This Article Full Text Full Text (PDF) Submit a related Letter to the Editor Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Copyright Permission Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Dickinson, A. J. Articles by Kendall-Taylor, P. Search for Related Content PubMed PubMed Citation Articles by Dickinson, A. J. Articles by Kendall-Taylor, P.

Double-Blind, Placebo-Controlled Trial of Octreotide Long-Acting Repeatable (LAR) in Thyroid-Associated Ophthalmopathy

Royal Victoria Infirmary (A.J.D., M.M., A.C.), Newcastle upon Tyne NE1 4LP, United Kingdom; University of Newcastle upon Tyne (B.V., P.P., P.K.-T.), Newcastle upon Tyne NE2 4HH, United Kingdom; Novartis Pharmaceuticals, Frimley GU16 7SR, United Kingdom (E.B., C.D.A.); and Phillips University Marburg (L.H., J.T.H., A.E.H.), Marburg 35033, Germany

Address all correspondence and requests for reprints to: Jane Dickinson, Department of Ophthalmology, Royal Victoria Infirmary, Newcastle on Tyne NE1 4LP, United Kingdom. E-mail: Jane.Dickinson{at}nuth.northy.nhs.uk.

Several uncontrolled studies suggest octreotide is beneficial in thyroid-associated ophthalmopathy (TAO); however, the natural tendency of TAO to improve mandates randomized, controlled trials.

We report results of a double-blind, placebo-controlled trial of octreotide long-acting repeatable (LAR).

Fifty euthyroid patients (11 males, 39 females; age 22–74 yr, median 50 yr) with active TAO [clinical activity score (CAS) 3, NOSPECS (no signs or symptoms; only signs, no symptoms; signs only; proptosis; eye muscle involvement; corneal involvement; sight visual acuity reduction) 2a-5a] of median duration 0.9 yr received either 30 mg LAR or placebo every 4 wk for 16 wk; both groups then received 30 mg LAR for wk 16–32 and were followed up without treatment for a further 24 wk. Objective assessments included all individual parameters of TAO, CAS, and derived scores for soft tissue inflammation (STI) and ophthalmopathy index (OI). During wk 0–16 there was significant reduction in STI, subjective diplopia, and CAS in LAR-treated patients; STI and CAS were also reduced with placebo. The OI reduced by –1.12 in LAR (P = 0.0017) vs. –0.23 in placebo (P = 0.33), giving a barely significant treatment effect by Wilcoxon (P = 0.043), but analysis of covariance failed to confirm this (P = 0.16). During wk 16–32 there was no significant change in OI in either group. The overall results (wk 0–32) showed reduction in STI and CAS in both groups.

In this double-blind, placebo-controlled trial, no significant therapeutic effect of octreotide LAR was seen in patients with moderately severe TAO. The improvements in both treated and placebo groups emphasize that the results of open studies must be viewed with caution.

This article has been cited by other articles:

				L. Bartalena, L. Baldeschi, A. Dickinson, A. Eckstein, P. Kendall-Taylor, C. Marcocci, M. Mourits, P. Perros, K. Boboridis, A. Boschi, et al. Consensus statement of the European Group on Graves' orbitopathy (EUGOGO) on management of GO Eur. J. Endocrinol., March 1, 2008; 158(3): 273 - 285. [Full Text] [PDF]

				I. Cozma, L. Zhang, J. Uddin, C. Lane, A. Rees, and M. Ludgate Modulation of expression of somatostatin receptor subtypes in Graves' ophthalmopathy orbits: relevance to novel analogs Am J Physiol Endocrinol Metab, December 1, 2007; 293(6): E1630 - E1635. [Abstract] [Full Text] [PDF]

				M. N. Stan, J. A. Garrity, E. A. Bradley, J. J. Woog, M. M. Bahn, M. D. Brennan, S. C. Bryant, S. J. Achenbach, and R. S. Bahn Randomized, Double-Blind, Placebo-Controlled Trial of Long-Acting Release Octreotide for Treatment of Graves' Ophthalmopathy J. Clin. Endocrinol. Metab., December 1, 2006; 91(12): 4817 - 4824. [Abstract] [Full Text] [PDF]

				T J Cawood, P Moriarty, C O'Farrelly, and D O'Shea The effects of tumour necrosis factor-{alpha} and interleukin1 on an in vitro model of thyroid-associated ophthalmopathy; contrasting effects on adipogenesis Eur. J. Endocrinol., September 1, 2006; 155(3): 395 - 403. [Abstract] [Full Text] [PDF]

				L. Bartalena, C. Marcocci, and A. Pinchera Somatostatin Analogs for Graves' Ophthalmopathy: Do They Bounce Off like a Rubber Bullet? J. Clin. Endocrinol. Metab., December 1, 2004; 89(12): 5908 - 5909. [Full Text] [PDF]