, Muros, T, Pascual, J, Casalla, F, Tornero, F, Fernandez, G, Pettersson, P, Olsen, H, Franke, F, Stroembom, U, Furuland, H, Larnefelt, H, Allemann, Y, Krapf, R, Gerber, P, Munger, R, Hayoz, D, Graf, Hj, Burnier, M, Petrillo, A, Batt, R, Constam, En, Moccetti, T, Bianda, T, Rickli, H, Bulliard, C, Wu, Kd, Lin, Sh, Wu, Cj, Sheu, Wh, Su, Sl, Chen, Sc, Chou, Cw, Lee, Ct, Yang, Tc, Chen, Hc, Sukonthasarn, A, Sriratanasathavorn, C, Eiam Ong, S, Supasyndh, O, Chanchairujira, T, Kitiyakara, C, Arici, M, Usalan, C, Guneri, S, Koc, M, Kalender, B, Ates, K, Gurgun, C, Araz, M, Demirbas, B, Biernacki, W, Calvert, J, Eavis, P, Kerrane, J, Litchfield, J, Middleton, A, Roberts, J, Simpson, H, Charles, H, Jardine, A, Fisher, M, Banerjee, D, Gallen, I, Gnudi, L, Harvey, J, O'Hare, P, Vora, J, Winocour, P, Soran, H, Browne, D, Darko, D, Mancebo, Jg, de Roa ER, Antepara, N, Carrillo, E, Berrizbeitia, M, Guevara, L, Pernalete, N, Ontiveros, C, Zigrang, W, Blakney, E, Rosenblit, P, Weinstein, R, Klaff, L, Lipetz, R, Busick, E, Tung, P, Cooperman, M, Michael, S, Sun, Ch, Hart, T, Maddux, A, Bowden, R, East, C, Arakaki, R, Villafuerte, B, Mamish, Z, Mendez, R, Connery, L, Nour, K, Wynne, A, Busch, R, Zamora, B, Sachson, R, Prasad, J, Lasala, G, Smith, M, Fitz Patrick, D, Ruiz Rivera, L, Barranco, E, Solomon, R, Woolley, A, Brown, C, Freedman, Z, Schmidt, S, Pollock, J, Ruddy, M, Kopyt, Np, Bazzi, A, Horowitz, B, Feng, W, Wahl, T, Duprez, D, Gilbert, J, Steigerwalt, S, Jacqmein, J, Gorton, S, 3rd, Allison J., Pino, J, Lock, J, Leimbach, W, Anderson, J, Beacom, M, Craig, W, Gorson, D, Kerstein, H, Segal, S, Downey, H, Ledger, G, Mcgill, J, Gabriel, J, Nolen, T, Levinson, L, Williams, T, Levenson, D, Lerman, S, Minehart, C, Agarwal, N, Verma, S, Valitutto, M, Demetry, K, Mersey, J, Koeper, D, Fanti, P, Eng, G, Grimm, R, Fagan, T, Bajaj, M, Katz, L, Portnay, G, Altschuller, A, Desai, V, Bilazarian, S, Ipp, E, Rodelas, R, Burstein, D, Berg, J, Velez, J, Lund, R, Rekhi, A, Martin, E, Robertson, D, Singh, N, Narayan, P, Moustafa, M, Lanier, D, Seidner, M, Phillips, A, Vaughters, B, Sprague, A, Swartz, S, Lopez, R, Kumar, J, Bressler, P, Sadler, L, Wise, J, Kilbane, A., and Groningen Kidney Center (GKC)

Subjects
Male, Hyperkalemia, CARDIOVASCULAR MORTALITY, BLOOD-PRESSURE, Angiotensin-Converting Enzyme Inhibitors, Type 2 diabetes, GLOMERULAR-FILTRATION-RATE, DOUBLE-BLIND, chemistry.chemical_compound, Fumarates, cardiovascular disease, Renin, Treatment Failure, Settore MED/49 - Scienze Tecniche Dietetiche Applicate, 610 Medicine & health, diabetes, Medicine (all), Hazard ratio, aliskiren, diabete, trial clinico, Liter, General Medicine, Middle Aged, hypertension, Cardiovascular Diseases, Combination, HEART-FAILURE, Drug Therapy, Combination, Female, Kidney Diseases, type 2 diabetes, medicine.symptom, Type 2, medicine.medical_specialty, Patient Dropouts, Urology, Hypokalemia, Aliskiren, chronic kidney disease, Placebo, Angiotensin Receptor Antagonists, LEFT-VENTRICULAR DYSFUNCTION, Drug Therapy, Double-Blind Method, Diabetes Mellitus, medicine, Humans, CONVERTING-ENZYME INHIBITORS, Antihypertensive Agents, Aged, Amides, Diabetes Mellitus, Type 2, Follow-Up Studies, business.industry, medicine.disease, Confidence interval, Surgery, Blood pressure, MYOCARDIAL-INFARCTION, chemistry, SYSTOLIC DYSFUNCTION, FOLLOW-UP, business
Abstract

BACKGROUND This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or both. METHODS In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level. RESULTS The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P = 0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pressures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, = 6 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P CONCLUSIONS The addition of aliskiren to standard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful. (Funded by Novartis; ALTITUDE ClinicalTrials.gov number, NCT00549757.)

