Bibliographic Details
| Title: |
Long-term efficacy and safety of once-monthly pasireotide in Cushing''s disease: A Phase III extension study. |
| Authors: |
Fleseriu, M., Petersenn, S., Biller, B. M. K., Kadioglu, P., De Block, C., T''''sjoen, G., Vantyghem, Marie-Christine, Tauchmanova, L., Wojna, J., Roughton, M., Lacroix, A., Newell-Price, J. |
| Contributors: |
Université de Lille, Inserm, CHU Lille, Recherche translationnelle sur le diabète (RTD) - U1190 |
| Publication Year: |
2024 |
| Collection: |
LillOA (Lille Open Archive - Université de Lille) |
| Subject Terms: |
Cushing syndrome, Cushing's disease, extension, hypercortisolism, pasireotide, Phase III, pituitary |
| Description: |
Objectives Many patients with Cushing's disease (CD) require chronic pharmacotherapy to control their hypercortisolism. We evaluated the efficacy and safety of long-acting pasireotide during a long-term extension study in patients with CD. Design Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906). Patients Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension. Results Eighty-one of 150 (54.0%) enrolled patients entered the extension. Median overall exposure to pasireotide at study end was 23.9 months; 39/81 (48.1%) patients completed the extension (received ≥ 12 months’ treatment during the extension and could transit to a separate pasireotide safety study). mUFC was ≤ULN in 42/81 (51.9%), 13/81 (16.0%) and 43/81 (53.1%) patients at extension baseline, month (M) 36 and last assessment. Median mUFC remained within normal limits. Median late-night salivary cortisol was 2.6 × ULN at core baseline and 1.3 × ULN at M36. Clinical improvements were sustained over time. Forty-two (51.9%) patients discontinued during the extension: 25 (30.9%) before M24 and 17 (21.0%) after M24. Hyperglycaemia-related AEs occurred in 39.5% of patients. Mean fasting glucose (FPG) and glycated haemoglobin (HbA1c) were stable during the extension, with antidiabetic medication initiated/escalated in some patients. Sixty-six (81.5%) and 71 (88.9%) patients were classified as having diabetes (HbA1c ≥ 6.5%, FPG ≥ 7.0 mmol/L, antidiabetic medication use, or history of diabetes) at extension baseline and last assessment. Conclusions Long-acting pasireotide provided sustained biochemical and clinical improvements, with no new safety signals emerging, supporting its use as an effective long-term therapy for CD. ; 91 |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/octet-stream; application/rdf+xml; charset=utf-8; application/pdf |
| Language: |
English |
| Relation: |
Clinical Endocrinology; Clin. Endocrinol. (Oxf); http://hdl.handle.net/20.500.12210/103437 |
| Availability: |
https://hdl.handle.net/20.500.12210/103437 |
| Rights: |
Attribution-NonCommercial 3.0 United States ; info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.4A1EB35 |
| Database: |
BASE |