Efficacy and stroke concerns halt trial of Abbott cholesterol drug Niaspan combo

US health care major Abbott Laboratories (NYSE ABT) has halted its AIM-HIGH clinical trial of Niaspan (niacin), started in September 2005, some 18 months ahead of schedule, after an interim analysis indicated that the cholesterol lowerer, in combination with simvastatin, not only failed to prevent heart attack, but may also raise the risk of ischemic stroke.

Niaspan is already marketed and generated sales of $927 million last year. It is also available in combination with simvastatin under the brand name Simcor, and in combination with lovastatin as Advicor.

The National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), which funded the study, yesterday disclosed early results from the trial, designed to test whether raising high density lipoprotein “good” cholesterol and lowering triglycerides in a patient population with established cardiovascular disease and very well controlled low-density lipoprotein “bad” cholesterol levels could produce an additional 25% benefit on cardiovascular outcomes. The study compared extended release niacin added to simvastatin to simvastatin alone. The interim study results concluded that this study objective could not be met.