Anacetrapib: Phase III data

The double-blind, international Phase III DEFINE trial in 1,623 patients with CHD or CHD risk-equivalent disease who were already receiving statins and were at a guideline-established LDL-C goal showed that once-daily 100 mg anacetrapib for 76 weeks met the primary endpoint of significantly reducing LDL-C from baseline to week 24 vs. placebo (36 vs. 5 mg/dL, p<0.001). Specifically, anacetrapib reduced LDL-C from 81 mg/dL at baseline to 45 mg/dL at week 24 vs. a reduction from 82 mg/dL at baseline to 77 mg/dL for placebo. Anacetrapib also met the secondary endpoint of significantly increasing mean HDL-C from baseline to week 24 vs. placebo (61 vs. 6 mg/dL, p<0.001). Additionally, anacetrapib significantly increased mean APOA1 by 45%, reduced mean APOB by 21% and reduced mean non-HDL-C by 32% compared to placebo at week 24 (p<0.001 for all). Furthermore, all changes in lipids were sustained through week 76. ...