Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.

Salvatore Novo, Jennifer B. Green, Shailaja Suryawanshi, John M. Lachin, Paul W. Armstrong, Frans Van De Werf, Eric D. Peterson, Joerg Koglin, Samuel S. Engel, John B. Buse, Joerg Koglin, M. Angelyn Bethel, Scott Korn, Eberhard Standl, Keith D. Kaufman, Robert Josse, Darren K. Mcguire, Rury R. Holman, Peter P. Stein, Jyotsna GargMichael J. Pencina

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    1526 Citazioni (Scopus)

    Abstract

    BACKGROUNDData 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 2diabetes and cardiovascular disease.METHODSIn this randomized, double-blind study, we assigned 14,671 patients to add eithersitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemictherapy was encouraged as required, aimed at reaching individually appropriateglycemic targets in all patients. To determine whether sitagliptin was noninferiorto placebo, we used a relative risk of 1.3 as the marginal upper boundary. Theprimary cardiovascular outcome was a composite of cardiovascular death, nonfatalmyocardial infarction, nonfatal stroke, or hospitalization for unstable angina.RESULTSDuring a median follow-up of 3.0 years, there was a small difference in glycatedhemoglobin 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 per100 person-years). Sitagliptin was noninferior to placebo for the primary compositecardiovascular 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 significantbetween-group differences in rates of acute pancreatitis (P=0.07) or pancreaticcancer (P=0.32).CONCLUSIONSAmong patients with type 2 diabetes and established cardiovascular disease, addingsitagliptin to usual care did not appear to increase the risk of major adverse cardiovascularevents, hospitalization for heart failure, or other adverse events.(Funded by Merck Sharp &amp; Dohme; TECOS ClinicalTrials.gov number, NCT00790205.)
    Lingua originaleEnglish
    pagine (da-a)232-242
    Numero di pagine11
    RivistaNew England Journal of Medicine
    Volume373
    Stato di pubblicazionePublished - 2015

    All Science Journal Classification (ASJC) codes

    • Medicine(all)

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    Novo, S., Green, J. B., Suryawanshi, S., Lachin, J. M., Armstrong, P. W., Van De Werf, F., Peterson, E. D., Koglin, J., Engel, S. S., Buse, J. B., Koglin, J., Bethel, M. A., Korn, S., Standl, E., Kaufman, K. D., Josse, R., Mcguire, D. K., Holman, R. R., Stein, P. P., ... Pencina, M. J. (2015). Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. New England Journal of Medicine, 373, 232-242.