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One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®

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Summary objective 

Somatostatin analogue treatment is first-line medical therapy for acromegaly. This study compared the efficacy and tolerability of titrated doses of the long-acting somatostatin analogue preparation lanreotide Autogel® with fixed doses and with lanreotide prolonged release (PR) 30 mg microparticles. patients 

Patients entering the initial study had received a diagnosis of active acromegaly within the previous 5 years. design 

This open, comparative, multicentre study was a 1-year extension of a previous trial during which patients with acromegaly had switched from lanreotide PR 30 mg microparticles injected intramuscularly every 7, 10 or 14 days, for at least 3 months, to one of three fixed doses of lanreotide Autogel® (120, 90, or 60 mg every 28 days, respectively). In this extension study, patients continued to receive 60, 90, or 120 mg of lanreotide Autogel® by deep subcutaneous injection every 28 days for 1 year. Doses could be titrated at entry or after four or eight injections, according to the GH/IGF-I response (dose increased if GH > 2·5 µg/l, or decreased if GH < 1 µg/l with normal IGF-I). measurements 

Mean ± SEM GH and IGF-I concentrations were analysed and gallbladder echography performed at weeks 0, 16, 32, and 48. Acromegaly symptoms were recorded monthly and tolerance and side-effects were monitored throughout the study. results 

In total, 130 patients entered this extension phase. After 1 year of treatment with titrated doses of lanreotide Autogel®, mean GH (2·4 ± 0·2 µg/l) and IGF-I (287 ± 12 µg/l) concentrations were significantly lower than with lanreotide microparticles (GH, 2·8 ± 0·2 µg/l, P < 0·001; IGF-I, 332 ± 15 µg/l, P < 0·01) or with fixed-dose lanreotide Autogel® (GH, 3·0 ± 0·2 µg/l, P < 0·001; IGF-I, 310 ± 14 µg/l, P = 0·02). GH hypersecretion was reduced to ≤ 2·5 µg/l in 68% of patients with titrated-dose lanreotide Autogel® compared with 49% with microparticles (P < 0·001) and 56% with fixed-dose lanreotide Autogel® (P ≤ 0·005). In the 65 patients who did not require any dose titration, there was no substantial change in serum lanreotide concentration, GH or IGF-I levels over the 12-month study duration. Acromegaly was effectively controlled (GH ≤ 2·5 µg/l and normalized IGF-I) in significantly more patients (43%) compared with microparticles (32%; P < 0·05). There was a trend for improved control of acromegalic symptoms with dose titration, whereas the incidence of gastrointestinal symptoms and local tolerance was similar with lanreotide Autogel® and lanreotide microparticles. Gallbladder echographies showed new lithiasis in 8% of lanreotide Autogel® patients. conclusion 

Dose titration of lanreotide Autogel® improved GH and IGF-I control in patients with acromegaly beyond that achieved using fixed doses of lanreotide Autogel® or lanreotide microparticles. Titrated long-term lanreotide Autogel® treatment is well tolerated.
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Document Type: Research Article

Affiliations: 1: Department of Endocrinology, CHU Rangueil, Toulouse, France; 2: Department of Endocrinology, UZ Gasthuisberg, Leuven, Belgium; 3: Department of Endocrinology, Royal Hallamshire Hospital, Sheffield, UK; 4: Rigshospitalet, Department of Medical Endocrinology, Copenhagen, Denmark; 5: Department of Endocrinology, Hospital General de Alicante, Spain; 6: Department of Endocrinology, Academy of Medicine, Szczecin, Poland; 7: 2nd Department of Medicine, Semmelweis University Medical School, Budapest, Hungary; 8: Medizinische Klinik Innenstadt, University of Munich, Germany; 9: Department of Endocrinology, Hôpital du Haut-Lévèque, Pessac, France; and 10: Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital, Finland

Publication date: June 1, 2004

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