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The objective was to evaluate the effectiveness and safety, with a specific focus on cardiovascular safety, of tirzepatide, a novel dual GIP and GLP-1 receptor agonist, compared to insulin glargine in adults with type 2 diabetes and a high risk of cardiovascular events who have not achieved adequate control with oral glucose-lowering medications.This phase 3 study was conducted at 187 sites across 14 countries on five continents

The FAERS database undergoes quarterly updates, with all data sets publicly accessible through the FDAs Open Data portal ( Data extraction and processing The FAERS database architecture incorporates seven distinct data tables, each serving specific pharmacovigilance functions: (1) DEMO (patient demographic and administrative information), (2) DRUG (medication-related data), (3) REAC (adverse event reports), (4) OUTC (patient outcomes), (5) RPSR (report source information), (6) THER (temporal drug administration data), and (7) INDI (therapeutic indications)

[DOI] [PubMed] [Google Scholar] 61.Mukherjee S., Im S.-S

This elevated risk reinforced the post-marketing signals regulators were already seeing

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