Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR

Abstract

Objective: This open label, multicentre study was designed to evaluate the efficacy and tolerability of lanreotide Autogel (L-Autogel) in acromegalic patients over a 24-week period. The outcome of treatment with this new, long-acting, aqueous formulation of lanreotide was also compared with the patients' previous treatment with octreotide long acting repeatable (LAR). Design and methods: Twenty-five acromegalic patients (13 males, mean age 51±12 years) were switched from octreotide LAR (20-40mg/4 weeks for at least 6 months) to L-Autogel, given deep subcutaneously at a fixed dose of 90 mg/4 weeks. After 12 weeks, the dose of L-Autogel was titrated according to patients' mean GH and IGF-I levels at week 8. It was increased to 120 mg/4 weeks if GH > 2.5 μg/l or if IGF-I was above the age-adjusted normal range. It was reduced to 60 mg/4 weeks if mean GH < 1 μg/l and IGF-I was within the normal range. If the values did not fall within these ranges, the dose remained unchanged at 90 mg. Results: After 24 weeks of treatment with L-Autogel (final doses 60mg in 3 patients, 90mg in 4 patients and 120mg in 18 patients), mean serum GH (2.9±2.41μg/l) and IGF-I concentrations (332± 193μg/l) remained statistically unchanged when compared with baseline values under octreotide LAR (GH 2.4±1.8μg/l and IGF-I 337±201μg/l, non significant (NS)). There was a significant improvement of the acromegalic symptom score-over the study period, from 4.8±3.4 to 2.8±2.5 (P < 0.001) and a small but significant reduction in the residual pituitary tumour volume (P < 0.05). Local side-effects were observed less frequently and no technical problems were encountered with the L-Autogel injections, as opposed to treatment with octreotide LAR (60 difficult injections/150 (P < 0.001). Conclusions: L-Autogel appears to be as effective as octreotide LAR in lowering GH and IGF-I concentrations in acromegalic patients. This treatment was also well tolerated by the patients, giving fewer local side-effects and technical problems with injections. These advantages may improve the long-term acceptability of medical treatment in acromegaly. © 2004 Society of the European Journal of Endocrinology.