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Cited by 38Pituitary Gland Disorders and TreatmentsAdrenal and Paraganglionic TumorsNeuroendocrine Tumor Research Advances

Pasireotide monotherapy in Cushing’s disease: a single-centre experience with 5-year extension of phase III Trial

MacKenzie Feder, Jessica, Bourdeau, Isabelle, Vallette, Sophie, Beauregard, Hugues, Ste-Marie, Louis-Georges, Lacroix, André·2014·Pituitary
DOI 10.1007/s11102-013-0539-4
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Abstract

Purpose A recent phase III randomized controlled trial (NCT00434148) showed efficacy of pasireotide in the treatment of patients with Cushing's disease (CD). Patients were invited to participate in an extension phase of the protocol and a subgroup had a sustained response. We report the experience with 4 patients in our center of which 2 full responders have completed 5.5 and 4.25 years of treatment with disease control.Methods The trial protocol was described previously. The extension phase consisted of 3-monthly visits with clinical, biochemical, and imaging evaluation and investigator-driven pasireotide titration. Research charts were retrospectively analyzed.Results Four patients with persistent CD following pituitary surgery completed the first 6 months of the trial and 3 continued in the next 6 month open-label phase. Two patients with baseline urinary free cortisol (UFC) 5.3-6.7 times the upper limit of normal had a rapid sustained response to pasireotide and entered the extension phase after 12 months. They remain in clinical and biochemical disease remission and 1 patient now only requires 300 μg daily of pasireotide. All 4 patients developed glucose intolerance; however, the two patients in the extension phase were eventually able to discontinue all diabetes pharmacotherapy. Adverse events included second degree atrioventicular block type 1 without QT prolongation in a patient with pre-existing sinus bradycardia, and symptomatic cholelithiasis requiring cholecystectomy in a second patient.Conclusions Pasireotide therapy can provide normalization of UFC and of clinical symptoms and signs of CD during up to 5 years of follow-up. This study demonstrates the possible recuperation of normoglycemia after continued use of pasireotide and control of underlying hypercortisolemia. Longer-term monitoring for potential adverse events related to continued use of pasireotide is indicated.

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Authors
MacKenzie Feder, J., Bourdeau, I., Vallette, S., Beauregard, H., Ste-Marie, L.-G., & Lacroix, A.
Affiliations
Centre Hospitalier de l’Université de Montréal (CA)
Corresponding author
Lacroix, André
ORCID
Venue
Pituitary
Publisher
Springer Science and Business Media LLC
Published
2013-11-28
Volume
17
Issue
6
Pages
519-529
ISSN
  • 1386-341X (ISSN-L)
  • 1573-7403
DOI
10.1007/s11102-013-0539-4
OpenAlex
W2061761565
Cited by
38
References
27
Citations by year
2026: 1 · 2025: 1 · 2024: 1 · 2023: 2 · 2021: 1 · 2020: 2 · 2019: 4 · 2018: 2 · 2017: 4 · 2016: 7 · 2015: 10 · 2014: 3
FWCI
5.24
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • Pituitary (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Eli Lilly and Company
  • Novartis
  • Sanofi
  • Society for Endocrinology
  • Canadian Society of Endocrinology and Metabolism
  • Novartis Pharma
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pituitary Gland Disorders and Treatments
  • Health Sciences › Medicine › Surgery › Adrenal and Paraganglionic Tumors
  • Health Sciences › Medicine › Epidemiology › Neuroendocrine Tumor Research Advances
Keywords
pasireotide, Cushing's disease, long-term treatment, urinary free cortisol, impaired glucose tolerance, hypercortisolism, atrioventricular block, gallstones, pituitary surgery, remission
MeSH terms
Adult, Electrocardiography, Female, Humans, Hydrocortisone, Male, Middle Aged, Somatostatin, Syncope, Cohort Studies, Treatment Outcome, Glucose Intolerance, Pituitary ACTH Hypersecretion

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