Pasireotide can induce sustained decreases in urinary cortisol and provide clinical benefit in patients with Cushing's disease: results from an open-ended, open-label extension trial

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art_SCHOPOHL_Pasireotide_can_induce_sustained_decreases_in_urinary_cortisol_2015.PDF (835.55 KB)
Citações na Scopus
50
Tipo de produção
article
Data de publicação
2015
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
SPRINGER
Autores
SCHOPOHL, Jochen
GU, Feng
RUBENS, Robert
GAAL, Luc Van
BERTHERAT, Jerome
LIGUEROS-SAYLAN, Monica
TROVATO, Andrew
HUGHES, Gareth
BOSCARO, Marco
Citação
PITUITARY, v.18, n.5, p.604-612, 2015
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Report the efficacy and safety of pasireotide sc in patients with Cushing's disease during an open-ended, open-label extension to a randomized, double-blind, 12-month, Phase III study. 162 patients entered the core study. 58 patients who had mean UFC a parts per thousand currency sign ULN at month 12 or were benefiting clinically from pasireotide entered the extension. Patients received the same dose of pasireotide as at the end of the core study (300-1,200 mu g bid). Dose titration was permitted according to efficacy or drug-related adverse events. 40 patients completed 24 months' treatment. Of the patients who entered the extension, 50.0 % (29/58) and 34.5 % (20/58) had controlled UFC (UFC a parts per thousand currency sign ULN) at months 12 and 24, respectively. The mean percentage decrease in UFC was 57.3 % (95 % CI 40.7-73.9; n = 52) and 62.1 % (50.8-73.5; n = 33) after 12 and 24 months' treatment, respectively. Improvements in clinical signs of Cushing's disease were sustained up to month 24. The most frequent drug-related adverse events in patients who received a parts per thousand yen1 dose of pasireotide (n = 162) from core baseline until the 24-month cut-off were diarrhea (55.6 %), nausea (48.1 %), hyperglycemia (38.9 %), and cholelithiasis (31.5 %). No new safety issues were identified during the extension. Reductions in mean UFC and improvements in clinical signs of Cushing's disease were maintained over 24 months of pasireotide treatment. The safety profile of pasireotide is typical for a somatostatin analogue, except for the frequency and degree of hyperglycemia; patients should be monitored for changes in glucose homeostasis. Pasireotide represents the first approved pituitary-targeted treatment for patients with Cushing's disease.
Palavras-chave
Pasireotide, Cushing's disease, Somatostatin analogue, Corticotroph tumor, Urinary free cortisol
URI
https://observatorio.fm.usp.br/handle/OPI/12512
Referências
  1. Henry RR, 2013, J CLIN ENDOCR METAB, V98, P3446, DOI 10.1210/jc.2013-1771
  2. Biller BMK, 2008, J CLIN ENDOCR METAB, V93, P2454, DOI 10.1210/jc.2007-2734
  3. Colao A, 2012, NEW ENGL J MED, V366, P914, DOI 10.1056/NEJMoa1105743
  4. Bruns C, 2002, EUR J ENDOCRINOL, V146, P707, DOI 10.1530/eje.0.1460707
  5. Pivonello R, 2009, J CLIN ENDOCR METAB, V94, P223, DOI 10.1210/jc.2008-1533
  6. Godbout A, 2010, EUR J ENDOCRINOL, V163, P709, DOI 10.1530/EJE-10-0382
  7. Pivonello R, 2014, CLIN ENDOCRINOL, V81, P408, DOI 10.1111/cen.12431
  8. Feelders RA, 2012, EUR J ENDOCRINOL, V167, P311, DOI 10.1530/EJE-11-1095
  9. [Anonymous], 2011, DATA CDC STAT NHANES
  10. Newell-Price J, 2006, LANCET, V367, P1605, DOI 10.1016/S0140-6736(06)68699-6
  11. Batista DL, 2006, 88 ANN M END SOC BOS
  12. Hofland LJ, 2005, EUR J ENDOCRINOL, V152, P645, DOI 10.1530/eje.1.01876
  13. National Cancer Institute, 2006, COMM TERM CRIT ADV E
  14. Novartis Pharma AG, 2012, SIGN SUMM PROD CHAR
  15. Novartis Pharma AG, 2012, SIGN FULL PRESCR INF
  16. Pivonello R, 2012, END ABSTR, V29, pP1406
  17. Pivonello R, 2008, ENDOCRIN METAB CLIN, V37, P135, DOI 10.1016/j.ecl.2007.10.010
  18. Turpeinen U, 1997, CLIN CHEM, V43, P1386

Coleções
Artigos e Materiais de Revistas Científicas - HC/ICHC