Pasireotide for the treatment of Cushing's disease

Bibliography

• Pivonello R, De Martino MC, De Leo M, et al. Cushing's Syndrome. Endocrinol Metab Clin North Am 2008;37:135-49
   PubMed Web of Science ®Google Scholar
• Newell-Price J, Bertagna X, Grossman AB, Nieman LK. Cushing's syndrome. Lancet 2006;367:1605-17
   PubMed Web of Science ®Google Scholar
• Arnaldi G, Angeli A, Atkinson AB, et al. Diagnosis and complications of Cushing's syndrome: a consensus statement. J Clin Endocrinol Metab 2003;88:5593-602
   PubMed Web of Science ®Google Scholar
• Boscaro M, Barzon L, Fallo F, et al. Cushing's syndrome. Lancet 2001;357:783-91
   PubMed Web of Science ®Google Scholar
• Lindholm J, Juul S, Jørgensen JO, et al. Incidence and late prognosis of Cushing's syndrome: a population-based study. J Clin Endocrinol Metab 2001;86:117-23
   PubMed Web of Science ®Google Scholar
• Steffensen C, Mosegaard Bak A, Rubeck KZ, Jørgensen JOL. Epidemiology of Cushing's syndrome. Neuroendocrinology 2010;92(Suppl 1):1-5
   PubMed Web of Science ®Google Scholar
• Clayton RN. Mortality and morbidity in Cushing's disease Neuroendocrinology. 2010;92(Suppl 1):71-6
   Google Scholar
• Clayton RN, Raskauskiene D, Reulen RC, et al. Mortality and morbidity in Cushing's disease over 50 years in Stoke-on-Trent UK: audit and meta-analysis of literature. J Clin Endocrinol Metab 2011;96:632-42
   PubMed Web of Science ®Google Scholar
• Mancini T, Kola B, Mantero F, et al. High cardiovascular risk in patients with Cushing's syndrome according to WHO/ISH guidelines. Clin Endocrinol (Oxf) 2004;61:768-77
   PubMed Web of Science ®Google Scholar
• De Leo M, Pivonello R, Auriemma RS, et al. Cardiovascular disease in Cushing's syndrome: heart versus vasculature. Neuroendocrinology 2010;92(Suppl 1):50-4
   PubMedGoogle Scholar
• Pivonello R, De Martino MC, De Leo M, et al. Cushing's syndrome: aftermath of the cure. Arq Bras Endocrinol Metabol 2007;51(8):1381-91; Review
   PubMedGoogle Scholar
• Colao A, Pivonello R, Spiezia S, et al. Persistence of increased cardiovascular risk in patients with Cushing's disease after five years of successful cure. J Clin Endocrinol Metab 1999;84(8):2664-72
   PubMed Web of Science ®Google Scholar
• Biller BMK, Grossman AB, Stewart PM, et al. Treatment of adrenocorticotropin dependent Cushing's syndrome: a consensus statement. J Clin Endocrinol Metab 2008;93:2454-62
   PubMed Web of Science ®Google Scholar
• Feelders RA, Hofland LJ, De Herder WW. Medical treatment of Cushing's syndrome: adrenal–blocking drugs and ketaconazole. Neuroendocrinology 2010;92(Suppl 1):111-15
   PubMed Web of Science ®Google Scholar
• Fleseriu M, Biller BM, Findling JW, et al. Mifepristone, a glucocorticoid receptor antagonist, produces clinical and metabolic benefits in patients with Cushing's syndrome. J Clin Endocrinol Metab 2012;97(6):2039-49
   PubMed Web of Science ®Google Scholar
• Castinetti F, Brue T, Conte-Devolx B. The use of the glucocorticoid receptor antagonist mifepristone in Cushing's syndrome. Curr Opin Endocrinol Diabetes Obes 2012;19(4):295-9
   PubMed Web of Science ®Google Scholar
• FDA approves Korlym (mifepristone) for patients with endogenous Cushing's syndrome. U.S. Food and Drug Administration Feb. 17, 2012. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292462.htm
   Google Scholar
• Pivonello R, De Martino MC, Cappabianca P, et al. The medical treatment of Cushing's disease: effectiveness of chronic treatment with the dopamine agonist cabergoline in patients unsuccessfully treated by surgery. J Clin Endocrinol Metab 2009;94:223-30
   PubMed Web of Science ®Google Scholar
• Godbout A, Manavela M, Danilowicz K, et al. Cabergoline monotherapy in the long–term treatment of Cushing's disease. Eur J Endocrinol 2010;163(5):709-16
