L-MARC Research Center, Louisville, KY 40213, USA.
Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.
According to prior analyses, extended-release niacin/laropiprant (ERN/LRPT) consistently reduces low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) and increases high-density lipoprotein cholesterol (HDL-C) levels across a wide range of dyslipidemic patient subgroups.
This analysis examined ERN/LRPT's consistency across four phase III, randomized, double-blind trials in improving other lipid/lipoprotein parameters associated with cardiovascular risk, across several key dyslipidemic patient subgroups.
In three of the studies, the randomized population included patients with primary hypercholesterolemia or mixed hyperlipidemia; in the remaining study, the population included patients with type 2 diabetes mellitus. The lipid-altering consistency of ERN/LRPT's efficacy was evaluated versus the pre-defined comparator (placebo or active control) among key subgroups of sex, race (White, non-White), region (US, ex-US), baseline age (<65 years, ≥65 years), use of statin therapy (yes, no), coronary heart disease (yes, no), risk status (low, multiple, high), and type of hyperlipidemia (primary hypercholesterolemia, mixed dyslipidemia), as well as across baseline LDL-C, HDL-C, and TG levels. The consistency of the treatment effects on lipoprotein(a).[Lp(a)], apolipoprotein B (ApoB), non-HDL-C, ApoA1, and ApoB/ApoA1 ratio was evaluated by examining treatment difference estimates of the percentage change from baseline with 95% confidence intervals.
Treatment with ERN/LRPT produced significantly greater improvements in Lp(a), ApoB, non-HDL-C, ApoA1, and ApoB/ApoA1 ratio compared with placebo/active comparator in each study. These effects were generally consistent across key subgroups within each study.
ERN/LRPT produced lipid-altering efficacy on the parameters evaluated in four controlled studies; these effects were generally consistent across all examined subgroups. ERN/LRPT represents an effective and reliable therapeutic option for the treatment of dyslipidemia in a wide range of patient types.
Registered as Clinicaltrials.gov NCT00269204, NCT00269217, NCT00479388, and NCT00485758.
根据先前的分析，烟酸/拉罗匹仑缓释片（ERN/LRPT）可一致降低低密度脂蛋白胆固醇（LDL-C）和甘油三酯（TG），并提高高密度脂蛋白胆固醇（HDL-C）水平，适用于广泛的血脂异常患者亚组。
本分析旨在评估 ERN/LRPT 在四项 III 期随机、双盲临床试验中的一致性，以改善与心血管风险相关的其他血脂/脂蛋白参数，包括多个关键血脂异常患者亚组。
在三项研究中，随机人群包括原发性高胆固醇血症或混合性高脂血症患者；在另一项研究中，人群包括 2 型糖尿病患者。通过与预先定义的对照（安慰剂或活性对照）比较，评估 ERN/LRPT 对关键亚组（性别、种族（白人、非白人）、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（是、否）、冠心病（是、否）、风险状况（低、多、高）和高脂血症类型（原发性高胆固醇血症、混合性血脂异常））的疗效在改善血脂方面的一致性，以及基于基线 LDL-C、HDL-C 和 TG 水平的一致性。通过检查从基线的百分比变化的治疗差异估计值及其 95%置信区间，评估对脂蛋白（a）[Lp（a）]、载脂蛋白 B（ApoB）、非高密度脂蛋白胆固醇（non-HDL-C）、载脂蛋白 A1（ApoA1）和载脂蛋白 B/ApoA1 比值的治疗效果的一致性。
与安慰剂/活性对照相比，ERN/LRPT 治疗可显著改善每个研究中的 Lp（a）、ApoB、非 HDL-C、ApoA1 和 ApoB/ApoA1 比值。这些作用在每个研究中的关键亚组内基本一致。
ERN/LRPT 在四项对照研究中对评估的参数产生了改变血脂的疗效；这些作用在所有检查的亚组中基本一致。ERN/LRPT 是治疗广泛类型患者血脂异常的有效且可靠的治疗选择。
Clinicaltrials.gov 注册号为 NCT00269204、NCT00269217、NCT00479388 和 NCT00485758。
