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Endocrine Abstracts (2012) 29 P1405

ICEECE2012 Poster Presentations Pituitary Clinical (183 abstracts)

Long-term use of pasireotide in Cushing’s disease: 24-month safety results from a randomized phase III study

J Bertherat 1 , W Ludlam 2 , R Pivonello 3 , M Maldonado 4 , A Trovato 4 , G Hughes 4 , F Gu 5 , J Schopohl 6 & L Salgado 7

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1Hôpital Cochin, Paris, France; 2Swedish Neuroscience Institute, Seattle, WA; 3University of Naples ‘Federico II’, Naples, Italy; 4Novartis Pharma AG, Basel, Switzerland; 5Ministry of Health, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China; 6Campus Innenstadt, University of Munich, Munich, Germany; 7Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.


Introduction: Rapid and sustained decreases in UFC and significant improvements in signs and symptoms were seen in a large, randomized, 12-month phase III study of pasireotide in Cushing’s disease. The safety profile of pasireotide was found to be similar to that of other somatostatin analogues, with the exception of hyperglycemia-related AEs (reported in 72.8% of patients). This abstract reports safety data from a 12-month extension to this phase III trial.

Methods: Patients with persistent/recurrent or de novo (if not surgical candidates) Cushing’s disease and UFC levels ≥1.5xULN were randomized to pasireotide 600 μg (n=82) or 900 μg (n=80) sc bid. Patients who had mean UFC≤ULN or were achieving clinical benefit from pasireotide at month 12 (end of core) were eligible to enter the extension. Dose titration was permitted at the investigator’s discretion (min: 300 μg sc bid; max: 1200 μg sc bid). Data on AEs were collected throughout the extension.

Results: Fifty-eight patients entered the extension phase and 19 discontinued prior to month 24. After 24 months’ pasireotide treatment, UFC was decreased by a mean of 59.5% (95% CI: −68.6, −50.5). During the core and extension phases, 98.1% of patients experienced≥1 AE, and 25.9% experienced≥1 SAE. There were no deaths. The safety profile in the extension phase was similar to that in the core; the majority of reported AEs were mild-to-moderate GI events. During the 24-month treatment period, 40.1% and 29.6% of patients had an AE of hyperglycemia and diabetes mellitus respectively. Mean HbA1c increased from 5.8% at baseline to 7.2, 6.8 and 6.8% at months 12, 18 and 24 respectively. In addition to the patients who reported these events during the core study, 2 additional patients experienced SAEs during the extension, 3 reported mild-to-moderate cholelithiasis, one reported a newly occurring QTcF >480 ms, and 2 had a >30 ms increase in QTcF. Three patients discontinued because of an AE during the extension. Further 24-month efficacy results are reported in a separate abstract (Schopohl et al.).

Conclusion: The long-term safety profile of pasireotide was similar to that reported following 12 months’ pasireotide treatment, including the proportion of patients with hyperglycemia-related AEs. These results support the use of pasireotide as a long-term treatment for Cushing’s disease.

Declaration of interest: I fully declare a conflict of interest. Details below:

Funding: This work was supported, however funding details unavailable.

Volume 29

15th International & 14th European Congress of Endocrinology

European Society of Endocrinology 

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