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Title: | Long-term treatment of Cushing's disease with pasireotide: 5-year results from an open-label extension study of a Phase III trial |
Authors: | PETERSENN, S.; SALGADO, L. R.; SCHOPOHL, J.; PORTOCARRERO-ORTIZ, L.; ARNALDI, G.; LACROIX, A.; SCARONI, C.; RAVICHANDRAN, S.; KANDRA, A.; BILLER, B. M. K. |
Citation: | ENDOCRINE, v.57, n.1, p.156-165, 2017 |
Abstract: | Treating hypercortisolism in patients with Cushing's disease after failed surgery often requires chronic medication, underlining the need for therapies with favourable long-term efficacy and safety profiles. In a randomised, double-blind study, 162 adult patients with persistent/recurrent or de novo Cushing's disease received pasireotide. Patients with mean urinary free cortisol at/below the upper limit of normal or clinical benefit at month 12 could continue receiving pasireotide during an open-ended, open-label phase, the outcomes of which are described herein. Sixteen patients received 5 years of pasireotide treatment. Among these, median (95% confidence interval) percentage change from baseline in mean urinary free cortisol was -82.6% (-89.0, -41.9) and -81.8% (-89.8, -67.4) at months 12 and 60. Eleven patients had mean urinary free cortisol > upper limit of normal at month 60. Improvements in clinical signs were sustained during long-term treatment. The safety profile of pasireotide at 5 years was similar to that reported after 12 months. Fifteen of 16 patients experienced a hyperglycaemia-related adverse event; glycated haemoglobin levels were stable between months 6 and 60. Adverse events related to hyperglycaemia, bradycardia, gallbladder/biliary tract, and liver safety were most likely to first occur by month 6; adverse event severity did not tend to worsen over time. This represents the longest prospective trial of a medical therapy for Cushing's disease to date. A subset of patients treated with pasireotide maintained biochemical and clinical improvements for 5 years, with no new safety signals emerging. These data support the use of pasireotide as an effective long-term therapy for some patients with Cushing's disease. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - HC/ICHC Artigos e Materiais de Revistas Científicas - ODS/03 |
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art_PETERSENN_Longterm_treatment_of_Cushings_disease_with_pasireotide_5year_2017.PDF Restricted Access | publishedVersion (English) | 1.09 MB | Adobe PDF | View/Open Request a copy |
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