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Clinical Trial of Wax-Matrix Sustained-Release Niacin in a Russian Population With Hypercholesterolemia
David M. Aronov, MD, PhD;
Joseph M. Keenan, MD;
Nadir M. Akhmedzhanov, MD, PhD;
Natalia V. Perova, MD, PhD;
Raphael Y. Oganov, MD, PhD;
Natalia Y. Kiseleva, MD, PhD
Arch Fam Med. 1996;5(10):567-575.
Abstract
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Objective
To assess the clinical effectiveness and tolerability of wax-matrix, controlled-release nicotinic acid (CNA) in persons with hypercholesterolemia.
Design
Randomized, double-blind, placebo controlled, crossover trial.
Setting
Ambulatory clinic at an academic cardiology center in Moscow, Russia.
Patients
A volunteer sample of 135 men and women, aged 20 to 70 years, with hypercholesterolemia greater than 5.82 mmol/L (225 mg/dL) (70th-95th percentile for age and sex) who otherwise met study inclusion and exclusion criteria, were initially recruited into the study. Cholesterol levels were reduced to less than 5.82 mmol/L (225 mg/dL) in 46 subjects who participated in the initial diet intervention and were excluded from the drug intervention. Eighty-nine subjects were randomized into the clinical trial; 4 subjects (4.5%) dropped out of the study because of intolerance of CNA.
Intervention
Eight weeks of diet alone (American Heart
Association Step I Diet) was followed by randomization to 2 treatment groups (1500 mg/d CNA ENDURACIN] or placebo) for 2 months followed by a crossover of treatments for 2 months, followed by all subjects taking 2000 mg/d of CNA for 2 months.
Main Outcome Measures
Significant improvements in baseline measures for total serum cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) were observed after initial diet (TC, 6%; LDL-C, 6%; P<.001, t test), after 1500 mg/d CNA (TC, 14%; LDL-C, 18%; P<.001, t test), and after 2000 mg/d CNA (TC, 16%; LDL-C, 21%; P;.001, t test). Triglyceride, high-density lipoprotein cholesterol, and lipoprotein(a) levels also improved. No serious toxic reactions were encountered, and 4 subjects withdrew from the study because of intolerance of cutaneous and gastrointestinal adverse effects.
Conclusion
Wax-matrix CNA is an effective and welltolerated pharmacological treatment for hypercholesterolemia.
Author Affiliations
From the National Research Centre for Preventive Medicine, Moscow, Russia (Drs Aronov, Akhmedzhanov, Perova, Oganov, and Kiseleva), and the Department of Family Practice and Community Health, University of Minnesota, Minneapolis (Dr Keenan).
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