Published
2012
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18. Patterns of treatment with PDE5 inhibitors in the clinical practice in Italy: longitudinal data from the Erectile Dysfunction Observational Study

Author

Ferdinando, Fusco, Riccardo, Sicuteri, Andrea, Rossi, Stathis, Kontodimas, Jose Maria Haro, Ciro, Imbimbo, Mirone, V., Italian Edos Study Group, Aiello, A., Amici, A., Aragona, F., Aragona, C., Artibani, W., Austoni, E., Avolio, A., Bellastella, A., Bonifacio, Vincenzo, Bono, A., Boscaro, M., Bozzo, W., Brausi, M., Breda, G., Caggiano, S., Calabro, A., Calatola, P., Canovaro, G., Caraceni, E., Carani, C., Casarico, A., Castiglioni, M., Ciambrone, G., Cicalese, V., Confortin, L., Conti, G., D'Agata, R., Dal Bianco, M., De Grande, G., Di Ceglie, F., Di Lena, S., Di Santo, V., D'Ottavio, G., Enria, T., Fantaccione, P., Fasolis, G., Foglini, P., Foresta, C., Forti, G., Francavilla, S., Frea, B., Gasparella, V., Gattuccio, F., Gentile, L., Gentile, V., Ghigo, E., Giannini, F., Guarasci, M., Guazzoni, G., Ippoliti, G. B., Jacobellis, U., Jannini, E., La Rocca, L., Lanzafame, F., Laudi, M., Laurenti, C., Leidi, G., Lenzi, A., Leoni, S., Lombardi, G., Lotti, T., Luciani, L., Luciano, M., Ludovico, G., Lunghi, F., Mancini, P., Manganelli, A., Manservigi, D., Mantero, F., Marin, A., Masala, A., Menchini Fabris, F., Miano, L., Monica, B., Montevecchi, R., Montorsi, F., Morrone, G., Motta, M., Muzzonigro, G., Nicita, G., Oliva, G., Pagano, S., Pagliarulo, A., Paola, Q., Paolini, R., Pareo, R. M., Pavone, C., Pecoraro, G., Pinchera, A., Pino, P., Pinzi, N., Pirozzi Farina, F., Pittaluga, P., Pizzocaro, A., Rago, R., Rizzo, M., Romanelli, F., Rovereto, B., Ruggeri, M., Salzano, L., Sanserverino, R., Savoca, G., Scarano, P., Scardapane, R., Scarpa, R., Selvaggi, F. P., Severini, G., Soli, M., Spera, G., Tengalia, R., Testa, G., Tracia, A., Traficante, A., Turriziani, M., Usai, E., Vaccarella, G., Valenti, P., Villanova, A., Vicentini, C., Vincenti, L., Vita, A., Volpi, R., Zambelli, S., and Zito, A.

Subjects
Adult, Male, medicine.medical_specialty, Sildenafil, Phosphodiesterase Inhibitors, Urology, MEDLINE, Carbolines, Erectile Dysfunction, Imidazoles, Patient Satisfaction, Phosphodiesterase Inhibitors, Piperazines, Lower risk, Sildenafil Citrate, Piperazines, Tadalafil, chemistry.chemical_compound, Patient satisfaction, Vardenafil Dihydrochloride, Erectile Dysfunction, prospective multicentric study, medicine, Humans, Sulfones, Practice Patterns, Physicians', PDE5 inhibitors, Aged, Aged, 80 and over, business.industry, Triazines, Imidazoles, General Medicine, Middle Aged, medicine.disease, Erectile dysfunction, Treatment Outcome, chemistry, Vardenafil, Purines, Patient Satisfaction, Physical therapy, Observational study, Original Article, business, medicine.drug, Carbolines
Abstract

The Erectile Dysfunction Observational Study (EDOS) is a 6-months observational prospective multicentric study enrolling men with erectile dysfunction (ED) who asked, to be started on a treatment or to change a previous treatment. Aims of the study were to analyse the pattern of treatment and compare the efficacy of treatments used. Patients were enrolled during a normal hospital visit and were prescribed a treatment for ED. They were asked at baseline and after 3 and 6 months, to answer a set of questions from the International Index of Erectile Function, Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and Short Form of the Psychological and Interpersonal Relationships Scale questionnaires (SF-PAIRS). Clinicians were free to prescribe any therapy for ED available in the market, and to change therapy at any time during the study. Out of 1 338 patients, available for analysis at 6 months, 624 (47%) changed their treatment during the study and 714 (53%) continued with the drug prescribed at baseline. Patients assuming tadalafil had a significantly higher probability of maintaining the same treatment compared to sildenafil or vardenafil. There was no clinically significant difference in terms of efficacy, patient satisfaction, self-confidence and spontaneity between the different inhibitors of PDE5. The 'time concerns' domain score of SF-PAIRS, was statistically better in patients assuming tadalafil. In conclusion sildenafil, vardenafil and tadalafil show similar efficacy in the clinical practice. However, patients receiving tadalafil display a lower risk to discontinue or change the treatment.

