The role of lanreotide Autogel® in the treatment of acromegaly

Expert Review of Endocrinology and Metabolism

Volumn 2, Issue 4, 2007, Pages 433-441

  Andersen, Marianne ^a  

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

Author keywords

Adenoma; Growth hormone; Lanreotide Autogel ; Pituitary; Somatostatin

Indexed keywords

ANGIOPEPTIN; BIM 23A760; BIM 23A779; BIM 23A781; CABERGOLINE; DOPAMINE RECEPTOR STIMULATING AGENT; GROWTH HORMONE; INSULIN; MICROSPHERE; OCTREOTIDE; PASIREOTIDE; PEGVISOMANT; PERGOLIDE; SOMATOMEDIN C; SOMATOSTATIN DERIVATIVE; SOMATOSTATIN RECEPTOR; UNCLASSIFIED DRUG; WATER;

ABDOMINAL DISCOMFORT; ACROMEGALY; ACUTE CHOLECYSTITIS; ADJUVANT THERAPY; ARTICLE; CHOLECYSTECTOMY; CLINICAL TRIAL; COMORBIDITY; CONTROLLED RELEASE FORMULATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MEGADOSE; DRUG STRUCTURE; DRUG TOLERABILITY; GASTROINTESTINAL SYMPTOM; GROWTH HORMONE SECRETING ADENOMA; HORMONE DETERMINATION; HUMAN; HYPOPITUITARISM; INJECTION SITE NODULE; INSULIN SENSITIVITY; MONOTHERAPY; NAUSEA; ORAL GLUCOSE TOLERANCE TEST; PARKINSON DISEASE; PHARMACODYNAMICS; PRIORITY JOURNAL; PROLACTINOMA; RADIOIMMUNOASSAY; RECEPTOR AFFINITY; RESTLESS LEGS SYNDROME; SIDE EFFECT; SINGLE DRUG DOSE; TRANSSPHENOIDAL SURGERY; TUMOR VOLUME;

EID: 34547526961     PISSN: 17446651     EISSN: None     Source Type: Journal    
DOI: 10.1586/17446651.2.4.433     Document Type: Article

References (92)

