Teng Monica, Lin Liang, Zhao Ying Jiao, Khoo Ai Leng, Davis Barry R, Yong Quek Wei, Yeo Tiong Cheng, Lim Boon Peng
Pharmacy and Therapeutics Office, Group Corporate Development, National Healthcare Group, 3 Fusionopolis Link, #03-08 Nexus@one-north, Singapore, 138543, Singapore,
Drugs Aging. 2015 Aug;32(8):649-61. doi: 10.1007/s40266-015-0290-9.
Statins have been shown to be beneficial in primary and secondary prevention settings; however, their role in the elderly remains a clinical conundrum, given that age-related factors could alter the risk-benefit ratio of statin treatment. This study aimed to critically evaluate the efficacy and safety of statins for primary prevention of cardiovascular disease (CVD) in the elderly.
We systematically reviewed randomized controlled trials comparing any statins with placebo or usual care for primary prevention of CVD in subjects aged ≥65 years. Relative risks (RRs) using a random effects model were calculated and sensitivity analyses were performed to assess the robustness of findings.
Eight studies (n = 25,952) were included in the meta-analysis. Statins significantly reduced the risks of composite major adverse cardiovascular events (RR 0.82, 95% CI 0.74-0.92), nonfatal myocardial infarction [MI] (0.75, 0.59-0.94) and total MI (0.74, 0.61-0.90). Treatment effects of statins were statistically insignificant in fatal MI (0.43, 0.09-2.01), stroke (fatal: 0.76, 0.24-2.45; nonfatal: 0.76, 0.53-1.11; total: 0.85, 0.68-1.06) and all-cause mortality (0.96, 0.88-1.04). Significant differences were not observed in myalgia (0.88, 0.69-1.13), elevation of hepatic transaminases (0.98, 0.71-1.34), new-onset diabetes (1.07, 0.77-1.48), serious adverse events (1.00, 0.97-1.04) and discontinuation due to adverse events (1.10, 0.85-1.42). The occurrence of myopathy, rhabdomyolysis and cognitive impairment was largely unreported in the included trials.
From a risk-benefit perspective, there is a role of statins for the primary prevention of major adverse cardiovascular events in elderly patients. Further studies are needed to ascertain the benefits of statins on fatal MI, stroke and all-cause mortality.
他汀类药物已被证明在一级和二级预防中有益;然而,鉴于与年龄相关的因素可能改变他汀类药物治疗的风险效益比,其在老年人中的作用仍是一个临床难题。本研究旨在严格评估他汀类药物在老年人心血管疾病(CVD)一级预防中的疗效和安全性。
我们系统回顾了比较任何他汀类药物与安慰剂或常规治疗用于≥65岁受试者CVD一级预防的随机对照试验。使用随机效应模型计算相对风险(RRs),并进行敏感性分析以评估研究结果的稳健性。
八项研究(n = 25,952)纳入荟萃分析。他汀类药物显著降低了复合主要不良心血管事件(RR 0.82,95%CI 0.74 - 0.92)、非致命性心肌梗死[MI](0.75,0.59 - 0.94)和总MI(0.74,0.61 - 0.90)的风险。他汀类药物在致命性MI(0.43,0.09 - 2.01)、中风(致命性:0.76,0.24 - 2.45;非致命性:0.76,0.53 - 1.11;总计:0.85,0.68 - 1.06)和全因死亡率(0.96,0.88 - 1.04)方面的治疗效果无统计学意义。在肌痛(0.88,0.69 - 1.13)、肝转氨酶升高(0.98,0.71 - 1.34)、新发糖尿病(1.07,0.77 - 1.48)、严重不良事件(1.00,0.97 - 1.04)和因不良事件停药(1.10,0.85 - 1.42)方面未观察到显著差异。纳入试验中关于肌病、横纹肌溶解和认知障碍的发生情况大多未报告。
从风险效益角度来看,他汀类药物在老年患者主要不良心血管事件的一级预防中具有作用。需要进一步研究以确定他汀类药物对致命性MI、中风和全因死亡率的益处。