Pharmacokinetic evaluation of lanreotide

Expert Opinion on Drug Metabolism and Toxicology

Volumn 6, Issue 10, 2010, Pages 1301-1312

  Hu, Miao ^a   Tomlinson, Brian ^a  

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

Acromegaly; Growth hormone; Lanreotide; Octreotide; Pharmacokinetics; Somatostatin analogs

Indexed keywords

ANGIOPEPTIN; BIM 23A 760; DOPAMINE RECEPTOR STIMULATING AGENT; HORMONE RECEPTOR AFFECTING AGENT; OCTREOTIDE; PASIREOTIDE; PEGVISOMANT; SOMATOMEDIN C; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ACROMEGALY; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; BRADYCARDIA; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CHOLELITHIASIS; CLINICAL FEATURE; CLINICAL TRIAL; DIABETES MELLITUS; DIARRHEA; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; ENDOCRINE SURGERY; GASTROINTESTINAL SYMPTOM; HORMONE RECEPTOR INTERACTION; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOGLYCEMIA; INJECTION SITE MASS; INJECTION SITE PAIN; INSULIN BLOOD LEVEL; LIVER CELL CARCINOMA; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NEUROENDOCRINE TUMOR; PLASMA HALF LIFE; PREVALENCE; PROTEIN BLOOD LEVEL; REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; THYROTROPIN SECRETING ADENOMA;

ACROMEGALY; ADULT; ANTINEOPLASTIC AGENTS; DELAYED-ACTION PREPARATIONS; GROWTH HORMONE-SECRETING PITUITARY ADENOMA; HUMANS; INJECTIONS, INTRAMUSCULAR; INJECTIONS, SUBCUTANEOUS; PEPTIDES, CYCLIC; SOMATOSTATIN;

EID: 77956843110     PISSN: 17425255     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425255.2010.513700     Document Type: Review

References (80)

