One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®

P. Caron, M. Bex, D. R. Cullen, U. Feldt-Rasmussen, A. M. Pico Alfonso, S. Pynka, K. Rácz, J. Schopohl, A. Tabarin, M. J. Valimaki

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Abstract

OBJECTIVE: Somatostatin analogue treatment is first-line medical therapy for acromegaly. This study compared the efficacy and tolerability of titrated doses of the long-acting somatostatin analogue preparation lanreotide Autogel® with fixed doses and with lanreotide prolonged release (PR) 30 mg microparticles. PATIENTS: Patients entering the initial study had received a diagnosis of active acromegaly within the previous 5 years. DESIGN: This open, comparative, multicentre study was a 1-year extension of a previous trial during which patients with acromegaly had switched from lanreotide PR 30 mg microparticles injected intramuscularly every 7, 10 or 14 days, for at least 3 months, to one of three fixed doses of lanreotide Autogel® (120, 90, or 60 mg every 28 days, respectively). In this extension study, patients continued to receive 60, 90, or 120 mg of lanreotide Autogel® by deep subcutaneous injection every 28 days for 1 year. Doses could be titrated at entry or after four or eight injections, according to the GH/IGF-I response (dose increased if GH > 2.5 μg/l, or decreased if GH <1 μg/l with normal IGF-I). MEASUREMENTS: Mean ± SEM GH and IGF-I concentrations were analysed and gallbladder echography performed at weeks 0, 16, 32, and 48. Acromegaly symptoms were recorded monthly and tolerance and side-effects were monitored throughout the study. RESULTS: In total, 130 patients entered this extension phase. After 1 year of treatment with titrated doses of lanreotide Autogel®, mean GH (2.4±0.2 μg/l) and IGF-I (287 ± 12 μg/l) concentrations were significantly lower than with lanreotide microparticles (GH, 2.8 ± 0.2 μg/l, P <0.001; IGF-I, 332 ± 15 μg/l, P <0.01) or with fixed-dose lanreotide Autogel® (GH, 3.0 ± 0.2 μg/l, P <0.001; IGF-I, 310 ± 14 μg/l, P = 0.02). GH hypersecretion was reduced to ≤2.5 μg/l in 68% of patients with titrated-dose lanreotide Autogel® compared with 49% with microparticles (P <0.001) and 56% with fixed-dose lanreotide Autogel® (P ≤ 0.005). In the 65 patients who did not require any dose titration, there was no substantial change in serum lanreotide concentration, GH or IGF-I levels over the 12-month study duration. Acromegaly was effectively controlled (GH ≤ 2.5 μg/l and normalized IGF-I) in significantly more patients (43%) compared with microparticles (32%; P <0.05). There was a trend for improved control of acromegalic symptoms with dose titration, whereas the incidence of gastrointestinal symptoms and local tolerance was similar with lanreotide Autogel® and lanreotide microparticles. Gallbladder echographies showed new lithiasis in 8% of lanreotide Autogel® patients. CONCLUSION: Dose titration of lanreotide Autogel® improved GH and IGF-I control in patients with acromegaly beyond that achieved using fixed doses of lanreotide Autogel® or lanreotide microparticles. Titrated long-term lanreotide Autogel® treatment is well tolerated.

Original languageEnglish
Pages (from-to)734-740
Number of pages7
JournalClinical Endocrinology
Volume60
Issue number6
DOIs
Publication statusPublished - Jun 2004

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Acromegaly
Insulin-Like Growth Factor I
lanreotide
Somatostatin
Gallbladder
Ultrasonography
Lithiasis

ASJC Scopus subject areas

  • Endocrinology

Cite this

Caron, P., Bex, M., Cullen, D. R., Feldt-Rasmussen, U., Pico Alfonso, A. M., Pynka, S., ... Valimaki, M. J. (2004). One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®. Clinical Endocrinology, 60(6), 734-740. https://doi.org/10.1111/j.1365-2265.2004.02045.x

One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®. / Caron, P.; Bex, M.; Cullen, D. R.; Feldt-Rasmussen, U.; Pico Alfonso, A. M.; Pynka, S.; Rácz, K.; Schopohl, J.; Tabarin, A.; Valimaki, M. J.

In: Clinical Endocrinology, Vol. 60, No. 6, 06.2004, p. 734-740.

