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, M. Boschetti, E. C Degli Uberti, S. Mariotti, S. Grottoli, P. Loli, G. Lombardi, G. Tamburrano, M. Arvigo, G. Angeletti, P. F. Boscani, P. Beck-Peccoz, M. Arosio

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Abstract

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.

Original languageEnglish
Pages (from-to)512-519
Number of pages8
JournalClinical Endocrinology
Volume67
Issue number4
DOIs
Publication statusPublished - Oct 2007

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Acromegaly
Octreotide
Multicenter Studies
Longitudinal Studies
Insulin-Like Growth Factor I
lanreotide
Injections
Syringes
Subcutaneous Injections
Italy
Gels

ASJC Scopus subject areas

  • Endocrinology

Cite this

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. / Ronchi, C. L.; Boschetti, M.; Uberti, E. C Degli; Mariotti, S.; Grottoli, S.; Loli, P.; Lombardi, G.; Tamburrano, G.; Arvigo, M.; Angeletti, G.; Boscani, P. F.; Beck-Peccoz, P.; Arosio, M.

In: Clinical Endocrinology, Vol. 67, No. 4, 10.2007, p. 512-519.

Research output: Contribution to journalArticle

Ronchi, CL, Boschetti, M, Uberti, ECD, Mariotti, S, Grottoli, S, Loli, P, Lombardi, G, Tamburrano, G, Arvigo, M, Angeletti, G, Boscani, PF, Beck-Peccoz, P & Arosio, M 2007, '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', Clinical Endocrinology, vol. 67, no. 4, pp. 512-519. https://doi.org/10.1111/j.1365-2265.2007.02917.x
Ronchi, C. L. ; Boschetti, M. ; Uberti, E. C Degli ; Mariotti, S. ; Grottoli, S. ; Loli, P. ; Lombardi, G. ; Tamburrano, G. ; Arvigo, M. ; Angeletti, G. ; Boscani, P. F. ; Beck-Peccoz, P. ; Arosio, M. / 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. In: Clinical Endocrinology. 2007 ; Vol. 67, No. 4. pp. 512-519.
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abstract = "Objective: Lanreotide Autogel{\circledR} 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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TY - JOUR

T1 - Efficacy of a slow-release formulation of lanreotide (Autogel® 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR)

T2 - An open, multicentre longitudinal study

AU - Ronchi, C. L.

AU - Boschetti, M.

AU - Uberti, E. C Degli

AU - Mariotti, S.

AU - Grottoli, S.

AU - Loli, P.

AU - Lombardi, G.

AU - Tamburrano, G.

AU - Arvigo, M.

AU - Angeletti, G.

AU - Boscani, P. F.

AU - Beck-Peccoz, P.

AU - Arosio, M.

PY - 2007/10

Y1 - 2007/10

N2 - 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.

AB - 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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