Article (Scientific journals)
Octreotide (long-acting release formulation) treatment in patients with graves' orbitopathy: clinical results of a four-month, randomized, placebo-controlled, double-blind study.
Wemeau, J. L.; Caron, P.; Beckers, Albert et al.
2005In Journal of Clinical Endocrinology and Metabolism, 90 (2), p. 841-848
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Keywords :
Delayed-Action Preparations; Demography; Double-Blind Method; Female; Graves Disease/drug therapy; Humans; Male; Middle Aged; Octreotide/administration & dosage/therapeutic use; Placebos; Time Factors
Abstract :
[en] There are few effective, safe modalities for the management of Graves' ophthalmopathy (GO), a cell-mediated immune comorbidity of thyroid disease. Somatostatin analogs inhibit lymphocyte proliferation and activation, and accumulate in the orbital tissue of patients with GO. A double-blind, placebo-controlled study of a long-acting somatostatin analog [16 wk of long-acting release formulation of octreotide (octreotide-LAR)] was conducted in 51 patients with mild active GO with the aim of preventing deterioration and precluding the need for more aggressive therapeutic modalities, such as glucocorticoids or radiotherapy. No treatment effect was observed for the primary end point (a composite parameter defining the outcome as either success or failure on the basis of changes in class/grade of the severity index and Clinical Activity Scale of GO). The Clinical Activity Scale score was reduced for patients treated with octreotide-LAR, but without any significant difference with respect to patients receiving placebo. However, octreotide-LAR significantly reduced proptosis (as measured by exophthalmometry). This was associated with nonsignificant differences in favor of octreotide-LAR in a series of proptosis-related parameters: class III grade, opening of the upper eyelid, the difference in ocular pressure between primary position and upgaze, and extraocular muscle involvement. By magnetic resonance imaging evaluation the extraocular muscle volumes appeared reduced, but nonsignificantly. No significant correlation between the initial uptake of the somatostatin analog indium-labeled and the response to treatment was observed. One patient in the octreotide-LAR group developed gallstones. In this study, octreotide-LAR did not seem suitable to mitigate activity in mild GO. Surprisingly, it significantly reduced proptosis, one of the most debilitating symptoms of GO. Additional studies are warranted to define the benefit to risk ratio of the somatostatin analogs in this indication.
Disciplines :
Endocrinology, metabolism & nutrition
Author, co-author :
Wemeau, J. L.
Caron, P.
Beckers, Albert ;  Université de Liège - ULiège > Département des sciences cliniques > Endocrinologie
Rohmer, V.
Orgiazzi, J.
Borson-Chazot, F.
Nocaudie, M.
Perimenis, P.
Bisot-Locard, S.
Bourdeix, I.
Dejager, S.
Language :
English
Title :
Octreotide (long-acting release formulation) treatment in patients with graves' orbitopathy: clinical results of a four-month, randomized, placebo-controlled, double-blind study.
Publication date :
February 2005
Journal title :
Journal of Clinical Endocrinology and Metabolism
ISSN :
0021-972X
eISSN :
1945-7197
Publisher :
Endocrine Society, Chevy Chase, United States - Maryland
Volume :
90
Issue :
2
Pages :
841-848
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 18 March 2010

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