Research output: Contribution to journalArticle

Caron, P, Bex, M, Cullen, DR, Feldt-Rasmussen, U, Pico Alfonso, AM, Pynka, S, Rácz, K, Schopohl, J, Tabarin, A & Valimaki, MJ 2004, 'One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®', Clinical Endocrinology, vol. 60, no. 6, pp. 734-740. https://doi.org/10.1111/j.1365-2265.2004.02045.x
Caron, P. ; Bex, M. ; Cullen, D. R. ; Feldt-Rasmussen, U. ; Pico Alfonso, A. M. ; Pynka, S. ; Rácz, K. ; Schopohl, J. ; Tabarin, A. ; Valimaki, M. J. / One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®. In: Clinical Endocrinology. 2004 ; Vol. 60, No. 6. pp. 734-740.
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abstract = "OBJECTIVE: Somatostatin analogue treatment is first-line medical therapy for acromegaly. This study compared the efficacy and tolerability of titrated doses of the long-acting somatostatin analogue preparation lanreotide Autogel{\circledR} with fixed doses and with lanreotide prolonged release (PR) 30 mg microparticles. PATIENTS: Patients entering the initial study had received a diagnosis of active acromegaly within the previous 5 years. DESIGN: This open, comparative, multicentre study was a 1-year extension of a previous trial during which patients with acromegaly had switched from lanreotide PR 30 mg microparticles injected intramuscularly every 7, 10 or 14 days, for at least 3 months, to one of three fixed doses of lanreotide Autogel{\circledR} (120, 90, or 60 mg every 28 days, respectively). In this extension study, patients continued to receive 60, 90, or 120 mg of lanreotide Autogel{\circledR} by deep subcutaneous injection every 28 days for 1 year. Doses could be titrated at entry or after four or eight injections, according to the GH/IGF-I response (dose increased if GH > 2.5 μg/l, or decreased if GH <1 μg/l with normal IGF-I). MEASUREMENTS: Mean ± SEM GH and IGF-I concentrations were analysed and gallbladder echography performed at weeks 0, 16, 32, and 48. Acromegaly symptoms were recorded monthly and tolerance and side-effects were monitored throughout the study. RESULTS: In total, 130 patients entered this extension phase. After 1 year of treatment with titrated doses of lanreotide Autogel{\circledR}, mean GH (2.4±0.2 μg/l) and IGF-I (287 ± 12 μg/l) concentrations were significantly lower than with lanreotide microparticles (GH, 2.8 ± 0.2 μg/l, P <0.001; IGF-I, 332 ± 15 μg/l, P <0.01) or with fixed-dose lanreotide Autogel{\circledR} (GH, 3.0 ± 0.2 μg/l, P <0.001; IGF-I, 310 ± 14 μg/l, P = 0.02). GH hypersecretion was reduced to ≤2.5 μg/l in 68{\%} of patients with titrated-dose lanreotide Autogel{\circledR} compared with 49{\%} with microparticles (P <0.001) and 56{\%} with fixed-dose lanreotide Autogel{\circledR} (P ≤ 0.005). In the 65 patients who did not require any dose titration, there was no substantial change in serum lanreotide concentration, GH or IGF-I levels over the 12-month study duration. Acromegaly was effectively controlled (GH ≤ 2.5 μg/l and normalized IGF-I) in significantly more patients (43{\%}) compared with microparticles (32{\%}; P <0.05). There was a trend for improved control of acromegalic symptoms with dose titration, whereas the incidence of gastrointestinal symptoms and local tolerance was similar with lanreotide Autogel{\circledR} and lanreotide microparticles. Gallbladder echographies showed new lithiasis in 8{\%} of lanreotide Autogel{\circledR} patients. CONCLUSION: Dose titration of lanreotide Autogel{\circledR} improved GH and IGF-I control in patients with acromegaly beyond that achieved using fixed doses of lanreotide Autogel{\circledR} or lanreotide microparticles. Titrated long-term lanreotide Autogel{\circledR} treatment is well tolerated.",
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T1 - One-year follow-up of patients with acromegaly treated with fixed or titrated doses of lanreotide Autogel®

AU - Caron, P.

AU - Bex, M.

AU - Cullen, D. R.

AU - Feldt-Rasmussen, U.

AU - Pico Alfonso, A. M.

AU - Pynka, S.

AU - Rácz, K.

AU - Schopohl, J.

AU - Tabarin, A.

AU - Valimaki, M. J.

