Introduction and Objective: The recent FDA-approved drug, Tirzepatide, a dual GIP and GLP-1 receptor agonist, showed superior efficacy in type-2 diabetes mellitus management and weight reduction. Awareness of the real-world incidence of adverse events(AEs) is crucial for a clinician to advise optimal treatment that ensures the best quality of life for the patient. While RCT-based reviews of AEs exist, no reviews analysed real-world AEs in patients on tirzepatide, and our study aims to fill this research gap.Methods: A systematic search was conducted using apt MeSH terms across PubMed, Embase and Scopus; the results obtained (n=1260) were screened, and the duplicates (n=482) were removed. The titles and abstracts of the rest (n=778) were screened. 8 full texts were reviewed, and 5 met the inclusion criteria and were assessed for bias and quality with the Newcastle-Ottawa scale (NOS). A random effects model in R 4.4.2 was used to estimate the pooled incidence of AEs and 95% CI.Results: 5 moderate-to-low quality studies with 18,387 tirzepatide patients were included. Meta-analysis of pooled proportions from 3 studies reported nausea (8%, CI: 1%-36%, I² = 66%), diarrhoea (6%, CI: 2%-19%, I² = 13.9%), constipation (5%, CI: 1%-25%, I² = 34.5%), hypoglycemia (5%, CI: 1%-32%, I² = 66.5%), and vomiting (2%, CI: 0%-22%, I² = 27.5%). Discontinuation due to adverse events in 4 studies was 3.2% (CI: 2.7%-3.7%, I² = 0%). Rare AEs, like cholelithiasis and gastroenteritis, etc., were reported.Conclusion: Nausea is the most common gastrointestinal(GI) AE, followed by diarrhoea, constipation, and vomiting, which suggests cautious use in patients with GI pathologies. Hypoglycaemia is the most notable non-GI AE. The incidence of AEs was lower than the findings of a meta-analysis of RCTs (Mishra et al., 2023) but had high variability, signifying a need for more extensive, high-quality observational studies to better comprehend its trends, clinical correlations and outcomes.
G. Chitiki: None. N. Gadepalli: None. H.J. Pandita: None. A. Ranjan: None. C. Kaur: None. M. Pathania: None.
Source link
Leave a Reply