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)
Keenan JM, Fontaine PL, Wenz JB, Myers S, Huang Z, Ripsin CM. Niacin RevisitedA Randomized, Controlled Trial of Wax-Matrix Sustained-Release Niacin in Hypercholesterolemia. Arch Intern Med. 1991;151(7):1424–1432. doi:10.1001/archinte.1991.00400070172024