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Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.

Publication ,  Journal Article
Green, JB; Bethel, MA; Armstrong, PW; Buse, JB; Engel, SS; Garg, J; Josse, R; Kaufman, KD; Koglin, J; Korn, S; Lachin, JM; McGuire, DK ...
Published in: N Engl J Med
July 16, 2015

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 16, 2015

Volume

373

Issue

3

Start / End Page

232 / 242

Location

United States

Related Subject Headings

  • Triazoles
  • Sitagliptin Phosphate
  • Pyrazines
  • Kaplan-Meier Estimate
  • Hypoglycemic Agents
  • Humans
  • Hospitalization
  • Heart Failure
  • Heart Diseases
  • Glycated Hemoglobin
 

Citation

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Green, J. B., Bethel, M. A., Armstrong, P. W., Buse, J. B., Engel, S. S., Garg, J., … TECOS Study Group, . (2015). Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med, 373(3), 232–242. https://doi.org/10.1056/NEJMoa1501352
Green, Jennifer B., M Angelyn Bethel, Paul W. Armstrong, John B. Buse, Samuel S. Engel, Jyotsna Garg, Robert Josse, et al. “Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.N Engl J Med 373, no. 3 (July 16, 2015): 232–42. https://doi.org/10.1056/NEJMoa1501352.
Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, et al. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015 Jul 16;373(3):232–42.
Green, Jennifer B., et al. “Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.N Engl J Med, vol. 373, no. 3, July 2015, pp. 232–42. Pubmed, doi:10.1056/NEJMoa1501352.
Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR, TECOS Study Group. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015 Jul 16;373(3):232–242.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 16, 2015

Volume

373

Issue

3

Start / End Page

232 / 242

Location

United States

Related Subject Headings

  • Triazoles
  • Sitagliptin Phosphate
  • Pyrazines
  • Kaplan-Meier Estimate
  • Hypoglycemic Agents
  • Humans
  • Hospitalization
  • Heart Failure
  • Heart Diseases
  • Glycated Hemoglobin