Darapladib: Additional Phase III data

Additional data from the double-blind, international Phase III STABILITY trial in 15,828 patients with chronic CHD showed that once-daily 160 mg oral darapladib plus standard of care (SOC) met the secondary endpoints of reducing the rates of major coronary events (9.3% vs. 10.3%, p=0.045) and total coronary events (14.9% vs. 16.1%, p=0.019) vs. placebo plus SOC. Major coronary events comprised CHD death, MI or urgent coronary revascularization for myocardial ischemia, while total coronary events comprised CHD death, MI, hospitalization for unstable angina or any coronary revascularization procedure. Additionally, darapladib plus SOC did not significantly improve any of the individual components of MACE - cardiovascular death (4.5% vs. 4.7%, p=0.59), MI (4.6% vs. 5.1%, p=0.11) or stroke (1.9% for both, p=0.92) - vs. placebo plus SOC. There was no difference in the rate of all-cause mortality between treatment groups (7.3% for both, p=0.87). Median follow-up was 3.7 years. SOC could include a statin, aspirin and blood pressure medications. Data were published in the New England Journal of Medicine and presented at the American College of Cardiology meeting in Washington, D.C. ...