1. Kane LA, Leinung MC, Scheithauer BW et al. Pituitary adenomas in childhood and adolescence. J. Clin. Endocrinol. Metab. 79(4), 1135-1140 (1994).
2. Mukai K, Seljeskog EL, Dehner LP. Pituitary adenomas in patients under 20 years old. A clinicopathological study of 12 cases. J. Neurooncol. 4(1), 79-89 (1986).
3. Jagannathan J, Dumont AS, Prevedello DM et al. Genetics of pituitary adenomas: current theories and future implications. Neurosurg. Focus 19(5), E4 (2005).
4. Salehi F, Cohen S, Syro LV et al. Plurihormonality in pituitary adenomas associated with acromegaly. Endocr. Pathol. 17(3), 291-296 (2006).
5. Lamberts SW, Klijn JG, van Vroonhoven CC, Stefanko SZ, Liuzzi A. The role of prolactin in the inhibitory action of bromocriptine on growth hormone secretion in acromegaly. Acta Endocrinol. (Copenh.) 103(4), 446-450 (1983).
6. Andersen M, Hansen TB, Bollerslev J, Bjerre P, Schrøder HD, Hagen C. Effect of 4 weeks of octreotide treatment on prolactin, thyroid stimulating hormone and thyroid hormones in acromegalic patients. A double blind placebo-controlled cross-over study. J. Endocrinol. Invest. 18, 840-846 (1995).
7. Abs R, Verhelst J, Maiter D et al. Cabergoline in the treatment of acromegaly: a study in 64 patients. J. Clin. Endocrinol. Metab. 83(2), 374-378 (1998).
8. Cozzi R, Attanasio R, Lodrini S, Lasio G. Cabergoline addition to depot somatostatin analogues in resistant acromegalic patients: efficacy and lack of predictive value of prolactin status. Clin. Endocrinol. (Oxf.) 61(2), 209-215 (2004).
9. Mestron A, Webb SM, Astorga R et al. Epidemiology, clinical characteristics, outcome, morbidity and mortality in acromegaly based on the Spanish Acromegaly Registry (Registro Espanol de Acromegalia, REA). Eur. J. Endocrinol. 151(4), 439-446 (2004).
10. Bengtsson BA, Eden S, Ernest I, Oden A, Sjogren B. Epidemiology and long-term survival in acromegaly. A study of 166 cases diagnosed between 1955 and 1984. Acta Med. Scand. 223, 327-335 (1988).
11. Alexander L, Appleton D, Hall R, Ross WM, Wilkinson R. Epidemiology of acromegaly in the Newcastle region. Clin. Endocrinol. (Oxf.) 12(1), 71-79 (1980).
12. Etxabe J, Gaztambide S, Latorre P, Vazquez JA. Acromegaly: an epidemiological study. J. Endocrinol. Invest. 16(3), 181-187 (1993).
13. Ritchie CM, Atkinson AB, Kennedy AL et al. Ascertainment and natural history of treated acromegaly in Northern Ireland. Ulster Med. J. 59(1), 55-62 (1990).
14. Melmed S. Medical progress: acromegaly. N. Engl. J. Med. 355(24), 2558-2573 (2006).
15. Andersen M, Hagen C, Frystyk J, Schroeder HD, Hagen C. Development of acromegaly in patients with prolactinomas. Eur. J. Endocrinol. 149(1), 17-22 (2003).
16. Sakharova AA, Dimaraki EV, Chandler WF, Barkan AL. Clinically silent somatotropinomas may be biochemically active. J. Clin. Endocrinol. Metab. 90(4), 2117-2121 (2005).
17. Clemmons DR. Clinical utility of measurements of insulin-like growth factor 1. Nat. Clin. Pract. Endocrinol. Metab. 2(8), 436-446 (2006).
18. Giustina A, Barkan A, Casanueva FF et al. Criteria for cure of acromegaly: a consensus statement. J. Clin. Endocrinol. Metab. 85(2), 526-529 (2000).
19. Baumann G. Growth hormone heterogeneity: genes, isohormones, variants, and binding proteins. Endocr. Rev. 12(4), 424-449 (1991).
20. Baumann G, Stolar MW. Molecular forms of human growth hormone secreted in vivo. nonspecificity of secretory stimuli. J. Clin. Endocrinol. Metab. 62(4), 789-790 (1986).
21. Baumann G, Stolar MW, Amburn K. Molecular forms of circulating growth hormone during spontaneous secretory episodes and in the basal state. J. Clin. Endocrinol. Metab. 60(6), 1216-1220 (1985).
22. Jansson C, Boguszewski C, Rosberg S, Carlsson L, Albertsson-Wikland K. Growth hormone (GH) assays: influence of standard preparations, GH isoforms, assay characteristics, and GH-binding protein. Clin. Chem. 43(6 Pt 1), 950-956 (1997).
23. Andersen M, Petersen PH, Blaabjerg O, Hangaard J, Hagen C. Evaluation of growth hormone assays using ratio plots. Clin. Chem. 44(5), 1032-1038 (1998).
24. Leung KC, Howe C, Gui LY, Trout G, Veldhuis JD, Ho KK. Physiological and pharmacological regulation of 20-kDa growth hormone. Am. J. Physiol. Endocrinol. Metab 283(4), E836-E843 (2002).
