Medical therapy with pasireotide in recurrent Cushing's disease: Experience of patients treated for at least 1 year at a single center

Christine (Chris) Yedinak, Sarah Hopkins, Jessica Williams, Aly Ibrahim, Justin Cetas, Maria Fleseriu

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1 Citation (Scopus)

Abstract

Subcutaneous (SC) injection of pasireotide, a somatostatin analog, is approved for the treatment of adults with Cushing's disease (CD) for whom pituitary surgery was unsuccessful or is not an option. We highlight the symptomatic and biochemical improvement of six patients with recurrent CD treated with pasireotide SC at a single center for at least 1 year. Patients were treated either through commercial use (n = 5) or through the Phase 3 trial (n = 1; http://ClinicalTrials.gov identifier, NCT00434148; study number, B2305). Most patients (n = 5) were female, and the mean age at diagnosis was 35.8 years. All patients demonstrated biochemical control at 1 year of treatment. Three of the five real-world patients followed for more than 1 year remain on pasireotide SC and are controlled. Two patients discontinued pasireotide SC; one patient because of persistently elevated urinary-free cortisol levels and gallstones, and the other because of treatment for an unrelated brain tumor. Symptomatic improvement varied, but all patients demonstrated weight loss. Nausea and mild, transient injection-site reactions were the most frequently reported adverse events. Although glycated hemoglobin (HbA1c) increased after treatment initiation, four of five patients maintained HbA1c levels ≤7.0% while receiving pasireotide SC and concomitant individualized diabetes medication, if necessary. In patients who discontinued pasireotide SC, HbA1c levels decreased within 6 weeks. This report documents real-world use of pasireotide SC and indicates its effectiveness as a long-term treatment option for patients with CD. Although hyperglycemia was observed in most patients, it was managed with appropriate monitoring and treatment and was reversible upon discontinuation of pasireotide SC.

Original languageEnglish (US)
Article number35
JournalFrontiers in Endocrinology
Volume8
Issue numberFEB
DOIs
StatePublished - Feb 27 2017

Fingerprint

Pituitary ACTH Hypersecretion
Therapeutics
pasireotide
Glycosylated Hemoglobin A
Gallstones
Subcutaneous Injections
Somatostatin
Brain Neoplasms
Hyperglycemia
Nausea
Hydrocortisone
Weight Loss

Keywords

  • Cushing's disease
  • Hyperglycemia
  • Pasireotide
  • Real-world clinical experience
  • Recurrent Cushing's disease

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

Cite this

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title = "Medical therapy with pasireotide in recurrent Cushing's disease: Experience of patients treated for at least 1 year at a single center",
abstract = "Subcutaneous (SC) injection of pasireotide, a somatostatin analog, is approved for the treatment of adults with Cushing's disease (CD) for whom pituitary surgery was unsuccessful or is not an option. We highlight the symptomatic and biochemical improvement of six patients with recurrent CD treated with pasireotide SC at a single center for at least 1 year. Patients were treated either through commercial use (n = 5) or through the Phase 3 trial (n = 1; http://ClinicalTrials.gov identifier, NCT00434148; study number, B2305). Most patients (n = 5) were female, and the mean age at diagnosis was 35.8 years. All patients demonstrated biochemical control at 1 year of treatment. Three of the five real-world patients followed for more than 1 year remain on pasireotide SC and are controlled. Two patients discontinued pasireotide SC; one patient because of persistently elevated urinary-free cortisol levels and gallstones, and the other because of treatment for an unrelated brain tumor. Symptomatic improvement varied, but all patients demonstrated weight loss. Nausea and mild, transient injection-site reactions were the most frequently reported adverse events. Although glycated hemoglobin (HbA1c) increased after treatment initiation, four of five patients maintained HbA1c levels ≤7.0{\%} while receiving pasireotide SC and concomitant individualized diabetes medication, if necessary. In patients who discontinued pasireotide SC, HbA1c levels decreased within 6 weeks. This report documents real-world use of pasireotide SC and indicates its effectiveness as a long-term treatment option for patients with CD. Although hyperglycemia was observed in most patients, it was managed with appropriate monitoring and treatment and was reversible upon discontinuation of pasireotide SC.",
keywords = "Cushing's disease, Hyperglycemia, Pasireotide, Real-world clinical experience, Recurrent Cushing's disease",
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T1 - Medical therapy with pasireotide in recurrent Cushing's disease

