CLINICAL-TRIAL OF WAX-MATRIX SUSTAINED-RELEASE NIACIN IN A RUSSIAN POPULATION WITH HYPERCHOLESTEROLEMIA

Objective: To assess the clinical effectiveness and tolerability of wa x-matrix, controlled-release nicotinic acid (CNA) in persons with hype rcholesterolemia. Design: Randomized, double-blind, placebo controlled , crossover trial. Setting: Ambulatory clinic at an academic cardiolog y 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 other wise met study inclusion and exclusion criteria, were initially recrui ted 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%) d ropped out of the study because of intolerance of CNA. Intervention: E ight weeks of diet alone (American Heart Association Step I Diet) was followed by randomization to 2 treatment groups (1500 mg/d CNA [ENDURA CIN] or placebo) for 2 months followed by a crossover of treatments fo r 2 months, followed by all subjects taking 2000 mg/d of CNA for 2 mon ths. Main Outcome Measures: Significant improvements in baseline measu res for total serum cholesterol (TC) and low-density lipoprotein chole sterol (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 tes t), and after 2000 mg/d CNA (TC, 16%; LDL-C, 21%; P<.001, t test). Tri glyceride, high-density lipoprotein cholesterol, and lipoprotein(a) le vels 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 well-tolerated pharmacological treatment for hyperchole sterolemia.