| Autor: |
Akira Shimatsu, Beverly MK Biller, Maria Fleseriu, Rosario Pivonello, Eun Jig Lee, Rattana Leelawattana, Jung Hee Kim, Rama Walia, Yerong Yu, Zhihong Liao, Andrea Piacentini, Alberto M Pedroncelli, Peter J Snyder |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Endocrine Journal, Vol 71, Iss 12, Pp 1103-1123 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
1348-4540 |
| DOI: |
10.1507/endocrj.EJ24-0153 |
| Popis: |
Cushing’s disease is associated with increased morbidity and mortality. Osilodrostat, a potent oral 11β-hydroxylase inhibitor, provided rapid, sustained mean urinary free cortisol (mUFC) normalization in Cushing’s disease patients in two Phase III studies (LINC 3, NCT02180217; LINC 4, NCT02697734). Here, we evaluate the efficacy and safety of osilodrostat in Cushing’s disease in patients of Asian origin compared with patients of non-Asian origin. Pooled data from LINC 3 and LINC 4 were analyzed. Outcomes were evaluated separately for Asian and non-Asian patients. For the analysis, 210 patients were included; 56 (27%) were of Asian origin. Median (minimum–maximum) osilodrostat dose was 3.8 (1–25) and 7.3 (1–47) mg/day in Asian and non-Asian patients, respectively. mUFC control was achieved at weeks 48 and 72 in 64.3% and 68.1% of Asian and 68.2% and 75.8% of non-Asian patients. Improvements in cardiovascular and metabolic-related parameters, physical manifestations of hypercortisolism, and quality of life were similar in both groups. Most common adverse events (AEs) were adrenal insufficiency (44.6%) in Asian and nausea (45.5%) in non-Asian patients. AEs related to hypocortisolism and pituitary tumor enlargement occurred in more Asian (58.9% and 21.4%) than non-Asian patients (40.3% and 9.1%). Of Asian and non-Asian patients, 23.2% and 13.6%, respectively, discontinued because of AEs. Asian patients with Cushing’s disease generally required numerically lower osilodrostat doses than non-Asian patients to achieve beneficial effects. Hypocortisolism-related AEs were reported in more Asian than non-Asian patients. Together, these findings suggest that Asian patients are more sensitive to osilodrostat than non-Asian patients. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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