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

Clinical Endocrinology

Volumn 66, Issue 6, 2007, Pages 859-868

  Mercado, Moises ^a   Borges, Fatima ^b   Bouterfa, Hakim ^c   Chang, Tien Chun ^d   Chervin, Alberto ^e   Farrall, Andrew J ^f   Patocs, Attila ^g   Petersenn, Stephan ^h   Podoba, Jan ⁱ   Safari, Mitra ^c   Wardlaw, Joanna ^f  

^a HOSPITAL DE ESPECIALIDADES   (Mexico)

^b HOSPITAL DE SANTO ANTÓNIO   (Portugal)

^c NOVARTIS PHARMA AG   (Switzerland)

^d NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^e Hospital Oftalmologico Santa Lucia   (Argentina)

^f UNIVERSITY OF EDINBURGH   (United Kingdom)

^g SEMMELWEIS UNIVERSITY   (Hungary)

^h UNIVERSITY HOSPITAL ESSEN   (Germany)

ⁱ V Interna Klinika LF UK a FNsP   (Slovakia)

Author keywords

[No Author keywords available]

Indexed keywords

GROWTH HORMONE; LONG ACTING DRUG; OCTREOTIDE; SOMATOMEDIN C;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ACROMEGALY; ADULT; AGED; ALTERNATIVE MEDICINE; ARTICLE; BIOCHEMISTRY; CHOLELITHIASIS; CLINICAL TRIAL; DIARRHEA; DISEASE SEVERITY; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HORMONE BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; MICROADENOMA; MULTICENTER STUDY; NAUSEA; POPULATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROTEIN BLOOD LEVEL; SYMPTOM; TUMOR REGRESSION; TUMOR VOLUME;

ACROMEGALY; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, HORMONAL; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; FEASIBILITY STUDIES; FEMALE; GALLBLADDER; GROWTH HORMONE; GROWTH HORMONE-SECRETING PITUITARY ADENOMA; HUMANS; INSULIN-LIKE GROWTH FACTOR I; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; OCTREOTIDE; PITUITARY NEOPLASMS; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 34347380169     PISSN: 03000664     EISSN: 13652265     Source Type: Journal    
DOI: 10.1111/j.1365-2265.2007.02825.x     Document Type: Article

References (29)

