title: Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly: a randomized, open-label, multicentre study.
abstract: OBJECTIVE
  This prospective randomized study evaluated the efficacy and safety of octreotide LAR vs. surgery in newly diagnosed acromegalic patients.
  
  
  METHODS
  Totally 104 male and female patients were enrolled in a 50-week, exploratory, open-label and randomized study. Eligible patients were randomized to receive either octreotide LAR 20 mg every 28 days or to undergo surgery. Efficacy was assessed by changes in mean GH and IGF-I serum concentrations, at weeks 12, 24 and 48. Tumour volume was assessed by contrast-enhanced MRI. In both groups, treatment adjustment was performed for patients uncontrolled at week 12 or 24. Octreotide LAR patients received a dose increased to 30 mg or, if already receiving this dose, investigator and patients could decide to cross-over to surgery. Patients uncontrolled after surgery received octreotide LAR 20 mg, increased to 30 mg if acromegaly was still uncontrolled.
  
  
  RESULTS
  Overall success rates at weeks 24 and 48 were 25% and 28% for the octreotide LAR group and 49% and 39% for the surgery group. Only the difference observed at week 24 was statistically significant (P = 0.047). Both groups had a significant (> 20%) tumour shrinkage: 73% of patients in the octreotide LAR group and 95% in the surgery group. Major differences between octreotide LAR and surgery group in the occurrence of adverse events were gastrointestinal (71%vs. 27%), hepatobiliary (41%vs. 8%) and respiratory (5%vs. 28%).
  
  
  CONCLUSIONS
  This first randomized study in unselected patients indicates that the 48-week treatment outcome of octreotide LAR as first-line treatment of acromegaly does not significantly differ from surgery. As a complete response to surgery in GH-secreting macro-adenomas can be difficult, first-line therapy with octreotide LAR can be considered as a viable alternative for most patients with acromegaly, due to its low complication rate.
authors.affiliation: Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology, Federico II University of Naples, Naples, Italy. colao@unina.it
authors.forename: Annamaria
authors.initials: A
authors.lastname: Colao
authors.forename: Paolo
authors.initials: P
authors.lastname: Cappabianca
authors.forename: Philippe
authors.initials: P
authors.lastname: Caron
authors.forename: Ernesto
authors.initials: E
authors.lastname: De Menis
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Farrall
authors.forename: Monica R
authors.initials: MR
authors.lastname: Gadelha
authors.forename: Abdel
authors.initials: A
authors.lastname: Hmissi
authors.forename: Aled
authors.initials: A
authors.lastname: Rees
authors.forename: Martin
authors.initials: M
authors.lastname: Reincke
authors.forename: Mitra
authors.initials: M
authors.lastname: Safari
authors.forename: Guy
authors.initials: G
authors.lastname: T'Sjoen
authors.forename: Hakim
authors.initials: H
authors.lastname: Bouterfa
authors.forename: Ross C
authors.initials: RC
authors.lastname: Cuneo
mesh_terms: D000172:Acromegaly / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery*; D000328:Adult; D000368:Aged; D005260:Female; D049912:Growth Hormone-Secreting Pituitary Adenoma / Q000097:blood / Q000150:complications / Q000188:drug therapy / Q000601:surgery; D019382:Human Growth Hormone / Q000097:blood; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I; D015282:Octreotide