The First Affiliated Hospital, Hunan Provincial Clinical Medical Research Center for Drug Evaluation of Major Chronic Diseases, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.
The First Affiliated Hospital, Hengyang Clinical Pharmacology Research Center, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.
Clin Res Cardiol. 2024 Jun;113(6):910-923. doi: 10.1007/s00392-024-02386-6. Epub 2024 Feb 14.
Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiac arrhythmias, which increases serious morbidity and mortality. Novel hypoglycemic drug sodium glucose cotransporter 2 (SGLT2) inhibitor has shown sufficient cardiovascular benefits in cardiovascular outcome trials.
This systematic review and meta-analysis aimed to investigate the relationship between SGLT2 inhibitors and cardiac arrhythmias in patients with T2DM.
We searched on PubMed and ClinicalTrials.gov for at least 24 weeks of randomized double-blind placebo-controlled trials involving T2DM subjects assigned to SGLT2 inhibitors or placebo as of May 5, 2023. Risk ratio (RR) with 95% confidence interval (CI) were used for binary variables. Primary outcomes included atrial arrhythmias, ventricular arrhythmias, bradyarrhythmias, cardiac arrest, and atrial fibrillation/atrial flutter. Secondary outcomes comprised atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular tachycardia, atrioventricular block, and sinus node dysfunction.
We included 32 trials covering 60,594 T2DM patients (SGLT2 inhibitor 35,432; placebo 25,162; mean age 53.9 to 68.5 years). SGLT2 inhibitors significantly reduced the risk of atrial arrhythmias (RR 0.86; 95%CI 0.74-0.99; P = 0.04) or atrial fibrillation/flutter (RR 0.85; 95%CI 0.74-0.99; P = 0.03) compared to placebo; in subgroup analysis, SGLT2 inhibitors achieved a consistent effect with overall results in T2DM with high cardiovascular risk or follow-up > 1 year populations. There was no substantial evidence to suggest that SGLT2 inhibitors reduced the risk of ventricular arrhythmias (RR 0.94; 95%CI 0.71-1.26; P = 0.69) and cardiac arrest (RR 0.88; 95%CI 0.66-1.18; P = 0.39). A neutral effect of SGLT2 inhibitors on bradyarrhythmias was observed (RR 1.02; 95%CI 0.79-1.33; P = 0.85). SGLT2 inhibitors had no significant impact on all secondary outcomes compared to placebo, while it had borderline effect for atrial fibrillation.
SGLT2 inhibitors were associated with a reduced risk of atrial arrhythmias in patients with T2DM. Our results support the use of SGLT2 inhibitors in T2DM with high cardiovascular risk populations. We also recommend the long-term use of SGLT2 inhibitors to achieve further benefits.
2 型糖尿病（T2DM）与心律失常风险增加相关，这增加了严重的发病率和死亡率。新型降糖药物钠-葡萄糖协同转运蛋白 2（SGLT2）抑制剂在心血管结局试验中显示出了充分的心血管获益。
本系统评价和荟萃分析旨在研究 SGLT2 抑制剂与 T2DM 患者心律失常之间的关系。
我们在 PubMed 和 ClinicalTrials.gov 上进行了检索，检索至少 24 周的随机双盲安慰剂对照试验，纳入 T2DM 患者，随机分配至 SGLT2 抑制剂或安慰剂组，检索截至 2023 年 5 月 5 日。使用风险比（RR）和 95%置信区间（CI）表示二分类变量。主要结局包括房性心律失常、室性心律失常、缓慢性心律失常、心脏骤停和心房颤动/心房扑动。次要结局包括心房颤动、心房扑动、心室颤动、室性心动过速、房室传导阻滞和窦房结功能障碍。
我们纳入了 32 项试验，共纳入 60594 例 T2DM 患者（SGLT2 抑制剂组 35432 例，安慰剂组 25162 例；平均年龄 53.9 岁至 68.5 岁）。与安慰剂相比，SGLT2 抑制剂显著降低了房性心律失常（RR 0.86；95%CI 0.74-0.99；P=0.04）或心房颤动/扑动（RR 0.85；95%CI 0.74-0.99；P=0.03）的风险；亚组分析显示，SGLT2 抑制剂在高心血管风险或随访时间>1 年的 T2DM 人群中，与总体结果具有一致的效果。没有充分的证据表明 SGLT2 抑制剂降低了室性心律失常（RR 0.94；95%CI 0.71-1.26；P=0.69）和心脏骤停（RR 0.88；95%CI 0.66-1.18；P=0.39）的风险。SGLT2 抑制剂对缓慢性心律失常的影响呈中性（RR 1.02；95%CI 0.79-1.33；P=0.85）。与安慰剂相比，SGLT2 抑制剂对所有次要结局均无显著影响，但对心房颤动有边缘影响。
SGLT2 抑制剂与 T2DM 患者的房性心律失常风险降低相关。我们的研究结果支持在高心血管风险的 T2DM 人群中使用 SGLT2 抑制剂。我们还建议长期使用 SGLT2 抑制剂以获得进一步的获益。
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