Department of Internal Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.
Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
Sci Rep. 2020 Nov 4;10(1):19033. doi: 10.1038/s41598-020-75594-5.
This study was performed to evaluate the long-term cardiovascular safety of gemigliptin in patients with type 2 diabetes mellitus (T2DM). After screening, eligible patients with T2DM were enrolled, received gemigliptin, and were followed up for a median of 2.50 years. The primary outcome was a composite of confirmed cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke (3-point major adverse cardiovascular event [MACE]). The key secondary outcomes were incidence of all-cause mortality and any other cardiovascular events. A total of 5179 patients were included in the study and 5113 were treated with gemigliptin. Overall, the primary outcome occurred in 26 patients within 12 months (estimated incidence by Cox proportional hazard model 0.49%, 95% CI 0.29-0.69%) and in 54 patients within 54 months (estimated incidence from Cox proportional hazard model 1.35%, 95% CI 0.92-1.77%). During the study period, the incidence rates of each component of the primary composite outcome were 0.04% (0.2 events per 1000 person-years) for cardiovascular death, 0.51% (2.2 events per 1000 person-years) for nonfatal myocardial infarction, and 0.61% (2.5 events per 1000 person-years) for nonfatal ischemic stroke. The incidence of all-cause mortality was 0.82% (3.2 events per 1000 person-years) and the incidences of other cardiovascular events were all less than 0.3%. In conclusion, T2DM patients who received gemigliptin exhibited a low incidence of the primary composite MACE and all-cause mortality. Therefore, the use of gemigliptin is expected to be safe without an increase in cardiovascular risk.Trial registration: The study was registered at ClinicalTrials.gov (identifier: NCT02290301).
本研究旨在评估二甲双胍格列净在 2 型糖尿病（T2DM）患者中的长期心血管安全性。经过筛选，合格的 T2DM 患者被纳入研究，接受二甲双胍格列净治疗，并随访中位数为 2.50 年。主要终点是确认的心血管死亡、非致死性心肌梗死或非致死性缺血性卒中的复合终点（3 点主要不良心血管事件[MACE]）。关键次要终点是全因死亡率和任何其他心血管事件的发生率。共有 5179 例患者入组研究，5113 例患者接受二甲双胍格列净治疗。总体而言，12 个月内 26 例患者发生主要终点事件（Cox 比例风险模型估计发生率为 0.49%，95%CI 0.29-0.69%），54 例患者在 54 个月内发生主要终点事件（Cox 比例风险模型估计发生率为 1.35%，95%CI 0.92-1.77%）。在研究期间，主要复合终点的每个组成部分的发生率为：心血管死亡为 0.04%（每 1000 人年 0.2 例事件），非致死性心肌梗死为 0.51%（每 1000 人年 2.2 例事件），非致死性缺血性卒中为 0.61%（每 1000 人年 2.5 例事件）。全因死亡率为 0.82%（每 1000 人年 3.2 例事件），其他心血管事件的发生率均低于 0.3%。总之，接受二甲双胍格列净治疗的 T2DM 患者的主要复合 MACE 和全因死亡率发生率较低。因此，使用二甲双胍格列净预计是安全的，不会增加心血管风险。试验注册：该研究在 ClinicalTrials.gov 注册（标识符：NCT02290301）。
