背景:达格列净和依格列净是抗糖尿病药物。它们是第一个获得美国食品和药物管理局批准管理心力衰竭的两种钠-葡萄糖协同转运蛋白-2抑制剂(SGLT2i)。新兴的新试验已检查了射血分数降低(HFpEF)和射血分数保留(HFrEF)的心力衰竭患者对达格列净和依帕格列净的临床显着反应的6分钟步行距离的变化。这项荟萃分析旨在评估达格列净和依格列净对HFpEF和HFrEF患者6分钟步行距离的影响。据我们所知,此类荟萃分析尚未发表.
方法:遵循PRISMA(系统评价和荟萃分析的首选报告项目)指南,我们搜索了四个电子数据库(PubMed,EMBASE,科克伦图书馆,和WebofScience),以确定截至2023年12月16日报告的合格研究。使用ReviewManager软件,我们将结局报告为风险比(RR)或平均差(MD)和置信区间(CIs).P值≤0.05被认为是统计学上显著的。
结果:荟萃分析共纳入8项研究,共纳入2624例患者。总的来说,结果显示,SGLT2i和安慰剂组6分钟步行时间无显著性差异(MD24,95%CI-0.30~18.78,p=0.06).解决异质性后,结果变得显着(MD6.72,95%CI0.13至13.31,p=0.05)。值得注意的是,每种药物的结果均不显著.HFpEF组的观察结果更为可靠(MD10.73,95%CI1.08至20.39,p=0.03)。与安慰剂相比,Dapagliflozin患者报告堪萨斯城心肌病问卷临床总结(KCCQ-CS)和总体总结(KCCQ-OS)的显着改善,MD值为5.18(95%CI2.80至7.57,p<0.0001)和MD4.06(95%CI1.66至6.46,p=0.0009),分别。达格列净组和HFpEF患者的体重与对照组相比有明显下降(MD-0.59CI-1.09至-0.08,p=0.02)和(MD-0.80CI-1.47至-0.13,p=0.02),分别。达格列净或依帕格列净未观察到明显的副作用。
结论:HFpEF患者从SGLT2i给药中获益,改善6分钟步行距离和减轻体重证明了这一点。Dapagliflozin在KCCQ评分方面表现出临床和总体改善,并且比安慰剂更有效地减轻体重。Dapagliflozin和Empagliflozin耐受性良好,并表现出良好的安全性。未来的研究可能会受益于更大的患者群体,较长的随访期,和更广泛的SGLT2i。
BACKGROUND: Dapagliflozin and empagliflozin are antidiabetic medications. They are the first two sodium-glucose cotransporter-2 inhibitors (
SGLT2i) to receive the US Food and Drug Administration approval to manage heart failure. Emerging new trials have examined changes in the 6-min walk distance as a clinically significant response to dapagliflozin and empagliflozin in patients with heart failure with reduced ejection fraction (HFpEF) and heart failure with preserved ejection fraction (HFrEF). This meta-analysis aims to evaluate the effects of dapagliflozin and empagliflozin on the 6-min walk distance in patients with HFpEF and HFrEF. To our knowledge, no such meta-analysis has been published.
METHODS: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched four electronic databases (PubMed, EMBASE, Cochrane Library, and Web of Science) to identify eligible studies reported up to December 16, 2023. Using
Review Manager software, we reported outcomes as risk ratios (RRs) or mean difference (MD) and confidence intervals (CIs). A p-value ≤ 0.05 is considered as statistically significant.
RESULTS: The meta-analysis included a total of 8 studies with 2624 patients. Overall, the results showed insignificant differences in the 6-min walk between the
SGLT2i and placebo (MD 24, 95% CI -0.30 to 18.78, p = 0.06). Results became significant after resolving the heterogeneity (MD 6.72, 95% CI 0.13 to 13.31, p = 0.05). Notably, the results of each drug separately were insignificant. More robust observations occurred in the HFpEF group (MD 10.73, 95% CI 1.08 to 20.39, p = 0.03). Compared to placebo, patients on dapagliflozin reported significant improvement in the Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) and Overall Summary (KCCQ-OS) with values of MD 5.18 (95% CI 2.80 to 7.57, p < 0.0001) and MD 4.06 (95% CI 1.66 to 6.46, p = 0.0009), respectively. The dapagliflozin group and patients with HFpEF had reported a significant reduction in their weight compared with the control group (MD -0.59 CI -1.09 to -0.08, p = 0.02) and (MD -0.80 CI -1.47 to -0.13, p = 0.02), respectively. No significant side effects were observed for dapagliflozin or empagliflozin.
CONCLUSIONS: Patients with HFpEF experienced benefits from
SGLT2i administration, as evidenced by improved 6-min walk distances and weight reduction. Dapagliflozin demonstrated clinical and overall improvements in KCCQ scores and was more effective in reducing weight than the placebo. Both Dapagliflozin and Empagliflozin were well-tolerated and exhibited favorable safety profiles. Future studies could benefit from a larger patient population, a longer follow-up period, and a broader range of
SGLT2i.