Niacin revisited. A randomized, controlled trial of wax-matrix sustained-release niacin in hypercholesterolemia.

Niacin revisited. A randomized, controlled trial of wax-matrix sustained-release niacin in hypercholesterolemia.
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烟酸重新审视。

DOI:
10.1001/archinte.1991.00400070172024
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发表时间:
1991
影响因子:
--
通讯作者:
C. Ripsin
C. Ripsin
中科院分区:
--
文献类型:
--
作者:
J. Keenan;P. Fontaine;J. Wenz;S. Myers;Z. Huang;C. Ripsin

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201名年龄在20至70岁之间、低密度脂蛋白胆固醇值升高(第75至95个月)的男性和女性受试者参加了一项使用新型烟酸(Enduracin)的随机、对照、双盲研究,该研究采用蜡基质载体进行缓释。将四个尼克酸治疗组(每日剂量为2000、1500、1250和1000 mg)与安慰剂和饮食治疗的对照组进行比较,以确定副作用特征和最佳功效范围。与饮食和安慰剂治疗的对照组相比,给予2000和1500 mg的组显示低密度脂蛋白胆固醇(分别为-26%和-19.3%)、总胆固醇(-18.4%和-13.3%)和总胆固醇-高密度脂蛋白胆固醇比率(-20.4%和-19.4%)显着降低。高密度脂蛋白胆固醇和甘油三酯水平的改善较小。血液化学监测表明,低密度脂蛋白胆固醇水平的降低与烟酸治疗受试者的某些酶的基线水平升高密切相关。烟酸的蜡基质形式的副作用特征的改善特别显著。由于副作用的脱落率仅为3.4%,并且具有良好的服药依从性。
Two hundred one male and female subjects, aged 20 to 70 years, with elevated low-density lipoprotein cholesterol values (in the 75th to 95th percentiles), participated in a randomized, controlled, double-blind study using a new form of niacin (Enduracin), which employs a wax-matrix vehicle for sustained release. Four niacin treatment groups (daily doses of 2000, 1500, 1250, and 1000 mg) were compared with placebo- and diet-treated controls to determine side-effect profile and optimal range of efficacy. The groups given 2000 and 1500 mg demonstrated significant reductions in values of low-density lipoprotein cholesterol (-26% and -19.3%, respectively), total cholesterol (-18.4% and -13.3%), and total cholesterol-high-density lipoprotein cholesterol ratio (-20.4% and -19.4%) when compared with diet- and placebo-treated controls. Smaller improvements were seen in high-density lipoprotein cholesterol and triglyceride levels. Blood chemistry monitoring indicated that reduction in low-density lipoprotein cholesterol level strongly correlated with an increase in baseline levels of some enzymes for niacin-treated subjects. The improved side-effect profile of the wax-matrix form of niacin was particularly notable. The dropout rate due to side effects was only 3.4% and was coupled with good medication compliance.
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