Gemfibrozil-Niacin Combination Greatly Increases Good Cholesterol
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Gemfibrozil-Niacin Combination Greatly Increases Good Cholesterol

PATCHOGUE, NY -- March 10, 2000 -- Low HDL-cholesterol occurs in anywhere from four to 19 per cent of the population and predisposes otherwise healthy individuals to premature atherosclerosis. Now, a study published in the March 1 issue of the Journal of the American College of Cardiology has shown that HDL-C can be raised substantially with the presently available drugs gemfibrozil and crystalline niacin, also known as nicotinic acid.

According to Dr. Michael Zema, a clinical professor of medicine at the State University of New York at Stony Brook low HDL-C, a condition known as hypoalphalipoproteinemia, is usually treated by using statins to lower LDL-C. This improves the overall ratio of HDL to LDL, but may also lower LDL cholesterol needlessly. Dieting is also an effective means of increasing HDL-C, although this may only increase HDL in the order of a few points and not to any significant degree.

Dr. Zema is also director of the cardiology program at the Brookhaven Memorial Hospital Medical Center, here.

In this study, 23 patients (22 men), all with clinically defined atherosclerosis and all of whom had failed previous attempts to raise their HDL-C without drugs received gemfibrozil (1200 mg/day) for three months, followed by nicotinic acid (2250 mg/day) for three months and a combination of the two for a final three-month period. The subjects had two-week washout periods when changing from one drug to the next.

The subjects were all "slightly over-weight" (BMI=26) Dr. Zema said, and all were either non-smokers, or had quit smoking at least three months before the study began.

Normal levels of HDL-cholesterol are different between men and women. Normal for a man would be considered 45-48 mg/dl, and for a woman 50-53 mg/dl. In this study, mean HDL-C levels were "around 34" Dr. Zema said.

Among the 14 patients who completed the study, the mean increase in HDL-C was 15 per cent when they were taking gemfibrozil, 35 per cent when they were taking nicotinic acid, and 45 per cent when they took both drugs together.

Dr. Zema speculated that increasing HDL by these amounts could lead to significant decreases in cardiac event rates. A study published last year in the New England Journal of Medicine showed that a six per cent increase in HDL-C can represent a 22 per cent reduction in cardiac events over a five-year period, he said in an interview.

Unfortunately, the side effect profile for this drug regimen is a problem. Adverse effects, which include skin flushing and itching caused 40 per cent of the participants dropped out of the study.

"If patients could tolerate those two agents together, they would have a 45 per cent rise in HDL which borders on the big effect we can get with statins. We can get the same magnitude of effect in these folks, if they can just tolerate the agents," he added.

"The bottom lines is that it's a myth that HDL cannot be pharmacologically driven upward by currently available therapies. It can in a large number of patients." He added that ultimately, a clinical endpoint trial among patients who are able to tolerate the drug over the longer term, to determine whether the combination therapy has an effect on cardiac morbid events.

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