1. Melmed S. Acromegaly pathogenesis and treatment. J Clin Invest 2009;119:3189-3202
2. Chanson P, Salenave S, Kamenicky P, et al. Pituitary tumours: acromegaly. Best Pract Res Clin Endocrinol Metab 2009;6:555-574
3. Melmed S. Acromegaly. N Engl J Med 1990;322:966-977
4. Holdaway IM, Rajasoorya C. Epidemiology of acromegaly. Pituitary 1999;2:29-41
5. Daly AF, Rixhon M, Adam C, et al. High prevalence of pituitary adenomas: a cross-sectional study in the province of Liege, Belgium. J Clin Endocrinol Metab 2006;91:4769-4775
6. Schneider HJ, Sievers C, Saller B, et al. High prevalence of biochemical acromegaly in primary care patients with elevated IGF-1 levels. Clin Endocrinol (Oxf) 2008;69:432-435
7. Nachtigall L, Delgado A, Swearingen B, et al. Changing patterns in diagnosis and therapy of acromegaly over two decades. J Clin Endocrinol Metab 2008;93:2035-2041
8. Dekkers OM, Biermasz NR, Pereira AM, et al. Mortality in acromegaly: a metaanalysis. J Clin Endocrinol Metab 2008;93:61-67
9. Holdaway IM, Bolland MJ, Gamble GD. A meta-analysis of the effect of lowering serum levels of GH and IGF-I on mortality in acromegaly. Eur J Endocrinol 2008;159:89-95
10. Melmed S, Casanueva F, Cavagnini F, et al. Consensus statement: medical management of acromegaly. Eur J Endocrinol 2005;153:737-740
11. Ferone D, Colao A, van der Lely AJ, Lamberts SW. Pharmacotherapy or surgery as primary treatment for acromegaly? Drugs Aging 2000;17:81-92
12. Muller AF, Van Der Lely AJ. Pharmacological therapy for acromegaly: a critical review. Drugs 2004;64:1817-1838
13. Trainer PJ, Drake WM, Katznelson L, et al. Treatment of acromegaly with the growth hormone-receptor antagonist pegvisomant. N Engl J Med 2000;342:1171-1177
14. Roelfsema F, Biermasz NR, Pereira AM, Romijn JA. Therapeutic options in the management of acromegaly: focus on lanreotide Autogel. Biologics 2008;2:463-479
15. Reichlin S. Secretion of somatostatin and its physiologic function. J Lab Clin Med 1987;109:320-326
16. Lamberts SW. The role of somatostatin in the regulation of anterior pituitary hormone secretion and the use of its analogs in the treatment of human pituitary tumors. Endocr Rev 1988;9:417-436
17. Croxtall JD, Scott LJ. Lanreotide Autogel: a review of its use in the management of acromegaly. Drugs 2008;68:711-723
18. Danila DC, Haidar JN, Zhang X, et al. Somatostatin receptor-specific analogs: effects on cell proliferation and growth hormone secretion in human somatotroph tumors. J Clin Endocrinol Metab 2001;86:2976-2981
19. Hofland LJ, Lamberts SW. The pathophysiological consequences of somatostatin receptor internalization and resistance. Endocr Rev 2003;24:28-47
20. Murray RD, Melmed S. A critical analysis of clinically available somatostatin analog formulations for therapy of acromegaly. J Clin Endocrinol Metab 2008;93:2957-2968
21. Zatelli MC, degli Uberti E. The significance of new somatostatin analogs as therapeutic agents. Curr Opin Investig Drugs 2009;10:1025-1031
22. Ben-Shlomo A, Melmed S. Pasireotide - a somatostatin analog for the potential treatment of acromegaly, neuroendocrine tumors and Cushings disease. IDrugs 2007;10:885-895
23. Petersenn S, Schopohl J, Barkan A, et al. Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase ii trial. J Clin Endocrinol Metab 2010;95:2781-2789
24. Debono M, Newell-Price J. New formulations and approaches in the medical treatment of acromegaly. Curr Opin Endocrinol Diabetes Obes 2010;17:350-355
25. Kumar SS, Ayuk J, Murray RD. Current therapy and drug pipeline for the treatment of patients with acromegaly. Adv Ther 2009;26:383-403
26. Castinetti F, Saveanu A, Morange I, Brue T. Lanreotide for the treatment of acromegaly. Adv Ther 2009;26:600-612
27. Valery C, Pouget E, Pandit A, et al. Molecular origin of the self-assembly of lanreotide into nanotubes: a mutational approach. Biophys J 2008;94:1782-1795
28. Bevan JS, Newell-Price J, Wass JA, et al. Home administration of lanreotide Autogel by patients with acromegaly, or their partners, is safe and effective. Clin Endocrinol (Oxf) 2008;68:343-349
29. Somatuline Depot (lanreotide) injection US prescribing information. Ipsen Pharma Biotech; 2007
30. Freda PU, Katznelson L, van der Lely AJ, et al. Long-acting somatostatin analog therapy of acromegaly: a meta-analysis. J Clin Endocrinol Metab 2005;90:4465-4473
31. Amato G, Mazziotti G, Rotondi M, et al. Long-term effects of lanreotide SR and octreotide LAR on tumour shrinkage and GH hypersecretion in patients with previously untreated acromegaly. Clin Endocrinol (Oxf) 2002;56:65-71
