The NIH has stopped a study with Abbott Laboratories' cholesterol fighter Niaspan 18 months early after results showed the drug failed to prevent heart attacks and even may have boosted stroke risk. And as Bloomberg notes, the results could heighten the debate over whether raising good cholesterol actually helps patients.
The AIM-HIGH trial enrolled 3,414 participants in the U.S. and Canada with a history of cardiovascular disease who were taking a statin drug to keep their LDL cholesterol low. Study participants also had low HDL cholesterol and high triglycerides. Eligible participants received either Niaspan in gradually increasing doses up to 2,000 mg per day or a placebo treatment. All participants were prescribed Zocor (simvastatin), and 515 participants were given a second LDL cholesterol-lowering drug, Zetia (ezetimibe) to maintain LDL cholesterol levels at the target range between 40-80 mg/dL, according to an NIH statement.
In a study follow-up, participants who took Niaspan and simvastatin had increased HDL cholesterol and lowered triglyceride levels compared to participants who took a statin alone. But the combination treatment failed to reduce heart attacks, strokes, hospitalizations for acute coronary syndromen or revascularization procedures to improve blood flow in the arteries of the heart and brain.
"Seeking new and improved ways to manage cholesterol levels is vital in the battle against cardiovascular disease," said Susan Shurin, acting director of the National Heart, Lung, and Blood Institute, in the statement. "This study sought to confirm earlier and smaller studies. Although we did not see the expected clinical benefit, we have answered an important scientific question about treatment for cardiovascular disease."
Abbott paid $3.4 billion for Kos Pharmaceuticals in 2006 to acquire Niaspan, a version of niacin that has led a new wave of heart drugs to raise good cholesterol, as Bloomberg notes. The findings may also jeopardize medicines in that group being developed by Merck, Eli Lilly and Roche, the news service adds.
"Right now, using niacin in high-risk patients, we ought not to really be doing it," Bob Eckel, a professor of medicine at the University of Colorado and past president of the heart association, said in a telephone interview with Bloomberg. "To say that the HDL door is shut is premature" for other drugs under development to raise good cholesterol, he said.
The drugmaker's shares were down roughly two percent after the news hit Thursday, according to Reuters.