Coordinatore: Gabriele Riccardi
TOSCA.IT (Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents. Intervention Trial)
EFFETTI SULL’INCIDENZA DI EVENTI CARDIOVASCOLARI DELL’AGGIUNTA DI PIOGLITAZONE O DI UNA SULFONILUREA ALLA METFORMINA IN PAZIENTI CON DIABETE MELLITO TIPO 2 IN MONOTERAPIA NON ADEGUATAMENTE COMPENSATI
Lo studio TOSCA ha arruolato pazienti con diabete mellito tipo 2 non adeguatamente compensati con metformina in monoterapia e valutato gli effetti di due schemi terapeutici: metformina + pioglitazone vs. metformina + sulfonilurea su: incidenza di eventi cardiovascolari fatali e non fatali, efficacia sul compenso glicemico e sui maggiori fattori di rischio cardiovascolare, sicurezza, tollerabilità e costi.
Pubblicazioni
Legume Consumption and Blood Pressure Control in Individuals with Type 2 Diabetes and Hypertension: Cross-Sectional Findings from the TOSCA.IT Study. Vitale M, Giosuè A, Sieri S, Krogh V, Massimino E, Rivellese AA, Riccardi G, Vaccaro O, Masulli M. Nutrients. 2023 Jun 26;15(13):2895. doi: 10.3390/nu15132895.
Association between Diet Quality and Index of Non-Alcoholic Steatohepatitis in a Large Population of People with Type 2 Diabetes: Data from the TOSCA.IT Study. Vitale M, Della Pepa G, Costabile G, Bozzetto L, Cipriano P, Signorini S, Leoni V, Riccardi G, Vaccaro O, Masulli M. Nutrients. 2022 Dec 15;14(24):5339. doi: 10.3390/nu14245339.
Pioglitazone even at low dosage improves NAFLD in type 2 diabetes: clinical and pathophysiological insights from a subgroup of the TOSCA.IT randomised trial.Della Pepa G, Russo M, Vitale M, Carli F, Vetrani C, Masulli M, Riccardi G, Vaccaro O, Gastaldelli A, Rivellese AA, Bozzetto L. Diabetes Res Clin Pract. 2021 Aug;178:108984. doi: 10.1016/j.diabres.2021.108984. Epub 2021 Jul 24.
A few clinical features improve the prediction of mortality and cardiovascular outcomes in patients with type 2 diabetes. Masulli M, Lucisano G, Bonora E, Del Prato S, Rivellese AA, Signorini S, Mocarelli P, Riccardi G, Vaccaro O, Nicolucci A; TOSCA.IT Investigators. Eur J Prev Cardiol. 2022 Feb 9;28(18):e1-e3. doi: 10.1093/eurjpc/zwaa002.
Cardiovascular risk factors control according to diabetes status and prior cardiovascular events in patients managed in different settings. Vaccaro O, Vitale M, Costanzo S, Masulli M, Riccardi G, De Curtis A, Donati MB, Rivellese AA, de Gaetano G, Iacoviello L. Diabetes Res Clin Pract. 2020 Oct;168:108370. doi: 10.1016/j.diabres.2020.108370.
Pasta Consumption and Connected Dietary Habits: Associations with Glucose Control, Adiposity Measures, and Cardiovascular Risk Factors in People with Type 2 Diabetes-TOSCA.IT Study.
Vitale M, Masulli M, Rivellese AA, Bonora E, Babini AC, Sartore G, Corsi L, Buzzetti R, Citro G, Baldassarre MPA, Bossi AC, Giordano C, Auciello S, Dall'Aglio E, Iannarelli R, Tonutti L, Sacco M, Di Cianni G, Clemente G, Gregori G, Grioni S, Krogh V, Riccardi G, Vaccaro O.
Nutrients. 2019 Dec 30;12(1):101. doi: 10.3390/nu12010101.
Cardiovascular Effects of Pioglitazone or Sulfonylureas According to Pretreatment Risk: Moving Toward Personalized Care. Vaccaro O, Lucisano G, Masulli M, Bonora E, Del Prato S, Rivellese AA, Giorda CB, Mocarelli P, Squatrito S, Maggioni AP, Riccardi G, Nicolucci A; TOSCA.IT Investigators.
J Clin Endocrinol Metab. 2019 Aug 1;104(8):3296-3302. doi: 10.1210/jc.2019-00361.
Impact of a Mediterranean Dietary Pattern and Its Components on Cardiovascular Risk Factors, Glucose Control, and Body Weight in People with Type 2 Diabetes: A Real-Life Study.
Vitale M, Masulli M, Calabrese I, Rivellese AA, Bonora E, Signorini S, Perriello G, Squatrito S, Buzzetti R, Sartore G, Babini AC, Gregori G, Giordano C, Clemente G, Grioni S, Dolce P, Riccardi G, Vaccaro O; TOSCA.IT Study Group.
Nutrients. 2018 Aug 10;10(8):1067. doi: 10.3390/nu10081067.
