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OUR MISSION: TO REDUCE THE BURDEN OF CARDIOVASCULAR DISEASE
Dr. Robert M Califf,
By Michelle O'Donoghue, FESC (Boston, United States of America)View Discussant report
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List of Authors:
Michelle L. O’Donoghue, Eugene Braunwald, Dylan P. Steen, Mary Ann Lukas, Elizabeth Tarka, Sharon Crugnale, Jennifer Shannon, Kyungah Im, Patrick Serruys, Harvey D. White, and Christopher P. Cannon
BackgroundLp-PLA2 has been hypothesized to play a causal role in the development of atherosclerosis and to contribute to plaque instability through pathways related to inflammation. Darapladib is a direct lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor that reduces Lp-PLA2 activity in plasma and in atherosclerotic plaques. In the phase III STABILITY trial of individuals with stable coronary heart disease (CHD), darapladib did not significantly reduce the risk of the primary endpoint of CV death, myocardial infarction (MI) and stroke, but darapladib reduced the incidence of the secondary endpoints of major coronary events and total coronary events.MethodsThe SOLID-TIMI 52 trial (ClinicalTrials.gov; NCT 01000727) was a randomized, double-blind, placebo-controlled trial that enrolled 13,026 subjects within 30 days of hospitalization with an acute coronary syndrome (ACS). Subjects were randomized to once daily darapladib (160 mg enteric-coated tablet daily) or matching placebo. The primary endpoint was the composite of CHD death, myocardial infarction (MI) or urgent coronary revascularization for myocardial ischemia. Selected secondary endpoints included the composite of cardiovascular death, MI or stroke; total coronary events; CHD death or MI; any coronary revascularization; individual components of the primary endpoint; and all-cause mortality. ResultsDuring a median duration of 2.5 years, darapladib did not reduce the risk of the primary endpoint as compared to placebo (903 vs 910 events, HR 1.00, 95% CI 0.91-1.09, P=0.93). Similarly, darapladib did not reduce the risk of the composite of cardiovascular death, MI or stroke (824 vs 838 events, HR 0.99, 95% CI 0.90-1.09, P=0.78). There were no differences between the treatment groups in additional secondary endpoints, in individual components of the primary endpoint, or in all-cause mortality (371 vs 395 events, HR 0.94, 95% CI 0.82-1.08, P=0.40). Patients treated with darapladib were more likely to report an odor-related complaint (11.5% versus 2.5%) and diarrhea (10.6% versus 5.6%) than those on placebo.ConclusionsIn patients after ACS, direct inhibition of Lp-PLA2 with darapladib on a background of optimal medical therapy did not reduce the risk of coronary events through 2.5 years of follow-up.
By Robert M Califf, FESC (Durham, United States of America)See Presenter abstract
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Hot Line: Coronary artery disease and lipids
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