Adverse Effects Associated With Tirzepatide Use in Patients at Increased Risk of Cardiovascular Events: Systematic Review With Meta-Analysis and Trial Sequential Analysis
Sillassen CDB, Faltemeier P, Bjerg JL, Andersen RK, Petersen JJ, Andersen PB, Kamp CB, Karlsson F, Grand J, Dominguez H, Frølich A, Gæde P, Gluud C, Mathiesen O, Jakobsen JC
Summary
This comprehensive meta-analysis of 21 trials (8,043 participants) found no significant difference in all-cause mortality (OR 1.02, 95% CI 0.57-1.81) or serious adverse events (OR 0.98, 95% CI 0.82-1.17) between tirzepatide and placebo. However, tirzepatide was associated with increased gastrointestinal non-serious adverse events including nausea, diarrhea, decreased appetite, and vomiting.
Clinical Significance
This meta-analysis provides the most comprehensive safety assessment of tirzepatide to date. The finding that serious adverse events are not increased is reassuring for prescribers, while confirming that GI side effects remain the primary tolerability concern that clinicians should proactively counsel patients about.
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