Glucose lowering strategies and cardiovascular disease in type 2 diabetes - teachings from the TOSCA.IT study. Vaccaro O, Masulli M, Riccardi G. Nutr Metab Cardiovasc Dis. 2018 Jul;28(7):722-726. doi: 10.1016/j.numecd.2018.04.008.
TOSCA.IT is an institutional, non-industry-supported, head-to-head study comparing long term cardiovascular effects, efficacy and safety of two antidiabetes drugs (pioglitazone vs sulphonylureas) used in combination with metformin in patients with type 2 diabetes mellitus. 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.
Vaccaro O, Masulli M, Nicolucci A, Bonora E, Del Prato S, Maggioni AP, Rivellese AA, Squatrito S, Giorda CB, Sesti G, Mocarelli P, Lucisano G, Sacco M, Signorini S, Cappellini F, Perriello G, Babini AC, 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 AC, 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; Thiazolidinediones Or Sulfonylureas Cardiovascular Accidents Intervention Trial (TOSCA.IT) study group; Italian Diabetes Society.
Lancet Diabetes Endocrinol. 2017 Nov;5(11):887-897. doi: 10.1016/S2213-8587(17)30317-0.
Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study.
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 E, 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. Eur J Nutr. 2018 Mar;57(2):679-688. doi: 10.1007/s00394-016-1355-1.
Polyphenol intake and cardiovascular risk factors in a population with type 2 diabetes: The TOSCA.IT study.
Vitale M, Vaccaro O, Masulli M, Bonora E, Del Prato S, Giorda CB, Nicolucci A, Squatrito S, Auciello S, Babini AC, Bani L, Buzzetti R, Cannarsa E, Cignarelli M, Cigolini M, Clemente G, Cocozza S, Corsi L, D'Angelo F, Dall'Aglio E, Di Cianni G, Fontana L, Gregori G, Grioni S, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Laviola L, Mazzucchelli C, Signorini S, Tonutti L, Trevisan R, Zamboni C, Riccardi G, Rivellese AA; TOSCA.IT Study Group. Clin Nutr. 2017 Dec;36(6):1686-1692. doi: 10.1016/j.clnu.2016.11.002.
Sex differences in food choices, adherence to dietary recommendations and plasma lipid profile in type 2 diabetes - The TOSCA.IT study. Vitale M, Masulli M, Cocozza S, Anichini R, Babini AC, Boemi M, Bonora E, Buzzetti R, Carpinteri R, Caselli C, Ceccarelli E, Cignarelli M, Citro G, Clemente G, Consoli A, Corsi L, De Gregorio A, Di Bartolo P, Di Cianni G, Fontana L, Garofolo M, Giorda CB, Giordano C, Grioni S, Iovine C, Longhitano S, Mancastroppa G, Mazzucchelli C, Montani V, Mori M, Perriello G, Rinaldi ME, Ruffo MC, Salvi L, Sartore G, Scaranna C, Tonutti L, Zamboni C, Zogheri A, Krogh V, Cappellini F, Signorini S, Riccardi G, Vaccaro O; TOSCA.IT Study Group. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):879-85. doi: 10.1016/j.numecd.2016.04.006.
Influence of dietary fat and carbohydrates proportions on plasma lipids, glucose control and low-grade inflammation in patients with type 2 diabetes-The TOSCA.IT Study. Vitale M, Masulli M, Rivellese AA, Babini AC, Boemi M, Bonora E, Buzzetti R, Ciano O, Cignarelli M, Cigolini M, Clemente G, Citro G, Corsi L, Dall'Aglio E, Del Prato S, Di Cianni G, Dolci MA, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Leotta S, Mazzucchelli C, Montani V, Perriello G, Romano G, Romeo F, Santarelli L, di Cola RS, Squatrito S, Tonutti L, Trevisan R, Turco AA, Zamboni C, Riccardi G, Vaccaro O.
Eur J Nutr. 2016 Jun;55(4):1645-51. doi: 10.1007/s00394-015-0983-1. Epub 2015 Aug 25.
Cardiovascular outcome trials of glucose-lowering strategies in type 2 diabetes.
Vaccaro O, Masulli M, Bonora E, Del Prato S, Riccardi G; TOSCA.IT Study Group.
Lancet. 2014 Sep 20;384(9948):1096. doi: 10.1016/S0140-6736(14)61672-X.
The TOSCA.IT trial: a study designed to evaluate the effect of pioglitazone versus sulfonylureas on cardiovascular disease in type 2 diabetes.
Vaccaro O, Masulli M, Bonora E, Del Prato S, Nicolucci A, Rivellese AA, Riccardi G; TOSCA.IT Study Group.
Diabetes Care. 2012 Dec;35(12):e82. doi: 10.2337/dc12-0954.
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.
Vaccaro O, Masulli M, Bonora E, Del Prato S, Giorda CB, Maggioni AP, Mocarelli P, Nicolucci A, Rivellese AA, Squatrito S, Riccardi G; TOSCA.IT study group (Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents. Intervention Trial).
Nutr Metab Cardiovasc Dis. 2012 Nov;22(11):997-1006. doi: 10.1016/j.numecd.2012.09.003.
