Thiazolidinediones or Sulphonylureas and Cardiovascular Accidents Intervention Trial

Introduction. All guidelines recommend the use of metformin as the initial treatment of type 2 diabetes mellitus. If metformin alone results in a non-satisfactory therapeutic effect, the addition of a second drug is recommended. However, the safety profile and long-term effect on cardiovascular complications arising from the use of two of the most common treatment options – sulfonylureas and pioglitazone – are still not clear.

Aims. The TOSCA study aims to clarify whether the addition of pioglitazone, compared to the addition of a sulfonylurea, reduces the incidence of cardiovascular events in patients with type 2 diabetes mellitus not adequately compensated with metformin. The two treatments are also compared in terms of efficacy on glycemic control, major cardiovascular risk factors, safety, tolerability and costs.

Type of study. Randomized, controlled parallel group (1: 1), multicenter study

Population. 3041 patients with type 2 diabetes without previous cardiovascular events

Centers. 61 Italian diabetes centers

Promoter. Italian Society of Diabetology (SID

Funding. AIFA – Italian Medicines Agency, non-profit study

Status. Study completed

Bibliography:

  1. 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; under the mandate of the Italian Diabetes Society. 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. Lancet Diabetes Endocrinol 2017; 5: 887-897.
  2. 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. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study. Eur J Nutr. 2016 Dec 21. [Epub ahead of print].
  3. 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.. Polyphenol intake and cardiovascular risk factors in a population with type 2 diabetes: The TOSCA.IT study. Clin Nutr. 2016. pii: S0261-5614(16)31316-4.
  4. 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). 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. Nutr Metab Cardiovasc Dis. 2012;22:997-1006.
  5. Vaccaro O, Masulli M, Bonora E, Del Prato S, Nicolucci A, Rivellese AA, Riccardi G; TOSCA.IT Study Group. The TOSCA.IT trial: a study designed to evaluate the effect of pioglitazone versus sulfonylureas on cardiovascular disease in type 2 diabetes. Diabetes Care. 2012;35:e82.