Date: 2014-05-13
Type of information:
phase: 3
Announcement: results
Company: GSK (UK)
Product: darapladib
Action
mechanism: Darapladib is a selective and orally active inhibitor of Lp-PLA2 (lipoprotein-associated phospholipase A2). Lp-PLA2 is an enzyme that is found in blood and in atherosclerotic plaques.
Disease: treatment of adults following an acute coronary syndrome
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: In SOLID-TIMI 52, darapladib was tested as a long-term therapy in patients within 30 days of an acute coronary syndrome. The randomised, placebo-controlled, double-blind, parallel group multi-centre study enrolled more than 13,000 patients across 36 countries. The study design of SOLID-TIMI 52 was published in the October 2011 edition of the American Heart Journal (M.L O’Donoghue et al).The SOLID-TIMI 52 study was led by the TIMI Study Group, Brigham and Women\'s Hospital, Boston, Massachusetts.About darapladib and atherosclerosisElevated Lp-PLA2 activity has been implicated in the development and progression of atherosclerosis.
Latest
news: * On May 13, 2014, GSK announced headline results from its second phase III study with darapladib, SOLID-TIMI 52, evaluating the efficacy of its investigational Lp-PLA2 inhibitor in adults following an acute coronary syndrome.In the study, darapladib did not achieve the primary endpoint of a reduction of major coronary events versus placebo when added to standard of care. The overall safety profile for darapladib showed no major safety concerns and was generally consistent with the safety data seen in the previously reported phase III study, STABILITY. Further analysis of the data is ongoing. GSK will now work to further analyse the data and better understand the findings.Full results of the SOLID-TIMI 52 study will be presented at a scientific meeting. In November 2013, GSK announced results of the first study, STABILITY, which showed that darapladib did not achieve a statistically significant reduction in the primary endpoint of major adverse cardiovascular events (comprised of cardiovascular death, myocardial infarction and stroke) versus placebo in patients with chronic coronary heart disease
