Molecular Cardiology Research Institute, Division of Cardiology, Department of Medicine, Tufts Medical Center, Boston, Massachusetts.
Molecular Cardiology Research Institute, Division of Cardiology, Department of Medicine, Tufts Medical Center, Boston, Massachusetts.
J Am Coll Cardiol. 2013 Jan 29;61(4):440-446. doi: 10.1016/j.jacc.2012.10.030. Epub 2012 Dec 19.
This study sought to assess the efficacy of niacin for reducing cardiovascular disease (CVD) events, as indicated by the aggregate body of clinical trial evidence including data from the recently published AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes) trial.
Previously available randomized clinical trial data assessing the clinical efficacy of niacin has been challenged by results from AIM-HIGH, which failed to demonstrate a reduction in CVD event incidence in patients with established CVD treated with niacin as an adjunct to intensive simvastatin therapy.
Clinical trials of niacin, alone or combined with other lipid-altering therapy, were identified via MEDLINE. Odds ratios (ORs) for CVD endpoints were calculated with a random-effects meta-analyses. Meta-regression modeled the relationship of differences in on-treatment high-density lipoprotein cholesterol with the magnitude of effect of niacin on CVD events.
Eleven eligible trials including 9,959 subjects were identified. Niacin use was associated with a significant reduction in the composite endpoints of any CVD event (OR: 0.66; 95% confidence interval [CI]: 0.49 to 0.89; p = 0.007) and major coronary heart disease event (OR: 0.75; 95% CI: 0.59 to 0.96; p = 0.02). No significant association was observed between niacin therapy and stroke incidence (OR: 0.88; 95% CI: 0.5 to 1.54; p = 0.65). The magnitude of on-treatment high-density lipoprotein cholesterol difference between treatment arms was not significantly associated with the magnitude of the effect of niacin on outcomes.
The consensus perspective derived from available clinical data supports that niacin reduces CVD events and, further, that this may occur through a mechanism not reflected by changes in high-density lipoprotein cholesterol concentration.
本研究旨在评估烟酸在降低心血管疾病（CVD）事件方面的疗效，这一结论基于临床试验证据的综合评估，包括最近发表的 AIM-HIGH（代谢综合征伴低 HDL/高甘油三酯患者的动脉粥样硬化血栓形成干预：对全球健康结局的影响）试验的数据。
以前评估烟酸临床疗效的随机临床试验数据受到 AIM-HIGH 结果的挑战，该试验未能证明在接受强化辛伐他汀治疗的已有 CVD 患者中，烟酸作为辅助治疗可降低 CVD 事件的发生率。
通过 MEDLINE 确定单独使用烟酸或与其他调脂治疗联合使用的烟酸临床试验。使用随机效应荟萃分析计算 CVD 终点的比值比（OR）。通过元回归模型，分析治疗期间高密度脂蛋白胆固醇差异与烟酸对 CVD 事件影响程度之间的关系。
确定了 11 项符合条件的试验，共纳入 9959 例受试者。烟酸的使用与复合 CVD 终点（任何 CVD 事件的 OR：0.66；95%置信区间 [CI]：0.49 至 0.89；p = 0.007）和主要冠心病事件（OR：0.75；95%CI：0.59 至 0.96；p = 0.02）的显著减少相关。烟酸治疗与卒中发生率之间未观察到显著关联（OR：0.88；95%CI：0.5 至 1.54；p = 0.65）。治疗组之间治疗期间高密度脂蛋白胆固醇差异的程度与烟酸对结局的影响程度之间没有显著关联。
现有临床数据得出的共识观点支持烟酸可降低 CVD 事件，并且进一步表明这可能通过高密度脂蛋白胆固醇浓度变化无法反映的机制发生。