Published
2009

19. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

Author

Vaccaro, Olga, Masulli, Maria, Nicolucci, Antonio, Bonora, Enzo, Del Prato, Stefano, Maggioni, Aldo P, Rivellese, Angela A, Squatrito, Sebastiano, Giorda, Carlo B, Sesti, Giorgio, Mocarelli, Paolo, Lucisano, Giuseppe, Sacco, Michele, Signorini, Stefano, Cappellini, Fabrizio, Perriello, Gabriele, Babini, Anna Carla, Lapolla, Annunziata, Gregori, Giovanna, Giordano, Carla, Corsi, Laura, Buzzetti, Raffaella, Clemente, Gennaro, Di Cianni, Graziano, Iannarelli, Rossella, Cordera, Renzo, La Macchia, Olga, Zamboni, Chiara, Scaranna, Cristiana, Boemi, Massimo, Iovine, Ciro, Lauro, Davide, Leotta, Sergio, Dall'Aglio, Elisabetta, Cannarsa, Emanuela, Tonutti, Laura, Pugliese, Giuseppe, Bossi, Antonio C, Anichini, Roberto, Dotta, Francesco, Di Benedetto, Antonino, Citro, Giuseppe, Antenucci, Daniela, Ricci, Lucia, Giorgino, Francesco, Santini, Costanza, Gnasso, Agostino, De Cosmo, Salvatore, Zavaroni, Donatella, Vedovato, Monica, Consoli, Agostino, Calabrese, Maria, di Bartolo, Paolo, Fornengo, Paolo, Riccardi, Gabriele, Vaccaro, Olga, Masulli, Maria, Nicolucci, Antonio, Maggioni, Aldo Pietro, Sesti, Giorgio, Mocarelli, Paolo, Lucisano, Giuseppe, Sacco, Michele, Signorini, Stefano, Cappellini, Fabrizio, Riccardi, Gabriele, Boemi, Massimo, D'Angelo, Federica, Giansanti, Roberto, Tanase, Laura, Lanari, Luigi, Testa, Ivano, Ricci, Lucia, Pancani, Francesca, Ranchelli, Anna, Vagheggi, Paolo, Scatona, Alessia, Fontana, Lucia, Giorgino, Francesco, Laviola, Luigi, Tarantino, Lucia, Ippolito, Claudia, Gigantelli, Vittoria, Manicone, Mariangela, Conte, Eleonora, Trevisan, Roberto, Scaranna, Cristiana, Rota, Rossella, Corsi, Anna, Dodesini, Alessandro R., Reggiani, Giulio Marchesini, Montesi, Luca, Mazzella, Natalia, Forlani, Gabriele, Caselli, Chiara, Di Luzio, Raffaella, Mazzotti, Arianna, Aiello, Antimo, Barrea, Angelina, Musto, Antonio, D'Amico, Fiorentina, Squatrito, Sebastiano, Sinagra, Tiziana, Longhitano, Sara, Trowpea, Vanessa, Sparti, Maria, Italia, Salvatore, Lisi, Enrico, Grasso, Giuseppe, Pezzino, Vincenzo, Insalaco, Federica, Gnasso, Agostino, Carallo, Claudio, Scicchitano, Caterina, De Franceschi, Maria Serena, Santini, Costanza, Mazzotti, Arianna, Caselli, Chiara, Calbucci, Giovanni, Ripani, Raffaella, Corsi, Laura, Cuneo, Giacomo, Corsi, Simona, Giorda, Carlo B., Romeo, Francesco, Lesina, Annalisa, Comoglio, Marco, Bonetto, Caterina, Robusto, Anna, Nada, Elisa, Asprino, Vincenzo, Cetraro, Rosa, Impieri, Michelina, Lucchese, Giuseppe, Donnarumma, Giovanna, Tizio, Biagio, Clemente, Gennaro, Lenza, Lazzaro, Paraggio, Pia, Tomasi, Franco, Zamboni, Chiara, Dozio, Nicoletta, Scalambra, Egle, Mannucci, Edoardo, Lamanna, Caterina, Cignarelli, Mauro, Macchia, Olga La, Fariello, Stefania, Sorrentino, Maria Rosaria, Franzetti, Ivano, Radin, Raffaella, Cordera, Renzo, Annunziata, Francesca, Bonabello, Laura Affinito, Durante, Arianna, Dolcino, Mara, Gallo, Fiorenza, Mazzucchelli, Chiara, Aleo, Anna, Melga, Pierluigi, Briatore, Lucia, Maggi, Davide, Storace, Daniela, Cecoli, Francesca, Antenucci, Daniela, D'Ugo, Ercole, Pupillo, Mario, Baldassarre, Maria Pompea Antonia, Salvati, Filippo, Minnucci, Anita, De Luca, Angelo, Zugaro, Antonella, Santarelli, Livia, Bosco, Angela, Petrella, Vittorio, La Verghetta, Grazia Giovanna, Iannarelli, Rossella, De Gregorio, Antonella, D'Andrea, Settimio, Giuliani, Anna Elisa, Polidoro, w Lorella, Sperandio, Alessandra, Sciarretta, Filomena, Pezzella, Alfonso, Buzzetti, Raffaella, Carlone, Angela, Potenziani, Stella, Venditti, Chiara, Foffi, Chiara, Carbone, Salvatore, Cipolloni, Laura, Moretti, Chiara, Leto, Gaetano, Serra, Rosalia, Petrachi, Francesca, Romano, Isabella, Di Cianni, Graziano, Lacaria, Emilia, Russo, Laura, Goretti, Chiara, Sannino, Claudia, Gregori, Giovanna, Dolci, Maria, Bruselli, Laura, Mori, Mary L., Baccetti, Fabio, Del Freo, Maria, Fontana, Lucia, Di Benedetto, Antonino, Cucinotta, Domenico, Giunta, Loretta, Ruffo, Maria Concetta, Cannizzaro, Desiree, Pintaudi, Basilio, Perrone, Giovanni, Pata, Pietro, Ragonese, Francesco, Lettina, Gabriele, Mancuso, Teresa, Coppolino, Aldo, Piatti, Pier