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Results of the Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial

Scott M. Grundy, MD, PhD; Gloria Lena Vega, PhD; Mark E. McGovern, MD; Brian R. Tulloch, MD; David M. Kendall, MD; David Fitz-Patrick, MD; Om P. Ganda, MD; Robert S. Rosenson, MD; John B. Buse, MD; David D. Robertson, MD; John P. Sheehan, MD; for the Diabetes Multicenter Research Group

Arch Intern Med. 2002;162:1568-1576.

Background  Diabetic dyslipidemia is characterized by high triglyceride levels; low high-density lipoprotein cholesterol levels; small, dense low-density lipoprotein particles; and high free fatty acid levels. Niacin reduces concentrations of triglyceride-rich and small low-density lipoprotein particles while increasing high-density lipoprotein cholesterol levels. It also lowers levels of free fatty acids and lipoprotein(a). However, the use of niacin in patients with diabetes has been discouraged because high doses can worsen glycemic control. We evaluated the efficacy and safety of once-daily extended-release (ER) niacin in patients with diabetic dyslipidemia.

Methods  During a 16-week, double-blind, placebo-controlled trial, 148 patients were randomized to placebo (n = 49) or 1000 (n = 45) or 1500 mg/d (n = 52) of ER niacin. Sixty-nine patients (47%) were also receiving concomitant therapy with statins.

Results  Dose-dependent increases in high-density lipoprotein cholesterol levels (+19% to +24% [P<.05] vs placebo for both niacin dosages) and reductions in triglyceride levels (–13% to –28% [P<.05] vs placebo for the 1500-mg ER niacin) were observed. Baseline and week 16 values for glycosylated hemoglobin levels were 7.13% and 7.11%, respectively, in the placebo group; 7.28% and 7.35%, respectively, in the 1000-mg ER niacin group (P= .16 vs placebo); and 7.2% and 7.5%, respectively, in the 1500-mg ER niacin group (P= .048 vs placebo). Four patients discontinued participation because of inadequate glucose control. Rates of adverse event rates other than flushing were similar for the niacin and placebo groups. Four patients discontinued participation owing to flushing (including 1 receiving placebo). No hepatotoxic effects or myopathy were observed.

Conclusion  Low doses of ER niacin (1000 or 1500 mg/d) are a treatment option for dyslipidemia in patients with type 2 diabetes.

From the Center for Human Nutrition, The University of Texas Southwestern Medical Center, Dallas (Drs Grundy and Vega); Kos Pharmaceuticals, Miami, Fla (Dr McGovern); the Diagnostic Clinic of Houston, Houston, Tex (Dr Tulloch); the International Diabetes Center, St Louis Park, Minn (Dr Kendall); the East-West Medical Research Institute, Honolulu, Hawaii (Dr Fitz-Patrick); the Joslin Diabetes Center, Department of Medicine, Harvard Medical School, Boston, Mass (Dr Ganda); the Preventive Cardiology Clinic, Northwestern University Medical School, Chicago, Ill (Dr Rosenson); the Diabetes Care Center, University of North Carolina School of Medicine, Chapel Hill (Dr Buse); the Atlanta Diabetes Association, Atlanta, Ga (Dr Robertson); and the North Coast Institute of Diabetes and Endocrinology, Westlake, Ohio (Dr Sheehan). Drs Tulloch and Ganda are on the Speakers' Bureau of Kos Pharmaceuticals, and Dr Tulloch has a small stock holding in Kos Pharmaceuticals shares.

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