Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Center for Bioethics, Harvard Medical School, Boston, MA, USA.
Cardiovasc Diabetol. 2020 Sep 29;19(1):154. doi: 10.1186/s12933-020-01133-1.
We explored whether clinically relevant baseline characteristics of patients with type 2 diabetes can modify the effect of glucagon-like peptide-1 receptor agonists (GLP-1 RA) or sodium-glucose cotransporter-2 inhibitors (SGLT-2i) on the risk of major adverse cardiovascular events (MACE).
We investigated Medline and EMBASE through June 2019. We included randomized clinical trials reporting the effect of GLP-1 RA or SGLT-2i on MACE in subgroups of patients with type 2 diabetes, identified through key baseline factors: established cardiovascular disease; heart failure; chronic kidney disease; uncontrolled diabetes; duration of diabetes; hypertension; obesity; age; gender and race. Hazard ratios (HRs) and 95% confidence intervals (CIs) from trials were meta-analyzed using random-effects models.
Ten trials enrolling 89,790 patients were included in the analyses. Subgroup meta-analyses showed a 14% risk reduction of MACE in patients with established cardiovascular disease [GLP1-RA: HR, 0.86 (95% CI, 0.80-0.93); SGLT-2i: 0.86 (0.80-0.93)], and no effect in at-risk patients without history of cardiovascular events [GLP1-RA: 0.94 (0.82-1.07); SGLT-2i: 1.00 (0.87-1.16)]. We observed a trend toward larger treatment benefits with SGLT-2i among patients with chronic kidney disease [0.82 (0.69-0.97)], and patients with uncontrolled diabetes for both GLP1-RA or SGLT-2i [GLP1-RA: 0.82 (0.71-0.95); SGLT-2i: 0.84 (0.75-0.95)]. Uncontrolled hypertension, obesity, gender, age and race did not appear to modify the effect of these drugs.
In this exploratory analysis, history of cardiovascular disease appeared to modify the treatment effect of SGLT2i or GLP1-RA on MACE. Chronic kidney disease and uncontrolled diabetes should be further investigated as potential effect modifiers.
我们探讨了 2 型糖尿病患者的临床相关基线特征是否会改变胰高血糖素样肽-1 受体激动剂(GLP-1RA)或钠-葡萄糖共转运蛋白-2 抑制剂(SGLT-2i)对主要不良心血管事件(MACE)风险的影响。
我们通过 2019 年 6 月的 Medline 和 EMBASE 进行了调查。我们纳入了报告 GLP-1RA 或 SGLT-2i 对 2 型糖尿病患者亚组 MACE 影响的随机临床试验,这些亚组通过关键基线因素确定:已确诊的心血管疾病;心力衰竭;慢性肾脏病;未控制的糖尿病;糖尿病病程;高血压;肥胖症;年龄;性别和种族。使用随机效应模型对试验中的风险比(HR)和 95%置信区间(CI)进行荟萃分析。
纳入的 10 项试验共纳入了 89790 名患者。亚组荟萃分析显示,在已确诊心血管疾病的患者中,MACE 的风险降低了 14%[GLP1-RA:HR,0.86(95%CI,0.80-0.93);SGLT-2i:0.86(0.80-0.93)],而在无心血管事件史的高危患者中无影响[GLP1-RA:0.94(0.82-1.07);SGLT-2i:1.00(0.87-1.16)]。我们观察到 SGLT-2i 在慢性肾脏病患者中具有更大的治疗益处的趋势[0.82(0.69-0.97)],以及在未控制的糖尿病患者中 GLP1-RA 或 SGLT-2i 均具有治疗益处[GLP1-RA:0.82(0.71-0.95);SGLT-2i:0.84(0.75-0.95)]。未控制的高血压、肥胖症、性别、年龄和种族似乎并未改变这些药物的疗效。
在这项探索性分析中,心血管疾病史似乎改变了 SGLT2i 或 GLP1-RA 对 MACE 的治疗效果。慢性肾脏病和未控制的糖尿病应进一步作为潜在的效应修饰剂进行研究。