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FDA has approved Aceon to reduce risk of cardiovascular mortality or non-fatal myocardial infarction in patients with stable coronary artery disease


FDA ( Food and Drug Administration ) 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.

Prior to this labeling expansion, Aceon was indicated for the treatment of essential hypertension.

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

In this study, 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 myocardial infarction and cardiac arrest compared to placebo.
This significant ( p=0.0003 ) 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 anti-coagulants, beta-blockers and other anti-hypertensive therapy and lipid lowering therapy, such as statins. Patients not randomized to receive Perindopril received placebo in addition to their conventional therapy.

" EUROPA demonstrated that Perindopril can provide benefit in stable coronary artery disease patients with or without hypertension and in a broad range of younger and older patients, when used in combination with current conventional therapy," said Kim Fox, Royal Brompton Hospital, London, UK and co-chairman of the EUROPA study. " Because of this outcomes benefit, our conclusion was that Perindopril should be considered in the management of patients with coronary heart disease."

Aceon is contraindicated in patients known to be hypersensitive to this product or to any other ACE inhibitors and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Aceon should be discontinued as soon as possible.

In the EUROPA study, the overall rate of discontinuation was about 22 percent on drug and placebo. The most common medical reasons for discontinuation that were more frequent on perindopril than placebo were cough, drug intolerance and hypotension.

Source: Solvay Pharmaceuticals, 2005


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