More Harm than Benefit Halts Aleglitazar Phase 3 Study
According to study data presented at the American College of Cardiology's 63rd Annual Scientific Session, patients treated with aleglitazar (Roche) showed higher rates of heart failure, kidney events, and gastrointestinal (GI) bleeding with no countering cardio benefits. Aleglitazar is a novel study drug with dual action on two subtypes of the PPAR cellular receptor–PPAR gamma that helps glucose regulation and PPAR alpha that helps lipid regulation.
The Phase 3 AleCardio trial evaluated 7,226 patients with type 2 diabetes after hospitalization for acute coronary syndrome. Patients were randomized to either aleglitazar 150μg daily or placebo. The initial trial design called for treatment until 7,000 patients were followed for 2.5 years with 950 primary endpoint event evaluations, the trial was halted at 522 events.
However, scientists did not find the counteracting benefit in the main efficacy endpoint: time to death from cardiovascular cause or first non-fatal heart attack or stroke. The rate of reversible kidney events was significantly higher at 7.4% for aleglitazar compared to 2.7% for the placebo group. Also, the rate of GI hemorrhage rate for aleglitazar was statistically significant higher at 2.4% compared to 1.7% for the placebo group. Heart failure did not reach a level of significant difference for the aleglitazar group but showed a strong trend at 3.4% vs. 2.8% for placebo. Bone fracture rates for the two groups were also not significantly different.
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