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The Effect of Darapladib on Plasma Lipoprotein-Associated Phospholipase A₂ Activity and Cardiovascular Biomarkers in Patients With Stable Coronary Heart Disease or Coronary Heart Disease Risk Equivalent

The Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Emile R. Mohler, III, MD, FACC^_*,_*, Christie M. Ballantyne, MD, FACC, Michael H. Davidson, MD, FACC, Markolf Hanefeld, MD, PhD, Luis M. Ruilope, MD, PhD^||, Joel L. Johnson, PharmD^¶, Andrew Zalewski, MD^¶,# for the Darapladib Investigators

^_* University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
Baylor College of Medicine and Methodist DeBakey Heart Center, Houston, Texas
Radiant Research, Rush University Medical Center, Chicago, Illinois
Center for Clinical Studies, Dresden, Germany
^|| Hospital 12 de Octubre, Madrid, Spain
^¶ GlaxoSmithKline, Philadelphia, Pennsylvania, and Research Triangle Park, North Carolina
^# Thomas Jefferson University, Philadelphia, Pennsylvania.

View larger version (20K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Subject Disposition All eligible subjects were initially randomized to double-blind atorvastatin 20 or 80 mg once daily. After 4 weeks, subjects who tolerated atorvastatin therapy and achieved low-density lipoprotein cholesterol levels of 115 mg/dl were then randomized to concomitant administration of darapladib 40 mg, 80 mg, 160 mg, or placebo once daily for 12 weeks. The number of subjects and reason for discontinuation are depicted in this figure.

View larger version (16K): [in this window] [in a new window] [Download PPT slide]   Figure 2 Plasma Lp-PLA2 Activity The results are presented as geometric means with 95% confidence interval. All doses of darapladib produced highly significant inhibition of lipoprotein-associated phospholipase A2 (Lp-PLA2) activity when compared with placebo at weeks 4 and 12 (p < 0.001).