Green, J. B. et al. (2015) Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine, 373(3), pp. 232-242. (doi: 10.1056/NEJMoa1501352) (PMID:26052984)
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Abstract
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).
Item Type: | Articles |
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Additional Information: | for the TECOS Study Group |
Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | McMurray, Professor John |
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., and McMurray, J. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
Journal Name: | New England Journal of Medicine |
Publisher: | Massachusetts Medical Society |
ISSN: | 0028-4793 |
ISSN (Online): | 1533-4406 |
Copyright Holders: | Copyright © 2015 The Authors |
First Published: | First published in New England Journal of Medicine 373(3)232-242 |
Publisher Policy: | Reproduced in accordance with the copyright policy of the publisher |
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