沙库巴曲缬沙坦与依那普利对射血分数降低的心力衰竭患者运动能力的影响：一项随机、双盲、阳性对照研究。
Sacubitril/valsartan versus enalapril on exercise capacity in patients with heart failure with reduced ejection fraction: A randomized, double-blind, active-controlled study.
机构信息
Instituto Do Coração (InCor), Hospital Das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Instituto Do Coração (InCor), Hospital Das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
出版信息
Am Heart J. 2021 Sep;239:1-10. doi: 10.1016/j.ahj.2021.05.005. Epub 2021 May 14.
UNLABELLED
Sacubitril/valsartan reduces mortality in patients with heart failure with reduced ejection fraction (HFrEF) when compared with enalapril. However, it is unknown the effect of both treatments on exercise capacity. We compared sacubitril/valsartan versus enalapril in patients with HFrEF based on peak oxygen consumption (VO) and 6-minute walk test (6-MWT).
METHODS
We included 52 participants with HFrEF with a left ventricular ejection fraction <40% to receive either sacubitril/valsartan (target dose of 400 mg daily) or enalapril (target dose of 40 mg daily). Peak VO was measured by using cardiopulmonary exercise testing. Six-minute walk test was also performed.
RESULTS
At 12 weeks, the sacubitril/valsartan (mean dose 382.6 ± 57.6 mg daily) group had increased peak VO of 13.1% (19.35 ± 0.99 to 21.89 ± 1.04 mL/kg/min) and enalapril (mean dose 34.4 ± 9.2 mg daily) 5.6% (18.58 ± 1.19 to 19.62 ± 1.25 mL/kg/min). However, no difference was found between groups (P = .332 interaction). At 24 weeks, peak VO increased 13.5% (19.35 ± 0.99 to 21.96 ± 0.98 mL/kg/min) and 12.0% (18.58 ± 1.19 to 20.82 ± 1.18 mL/kg/min) in sacubitril/valsartan (mean dose 400 ± 0 mg daily) and enalapril (mean dose 32.7 ± 11.0 mg daily), respectively. However, no differences were found between groups (P= .332 interaction). At 12 weeks, 6-MWT increased in both groups (sacubitril/valsartan: 459 ± 18 to 488 ± 17 meters [6.3%] and enalapril: 443 ± 22 to 477 ± 21 meters [7.7%]). At 24 weeks, sacubitril/valsartan increased 18.3% from baseline (543 ± 26 meters) and enalapril decreased slightly to 6.8% (473 ± 31 meters), but no differences existed between groups (P= .257 interaction).
CONCLUSIONS
Compared to enalapril, sacubitril/valsartan did not substantially improve peak VO or 6-MWT after 12 or 24 weeks in participants with HFrEF. (NEPRIExTol-HF Trial, ClinicalTrials.gov number, NCT03190304).
背景
沙库巴曲缬沙坦可降低射血分数降低的心力衰竭（HFrEF）患者的死亡率，与依那普利相比。然而，尚不清楚这两种治疗方法对运动能力的影响。我们比较了 HFrEF 患者沙库巴曲缬沙坦与依那普利的疗效，以峰值摄氧量（VO）和 6 分钟步行试验（6-MWT）为指标。
方法
我们纳入了 52 名射血分数<40%的 HFrEF 患者，分别接受沙库巴曲缬沙坦（目标剂量 400mg/天）或依那普利（目标剂量 40mg/天）治疗。采用心肺运动试验测量峰值 VO。同时进行 6 分钟步行试验。
结果
12 周时，沙库巴曲缬沙坦（平均剂量 382.6±57.6mg/天）组峰值 VO 增加 13.1%（19.35±0.99 至 21.89±1.04mL/kg/min），依那普利组增加 5.6%（18.58±1.19 至 19.62±1.25mL/kg/min）。然而，两组间无差异（P=0.332 交互）。24 周时，沙库巴曲缬沙坦（平均剂量 400±0mg/天）组峰值 VO 增加 13.5%（19.35±0.99 至 21.96±0.98mL/kg/min），依那普利组增加 12.0%（18.58±1.19 至 20.82±1.18mL/kg/min）。然而，两组间无差异（P=0.332 交互）。12 周时，两组 6-MWT 均增加（沙库巴曲缬沙坦：459±18 至 488±17 米[6.3%]和依那普利：443±22 至 477±21 米[7.7%]）。24 周时，沙库巴曲缬沙坦组增加 18.3%（543±26 米），依那普利组略有下降（6.8%，473±31 米），但两组间无差异（P=0.257 交互）。
结论
与依那普利相比，沙库巴曲缬沙坦在 HFrEF 患者中，12 或 24 周时，峰值 VO 或 6-MWT 无明显改善。（NEPRIExTol-HF 试验，ClinicalTrials.gov 编号：NCT03190304）。
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