A prospective cohort study on effects of gemigliptin on cardiovascular outcomes in patients with type 2 diabetes (OPTIMUS study)

Eun Heui Kim, Sang Soo Kim, Dong Jun Kim, Young Sik Choi, Chang Won Lee, Bon Jeong Ku, Kwang Soo Cha, Kee Ho Song, Dae Kyeong Kim, In Joo Kim, Eun Heui Kim, Sang Soo Kim, Dong Jun Kim, Young Sik Choi, Chang Won Lee, Bon Jeong Ku, Kwang Soo Cha, Kee Ho Song, Dae Kyeong Kim, In Joo Kim

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).

Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Patient disposition, MACE, major adverse cardiovascular event.
Figure 2
Figure 2
Time to occurrence of the primary composite MACE, MACE, major adverse cardiovascular event.
Figure 3
Figure 3
The Kaplan–Meier curve for overall survival.
Figure 4
Figure 4
HbA1c level over time. HbA1c, glycated hemoglobin; SE, standard error. * The change in HbA1c from baseline was significant (p < 0.0001). p value was obtained from Wilcoxon signed rank test.

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