Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes
Open accessAbstract
BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P=0.98). There were no significant between-group differences in rates of acute pancreatitis (P=0.07) or pancreatic cancer (P=0.32). CONCLUSIONS: Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events. (Funded by Merck Sharp & Dohme; TECOS ClinicalTrials.gov number, NCT00790205.).
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Other trials in high-risk type 2 diabetes patients showed similar glycemic control effects but without significant benefits for cardiovascular events or death.
“There are a number of other trials regarding cardiovascular outcomes in high-risk cohorts of patients with type 2 diabetes in which similar magnitude effects on glycemic control have been shown but without significant benefits with respect to rates of cardiovascular events or death.”
From Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (2016) · cites this paper as [17]
The Results (p. 1) report a small improvement in glycated hemoglobin with sitagliptin and no reduction in the primary cardiovascular outcome; Other Secondary Outcomes (p. 4) report no significant difference in deaths. The Discussion (p. 8) also says two other DPP-4 inhibitor trials found no reduction in major adverse cardiovascular events. It does not establish that those other trials had similar-magnitude glycemic effects or no mortality benefit. (LLM, conf=0.85)
Experimental — accuracy not yet measuredDPP4 inhibitors exhibit cardiovascular neutrality in T2DM patients.
“have shown that DPP4i exhibit cardiovascular neutrality in T2DM patients.”
From The effect of <scp>GLP</scp> ‐1 receptor agonists on circulating inflammatory markers in type 2 diabetes patients: A systematic review and meta‐analysis (2025) · cites this paper as [136]
The Discussion (p. 8) reports no change in major adverse cardiovascular events with sitagliptin and says trials of two other DPP-4 inhibitors likewise found no increase or decrease in those events. But it also reports increased heart-failure hospitalization with saxagliptin, so unqualified cardiovascular neutrality for the class overstates the evidence. (LLM, conf=0.88)
Experimental — accuracy not yet measuredEvidence that glucose lowering reduces the rates of cardiovascular events and death has not been convincingly shown.
“Evidence that glucose lowering reduces the rates of cardiovascular events and death has not been convincingly shown, 4-6”
From Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes (2015) · cites this paper as [4]
The Results (p. 1) report that sitagliptin lowered glycated hemoglobin but did not reduce the primary cardiovascular outcome; Other Secondary Outcomes (p. 4) show no reduction in death from any cause. These findings support the lack of a demonstrated benefit for sitagliptin in this trial, but do not establish the broader claim about glucose lowering generally. (LLM, conf=0.83)
Experimental — accuracy not yet measuredAcross trials of DPP-4 inhibitors, there appears to be no interaction by age-group.
“Across the trials of this drug class, there appears to be no interaction by age-group (110-112).”
From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [111]
The Statistical Analysis section (p. 3) lists age at randomization among the prespecified subgroups, and Subgroup Analyses (p. 6) reports no significant interaction apart from body-mass index. That supports the age-group point for this sitagliptin trial, but the paper does not establish an absence of age-group interaction across trials of DPP-4 inhibitors. (LLM, conf=0.86)
Experimental — accuracy not yet measuredEXAMINE, TECOS, and CARMELINA did not find a significant increase in risk of heart failure hospitalization with DPP-4 inhibitor use compared with placebo.
“However, three other cardiovascular outcomes trials-Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) (293), Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) (294), and the Cardiovascular and Renal Microvascular Outcome Study With Linagliptin (CARMELINA) (295)-did not find a significant increase in risk of heart failure hospitalization with D”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [294]
Three other cardiovascular outcomes trials-EXAMINE, TECOS, and CARMELINA-did not find a significant increase in risk of heart failure hospitalization with DPP-4 inhibitor use compared with placebo.
“However, three other cardiovascular outcomes trials—Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) (312), Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) (313), and the Cardiovascular and Renal Microvascular Outcome Study With Linagliptin (CARMELINA) (314)—did not find a significant increase in risk of heart failure hospitalization with D”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [313]
The observed annualized primary endpoint event rate for placebo patients in REDUCE-IT is consistent with historical cardiovascular outcome studies with comparable patient populations and expanded or hard MACE.
“The observed annualized primary endpoint event rate for placebo patients in REDUCE-IT was 5.74%, which is consistent with historical cardiovascular outcome studies, including those published since the design of REDUCE-IT, with comparable patient populations and expanded or hard major adverse cardiovascular events (MACE) (4,8,9,30-44).”
From Effects of Icosapent Ethyl on Total Ischemic Events (2019) · cites this paper as [31]
Excepting glimepiride, which was assessed for cardiovascular safety and efficacy head-to-head against linagliptin in the CAROLINA trial, and gliclazide-modified release, which was compared with usual care in the ADVANCE trial, dedicated cardiovascular safety assessments have not been conducted for the other sulphonylureas.
“Excepting glimepiride, which was assessed for CV safety and efficacy head-to-head against linagliptin in the CAROLINA trial, and gliclazidemodified release, which was compared with usual care (that could have included treatment with a sulphonylurea other than gliclazide) in the ADVANCE trial, dedicated CV safety assessments have not been conducted for the other sulphonylureas.132,173,174,184”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [174]
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 [174]
In four trials to date, DPP4 inhibitors have been shown to be neutral in terms of cardiovascular outcomes.
