Clinical trial of wax-matrix sustained-release niacin in a Russian population with hypercholesterolemia
D. M. Aronov, J. M. Keenan, N. M. Akhmedzhanov, N. V. Perova, R. Y. Oganov and N. Y. Kiseleva
National Research Centre for Preventive Medicine, Moscow, Russia.
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.
