Darapladib does not meet primary endpoint in STABILITY trial
GlaxoSmithKline has announced that its large phase III STABILITY trial (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY), which tested the new agent darapladib, has not met the primary endpoint.
Darapladib is a selective Lp-PLA2 inhibitor. Elevated Lp-PLA2 activity has been implicated in the development and progression of atherosclerosis. The STABILITY trial compared the efficacy of darapladib with placebo in adults with chronic coronary heart disease (CHD), to reduce the number of cardiovascular (CV) events.
The primary endpoint of time to first occurrence of any major adverse cardiovascular event (composite of myocardial infarction, stroke, and CV death) was not met: a relative risk reduction of 6% was seen (P=0.199). Some of the predefined secondary endpoints showed greater nominal risk reductions, which require further analysis.
No major imbalance in serious adverse events was observed between patients receiving darapladib and placebo. Diarrhoea and odour were frequently reported adverse events that occurred at a similar frequency to that seen in phase II.
The company declares that they ‘continue to investigate the role of Lp-PLA2 inhibition in coronary heart disease and other diseases.’ Outcomes of a second phase III study of darapladib in acute coronary syndrome, SOLID-TIMI 52, will ‘help determine the next steps’.
Full results of the STABILITY trial will be submitted for presentation at a scientific meeting in 2014.
Source: press release GlaxoSmithKline 12 november 2013