Study highlights potential benefits of GSK heart drug

A way of fighting heart disease being pioneered by GlaxoSmithKline (NYSE: GSK) got a boost today from a scientific study that appears in The Lancet stressed the significance of an artery-clogging enzyme. The study suggests that the enzyme, Lp-PLA2, plays as much of a role in the risk of heart disease as high blood pressure and bad cholesterol.

"Lp-PLA2 activity and mass each show continuous associations with risk of coronary heart disease, similar in magnitude to that with non-HDL cholesterol or systolic blood pressure in this population," according to the study abstract. The researchers evaluated individual records from 79,036 participants in 32 prospective studies and did a meta-analysis of within-study regressions. Alex Thompson and John Danesh of Cambridge University, who conducted the research, said their findings would sharpen focus on an experimental drug called darapladib being developed by GSK and currently being studied in two large-scale clinical trials involving 27,000 patients worldwide, Reuters reports. Results of the trials are expected between 2012 and 2014.

"We've demonstrated that there is this positive association between Lp-PLA2 levels and vascular and nonvascular outcomes," lead researcher Thompson told heartwire, "but what an observational study can't do is establish causality. Given all the complexities about disentangling the effects of a measured level of an enzyme in the blood, given that it is carried around and is physically bound to apolipoprotein B on LDL, it is extremely difficult to do. To get that level of evidence, we are going to need randomized, clinical trials."

"This BHF-funded research shows that Lp-PLA2, an enzyme that's produced by inflammatory cells involved in the development of artery disease, appears to play a significant role in the progression of that disease," Professor Peter Weissberg, medical director at the British Heart Foundation, says in a statement. "The acid test will then be to find out if such drugs reduce the risk of heart attacks and strokes in large clinical trials. It will be some time yet before we have the answers."

GSK discovered darapladib through the use of gene technology from Human Genome Sciences. It is the first in a new class of drugs targeting Lp-PLA2 and is designed to offer something beyond the hugely successful class of cholesterol-lowering statin drugs like Pfizer' (NYSE: PFE) Lipitor and AstraZeneca's (NYSE: AZN) Crestor.

- read the release from the British Heart Foundaton
- check out the Reuters coverage
- see heartwire's report
- click here to read the study abstract