The combination of the prescription formula of niacin and the pioneering cholesterol-lowering drug, lovastatin, markedly reduces cholesterol and triglyceride levels, according to the results of an open-label study.

Moti Kashyap, MD, professor in residence at University of California-Irvine, reported that during six-month to one-year treatment with the once-daily Nicostatin, the 814 patients with dyslipidemia taking the combination drug were able to achieve a 47-percent reduction of low density lipoprotein (LDL). In addition, he said the use of Nicostatin also produced a 42 percent reduction in triglyceride levels and increased high density lipoprotein (HDL) levels by 41 percent.

“These preliminary data indicate that this potent combination could be useful in the treatment of most lipid disorders,” Kashyap said.

The average age of the patients in the study was 59 years and about 64 percent of the population was male. He reported that 47 percent of the cohort were hypertensive and 11 percent had diabetes; 127 patients - 16 percent were smokers. “These patients had very High cholesterol levels,” Dr. Kashyap said. Their total cholesterol averaged 283; their LDL cholesterol was 195. Their total cholesterol/HDL-cholesterol ratio was 6.2.

In his report to the 49th annual scientific session of the American College of Cardiology, on March 15, 2000, Kashyap said that 600 patients had been on the combination for about six months; about 200 had been treated for a year. About 30 percent of the patients dropped out of the study, he said, most often for flushing, a common side effect of niacin.

Dr. Kashyap said that half the people with Heart disease were able to lower their cholesterol to a level advocated by the National Cholesterol Education Program. Similarly 75 percent of the diabetic patients were able to achieve that level.

“An important finding of this study is that the combination of niacin and lovastatin in Nicostatin provides a true additive effect,” Kashyap said. “This means that all the benefits achieved with each product individually are maintained in the combination, resulting in significant overall increases in HDL cholesterol levels and decreases in LDL cholesterol levels.

Kos Pharmaceuticals of Miami Lakes, Fla., is developing Nicostatin.