“In 4 trials to date, the DPP4 inhibitors have been shown to be neutral in terms of cardiovascular outcomes.”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [215]
Not all DPP4 inhibitors are associated with higher rates of HF.
“Not all DPP4 inhibitors are associated with higher rates of HF (Table 8).16 -24,184-186”
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 [18]
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 [18]
In mice, GLP-1 causes vasodilation through both GLP-1 receptor-dependent and -independent mechanisms.
“In mice, GLP-1 causes vasodilation through both GLP-1 receptor-dependent and -independent mechanisms.211”
From The Vasculature in Prediabetes (2018) · cites this paper as [211]
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Obesity in Type 1 Diabetes: Pathophysiology, Clinical Impact, and Mechanisms
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MANAGEMENT OF ENDOCRINE DISEASE: Are all GLP-1 agonists equal in the treatment of type 2 diabetes?
Nauck, M. A., & Meier, J. J. (2019) · European Journal of Endocrinology · doi:10.1530/eje-19-0566 · Cited by 254 · see citing works
Effects of Icosapent Ethyl on Total Ischemic Events
Bhatt, D. L., Steg, P. G., Miller, M., Brinton, E. A., Jacobson, T. A., Ketchum, S. B., Doyle, R. T., Juliano, R. A., Jiao, L., Granowitz, C., et al. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.02.032 · Cited by 259 · see citing works
Diabetes Mellitus and Heart Failure
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Cardiac and Renal Effects of Sodium-Glucose Co-Transporter 2 Inhibitors in Diabetes
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9. Cardiovascular Disease and Risk Management
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Patorno, E., Pawar, A., Franklin, J. M., Najafzadeh, M., Déruaz-Luyet, A., Brodovicz, K. G., Sambevski, S., Bessette, L. G., Santiago Ortiz, A. J., Kulldorff, M., et al. (2019) · Circulation · doi:10.1161/circulationaha.118.039177 · Cited by 215 · see citing works
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Self-citationXiao, C., Dash, S., Morgantini, C., Hegele, R. A., & Lewis, G. F. (2016) · Diabetes · doi:10.2337/db16-0046 · Cited by 212 · see citing works
Buse, J. B., Bain, S. C., Mann, J. F. E., Nauck, M. A., Nissen, S. E., Pocock, S., Poulter, N. R., Pratley, R. E., Linder, M., Monk Fries, T., et al. (2020) · Diabetes Care · doi:10.2337/dc19-2251 · Cited by 175 · see citing works
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13. Older Adults: <i>Standards of Care in Diabetes—2024</i>
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Glycemia reduction in type 2 diabetes–microvascular and cardiovascular outcomes
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Benefits and harms of intensive glycemic control in patients with type 2 diabetes
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Pioglitazone for Secondary Stroke Prevention: A Systematic Review and Meta-Analysis
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Postprandial Hyperlipidemia and Remnant Lipoproteins
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The Vasculature in Prediabetes
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Self-citationPersonalized type 2 diabetes management: an update on recent advances and recommendations
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Self-citationCardiometabolic-Based Chronic Disease, Addressing Knowledge and Clinical Practice Gaps
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10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026
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Glucagon-like peptide 1 receptor agonists and the risk of incident diabetic retinopathy
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AMPK is associated with the beneficial effects of antidiabetic agents on cardiovascular diseases
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Glucose-dependent insulinotropic polypeptide (GIP) and cardiovascular disease
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Self-citation
- Authors
- Green, J. B., Bethel, M. A., Armstrong, P. W., Buse, J. B., Engel, S. S., Garg, J., Josse, R., Kaufman, K. D., Koglin, J., Korn, S., Lachin, J. M., McGuire, D. K., Pencina, M. J., Standl, E., Stein, P. P., Suryawanshi, S., Van de Werf, F., Peterson, E. D., & Holman, R. R.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- University of Oxford (GB)
- University of Alberta (CA)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Duke University (US)
- St. Michael's Hospital (CA)
- George Washington University (US)
- The University of Texas Southwestern Medical Center (US)
- Helmholtz Munich (DE)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-07-16
- Volume
- 373
- Issue
- 3
- Pages
- 232-242
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2142830692
- Semantic Scholar
- 5f5aabad35a6c6137b19d8640d5d6cafc91815e5
- Cited by
- 2,577
- References
- 16
- Citations by year
- 2026: 68 · 2025: 121 · 2024: 120 · 2023: 139 · 2022: 170 · 2021: 210 · 2020: 289 · 2019: 267 · 2018: 343 · 2017: 343 · 2016: 378 · 2015: 120 · 2014: 2
- FWCI
- 341.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (acceptedVersion, cc-by-nc-nd)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion, other-oa)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Lithuanian University of Health Sciences (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- UNC Libraries
- Funders
- South Australian Health and Medical Research Institute
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Keywords
- sitagliptin, type 2 diabetes, cardiovascular disease, DPP-4 inhibitors, major adverse cardiovascular events, heart failure hospitalization, acute pancreatitis, pancreatic cancer, HbA1c, glycemic control, non-inferiority
- MeSH terms
- Sitagliptin Phosphate, Administration, Oral, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Drug Therapy, Combination, Follow-Up Studies, Heart Diseases, Heart Failure, Glycated Hemoglobin, Hospitalization, Humans, Hypoglycemic Agents, Pyrazines, Triazoles, Kaplan-Meier Estimate
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