7 Multi-center, double-blind, randomized, placebo-controlled, event-driven superiority trail 804 participating clinical sites in 41 countries Enrollment Criteria Intervention o 1:1 double-blinded non-stratified randomization to receive either 2.4mg semaglutide SC weekly or placebo o Initial dose of 0.24mg weekly x 4 weeks, uptitrated to 0.5, 1.0, 1.7, and eventually 2.4mg every 4 weeks If significant adverse effects encountered, patients could be placed on slower uptitration, pause treatment, or continue reduced maintenance dose therapy o Placebo/semaglutide discontinued if: Patients became/planned to become pregnant Developed pancreatitis Calcitonin level 100 ng/L Patients were to continue on treatment if diabetes was diagnosed after initiation of treatment/placebo Primary Outcome Composite of death from cardiovascular causes, nonfatal MI, nonfatal stroke, (assessed in time-to-first-event analysis) Secondary Outcome: (all assessed in time-to-first-event analysis) Death from cardiovascular causes Composite heart failure end-point (death from CV causes or hospitalization/urgent medical visit for heart failure) Death from any cause Statistical Analysis o Event-driven trial designed to provide 90% power to detect relative risk reduction of 17% for primary endpoint (HR 0.83) at overall one-sided significance level of 0.025 o Required minimum 1225 primary end-point events accrued o Intention-to-treat analysis performed o Hazard ratios and 95% confidence intervals generated with Cox proportional hazard model Baseline Characteristics 17604 patients randomized between Oct
There is no clinical evidence that tapering provides any benefit before switching
The best part
Rather than stimulating the nervous system, semaglutide slows gastric emptying and increases feelings of fullness through receptor activation in your brain and digestive tract
