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Efficacy of the Long-Acting Octreotide Formulation (Octreotide-Lar) in Patients with Thyrotropin-Secreting Pituitary Adenomas

Department of Endocrinology, University Hospital (P.Ca.), 31403 Toulouse; Department of Endocrinology, University Hospital (S.A.), 80054 Amiens; Department of Endocrinology, University Hospital (C.B.), 59037 Lille; Department of Endocrinology, University Hospital (P.Ch.), 94276 Paris; Department of Endocrinology, University Hospital (J.M.K.), 76233 Rouen; Department of Endocrinology, University Hospital (M.P.), 69321 Lyon; Department of Endocrinology, University Hospital (R.M.)., 86021 Poitiers; Department of Endocrinology, University Hospital (C.T.), 63003 Clermont-Ferrand; Department of Endocrinology, University Hospital (E.V.), 87042 Limoges; and Novartis Pharma SA (P.S.), 92506 Rueil Malmaison, France

Address all correspondence and requests for reprints to: Philippe Caron, M.D., Service d’Endocrinologie et Maladies Métaboliques, University Hospital Rangueil, 1 avenue J. Poulhés, 31403 Toulouse Cedex, France. E-mail: caron.p{at}chu-toulouse.fr

Abstract

The presence of somatostatin receptors on TSH-secreting pituitary adenomas allows treatment of central hyperthyroidism with somatostatin analogs. Six women and 5 men (mean ± SEM age, 43 ± 3 yr) presented TSH-secreting pituitary adenomas (micro, n = 2; macro, n = 9). Seven patients had previously been treated with partial surgical removal (n = 6) and/or external radiation (n = 4) of their adenoma at least 1 yr before the study, whereas 4 patients had not been treated before somatostatin analog therapy. TSH, free T₄, and free T₃ levels were in the normal range during treatment with sc injections (n = 9) or continuous infusion (n = 2) of octreotide (280 ± 25 µg/day). Mean thyroid hormone levels increased (P < 0.01) after the washout period (34 ± 6 days). The patients received monthly im injections of 20 mg Octreotide-LAR. In patients with an elevated free T₄ level after 3 months (n = 1) the Octreotide-LAR dose was increased to 30 mg. After 3 months of Octreotide-LAR treatment, TSH, free T₄/T₃, and -subunit levels decreased, and 10 patients were euthyroid with normal free T₄ levels. These results remained at the same level over the next 3 months. There were no statistically significant differences in the TSH and free T₄ responses to sc octreotide or im Octreotide-LAR between previously untreated patients and patients who had undergone surgical resection and/or pituitary radiation before somatostatin analog treatment. During Octreotide-LAR treatment, minor digestive problems or moderate discomfort at the injection site, lasting less than 48 h, were reported in 6 and 5 patients, respectively. Gallbladder echographies did not reveal new gallstones during Octreotide-LAR treatment. In conclusion, this study shows that monthly im Octreotide-LAR is as effective as daily sc octreotide in controlling hyperthyroidism in patients with TSH-secreting pituitary adenomas, in both previously untreated patients and patients treated with surgery and/or pituitary radiotherapy. Octreotide-LAR is well tolerated, except for minor digestive problems or mild pain at the injection site. Therefore, Octreotide-LAR appears to be a useful therapeutic tool to facilitate medical treatment of TSH-secreting pituitary adenomas in patients who need long-term somatostatin analog therapy.

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