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Efficacy of the New Long-Acting Formulation of Lanreotide (Lanreotide Autogel) in the Management of Acromegaly

Department of Endocrinology CHU Rangueil (P.C.), 31403 Toulouse, France; Department of Endocrinology, CHU de Liege (A.B.), 44000 Liege, Belgium; Department of Endocrinology, Royal Hallamshire Hospital (D.R.C.), Sheffield, United Kingdom S25 46B; Department of Medicine and Geriatrics, Faculty of Health Sciences, Semmelweis University (M.I.G.), 1135 Budapest, Hungary; Department of Medicine, Medizinische Klinik Innenstadt (B.G.), 80336 Munich, Germany; Department of Endocrinology, Aalborg Sygehus Nord (P.L.), 9100 Aalborg, Denmark; Department of Endocrinology, Hospital General díAlicante (A.H.P.), 03012 Alicante, Spain; Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital (M.V.), SF-00290 Helsinki, Finland; and Department of Endocrinology, Postgraduate Medical Teaching Center (W.Z.), 01-809 Warsaw, Poland

Address all correspondence and requests for reprints to: Philippe Caron, M.D., Service d’Endocrinologie et Maladies Métaboliques, CHU Rangueil, 1, avenue J. Poulhès, 31054 Toulouse Cedex, France. E-mail: caron.p{at}chu-toulouse.fr

Lanreotide Autogel is a new long-acting aqueous preparation of lanreotide for the treatment of acromegaly and is administered by deep sc injection from a small volume, prefilled syringe. The aim of this study was to evaluate the efficacy and safety of this new long-acting formulation in a large population of acromegalic patients previously responsive to lanreotide 30 mg, im (sustained release microparticle formulation). Lanreotide Autogel was administered by deep sc injection every 28 d to 107 patients (54 males and 53 females; mean age, 54 ± 1.2 yr). All patients had been treated with lanreotide (30 mg) for at least 3 months before study entry and had a mean GH level less than 10 ng/ml after at least 4 subsequent im injections every 14 d (48%), 10 d (32%), or 7 d (20%). Treatment was switched from lanreotide 30 mg injected every 14, 10, or 7 d to 60, 90, or 120 mg lanreotide Autogel, respectively, every 28 d. After three fixed dose injections of lanreotide Autogel, mean lanreotide levels were similar to those obtained at steady state with lanreotide 30 mg. During lanreotide Autogel treatment, the control of acromegalic symptoms was comparable with that previously achieved during lanreotide 30 mg treatment. After 3 injections of lanreotide Autogel, mean GH (2.87 ± 0.22 ng/ml) and IGF-I (317 ± 15 ng/ml) values were comparable with those recorded at the end of lanreotide 30 mg treatment (GH, 2.82 ± 0.19 ng/ml; IGF-I, 323 ± 16 ng/ml). GH levels below 2.5 ng/ml and age-/sex-normalized IGF-I were achieved in 33% and 39% of patients during lanreotide 30 mg and lanreotide Autogel treatment, respectively. Diarrhea, abdominal pain, and nausea were reported by 38%, 22%, and 18% of patients during lanreotide 30 mg treatment and by 29%, 17%, and 9% of patients, respectively, during lanreotide Autogel treatment. In conclusion, this clinical study shows that lanreotide Autogel is at least as efficacious and well tolerated as lanreotide 30 mg. This new long-acting lanreotide formulation, lanreotide Autogel, which is administered from a small volume, prefilled syringe by deep sc injection, is therefore likely to improve the acceptability of medical treatment for patients requiring long-term somatostatin analog therapy.

Abbreviations: CI, Confidence interval.

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