Marco, Monti, Lucilla, Stuccillo, Michela, Lucotti, Pietro, Setola, Manuela, Crippa, Giulia Valentina, Loi, Cinzia, Oldani, Matteo, Bottalico, Maria Luisa, Pellegata, Beatrice, Bonomo, Matteo, Menicatti, Laura Silvia Maria, Resi, Veronica, Bertuzzi, Federico, Disoteo, Eugenia Olga, Pizzi, Gianluigi, Rivellese, Angela Albarosa, Annuzzi, Giovanni, Capaldo, Brunella, Nappo, Rossella, Auciello, Stefania Michela, Turco, Anna Amelia, Costagliola, Lucia, Iovine, Ciro, Corte, Giuseppina Della, Vallefuoco, Pasquale, Nappi, Francesca, Vitale, Marilena, Cocozza, Sara, Ciano, Ornella, Massimino, Elena, Garofalo, Nadia, Avogaro, Angelo, Vedovato, Monica, Guarneri, Gabriella, Lapolla, Annunziata, Fedele, Domenico, Sartore, Giovanni, Chilelli, Nino Cristiano, Burlina, Silvia, Bonsembiante, Barbara, Giordano, Carla, Galluzzo, Aldo, Torregrossa, Vittoria, Dall'Aglio, Elisabetta, Mancastroppa, Giovanni, Arsenio, Leone, Cioni, Federico, Caronna, Silvana, Papi, Matteo, Babini, Massimiliano, Perriello, Gabriele, Santeusanio, Fausto, Calagreti, Gioia, Timi, Alessia, Tantucci, Alice, Marino, Cecilia, Consoli, Agostino, Ginestra, Federica, Di Biagio, Rosamaria, Taraborelli, Merilda, Del Prato, Stefano, Miccoli, Roberto, Bianchi, Cristina, Garofolo, Monia, Politi, Konstantina Savina, Penno, Giuseppe, Zavaroni, Donatella, Livraga, Stefania, Calzoni, Fabio, Mancastroppa, Giovanni Luigi Francesco, Anichini, Roberto, Corsini, Elisa, Tedeschi, Anna, Gaglianò, Maria Sole, Ippolito, Giulio, Salutini, Elisabetta, Citro, Giuseppe, Cervellino, Francesco, Natale, Maria, Salvatore, Vita, Zampino, Armando, Sinisi, Rosa, Calabrese, Maria, Arcangeli, Adolfo, Zogheri, Alessia, Guizzotti, Sandra, Longo, Rossella, Di Bartolo, Paolo, Caselli, Chiara, Pellicano, Francesca, Scolozzi, Patrizia, Termine, Simona, Luberto, Alessandra, Ballardini, Giorgio, Babini, Anna Carla, Ripani, Raffaella, Trojani, Cristina, Mazzuca, Paolo, Bruglia, Matteo, Ciamei, Monica, Genghini, Silvia, Zannoni, Chiara, Pugliese, Giuseppe, Vitale, Martina, Rangel, Graziela, Salvi, Laura, Zappaterreno, Alessandra, Cordone, Samantha, Simonelli, Paola, Meggiorini, Marilla, Frasheri, Aurora, Di Pippo, Clelia, Maglio, Cristina, Mazzitelli, Giulia, Lauro, Davide, Rinaldi, Maria Elena, Galli, Angelica, Romano, Maria, D'Angelo, Paola, Leotta, Sergio, Suraci, Concetta, De Cosmo, Salvatore, Bacci, Simonetta, Palena, Antonio Pio, Genovese, Stefano, Mancino, Monica, Rondinelli, Maurizio, Capone, Filippo, Calabretto, Elisabetta, Bulgheroni, Monica, Bucciarelli, Loredana, Dotta, Francesco, Ceccarelli, Elena, Fondelli, Cecilia, Santacroce, Clorinda, Guarino, Elisa, Nigi, Laura, Lalli, Carlo, Di Vizia, Giovanni, Scarponi, Maura, Montani, Valeria, Di Bernardino, Paolo, Romagni, Paola, Dolcetti, Katia, Cannarsa, Emanuela, Forte, Elisa, Potenziani, Stella, Tamburo, Lucilla, Fornengo, Paolo, Perin, Paolo Cavallo, Prinzis, Tania, Gruden, Gabriella, Bruno, Graziella, Zucco, Chiara, Perotta, Massimo, Marena, Saverio, Monsignore, Simona, Panero, Francesco, Ponzi, Fulvia, Bossi, Antonio Carlo, Carpinteri, Rita, Casagrande, Maria Linda, Coletti, Maria Francesca, Menicatti, Laura Silvia Maria, Balini, Annalisa, Filopanti, Marcello, Madaschi, Sara, Pulcina, Anna, Grimaldi, Franco, Tonutti, Laura, Venturini, Giorgio, Agus, Sandra, Pagnutti, Stefania, Guidotti, Francesca, Cavarape, Alessandro, Casagrande, Maria Linda, Bonora, Enzo, Cigolini, Massimo, Pichiri, Isabella, Brangani, Corinna, Fainelli, Giulia, Tomasetto, Elena, Zoppini, Giacomo, Galletti, Anna, Perrone, Dominica, Capra, Claudio, Bianchini, Francesca, Ceseri, Martina, Di Nardo, Barbara, Sasso, Elisa, Bartolomei, Barbara, Suliman, Irina, Fabbri, Gianna, Romano, Geremia, Maturo, Nicola, Nunziata, Giuseppe, Capobianco, Giuseppe, De Simone, Giuseppina, Villa, Valeria, Rota, Giuseppe, Pentangelo, Carmine, Carbonara, Ornella, Caiazzo, Gennaro, Cutolo, Michele, Sorrentino, Tommasina, Mastrilli, Valeria, Amelia, Umberto, Masi, Stefano, Corigliano, Gerardo, Gaeta, Iole, Armentano, Vincenzo, Calatola, Pasqualino, Capuano, Gelsomina, Angiulli, Bruno, Auletta, Pasquale, Petraroli, Ettore, Iodice, Cinzia E., and Agrusta, Mariano

