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Wiley InterScience | ||||||||||||||||
  Clinical EndocrinologyVolume 67 Issue 4, Pages 512 - 519 Published Online: 19 May 2007 © 2010 Blackwell Publishing Ltd The Clinical Journal of the Society for Endocrinology
Abstract | References | Full Text: HTML, PDF (Size: 389K) | Related Articles | Citation Tracking  ORIGINAL ARTICLE Efficacy of a slow-release formulation of lanreotide (Autogel †††The Italian Multicenter Autogel Study Group in Acromegaly comprises L. De Marinis (Division of Endocrinology, Catholic University, Rome, Italy), E. De Menis (Service of Endocrinology, Cà Foncello Hospital, Treviso, Italy), M. Giusti (Di.S.E.M. Department of Endocrinology and Metabolism, Genova, Italy), F. Grimaldi (Division of Endocrinology, S. Maria della Misericordia Hospital, Udine, Italy), F. Mantero (Division of Endocrinology, Department of Surgical and Medical Sciences, University of Padua, Padua, Italy), P. Tita (Garibaldi Hospital, Catania, Italy), R. Valcavi (Arcispedale S. Maria Nuova, Reggio Emilia, Italy), F. Minuto (Di.S.E.M. Department of Endocrinology and Metabolism, Genova, Italy), M. R. Ambrosio (Department of Biomedical Sciences and Advanced Therapies, University of Ferrara, Unit of Endocrinology, Ferrara, Italy), F. Pigliaru (Institute of Endocrinology, Department of Medical Sciences, University of Cagliari, Policlinico Monserrato, Cagliari, Italy), R. Baldelli (Policlinico Umberto I, Rome, Italy), A. Colao (Department of Molecular and Clinical Endocrinology and Oncology, University Federico II, Naples, Italy), R. Cozzi (Division of Endocrinology, Niguarda Cà Granda Hospital, Milan, Italy; ), E. Ghigo, V. Gasco (Department of Internal Medicine, University of Turin, Division of Endocrinology and Metabolism, Turin, Italy), P. Ferolla, D. La Torre (University of Perugia, Italy). Copyright © 2007 The Authors Journal compilation © 2007 Blackwell Publishing Ltd Summary
Objective Lanreotide Autogel® 120 mg (ATG120; Ipsen S.p.A, Milan, Italy) is a high-dose, sustained-release aqueous gel formulation, supplied in a prefilled syringe and given by deep subcutaneous injection. The aim of this study was to compare efficacy and tolerability of ATG120 given every 4–8 weeks with those of octreotide LAR (o-LAR) given every 4 weeks. Design patients and intervention A phase III multicentre Italian open clinical study of 23 acromegalic patients (15 female, 8 male). All patients had received o-LAR for 6–18 months and, after 3 months wash out, ATG120 was given every 6 weeks for a total of four injections (Period 1). Then the interval between ATG120 injections was adjusted according to three different schemes: every 4, 6 or 8 weeks depending on GH levels (GH > 2·5 µg/l; 1 < GH ≤ 2·5 µg/l; GH ≤ 1 µg/l, respectively). ATG120 was given for a further two to three doses, with a final assessment (Period 2) at Week 34, 36 or 42. Measurements Hormonal (GH and IGF-I) and clinical efficacy and tolerability. Results ATG120 induced a significant GH decrease from 9·9 ± 11·3 at baseline (Visit 1) to 3·5 ± 5·7 at the end of Period 1 (P < 0·01) and to 3·8 ± 5·7 µg/l at the final visit (P < 0·01). IGF-I also decreased from 544 ± 312 at baseline (Visit 1) to 318 ± 181 at Period 1 and to 356 ± 187 µg/l at the final visit (both P < 0·05 vs. baseline). The frequency of ATG120 administrations was adjusted to every 4 weeks in 12 patients, every 6 weeks in 4 patients and every 8 weeks in 6 patients; 1 patient withdrew before the dose adjustment. Serum GH and IGF-I achieved at the end of Period 1 and Period 2 were similar to those reached with o-LAR. The number of patients who achieved GH < 2·5 µg/l was comparable between o-LAR (43%) and ATG120 at Period 1 (48%) and at Period 2 (62%). Normal IGF-I levels were recorded in 8 patients during o-LAR (35%), 11 during ATG Period 1 (48%) and 10 at the final visit (43%). Last, 4 patients showed a better response to ATG120 and 2 to o-LAR. Conclusions Lanreotide Autogel 120 mg is an effective and well-tolerated therapy for acromegaly. In approximately half of patients ATG120 may be administered every 6–8 weeks, instead of every 4 weeks, without lost of efficacy. (Received 11 December 2006; returned for revision 26 December 2006; finally revised 22 February 2007; accepted 5 April 2007) | 
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