Update on the use of oral octreotide therapy for acromegaly

References

• Melmed S. Medical progress: acromegaly. N Engl J Med. 2006;355(24):2558–2573.
   PubMed Web of Science ®Google Scholar
• Varadhan L, Reulen RC, Brown M, et al. The role of cumulative growth hormone exposure in determining mortality and morbidity in acromegaly: a single centre study. Pituitary. 2016;19:251–261.
   PubMed Web of Science ®Google Scholar
• Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933–3951.
   PubMed Web of Science ®Google Scholar
• Ben-Shlomo A, Sheppard MC, Stephens JM, et al. Clinical, quality of life, and economic value of acromegaly disease control. Pituitary. 2011;14(3):284–294.
   PubMed Web of Science ®Google Scholar
• Strasburger CJ, Karavitaki N, Störmann S, et al. Patient-reported outcomes’ of parenteral somatostatin analogue injections in 195 patients with acromegaly. Eur J Endocrinol. 2016;174(3):355–362.
   PubMed Web of Science ®Google Scholar
• Postma MR, Netea-Maier RT, van den Berg G, et al. Quality of life is impaired in association with the need for prolonged postoperative therapy by somatostatin analogs in patients with acromegaly. Eur J Endocrinol. 2012;166(4):585–592.
   PubMed Web of Science ®Google Scholar
• Franck SE, Muhammad A, van der Lely AJ, et al. Combined treatment of somatostatin analogues with pegvisomant in acromegaly. Endocrine. 2015;52(2):206–213.
   PubMed Web of Science ®Google Scholar
• Cozzi R, Attanasio R, Lodrini S, et al. Cabergoline addition to depot somatostatin analogues in resistant acromegalic patients: efficacy and lack of predictive value of prolactin status. Clin Endocrinol (Oxf). 2004;61(2):209–215.
   PubMed Web of Science ®Google Scholar
• Bernabeu I, Alvarez-Escolá C, Paniagua AE, et al. Pegvisomant and cabergoline combination therapy in acromegaly. Pituitary. 2013;16(1):101–108.
   PubMed Web of Science ®Google Scholar
• Higham CE, Atkinson AB, Aylwin S, et al. Effective combination treatment with cabergoline and low-dose pegvisomant in active acromegaly: a prospective clinical trial. J Clin Endocrinol Metab. 2012;97(4):1187–1193.
   PubMed Web of Science ®Google Scholar
• Feelders RA, De Herder WW, Neggers SJ, et al. Pasireotide, a multi-somatostatin receptor ligand with potential efficacy for treatment of pituitary and neuroendocrine tumors. Drugs Today(Barc). 2013;49(2):89–103.
   PubMed Web of Science ®Google Scholar
• Lamberts SW, van der Lely AJ, de Herder WW, et al. Octreotide. N Engl J Med. 1996;334(24):246–254.
   PubMed Web of Science ®Google Scholar
• Burness CB, Dhillon S, Keam SJ. Lanreotide autogel((R)): a review of its use in the treatment of patients with acromegaly. Drugs. 2014;74(14):1673–1691.
   PubMed Web of Science ®Google Scholar
• Comi RJ, Gorden P. The response of serum growth hormone levels to the long-acting somatostatin analog SMS 201-995 in acromegaly. J Clin Endocrinol Metab. 1987;64(1):37–42.
   PubMed Web of Science ®Google Scholar
• Sheppard M, Bronstein MD, Freda P, et al. Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, phase III study. Pituitary. 2015;18(3):385–394.
   PubMed Web of Science ®Google Scholar
• Newman CB, Melmed S, Snyder PJ, et al. Safety and efficacy of long-term octreotide therapy of acromegaly: results of a multicenter trial in 103 patients – a clinical research center study. J Clin Endocrinol Metab. 1995;80(9):2768–2775.
   PubMed Web of Science ®Google Scholar
• Grasso LF, Auriemma RS, Pivonello R, et al. Adverse events associated with somatostatin analogs in acromegaly. Expert Opin Drug Saf. 2015;14(8):1213–1226.
   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(10):914–24.
   PubMed Web of Science ®Google Scholar
• Thorner, M.O., Strasburger CJ, Wu Z, et al. Growth hormone (GH) receptor blockade with a PEG-modified GH (B2036-PEG) lowers serum insulin-like growth factor-I but does not acutely stimulate serum GH. J Clin Endocrinol Metab. 1999;84(6):2098–2103.
   PubMed Web of Science ®Google Scholar
• Shimatsu A, Nagashima M, Hashigaki S, et al. Efficacy and safety of monotherapy by pegvisomant, a growth hormone receptor antagonist, in Japanese patients with acromegaly. Endocr J. 2016;63(4):337–347.
