Disproportionality Analysis Among all the 137583 PTs involving 26 SOC categories, significant SOCs related to tirzepatide which met at least one of the four algorithms were Injury, poisoning and procedural complications (SOC:10022117, n = 39065, ROR = 2.63), General disorders and administration site conditions (SOC:10018065, n = 34930, ROR = 1.62), Gastrointestinal disorders (SOC: 10017947, n = 26395, ROR = 2.66), and Metabolism and nutrition disorders (SOC:10027433, n = 4551, ROR = 1.77) ( Table S3 )
The primary efficacy endpoint for gastric interventions (e.g., intragastric balloons and endoscopic gastric remodeling) is weight loss, whereas the primary efficacy endpoint for small-bowel interventions (e.g., duodenal-jejunal bypass liner and duodenal mucosal resurfacing) is glycemic improvement with weight loss as co-primary or secondary objective [19]
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GLP-1 therapy improves blood pressure, triglycerides, and LDL cholesterol independent of weight loss alone