25. Ronchi CL, Arosio M, Rizzo E, Lania AG, Beck-Peccoz P, Spada A. Adequacy of current postglucose GH nadir limit (<1 microg/1) to define long-lasting remission of acromegalic disease. Clin. Endocrinol. (Oxf.) 66(4), 538-542 (2007).
26. Freda PU, Nuruzzaman AT, Reyes CM, Sundeen RE, Post KD. Significance of "abnormal" nadir growth hormone levels after oral glucose in postoperative patients with acromegaly in remission with normal insulin-like growth factor-I levels. J. Clin. Endocrinol. Metab. 89(2), 495-500 (2004).
27. Dimaraki EV, Jaffe CA, Mott-Friberg R, Chandler WF, Barkan AL. Acromegaly with apparently normal GH secretion: implications for diagnosis and follow-up. J. Clin. Endocrinol. Metab. 87(8), 3537-3542 (2002).
28. Puder JJ, Nilavar S, Post KD, Freda PU. Relationship between disease-related morbidity and biochemical markers of activity in patients with acromegaly. J. Clin. Endocrinol. Metab. 90(4), 1972-1978 (2005).
29. Jones JI, Clemmons DR. Insulin-like growth factors and their binding proteins: biological actions. Endocr. Rev. 16(1), 3-34 (1995).
30. Daughaday WH, Kapadia M, Mariz I. Serum somatomedin binding proteins: physiologic significance and interference in radioligand assay. J. Lab. Clin. Med. 109(3), 355-363 (1987).
31. Juul A. Determination of insulin-like growth factor I in children: normal values and clinical use. Horm. Res. 55(Suppl. 2), 94-99 (2001).
32. Clemmons DR. Commercial assays available for insulin-like growth factor I and their use in diagnosing growth hormone deficiency. Horm. Res. 55(Suppl. 2), 73-79 (2001).
33. Melmed S. Mechanisms for pituitary tumorigenesis: the plastic pituitary. J. Clin. Invest. 112(11), 1603-1618 (2003).
34. Weinstein LS, Shenker A, Gejman PV, Merino MJ, Friedman E, Spiegel AM. Activating mutations of the stimulatory G protein in the McCune-Albright syndrome. N. Engl. J. Med. 325(24), 1688-1695 (1991).
35. Vallar L, Spada A, Giannattasio G. Altered Gs and adenylate cyclase activity in human GH-secreting pituitary adenomas. Nature 330(6148), 566-568 (1987).
36. Ludecke DK, Abe T. Transsphenoidal microsurgery for newly diagnosed acromegaly: a personal view after more than 1,000 operations. Neuroendocrinology 83(3-4), 230-239 (2006).
37. Nomikos P, Buchfelder M, Fahlbusch R. The outcome of surgery in 668 patients with acromegaly using current criteria of biochemical 'cure'. Eur. J. Endocrinol. 152(3), 379-387 (2005).
38. Grottoli S, Celleno R, Gasco V et al. Efficacy and safety of 48 weeks of treatment with octreotide LAR in newly diagnosed acromegalic patients with macroadenomas: an open-label, multicenter, non-comparative study. J. Endocrinol. Invest. 28(11), 978-983 (2005).
39. Cozzi R, Montini M, Attanasic, R et al. Primary treatment of acromegaly with octreotide LAR: a long-term (up to nine years) prospective study of its efficacy in the control of disease activity and tumor shrinkage. J. Clin. Endocrinol. Metab. 91(4), 1397-1403 (2006).
40. 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.) 66(6), 859-868 (2007).
41. Colao A, Pivonello, R, Rosato F et al. First-line octreotide-LAR therapy induces tumour shrinkage and controls hormone excess in patients with acromegaly: results from an open, prospective, multicentre trial. Clin. Endocrinol. (Oxf.) 64(3), 342-351 (2006).
42. Lucas T, Astorga R, Catala M. Preoperative lanreotide treatment for GH-secreting pituitary adenomas: effect on tumour volume and predictive factors of significant tumour shrinkage. Clin. Endocrinol. (Oxf.) 58(4), 471-481 (2003).
43. Colac, A, Attanasio R, Pivonello R et al. Partial surgical removal of growth hormone-secreting pituitary tumors enhances the response to somatostatin analogs in acromegaly. J. Clin. Endocrinol. Metab. 91(1), 85-92 (2006).
44. Ayuk J, Clayton RN, Holder G, Sheppard MC, Stewart PM, Bates AS. Growth hormone and pituitary radiotherapy, but not serum insulin-like growth factor-I concentrations, predict excess mortality in patients with acromegaly. J. Clin. Endocrinol. Metab. 89(4), 1613-1617 (2004).
