Department of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jing 5 Road, Jinan, Shandong Province 250021, China; Shandong Clinical Medical Center of Endocrinology and Metabolism, 324 Jing 5 Road, Jinan, Shandong Province 250021, China; Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, 324 Jing 5 Road, Jinan, Shandong Province 250021, China.
Shandong Clinical Medical Center of Endocrinology and Metabolism, 324 Jing 5 Road, Jinan, Shandong Province 250021, China; Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, 324 Jing 5 Road, Jinan, Shandong Province 250021, China; Scientific Center, Shandong Provincial Hospital Affiliated to Shandong University, 324 Jing 5 Road, Jinan, Shandong Province 250021, China.
Diabetes Res Clin Pract. 2018 Sep;143:34-42. doi: 10.1016/j.diabres.2018.06.009. Epub 2018 Jun 20.
To show long-term cardiovascular safety of the GLP-1 receptor agonists for diabetes patients with cardiovascular risk.
For cardiovascular outcomes, the association between treatment and outcomes was estimated using the odds ratio and 95% confidence interval. I test was adopted to assess the magnitude of heterogeneity between studies, with values more than 25%, 50%, and 75% defined as low, moderate, or high heterogeneity.
We combined data from four cardiovascular outcomes trials and prospectively blinded endpoint adjudication. 4105 cardiovascular events including cardiovascular death, acute MI or stroke experienced during the trials. And the odds ratios of the cardiovascular outcomes were 0.90 (95% CI 0.81, 1.00) for the cardiovascular outcome, 0.93 (95% CI 0.85, 1.02) for nonfatal myocardial infarction, 0.88 (95% CI 0.76, 1.03) for nonfatal stroke, 0.94 (95% CI 0.84, 1.05) for heart failure hospitalization, 0.89 (95% CI 0.63, 1.27) for pancreatitis, 0.98 (95% CI 0.92, 1.05) for any hypoglycemic events, 0.92 (95% CI 0.83, 1.01) for the severe hypoglycemic events, 0.96 (95% CI 0.83, 1.01) for serious adverse events. Significant differences showed in mortality parameters: 0.88 (95% CI 0.81, 0.95) for all-cause mortality, 0.87 (95% CI 0.79, 0.97) for cardiovascular mortality. CV benefits were obtained in the male, black, Asian patients and patients with BMI ≥ 30 kg/m.
Additional GLP-1 receptor agonists treatment did not increase cardiovascular outcomes in diabetes patients with high cardiovascular risk or established cardiovascular disease.
展示 GLP-1 受体激动剂对有心血管风险的糖尿病患者的长期心血管安全性。
对于心血管结局，使用比值比和 95%置信区间估计治疗与结局之间的关联。采用 I 检验评估研究之间异质性的大小，25%、50%和 75%以上的值定义为低、中和高度异质性。
我们结合了四项心血管结局试验的数据，并进行了前瞻性盲终点裁决。4105 例心血管事件，包括试验期间发生的心血管死亡、急性心肌梗死或中风。心血管结局的比值比为 0.90（95%CI 0.81，1.00），非致死性心肌梗死为 0.93（95%CI 0.85，1.02），非致死性中风为 0.88（95%CI 0.76，1.03），心力衰竭住院为 0.94（95%CI 0.84，1.05），胰腺炎为 0.89（95%CI 0.63，1.27），任何低血糖事件为 0.98（95%CI 0.92，1.05），严重低血糖事件为 0.92（95%CI 0.83，1.01），严重不良事件为 0.96（95%CI 0.83，1.01）。在死亡率参数方面显示出显著差异：全因死亡率为 0.88（95%CI 0.81，0.95），心血管死亡率为 0.87（95%CI 0.79，0.97）。在男性、黑人、亚洲患者和 BMI≥30kg/m2 的患者中获得了 CV 获益。
在有高心血管风险或已患有心血管疾病的糖尿病患者中，额外的 GLP-1 受体激动剂治疗并未增加心血管结局。
