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SUSTAIN 6 was time and eventdriven (104 weeks exposure and 122 primary outcome events),32 whereas PIONEER 6 was solely eventdriven (122 primary outcome events).33 SUSTAIN 6 was a fourarmed trial (semaglutide 0.5 mg and 1.0 mg once weekly, and volumematched placebo), with the primary analysis performed on pooled semaglutide and placebo groups,32 whereas PIONEER 6 was a twoarmed trial (oral semaglutide target dose 14 mg once daily and placebo).33 The primary outcome in both trials was the time to first occurrence of a threecomponent MACE (CV death, nonfatal myocardial infarction [MI], or nonfatal stroke).32 There were fewer MACE with semaglutide versus placebo in both trials: the hazard ratios (HRs) for SUSTAIN 6 and PIONEER 6 were 0.74 (95% confidence interval [CI] 0.58, 0.95) and 0.79 (0.57, 1.11), respectively.32, 33 In SUSTAIN 6, the results were significant for noninferiority and superiority, although the latter was not prespecified.32 SUSTAIN 6 and PIONEER 6 aimed to rule out an excess risk of CV events with semaglutide versus placebo, defined by the US Food and Drug Administration as having an upper bound of the 95% CI 0.05), suggesting no heterogeneity in the treatment effects across these subgroups

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