钠-葡萄糖协同转运蛋白2抑制剂对射血分数保留的心力衰竭的影响：一项随机临床试验的系统评价和荟萃分析
Effect of Sodium-Glucose Cotransporter 2 Inhibitors for Heart Failure With Preserved Ejection Fraction: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
作者信息
Zhou Hufang, Peng Wenhua, Li Fuyao, Wang Yuelin, Wang Baofu, Ding Yukun, Lin Qian, Zhao Ying, Pan Guozhong, Wang Xian
机构信息
Institute of Cardiovascular Diseases, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Jinan Municipal Hospital of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.
出版信息
Front Cardiovasc Med. 2022 May 4;9:875327. doi: 10.3389/fcvm.2022.875327. eCollection 2022.
BACKGROUND
Heart failure with preserved ejection fraction (HFpEF) is associated with a high risk of mortality and frequent hospitalization. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have favorable cardiovascular protective effect and could decrease the risk of mortality and hospitalization in patients with heart failure with reduced ejection fraction. However, the effect of SGLT2 inhibitors for HFpEF has not been well studied.
PURPOSE
The aim of this meta-analysis is to systematically assess the effects of SGLT2 inhibitors in patients with HFpEF.
METHODS
MEDLINE, EMBASE, Ovid, Cochrane Library, Chinese National Knowledge Infrastructure Database, VIP database, Chinese Biomedical Database, and Wanfang Database were searched from inception to November 2021 for randomized controlled trials (RCTs) of SGLT2 inhibitors for HFpEF. Risk bias was assessed for included studies according to Cochrane handbook. The primary outcome was the composite of first hospitalization for heart failure (HHF) or cardiovascular mortality. First HHF, cardiovascular mortality, total HHF, all-cause mortality, exercise capacity, ventricular diastolic function, and adverse events were considered as secondary endpoints. PROSPERO registration: CRD42021291122.
RESULTS
A total of 12 RCTs including 10,883 patients with HFpEF (SGLT2 inhibitors group: 5,621; control group: 5,262) were included. All included RCTs were at low risk of bias. Meta-analysis showed that SGLT2 inhibitors significantly reduced the composite of first HHF or cardiovascular mortality (HR:0.78, 95% CI: [0.70, 0.87], < 0.00001, = 0%), first HHF (HR:0.71, 95% CI: [0.62, 0.83], < 0.00001, = 0%), total HHF (RR:0.75, 95% CI: [0.67, 0.84], <0.00001, = 0%), E/e' (MD: -1.22, 95% CI: [-2.29, -0.15], = 0.03, = 59%) and adverse events (RR:0.92, 95% CI: [0.88, 0.97], = 0.001, = 0%). No statistical differences were found in terms of cardiovascular mortality, all-cause mortality, NT-proBNP, BNP and 6-min walk test distance.
CONCLUSION
SGLT2 inhibitors significantly improve cardiovascular outcomes with a lower risk of serious adverse events in patients with HFpEF. However, these findings require careful recommendation due to the small number of RCTs at present. More multi-center, randomized, double-blind, placebo-controlled trials are needed.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.Uk/prospero/], identifier [CRD42021291122].
背景
射血分数保留的心力衰竭（HFpEF）与高死亡率和频繁住院风险相关。钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂具有良好的心血管保护作用，可降低射血分数降低的心力衰竭患者的死亡率和住院风险。然而，SGLT2抑制剂对HFpEF的影响尚未得到充分研究。
目的
本荟萃分析的目的是系统评估SGLT2抑制剂对HFpEF患者的影响。
方法
检索MEDLINE、EMBASE、Ovid、Cochrane图书馆、中国知网数据库、维普数据库、中国生物医学数据库和万方数据库，从建库至2021年11月，查找SGLT2抑制剂用于HFpEF的随机对照试验（RCT）。根据Cochrane手册对纳入研究进行风险偏倚评估。主要结局是首次因心力衰竭住院（HHF）或心血管死亡的复合结局。首次HHF、心血管死亡、总HHF、全因死亡、运动能力、心室舒张功能和不良事件被视为次要终点。PROSPERO注册号：CRD42021291122。
结果
共纳入1,2项RCT，包括10,883例HFpEF患者（SGLT2抑制剂组：5,621例；对照组：5,262例）。所有纳入的RCT偏倚风险均较低。荟萃分析表明，SGLT2抑制剂显著降低了首次HHF或心血管死亡的复合结局（HR：0.78，95%CI：[0.70, 0.87]），P<0.00001，I²=0%）、首次HHF（HR：0.71，95%CI：[0.62, 0.83]，P<0.00001，I²=0%）、总HHF（RR：0.75，95%CI：[0.67, 0.84]，P<0.00001，I²=0%）、E/e'（MD：-1.22，95%CI：[-2.29, -0.15]，P=0.03，I²= 59%）和不良事件（RR：0.92，95%CI：[0.88, 0.97]，P=0.001，I²=0%）。在心血管死亡、全因死亡、NT-proBNP、BNP和6分钟步行试验距离方面未发现统计学差异。
结论
SGLT2抑制剂可显著改善HFpEF患者的心血管结局，严重不良事件风险较低。然而，由于目前RCT数量较少，这些发现需要谨慎推荐。需要更多的多中心、随机、双盲、安慰剂对照试验。
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