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FDA Approves Expanded Use of Aceon

ACE inhibitor is now indicated for stable coronary artery disease

THURSDAY, Aug. 29 (HealthDay Physician's Briefing) -- The U.S. Food and Drug Administration expanded the use of perindopril erbumine (Aceon) tablets to include the treatment of patients with stable coronary artery disease. Before the FDA's August 23 decision, Aceon was indicated for the treatment of essential hypertension, according to the drug's manufacturer, Solvay Pharmaceuticals. CV Therapeutics markets the drug.

The FDA action was based on a study of more than 12,000 patients with stable coronary artery disease, which showed a drop in the risk of cardiovascular mortality or nonfatal myocardial infarction (MI) in patients taking the drug. The EUROPA study (European trial on reduction of cardiac events with perindopril in patients with stable coronary artery disease) was a randomized, double-blind, placebo-controlled clinical trial that assessed the ability of perindopril to reduce cardiovascular death, nonfatal MI or cardiac arrest.

Over a mean follow-up period of 4.2 years, there was a 20% drop in the combined endpoint of cardiovascular death, nonfatal MI, and cardiac arrest in patients taking 8 mg of perindopril compared to patients taking a placebo, according to the companies. The FDA approved use of the drug by mouth in 2, 4 and 8 mg tablets.

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