Efficacy of the new long-acting formulation of lanreotide (Lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly

G. Lombardi, F. Minuto, G. Tamburrano, M. R. Ambrosio, G. Arnaldi, M. Arosio, V. Chiarini, R. Cozzi, S. Grottoli, F. Mantero, F. Bogazzi, M. Terzolo, P. Tita, P. F. Boscani, A. Colao

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Objective: To evaluate efficacy and safety of lanreotide autogel (ATG) 120 mg injections every 4-8 weeks in somatostatin analogue-naïve patients with acromegaly. Design: Open, non-comparative, phase III, multicenter clinical study. Methods: Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied. ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if ≤2.5 μg/l every 8 weeks (group A, 17 patients); if 2.5-5 μg/l every 6 weeks (group B, 15 patients); and if >5 μg/l every 4 weeks (group C, 19 patients). Treatment duration was 48-52 weeks. The primary objective was to control GH and IGF-I levels (GH≤2.5 μg/l and IGF-I normalized for age/gender). Secondary objectives were to assess GH, IGF-I, and acid-labile subunit (ALS) decrease, improvement of clinical symptoms and quality of life (QoL). Results: GH levels normalized in 32 patients (63%), similarly in de novo and post-op patients (72% vs 50%, p=0.48); in 100% of group A, in 73% of group B and in 21% of group C (p

Original languageEnglish
Pages (from-to)202-209
Number of pages8
JournalJournal of Endocrinological Investigation
Volume32
Issue number3
Publication statusPublished - Mar 2009

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Acromegaly
Somatostatin
Insulin-Like Growth Factor I
lanreotide
Multicenter Studies
Quality of Life
Safety
Injections

Keywords

  • Acromegaly
  • GH
  • IGF-I
  • Lanreotide
  • Pituitary tumors

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Efficacy of the new long-acting formulation of lanreotide (Lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. / Lombardi, G.; Minuto, F.; Tamburrano, G.; Ambrosio, M. R.; Arnaldi, G.; Arosio, M.; Chiarini, V.; Cozzi, R.; Grottoli, S.; Mantero, F.; Bogazzi, F.; Terzolo, M.; Tita, P.; Boscani, P. F.; Colao, A.

In: Journal of Endocrinological Investigation, Vol. 32, No. 3, 03.2009, p. 202-209.

Research output: Contribution to journalArticle

Lombardi, G, Minuto, F, Tamburrano, G, Ambrosio, MR, Arnaldi, G, Arosio, M, Chiarini, V, Cozzi, R, Grottoli, S, Mantero, F, Bogazzi, F, Terzolo, M, Tita, P, Boscani, PF & Colao, A 2009, 'Efficacy of the new long-acting formulation of lanreotide (Lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly', Journal of Endocrinological Investigation, vol. 32, no. 3, pp. 202-209.
Lombardi, G. ; Minuto, F. ; Tamburrano, G. ; Ambrosio, M. R. ; Arnaldi, G. ; Arosio, M. ; Chiarini, V. ; Cozzi, R. ; Grottoli, S. ; Mantero, F. ; Bogazzi, F. ; Terzolo, M. ; Tita, P. ; Boscani, P. F. ; Colao, A. / Efficacy of the new long-acting formulation of lanreotide (Lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. In: Journal of Endocrinological Investigation. 2009 ; Vol. 32, No. 3. pp. 202-209.
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abstract = "Objective: To evaluate efficacy and safety of lanreotide autogel (ATG) 120 mg injections every 4-8 weeks in somatostatin analogue-na{\"i}ve patients with acromegaly. Design: Open, non-comparative, phase III, multicenter clinical study. Methods: Fifty-one patients (28 women, aged 19-78 yr): 39 newly diagnosed (de novo) and 12 who had previously undergone unsuccessful surgery (post-op, 11 macro and 1 micro) were studied. ATG 120 mg was initially given every 8 weeks for 24 weeks and subsequently changed according to GH levels: if ≤2.5 μg/l every 8 weeks (group A, 17 patients); if 2.5-5 μg/l every 6 weeks (group B, 15 patients); and if >5 μg/l every 4 weeks (group C, 19 patients). Treatment duration was 48-52 weeks. The primary objective was to control GH and IGF-I levels (GH≤2.5 μg/l and IGF-I normalized for age/gender). Secondary objectives were to assess GH, IGF-I, and acid-labile subunit (ALS) decrease, improvement of clinical symptoms and quality of life (QoL). Results: GH levels normalized in 32 patients (63{\%}), similarly in de novo and post-op patients (72{\%} vs 50{\%}, p=0.48); in 100{\%} of group A, in 73{\%} of group B and in 21{\%} of group C (p",
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AU - Minuto, F.

AU - Tamburrano, G.

AU - Ambrosio, M. R.

AU - Arnaldi, G.

AU - Arosio, M.

AU - Chiarini, V.

AU - Cozzi, R.

AU - Grottoli, S.

AU - Mantero, F.

AU - Bogazzi, F.

AU - Terzolo, M.

AU - Tita, P.

AU - Boscani, P. F.

AU - Colao, A.

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