A prospective cohort study on effects of gemigliptin on cardiovascular outcomes in patients with type 2 diabetes
Eun Heui Kim1, Sang Soo Kim1, Dong Jun Kim2
1Department of Internal Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.
Abstract:
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).
Insights
Gemigliptin demonstrated long-term cardiovascular safety in type 2 diabetes patients. The study found a low incidence of major adverse cardiovascular events (MACE) and all-cause mortality, indicating safe use.
Area of Science:
- Cardiology
- Endocrinology
- Pharmacology
Background:
- Type 2 diabetes mellitus (T2DM) is associated with increased cardiovascular risk.
- Assessing the long-term cardiovascular safety of antidiabetic medications is crucial.
Purpose of the Study:
- To evaluate the long-term cardiovascular safety of gemigliptin in patients with T2DM.
- To determine the incidence of major adverse cardiovascular events (MACE) and all-cause mortality.
Main Methods:
- A prospective study involving 5179 T2DM patients treated with gemigliptin.
- Median follow-up of 2.50 years.
- Primary outcome: composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke (3-point MACE).
Main Results:
- The 3-point MACE incidence was 1.35% over 54 months.
- Incidence rates per 1000 person-years: cardiovascular death (0.2), nonfatal myocardial infarction (2.2), nonfatal ischemic stroke (2.5).
- All-cause mortality incidence was 3.2 events per 1000 person-years.
Conclusions:
- Gemigliptin treatment in T2DM patients showed a low incidence of MACE and all-cause mortality.
- Gemigliptin is considered safe for T2DM patients, with no increased cardiovascular risk observed.
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