32. Bevan JS. Clinical review: the antitumoral effects of somatostatin analog therapy in acromegaly. J Clin Endocrinol Metab 2005;90:1856-1863
33. Melmed S, Colao A, Barkan A, et al. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab 2009;94:1509-1517
34. Colao A, Filippella M, Di Somma C, et al. Somatostatin analogs in treatment of non-growth hormone-secreting pituitary adenomas. Endocrine 2003;20:279-283
35. Colao A, Faggiano A, Pivonello R. Somatostatin analogues: treatment of pituitary and neuroendocrine tumors. Prog Brain Res 2010;182:281-294
36. Appetecchia M, Baldelli R. Somatostatin analogues in the treatment of gastroenteropancreatic neuroendocrine tumours, current aspects and new perspectives. J Exp Clin Cancer Res 2010;29:19
37. Beck-Peccoz P, Persani L, Mannavola D, Campi I. Pituitary tumours: TSH-secreting adenomas. Best Pract Res Clin Endocrinol Metab 2009;23:597-606
38. Modlin IM, Pavel M, Kidd M, Gustafsson BI. Review article: somatostatin analogues in the treatment of gastroenteropancreatic neuroendocrine (carcinoid) tumours. Aliment Pharmacol Ther 2010;31:169-188
39. Samonakis DN, Notas G, Christodoulakis N, Kouroumalis EA. Mechanisms of action and resistance of somatostatin analogues for the treatment of hepatocellular carcinoma: a message not well taken. Dig Dis Sci 2008;53:2359-2365
40. van Keimpema L, Nevens F, Vanslembrouck R, et al. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology 2009;137:1661-8 e1-2
41. Hogan MC, Masyuk TV, Page LJ, et al. Randomized clinical trial of long-acting somatostatin for autosomal dominant polycystic kidney and liver disease. J Am Soc Nephrol 2010;21:1052-1061
42. Foxx-Orenstein A, Camilleri M, Stephens D, Burton D. Effect of a somatostatin analogue on gastric motor and sensory functions in healthy humans. Gut 2003;52:1555-1561
43. Mazziotti G, Floriani I, Bonadonna S, et al. Effects of somatostatin analogs on glucose homeostasis: a metaanalysis of acromegaly studies. J Clin Endocrinol Metab 2009;94:1500-1508
44. Kuhn JM, Basin C, Mollard M, et al. Pharmacokinetic study and effects on growth hormone secretion in healthy volunteers of the new somatostatin analogue BIM 23014. Eur J Clin Pharmacol 1993;45:73-77
45. Antonijoan RM, Barbanoj MJ, Cordero JA, et al. Pharmacokinetics of a new Autogel formulation of the somatostatin analogue lanreotide after a single subcutaneous dose in healthy volunteers. J Pharm Pharmacol 2004;56:471-476
46. Drewe J, Sieber CC, Mottet C, et al. Dose-dependent gastrointestinal effects of the somatostatin analog lanreotide in healthy volunteers. Clin Pharmacol Ther 1999;65:413-419
47. Sieber CC, Beglinger C, Bart S, et al. Lanreotide effect on splanchnic blood flow in healthy subjects: effect of the rate of infusion. Clin Pharmacol Ther 2004;75:70-79
48. Barbanoj M, Antonijoan R, Morte A, et al. Pharmacokinetics of the somatostatin analog lanreotide in patients with severe chronic renal insufficiency. Clin Pharmacol Ther 1999;66:485-491
49. Tomlinson B, Thomas NG, Lan IW, et al. Pharmacokinetic profile of the somatostatin analogue lanreotide in individuals with chronic hepatic insufficiency. Clin Pharmacokinet 2006;45:1003-1011
50. Kuhn JM, Legrand A, Ruiz JM, et al. Pharmacokinetic and pharmacodynamic properties of a long-acting formulation of the new somatostatin analogue, lanreotide, in normal healthy volunteers. Br J Clin Pharmacol 1994;38:213-219
51. Heron I, Thomas F, Dero M, et al. Pharmacokinetics and efficacy of a long-acting formulation of the new somatostatin analog BIM 23014 in patients with acromegaly. J Clin Endocrinol Metab 1993;76:721-727 (Pubitemid 23086495)
52. Kuhn JM, Arlot S, Lefebvre H, et al. Evaluation of the treatment of thyrotropin-secreting pituitary adenomas with a slow release formulation of the somatostatin analog lanreotide. J Clin Endocrinol Metab 2000;85:1487-1491
53. Astruc B, Marbach P, Bouterfa H, et al. Long-acting octreotide and prolonged-release lanreotide formulations have different pharmacokinetic profiles. J Clin Pharmacol 2005;45:836-844
54. Troconiz IF, Cendros JM, Peraire C, et al. Population pharmacokinetic analysis of lanreotide Autogel in healthy subjects: evidence for injection interval of up to 2 months. Clin Pharmacokinet 2009;48:51-62
55. Caron P. Somatuline(R) Autogel(R), a new formulation of lanreotide for the treatment of acromegalic patients. Ann Endocrinol (Paris) 2002;63:2S19-24
56. Bronstein M, Musolino N, Jallad R, et al. Pharmacokinetic profile of lanreotide Autogel in patients with acromegaly after four deep subcutaneous injections of 60, 90 or 120 mg every 28 days. Clin Endocrinol (Oxf) 2005;63:514-519
