The results of an aborted study on the cholesterol drug Niaspan suggest that the Abbott Laboratories medication may increase the risk of a stroke.
Earlier this week, the National Heart, Lung and Blood Institute (NHLBI) released the final data from its AIM-HIGH clinical trial, which was halted 18 months early in May.
The study was stopped due to concerns about an increased risk of stroke from side effects of Niaspan and because the drug showed no signs of lowering LDL cholesterol levels, often referred to as “bad” cholesterol.
The clinical trial involved 3,414 patients given either Niaspan or a placebo. While there were significant increases in HDL cholesterol (“good” cholesterol) and lowered triglyceride levels, there was no clinical benefit on LDL levels or in people suffering from atherosclerotic cardiovascular disease, which is caused by high levels of LDL cholesterol. Additionally, 27 patients given Niaspan suffered an ischemic stroke, compared to only 15 patients given a placebo.
The results of the study, and its cancellation, sparked controversy among researchers, some of whom say the clinical trial should have continued and believe that the rate of strokes may have be due to chance and are statistically insignificant. The subjects of the trial also had levels of bad cholesterol that were already under control.
Niaspan (niacin) was approved by the FDA in 2005, but is an extended release version of a cholesterol drug that was first approved in 1957. Niacin is also available in generic form. However, following the AIM-HIGH trial results, some researchers say the drug may not have much of a future.
Another, larger, clinical trial known as HPS2-THRIVE is currently underway. Some experts suggest that if THRIVE also shows a lack of efficacy or increased stroke risk then doctors should consider taking patients off the drug. Until then, most experts think that patients should not stop taking Niaspan.
THRIVE will involve 24,000 participants with more varying cholesterol levels.