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Glaxosmithkline PLC presents data from phase III STABILITY study of darapladib in patients with chronic coronary

Sunday, 30 Mar 2014 07:00pm EDT 

Glaxosmithkline PLC:Presents data from the pivotal Phase III STABILITY study of darapladib.The global, double-blind, event-driven trial randomized 15,828 patients with chronic coronary heart disease (CHD) to receive 160mg of darapladib or placebo once daily on a background of standard of care.The primary endpoint was time to first occurrence of any major adverse cardiovascular event (MACE) comprising cardiovascular death, myocardial infarction (MI) and stroke.Secondary endpoints included coronary events comprising CHD death, urgent coronary revascularisation for myocardial ischemia, total coronary events comprising CHD death, MI, hospitalisation for unstable angina or any coronary revascularisation procedure.No difference was seen in the treatment groups in the time to first occurrence of MACE.During 3.7 years median follow-up, the primary endpoint of MACE occurred in 9.7 pct of patients in the darapladib group and 10.4 pct of patients in the placebo group, hazard ratio (HR) 0.94, 95 pct confidence interval (0.85 - 1.03), p=0.199.HRs for individual components were cardiovascular death 0.96 (0.83 - 1.11), MI 0.89 (0.77 - 1.03) and stroke 1.01 (0.81 - 1.27).The safety profile was well-characterised in this large outcome study.The study didn not meet its primary endpoint, the effects of darapladib on the reduction of coronary events are of potential interest. 

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28 Aug 2014