PY - 2004/6

Y1 - 2004/6

N2 - OBJECTIVE: Somatostatin analogue treatment is first-line medical therapy for acromegaly. This study compared the efficacy and tolerability of titrated doses of the long-acting somatostatin analogue preparation lanreotide Autogel® with fixed doses and with lanreotide prolonged release (PR) 30 mg microparticles. PATIENTS: Patients entering the initial study had received a diagnosis of active acromegaly within the previous 5 years. DESIGN: This open, comparative, multicentre study was a 1-year extension of a previous trial during which patients with acromegaly had switched from lanreotide PR 30 mg microparticles injected intramuscularly every 7, 10 or 14 days, for at least 3 months, to one of three fixed doses of lanreotide Autogel® (120, 90, or 60 mg every 28 days, respectively). In this extension study, patients continued to receive 60, 90, or 120 mg of lanreotide Autogel® by deep subcutaneous injection every 28 days for 1 year. Doses could be titrated at entry or after four or eight injections, according to the GH/IGF-I response (dose increased if GH > 2.5 μg/l, or decreased if GH <1 μg/l with normal IGF-I). MEASUREMENTS: Mean ± SEM GH and IGF-I concentrations were analysed and gallbladder echography performed at weeks 0, 16, 32, and 48. Acromegaly symptoms were recorded monthly and tolerance and side-effects were monitored throughout the study. RESULTS: In total, 130 patients entered this extension phase. After 1 year of treatment with titrated doses of lanreotide Autogel®, mean GH (2.4±0.2 μg/l) and IGF-I (287 ± 12 μg/l) concentrations were significantly lower than with lanreotide microparticles (GH, 2.8 ± 0.2 μg/l, P <0.001; IGF-I, 332 ± 15 μg/l, P <0.01) or with fixed-dose lanreotide Autogel® (GH, 3.0 ± 0.2 μg/l, P <0.001; IGF-I, 310 ± 14 μg/l, P = 0.02). GH hypersecretion was reduced to ≤2.5 μg/l in 68% of patients with titrated-dose lanreotide Autogel® compared with 49% with microparticles (P <0.001) and 56% with fixed-dose lanreotide Autogel® (P ≤ 0.005). In the 65 patients who did not require any dose titration, there was no substantial change in serum lanreotide concentration, GH or IGF-I levels over the 12-month study duration. Acromegaly was effectively controlled (GH ≤ 2.5 μg/l and normalized IGF-I) in significantly more patients (43%) compared with microparticles (32%; P <0.05). There was a trend for improved control of acromegalic symptoms with dose titration, whereas the incidence of gastrointestinal symptoms and local tolerance was similar with lanreotide Autogel® and lanreotide microparticles. Gallbladder echographies showed new lithiasis in 8% of lanreotide Autogel® patients. CONCLUSION: Dose titration of lanreotide Autogel® improved GH and IGF-I control in patients with acromegaly beyond that achieved using fixed doses of lanreotide Autogel® or lanreotide microparticles. Titrated long-term lanreotide Autogel® treatment is well tolerated.

AB - OBJECTIVE: Somatostatin analogue treatment is first-line medical therapy for acromegaly. This study compared the efficacy and tolerability of titrated doses of the long-acting somatostatin analogue preparation lanreotide Autogel® with fixed doses and with lanreotide prolonged release (PR) 30 mg microparticles. PATIENTS: Patients entering the initial study had received a diagnosis of active acromegaly within the previous 5 years. DESIGN: This open, comparative, multicentre study was a 1-year extension of a previous trial during which patients with acromegaly had switched from lanreotide PR 30 mg microparticles injected intramuscularly every 7, 10 or 14 days, for at least 3 months, to one of three fixed doses of lanreotide Autogel® (120, 90, or 60 mg every 28 days, respectively). In this extension study, patients continued to receive 60, 90, or 120 mg of lanreotide Autogel® by deep subcutaneous injection every 28 days for 1 year. Doses could be titrated at entry or after four or eight injections, according to the GH/IGF-I response (dose increased if GH > 2.5 μg/l, or decreased if GH <1 μg/l with normal IGF-I). MEASUREMENTS: Mean ± SEM GH and IGF-I concentrations were analysed and gallbladder echography performed at weeks 0, 16, 32, and 48. Acromegaly symptoms were recorded monthly and tolerance and side-effects were monitored throughout the study. RESULTS: In total, 130 patients entered this extension phase. After 1 year of treatment with titrated doses of lanreotide Autogel®, mean GH (2.4±0.2 μg/l) and IGF-I (287 ± 12 μg/l) concentrations were significantly lower than with lanreotide microparticles (GH, 2.8 ± 0.2 μg/l, P <0.001; IGF-I, 332 ± 15 μg/l, P <0.01) or with fixed-dose lanreotide Autogel® (GH, 3.0 ± 0.2 μg/l, P <0.001; IGF-I, 310 ± 14 μg/l, P = 0.02). GH hypersecretion was reduced to ≤2.5 μg/l in 68% of patients with titrated-dose lanreotide Autogel® compared with 49% with microparticles (P <0.001) and 56% with fixed-dose lanreotide Autogel® (P ≤ 0.005). In the 65 patients who did not require any dose titration, there was no substantial change in serum lanreotide concentration, GH or IGF-I levels over the 12-month study duration. Acromegaly was effectively controlled (GH ≤ 2.5 μg/l and normalized IGF-I) in significantly more patients (43%) compared with microparticles (32%; P <0.05). There was a trend for improved control of acromegalic symptoms with dose titration, whereas the incidence of gastrointestinal symptoms and local tolerance was similar with lanreotide Autogel® and lanreotide microparticles. Gallbladder echographies showed new lithiasis in 8% of lanreotide Autogel® patients. CONCLUSION: Dose titration of lanreotide Autogel® improved GH and IGF-I control in patients with acromegaly beyond that achieved using fixed doses of lanreotide Autogel® or lanreotide microparticles. Titrated long-term lanreotide Autogel® treatment is well tolerated.

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