The efficacy and safety of lanreotide Autogel in patients with acromegaly previously treated with octreotide LAR

Abstract

Objective: Lanreotide Autogel is a sustained-release aqueous gel formulation supplied in a prefilled syringe, with injection volume < 0.5 ml. The aim of this study was to establish the efficacy and safety of Autogel in patients with acromegaly previously treated with octreotide LAR. Design: A 28-week, open, multicentre study. Patients: Twelve patients with acromegaly, treated with 20 mg octreotide LAR for > 4 months, with serum GH levels < 10.0 mU/l. Methods: Autogel (90 mg) was given every 28 days during weeks 0-12. At week 16 the dose was titrated based on GH levels at weeks 8 and 12. If GH levels were <2.0, 2.0-5.0, or > 5.0 mU/l, Autogel was reduced to 60 mg, maintained at 90 mg, or increased to 120 mg respectively, for the next three injections. GH and IGF-I levels were reassessed at weeks 24 and 28. Results: Ten patients completed the study. Five remained on 90 mg Autogel throughout the study: in two patients the dose was reduced to 60 mg from week 16: in three patients it was increased to 120 mg. Mean GH levels were: baseline, 3.0 ± 1.7 mg/l; week 12, 3.5 ± 1.8 mU/l; week 28, 3.3 ± 1.6 mU/l (NS). Mean IGF-I levels were: baseline, 212 ± 70 μg/l; week 12, 185 ± 91 μg/l; week 28: 154 ± 61 μg/l (P = 0.027). Six patients at baseline and eight at week 28 had normalised GH and IGF-I levels. Three patients reported adverse events: musculoskeletal pain (n = 2) and injection-site symptoms (n = 1). Conclusions: Lanreotide Autogel is effective and well tolerated in patients with acromegaly. This study in a small group of patients with well-controlled acromegaly suggests that the majority of patients switched from 20 mg LAR to 90 mg Autogel will have equivalent or better disease control. © 2004 Society of the European Journal of Endocrinology.