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In a meta-analysis 6 of eight trials with 60080 patients (ELIXA, LEADER, SUSTAIN-6, EXSCEL, Harmony Outcomes, REWIND, PIONEER 6, and AMPLITUDE-O) , treatment with a GLP-1 receptor agonist led to a 14% relative risk reduction in three-point MACE (HR 086 [95% CI 080093]
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FDA-approved semaglutide has earned global trust because its manufacturing and testing standards make that consistency possible
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Safety First: FDA Commissioner Marty Makary emphasized that this action is designed to prioritize patient safety and preserve the science-based drug approval pathway
