L-MARC Research Center, Louisville, KY 40213, USA.
Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.
In patients with primary hypercholesterolemia or mixed dyslipidemia, extended-release niacin/laropiprant (ERN/LRPT) improves key lipid parameters associated with increased atherosclerotic coronary heart disease (CHD) risk.
This analysis examined data from four Phase III, randomised, double-blind trials to determine the consistency of ERN/LRPT's lipid-altering efficacy among subgroups of patients.
Data from four Phase III, randomised, double-blind trials of ERN/LRPT were analysed to determine the consistency of ERN/LRPT's lipid-altering efficacy among subgroups of gender, race (white, non-white), region (US, ex-US), baseline age (<65, ≥65 years), use of statin therapy, CHD risk status (low, multiple, high) and type of hyperlipidemia (primary hypercholesterolemia, mixed dyslipidemia), as well as across baseline low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels. End-points included the per cent change from baseline in LDL-C, HDL-C and TG levels. Consistency of the treatment effects on LDL-C, HDL-C and TG across subgroups was evaluated by examining treatment difference estimates with 95% confidence intervals.
Treatment with ERN/LRPT significantly improved LDL-C, HDL-C and TG levels compared with placebo/active comparator in each study cohort. These effects were generally consistent across all examined subgroups.
Extended-release niacin/laropiprant represents an effective therapeutic option for the treatment of dyslipidemia across a range of patient types.
在原发性高胆固醇血症或混合性血脂异常患者中,烟酸/拉罗匹仑缓释片(ERN/LRPT)可改善与动脉粥样硬化性冠心病(CHD)风险增加相关的关键血脂参数。
本分析旨在通过四项 III 期随机、双盲试验的数据,确定 ERN/LRPT 在不同患者亚组中的降脂疗效是否一致。
对四项 ERN/LRPT 的 III 期随机、双盲试验的数据进行分析,以确定 ERN/LRPT 在不同亚组(性别、种族(白种人、非白种人)、地区(美国、非美国)、基线年龄(<65 岁、≥65 岁)、他汀类药物治疗的使用、CHD 风险状况(低危、中危、高危)和血脂异常类型(原发性高胆固醇血症、混合性血脂异常))中对血脂的改变效果是否一致,以及基线低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)和甘油三酯(TG)水平。终点包括 LDL-C、HDL-C 和 TG 水平自基线的变化百分比。通过检查各亚组中 LDL-C、HDL-C 和 TG 的治疗差异估计值及其 95%置信区间,评估治疗效果在各亚组之间的一致性。
与安慰剂/活性对照相比,ERN/LRPT 治疗显著改善了每个研究队列的 LDL-C、HDL-C 和 TG 水平。这些效果在所有检查的亚组中基本一致。
烟酸/拉罗匹仑缓释片是治疗多种类型血脂异常的有效治疗选择。