Osilodrostat Safety Profile: Findings from Real-World Data in the FAERS Database DOI Open Access

Ioana Ilie,

Anca Butucă, Cãlin Homorodean

и другие.

Journal of Clinical Medicine, Год журнала: 2025, Номер 14(10), С. 3518 - 3518

Опубликована: Май 17, 2025

Background/Objectives: Cushing’s syndrome (CS), including disease (CD)—the most common type—has a substantial negative impact on morbidity, mortality, and patients’ quality of life. Medical management CS is essential for controlling hypercortisolism as part preoperative preparation definitive surgical treatment managing residual or relapsed post-surgery. Osilodrostat, dual inhibitor glucocorticoid mineralocorticoid biosynthetic pathways, has been approved the medical since early 2020. However, real-world data its adverse effects remain limited. We mined FAERS database analyzed reports associated with osilodrostat up to 1 October 2024. Methods: Descriptive disproportionality methods based Relative Odds Ratio (ROR), Chi-square (χ2), Proportional Reporting (PRR), were used discern potential safety signals assess significance osilodrostat-associated events. Results: This study identified 782 in which was primary suspected drug, containing 593 preferred terms (PTs) 2481 occurrences. The frequently registered events belonged following SOCs: “General disorders administration site conditions” (n = 457, 18.4%), “Injury, poisoning procedural complications” 311, 12.5%), “Gastrointestinal disorders” 278, 11.2%), “Investigations” 260, 10.5%), “Nervous system 184, 7.4%). Among PTs, off-label use commonly reported, aligning fact that vast majority cases originated from U.S. (84%), where officially only CD. Disproportionality analysis confirmed previously known new drug reactions treatment, cardiac flutter (n: 4; PRR: 19.42; χ2: 49.57), ventricular extrasystoles 11.85; 29.62), muscular weakness 8; 2.25; 4.38), rib fracture 6.66; 13.99), spinal 3; 4.66; 5.35), sepsis 9; 2.63; 7.56), fungal infections 3.67; 5.33), COVID-19 32; 5.07; 101.16). Conclusions: highlights risks offers valuable insights into use; however, further research validation are necessary, particularly not yet explicitly documented summary product characteristics.

Язык: Английский

Osilodrostat Safety Profile: Findings from Real-World Data in the FAERS Database DOI Open Access

Ioana Ilie,

Anca Butucă, Cãlin Homorodean

и другие.

Journal of Clinical Medicine, Год журнала: 2025, Номер 14(10), С. 3518 - 3518

Опубликована: Май 17, 2025

Background/Objectives: Cushing’s syndrome (CS), including disease (CD)—the most common type—has a substantial negative impact on morbidity, mortality, and patients’ quality of life. Medical management CS is essential for controlling hypercortisolism as part preoperative preparation definitive surgical treatment managing residual or relapsed post-surgery. Osilodrostat, dual inhibitor glucocorticoid mineralocorticoid biosynthetic pathways, has been approved the medical since early 2020. However, real-world data its adverse effects remain limited. We mined FAERS database analyzed reports associated with osilodrostat up to 1 October 2024. Methods: Descriptive disproportionality methods based Relative Odds Ratio (ROR), Chi-square (χ2), Proportional Reporting (PRR), were used discern potential safety signals assess significance osilodrostat-associated events. Results: This study identified 782 in which was primary suspected drug, containing 593 preferred terms (PTs) 2481 occurrences. The frequently registered events belonged following SOCs: “General disorders administration site conditions” (n = 457, 18.4%), “Injury, poisoning procedural complications” 311, 12.5%), “Gastrointestinal disorders” 278, 11.2%), “Investigations” 260, 10.5%), “Nervous system 184, 7.4%). Among PTs, off-label use commonly reported, aligning fact that vast majority cases originated from U.S. (84%), where officially only CD. Disproportionality analysis confirmed previously known new drug reactions treatment, cardiac flutter (n: 4; PRR: 19.42; χ2: 49.57), ventricular extrasystoles 11.85; 29.62), muscular weakness 8; 2.25; 4.38), rib fracture 6.66; 13.99), spinal 3; 4.66; 5.35), sepsis 9; 2.63; 7.56), fungal infections 3.67; 5.33), COVID-19 32; 5.07; 101.16). Conclusions: highlights risks offers valuable insights into use; however, further research validation are necessary, particularly not yet explicitly documented summary product characteristics.

Язык: Английский

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