STABILITY Trial Does Not Meet Primary Endpoint of Reducing CV Events in CHD Adults
The Phase III STABILITY trial evaluating the efficacy of direct Lp-PLA2 inhibition in patients with chronic coronary artery disease did not meet its primary endpoint measure in terms of time to first occurrence of any major adverse cardiovascular event from the composite of myocardial infarction (heart attack), stroke, and cardiovascular death (relative risk reduction of 6 percent; p=0.199), according to top-line study results released on Nov. 12.
The STABILITY study randomized 15,828 patients from 39 countries with chronic coronary heart disease receiving standard of care to darapladib (160 mg) or placebo. It is the first phase III study testing Lp-PLA2 inhibition with darapladib, which is currently not approved for use anywhere in the world. According to the top-line results the overall safety profile showed no major imbalance in serious adverse events between the darapladib and placebo groups. However, there were greater reductions (nominal p<=0.05) in some of the pre-defined secondary endpoints that require further analysis, according to GlaxoSmithKline. Key secondary end points included major coronary events, total coronary events, individual components of MACE, and all-cause mortality. Frequently reported adverse events including diarrhea and odor were also noted and occurred at a similar frequency to that of Phase II.
In announcing the results, Patrick Vallance, president of Pharmaceuticals R&D at GlaxoSmithKline, said the company "will now work to better understand the data, including evaluation of the patient sub-groups, and await the outcome of a second PHASE III study of darapladib in acute coronary syndrome, called SOLID-TIMI 52, to determine our next steps." He noted that results of this trial will be submitted to a scientific meeting in 2014. The second Phase III study, SOLID-TIMI 52, evaluating the efficacy of darapladib in patients with acute coronary syndrome, is ongoing and expected to be completed in 2014.
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