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

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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"ive 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<0.0001). IGF-I levels normalized in 19 patients (37%), similarly in the de novo and post-op patients (33% vs 50%, p=0.48): in 65% of group A, 33% of group B, and in 16% of group C. Circulating GH levels decreased by 80±17%, IGF-I levels by 44±27%, and ALS by 30±17%. Symptoms (hyperhidrosis (68.6%), swelling (68.6%), asthenia (58.8%), spine arthralgia (54.9%), and paresthesias (52.9%) and QoL (from 9.1 ±7.9 to 6.1 ±6.6) significantly improved (p<0.001). No patient withdrew from the study because of adverse events (AE). The most frequent AE was diarrhea (76.2% of patients): at study end 16 mild and 1 moderate diarrhea were recorded. Gallstones developed in 12% of patients. Conclusion: ATG 120 mg in somatostatin-naïve patients with acromegaly controls GH secretion in 63% and IGF-I secretion in 37% during a 48–52 week period without any difference between de novo and post-op patients. The treatment was associated with improvement in clinical symptoms and QoL and with a good, safe profile.

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Authors and Affiliations

  1. Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples, via S. Pansini 5, 80131, Naples, Italy

    G. Lombardi MD, PhD & A. Colao

  2. Di.S.E.M. Department of Endocrinology and Metabolism, Genoa

    F. Minuto

  3. Department of Endocrinology, University of Rome “Sapienza”, Policlinico Umberto I, Rome

    G. Tamburrano

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

    M. R. Ambrosio

  5. Department of Endocrinology, Polytechnic University of Marche, Ancona

    G. Arnaldi

  6. Department of Medical Sciences, University of Milan, Milan

    M. Arosio

  7. Division of Endocrinology, “Maggiore” Hospital, Bologna

    V. Chiarini

  8. Division of Endocrinology, “Niguarda Cà Granda” Hospital, Milan

    R. Cozzi

  9. Department of Internal Medicine, Division of Endocrinology and Metabolism, University of Turin, Turin

    S. Grottoli

  10. Division of Endocrinology, Department of Surgical and Medical Sciences, University of Padua, Padua

    F. Mantero

  11. Department of Endocrinology, University of Pisa, “Cisanello” Hospital, Pisa

    F. Bogazzi

  12. Division of Endocrinology, “San Luigi Gonzaga” Hospital, Orbassano

    M. Terzolo

  13. Division of Endocrinology, “Garibaldi” Hospital, Catania

    P. Tita

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

    P. F. Boscani

Authors
  1. G. Lombardi MD, PhD
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  2. F. Minuto
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  3. G. Tamburrano
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  4. M. R. Ambrosio
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  7. V. Chiarini
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  8. R. Cozzi
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  9. S. Grottoli
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  14. P. F. Boscani
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  15. A. Colao
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Corresponding author

Correspondence to G. Lombardi MD, PhD.

Additional information

The study (A-93-52030-077) has been registered in www.clinicaltrials.gov as NCT00499993

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Lombardi, G., Minuto, F., Tamburrano, G. et al. Efficacy of the new long-acting formulation of lanreotide (Lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. J Endocrinol Invest 32, 202–209 (2009). https://doi.org/10.1007/BF03346453

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