Nauck, M.A., McGuire, D.K., Pieper, K.S. et al. Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes: observations from TECOS. Cardiovasc Diabetol 18, 116 (2019). https://doi.org/10.1186/s12933-019-0921-2
Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes : observations from TECOS
|Author:||Nauck, Michael A.1; McGuire, Darren K.2; Pieper, Karen S.3;|
1Division of Diabetology, Medical Department I, St. Josef-Hospital (Ruhr-University), Bochum, Germany.
2Division of Cardiology, University of Texas South-western Medical Center, Dallas, TX, USA
3Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA
4Helsinki University Hospital, University of Helsinki, Helsinki, Finland
5Center for Life Course Health Research, University of Oulu, Oulu, Finland
6Practise Internal Medicine/Diabetology, Husby, Germany
7Department of Internal Medicine, Hacettepe Univer-sity, Ankara, Turkey
8Coronary Care and Cardiovascular Research at the Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
9Don Beaven Medical Research Center, Christchurch Hospital, Christchurch, New Zealand
10Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, UK
|Online Access:||PDF Full Text (PDF, 0.9 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2020040710670
|Publish Date:|| 2020-04-07
Background: To examine the effects of the DPP-4i sitagliptin on CV outcomes during and after incident MI in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).
Methods: TECOS randomized 14,671 participants with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) to sitagliptin or placebo, in addition to usual care. For those who had a within-trial MI, we analyzed case fatality, and for those with a nonfatal MI, we examined a composite cardiovascular (CV) outcome (CV death or hospitalization for heart failure [hHF]) by treatment group, using Cox proportional hazards models left-censored at the time of the first within-trial MI, without and with adjustment for potential confounders, in intention-to-treat analyses.
Results: During TECOS, 616 participants had ≥ 1 MI (sitagliptin group 300, placebo group 316, HR 0.95, 95% CI 0.81–1.11, P = 0.49), of which 25 were fatal [11 and 14, respectively]). Of the 591 patients with a nonfatal MI, 87 (15%) died subsequently, with 66 (11%) being CV deaths, and 57 (10%) experiencing hHF. The composite outcome occurred in 58 (20.1%; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6%; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95% CI 0.83–1.77, P = 0.32, adjusted HR 1.23, 95% CI 0.83–1.82, P = 0.31). On-treatment sensitivity analyses also showed no significant between-group differences in post-MI outcomes.
Conclusions: In patients with type 2 diabetes and ASCVD experiencing an MI, sitagliptin did not reduce subsequent risk of CV death or hHF, contrary to expectations derived from preclinical animal models.
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3121 General medicine, internal medicine and other clinical medicine
The TECOS trial was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. The study was designed and run independently by the Duke Clinical Research Institute (DCRI) and the University of Oxford Diabetes Trials Unit (DTU) in an academic collaboration with the sponsor. All analyses were performed by DCRI and DTU independent of the sponsor. The authors are solely responsible for the design and conduct of this study, all analyses, the drafting and editing of the paper, and its final contents. All authors agreed to submit the report for publication; the funder had no role in this decision.
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