Abstract

The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes.

Published
2017
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21. The DAI prospective study on macrovascular complications in patients with type 2 diabetes. Characteristics of the study population

Author

Avogaro, A., carlo giorda, Maggini, M., Mannucci, E., Raschetti, R., Turco, S., Veluss, M., Da Ca, R., Sarli, E., Crescioli, C., Bellis, A., Iacovino, F., Ianni, L., Mencucci, A., Pezzatini, A., Pierazzuoli, E., Pala, L., Sposato, I., Alegiani, S. S., Grosso, J., Capani, F., Ciccarone, A., Pupillo, M., Luca, F., Alfidi, P., Paciotti, V., Venezia, A., Morea, R., Mazzuca, S., Ferraro, M. A., Anastasio, L., Vetrò, T., Caparelli, A., Puccio, L., Iannuzzi, F., Angozzi, G., Pipicelli, G., Tirinato, D., Calatola, P., Malinconico, V., Frullone, S., Mazzocca, S., Pontieri, A., Lutri, Perrelli, A., Carleo, R., Gatti, A., Bonavita, M., Gobbo, M., Creso, E., Giannettino, R., Federico, P., Ragozzino, Torella, R., Masi, R., Santorelli, Sgambato, S., Petraroli, E., De Chiara, Di Giovanni, G., Simone, G., Pappalardo, L., Marro, A., Lucibelli, L., Marrone, M., Caiazzo, G., Gaeta, I., Corigliano, G., Fiordelisi, F., Cresta, G., Pareschi, P., Manservigi, D., Gaiti, D., Manicardi, V., Bosi, E., Magotti, M. G., Trojani, C., Rastelli, E., Marrino, P., Pierfranceschi, D. G., Caronna, S., Ruggiero, F., Castelvetri, G., Brusa, G., D Antonio, C., Parini, S., Savorgnani, M. N., Cernigoi, A. M., Monte, A., Sancandi, M., Maschio, M., Ariatta, M. C., Pellegrini, M. A., Miniussi, P., Donadon, W., Zanette, G., Chiaramonte, F., Serra, M. A., La Saracina, F., Ghisoni, G., Avogaro, A., Giorda, C., Maggini, M., Mannucci, E., Raschetti, R., Turco, S., Veluss, M., Da Ca, R., Sarli, E., Crescioli, C., De Bellis, A., Iacovino, F., Ianni, L., Mencucci, A., Pezzatini, A., Pierazzuoli, E., Pala, L., Sposato, I., Alegiani, S. S., Grosso, J., Capani, F., Ciccarone, A., Pupillo, M., De Luca, F., Alfidi, P., Paciotti, V., Venezia, A., Morea, R., Mazzuca, S., Ferraro, M. A., Anastasio, L., Vetro, T., Caparelli, A., Puccio, L., Iannuzzi, F., Angozzi, G., Pipicelli, G., Tirinato, D., Calatola, P., Malinconico, V., Frullone, S., Mazzocca, S., Pontieri, A., Lutri, Perrelli, A., Carleo, R., Gatti, A., Bonavita, M., Gobbo, M., Creso, E., Giannettino, R., Federico, P., Ragozzino, Torella, R., Masi, R., Santorelli, Sgambato, S., Petraroli, E., De, Chiara, Di Giovanni, G., De Simone, G., Pappalardo, L., Marro, A., Lucibelli, L., Marrone, M., Caiazzo, G., Gaeta, I., Corigliano, G., Fiordelisi, F., Cresta, G., Pareschi, P., Manservigi, D., Gaiti, D., Manicardi, V., Bosi, E., Magotti, M. G., Trojani, C., Rastelli, E., Marrino, P., Pierfranceschi, D. G., Caronna, S., Ruggiero, F., Castelvetri, G., Brusa, G., D'Antonio, C., Parini, S., De Savorgnani, M. N., Cernigoi, A. M., De Monte, A., Sancandi, M., Maschio, M., Ariatta, M. C., Pellegrini, M. A., Miniussi, P., Donadon, W., Zanette, G., Chiaramonte, F., Serra, M. A., La Saracina, F., and Ghisoni, G.

Subjects
Type 2 diabetes mellitus, Cohort study, Macrovascular complications
Abstract

A large multicenter cohort study, the DAI study, is being performed on patients with type 2 diabetes mellitus who are followed by diabetic care units in Italy, to study the prevalence and incidence of myocardial infarction, ischemic heart disease, coronary artery bypass, coronary angioplasty, cerebral thrombo-embolism, and amputations. The reference population consists of all patients visited at the participating units in the period September-December 1998 or March-June 1999. Patients were randomly chosen so as to create a sample representative of the diabetic population visited at the units. Overall, 201 of the approximately 650 Italian diabetic care units participated in the study and 24 094 patients were included in the study. The paper presents the protocol and the characteristics of the DAI study population.

22. Eating habits of patients with type 2 diabetes mellitus: Impact of regional gastronomic traditions. A population based study | Abitudini alimentari dei pazienti con diabete di tipo 2: Impatto delle tradizioni gastronomiche regionali. Uno studio di popolazione

Author

Vitale, M., Masulli, M., Turco, A., Ciano, O., Riccardi, G., Rivellese, A. A., Auletta, P., Babini, A. C., Boemi, M., Bonora, E., Burlina, S., Raffaella Buzzetti, Calatola, P., Capuano, G., Cignarelli, M., Cigolini, M., Citro, G., Clemente, G., Corsi, L., Cutolo, M., Dall Aglio, E., Del Prato, S., Simone, G., Di Cianni, G., Dolci, M. A., D Ugo, E., Giordano, C., Iannarelli, R., Iovine, C., Lauro, D., Leotta, S., Mazzucchelli, C., Montani, V., Perriello, G., Romano, G., Romeo, F., Squatrito, S., Tizio, B., Tomasi, F., Tonutti, L., Trevisan, R., and Vaccaro, O.

