Kos Pharmaceuticals has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Niaspan to expand the current label to include reducing the risk of stroke or transient ischemic attack (TIA: sometimes referred to as "ministrokes") in patients with a previous heart attack and elevated cholesterol levels.

Niaspan is the only FDA-approved once-daily formulation of niacin for the treatment of lipid disorders. It is also indicated for the secondary prevention of heart attacks, and in combination with a bile-acid binding resin, to promote regression of coronary atherosclerosis in patients with high cholesterol.

The sNDA for Niaspan is based on results from the landmark Coronary Drug Project, a double-blind, placebo-controlled, long term secondary prevention study. This morbidity/mortality study, sponsored by the National Institutes of Health, showed that people taking niacin had significantly fewer strokes and TIAs compared with patients taking the placebo. The study involved 1,119 patients randomized to niacin and 2,789 to a placebo, who were then followed for a period of 5 to 8.5 years. The data show that the risk of stroke or TIA was reduced by 21% to 26% in the niacin group compared with placebo, during the follow-up time period. For example, among all patients followed through the end of the study, 11.2% in the placebo group had suffered a stroke or TIA compared with 8.5% receiving niacin (p<0.05).

The reduction in the risk of stroke or TIA in the Coronary Drug Project is comparable to that observed in two other secondary prevention studies: the CARE trial, which resulted in a 26% reduction (6.0% in the placebo group versus 4.5% with pravastatin) and the 4S trial, which found a 28% reduction (4.6% in the placebo group versus 3.4% with simvastatin).

According to the American Heart Association, 600,000 Americans suffer a stroke each year and $50 billion will be spent in 2002 alone for stroke-related medical costs and disability. But despite the devastating effects and economic expense related to stroke, American Stroke Association surveys have shown that nearly 43% of Americans cannot name a single warning sign of stroke. With the number of deaths from stroke rising 8.6% from 1989 to 1999, it is now the third leading cause of death after heart disease and cancer.