为了评估在患有血脂异常的成年人中,他汀类药物减少心血管事件,死亡率,和副作用相比贝特类药物。
他汀类药物和贝特类药物单药治疗头对头随机试验的系统评价和荟萃分析。MEDLINE,EMBASE,科克伦,世卫组织国际受控试验注册平台,和ClinicalTrials.gov在2019年10月30日进行了搜索。随访至少28天的试验,报告的死亡率或感兴趣的心血管结局符合纳入标准.疗效结果为心血管死亡率和主要心血管事件。安全性结果包括肌痛,严重的不良影响,血清肌酐升高,血清丙氨酸转氨酶升高.使用Mantel-Haenszel固定效应模型估计赔率(OR)和95%置信区间(CI),异质性使用I2统计量进行评估。
我们纳入了19项符合条件的试验,这些试验直接比较了他汀类药物和贝特类药物单药治疗,并报告了死亡率或心血管事件。研究的随访时间有限(范围为10周至2年)。我们没有发现任何证据表明他汀类药物和贝特类药物在心血管死亡率方面存在差异(OR2.35,95%CI0.94-5.86,I2=0%;十项研究,n=2657;低确定性),主要心血管事件(OR1.15,95%CI0.80-1.65,I2=13%;19项研究,n=7619;低确定性),和肌痛(OR1.32,95%CI0.95-1.83,I2=0%;十项研究,n=6090;低确定性)。他汀类药物的不良反应较少(OR0.57,95%CI0.36-0.91,I2=0%;9项研究,n=3749;中等确定性),血清肌酐升高较少(OR0.17,95%CI0.08-0.36,I2=0%;6项研究,n=2553;高确定性),丙氨酸转氨酶升高更多(OR1.43,95%CI1.03-1.99,I2=44%;七项研究,n=5225;低确定性)。
符合条件的他汀类药物与贝特类药物的随机试验旨在评估短期血脂结果,这使得很难确定对心血管结局和死亡率的直接比较影响。除了肌痛,与使用贝特类药物相比,使用他汀类药物的不良反应发生率较低.
To assess whether in adults with dyslipidemia, statins reduce cardiovascular events, mortality, and adverse effects when compared to fibrates.
Systematic review and meta-analysis of head-to-head randomized trials of statin and fibrate monotherapy. MEDLINE, EMBASE, Cochrane, WHO International Controlled Trials Registry Platform, and ClinicalTrials.gov were searched through October 30, 2019. Trials that had a follow-up of at least 28 days, and reported mortality or a cardiovascular outcome of interest were eligible for inclusion. Efficacy outcomes were cardiovascular mortality and major cardiovascular events. Safety outcomes included myalgia, serious adverse effects, elevated serum creatinine, and elevated serum alanine aminotransferase. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using the Mantel-Haenszel fixed-effect model, and heterogeneity was assessed using the I2 statistic.
We included 19 eligible trials that directly compared statin and fibrate monotherapy and reported mortality or a cardiovascular event. Studies had a limited duration of follow-up (range 10 weeks to 2 years). We did not find any evidence of a difference between statins and fibrates for cardiovascular mortality (OR 2.35, 95% CI 0.94-5.86, I2 = 0%; ten studies, n = 2657; low certainty), major cardiovascular events (OR 1.15, 95% CI 0.80-1.65, I2 = 13%; 19 studies, n = 7619; low certainty), and myalgia (OR 1.32, 95% CI 0.95-1.83, I2 = 0%; ten studies, n = 6090; low certainty). Statins had less serious adverse effects (OR 0.57, 95% CI 0.36-0.91, I2 = 0%; nine studies, n = 3749; moderate certainty), less elevations in serum creatinine (OR 0.17, 95% CI 0.08-0.36, I2 = 0%; six studies, n = 2553; high certainty), and more elevations in alanine aminotransferase (OR 1.43, 95% CI 1.03-1.99, I2 = 44%; seven studies, n = 5225; low certainty).
The eligible randomized trials of statins versus fibrates were designed to assess short-term lipid outcomes, making it difficult to have certainty about the direct comparative effect on cardiovascular outcomes and mortality. With the exception of myalgia, use of a statin appeared to have a lower incidence of adverse effects compared to use of a fibrate.