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Title: Niacin Appears Safe for Treating Patients Who Have Diabetes and High Cholesterol: Presented at AHA

"Niacin Appears Safe for Treating Patients Who Have Diabetes and High Cholesterol: Presented at AHA"

By Ed Susman CHICAGO, IL -- November 21, 2002 -- Treating diabetic patients with the cholesterol-lowering agent niacin does not result in increased heart attacks or mortality, despite historical evidence that niacin raises blood sugars. Paul Canner, PhD, senior biostatistician at the Maryland Medical Research Institute, Baltimore, Maryland, United States, performed a new analysis of the data accumulated during the landmark Coronary Drug Project, which evaluated the effects of several medications on heart disease parameters. Looking at the 6- and 15-year data, Dr. Canner said, "In the Coronary Drug Project, niacin reduced non-fatal myocardial infarctions and mortality similarly in patients at all levels of blood glucose, including those with fasting blood glucose of 126 mg/dL". Co-investigator, Mark McGovern, MD, senior vice president and chief medical officer for Kos Pharmaceuticals, Inc., Miami Lakes, Florida, United States, said the results were somewhat counterintuitive. Even though diabetic patients who were given niacin had increases in blood glucose levels their risk of heart attack and death decreased. "This study, which we asked Dr. Canner to perform, and others suggest that you can give diabetic patients niacin and they tolerate it very well," Dr. McGovern said. "Niacin is very effective at raising HDL [high-density lipoprotein] and in reducing triglycerides in patients with diabetes, and that is important because the type of metabolic abnormalities diabetics have are often characterized by low HDL and high triglycerides." Among subjects who were not diabetic at baseline, Dr. Canner said 11.1 percent of the niacin group had a non-fatal heart attack within six years of the end of the trial compared with 15.4 percent of the placebo group. After 15 years, about 50.5 percent of the niacin patients had died, compared to 53.5 percent of the patients on placebo. Among patients who were diabetic at the start of the trial and were taking niacin, 7.1 percent experience a heart attack at six years and 71.4 percent had died compared to 15.5 percent and 77.9 for the placebo group, respectively. Those differences were statistically significant at the p<0.005 level, Dr. Canner said. Dr. Canner also evaluated the hypothesis that taking niacin would result in detriment to cardiovascular health. He determined that hypothesis produced a z-value of 0.21. Z-values are another way of expressing statistical significance. A z-value of 1.96 would be equivalent to statistical significance at p=0.05, Dr. McGovern said. A low z-value would indicate that the hypothesis -- in this case that niacin is bad for diabetics -- is not true. The study was funded by Kos Pharmaceuticals.

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