Volume 67, Issue 4 pp. 512-519

Efficacy of a slow-release formulation of lanreotide (Autogel® 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study

C. L. Ronchi

C. L. Ronchi

Department of Medical Sciences, University of Milan, Unit of Endocrinology and Metabolism, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy,

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M. Boschetti

M. Boschetti

Di.S.E.M. Department of Endocrinology and Metabolism, Genova, Italy,

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E. C. Degli Uberti

E. C. Degli Uberti

Department of Biomedical Sciences and Advanced Therapies, University of Ferrara, Unit of Endocrinology, Ferrara, Italy,

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S. Mariotti

S. Mariotti

Institute of Endocrinology, Department of Medical Sciences, University of Cagliari, Policlinico Monserrato, Cagliari, Italy,

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S. Grottoli

S. Grottoli

Department of Internal Medicine, Division of Endocrinology and Metabolism, University of Turin, Turin, Italy,

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P. Loli

P. Loli

Division of Endocrinology, Niguarda Cà Granda Hospital, Milan, Italy,

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G. Lombardi

G. Lombardi

Department of Molecular and Clinical Endocrinology and Oncology, University Federico II, Naples, Italy,

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G. Tamburrano

G. Tamburrano

Department of Endocrinology, University La Sapienza, Policlinico Umberto I, Rome, Italy,

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M. Arvigo

M. Arvigo

Di.S.E.M. Department of Endocrinology and Metabolism, Genova, Italy,

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G. Angeletti

G. Angeletti

Department of Internal Medicine and Endocrinological and Metabolic Sciences, University of Perugia, Perugia, Italy,

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P. F. Boscani

P. F. Boscani

Ipsen S.p.A., Milan, Italy,

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P. Beck-Peccoz

P. Beck-Peccoz

Department of Medical Sciences, University of Milan, Unit of Endocrinology and Metabolism, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy,

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M. Arosio

M. Arosio

Unit of Endocrinology, Ospedale S. Giuseppe Milano-Cuore, AFaR, University of Milan; Milan, Italy

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for the Italian Multicenter Autogel Study Group in Acromegaly

for the Italian Multicenter Autogel Study Group in Acromegaly

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).

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First published: 19 May 2007
Citations: 63
Cristina L. Ronchi, Unit of Endocrinology, Department Medical Sciences, Fondazione IRCCS Osp. Maggiore Policlinico, Mangiagalli e Regina Elena, Via F. Sforza 35, I 20122 Milano, Italy. Tel.: +39 0250320608; Fax: +39 0250320605; E-mail: [email protected]

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.

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