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

• DOI: 10.1001/archfami.5.10.567
• Publication Date: 2003-03-18T14:08:55Z
• Authors: D. M. Aronov
• Keywords: Niacin; Tolerability; Crossover study

To assess the clinical effectiveness and tolerability of wax-matrix, controlled-release nicotinic acid (CNA) in persons with hypercholesterolemia.Randomized, double-blind, placebo controlled, crossover trial.Ambulatory clinic at an academic cardiology center Moscow, Russia.A volunteer sample 135 men women, aged 20 to 70 years, hypercholesterolemia greater than 5.82 mmol/L (225 mg/dL) (70th-95th percentile for age sex) who otherwise met study inclusion exclusion criteria, were initially recruited into study. Cholesterol levels reduced less 46 subjects participated initial diet intervention excluded from drug intervention. Eighty-nine randomized trial; 4 (4.5%) dropped out because intolerance CNA.Eight weeks alone (American Heart Association Step I Diet) was followed by randomization 2 treatment groups (1500 mg/d CNA [ENDURACIN] or placebo) months a treatments months, all taking 2000 months.Significant improvements baseline measures total serum cholesterol (TC) low-density lipoprotein (LDL-C) observed after (TC, 6%; LDL-C, P < .001, t test), 1500 14%; 18%; 16%; 21%; test). Triglyceride, high-density cholesterol, lipoprotein(a) also improved. No serious toxic reactions encountered, withdrew cutaneous gastrointestinal adverse effects.Wax-matrix is effective well-tolerated pharmacological hypercholesterolemia.