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These effects typically occur during the first weeks of treatment and often improve as the body adapts

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Cardiovascular Outcomes# EXSCEL Trial (Exenatide)# The EXSCEL trial (Holman et al., NEJM 2017) enrolled 14,752 patients with type 2 diabetes (73.1% with prior cardiovascular disease) and followed them for a median of 3.2 years: Primary MACE endpoint : HR 0.91 (95% CI 0.83-1.00), p=0.06 for superiority Met non-inferiority but narrowly missed superiority (p=0.06) All-cause mortality was reduced by 14% (HR 0.86, p=0.016) in a secondary analysis EXSCEL confirmed cardiovascular safety but did not prove cardiovascular benefit -- a critical distinction

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Label Changes Coming The gap between European warnings (added August 2024) and U.S

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