   PubMed Web of Science ®Google Scholar
• Freda PU, Gordon M, Kelepouris N, et al. Long-term treatment with pegvisomant as monotherapy in patients with acromegaly: experience from acrostudy. Endocr Pract. 2015;21(3):264–274.
   PubMed Web of Science ®Google Scholar
• van der Lely AJ, Biller BMK, Brue T, et al. Long-term safety of pegvisomant in patients with acromegaly: comprehensive review of 1288 subjects in ACROSTUDY. J Clin Endocrinol Metab. 2012;97(5):1589–1597.
   PubMed Web of Science ®Google Scholar
• Ramos-Levi, A.M., Bernabeu I, Álvarez-Escolá C, et al. Long-term treatment with pegvisomant for acromegaly: a 10-year experience. Clin Endocrinol (Oxf). 2015;172(2):115–122.
   Google Scholar
• Sesmilo G, Resmini E, Bernabeu I, et al. Escape and lipodystrophy in acromegaly during pegvisomant therapy, a retrospective multicentre Spanish study. Clin Endocrinol (Oxf). 2014;81(6):883–890.
   PubMed Web of Science ®Google Scholar
• Neggers SJ, Franck SE, de Rooij FWM, et al. Long-term efficacy and safety of pegvisomant in combination with long-acting somatostatin analogs in acromegaly. J Clin Endocrinol Metab. 2014;99(10):3644–3652.
   PubMed Web of Science ®Google Scholar
• Neggers SJ, de Herder WW, Feelders RA, et al. Conversion of daily pegvisomant to weekly pegvisomant combined with long-acting somatostatin analogs, in controlled acromegaly patients. Pituitary. 2011;14(3):253–258.
   PubMed Web of Science ®Google Scholar
• van der Lely AJ, Bernabeu I, Cap J, et al. Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alone. Eur J Endocrinol. 2011;164(3):325–333.
   PubMed Web of Science ®Google Scholar
• Kepicoglu H, Hatipoglu E, Bulut I, et al. Impact of treatment satisfaction on quality of life of patients with acromegaly. Pituitary. 2014;17(6):557–563.
   PubMed Web of Science ®Google Scholar
• Neggers SJ, van Aken MO, de Herder WW, et al. Quality of life in acromegalic patients during long-term somatostatin analog treatment with and without pegvisomant. J Clin Endocrinol Metab. 2008;93(10):3853–3859.
   PubMed Web of Science ®Google Scholar
• Neggers SJ, van der Lely AJ. Pegvisomant and improvement of quality of life in acromegalic patients. Horm Res Paediatr. 2011;76(Suppl 1):102–105.
   PubMed Web of Science ®Google Scholar
• Abs R, Verhelst J, Maiter D, et al. Cabergoline in the treatment of acromegaly: a study in 64 patients. J Clin Endocrinol Metab. 1998;83(2):374–378.
   PubMed Web of Science ®Google Scholar
• Vandeva S, Elenkova A, Natchev E, et al. Treatment outcome results from the Bulgarian Acromegaly Database: adjuvant dopamine agonist therapy is efficient in less than one fifth of non-irradiated patients. Exp Clin Endocrinol Diabetes. 2015;123(1):66–71.
   PubMed Web of Science ®Google Scholar
• Sandret L, Maison P, Chanson P. Place of cabergoline in acromegaly: a meta-analysis. J Clin Endocrinol Metab. 2011;96(5):1327–1335. .
   PubMed Web of Science ®Google Scholar
• Lamberts SW, Zweens M, Verschoor L, et al. A comparison among the growth hormone-lowering effects in acromegaly of the somatostatin analog SMS 201-995, bromocriptine, and the combination of both drugs. J Clin Endocrinol Metab. 1986;63(1):16–19.
   PubMed Web of Science ®Google Scholar
• Melmed S, Colao A, Barkan A, et al. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009;94(5):1509–1517.
   PubMed Web of Science ®Google Scholar
• Howlett, TA, Willis D, Walker G, et al. Control of growth hormone and IGF1 in patients with acromegaly in the UK: responses to medical treatment with somatostatin analogues and dopamine agonists. Clin Endocrinol (Oxf). 2013;79(5):689–699.
   PubMed Web of Science ®Google Scholar
• Sherlock M, Fernandez-Rodriguez E, Alonso AA, et al. Medical therapy in patients with acromegaly: predictors of response and comparison of efficacy of dopamine agonists and somatostatin analogues. J Clin Endocrinol Metab. 2009;94(4):1255–1263.
   PubMed Web of Science ®Google Scholar
• Martinkova J, Trejbalova L, Sasikova M, et al. Impulse control disorders associated with dopaminergic medication in patients with pituitary adenomas. Clin Neuropharmacol. 2011;34(5):179–181.
