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ObjectiveLanreotide 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.DesignA 28-week, open, multicentre study.PatientsTwelve patients with acromegaly, treated with 20 mg octreotide LAR for >4 months, with serum GH levels <10.0 mU/l.MethodsAutogel (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.ResultsTen 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 mU/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 microg/l; week 12, 185+/-91 microg/l; week 28: 154+/-61 microg/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).ConclusionsLanreotide 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.

Original publication

DOI

10.1530/eje.0.1500473

Type

Journal

European journal of endocrinology

Publication Date

04/2004

Volume

150

Pages

473 - 480

Addresses

School of Clinical Medical Sciences, University of Newcastle upon Tyne, UK. s.g.ashwell@ncl.ac.uk

Keywords

Humans, Acromegaly, Peptides, Cyclic, Octreotide, Somatostatin, Anti-Inflammatory Agents, Non-Steroidal, Antineoplastic Agents, Hormonal, Delayed-Action Preparations, Treatment Outcome, Injections, Intramuscular, Adult, Aged, Middle Aged, Female, Male