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FDA approves perindopril for coronary heart disease
Perindopril had been previously indicated to treat hypertension, but the EUROPA trial showed a benefit for CAD.
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Continuing a trend in secondary prevention, the FDA has approved perindopril for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality and nonfatal myocardial infarction.
“The introduction of ACE inhibitors as tools for secondary prevention of stable coronary disease is a relatively new concept. Previously it had always been an armamentarium of aspirin, statins and, if a patient had a prior MI, beta-blockers,” Kim Fox, MD, professor of clinical cardiology at Royal Brompton Hospital in London, told Cardiology Today.
Fox was the lead investigator on the Efficacy of Perindopril in the Reduction of Cardiovascular Events Among Patients with Stable Coronary Artery Disease (EUROPA) study, which provided the basis for the new indication for perindopril (Aceon, Solvay Pharmaceuticals).
Perindopril had been previously indicated for the treatment of hypertension.
EUROPA
EUROPA was a multicenter, randomized, double-blind, placebo-controlled trial, which enrolled 12,218 patients with stable coronary disease and without heart failure.
Researchers assessed the efficacy of 8 mg of daily perindopril in reducing cardiovascular death, nonfatal MI or cardiac arrest over a mean follow-up of 4.2 years.
The mean age of the patients was 60 years and 85% of the cohort were men. Assessment of concomitant medications showed that 92% were taking platelet inhibitors, 62% were taking beta-blockers and 58% were taking lipid-lowering therapy.
By the end of follow-up, 603 patients (10%) in the placebo group had experienced a primary outcome event compared to 488 patients in the treatment group (8%), which yielded a 20% relative risk reduction.
Perindopril
Perindopril is contraindicated for patients known to be hypersensitive to ACE inhibitors and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. It should not be taken by women who are pregnant.
In the EUROPA study, about 22% of patients stopped taking perindopril primarily due to cough, drug intolerance or hypotension.
“The EUROPA trial was important because it observed a broad range of patients with coronary disease,” Fox said. – by Jeremy Moore