| アブストラクト | BACKGROUND: Vismodegib and sonidegib are currently the only Hedgehog inhibitors (HHIs) approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced BCC (laBCC). However, there is limited systematic research comparing the adverse drug events (ADEs) associated with these two inhibitors. RESEARCH DESIGN AND METHODS: Data were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) for the period from 2019 to the second quarter of 2024. Disproportionality analysis was conducted to compare ADEs between vismodegib and sonidegib. RESULTS: The occurrence of ADEs was notably higher among patients aged >/= 65 years (72.98%) and males (60.17%). The most frequently reported ADEs associated with HHIs included skeletal muscle and joint diseases and nervous system disorders, particularly muscle spasms and dysgeusia. Differences in adverse reactions between vismodegib and sonidegib were observed, mainly in nervous system, gastrointestinal system, skin and subcutaneous tissue, and renal and urinary disorders. CONCLUSIONS: This analysis, using the FAERS database, enhances understanding of the ADE profiles associated with both vismodegib and sonidegib. Further research is needed to validate the hypotheses generated by this study. |
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| 組織名 | Department of Pharmacy and Evidence Based Pharmacy Center, West China Second;University Hospital, Sichuan University, Chengdu, China.;China Key Laboratory of Birth Defects and Related Diseases of Women and Children,;Ministry of Education, Chengdu, China.;West China School of Medicine, West China Hospital, Sichuan University, Chengdu,;China.;Department of Pharmacy, Sichuan Provincial Maternity and Child Health Care;Hospital, Chengdu, China.;Department of Pharmacy, People's Hospital of Ganzi Tibetan Autonomous Prefecture,;Kangding, China.;Department of Pharmacy, Chengdu Jinniu District People's Hospital, Chengdu,;Sichuan, China.;Department of Pharmacology, Faculty of Medicine, University of the Basque;Country, Leioa, UPV/EHU, Spain. |
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