45. Orme SM, McNally RJ, Cartwright RA, Belchetz PE. Mortality and cancer incidence in acromegaly: a retrospective cohort study. United Kingdom Acromegaly Study Group. J. Clin. Endocrinol. Metab. 83(8), 2730-2734 (1998).
46. Holdaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J. Clin. Endocrinol. Metab. 89(2), 667-674 (2004).
47. Biermasz NR, Dekker FW, Pereira AM et al. Determinants of survival in treated acromegaly in a single center: predictive value of serial insulin-like growth factor I measurements. J. Clin. Endocrinol. Metab. 89(6), 2789-2796 (2004).
48. Monson JP. Is there still a role for radiotherapy in acromegaly? Neuroendocrinology 83(3-4), 269-273 (2006).
49. Minniti G, Traish D, Ashley S, Gonsalves A, Brada M. Fractionated stereotactic conformal radiotherapy for secreting and nonsecreting pituitary adenomas. Clin. Endocrinol. (Oxf.) 64(5), 542-548 (2006).
50. Sheehan JP, Jagannathan J, Pouratian N, Steiner L. Stereotactic radiosurgery for pituitary adenomas: a review of the literature and our experience. Front Horm. Res. 34, 185-205 (2006).
51. Tomlinson JW, Holden N, Hills RK et al. Association between premature mortality and hypopituitarism. West Midlands Prospective Hypopituitary Study Group. Lancet 357(9254), 425-431 (2001).
52. Biermasz NR, van Thiel SW, Pereira AM et al. Decreased quality of life in patients with acromegaly despite long-term cure of growth hormone excess. J. Clin. Endocrinol. Metab. 89(11), 5369-5376 (2004).
53. Rowles SV, Prieto L, Badia X, Shalet SM, Webb SM. Trainer PJ. Quality of life (QOL) in patients with acromegaly is severely impaired: use of a novel measure of QOL: acromegaly quality of life questionnaire. J. Clin. Endocrinol. Metab. 90(6), 3337-3341 (2005).
54. Kauppinen-Makelin R, Sane T, Sintonen H et al. Quality of life in treated patients with acromegaly. J. Clin. Endocrinol. Metab. 91(10), 3891-3896 (2006).
55. Webb SM. Quality of life in acromegaly. Neuroendocrinology 83(3-4), 224-229 (2006).
56. Burt MG, Ho KK. Newer options in the management of acromegaly. Intern. Med. J. 36(7), 437-444 (2006).
57. Gatta B, Hau DH, Catargi B, Roger P, Tabarin A. Re-evaluation of the efficacy of the association of cabergoline to somatostatin analogues in acromegalic patients. Clin. Endocrinol. (Oxf.) 63(4), 477-478 (2005).
58. Fuh G, Cunningham BC, Fukunaga R, Nagata S, Goeddel DV, Wells JA. Rational design of potent antagonists to the human growth hormone receptor. Science 256(5064), 1677-1680 (1992).
59. van der Lely AJ, Hutson RK, Trainer PJ et al. Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist. Lancet 358(9295), 1754-1759 (2001).
60. Besser GM, Burman P, Daly AF, Predictors and rates of treatment-resistant tumor growth in acromegaly. Eur. J. Endocrinol. 153(2), 187-193 (2005).
61. Lindberg-Larsen R, Moller N, Schmitz O et al. The impact of pegvisomant treatment on substrate metabolism and insulin sensitivity in patients with acromegaly. J. Clin. Endocrinol. Metab. 92(5), 1724-1728 (2007).
62. Feenstra J, de Herder WW, ten Have SM et al. Combined therapy with somatostatin analogues and weekly pegvisomant in active acromegaly. Lancet 365(9471), 1644-1646 (2005).
63. Jorgensen JO, Feldt-Rasmussen U, Frystyk J et al. Cotreatment of acromegaly with a somatostatin analog and a growth hormone receptor antagonist. J. Clin. Endocrinol. Metab. 90(10), 5627-5631 (2005).
64. Vitale G, Pivonello R, Ferone D et al. The role of somatostatin receptors in the medical treatment of acromegaly. Dig. Liver Dis. 36(Suppl. 1), S55-S59 (2004).
65. Lamberts SW, van der Lely AJ, de Herder WW, Holland LJ. Octreotide. N. Engl. J. Med. 334, 246-254 (1996).
66. van der Hoek J, Lamberts SW, Hofland LJ. Preclinical and clinical experiences with the role of somatostatin receptors in the treatment of pituitary adenomas. Eur. J. Endocrinol. 156(Suppl. 1), S45-S51 (2007).
67. 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. 76(3), 721-727 (1993).
68. Lancranjan I, Bruns C, Grass P et al. Sandostatin LAR: a promising therapeutic tool in the management of acromegalic patients. Metabolism 45 (8 Suppl. 1), 67-71 (1996).
69. Cozzi R, Dallabonzana D, Attanasio R, Barausse M, Oppizzi G. A comparison between octreotide-LAR and lanreotide-SR in the chronic treatment of acromegaly. Eur. J. Endocrinol. 141(3), 267-271 (1999).
