Shah Yaksh R, Turgeon Ricky D
Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada.
CJC Open. 2023 Dec 10;6(4):639-648. doi: 10.1016/j.cjco.2023.12.002. eCollection 2024 Apr.
Use of a sodium-glucose cotransporter-2 inhibitor (SGLT2i) reduces hospitalization in heart failure (HF) patients across the spectrum of ejection fraction, but no study has comprehensively explored their impact on quality of life (QoL) with respect to different subgroup populations. We aimed to explore the QoL impact of SGLT2i use in HF patients across the spectrum of ejection fraction and over time.
We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) covering the period from 2019 to February 2022. We included placebo-controlled randomized controlled trials (RCTs) enrolling HF patients that evaluated QoL as an outcome. Two reviewers independently assessed studies for eligibility, extracted data, and assessed risk of bias (RoB), using the Cochrane RoB2 tool, and certainty of evidence, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Primary and secondary outcomes were the mean difference in QoL, and clinically important improvement in QoL, as defined in the original study, respectively. We conducted subgroup analyses based on ejection fraction category, SGLT2i agent, and timing of QoL measurement.
From 1477 identified reports, we included 14 RCTs (n = 23,361). The mean age was 68 years, and 34% were female. All included RCTs reported QoL using the Kansas City Cardiomyopathy Questionnaire (KCCQ). SGLT2i use improved KCCQ-overall summary score, compared with placebo (mean difference 2.0, 95% confidence interval 1.6-2.5; high certainty). More patients receiving an SGLT2i achieved a clinically important QoL improvement (risk ratio 1.14, 95% confidence interval 1.02-1.28; moderate certainty). Similar improvements were observed in the KCCQ clinical summary and total symptom subscores, and across all subgroups and timeframes.
Use of an SGLT2i consistently provides a clinically important improvement in QoL among patients with HF, regardless of ejection fraction, with noticeable improvements seen as early as week 2.
使用钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)可降低各射血分数范围内心力衰竭(HF)患者的住院率,但尚无研究全面探讨其对不同亚组人群生活质量(QoL)的影响。我们旨在探讨SGLT2i在各射血分数范围的HF患者中使用以及随时间推移对生活质量的影响。
我们检索了MEDLINE、Embase和Cochrane对照试验中央注册库(CENTRAL),检索时间范围为2019年至2022年2月。我们纳入了以安慰剂为对照、纳入HF患者且将生活质量作为结局指标进行评估的随机对照试验(RCT)。两名研究者使用Cochrane偏倚风险2工具独立评估研究的纳入资格、提取数据并评估偏倚风险(RoB),并使用推荐分级的评估、制定与评价(GRADE)框架评估证据的确定性。主要和次要结局分别是生活质量的平均差异以及原始研究中定义的生活质量临床上的重要改善。我们根据射血分数类别、SGLT2i药物以及生活质量测量时间进行亚组分析。
从1477份已识别的报告中,我们纳入了14项RCT(n = 23361)。平均年龄为68岁,34%为女性。所有纳入的RCT均使用堪萨斯城心肌病问卷(KCCQ)报告生活质量。与安慰剂相比,使用SGLT2i可改善KCCQ总体汇总评分(平均差异2.0,95%置信区间1.6 - 2.