57. Cendros JM, Peraire C, Troconiz IF, Obach R. Pharmacokinetics and population pharmacodynamic analysis of lanreotide Autogel. Metabolism 2005;54:1276-1281
58. Feelders RA, Hofland LJ, van Aken MO, et al. Medical therapy of acromegaly: efficacy and safety of somatostatin analogues. Drugs 2009;69:2207-2226
59. Mazziotti G, Giustina A. Effects of lanreotide SR and Autogel on tumor mass in patients with acromegaly: a systematic review. Pituitary 2010;13:60-67
60. Anthony L, Freda PU. From somatostatin to octreotide LAR: evolution of a somatostatin analogue. Curr Med Res Opin 2009;25:2989-2999
61. Maiza JC, Vezzosi D, Matta M, et al. Long-term (up to 18 years) effects on GH/IGF-1 hypersecretion and tumour size of primary somatostatin analogue (SSTa) therapy in patients with GH-secreting pituitary adenoma responsive to SSTa. Clin Endocrinol (Oxf) 2007;67:282-289
62. Caron P, Bex M, Cullen DR, et al. One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel. Clin Endocrinol (Oxf) 2004;60:734-740
63. Mercado M, Borges F, Bouterfa H, et al. A prospective, multicentre study to investigate the efficacy, safety and tolerability of octreotide LAR (long-acting repeatable octreotide) in the primary therapy of patients with acromegaly. Clin Endocrinol (Oxf) 2007;66:859-868
64. Melmed S, Cook D, Schopohl J, et al. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary 2010;13:18-28
65. Lombardi G, Minuto F, Tamburrano G, et al. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. J Endocrinol Invest 2009;32:202-209
66. Resmini E, Dadati P, Ravetti JL, et al. Rapid pituitary tumor shrinkage with dissociation between antiproliferative and antisecretory effects of a long-acting octreotide in an acromegalic patient. J Clin Endocrinol Metab 2007;92:1592-1599
67. Colao A, Auriemma RS, Rebora A, et al. Significant tumour shrinkage after 12 months of lanreotide Autogel-120 mg treatment given first-line in acromegaly. Clin Endocrinol (Oxf) 2009;71:237-245
68. Resmini E, Murialdo G, Giusti M, et al. Pituitary tumor disappearance in a patient with newly diagnosed acromegaly primarily treated with octreotide LAR. J Endocrinol Invest 2005;28:166-169
69. Livadas S, Hadjidakis DJ, Argyropoulou MI, et al. Disappearance of a growth hormone secreting macro adenoma during long-term somatostatin analogue administration and recurrence following somatostatin withdrawal. Hormones (Athens) 2006;5:57-63
70. Auriemma RS, Galdiero M, Grasso LF, et al. Complete disappearance of a GH-secreting pituitary macroadenoma in a patient with acromegaly: effect of treatment with lanreotide Autogel and consequence of treatment withdrawal. Eur J Endocrinol 2010;162:993-999
71. Kelly P, Maher KT, Chew SL, et al. A single-center open-label study to investigate the efficacy and safety of repeated subcutaneous injections of lanreotide Autogel in patients with acromegaly previously treated with octreotide. Endocr Pract 2010;16:191-197
72. Salvatori R, Nachtigall LB, Cook DM, et al. Effectiveness of self- or partner-administration of an extended-release aqueous-gel formulation of lanreotide in lanreotide-naive patients with acromegaly. Pituitary 2010;13:115-122
73. Mao ZG, Zhu YH, Tang HL, et al. Preoperative lanreotide treatment in acromegalic patients with macroadenomas increases short-term postoperative cure rates: a prospective, randomised trial. Eur J Endocrinol 2010;162:661-666
74. OToole D, Ducreux M, Bommelaer G, et al. Treatment of carcinoid syndrome: a prospective crossover evaluation of lanreotide versus octreotide in terms of efficacy, patient acceptability, and tolerance. Cancer 2000;88:770-776
75. Rinke A, Muller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol 2009;27:4656-4663
76. Colao A, Martino E, Cappabianca P, et al. First-line therapy of acromegaly: a statement of the A.L.I.C.E. (Acromegaly primary medical treatment Learning and Improvement with Continuous Medical Education) Study Group. J Endocrinol Invest 2006;29:1017-1020
77. Carlsen SM, Lund-Johansen M, Schreiner T, et al. Preoperative octreotide treatment in newly diagnosed acromegalic patients with macroadenomas increases cure short-term postoperative rates: a prospective, randomized trial. J Clin Endocrinol Metab 2008;93:2984-2990
78. Caron P, Beckers A, Cullen DR, et al. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegaly. J Clin Endocrinol Metab 2002;87:99-104
79. Chanson P, Borson-Chazot F, Kuhn JM, et al. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf) 2008;69:299-305
80. Lucas T, Astorga R. Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial. Clin Endocrinol (Oxf) 2006;65:320-326