   PubMed Web of Science ®Google Scholar
• Bancos I, Nannenga MR, Bostwick JM, et al. Impulse control disorders in patients with dopamine agonist-treated prolactinomas and nonfunctioning pituitary adenomas: a case-control study. Clin Endocrinol (Oxf). 2014;80(6):863–868.
   PubMed Web of Science ®Google Scholar
• Zanettini R, AntoniniA, Gatto G, et al. Valvular heart disease and the use of dopamine agonists for Parkinson’s disease. N Engl J Med. 2007;356(1):39–46.
   PubMed Web of Science ®Google Scholar
• Bauer, W., Briner U, Doepfner W, et al. SMS 201-995: a very potent and selective octapeptide analogue of somatostatin with prolonged action. Life Sci. 1982;31(11):1133–1140.
   PubMed Web of Science ®Google Scholar
• Lamberts SW, Oosterom R, Neufeld M, et al. The somatostatin analog SMS 201-995 induces long-acting inhibition of growth hormone secretion without rebound hypersecretion in acromegalic patients. J Clin Endocrinol Metab. 1985;60(6):1161–1165.
   PubMed Web of Science ®Google Scholar
• Reubi J.C, Landolt AM. The growth hormone responses to octreotide in acromegaly correlate with adenoma somatostatin receptor status. J Clin Endocrinol Metab. 1989;68(4):844–850.
   PubMed Web of Science ®Google Scholar
• Murray RD, Kim K, Ren S-G, et al. Central and peripheral actions of somatostatin on the growth hormone-IGF-I axis. J Clin Invest. 2004;114(3):349–356.
   PubMed Web of Science ®Google Scholar
• Pokrajac A, Frystyk J, Flyvbjerg A, et al. Pituitary-independent effect of octreotide on IGF1 generation. Eur J Endocrinol. 2009;160(4):543–548.
   PubMed Web of Science ®Google Scholar
• Ezzat S, Snyder PJ, Young WF, et al. Octreotide treatment of acromegaly. A randomized, multicenter study. Ann Intern Med. 1992;117(9):711–718.
   PubMed Web of Science ®Google Scholar
• Lancranjan I, Bruns C, Grass P, et al. Sandostatin LAR: a promising therapeutic tool in the management of acromegalic patients. Metabolism. 1996;45(Suppl 8):67–71.
   PubMed Web of Science ®Google Scholar
• Giustina A, Mazziotti G, Torri V, et al. Meta-analysis on the effects of octreotide on tumor mass in acromegaly. PLoS One. 2012;7(5):e36411.
   PubMed Web of Science ®Google Scholar
• Fuessl HS, Domin J, Bloom SR. Oral absorption of the somatostatin analogue SMS 201-995: theoretical and practical implications. Clin Sci (Lond). 1987;72(2):255–257.
   PubMed Web of Science ®Google Scholar
• Sherlock M, Reulen RC, Alonso AA, et al. ACTH deficiency, higher doses of hydrocortisone replacement, and radiotherapy are independent predictors of mortality in patients with acromegaly. J Clin Endocrinol Metab. 2009;94(11):4216–4223.
   PubMed Web of Science ®Google Scholar
• Song H, Johns R, Griesgraber GW, et al. Disposition and oral bioavailability in rats of an antiviral and antitumor amino acid phosphoramidate prodrug of AZT-monophosphate. Pharm Res. 2003;20(3):448–451.
   PubMed Web of Science ®Google Scholar
• Maher S, Brayden DJ. Overcoming poor permeability: translating permeation enhancers for oral peptide delivery. Drug Discov Today Technol. 2012;9(2):e71–e174.
   Google Scholar
• Dorkoosh, F.A., Verhoef JC, Verheijden JH, et al. Peroral absorption of octreotide in pigs formulated in delivery systems on the basis of superporous hydrogel polymers. Pharm Res. 2002;19(10):1532–1536.
   PubMed Web of Science ®Google Scholar
• Drewe J, Fricker G, Vonderscher J, et al. Enteral absorption of octreotide: absorption enhancement by polyoxyethylene-24-cholesterol ether. Br J Pharmacol. 1993;108(2):298–303.
   PubMed Web of Science ®Google Scholar
• Thanou, M., Verhoef JC, Marbach P, et al. Intestinal absorption of octreotide: N-trimethyl chitosan chloride (TMC) ameliorates the permeability and absorption properties of the somatostatin analogue in vitro and in vivo. J Pharm Sci. 2000;89(7):951–957.
