21-PUB: A Real-World Adverse Event Profile of Tirzepatide—A Pilot Systematic Review and Meta-analysis of Observational Studies
Bibliographic record
Abstract
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. Disclosure G. Chitiki: None. N. Gadepalli: None. H.J. Pandita: None. A. Ranjan: None. C. Kaur: None. M. Pathania: None.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.032 | 0.066 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.018 | 0.034 |
| Bibliometrics | 0.014 | 0.012 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.005 | 0.003 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".