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Evaluation of the Treatment of Thyrotropin-Secreting Pituitary Adenomas with a Slow Release Formulation of the Somatostatin Analog Lanreotide

Departments of Endocrinology, University Hospital, 76031 Rouen (J.M.K., H.L.), 80054 Amiens (S.A.), 31403 Toulouse (P.C.), 59037 Lille (C.C.), 87042 Limoges (F.A.), 94275 Paris (P.C.), and 33604 Bordeaux (A.T.), France; Department of Endocrinology (M.I.G.), University Hospital, 1389 Budapest; Department of Endocrinology (M.G.), University Hospital, Hungary; Department of Endocrinology (P.B.-P.), University Hospital, 20089 Milan, Italy; Ipsen-Biotech Laboratories (J.B., F.C., S.I.), 75016 Paris, France; IFR Peptides (J.M.K., H.L.) and U-413, INSERM (J.M.K., H.L.), University of Rouen, 76130 Rouen, France

Address all correspondence and requests for reprints to: Dr. J. M. Kuhn, Department of Endocrinology, Hopital de Bois-Guillaume, 147 avenue du Maréchal Juin, 76230 Bois-Guillaume, France.

Somatostatin analogs have been shown to be effective for the treatment of TSH-secreting pituitary adenomas. However, their use in this indication is limited by the fact that available analogs require several daily sc injections. The present study was performed to evaluate the effects of a slow release formulation of the somatostatin analog lanreotide (SR-L) on both hormone secretion and tumor size and to assess the tolerance in a series of thyrotropinomas treated for 6 months. Eighteen patients with hyperthyroidism related to a TSH-secreting pituitary adenoma, evidenced by pituitary magnetic resonance imaging, were studied. After a basal assessment, each patient received 30 mg SR-L, im, every 14 days for 1 month. Then, according to the free T₃ (fT₃) plasma level measured, 9 of 18 patients were injected twice monthly, and 7 of 18 patients received SR-L every 10 days for 5 additional months. One patient was dismissed from the study in month 1 of the study for side-effects and another in month 3 for noncompliance to the protocol. Clinical and biological evaluations (plasma TSH, free -subunit, fT₄, fT₃, and lanreotide levels) were performed before and in months 1, 3, and 6 of treatment. Pituitary magnetic resonance imaging and gallbladder ultrasonography were performed both at entry and at the end of the study. Clinical signs of hyperthyroidism improved within 1 month in all 16 evaluable patients. Mean (±SEM) plasma lanreotide levels reached 1.11 ± 0.43 and 1.69 ± 0.65 ng/mL in month 3 using 2 and 3 injections/month, respectively, then remained stable until the end of the study. During therapy, the plasma TSH level decreased from 2.72 ± 0.32 to 1.89 ± 0.27 mU/L (P < 0.01), with parallel significant changes in free -subunit. During the same period, plasma fT₄ and fT₃ levels decreased from 37.9 ± 2.9 to 19.7 ± 2.3 pmol/L (P < 0.01) and from 14.6 ± 1.1 to 8.3 ± 0.8 pmol/L (P < 0.01), respectively. No statistically significant change in mean adenoma size was observed after 6 months of treatment. Side-effects, including pain at the injection point, abdominal cramps, and diarrhea, were mild and transient and did not lead to interruption of the treatment. No gallstones occurred during the study. SR-L appears to be able to suppress clinical signs of hyperthyroidism in our series of patients with TSH-secreting pituitary adenomas. The analog also reduces plasma TSH and thyroid hormone levels, which were normalized in 13 of 16 cases. The effect was maintained throughout the treatment using 2 or 3 SR-L injections monthly without any problem of tolerance. We conclude that SR-L is a safe and effective treatment of thyrotropinomas and avoids the drawbacks of the modes of administration of other somatostatin analogs, given three times daily.

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