Extended-release wax-matrix nicotinic acid supports cholesterol metabolism, study shows

Summary

This randomized, double-blind, placebo controlled, crossover trial is a collaborative effort between researchers at the University of Minnesota, Minneapolis, and the National Research Centre for Preventive Medicine, Moscow, Russia.

For this study, researchers recruited participants from a volunteer sample of 135 patients, aged 20 to 70 years, with high blood cholesterol (>225 mg/dl), from an academic cardiology center in Moscow. The volunteers were asked to follow diet therapy alone (American Heart Association Step I Diet) for 8 weeks and those (89 men and women) who did not reduce total cholesterol below 225 mg/dl after 8 weeks were enrolled in the study.

Participants were given one of two treatments for 2 months in random order: Extended-release wax-matrix nicotinic acid (WMNA) (1,500 mg/day) or a placebo, followed by an uncontrolled 2-month period during which all participants took higher dose WMNA (2,000 mg/day). Participants continued to follow the Step 1 Diet for the duration of the study.

Results indicate that, compared to baseline, significant improvements in total cholesterol and LDL-cholesterol were reported after the initial diet intervention and after WMNA treatment (see Table 1). Triglycerides, HDL-cholesterol, and lipoprotein(a) levels also improved. No significant changes in lipid variables occurred during the placebo period.

WMNA treatment was well tolerated with no serious adverse effects were reported. Only 4.5% (4/89) of the participants withdrew from the study because of intolerance to WMNA, primarily related to skin flushing or gastrointestinal upset. These findings indicate that WMNA is an effective treatment for hypercholesterolemia that is well tolerated by patients.