Cited by 628Pituitary Gland Disorders and TreatmentsNeuroendocrine Tumor Research AdvancesAdrenal Hormones and Disorders

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A 12-Month Phase 3 Study of Pasireotide in Cushing's Disease

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Colao, Annamaria, Petersenn, Stephan, Newell-Price, John, Findling, James W., Gu, Feng, Maldonado, Mario, Schoenherr, Ulrike, Dipl.-Biol., Mills, David, Salgado, Luiz Roberto, Biller, Beverly M.K.·2012·New England Journal of Medicine

DOI 10.1056/nejmoa1105743

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Abstract

BACKGROUND: Cushing's disease is associated with high morbidity and mortality. Pasireotide, a potential therapy, has a unique, broad somatostatin-receptor-binding profile, with high binding affinity for somatostatin-receptor subtype 5. METHODS: In this double-blind, phase 3 study, we randomly assigned 162 adults with Cushing's disease and a urinary free cortisol level of at least 1.5 times the upper limit of the normal range to receive subcutaneous pasireotide at a dose of 600 μg (82 patients) or 900 μg (80 patients) twice daily. Patients with urinary free cortisol not exceeding 2 times the upper limit of the normal range and not exceeding the baseline level at month 3 continued to receive their randomly assigned dose; all others received an additional 300 μg twice daily. The primary end point was a urinary free cortisol level at or below the upper limit of the normal range at month 6 without an increased dose. Open-label treatment continued through month 12. RESULTS: Twelve of the 82 patients in the 600-μg group and 21 of the 80 patients in the 900-μg group met the primary end point. The median urinary free cortisol level decreased by approximately 50% by month 2 and remained stable in both groups. A normal urinary free cortisol level was achieved more frequently in patients with baseline levels not exceeding 5 times the upper limit of the normal range than in patients with higher baseline levels. Serum and salivary cortisol and plasma corticotropin levels decreased, and clinical signs and symptoms of Cushing's disease diminished. Pasireotide was associated with hyperglycemia-related adverse events in 118 of 162 patients; other adverse events were similar to those associated with other somatostatin analogues. Despite declines in cortisol levels, blood glucose and glycated hemoglobin levels increased soon after treatment initiation and then stabilized; treatment with a glucose-lowering medication was initiated in 74 of 162 patients. CONCLUSIONS: The significant decrease in cortisol levels in patients with Cushing's disease who received pasireotide supports its potential use as a targeted treatment for corticotropin-secreting pituitary adenomas. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT00434148.).

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Authors: Colao, A., Petersenn, S., Newell-Price, J., Findling, J. W., Gu, F., Maldonado, M., Schoenherr, U., Dipl.-Biol., Mills, D., Salgado, L. R., & Biller, B. M. K.
Affiliations: Federico II University Hospital (IT)
University of Duisburg-Essen (DE)
University of Sheffield (GB)
Medical College of Wisconsin (US)
Peking Union Medical College Hospital (CN)
Novartis (Switzerland) (CH)
Universidade de São Paulo (BR)
Massachusetts General Hospital (US)
ORCID: Colao, Annamaria
Petersenn, Stephan
Newell-Price, John
Findling, James W.
Gu, Feng
Biller, Beverly M.K.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2012-03-08
Volume: 366
Issue: 10
Pages: 914-924
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1105743
OpenAlex: W2133418708
Semantic Scholar: d3443b929babd2daf7d6ae90395d546356fda173
Cited by: 628
References: 22
Citations by year: 2026: 13 · 2025: 31 · 2024: 28 · 2023: 28 · 2022: 33 · 2021: 35 · 2020: 32 · 2019: 41 · 2018: 46 · 2017: 46 · 2016: 52 · 2015: 66 · 2014: 68 · 2013: 77 · 2012: 29
FWCI: 61.61
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Scientific Electronic Library Online (São Paulo Research Foundation, Latin American and Caribbean Center on Health Sciences Information, Conselho Nacional de Desenvolvimento Científico e Tecnológico) (publishedVersion)
HAL (submittedVersion)
Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pituitary Gland Disorders and Treatments
Health Sciences › Medicine › Oncology › Neuroendocrine Tumor Research Advances
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Keywords: pasireotide, Cushing's disease, somatostatin receptor type 5, somatostatin analogues, urinary free cortisol, hypercortisolism, hyperglycemia, HbA1c, dose escalation
MeSH terms: Adolescent, Adrenocorticotropic Hormone, Adult, Aged, Child, Double-Blind Method, Female, Humans, Hydrocortisone, Male, Middle Aged, Recurrence, Saliva, Somatostatin, Pituitary ACTH Hypersecretion, Young Adult

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A 12-Month Phase 3 Study of Pasireotide in Cushing's Disease

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