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射血分数降低的心力衰竭患者中依那普利玛咖的疗效与血压的关系:GALACTIC-HF 试验。

Effects of omecamtiv mecarbil in heart failure with reduced ejection fraction according to blood pressure: the GALACTIC-HF trial.

机构信息

Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.

Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

出版信息

Eur Heart J. 2022 Dec 21;43(48):5006-5016. doi: 10.1093/eurheartj/ehac293.

DOI:10.1093/eurheartj/ehac293
PMID:35675469
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9769958/
Abstract

AIM

Patients with heart failure with reduced ejection fraction and low systolic blood pressure (SBP) have high mortality, hospitalizations, and poorly tolerate evidence-based medical treatment. Omecamtiv mecarbil may be particularly helpful in such patients. This study examined its efficacy and tolerability in patients with SBP ≤100 mmHg enrolled in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF).

METHODS AND RESULTS

The GALACTIC-HF enrolled patients with baseline SBP ≥85 mmHg with a primary outcome of time to cardiovascular death or first heart failure event. In this analysis, patients were divided according to their baseline SBP (≤100 vs. >100 mmHg). Among the 8232 analysed patients, 1473 (17.9%) had baseline SBP ≤100 mmHg and 6759 (82.1%) had SBP >100 mmHg. The primary outcome occurred in 715 (48.5%) and 2415 (35.7%) patients with SBP ≤100 and >100 mmHg, respectively. Patients with lower SBP were at higher risk of adverse outcomes. Omecamtiv mecarbil, compared with placebo, appeared to be more effective in reducing the primary composite endpoint in patients with SBP ≤100 mmHg [hazard ratio (HR), 0.81; 95% confidence interval (CI), 0.70-0.94] compared with those with SBP >100 mmHg (HR, 0.95; 95% CI, 0.88-1.03; P-value for interaction = 0.051). In both groups, omecamtiv mecarbil did not change SBP values over time and did not increase the risk of adverse events, when compared with placebo.

CONCLUSION

In GALACTIC-HF, risk reduction of heart failure outcomes with omecamtiv mecarbil compared with placebo was large and significant in patients with low SBP. Omecamtiv mecarbil did not affect SBP and was well tolerated independent of SBP values.

摘要

目的

射血分数降低和收缩压低(SBP)的心力衰竭患者死亡率、住院率高,且对循证医学治疗的耐受性差。Omecamtiv mecarbil 可能对这些患者特别有帮助。本研究在基线 SBP≤100mmHg 并纳入 Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure(GALACTIC-HF)的心力衰竭患者中评估了其疗效和耐受性。

方法和结果

GALACTIC-HF 纳入了 SBP≥85mmHg 的基线患者,主要终点为心血管死亡或首次心力衰竭事件的时间。在这项分析中,根据基线 SBP(≤100 vs. >100mmHg)将患者分为两组。在分析的 8232 名患者中,1473 名(17.9%)基线 SBP≤100mmHg,6759 名(82.1%)SBP>100mmHg。主要终点分别发生在 SBP≤100mmHg 和 >100mmHg 的 715(48.5%)和 2415(35.7%)名患者中。SBP 较低的患者发生不良结局的风险更高。与安慰剂相比,Omecamtiv mecarbil 在 SBP≤100mmHg 的患者中似乎更能有效降低主要复合终点的发生率[风险比(HR),0.81;95%置信区间(CI),0.70-0.94],而在 SBP>100mmHg 的患者中则无显著差异(HR,0.95;95%CI,0.88-1.03;交互检验 P 值=0.051)。在两组中,与安慰剂相比,Omecamtiv mecarbil 不会随时间改变 SBP 值,也不会增加不良事件的风险。

结论

在 GALACTIC-HF 中,与安慰剂相比,Omecamtiv mecarbil 降低心力衰竭结局的风险在 SBP 较低的患者中显著且幅度较大。Omecamtiv mecarbil 不影响 SBP,且无论 SBP 值如何,耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/f4c057c72c21/ehac293f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/447548b69300/ehac293ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/12bc0a57903c/ehac293f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/6810ef18b086/ehac293f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/8e787ec99059/ehac293f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/f4c057c72c21/ehac293f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/447548b69300/ehac293ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/12bc0a57903c/ehac293f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/6810ef18b086/ehac293f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/8e787ec99059/ehac293f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb79/9769958/f4c057c72c21/ehac293f4.jpg

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