1. Molitch, M.E. (1992) Clinical manifestations of acromegaly. Endocrinology and Metabolism Clinics of North America, 21, 597 614.
2. Melmed, S., Ho, K., Klibsanski, A., Reichlin, S. Thorner, M. (1995) Clinical review 75: recent advances in pathogenesis, diagnosis, and management of acromegaly. Journal of Clinical Endocrinology and Metabolism, 80, 3395 3402.
3. Rajasoorya, I., Holdaway, I.M., Wrightson, P., Scott, D.J. Ibbertson, H.K. (1994) Determinants of clinical outcome and survival in acromegaly. Clinical Endocrinology, 41, 95 102.
4. Holdaway, I.M., Rajasoorya, R.C. Gamble, G.D. (2004) Factors influencing mortality in acromegaly. Journal of Clinical Endocrinology and Metabolism, 89, 667 674.
5. Melmed, S., Casanueva, F.F., Cavagnini, F., Chanson, P., Frohman, L., Grossman, A., Ho, K., Kleinberg, D., Lamberts, S., Laws, E., Lombardi, G., Vance, M.L., Werder, K.V., Wass, J. Giustina, A. (2002) Guidelines for acromegaly management. Journal of Clinical Endocrinology and Metabolism, 87, 4054 4058.
6. Giustina, A. Melmed, S. (2003) Acromegaly consensus: the next steps. Journal of Clinical Endocrinology and Metabolism, 88, 1913 1914.
7. Melmed, S., Casanueva, F., Cavagnini, F., Chanson, P., Frohman, L.A., Gaillard, R., Ghigo, E., Ho, K., Jaquet, P., Kleinberg, D., Lamberts, S., Laws, E., Lombardi, G., Sheppard, M.C., Thorner, M., Vance, M.L., Wass, J.A. Giustina, A. (2005) Consensus statement: medical management of acromegaly. European Journal of Endocrinology, 153, 737 740.
8. Sheaves, R., Jenkins, P., Blackburn, P., Huneidi, A.M., Afshar, F., Medback, S., Grossman, A.B., Besser, G.M. Wass, J.A. (1996) Outcome of transsphenoidal surgery for acromegaly using strict criteria for surgical cure. Clinical Endocrinology, 45, 407 413.
9. Swearingen, B., Barker, F.G., Katznelson, L., Biller, B.M., Grinspoon, S., Klibanski, A., Moayeri, N., Black, P.M. Zervas, N.T. (1998) Long-term mortality after transsphenoidal surgery and adjunctive therapy for acromegaly. Journal of Clinical Endocrinology and Metabolism, 83, 3409 3410.
10. Nomitos, P., Buchfelder, M. Fahlbusch, R. (2005) The outcome of surgery in 668 patients with acromegaly using current criteria of biochemical cure. European Journal of Endocrinology, 152, 379 387.
11. Espinosa-de-Ios-Monteros, A.L., Sosa, E., Cheng, S., Ochoa, R., Sandoval, C., Guinto, G., Mendoza, V., Hernández, I., Molina, M. Mercado, M. (2006) Biochemical evaluation of disease activity after pituitary surgery in acromegaly: a critical analysis of patients who spontaneously change disease status. Clinical Endocrinology, 64, 245 249.
12. Sheppard, M.C. (2003) Primary medical therapy for acromegaly. Clinical Endocrinology, 58, 387 399.
13. Colao, A., Ferone, D., Marzullo, P., Cappabianca, P., Cirillo, S., Boerlin, V., Lancranjan, I. Lombardi, G. (2001) Long-term effects of depot long-acting somatostatin analog octreotide on hormone levels and tumour mass in acromegaly. Journal of Clinical Endocrinology and Metabolism, 86, 2779 2786.
14. Bevan, J.S., Atkin, S.L., Atkinson, A.B., Bouloux, P.-M., Hanna, F., Harris, P.E., James, R.A., McConnell, M., Roberrts, G.A., Scanlon, M.F., Stewart, P.M., Teasdale, E., Turner, H.E., Wass, J.A.H. Wardlaw, J.M. (2002) Primary medical therapy for acromegaly: an open, prospective, multicenter study of the effects of subcutaneous and intramuscular slow release octreotide on growth hormone, insulin-like growth factor-1 and tumour size. Journal of Clinical Endocrinology and Metabolism, 87, 4554 4563.
15. Cozzi, R., Attanasio, R., Montini, M., Pagani, G., Lasio, G., Lodrini, S., Barausse, M., Albizzi, M., Dallabonzana, D. Pedroncelli, A.M. (2003) Four-year treatment with octreotide-long-acting repeatable in 110 acromegalic patients: predictive value of short-term results? Journal of Clinical Endocrinology and Metabolism, 88, 3090 3098.
16. Ayuk, J., Stewart, S.E., Stewart, P.M. Sheppard, M.C. the European Sandostatin® LAR® Group (2004) Efficacy of Sandostatin® LAR® (long-acting somatostatin analogue) is similar in patients with untreated acromegaly and in those previously treated with surgery and/or radiotherapy. Clinical Endocrinology, 60, 375 381.
17. Lundin, P. Pedersen, F. (1992) Volume of pituitary macroadenomas: assessment by MRI. Journal of Computer Assisted Tomography, 16, 519 528.
18. Clooper, C. Pearson, S. (1934) The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika, 26, 404 413.
19. Spada, A., Arosio, M., Bochicchio, D., Bazzoni, N., Vallar, L., Bassetti, M. Faglia, G. (1990) Clinical, biochemical, and morphological correlates in patients bearing growth hormone-secreting pituitary tumours with or without constitutively active adenylyl cyclase. Journal of Clinical Endocrinology and Metabolism, 71, 1421 1426.
20. Barlier, A., Gunz, G., Zamora, A.J., Morange-Ramos, I., Figarella-Branger, D. Dufour, H. (1998) Prognostic and therapeutic consequences of Gs alpha mutations in somatotroph adenomas. Journal of Clinical Endocrinology and Metabolism, 83, 1604 1610.
21. Kim, H.J., Kim, M.S., Park, Y.J., Kim, S.W., Park, D.J., Park, K.S., Kim, S.Y., Cho, B.Y., Lee, H.K., Jung, H.W., Han, D.H., Lee, H.S. Chi, J.G. (2001) Prevalence of Gs alpha mutations in Korean patients with pituitary adenomas. Journal of Endocrinology, 168, 221 226.
22. Mendoza, V., Sosa, E., Espinosa-de-Los-Monteros, A.L., Salcedo, M., Guinto, G., Cheng, S., Sandoval, C. Mercado, M. (2005) GSP alpha mutations in Mexican patients with acromegaly: potential impact on long term prognosis. Growth Hormone and IGF Research, 15, 28 32.
23. Cozzi, R., Montini, M., Attanasio, R., Albizzi, M., Lasio, G., Lodrini, S., Doneda, P., Cortesi, L. Pagani, G. (2006) 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 tumour shrinkage. Journal of Clinical Endocrinology and Metabolism, 91, 1397 1403.
24. Colao, A., Pivonello, R., Rosato, F., Tita, P., De Menis, E., Barreca, A., Ferrara, R., Mainini, F., Arosio, M. Lombardi, G. (2006) First-line octreotide-LAR therapy induces tumour shrinkage and controls hormone excess in patients with acromegaly: results from an open, prospective, multicentre trial. Clinical Endocrinology, 64, 342 351.
25. Freda, P.U. (2002) Somatostatin analogs in acromegaly. Journal of Clinical Endocrinology and Metabolism, 87, 3013 3018.
26. Bevan, J.S. (2005) The antitumoural effects of somatostatin analog therapy in acromegaly. Journal of Clinical Endocrinology and Metabolism, 90, 1856 1863.
27. Melmed, S., Sternberg, R., Cook, D., Kilbanski, A., Chanson, P., Bonert, V., Vance, M.L., Rhew, D., Kleinberg, D. Barkan, A. (2005) A critical analysis of pituitary tumour shrinkage during primary medical therapy in acromegaly. Journal of Clinical Endocrinology and Metabolism, 90, 4405 4410.
28. Jaquet, P., Saveanu, A., Gunz, G., Fina, F., Zamora, A.J., Grino, M., Culler, M.D., Moreau, J.P., Enjalbert, A. Ouafik, L.H. (2000) Human somatostatin receptor subtypes in acromegaly: distinct patterns of messenger ribonucleic acid expression and hormone suppression identify different tumoural phenotypes. Journal of Clinical Endocrinology and Metabolism, 85, 781 792.
29. Casarini, A.P., Pinto, E.M., Jallad, R.S., Giorgi, R.R., Giannella-Neto, D. Bronstein, M.D. (2006) Dissociation between tumour shrinkage and hormonal response during somatostatin analog treatment in an acromegalic patient: preferential expression of somatostatin receptor subtype 3. Journal of Endocrinological Investigation, 29, 826 830.