   PubMed Web of Science ®Google Scholar
• Thanou M, Verhoef JC, Verheijden JHM, et al. Intestinal absorption of octreotide using trimethyl chitosan chloride: studies in pigs. Pharm Res. 2001;18(6):823–828.
   PubMed Web of Science ®Google Scholar
• Maggio ET, Grasso P. Oral delivery of octreotide acetate in Intravail® improves uptake, half-life, and bioavailability over subcutaneous administration in male Swiss webster mice. Regul Pept. 2011;167(2–3):233–238.
   PubMedGoogle Scholar
• Fricker G, Bruns C, Munzer J, et al. Intestinal absorption of the octapeptide SMS 201-995 visualized by fluorescence derivatization. Gastroenterology. 1991;100(6):1544–1552.
   PubMed Web of Science ®Google Scholar
• Tuvia S, Atsmon J, Teichman SL, et al. Oral octreotide absorption in human subjects: comparable pharmacokinetics to parenteral octreotide and effective growth hormone suppression. J Clin Endocrinol Metab. 2012;97(7):2362–2369.
   PubMed Web of Science ®Google Scholar
• Melmed S, Popovic V, Bidlingmaier M, et al. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015;100(4):1699–708.
   PubMed Web of Science ®Google Scholar
• Cano-Cebrian MJ, Zornoza T, Granero L, et al. Intestinal absorption enhancement via the paracellular route by fatty acids, chitosans and others: a target for drug delivery. Curr Drug Deliv. 2005;2(1):9–22.
   PubMedGoogle Scholar
• Tuvia S, Pelled D, Marom K, et al. A novel suspension formulation enhances intestinal absorption of macromolecules via transient and reversible transport mechanisms. Pharm Res. 2014;31(8):2010–2021.
   PubMed Web of Science ®Google Scholar
• Sherlock M, Aragon Alonso A, Reulen RC, et al. Monitoring disease activity using GH and IGF-I in the follow-up of 501 patients with acromegaly. Clin Endocrinol (Oxf). 2009;71(1):74–81.
   PubMed Web of Science ®Google Scholar
• Giustina A, Karamouzis I, Patelli I, et al. Octreotide for acromegaly treatment : a reappraisal. Expert Opin Pharmacother. 2013;14(17):2433–47.
   PubMed Web of Science ®Google Scholar
• Mazziotti G, Bianchi A, Porcelli T, et al. Vertebral fractures in patients with acromegaly: a 3-year prospective study. J Clin Endocrinol Metab. 2013;98(8):3402–3410.
   PubMed Web of Science ®Google Scholar
• Colao A. 5 Long-term acromegaly and associated cardiovascular complications: a case-based review. Best Pract Res Clin Endocrinol Metab. 2009;23(Suppl 1):S31–S38.
   PubMed Web of Science ®Google Scholar
• Cozzi R, Baldelli R, Colao A, et al. AME position statement on clinical management of acromegaly. J Endocrinol Invest. 2009;32(6 Suppl):2–25.
   PubMedGoogle Scholar
• Stormann S, Schopohl J. Perspectives on investigational drugs for acromegaly. Expert Opin Investig Drugs. 2016;25(4):381–384.
   PubMed Web of Science ®Google Scholar
• Shimon I, Rubinek T, Hadani M, et al. PTR-3173 (somatoprim), a novel somatostatin analog with affinity for somatostatin receptors 2, 4 and 5 is a potent inhibitor of human GH secretion. J Endocrinol Invest. 2004;27(8):721–727.
   PubMed Web of Science ®Google Scholar
• Afargan M, Janson ET, Gelerman G, et al. Novel long-acting somatostatin analog with endocrine selectivity: potent suppression of growth hormone but not of insulin. Endocrinology. 2001;142(1):477–486.
   PubMed Web of Science ®Google Scholar
• Plockinger U, Hoffmann U, Geese M, et al. DG3173 (somatoprim), a unique somatostatin receptor subtypes 2-, 4- and 5-selective analogue, effectively reduces GH secretion in human GH-secreting pituitary adenomas even in octreotide non-responsive tumours. Eur J Endocrinol. 2012;166(2):223–234.
   PubMed Web of Science ®Google Scholar
• Tiberg F, Roberts J, Cervin C, et al. Octreotide s.c. depot provides sustained octreotide bioavailability and similar IGF-1 suppression to octreotide LAR in healthy volunteers. Br J Clin Pharmacol. 2015;80(3):460–472.
   PubMed Web of Science ®Google Scholar
• Tachas G, Lofthouse S, Wraight CJ, et al. A GH receptor antisense oligonucleotide inhibits hepatic GH receptor expression, IGF-I production and body weight gain in normal mice. J Endocrinol. 2006;189(1):147–154.
   PubMed Web of Science ®Google Scholar