钠-葡萄糖共转运蛋白 2 抑制剂在心力衰竭患者中的应用：系统评价和荟萃分析。
Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Heart Failure : A Systematic Review and Meta-analysis.
机构信息
Department of Endocrinology and Metabolism, Division of Guideline and Rapid Recommendation, Cochrane China Center, MAGIC China Center, Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China (X.Z., Q.S., Y.Zhou, H.T.).
Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway (P.O.V.).
出版信息
Ann Intern Med. 2022 Jun;175(6):851-861. doi: 10.7326/M21-4284. Epub 2022 Apr 12.
BACKGROUND
Randomized controlled trials established the cardiac protection of sodium-glucose cotransporter-2 (SGLT2) inhibitors among adults with type 2 diabetes. New evidence suggests that these results could extend to people without diabetes.
PURPOSE
To evaluate the effect of SGLT2 inhibitors in patients with heart failure, regardless of the presence of type 2 diabetes.
DATA SOURCES
PubMed, Web of Science, Cochrane Library, and Embase (OVID interface).
STUDY SELECTION
Eligible trials randomly assigned adults with heart failure to SGLT2 inhibitors or control.
DATA EXTRACTION
Time-to-event individual patient data were reconstructed from published Kaplan-Meier plots; time-varying risk ratios (RRs) were calculated in half-, 1-, and 2-year time frames; and anticipated absolute benefits were calculated using simple models applying relative effects to baseline risks.
DATA SYNTHESIS
Sodium-glucose cotransporter-2 inhibitors reduce hospitalization for heart failure by 37% (95% CI, 25% to 47%) at 6 months, 32% (CI, 20% to 42%) at 1 year, and 26% (CI, 10% to 40%) at 2 years (all high certainty) and reduce cardiovascular death by 14% (CI, 1% to 25%) at 1 year (high certainty). Nevertheless, low-certainty evidence did not indicate protection against all-cause death, kidney disease progression, or kidney failure. Anticipated absolute benefits are greater for patients treated in the first year and for those with poorer prognoses, such as those newly diagnosed with heart failure in the hospital. In addition, SGLT2 inhibitors doubled the risk for genital infections (RR, 2.69 [CI, 1.61 to 4.52]; high certainty).
LIMITATION
Covariates were unavailable in meta-analyses with reconstructed individual patient data.
CONCLUSION
Among people with heart failure, SGLT2 inhibitors reduce hospitalizations for heart failure regardless of the presence of diabetes; absolute benefits are most pronounced in first-year treatment and vary with prognostic factors. Clinicians should note the increased risk for genital infection in patients receiving SGLT2 inhibitors.
PRIMARY FUNDING SOURCE
1.3.5 Project for Disciplines of Excellence, West China Hospital of Sichuan University. (PROSPERO: CRD42021255544).
背景
随机对照试验已经证实钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂对 2 型糖尿病患者的心脏保护作用。新的证据表明，这些结果可能适用于没有糖尿病的人群。
目的
评估 SGLT2 抑制剂在心力衰竭患者中的疗效，无论其是否患有 2 型糖尿病。
数据来源
PubMed、Web of Science、Cochrane 图书馆和 Embase（OVID 接口）。
研究选择
合格的试验将心力衰竭患者随机分配到 SGLT2 抑制剂组或对照组。
数据提取
从已发表的 Kaplan-Meier 图中重建了生存时间的个体患者数据；在半年、1 年和 2 年的时间框架内计算了时变风险比（RR）；并使用简单的模型，将相对效果应用于基线风险，计算了预期的绝对获益。
数据综合
SGLT2 抑制剂可使心力衰竭住院率在 6 个月时降低 37%（95%CI，25%至 47%），在 1 年时降低 32%（CI，20%至 42%），在 2 年时降低 26%（CI，10%至 40%）（均为高确定性）；同时还可降低 1 年时的心血管死亡风险 14%（CI，1%至 25%）（高确定性）。然而，低确定性证据并未表明 SGLT2 抑制剂可以预防全因死亡、肾脏疾病进展或肾功能衰竭。对于在第一年接受治疗的患者和预后较差的患者（例如在医院新诊断为心力衰竭的患者），预期的绝对获益更大。此外，SGLT2 抑制剂使生殖器感染的风险增加了一倍（RR，2.69 [CI，1.61 至 4.52]；高确定性）。
局限性
在使用重建的个体患者数据进行荟萃分析时，无法获得协变量。
结论
在心力衰竭患者中，SGLT2 抑制剂可降低心力衰竭住院率，无论是否存在糖尿病；在第一年的治疗中，绝对获益最为显著，且因预后因素而异。临床医生应注意接受 SGLT2 抑制剂治疗的患者发生生殖器感染的风险增加。
主要资金来源
四川大学华西医院 1.3.5 学科卓越发展计划（PROSPERO：CRD42021255544）。
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