PIONEER 6: cardiovascular safety6,7
Study design: In a double-blind trial, 3183 adult patients with inadequately controlled type 2 diabetes and patients ≥50 years of age with CVD or CKD or ≥60 years with CV risk factors were randomized to RYBELSUS® 14 mg (n=1591) once daily or placebo (n=1592), both in addition to standard of care. Background antidiabetic therapy included OADs and/or insulin. Patients could also be treatment naïve. Most patients were also on antihypertensive therapies, lipid-lowering therapies, and antiplatelet or antithrombotic therapy.
The primary endpoint was the time to first occurrence of MACE which included CV death, nonfatal myocardial infarction, or nonfatal stroke.
Secondary endpoint: Time from randomization to the first occurrence of an expanded composite outcome consisting of the primary composite plus unstable angina resulting in hospitalization or heart failure resulting in hospitalization or a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke.
CV=cardiovascular; CVOT=cardiovascular outcomes trial; MACE=major adverse cardiovascular event.