Perindopril approved for cardiovascular and nonfatal-MI risk reduction in stable CAD patients

August 25, 2005

Marietta, GA and Palo Alto, CA - The Food and Drug Administration yesterday approved a new indication for the ACE inhibitor perindopril (Aceon, Solvay Pharmaceuticals Inc and CV Therapeutics Inc) on the basis of results from the European Trial on Reduction of Cardiac Events with Perindopril in Stable Coronary Artery Disease (EUROPA): to reduce the risk of cardiovascular mortality or nonfatal MI in patients with stable coronary artery disease.

Before the new indication, perindopril was approved for the treatment of essential hypertension.

In the EUROPA study, 12 218 patients from 24 European countries were randomized to perindopril 8 mg once daily or placebo in addition to optimal therapy for an average of four years. The selection criteria for entrants to EUROPA were broad, including patients 18 years of age and older with documented coronary disease, not scheduled for revascularization, and with no clinical signs of heart failure. As reported by heart wire , the study showed perindopril reduced the primary end point of cardiovascular death, MI, and cardiac arrest by 20%, as well as reduced fatal or nonfatal MI by 24%.

"Because of this outcomes benefit, our conclusion was that perindopril should be considered in the management of patients with coronary heart disease," commented EUROPA lead investigator Dr Kim Fox (Royal Brompton Hospital, London, UK) in a press release issued jointly by Solvay Pharmaceuticals and CV Therapeutics.

In October 2004, the American College of Physicians (ACP) published a recommendation in the Annals of Internal Medicinebased on HOPE and EUROPAthat all patients with coronary heart disease should be taking an ACE inhibitor [1].

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