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Trial Shows No Benefit from GSK Chronic Heart Disease Drug



The global pharmaceutical company GlaxoSmithKline (GSK)  reported today in a late-stage clinical trial its candidate drug darapladib to treat chronic coronary heart disease did not meet its goal of increasing the amount of time between severe heart problems compared to a placebo. The company says some of the trial’s secondary goals related to coronary events and overall mortality were achieved, and continue to be analyzed.

Coronary heart disease is the result of a build-up of plaque in arteries, a condition known as atherosclerosis, that reduces or blocks the flow of blood to the heart. Over time, the condition hardens and narrows the arteries, and also increases the chance for blood clots to develop. Coronary heart disease is a common disorder leading to heart attacks and stroke, and the leading cause of death for men and women in the U.S.

Darapladib acts by inhibiting the enzyme lipoprotein-associated phospholipase A2 or Lp-PLA2 found in blood and in atherosclerotic plaques. Earlier studies show  an association between activity or  volume of Lp-PLA2 and the risk of coronary heart disease.

The clinical trial, known as STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY or STABILITY, enrolled more than 15,800 adult patients with coronary heart disease at 634 locations in 39 countries, beginning in 2008. Patients were randomly assigned to receive a daily tablet of 160 mg of darapladib or a placebo, in addition to standard care, such a statin drug to lower cholesterol, aspirin, and blood pressure medicine.

The primary indicator of darapladib’s effectiveness in the trial was the amount of time patients went without a major cardiovascular event: death from cardiovascular causes, or a non-fatal heart attack or stroke. GSK says the difference between the test and placebo groups on this measure was not enough to be statistically reliable. The company found statistically reliable differences on some of the trial’s secondary measures — occurrence of heart problems and all causes of death — that it says merit additional analysis.

GSK is also conducting a related late-stage clinical trial testing darapladib against a placebo as a treatment for acute coronary syndrome, covering situations where blood supplied to heart muscles is blocked, resulting in damage to the heart. That trial expects to enroll some 13,000 patients in more than 900 locations.

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Hat tip: Fierce Biotech

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