Department of Internal Medicine, San Francesco Hospital, Viale Europa 21, 82037, Telese Terme, BN, Italy.
Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza G. Cesare, 11, 70124, Bari, Italy.
Clin Drug Investig. 2020 May;40(5):493-501. doi: 10.1007/s40261-020-00908-4.
Sacubitril/valsartan improved the prognosis of patients with heart failure with reduced ejection fraction in the PARADIGM-HF study. Recently, the TRANSITION and PIONEER-HF studies demonstrated the safety and efficacy of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure, with treatment initiated after hemodynamic and clinical stabilization. In this case series study, we assessed the short-term effects of sacubitril/valsartan on exercise capacity, inflammation, and biomarkers in patients with acute decompensated heart failure.
Patients admitted for acute decompensated heart failure to the Department of Internal Medicine of Telese Terme Hospital and Cardiovascular Department, University of Bari, from 9 March, 2017 to 9 June, 2018 were enrolled. Following hemodynamic stabilization, patients initiated sacubitril/valsartan 24/26 mg twice a day for 4 weeks, with up-titration to 49/51 mg twice a day based on tolerability after 1 week. Efficacy outcomes included the 6-min walking test, N-terminal pro-B-type natriuretic peptide, high-sensitivity C-reactive protein, and lymphocyte count. Safety outcomes included renal function, hyperkalemia, and symptomatic hypotension.
In total, 40 patients completed the study and 27 (67.5%) patients were up-titrated. Compared with baseline, exercise capacity and relative lymphocyte count increased significantly after 4 weeks of treatment, while N-terminal pro-B-type natriuretic peptide and high-sensitivity C-reactive protein decreased significantly. N-terminal pro-B-type natriuretic peptide and relative lymphocyte count independently predicted the 6-min walking test distance (p = 0.021). No patients experienced any relevant side effects.
Early initiation of sacubitril/valsartan in patients with heart failure with reduced ejection fraction after acute decompensated heart failure may be safe and effective in terms of functional capacity and biomarkers.
在 PARADIGM-HF 研究中,沙库巴曲缬沙坦改善了射血分数降低的心力衰竭患者的预后。最近,TRANSITION 和 PIONEER-HF 研究表明,在因急性失代偿性心力衰竭住院的患者中,在血流动力学和临床稳定后开始使用沙库巴曲缬沙坦是安全且有效的。在这项病例系列研究中,我们评估了沙库巴曲缬沙坦对急性失代偿性心力衰竭患者运动能力、炎症和生物标志物的短期影响。
本研究纳入了 2017 年 3 月 9 日至 2018 年 6 月 9 日期间因急性失代偿性心力衰竭入住特莱塞泰尔姆医院内科和巴里大学心血管科的患者。在血流动力学稳定后,患者开始接受沙库巴曲缬沙坦 24/26mg,每日两次,持续 4 周,根据 1 周后的耐受性,将剂量增至 49/51mg,每日两次。疗效终点包括 6 分钟步行试验、氨基末端 B 型利钠肽前体、高敏 C 反应蛋白和淋巴细胞计数。安全性终点包括肾功能、高钾血症和症状性低血压。
共有 40 例患者完成了研究,其中 27 例(67.5%)患者进行了滴定。与基线相比,治疗 4 周后运动能力和相对淋巴细胞计数显著增加,而氨基末端 B 型利钠肽前体和高敏 C 反应蛋白显著降低。氨基末端 B 型利钠肽前体和相对淋巴细胞计数独立预测 6 分钟步行试验距离(p=0.021)。无患者出现任何相关不良反应。
急性失代偿性心力衰竭后射血分数降低的心力衰竭患者早期开始使用沙库巴曲缬沙坦,在功能能力和生物标志物方面可能是安全且有效的。