LONG-TERM THERAPY WITH LONG-ACTING OCTREOTIDE (SANDOSTATIN-LAR(R)) FOR THE MANAGEMENT OF ACROMEGALY

OBJECTIVES To evaluate the efficacy and safety of a long-acting prepar ation of the somatostatin analogue octreotide, Sandostatin-LAR(R) (SMS -LAR) for the treatment of acromegaly, DESIGN AND PATIENTS Thirteen pa tients with acromegaly received intramuscular injections of SMS-LAR 20 -40 mg at 4-6-week intervals for a period of up to 3 years, MEASUREMEN TS Serial measurement of serum GH and IGF-1 concentrations were obtain ed, Symptoms related to acromegaly were scored by patients at baseline and following each injection, Serial gallbladder ultrasound and pitui tary imaging was performed throughout the study, RESULTS One patient w as withdrawn from the study after 6 months because of continued gastro intestinal side effects; 4 patients were treated with monthly injectio ns for 12 months and 8 patients with injections at either 1 month or 6 -week intervals for 36 months; hence data is presented for n=12 for up to 12 months and thereafter n=8, SMS-LAR significantly reduced serum GH and IGF-1 values: for the whole group GH concentrations fell from 2 4.8 +/- 4.2 mU/l (mean +/- SE) at baseline to 5.2 +/- 0.8 mU/l at 12 m onths (P < 0.01, n=12), In the 8 patients treated for 3 years GH fell from 27.8 +/- 6.1 mU/l at baseline to 4.2 +/- 0.8 mU/l at the end of 3 years (P < 0.01, n=8), GH fell to < 10 mU/l in all subjects and was < 5 mU/l in 50% after both 1 and 3 years. IGF-1 concentrations fell fro m 95 +/- 13 nmol/l at baseline to 63 +/- 13 nmol/l after 1 year(P < 0. 01, n=12; reference range < 65 nmol/l). In the 8 patients treated for 3 years IGF-1 concentrations fell from 119 +/- 14 nmol/l at baseline t o 60 +/- 13 nmol/l after 3 years (P < 0.001, n=8), IGF-1 was < 65 nmol /l in 60% of patients after 1 year and 75% after 3 years, Treatment re sulted in trends towards improvement in symptoms of acromegaly and sta tistically significant improvement in sweating, There was no evidence of tachyphylaxis or evidence to suggest development of glucose intoler ance, Only 2 patients (15%) developed gallbladder sludge which was asy mptomatic; no patient developed gallstones. CONCLUSIONS We conclude th at SMS-LAR is a safe, effective and well tolerated treatment, making i t an important therapeutic option in the management of acromegaly.