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A Randomized, Controlled Trial of Wax-Matrix Sustained-Release Niacin in Hypercholesterolemia

Joseph M. Keenan, MD; Patricia L. Fontaine, MD; Joyce B. Wenz, RDMS; Shepherd Myers, MA; Zhiquan Huang, MD; Cynthia M. Ripsin, MS

Arch Intern Med. 1991;151(7):1424-1432.

Abstract
Two hundred one male and female subjects, aged 20 to 70 years, with elevated low-density lipoprotein cholesterol values (in the 75th to 95th percentiles), participated in a randomized, controlled, double-blind study using a new form of niacin (Enduracin), which employs a wax-matrix vehicle for sustained release. Four niacin treatment groups (daily doses of 2000, 1500,1250, and 1000 mg) were compared with placebo- and diet-treated controls to determine side-effect profile and optimal range of efficacy. The groups given 2000 and 1500 mg demonstrated significant reductions in values of low-density lipoprotein cholesterol (—26% and —19.3%, respectively), total cholesterol (—18.4% and —13.3%), and total cholesterol-high-density lipoprotein cholesterol ratio ( — 20.4% and —19.4%) when compared with diet- and placebo-treated controls. Smaller improvements were seen in high-density lipoprotein cholesterol and triglyceride levels. Blood chemistry monitoring indicated that reduction in low-density lipoprotein cholesterol level strongly correlated with an increase in baseline levels of some enzymes for niacintreated subjects. The improved side-effect profile of the wax-matrix form of niacin was particularly notable. The dropout rate due to side effects was only 3.4% and was coupled with good medication compliance.

(Arch Intern Med. 1991;151:1424-1432)

Author Affiliations
From the Department of Family Practice and Community Health, University of Minnesota, Minneapolis.

Footnotes
Accepted for publication November 14, 1990.

Reprint requests to Department of Family Practice, 825 Washington Ave SE, Box25, Minneapolis, MN 55414(Dr Keenan).

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