| Contributors: |
Scirica, B; Bhatt, D; Braunwald, E; Steg, P; Davidson, J; Hirshberg, B; Ohman, P; Frederich, R; Wiviott, S; Hoffman, E; Cavender, M; Udell, J; Desai, N; Mosenzon, O; Mcguire, D; Ray, K; Leiter, L; Raz, I; Abrahamsen, T; Grossman, M; Morin, S; Im, K; Gabovitch, D; Pricken, A; Buskila, A; Stahre, C; Price, D; Billing-Clason, S; Sabel, K; Monyak, J; Sjostrand, M; Wei, C; Lu, J; Miller, E; Raichlen, J; Fitt, S; Iqbal, N; Donovan, M; Aguilar-Salinas, C; Alvarsson, M; Amerena, J; Ardissino, D; Averkov, O; Avogaro, A; Barnett, A; Bretzel, R; Chiang, C; Codoceo, V; Corbalan, R; Dalby, A; Darius, H; Deerochanawong, C; Dellborg, M; Eliaschewitz, F; Garcia-Castillo, A; Gomis, R; Henry, P; Hoekstra, J; Jermendy, G; Kastelein, J; Keech, A; Kiss, R; Krempf, M; Laakso, M; Leitersdorf, E; Lewis, B; Litwak, L; Lopez-Sendon, J; Ma, R; Medina, F; Moses, R; Nicolau, J; Opolski, G; Ophuis, T; Paolasso, E; Ruda, M; Kumar, K; Shestakova, M; Sheu, W; Smahelova, A; Bhupathiraju, B; Spinar, J; Sritata, P; Strojeck, K |
| Description: |
BACKGROUND: The cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear. METHODS: We randomly assigned 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. RESULTS: A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P |