Overall MACE occurred in 108 patients of 1648 (6.6%) on Ozempic® and 146 patients of 1649 (8.9%) on placebo (HR, 0.74 [95% CI, 0.58-0.95] P<0.001 for noninferiority, P=0.02 for superiority, not prespecified.); nonfatal stroke occurred in 27 patients (1.6%) on Ozempic® and 44 patients (2.7%) on placebo; nonfatal Ml occurred in 47 patients (2.9%) on Ozempic® and 64 patients (3.9%) on placebo; CV death occurred in 44 patients (2.7%) on Ozempic® and 46 patients (2.8%) on placebo.1
aStandards of care included, but were not limited to, oral antidiabetic treatments, insulin, antihypertensives, diuretics, lipid-lowering therapies, and antithrombotic medications.
bHazard ratio vs placebo (95% CI). Median study observation time of 2.1 years. Cox proportional-hazards models with treatment as factor and stratified by evidence of cardiovascular disease, insulin treatment, and renal impairment.
cThe primary endpoint in the SUSTAIN 6 CVOT was time to first occurrence of a 3-part composite MACE that included CV death, nonfatal MI, or nonfatal stroke.
ARR=absolute risk reduction; CI=confidence interval; CVOT=cardiovascular outcomes trial; RRR=relative risk reduction; SOC=standard of care; CV=cardiovascular; CVD=cardiovascular disease; HR=hazard ratio; MACE=major adverse cardiovascular event; NS=nonsignificant.