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FDA action is the next regulatory event The meeting has ended, but none of its recommendations changed the final 503A regulation by itself
doi: 10.1056/NEJMoa2306963 65 KosiborodMNAbildstrmSZBorlaugBAButlerJChristensenLDaviesMet al
people ages 50+ were more aware than those younger than 50 (43% vs 31%) as were Hispanics (41%) and Blacks (39%) compared to Whites (33%)
Starting assumptions for a hypothetical 220 lb (100 kg) patient: Baseline BMR: approximately 2,000 calories/day Total daily expenditure (TDEE): approximately 2,400 calories/day (sedentary) Retatrutide effects on the energy equation: Caloric intake reduction: 25-35% (based on food intake data) = 600-840 fewer calories consumed Estimated thermogenic increase: 5-10% of BMR = 100-200 additional calories burned Combined daily deficit: 700-1,040 calories At 48 weeks, this deficit accounts for approximately 54-80 pounds of weight loss, aligning with observed clinical results
