Cardiovascular Division, King's College Hospital London, British Heart Foundation Centre of Research Excellence, London, UK.
Department of Cardiovascular Medicine, King's College Hospital, London, UK.
Heart. 2018 Mar;104(5):407-415. doi: 10.1136/heartjnl-2017-311652. Epub 2017 Aug 5.
Clinical drug trials in patients with heart failure and preserved ejection fraction have failed to demonstrate improvements in mortality.
We systematically searched Medline, Embase and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCT) assessing pharmacological treatments in patients with heart failure with left ventricular (LV) ejection fraction≥40% from January 1996 to May 2016. The primary efficacy outcome was all-cause mortality. Secondary outcomes were cardiovascular mortality, heart failure hospitalisation, exercise capacity (6-min walk distance, exercise duration, VO max), quality of life and biomarkers (B-type natriuretic peptide, N-terminal pro-B-type natriuretic peptide). Random-effects models were used to estimate pooled relative risks (RR) for the binary outcomes, and weighted mean differences for continuous outcomes, with 95% CI.
We included data from 25 RCTs comprising data for 18101 patients. All-cause mortality was reduced with beta-blocker therapy compared with placebo (RR: 0.78, 95%CI 0.65 to 0.94, p=0.008). There was no effect seen with ACE inhibitors, aldosterone receptor blockers, mineralocorticoid receptor antagonists and other drug classes, compared with placebo. Similar results were observed for cardiovascular mortality. No single drug class reduced heart failure hospitalisation compared with placebo.
The efficacy of treatments in patients with heart failure and an LV ejection fraction≥40% differ depending on the type of therapy, with beta-blockers demonstrating reductions in all-cause and cardiovascular mortality. Further trials are warranted to confirm treatment effects of beta-blockers in this patient group.
在射血分数保留的心力衰竭患者中进行的临床药物试验未能显示死亡率的改善。
我们系统地检索了 Medline、Embase 和 Cochrane 对照试验中心注册库,以寻找评估左心室(LV)射血分数≥40%的心力衰竭患者药物治疗的随机对照试验(RCT)。主要疗效终点为全因死亡率。次要终点为心血管死亡率、心力衰竭住院、运动能力(6 分钟步行距离、运动持续时间、VO max)、生活质量和生物标志物(B 型利钠肽、N 末端 B 型利钠肽)。使用随机效应模型估计二分类结局的合并相对风险(RR),并估计连续结局的加权均数差值,置信区间为 95%。
我们纳入了 25 项 RCT 的数据,共纳入了 18101 例患者。与安慰剂相比,β受体阻滞剂治疗降低了全因死亡率(RR:0.78,95%CI 0.65 至 0.94,p=0.008)。与安慰剂相比,ACE 抑制剂、醛固酮受体阻滞剂、盐皮质激素受体拮抗剂和其他药物类别对死亡率没有影响。心血管死亡率也观察到类似的结果。与安慰剂相比,没有任何单一药物类别可降低心力衰竭住院率。
不同类型的治疗在射血分数保留的心力衰竭患者中的疗效不同,β受体阻滞剂可降低全因和心血管死亡率。需要进一步的试验来证实β受体阻滞剂在该患者群体中的治疗效果。