ACC.14: Darapladib may not affect development of coronary plaque

WASHINGTON, D.C.—Darapladib did not significantly reduce the risk of cardiovascular death, MI or stroke associated with coronary heart disease, according to study results presented March 30 at the American College of Cardiology scientific session in Washington, D.C.

In the Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy (STABILITY) trial, Harvey D. White, D.Sc., of Auckland City Hospital in Auckland, New Zealand, and co-investigators evaluated the safety and efficacy of darapldib, a selective oral inhibitor of phospholipase A, in patients with chronic coronary heart disease.

They randomly assigned 15,828 patients with stable coronary heart disease in 39 countries to receive 160 mg of darapladib once a day or a placebo. The primary outcome was time to cardiovascular death, MI or stroke. Secondary outcomes included the components of the primary outcome and major coronary events. The average follow-up period was 3.7 years.

About 10 percent of both groups experienced the primary outcome (9.7 percent in the darapladib group and 10.4 percent in the placebo group). The rates of the individual components of the primary end point and all-cause mortality were also similar in both groups. There were fewer major coronary events (9.3 percent vs. 10.3 percent) and total coronary events (14.6 percent vs. 16.1 percent) in the darapladib group.

Previous studies suggested darapladib may stop the development of coronary artery plaques, but White and colleagues noted the “lack of effect of the administered dose of darapladib on the primary end point may relate to a smaller effect on vulnerable coronary plaque than was anticipated on the basis of previous studies.”

The results were published simultaneously in The New England Journal of Medicine.

GlaxoSmithKline funded the trial and also collected and managed the data.