Association Between Sitagliptin Use and Heart Failure Hospitalization and Related Outcomes in Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Clinical Trial
Open accessAbstract
IMPORTANCE: Previous trial results have suggested that dipeptidyl peptidase 4 inhibitor (DPP4i) use might increase heart failure (HF) risk in type 2 diabetes mellitus (T2DM). The DPP4i sitagliptin has been shown to be noninferior to placebo with regard to primary and secondary composite atherosclerotic cardiovascular (CV) outcomes in the Trial Evaluating Cardiovascular Outcomes With Sitagliptin (TECOS). OBJECTIVE: To assess the association of sitagliptin use with hospitalization for HF (hHF) and related outcomes. DESIGN, SETTING, AND PARTICIPANTS: TECOS was a randomized, double-blind, placebo-controlled study evaluating the CV safety of sitagliptin vs placebo, each added to usual antihyperglycemic therapy and CV care among patients with T2DM and prevalent atherosclerotic vascular disease. The median follow-up was 2.9 years. The setting was 673 sites in 38 countries. Participants included 14 671 patients with T2DM and atherosclerotic vascular disease. The study dates were December 2008 through March 2015. INTERVENTIONS: Patients were randomized to sitagliptin vs placebo added to standard care. MAIN OUTCOMES AND MEASURES: Prespecified secondary analyses compared the effect on hHF, hHF or CV death, and hHF or all-cause death composite outcomes overall and in prespecified subgroups. Supportive analyses included total hHF events (first plus recurrent) and post-hHF death. Meta-analyses evaluated DPP4i effects on hHF and on hHF or CV death. RESULTS: Of 14 671 patients, 7332 were randomized to sitagliptin and 7339 to placebo. Hospitalization for HF occurred in 3.1% (n = 228) and 3.1% (n = 229) of the sitagliptin and placebo groups, respectively (unadjusted hazard ratio, 1.00; 95% CI, 0.83-1.19). There was also no difference in total hHF events between the sitagliptin (n = 345) and placebo (n = 347) groups (unadjusted hazard ratio, 1.00; 95% CI, 0.80-1.25). Post-hHF all-cause death was similar in the sitagliptin and placebo groups (29.8% vs 28.8%, respectively), as was CV death (22.4% vs 23.1%, respectively). No heterogeneity for the effect of sitagliptin on hHF was observed in subgroup analyses across 21 factors (P > .10 for all interactions). Meta-analysis of the hHF results from the 3 reported DPP4i CV outcomes trials revealed moderate heterogeneity (I2 = 44.9, P = .16). CONCLUSIONS AND RELEVANCE: Sitagliptin use does not affect the risk for hHF in T2DM, both overall and among high-risk patient subgroups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00790205.
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In the TECOS and CARMELINA trials, there was no increased risk of heart failure with either sitagliptin or linagliptin compared with placebo.
“These observations led to the development and regulatory filing of prospective HF analysis plans for the TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) and CARMELINA (Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus) trials, each of which revealed no increased risk of HF with either sitagliptin or linagliptin”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [178]
Sitagliptin and linagliptin have a neutral effect on heart failure hospitalization.
“Sitagliptin and linagliptin had a neutral effect.174,[178][179][180]”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [178]
Sitagliptin in the TECOS trial had no signal of excess rates of HF.
“Likewise, sitagliptin in the TECOS trial had no signal of excess rates of HF. 18,185”
From Type 2 diabetes mellitus and heart failure: A position statement from the Heart Failure Association of the European Society of Cardiology (2018) · cites this paper as [185]
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- Authors
- McGuire, D. K., Van de Werf, F., Armstrong, P. W., Standl, E., Koglin, J., Green, J. B., Bethel, M. A., Cornel, J. H., Lopes, R. D., Halvorsen, S., Ambrosio, G., Buse, J. B., Josse, R. G., Lachin, J. M., Pencina, M. J., Garg, J., Lokhnygina, Y., Holman, R. R., Peterson, E. D., & for the Trial Evaluating Cardiovascular Outcomes With Sitagliptin (TECOS) Study Group
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium
- University of Alberta (CA)
- Helmholtz Munich (DE)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Duke University (US)
- University of Oxford (GB)
- Medisch Centrum Alkmaar (NL)
- Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
- Oslo University Hospital (NO)
- University of Perugia (IT)
- University of North Carolina at Chapel Hill (US)
- St. Michael's Hospital (CA)
- George Washington University (US)
- Corresponding author
- McGuire, Darren K.
- ORCID
- Venue
- JAMA Cardiology
- Publisher
- American Medical Association (AMA)
- Published
- 2016-05-01
- Volume
- 1
- Issue
- 2
- Pages
- 126
- ISSN
- 2380-6583 (ISSN-L)
- OpenAlex
- W2335973015
- Cited by
- 217
- References
- 22
- Citations by year
- 2026: 5 · 2025: 4 · 2024: 9 · 2023: 8 · 2022: 15 · 2021: 16 · 2020: 31 · 2019: 31 · 2018: 46 · 2017: 38 · 2016: 13
- FWCI
- 42.85
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Diabetes Association
- Bristol-Myers Squibb Foundation
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Gilead Sciences
- Intarcia Therapeutics
- Halozyme
- AstraZeneca HealthCare Foundation
- MacroGenics
- Novo Nordisk
- Astellas Pharma
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Keywords
- sitagliptin, heart failure hospitalization, type 2 diabetes, DPP-4 inhibitors, cardiovascular safety, TECOS trial, atherosclerosis, cardiovascular mortality, all-cause mortality, glycemic control, antihyperglycemic therapy, subgroup analysis
- MeSH terms
- Sitagliptin Phosphate, Aged, Cardiovascular Diseases, Cause of Death, Diabetes Mellitus, Type 2, Female, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Risk Factors, Prevalence, Hospital Mortality, Outcome Assessment, Health Care, Atherosclerosis, Dipeptidyl-Peptidase IV Inhibitors
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