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Randomized, double-blind, placebo-controlled trial of long-acting release octreotide for treatment of Graves' ophthalmopathy.

CONTEXT: 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.

DESIGN: This was a prospective, randomized, double-blind, placebo-controlled study.

SETTING: The setting was a single tertiary referral center.

PATIENTS: Twenty-nine consecutive euthyroid patients with active GO [clinical activity score (CAS) >or= 3] were enrolled; 25 completed the study.

INTERVENTION: Patients received four monthly doses of either octreotide LAR (20 mg) or saline by im injections.

MAIN OUTCOME MEASURES: 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.

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