Perindopril Erbumine for Reduced Cardiovascular Risk
Solvay Pharmaceuticals, Inc., and CV Therapeutics, Inc., have announced the FDA’s approval of perindopril erbumine (Aceon®) tablets for patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction (MI). Prior to this labeling expansion, Aceon generic, an ACE-inhibitor, was indicated for the treatment of essential hypertension.
The new indication is based on the multicenter .European trial on deduction of cardiac events with Drug Perindopril in patients with stable coronary artery disease (EUROPA). This was a randomized, double-blind, placebo-controlled trial of 12,218 patients with stable coronary disease and without heart failure. A 20% reduction in the risk of cardiovascular events was observed with 8 mg. The overall discontinuation rate was 22% for those receiving the drug and placebo. The mean follow-up observation period was 4.2 years.
