| アブストラクト | BACKGROUND: Setmelanotide is approved for genetically determined obesity. While clinical trials and clinical evidence and practice provide some insights, a comprehensive assessment of its adverse event profile is needed that led to carrying out an assessment of reported adverse events in the USFDA Adverse Event Reporting System database, case reports and clinical trials. RESEARCH DESIGN AND METHODS: Multi-faceted analyses were carried out as follows: disproportionality measures employing frequentist and Bayesian methods; systematic review and meta-analysis (Medline, Cochrane CENTRAL and Google Scholar) generated-pooled estimates [proportion with 95% confidence intervals (CI)]; and published reports with adverse events to setmelanotide. RESULTS: The disproportionality analysis (n = 228) identified skin hyperpigmentation, injection-site reactions, nausea, melanocytic nevus and ephelides as key safety signals. Meta-analysis (seven trials; n = 185) confirmed high rates of injection-site reactions (96%; 95% CI: 89, 100), skin hyperpigmentation (62%; 95% CI: 43, 78), nausea (36%; 95% CI: 24, 49), vomiting (26%; 95% CI: 18, 34), and diarrhea (21%; 95% CI: 14, 29). Individual case reports corroborated these findings. CONCLUSION: This study provides a detailed overview of setmelanotide's adverse event profile, highlighting the need for careful patient monitoring, emphasizing the importance of ongoing safety surveillance for at least 1.5 years, and further research to refine patient management strategies. |
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| 組織名 | Department of Pharmacology & Therapeutics, College of Medicine & Health Sciences,;Arabian Gulf University, Manama, Kingdom of Bahrain.;The Crown Prince Center for Training and Medical Research, Bahrain Defence Force;Royal Medical Services, Riffa, Kingdom of Bahrain. |
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