Effect of @entity12350 on Cardiovascular Outcomes in Type 2 XXXX .

@entity1 @entity788 @entity64 @entity712 @entity5735 @entity6 @entity951 @entity12350 @entity164 @entity583 @entity65
BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding @entity12350 , a @entity5735 inhibitor, to usual care in @entity1 with @entity164 2 @entity6 and @entity65 . METHODS: In this randomized, double-blind study, we assigned 14,671 @entity1 to add either @entity12350 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 @entity1 . To determine whether @entity12350 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 @entity65 , nonfatal @entity583 , @entity64 , or hospitalization for unstable @entity951 . RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for @entity12350 vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 @entity1 in the @entity12350 group (11.4%; 4.06 per 100 @entity1 -years) and 851 @entity1 in the placebo group (11.6%; 4.17 per 100 @entity1 -years). @entity12350 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 @entity712 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 @entity788 (P=0.32). CONCLUSIONS: Among @entity1 with @entity164 2 @entity6 and established @entity65 , adding @entity12350 to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for @entity712 , or other adverse events. (Funded by Merck Sharp _ Dohme; TECOS ClinicalTrials.gov number, NCT00790205.).