23. Intensive dietary intervention promoting the Mediterranean diet in people with high cardiometabolic risk: a non-randomized study

Author

M Rispoli, S Pardo, M Guglielmi, M Grimaldi, M Manzo, Brunella Capaldo, Gabriele Riccardi, A Limardi, M Lucibello, O Ciano, P. Calatola, Grimaldi, M., Ciano, O., Manzo, M., Rispoli, M., Guglielmi, M., Limardi, A., Calatola, P., Lucibello, M., Pardo, S., Capaldo, B., and Riccardi, G.

Subjects
Adult, Male, Lifestyle intervention, medicine.medical_specialty, Mediterranean diet, Saturated fat, Endocrinology, Diabetes and Metabolism, Psychological intervention, Blood Pressure, 030209 endocrinology & metabolism, Type 2 diabetes, Diet, Mediterranean, Weight lo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, Risk Factors, Weight loss, law, Internal medicine, Diabetes mellitus, Weight Loss, medicine, Internal Medicine, Humans, 030212 general & internal medicine, Triglycerides, Aged, Metabolic Syndrome, business.industry, Cholesterol, HDL, General Medicine, Middle Aged, medicine.disease, Cardiometabolic risk, Weight Reduction Programs, Blood pressure, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Female, medicine.symptom, business
Abstract

Mediterranean diet (MD) is acknowledged to exert a number of beneficial health effects. We assessed the efficacy and the durability of a 3-month intensive dietary intervention aimed at implementing the MD on body weight and cardiometabolic risk factors in subjects at high risk. One hundred and sixteen subjects participated in the study (71 assigned to the intensive intervention and 45 to the conventional intervention). The intensive intervention consisted of 12 weekly group educational meetings and a free-of-charge supply of meals prepared according to the MD model. The conventional intervention consisted of an individual education session along with monthly reinforcements of nutritional messages by the general practitioner. All participants were followed up for 9 months. The two groups had similar pre-intervention characteristics. After the intervention, mean body weight decreased significantly in both groups (p

Published
2017

24. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study

Author

Vitale, M., Masulli, M., Rivellese, A. A., Bonora, E., Cappellini, F., Nicolucci, Andrea, Squatrito, S., Antenucci, D., Barrea, A., Bianchi, C., Bianchini, F., Fontana, L., Fornengo, P., Giorgino, F., Gnasso, A., Mannucci, E., Mazzotti, A., Nappo, R., Palena, A. P., Pata, P., Perriello, G., Potenziani, S., Radin, R., Ricci, L., Romeo, F., Santini, C., Scarponi, M., Serra, Riccardo, Timi, A., Turco, A. A., Vedovato, M., Zavaroni, D., Grioni, S., Riccardi, G., Vaccaro, O., Rivellese, Angela Albarosa, Cocozza, Sara, Auciello, Stefania, Turco, Anna Amelia, Bonora, Enzo, Cigolini, Massimo, Pichiri, Isabella, Brangani, Corinna, Tomasetto, Elena, Perriello, Gabriele, Timi, Alessia, Squatrito, Sebastiano, Sinagra, Tiziana, Longhitano, Sara, Tropea, Vanessa, Ballardini, Giorgio, Babini, Anna Carla, Ripani, Raffaella, Gregori, Giovanna, Dolci, Maria, Bruselli, Laura, Salutini, Isabella, Mori, Mary, Baccetti, Fabio, Lapolla, Annunziata, Sartore, Giovanni, Burlina, Silvia, Chilelli, Nino Cristiano, Buzzetti, Raffaella, Venditti, Chiara, Potenziani, Stella, Carlone, Angela, Galluzzoâ€&nbsp, Aldo, Giordano, Carla, Torregrossa, Vittoria, Corsi, Laura, Cuneo, Giacomo, Corsi, Simona, Tizio, Biagio, Clemente, Gennaro, Citro, Giuseppe, Natale, Maria, Salvatore, Vita, Di Cianni, Graziano, Lacaria, Emilia, Russo, Laura, Iannarelli, Rossella, de Gregorio, Antonella, Sciarretta, Filomena, D’Andrea, Settimio, Montani, Valeria, Cannarsa, Emanuela, Dolcetti, Katia, Cordera, Renzo, Bonabello, Laura Affinito, Mazzucchelli, Chiara, Giorda, Carlo Bruno, Romeo, Francesco, Bonetto, Caterina, Antenucci, Daniela, Baldassarre, Maria Pompea Antonia, Iovine, Ciro, Nappo, Rossella, Ciano, Ornella, Dall’Aglio, Elisabetta, Mancastroppa, Giovanni, Grimaldi, Franco, Tonutti, Laura, Boemi, Massimo, D’Angelo, Federica, Leotta, Sergio, Fontana, Lucia, Lauro, Davide, Rinaldi, Maria Elena, Cignarelli, Mauro, la Macchia, Olga, Fariello, Stefania, Tomasi, Franco, Zamboni, Chiara, Dozio, Nicoletta, Trevisan, Roberto, Scaranna, Cristiana, Del Prato, Stefano, Miccoli, Roberto, Bianchi, Cristina, Garofolo, Monia, Pugliese, Giuseppe, Salvi, Laura, Rangel, Graziela, Vitale, Martina, Anichini, Roberto, Tedeschi, Anna, Corsini, Elisa, Cucinotta, Domenico, Di Benedetto, Antonino, Giunta, Loretta, Ruffo, Maria Concetta, Bossi, Antonio Carlo, Carpinter, Rita, Dotta, Francesco, Ceccarelli, Elena, Bartolo, Paolo Di, Caselli, Chiara, Luberto, Alessandra, Santini, Costanza, Mazzotti, Arianna, Calbucci, Giovanni, Consoli, Agostino, Ginestra, Federica, Calabrese, Maria, Zogheri, Alessia, Ricci, Lucia, Giorgino, Francesco, Laviola, Luigi, Ippolito, Claudia, Tarantino, Lucia, Avogaro, Angelo, Vedovato, Monica, Gnasso, Agostino, Carallo, Claudio, Scicchitano, Caterina, Zavaroni, Donatella, Livraga, Stefania, Perin, Paolo Cavallo, Forrnengo, Paolo, Prinzis, Tania, de Cosmo, Salvatore, Palena, Antonio Pio, Bacci, Simonetta, Mannucci, Edoardo, Lamanna, Caterina, Pata, Pietro, Lettina, Gabriele, Aiello, Antimo, Barrea, Angelina, Lalli, Carlo, Scarponi, Maura, Franzetti, Ivano, Radin, Raffaella, Serra, Rosalia, Petrachi, Francesca, Asprino, Vincenzo, Capra, Claudio, Forte, Elisa, Reggiani, Giulio Marchesini, Forlani, Gabriele, Montesi, Luca, Mazzella, Natalia, Piatti, Pier Marco, Monti, Lucilla, Stuccillo, Michela, Auletta, Pasquale, Petraroli, Ettore, Capobianco, Giuseppe, Romano, Geremia, Cutolo, Michele, de Simone, Giosetta, Caiazzo, Gennaro, Nunziata, Peppe, Sorrentino, Susy, Amelia, Umberto, Calatola, Pasqualino, Capuano, Gelsomina, Vitale, M, Masulli, M, Rivellese, AA, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo,P, Giorgino, F, Gnasso, A, Mannucci, Mazzotti, A, Nappo, R, Palena, AP, Pata, P,Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, AA, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, TOSCA.IT Study Group., Giordano, C., Rivellese, Aa, Fornengo, P, Mannucci, E, Mazzotti, A, Nappo, R, Palena, Ap, Pata, P, Perriello, G, Turco, Aa, Tosc, A. IT Study Group., Rivellese, A, Palena, A, Turco, A, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, and Capuano, G

