Clinical trial of wax-matrix sustained-release niacin in a Russian population with hypercholesterolemia.

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 well-tolerated pharmacological treatment for hypercholesterolemia.