   PubMed Web of Science ®Google Scholar
• Petrossians P, Thonnard AS, Beckers A. Medical treatment in Cushing's syndrome: dopamine agonists and cabergoline. Neuroendocrinology 2010;92(Suppl 1):116-19
   PubMed Web of Science ®Google Scholar
• Pivonello R, Ferone D, Lombardi G, et al. Novel insights in dopamine receptor physiology. Eur J Endocrinol 2007;156(Suppl 1):S13-21; Erratum in: Eur J Endocrinol 2007;157(4):543
   PubMed Web of Science ®Google Scholar
• Pivonello R, Ferone D, de Herder WW, et al. Dopamine receptor expression and function in corticotroph pituitary tumours. J Clin Endocrinol Metab 2004;89(5):2452-62
   PubMed Web of Science ®Google Scholar
• Colao A, Filippella M, Pivonello R, et al. Combined therapy of somatostatin analogues and dopamine agonists in the treatment of pituitary tumours. Eur J Endocrinol 2007;157(4):543
   Google Scholar
• Colao A, Faggiano A, Pivonello R. Somatostatin analogues: treatment of pituitary and neuroendocrine tumours. Prog Brain Res 2010;182:281-94
   PubMed Web of Science ®Google Scholar
• Colao A, Petersenn S, Newell-Price J, et al. A 12-month phase 3 study of pasireotide in Cushing's disease. N Engl J Med 2012;366:32-42
   Web of Science ®Google Scholar
• Lacroix A, Pivonello R. Medical treatment of Cushing's disease with pasireotide. Eur Endocrinol 2012;8(2):99-104
   Google Scholar
• Van der Hoek J, Waaijers M, van Koetsveld PM, et al. Distinct functional properties of native somatostatin receptor subtype 5 compared with subtype 2 in the regulation of ACTH release by corticotroph tumour cells. Am J Physiol Endocrinol Metab 2005;289(2):278-87
   PubMed Web of Science ®Google Scholar
• Schmid HA, Schoeffter P. Functional activity of the multiligand analog SOM230 at human recombinant somatostatin receptor subtypes supports its usefulness in neuroendocrine tumours. Neuroendocrinology 2004;80(Suppl 1):47-50
   PubMedGoogle Scholar
• Dasgupta P. Somatostatin analogue: multiple roles in cellular proliferation, neoplasia and angiogenesis. Pharmacol Ther 2004;102:61-85
   PubMed Web of Science ®Google Scholar
• Hubina A, Nanzer AM, Hanson HR, et al. Somatostatin analogues stimulate p27 expression and inhibit the MAP kinase pathway in pituitary tumours. Eur J Endocrinol 2006;155:371-9
   PubMed Web of Science ®Google Scholar
• Batista DL, Zhang X, Gejman R, et al. The effects of SOM230 on cell proliferation and adrenocorticotropin secretion in human corticotroph pituitary adenomas. J Clin Endocrinol Metab 2006;91:4482-8
   PubMed Web of Science ®Google Scholar
• Hofland LJ, Lamberts SW. Somatostatin receptors in pituitary function, diagnosis and therapy. Front Horm Res 2004;32:235-52
   PubMed Web of Science ®Google Scholar
• Hofland L.J. Somatostatin and somatostatin receptors in Cushing's disease. Mol Cell Endocrinol 2008;286:199-205
   PubMed Web of Science ®Google Scholar
• Pedroncelli AM. Medical treatment of Cushing's disease: somatostatin analogues and pasireotide Neuroendocrinology. 2010;92(Suppl 1):120-4
   Google Scholar
• Hofland LJ, Van der Hoek J, Feelders R, et al. The multi-ligand somatostatin analogue SOM230 inhibits ACTH secretion by cultured human corticotroph adenomas via somatostatin receptor type 5. Eur J Endocrinol 2005;152:645-54
   PubMed Web of Science ®Google Scholar
• Silva AP, Schoeffter P, Weckbecker G, et al. Regulation of CRH-induced secretion of ACTH and corticosterone by SOM230 in rats. Eur J Endocrinol 2005;153:7-10
   Web of Science ®Google Scholar
• Schmid HA. Pasireotide (SOM230): development, mechanism of action and potential applications. Mol Cell Endocrinol 2008;286:69-74
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Signifor solution for injection: summary of product characteristics. 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002052/WC500128056.pdf