T2 - Experience of patients treated for at least 1 year at a single center

AU - Yedinak, Christine (Chris)

AU - Hopkins, Sarah

AU - Williams, Jessica

AU - Ibrahim, Aly

AU - Cetas, Justin

AU - Fleseriu, Maria

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N2 - Subcutaneous (SC) injection of pasireotide, a somatostatin analog, is approved for the treatment of adults with Cushing's disease (CD) for whom pituitary surgery was unsuccessful or is not an option. We highlight the symptomatic and biochemical improvement of six patients with recurrent CD treated with pasireotide SC at a single center for at least 1 year. Patients were treated either through commercial use (n = 5) or through the Phase 3 trial (n = 1; http://ClinicalTrials.gov identifier, NCT00434148; study number, B2305). Most patients (n = 5) were female, and the mean age at diagnosis was 35.8 years. All patients demonstrated biochemical control at 1 year of treatment. Three of the five real-world patients followed for more than 1 year remain on pasireotide SC and are controlled. Two patients discontinued pasireotide SC; one patient because of persistently elevated urinary-free cortisol levels and gallstones, and the other because of treatment for an unrelated brain tumor. Symptomatic improvement varied, but all patients demonstrated weight loss. Nausea and mild, transient injection-site reactions were the most frequently reported adverse events. Although glycated hemoglobin (HbA1c) increased after treatment initiation, four of five patients maintained HbA1c levels ≤7.0% while receiving pasireotide SC and concomitant individualized diabetes medication, if necessary. In patients who discontinued pasireotide SC, HbA1c levels decreased within 6 weeks. This report documents real-world use of pasireotide SC and indicates its effectiveness as a long-term treatment option for patients with CD. Although hyperglycemia was observed in most patients, it was managed with appropriate monitoring and treatment and was reversible upon discontinuation of pasireotide SC.

AB - Subcutaneous (SC) injection of pasireotide, a somatostatin analog, is approved for the treatment of adults with Cushing's disease (CD) for whom pituitary surgery was unsuccessful or is not an option. We highlight the symptomatic and biochemical improvement of six patients with recurrent CD treated with pasireotide SC at a single center for at least 1 year. Patients were treated either through commercial use (n = 5) or through the Phase 3 trial (n = 1; http://ClinicalTrials.gov identifier, NCT00434148; study number, B2305). Most patients (n = 5) were female, and the mean age at diagnosis was 35.8 years. All patients demonstrated biochemical control at 1 year of treatment. Three of the five real-world patients followed for more than 1 year remain on pasireotide SC and are controlled. Two patients discontinued pasireotide SC; one patient because of persistently elevated urinary-free cortisol levels and gallstones, and the other because of treatment for an unrelated brain tumor. Symptomatic improvement varied, but all patients demonstrated weight loss. Nausea and mild, transient injection-site reactions were the most frequently reported adverse events. Although glycated hemoglobin (HbA1c) increased after treatment initiation, four of five patients maintained HbA1c levels ≤7.0% while receiving pasireotide SC and concomitant individualized diabetes medication, if necessary. In patients who discontinued pasireotide SC, HbA1c levels decreased within 6 weeks. This report documents real-world use of pasireotide SC and indicates its effectiveness as a long-term treatment option for patients with CD. Although hyperglycemia was observed in most patients, it was managed with appropriate monitoring and treatment and was reversible upon discontinuation of pasireotide SC.

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