70. Turner HE, Vadivale A, Keenan J, Wass JA. A comparison of lanreotide and octreotide LAR for treatment of acromegaly. Clin. Endocrinol. (Oxf.) 51(3), 275-280 (1999).
71. Freda PU, Katznelson L, van der Lely AJ, Reyes CM, Zhao S, Rabinowitz D. Long-acting somatostatin analog therapy of acromegaly: a meta-analysis. J. Clin. Endocrinol. Metab. 90(8), 4465-4473 (2005).
72. Flogstad AK, Halse J, Haldorsen T et al. Sandostatin LAR in acromegalic patients: a dose-range study. J. Clin. Endocrinol. Metab. 80(12), 3601-3607 (1995).
73. 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. 56(4), 471-476 (2004).
74. 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.) 65(3), 320-326 (2006).
75. Saveanu A, Gunz G, Dufour H et al. Bim-23244, a somatostatin receptor subtype 2- and 5-selective analog with enhanced efficacy in suppressing growth hormone (GH) from octreotide-resistant human GH-secreting adenomas. J. Clin. Endocrinol. Metab. 86(1), 140-145 (2001).
76. Bronstein MD. Acromegaly: molecular expression of somatostatin receptor subtypes and treatment outcome. Front. Horm. Res. 35, 129-134 (2006).
77. Hofland LJ, Lamberts SW. The pathophysiological consequences of somatostatin receptor internalization and resistance. Endocr. Rev. 24(1), 28-47 (2003).
78. Cendros JM, Peraire C, Troconiz IF, Obach R. Pharmacokinetics and population pharmacodynamic analysis of lanreotide Autogel. Metabolism 54 (10), 1276-1281 (2005).
79. 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.) 63(5), 514-519 (2005).
80. Caron P, Cogne M, Raingeard I, Bex-Bachellerie V, Kuhn JM. Effectiveness and tolerability of 3-year lanreotide Autogel. treatment in patients with acromegaly, Clin. Endocrinol. (Oxf.) 64(2), 209-214 (2006).
81. 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. 87(1), 99-104 (2002).
82. 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.) 60(6), 734-740 (2004).
83. van Thiel SW, Romijn JA Biermasz NR et al. Octreotide long-acting repeatable and lanreotide Autogel are equally effective in controlling growth hormone secretion in acromegalic patients. Eur. J. Endocrinol. 150(4), 489-495 (2004).
84. Ashwell SG, Bevan JS, Edwards OM et al. The efficacy and safety of lanreotide Autogel in patients with acromegaly previously treated with octreotide LAR. Eur. J. Endocrinol. 150(4), 473-480 (2004).
85. Alexopoulou O, Abrams P, Verhelst J et al. Efficacy and tolerability of lameotide Autogel therapy in acromegalic patients previously treated with octreotide LAR. Eur. J. Endocrinol. 151(3), 317-324 (2004).
86. Andersen M, Andries M, Flogstad A, Gram J, Hagen C. Comparable effects of lanreotide Autogel and Sandostatin LAR, a 12 months cross-over study in acromegalic patients. Presented at: 12th International Congress of Endocrinology (ICE). Lisbon, Portugal, 31 August-4 September 2004 (Poster).
87. Pereira AM, Biermasz NR, Roelfsema F, Romijn JA. Pharmacologic therapies for acromegaly: a review of their effects on glucose metabolism and insulin resistance. Treat. Endocrinol. 4(1), 43-53 (2005).
88. Steffin B, Gutt B, Bidlingmaier M, Dieterle C, Oltmann F, Schopohl J. Effects of the long-acting somatostatin analogue Lanreotide Autogel on glucose tolerance and insulin resistance in acromegaly. Eur. J. Endocrinol. 155(1), 73-78 (2006).
89. Gutt B, Bidlingmaier M, Kretschmar K, Dieterle C, Steffin B, Schopohl J. Four-year follow-up of acromegalic patients treated with the new long-acting formulation of lanreotide (lanreotide Autogel). Exp. Clin. Endocrinol. Diabetes 113(3), 139-144 (2005).
90. Cozzi R, Attanasio R, Montini M et al. Four-year treatment with octreotide-long-acting repeatable in 110 acromegalic patients: predictive value of short-term results? J. Clin. Endocrinol. Metab. 88(7), 3090-3098 (2003).
91. Saveanu A, Gunz G, Guillen S, Dufour H, Culler MD, Jaquet P. Somatostatin and dopamine-somatostatin multiple ligands directed towards somatostatin and dopamine receptors in pituitary adenomas. Neuroendocrinology 83(3-4), 258-263 (2006).
92. Schade R, Andersohn F, Suissa S, Haverkamp W, Garbe E. Dopamine agonists and the risk of cardiac-valve regurgitatlon. N. Engl. J. Med. 356(1), 29-38 (2007).