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Efficacy of octreotide-LAR in dieting women with abdominal obesity and polycystic ovary syndrome.

Gambineri A, Patton L, De Iasio R, Cantelli B, Cognini GE, Filicori M, Barreca A, Diamanti-Kandarakis E, Pagotto U, Pasquali R

Division of Endocrinology, Department of Internal Medicine, Center for Applied Biomedical Research, S. Orsola-Malpighi Hospital, Via Massarenti 9, 40138 Bologna, Italy.

CONTEXT: Somatostatin reduces LH, GH, and insulin, and somatostatin receptors are present at the ovarian level; somatostatin analogs are thus potential candidates for treatment of the polycystic ovary syndrome (PCOS). OBJECTIVE: The purpose of this study was to evaluate the effect of octreotide-LAR, a long-acting somatostatin analog, in anovulatory abdominal obese women with PCOS. DESIGN: A single-blind, placebo-controlled study was performed, lasting for 7 months. SETTING: The patients were ambulatory throughout the study. PATIENTS: Twenty PCOS subjects were enrolled. Eighteen completed the study. INTERVENTIONS: A low-calorie diet was given during the first month, a low-calorie diet plus octreotide-LAR (10 mg; n = 10 subjects) or placebo (n = 10 subjects) was then given, with one im injection every 28 d (for 6 months). MAIN OUTCOME MEASURES: The main outcome measures were clinical features, computerized tomography measurement of fat distribution, androgens, GH, IGF-I, IGF-binding proteins (IGFBPs), fasting and glucose-stimulated insulin, and ovulation. RESULTS: Octreotide had no additional effect in reducing body fat or improving fat distribution than placebo. Conversely, octreotide produced an additional decrease in fasting (P = 0.018) and glucose-stimulated (P = 0.038) insulin levels, an increase in IGFBP-2 (P = 0.042) and IGFBP-3 (P = 0.047), and an improvement in hirsutism (P = 0.004). Moreover, a trend toward greater reductions in testosterone (P = 0.061) and androstenedione (P = 0.069) was observed in women treated with octreotide-LAR compared with those given placebo. All women treated with octreotide ovulated at the end of the study compared with only one of those receiving placebo (P < 0.001). CONCLUSIONS: Octreotide-LAR may be usefully applied to hypocalorically dieting, abdominal obese PCOS women to improve hyperandrogenism and the insulin-IGF-I system. Restoration of ovulatory menstrual cycles appears to be another advantage of this treatment.

Published 8 July 2005 in J Clin Endocrinol Metab, 90(7): 3854-62.
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