This improves glycemic control in patients with type 2 diabetes, primarily by suppressing glucagon levels and increasing endogenous insulin secretion. Sitagliptin, an orally administered dipeptidyl peptidase 4 (DPP-4) inhibitor, prolongs the action of incretin hormones, including glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide, by inhibiting their breakdown. 4,5 International regulatory agencies have responded by requiring that new antihyperglycemic agents not only show glucose-lowering ability but also are not associated with clinically meaningful increases in rates of major adverse cardiovascular events. 1-3 Many antihyperglycemic agents are licensed for the treatment of type 2 diabetes, but questions regarding the long-term cardiovascular safety of some of these agents have been raised. Good glycemic control among patients with type 2 diabetes reduces the risk of diabetes-related microvascular complications. (Funded by Merck Sharp & Dohme TECOS number, NCT00790205.) Introduction ConclusionsĪmong 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. There were no significant between-group differences in rates of acute pancreatitis (P=0.07) or pancreatic cancer (P=0.32).
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). 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).
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). placebo, −0.29 percentage points 95% confidence interval, −0.32 to −0.27). Resultsĭuring a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. The most trusted, influential source of new medical knowledge and clinical best practices in the world.ĭata 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.
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