Rationale and Design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) Trial

Publication date: Available online 21 December 2015 Source:American Heart Journal Author(s): Rury R. Holman, M. Angelyn Bethel, Jyothis George, Harald Sourij, Zoë Doran, Joanne Keenan, Nardev S. Khurmi, Robert J. Mentz, Abderrahim Oulhaj, John B. Buse, Juliana C. Chan, Nayyar Iqbal, Sudeep Kundu, Aldo P. Maggioni, Steven P. Marso, Peter Öhman, Michael J. Pencina, Neil Poulter, Lisa E. Porter, Ambady Ramachandran, Bernard Zinman, Adrian F. Hernandez Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide (GLP)-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically-led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1360 confirmed primary composite cardiovascular endpoints, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, have occurred. Th...
Source: American Heart Journal - Category: Cardiology Source Type: research