title: Randomized, double-blind, placebo-controlled trial of long-acting release octreotide for treatment of Graves' ophthalmopathy.
abstract: BACKGROUND
  Despite a strong rationale for trials of somatostatin analogs in the treatment of Graves' ophthalmopathy (GO), recent studies have provided conflicting results.
  
  
  OBJECTIVE
  The objective of the study was to determine whether octreotide long-acting release (LAR) is effective treatment for active GO.
  
  
  METHODS
  This was a prospective, randomized, double-blind, placebo-controlled study.
  
  
  METHODS
  The setting was a single tertiary referral center.
  
  
  METHODS
  Twenty-nine consecutive euthyroid patients with active GO [clinical activity score (CAS) >or= 3] were enrolled; 25 completed the study.
  
  
  METHODS
  Patients received four monthly doses of either octreotide LAR (20 mg) or saline by im injections.
  
  
  METHODS
  Primary measure was a change in CAS; the secondary measure was changes in retrobulbar tissue volume, proptosis, lid fissure width, range of motion, and diplopia fields.
  
  
  RESULTS
  Median (range) CAS change was 2.5 (1, 5) in the treatment and 1.0 (0, 7) in the placebo group (P = 0.02). Median lid fissure width improved in the treatment group, (decreased 1 mm on the right and 0.5 mm on the left), compared with the placebo group (no change on the right, P < 0.01; increased 1 mm on the left, P < 0.01). No other significant differences between groups were identified.
  
  
  CONCLUSIONS
  CAS improved to a greater extent in octreotide-LAR-treated patients than the control group. However, this finding may not represent clinical benefit because patients with higher baseline CAS were overrepresented in the treatment group, and the control group was small. In contrast, treatment-related improvement in eyelid fissure width was noted, suggesting that octreotide LAR may be useful in the treatment of a subgroup of active GO patients with significant lid retraction.
authors.affiliation: Department of Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905, USA.
authors.forename: Marius N
authors.initials: MN
authors.lastname: Stan
authors.forename: James A
authors.initials: JA
authors.lastname: Garrity
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Bradley
authors.forename: John J
authors.initials: JJ
authors.lastname: Woog
authors.forename: Mark M
authors.initials: MM
authors.lastname: Bahn
authors.forename: Michael D
authors.initials: MD
authors.lastname: Brennan
authors.forename: Sandra C
authors.initials: SC
authors.lastname: Bryant
authors.forename: Sara J
authors.initials: SJ
authors.lastname: Achenbach
authors.forename: Rebecca S
authors.initials: RS
authors.lastname: Bahn
mesh_terms: D000368:Aged; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004311:Double-Blind Method; D005123:Eye / Q000033:anatomy & histology; D005260:Female; D049970:Graves Ophthalmopathy / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D012107:Research Design; D013004:Somatostatin / Q000031:analogs & derivatives; D011795:Surveys and Questionnaires; D013997:Time Factors; D014787:Vision Tests; D014785:Vision, Ocular / Q000187:drug effects
chemical_list: D003692:Delayed-Action Preparations; D010919:Placebos; D013004:Somatostatin; D015282:Octreotide