title: 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.
abstract: OBJECTIVE
  To evaluate the efficacy, safety and tolerability of octreotide LAR (long-acting repeatable octreotide) in the primary therapy of acromegaly.
  
  
  METHODS
  Ninety-eight previously untreated acromegalics were recruited into this prospective multicentre study. A total of 68 patients successfully completed 48 weeks of the study period, received 12 doses of octreotide LAR 10-30 mg every 4 weeks, and constituted the population used for this analysis.
  
  
  RESULTS
  A clinically relevant reduction (i.e. to < or = 5 microg/l) in mean GH (mGH) was recorded in 72% of patients after 24 weeks of treatment, and 42% reached a 'safe' GH value (< or = 2.5 microg/l). At week 48, 16 more patients were considered partial GH responders (GH > 2.5 microg/l and < or = 5 microg/l) and 44% had reached a GH level < or = 2.5 microg/l. IGF-1 levels normalized in 38% and 34% of patients after 24 and 48 weeks of treatment, respectively. At study completion, 10 patients (14.7%) who had not normalized their IGF-1 levels had achieved at least a 50% decrement in this marker. In eight microadenoma patients, tumour volume decreased from a mean baseline level of 298 +/- 145 mm3 to 139 +/- 94 mm3 after 24 weeks and to 99 +/- 70 mm3 after 48 weeks of therapy. In 60 patients with macroadenoma, the corresponding values were 3885 +/- 5077 mm3 at baseline and 2723 +/- 3435 and 2406 +/- 3207 mm3 after 24 and 48 weeks, respectively. At weeks 24 and 48, a significant (> 20%) tumour volume reduction was reported in 63% and 75% of patients, respectively. A reduction in the severity of symptoms of acromegaly was observed early in treatment and was maintained throughout the study period.
  
  
  CONCLUSIONS
  Octreotide LAR represents a viable alternative to surgery for primary treatment of acromegaly leading to a progressive regression of tumour volume, a sustained control of biochemical abnormalities and an adequate relief of symptoms of the disease.
authors.affiliation: Hospital de Especialidades, Centro Medico Nacional Siglo XXI, IMSS, Mexico City, Mexico. moises.mercado@imss.gob.mx
authors.forename: Moises
authors.initials: M
authors.lastname: Mercado
authors.forename: Fatima
authors.initials: F
authors.lastname: Borges
authors.forename: Hakim
authors.initials: H
authors.lastname: Bouterfa
authors.forename: Tien-Chun
authors.initials: TC
authors.lastname: Chang
authors.forename: Alberto
authors.initials: A
authors.lastname: Chervin
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Farrall
authors.forename: Attila
authors.initials: A
authors.lastname: Patocs
authors.forename: Stephan
authors.initials: S
authors.lastname: Petersenn
authors.forename: Jan
authors.initials: J
authors.lastname: Podoba
authors.forename: Mitra
authors.initials: M
authors.lastname: Safari
authors.forename: Joanna
authors.initials: J
authors.lastname: Wardlaw
mesh_terms: D000172:Acromegaly / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005704:Gallbladder / Q000000981:diagnostic imaging; D013006:Growth Hormone / Q000097:blood; D049912:Growth Hormone-Secreting Pituitary Adenoma / Q000097:blood / Q000188:drug therapy / Q000473:pathology; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use*; D010911:Pituitary Neoplasms / Q000097:blood / Q000188:drug therapy / Q000473:pathology; D011446:Prospective Studies; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D018931:Antineoplastic Agents, Hormonal; D003692:Delayed-Action Preparations; D007334:Insulin-Like Growth Factor I; D013006:Growth Hormone; D015282:Octreotide