Medical Department, Novartis Pharma NV/SA, Medialaan 40 Bus 1, 1800, Vilvoorde, Belgium.
Department of Public Health and Primary Care, I-BioStat, KU Leuven, Leuven, Belgium.
Sci Rep. 2024 Jun 12;14(1):13512. doi: 10.1038/s41598-024-64243-w.
We assessed the real-world effectiveness of sacubitril/valsartan in patients with chronic heart failure (HF) and reduced ejection fraction (HFrEF) with an emphasis on those with older age (≥ 75 years) or with New York Heart Association (NYHA) class IV, for whom greater uncertainty existed regarding clinical outcomes. We conducted a retrospective cohort study based on patient-level linkage of electronic healthcare datasets. Data from all adults with HFrEF in Belgium receiving a prescription for sacubitril/valsartan between 01-November-2016 and 31-December-2018 were collected, with a follow-up of > 6 years. The total study population comprised 5446 patients, older than the PARADIGM-HF trial participants, and with higher NYHA class (all P < 0.0001). NYHA class improved following sacubitril/valsartan initiation (P < 0.0001 baseline vs. reassessment). Most concomitant medications were reduced. Remarkably, the risk of hospitalization for a cardiovascular reason and for HF was reduced by > 26% in the overall cohort, and in subgroups of patients ≥ 75 years, with NYHA class III/IV (all P < 0.0001) or with NYHA class IV (P < 0.05), vs. baseline. All-cause mortality did not increase in real-world patients with NYHA class III/IV. The results support the long-term beneficial effects of sacubitril/valsartan in older patients and in those experiencing the most severe symptoms.
我们评估了沙库巴曲缬沙坦在慢性心力衰竭(HF)和射血分数降低(HFrEF)患者中的真实世界疗效,重点关注年龄较大(≥75 岁)或纽约心脏协会(NYHA)心功能分级为 IV 级的患者,因为对于这些患者的临床结局存在更大的不确定性。我们开展了一项回顾性队列研究,该研究基于电子医疗记录数据集的患者水平关联。收集了 2016 年 11 月 1 日至 2018 年 12 月 31 日期间所有在比利时接受沙库巴曲缬沙坦处方的 HFrEF 成年患者的数据,随访时间超过 6 年。总研究人群包括 5446 例患者,这些患者的年龄均大于 PARADIGM-HF 试验参与者,且 NYHA 心功能分级更高(均 P<0.0001)。沙库巴曲缬沙坦治疗开始后 NYHA 心功能分级得到改善(P<0.0001,基线 vs. 再评估)。大多数合并用药剂量减少。值得注意的是,在整个队列以及年龄≥75 岁、NYHA 心功能分级为 III/IV 级(均 P<0.0001)或 NYHA 心功能分级为 IV 级(P<0.05)的亚组中,因心血管原因和 HF 住院的风险均降低了 26%以上。与基线相比,NYHA 心功能分级为 III/IV 级的真实世界患者的全因死亡率没有增加。这些结果支持了沙库巴曲缬沙坦在老年患者和症状最严重患者中的长期有益作用。