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 language | English |
|---|---|
| Pages (from-to) | 512-519 |
| Number of pages | 8 |
| Journal | Clinical Endocrinology |
| Volume | 67 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Oct 2007 |
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ASJC Scopus subject areas
- Endocrinology
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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 journal › Article
}
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.
UR - http://www.scopus.com/inward/record.url?scp=34548665710&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34548665710&partnerID=8YFLogxK
U2 - 10.1111/j.1365-2265.2007.02917.x
DO - 10.1111/j.1365-2265.2007.02917.x
M3 - Article
C2 - 17555511
AN - SCOPUS:34548665710
VL - 67
SP - 512
EP - 519
JO - Clinical Endocrinology
JF - Clinical Endocrinology
SN - 0300-0664
IS - 4
ER -