Mittal Niti, Shafiq Nusrat, Reddy Sreenivas, Malhotra Samir, Kumari Savita, Varma Subhash
Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Cardiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Perspect Clin Res. 2017 Jul-Sep;8(3):124-131. doi: 10.4103/2229-3485.210449.
There is a lack of evidence-based therapies for the treatment of heart failure (HF) with preserved ejection fraction (HFpEF). Beta blockers may provide some benefit in HFpEF due to their proven role in HF with reduced ejection fraction.
The main objective of the present study was to evaluate the efficacy of controlled-release metoprolol (metoprolol succinate) in HFpEF.
This was an investigator-initiated, randomized, double-blind, placebo-controlled, 14-week pilot study with metoprolol succinate as a study drug. Dose titration protocol was used with optional upward titration of doses ranging from 25 to 100 mg. The end points included clinical, echocardiographic, biochemical (N-terminal pro-B-type natriuretic peptide and serum carboxy-terminal propeptide of procollagen type I), and quality of life (QoL) (SF-36) parameters.
Twenty patients were enrolled in each of the treatment arms. An improvement in New York Heart Association class and exercise capacity was seen in both treatment arms. The mean change in various echocardiographic and biochemical parameters between the two groups was statistically insignificant. A significant improvement in some QoL parameters was observed in both the groups. No serious adverse events were seen.
Hence, this pilot study showed that metoprolol succinate possibly has some beneficial role in HFpEF as reflected by improvement in some parameters. The findings highlight the need of a larger study with longer follow-up to provide a definitive answer.
对于射血分数保留的心力衰竭(HFpEF),缺乏基于证据的治疗方法。β受体阻滞剂在射血分数降低的心力衰竭中已证实有作用,可能对HFpEF有益。
本研究的主要目的是评估控释美托洛尔(琥珀酸美托洛尔)治疗HFpEF的疗效。
这是一项由研究者发起的、随机、双盲、安慰剂对照的14周试点研究,使用琥珀酸美托洛尔作为研究药物。采用剂量滴定方案,可选择将剂量从25毫克滴定至100毫克。终点指标包括临床、超声心动图、生化指标(N末端B型利钠肽原和I型前胶原血清羧基末端前肽)以及生活质量(QoL)(SF-36)参数。
每个治疗组招募了20名患者。两个治疗组的纽约心脏协会心功能分级和运动能力均有改善。两组之间各种超声心动图和生化参数的平均变化无统计学意义。两组的一些生活质量参数均有显著改善。未观察到严重不良事件。
因此,这项试点研究表明,琥珀酸美托洛尔在HFpEF中可能具有一些有益作用,一些参数的改善反映了这一点。研究结果凸显了需要进行一项随访时间更长的更大规模研究,以提供明确答案。