Subjects
0301 basic medicine, Male, Age, BMI, Diabetes, Diet, Flavonoids, Food groups, Geographical area, Intake, Phenolic acids, Polyphenols, TOSCA.IT study, Aged, Antioxidants, Beverages, Cinnamates, Cohort Studies, Cross-Sectional Studies, Databases, Factual, Diabetes Mellitus, Type 2, Female, Flavonoids, Fruit, Glycosides, Humans, Italy, Male, Middle Aged, Nutritive Value, Phenols, Polyphenols, Diet, Diabetic, Diet, Healthy, Patient Compliance, Settore MED/09 - Medicina Interna, Databases, Factual, Cross-sectional study, Medicine (miscellaneous), Type 2 diabetes, Diabete, Antioxidants, Settore MED/13 - Endocrinologia, Food group, Cohort Studies, 0302 clinical medicine, Diet, Diabetic, Medicine, Food science, Glycosides, Age, BMI, Diabetes, Diet, Flavonoids, Food groups, Geographical area, Intake, Phenolic acids, Polyphenols, TOSCA.IT study, Nutrition and Dietetics, Phenolic acid, food and beverages, Middle Aged, Polyphenols, Flavonoids, Phenolic acids, Diabetes, Food groups, Diet, Age, BMI, Geographical area, Intake, TOSCA.IT study, Italy, Tosca,Age,BMI,Diabetes,Diet,Flavonoids,Food groups,Geographical area,Intake,Phenolic acids,Polyphenols,TOSCA.IT study, Cohort, Female, Diet, Healthy, Nutritive Value, Cohort study, Polyphenol, 030209 endocrinology & metabolism, Beverages, 03 medical and health sciences, Phenols, Diabetes mellitus, Humans, Aged, 030109 nutrition & dietetics, business.industry, Anthropometry, medicine.disease, Tosca, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Cinnamates, Fruit, Flavonoid, Patient Compliance, business
Abstract

Purpose: Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. Methods: We studied 2573 men and women aged 50–75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results: The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. Conclusions: The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes. © 2016 Springer-Verlag Berlin Heidelberg

Published
2016
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25. Abitudini alimentari dei pazienti con diabete di tipo 2: Impatto delle tradizioni gastronomiche regionali. Uno studio di popolazione

Author

M. Vitale1, M. Masulli1, A. Turco1, O. Ciano1, G. Riccardi1, A.A. Rivellese1, P. Auletta, A.C. Babini, M. Boemi, E. Bonora, S. Burlina, R. Buzzetti, P. Calatola, G. Capuano, M. Cignarelli, M. Cigolini, G. Citro, G. Clemente2, L. Corsi, M. Cutolo, E. Dall'Aglio, S. Del Prato, G. De Simone, G. Di Cianni, M.A. Dolci, E. D'Ugo, C. Giordano, R. Iannarelli, C. Iovine, D. Lauro, S. Leotta, C. Mazzucchelli, V. Montani, G. Perriello, G. Romano, F. Romeo, S. Squatrito, B. Tizio, F. Tomasi, L. Tonutti, R. Trevisan, O. Vaccaro1 (a nome del Gruppo di Studio TOSCA.IT), Vitale, Marilena, Masulli, Maria, Turco, ANNA AMELIA, Ciano, Ornella, Riccardi, Gabriele, Rivellese, ANGELA ALBAROSA, Auletta, P., Babini, A. C., Boemi, M., Bonora, E., Burlina, S., Buzzetti, R., Calatola, P., Capuano, G., Cignarelli, M., Cigolini, M., Citro, G., Clemente, G., Corsi, L., Cutolo, M., Dall'Aglio, E., Del Prato, S., De Simone, G., Di Cianni, G., Dolci, M. A., D'Ugo, E., Giordano, Ciro, Iannarelli, R., Iovine, Ciro, Lauro, D., Leotta, S., Mazzucchelli, C., Montani, V., Perriello, G., Romano, G., Romeo, F., Squatrito, S., Tizio, B., Tomasi, F., Tonutti, L., Trevisan, R., and Vaccaro, Olga

