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.
