Al-Gobari Muaamar, Le Hai-Ha, Fall Mor, Gueyffier François, Burnand Bernard
Institute of social & preventive medicine (IUMSP) and Cochrane Switzerland, Lausanne University Hospital (CHUV), Lausanne, Switzerland.
Laboratoire de Biologie et Biométrie Evolutive-Service de pharmacologie clinique, Equipe Modélisation des Effets Thérapeutiques (EMET), UMR, Université Claude Bernard Lyon1, Lyon, France.
PLoS One. 2017 Feb 6;12(2):e0171168. doi: 10.1371/journal.pone.0171168. eCollection 2017.
Statins showed mixed results in heart failure (HF) patients. The benefits in major HF outcomes, including all-cause mortality and sudden cardiac death (SCD), have always been discordant across systematic reviews and meta-analyses. We intended to systematically identify and appraise the available evidence that evaluated the effectiveness of statins in clinical outcomes for HF patients.
Systematic review and meta-analysis.
We searched, until April 28, 2016: Medline, Embase, ISI Web of Science and EBM reviews (Cochrane DSR, ACP journal club, DARE, CCTR, CMR, HTA, and NHSEED), checked clinicaltrials.gov for ongoing trials and manually searched references of included studies.
We identified 24 randomized clinical trials that evaluated the efficacy of statins for HF patients. All randomized clinical trials were assessed for risk of bias and pooled together in a meta-analysis. Pre-specified outcomes were sudden cardiac death, all-cause mortality, and hospitalization for worsening heart failure.
Statins did not reduce sudden cardiac death (SCD) events in HF patients [relative risk (RR) 0.92, 95% confidence interval (CI) 0.70 to 1.21], all-cause mortality [RR 0.88, 95% CI 0.75 to 1.02] but significantly reduced hospitalization for worsening heart failure (HWHF) although modestly [RR 0.79, 95% CI 0.66 to 0.94]. Nevertheless, estimated predictive intervals were insignificant in SCD, all-cause mortality and HWHF [RR, 0.54 to 1.63, 0.64 to 1.19, and 0.54 to 1.15], respectively. An important finding was the possible presence of publication bias, small-study effects and heterogeneity of the trials conducted in HF patients.
Statins do not reduce sudden cardiac death, all-cause mortality, but may slightly decrease hospitalization for worsening heart failure in HF patients. The evaluation of the risk of biases suggested moderate quality of the published results. Until new evidence is available, this study supports the 2013 ACCF/AHA guidelines to not systematically prescribe statins in "only" HF patients, which should help avoid unnecessary polypharmacy.
他汀类药物在心力衰竭（HF）患者中的疗效存在争议。在包括全因死亡率和心源性猝死（SCD）在内的主要HF结局方面，系统评价和荟萃分析的结果一直不一致。我们旨在系统地识别和评估评估他汀类药物对HF患者临床结局有效性的现有证据。
系统评价和荟萃分析。
我们检索至2016年4月28日：医学文献数据库（Medline）、荷兰医学文摘数据库（Embase）、科学引文索引（ISI Web of Science）和循证医学评价（EBM reviews，包括Cochrane系统评价数据库、美国内科医师学会杂志俱乐部、循证医学数据库、临床对照试验注册库、临床方法学评价、卫生技术评估和英国国家卫生服务经济评价数据库），在临床研究数据库（clinicaltrials.gov）中查询正在进行的试验，并手动检索纳入研究的参考文献。
我们确定了24项评估他汀类药物对HF患者疗效的随机临床试验。所有随机临床试验均评估偏倚风险，并汇总进行荟萃分析。预先设定的结局为心源性猝死、全因死亡率和因心力衰竭恶化住院。
他汀类药物未降低HF患者的心源性猝死（SCD）事件[相对危险度（RR）0.92，95%置信区间（CI）0.70至1.21]、全因死亡率[RR 0.88，95%CI 0.75至1.02]，但显著降低了因心力衰竭恶化住院（HWHF）的发生率，尽管降幅较小[RR 0.79，95%CI 0.66至0.94]。然而，SCD、全因死亡率和HWHF的估计预测区间均无统计学意义[RR分别为0.54至1.63、0.64至1.19和0.54至1.15]。一个重要发现是可能存在发表偏倚、小研究效应以及HF患者试验的异质性。
他汀类药物不能降低心源性猝死和全因死亡率，但可能会略微降低HF患者因心力衰竭恶化住院的发生率。对偏倚风险的评估表明已发表结果的质量中等。在获得新证据之前，本研究支持2013年美国心脏病学会基金会/美国心脏协会（ACCF/AHA）指南，即不建议仅对HF患者常规使用他汀类药物，这有助于避免不必要的联合用药。
