Researchers have indicated that an enzyme found in coronary plaques may be responsible for significant number of cardiac patients suffering from heart attacks and stroke, despite the widespread use of cholesterol-lowering drugs. The enzyme makes plaque more vulnerable to rupture and block blood flow. According to new research, the drug darapladib, taken in adjunct to the treatment of statin drugs, may offer a way to fight that risk as it safely and effectively lowers the activity of the Lp-PLA2 enzyme.

Photo by Patrick J. Lynch

The FDA has decided to continue to regulate Vasogen’s Celacade system as a medical device. The Celacade system is a treatment for patients with New York Heart Association (NYHA) Class II heart failure. The FDA’s Center for Biologics Evaluation and Research (CBER) is to take over as the lead reviewer of the programme. The CBER has informed Vasogen that it does not agree with the use of a Bayesian approach in the ACCLAIM II study of the system. The FDA had earlier recommended the design.