Subjects
Diet composition, Dietary habits, Endocrinology, Diabetes and Metabolism, Type 2 diabetes, Nutritional recommendation, Dietary habit, Type 2 diabete, Regional differences, Endocrinology, Internal Medicine, Settore MED/13 - Endocrinologia, Diabetes and Metabolism, Regional difference
Abstract

RIASSUNTO Nonostante gli sforzi per diffondere e implementare le raccomandazioni nutrizionali per il trattamento del diabete, la loro applicazione nella pratica clinica è ancora largamente insufficiente. Tra le possibili ragioni va considerato il fatto che le abitudini alimentari risentono molto delle tradizioni gastronomiche locali. Lo studio si propone di valutare le abitudini alimentari delle persone con diabete in tre macroaree geografiche italiane, nord, centro e sud, per studiare in che misura le tradizioni gastronomiche locali possano influenzare l'adesione alle raccomandazioni nutrizionali. Sono stati studiati 1786 pazienti diabetici di tipo 2; le abitudini alimentari sono state indagate con un questionario alimentare semiquantitativo di frequenza validato (EPIC, European Prospective Investigation on Cancer and Nutrition). L'introito energetico è sovrapponibile nelle 3 macroaree geografiche, ma gli alimenti che contribuiscono alla composizione della dieta sono diversi a seconda della locazione geografica: al nord si osserva un maggiore consumo di carne, salumi e grassi animali; al sud, un maggiore consumo di pane integrale e legumi. Questo si traduce in una differente composizione in nutrienti della dieta: il consumo di grassi totali, grassi saturi e polinsaturi risulta significativamente più basso al sud e al centro rispetto al nord (p < 0,05); il contrario si osserva, invece, per i carboidrati totali e la fibra alimentare (p < 0,05). Infine, la proporzione di pazienti che aderiscono alle raccomandazioni nutrizionali è generalmente scarsa sia per il consumo di fibra, mediamente inferiore rispetto a quanto raccomandato, sia per il consumo di grassi saturi, mediamente superiore ai livelli consigliati. In conclusione, le raccomandazioni nutrizionali sono scarsamente seguite su tutto il territorio nazionale; si osservano, tuttavia, significative differenze geografiche verosimilmente dovute all'influenza delle tradizioni gastronomiche locali che vanno tenute in conto per migliorare l'adesione dei pazienti alle raccomandazioni dietetiche.

Published
2013

26. [Anticoagulants in therapy of patients with heart valve prostheses].

Author

Mauro R and Calatola P

Subjects
Adenosine Diphosphate metabolism, Blood Coagulation Factors biosynthesis, Humans, Platelet Adhesiveness drug effects, Platelet Aggregation drug effects, Postoperative Complications, Serotonin metabolism, Anticoagulants therapeutic use, Coumarins therapeutic use, Heart Valve Prosthesis adverse effects, Thrombosis prevention & control
Abstract

Thrombosis in subjects with valvular prostheses is primarily attributable to the tendency of platelets to adhere to non-natural surfaces. In addition, the release of ADP and serotonin leads to their clumping. Anticoagulant management is based on the employment of dicumarols, which inhibit the synthesis of factors VII, IX & X, and anti-clumping substances. When using the former, care must be taken to prevent unwanted side-effects and to watch for possible interactions with drugs that may enhance or diminish their effectiveness. Among the latter, a preference should be shown for those that act on the release of endogenous ADP; these are free from toxicity and significant side-effects. The main remedy, however, remains that elaborating prostheses coated with protein material to prevent adhesion by platelets and so obtain a non-thrombogenic surface.

Published
1975

27. [Arteriosclerosis and thrombocyte antiaggregants].

Author

Mauro R, Calatola P, Di Donato F, and Lettieri A

Subjects
Cholesterol blood, Fatty Acids, Nonesterified blood, Humans, Triglycerides blood, Anticoagulants pharmacology, Arteriosclerosis blood, Platelet Aggregation drug effects
Published
1977

28. [Clinical evaluation of the use of a chronopluricorticoid in the therapy of active chronic hepatitis].

Author

Mauro R, Calatola P, D'Arco AM, Lettieri A, Maiorino A, and Santoro A

Subjects
Adult, Aged, Clinical Trials as Topic, Cortisone therapeutic use, Drug Combinations therapeutic use, Endocrine Glands drug effects, Humans, Liver drug effects, Liver Function Tests, Middle Aged, Prednisolone therapeutic use, Adrenal Cortex Hormones therapeutic use, Cortisone analogs & derivatives, Hepatitis drug therapy, Prednisolone analogs & derivatives
Published
1979

29. [Anti-platelet-aggregation drugs and atherosclerosis].

Author

Mauro R, Calatola P, Di Donato F, Frey L, and Lettieri A

Subjects
Arteriosclerosis blood, Humans, Hyperlipidemias blood, Hypertension blood, Anticoagulants therapeutic use, Arteriosclerosis drug therapy, Platelet Aggregation drug effects
Abstract

The relationship between hyperlipidaemia and thrombophilic state in atherosclerosis was appraised by evaluation of platelet aggregation according to Breddin in 20 patients with clinically established atherosclerosis, 10 normal controls, and 22 subjects taken from the average population of a medical department aged 12-58 yr with no history of atherosclerosis. Normal screening for the disease was carried out in all patients. Drugs inhibiting platelet-aggregation were given to all subjects in Breddin's 3rd or 4th stage. A relationship was noted between Breddin stage and the seriousness of atherosclerosis, while the former was a pointer to thrombophilic states. The drugs administered were able to reverse the aggregation stage.

Published
1978

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