FDA APPROVES ACEON TO REDUCE RISK OF CARDIOVASCULAR MORTALITY

Solvay Pharmaceuticals and CV Therapeutics have announced that the FDA has approved Aceon (perindopril erbumine) tablets for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction (MI). Prior to this labeling expansion, Aceon was indicated for the treatment of essential hypertension.

The new indication is based on the EUROPA study. EUROPA was a multicenter, randomized, double-blind, placebo-controlled trial in 12,218 patients with stable coronary disease and without heart failure. The trial assessed the ability of perindopril to reduce cardiovascular death, non-fatal MI or cardiac arrest. Patients had a mean follow-up of 4.2 years.

In a broad population of patients with stable coronary artery disease, there was a 20 percent reduction in the combined endpoint of cardiovascular mortality, non-fatal MI and cardiac arrest compared to placebo. This significant reduction in relative risk was seen in patients on a treatment regimen of 8 mg of perindopril, including patients treated with conventional cardiovascular preventive therapy, such as aspirin, other anticoagulants, beta-blockers and other antihypertensive therapy and lipid lowering therapy, such as statins. Patients not randomized to receive perindopril received placebo in addition to their conventional therapy.