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A trial of aleglitazar to improve cardiovascular outcomes in patients with type 2 diabetes who had recent-onset acute coronary syndrome has been terminated early because of a lack of efficacy and an increased risk of adverse events.
The phase III trial found no significant improvements in the primary endpoint of time to cardiovascular death, nonfatal MI, or nonfatal stroke.
Specifically, the primary endpoint occurred in 344 patients (9.5%) in the aleglitazar group and 360 patients (10%) in the placebo group (hazard ratio, 0.96; 95% confidence interval, 0.83-1.1; P = .57), and a significant increase in gastrointestinal hemorrhages, renal dysfunction, peripheral edema, and hypoglycemia in the aleglitazar arm, Dr. A. Michael Lincoff of the Cleveland Clinic and his colleagues said at the annual meeting of the American College of Cardiology.
"These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk," the authors reported in a study simultaneously published online March 30 in JAMA (2014 [doi:10.1001/jama.2014.3321]).
The double-blind, placebo-controlled trial in 7,226 patients of dual peroxisome proliferator-activated receptor agonist aleglitazar 150 mcg daily followed an earlier phase II trial that showed the drug significantly reduced glycated hemoglobin, triglycerides, and LDL cholesterol, and raised HDL cholesterol.
The trial was sponsored by F. Hoffmann-La Roche, and the authors reported research grants, honoraria and consultancy fees from a range of pharmaceutical companies.
A trial of aleglitazar to improve cardiovascular outcomes in patients with type 2 diabetes who had recent-onset acute coronary syndrome has been terminated early because of a lack of efficacy and an increased risk of adverse events.
The phase III trial found no significant improvements in the primary endpoint of time to cardiovascular death, nonfatal MI, or nonfatal stroke.
Specifically, the primary endpoint occurred in 344 patients (9.5%) in the aleglitazar group and 360 patients (10%) in the placebo group (hazard ratio, 0.96; 95% confidence interval, 0.83-1.1; P = .57), and a significant increase in gastrointestinal hemorrhages, renal dysfunction, peripheral edema, and hypoglycemia in the aleglitazar arm, Dr. A. Michael Lincoff of the Cleveland Clinic and his colleagues said at the annual meeting of the American College of Cardiology.
"These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk," the authors reported in a study simultaneously published online March 30 in JAMA (2014 [doi:10.1001/jama.2014.3321]).
The double-blind, placebo-controlled trial in 7,226 patients of dual peroxisome proliferator-activated receptor agonist aleglitazar 150 mcg daily followed an earlier phase II trial that showed the drug significantly reduced glycated hemoglobin, triglycerides, and LDL cholesterol, and raised HDL cholesterol.
The trial was sponsored by F. Hoffmann-La Roche, and the authors reported research grants, honoraria and consultancy fees from a range of pharmaceutical companies.
A trial of aleglitazar to improve cardiovascular outcomes in patients with type 2 diabetes who had recent-onset acute coronary syndrome has been terminated early because of a lack of efficacy and an increased risk of adverse events.
The phase III trial found no significant improvements in the primary endpoint of time to cardiovascular death, nonfatal MI, or nonfatal stroke.
Specifically, the primary endpoint occurred in 344 patients (9.5%) in the aleglitazar group and 360 patients (10%) in the placebo group (hazard ratio, 0.96; 95% confidence interval, 0.83-1.1; P = .57), and a significant increase in gastrointestinal hemorrhages, renal dysfunction, peripheral edema, and hypoglycemia in the aleglitazar arm, Dr. A. Michael Lincoff of the Cleveland Clinic and his colleagues said at the annual meeting of the American College of Cardiology.
"These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk," the authors reported in a study simultaneously published online March 30 in JAMA (2014 [doi:10.1001/jama.2014.3321]).
The double-blind, placebo-controlled trial in 7,226 patients of dual peroxisome proliferator-activated receptor agonist aleglitazar 150 mcg daily followed an earlier phase II trial that showed the drug significantly reduced glycated hemoglobin, triglycerides, and LDL cholesterol, and raised HDL cholesterol.
The trial was sponsored by F. Hoffmann-La Roche, and the authors reported research grants, honoraria and consultancy fees from a range of pharmaceutical companies.
FROM ACC 14
Major finding: Aleglitazar failed to improve cardiovascular outcomes when compared with placebo and was linked with an increased risk of adverse events, such as gastrointestinal bleeding and renal dysfunction, in a trial that has been terminated early.
Data source: A phase III, multicenter, randomized, double-blind, placebo-controlled trial in 7,226 patients with type 2 diabetes who were hospitalized for acute coronary syndrome (MI or unstable angina).
Disclosures: The trial was sponsored by F. Hoffmann-La Roche, and the authors reported research grants, honoraria, and consultancy fees from a range of pharmaceutical companies.
