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Efficacy and Tolerability of a New Extended-Release Formulation of Nicotinic Acid in Korean Adults With Mixed Dyslipidemia: An 8-Week, Multicenter, Prospective, Randomized, Double-Blind, and Placebo-Controlled Trial
- Source :
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Clinical Therapeutics . Oct2011, Vol. 33 Issue 10, p1357-1364. 8p. - Publication Year :
- 2011
-
Abstract
- Abstract: Background: Nicotinic acid is an effective treatment for dyslipidemia. Patients are more tolerant of the extended-release form of nicotinic acid because it has a lower incidence of side effects, such as facial flushing, than the immediate-release formulation. Objective: This study was designed to evaluate the efficacy and tolerability of an experimental extended-release formulation of nicotinic acid in Korean adults with mixed dyslipidemia as a regulatory requirement to allow marketing of this product in Korea. Methods: This study was a multicenter, prospective, randomized, double-blind, and placebo-controlled trial. Patients with low high-density lipoprotein cholesterol (HDL-C) levels, high low-density lipoprotein cholesterol (LDL-C) levels, or high triglyceride levels were enrolled. Patients in the treatment group received 500 mg of extended-release niacin for 4 weeks and 1000 mg of extended-release niacin for the next 4 weeks. Results: Twenty-five patients (24% males; mean [SD] age, 57.4 [6.9] years) comprised the treatment group, and 22 patients (5% males; mean [SD] age 61.8 [8.3] years) comprised the placebo group. After 8 weeks of treatment, HDL-C levels were increased significantly in the treatment group (17.6% vs –1.7%, respectively, from 35 [7] mg/dL to 42 [11] mg/dL in the treatment group and from 38 [6] mg/dL to 36 [7] mg/dL in the placebo group; P < 0.001). LDL-C levels were decreased significantly in the treatment group (–11.4% vs 3.6%, respectively, from 147 [33] mg/dL to 126 [22] mg/dL in the treatment group and from 146 [31] mg/dL to 148 [26] mg/dL in the placebo group; P = 0.003). The incidence of drug-related adverse events, including facial flushing in the treatment group, was not significantly different from that in the placebo group. Conclusions: The tested extended-release formulation of nicotinic acid increased HDL-C levels significantly but decreased LDL-C levels with a low incidence of facial flushing in this small, select group of Korean adults with mixed dyslipidemia. [Copyright &y& Elsevier]
- Subjects :
- *DRUG therapy for hyperlipidemia
*ANALYSIS of variance
*BLOOD testing
*CHI-squared test
*CONTROLLED release preparations
*HIGH density lipoproteins
*LONGITUDINAL method
*MEDICAL cooperation
*NIACIN
*HEALTH outcome assessment
*PLACEBOS
*RESEARCH
*RESEARCH funding
*STATISTICS
*SURVIVAL analysis (Biometry)
*T-test (Statistics)
*U-statistics
*DATA analysis
*EQUIPMENT & supplies
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*BLIND experiment
*DATA analysis software
Subjects
Details
- Language :
- English
- ISSN :
- 01492918
- Volume :
- 33
- Issue :
- 10
- Database :
- Academic Search Index
- Journal :
- Clinical Therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 66945509
- Full Text :
- https://doi.org/10.1016/j.clinthera.2011.08.015