   Google Scholar
• Novartis Pharmaceuticals Corporation. Signifor: full prescribing information December. 2012. Available from: http://www.pharma.us.novartis.com/product/pi/pdf/signifor.pdf
   Google Scholar
• Golor G, Hu K, Ruffin M, et al. A first-in-man study to evaluate the safety, tolerability, and pharmacokinetics of pasireotide (SOM230), a multireceptor-targeted somatostatin analog, in healthy volunteers. Drug Des Devel Ther 2012;6:71-9
   PubMed Web of Science ®Google Scholar
• Beglinger C, Hu K, Wang Y, et al. Multiple once-daily subcutaneous doses of pasireotide were well tolerated in healthy male volunteers: a randomized, double-blind, placebo-controlled, cross-over, Phase I study. Endocrine 2012;42(2):366-74
   PubMed Web of Science ®Google Scholar
• Petersenn S, Hu K, Maldonado M, et al. Tolerability and dose proportional pharmacokinetics of pasireotide administered as a single dose or two divided doses in healthy male volunteers: a single-center, open- label ascending- dose study. Clin Ther 2012;34:677-88
   PubMed Web of Science ®Google Scholar
• Bruns C, Lewis I, Briner U, et al. SOM230: a novel somatostatin peptidomimetic with broad somatotropin release inhibiting factor (SRIF) receptor binding and a unique antisecretory profile. Eur J Endocrinol 2002;146:707-16
   PubMed Web of Science ®Google Scholar
• Feelders RA, Yasothan U, Kirkpatrick P. Pasireotide. Nat Rev Drug Discovery 2012;11:597-8
   PubMed Web of Science ®Google Scholar
• Horsmans Y, Hu K, Ruffin M, et al. Effect of hepatic impairment on the pharmacokinetics of pasireotide (SOM230): results from a multicenter phase I study. J Clin Pharmacol 2012;52(4):552-8
   PubMed Web of Science ®Google Scholar
• Boscaro M, Ludlam WH, Atkinson B, et al. Treatment of pituitary dependent Cushing's disease with the multireceptor ligand somatostatin analog pasireotide (SOM230): a multicenter, phase II trial. J Clin Endocrinol Metab 2009;94:115-22
   PubMed Web of Science ®Google Scholar
• Feelders R, de Bruin C, Pereira AM, et al. Pasireotide alone or with cabergoline and ketoconazole in Cushing's disease. N Engl J Med 2010;362:1846-8
   PubMed Web of Science ®Google Scholar
• Shenouda M, Maldonado M, Wang Y, et al. An open-label, dose-escalation study of once- and twice-daily pasireotide in healthy volunteers: safety, tolerability and effects on glucose, insulin and glucagon levels. Am J Ther 2012; Epub ahead of print
   Web of Science ®Google Scholar
• Henry RR, Mudaliar S, Wetli-Hermosillo K, et al. Mechanism and management of hyperglycemia associated with pasireotide: results from studies in healthy volunteers. Endocrine Soc 2011;Abstract P3-274
   Google Scholar
• Pivonello R, De Leo M, Vitale P, et al. Pathophysiology of diabetes mellitus in Cushing's syndrome. Neuroendocrinology 2010;92(Suppl 1):77-81
   PubMedGoogle Scholar
• FDA approves Signifor, a new orphan drug for Cushing's disease U.S. Food and Drug Administration December 14, 2012. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332351.htm
   Google Scholar
• De Bruin C, Pereire AM, Feelders RA, et al. Coexpression of dopamine and somatostatin receptors subtypes in corticotroph adenomas. J Clin Endocrinol Metab 2009;1118-24
   PubMed Web of Science ®Google Scholar
• Rocheville M, Lange DC, Kumar U, et al. Receptors for dopamine and somatostatin: formation of hetero-oligomers with enhanced functional activity. Science 2000;288:154-7
   PubMed Web of Science ®Google Scholar
• Bertagna Pivonello R, Fleseriu M, et al. Patients with Cushing's disease achieve normal urinary cortisol with LCI699, a potent 11β-hydroxylase inhibitor: preliminary results from a multicenter, proof-of-concept study. Endocrine 2012;Abstracts 29 OC1.2
   Google Scholar