Electronic Letters to:

Endocrine Care: Marius N. Stan, James A. Garrity, Elizabeth A. Bradley, John J. Woog, Mark M. Bahn, Michael D. Brennan, Sandra C. Bryant, Sara J. Achenbach, and Rebecca S. Bahn Randomized, Double-Blind, Placebo-Controlled Trial of Long-Acting Release Octreotide for Treatment of Graves’ Ophthalmopathy J Clin Endocrinol Metab 2006; 91: 4817-4824 [Abstract] [Full text] [PDF]

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Somatostatin analogs and Graves' orbitopathy

Luigi Bartalena   (31 January 2007)

Somatostatin analogs and Graves' orbitopathy 31 January 2007
Luigi Bartalena, Professor of Endocrinology University of Insubria, Varese, Italy Send letter to journal: Re: Somatostatin analogs and Graves' orbitopathy l.bartalena{at}libero.it Luigi Bartalena	I read with interest the paper by Stan et al. (1) on the results of long-acting release (LAR) octreotide treatment for Graves’ orbitopathy (GO). The reported results of this small randomized, placebo-controlled trial reinforce my opinion (2) that currently available somatostatin analogs, octreotide and lanreotide, have no role in GO management. Stan et al. (1) reported a marginally significant improvement in lid fissure width, while overall changes in remaining ocular parameters did not substantially differ in LAR octreotide-treated and placebo-treated groups. Furthermore, although the authors stated that results were adjusted for a previous history of glucocorticoid administration, the fact that 50% of LAR octreotide-treated patients and only 27% of placebo-treated patients had received glucocorticoid treatment cannot rule out the possibility that this modest effect was the tail of glucocorticoid therapy, also because the 4-week period off steroids selected as inclusion criterion was rather short. Their results were, in my opinion, further weakened by the fact that LAR octreotide-treated patients had a slightly more active GO, which has a greater likelihood of improving spontaneously as expression of its natural history. Finally, at least three (or four?) patients in placebo group dropped out the study, reducing number of controls and significance of minor differences observed between the two groups. In addition to two larger randomized, placebo-controlled studies by Dickinson et al. (3) and Wemeau et al. (4), in which LAR octreotide produced no substantial GO improvement, a third, recently published, randomized, placebo-controlled clinical trial of lanreotide effect on GO also failed to detect any relevant GO amelioration following a 4-month somatostatin analog course (5). Likewise, the modest effect, if any, reported by Stan et al. (1) is unlikely to have any clinical relevance, and should, in my opinion, be regarded as a further demonstration that currently available somatostation analogs are not clinically effective for GO and should not be used to treat it, also in view of their high cost (2). Whether novel somatostatin analogs under investigation may be more beneficial for this invalidating disease remains to be seen, but I am skeptical about it. References 1. Stan MN, Garrity JA, Bradley EA, Woog JJ, Bahn MM, Brennan MD, Bryant SC, Achenbach SJ, Bahn RS 2006 Randomized, double-blind, placebo- controlled trial of long-acting release octreotide for treatment of Graves’ ophthalmopathy. J Clin Endocrinol Metab 91: 4817-4824 2. Tanda ML, Bartalena L 2006 Currently available somatostatin analogs are not good for Graves’ orbitopathy. J Endocrinol Invest 29: 389-390 3. Dickinson AJ, Vaidya B, Miller M, Coulthard A, Perros P, Baister E, Andrews CD, Hesse L, Heverhagen JT, Heufelder AE, Kendall-Taylor P 2004 Double-blind, placebo-controlled trial of octreotide long-acting repeatable (LAR) in thyroid-associated ophthalmopathy. J Clin Endocrinol Metab 89: 5910-5915 4. Wemeau JL, Caron P, Beckers A, Rohmer V, Orgiazzi J, Borson-Chazot F, Nocuadie M, Perimenis P, Bisot-Locard S, Bourdeix I, Dejager S 2005 Octreotide (long-acting release formulation) treatment in patients with Graves’ orbitopathy: clinical results of a four-month, randomized, placebo-controlled, double-blind study. J Clin Endocrinol Metab 90: 841-848 5. Chang T-C, Liao S-L 2006 Slow-release lanreotide in Graves’ ophthalmopathy: a double-blind randomized, placebo-controlled clinical trial. J Endocrinol Invest 29: 413-422