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

2009; Springer Science+Business Media; Volume: 32; Issue: 3 Linguagem: Inglês

10.1007/bf03346453

1720-8386

Gaetano Lombardi, Francesco Minuto, G. Tamburrano, Maria Rosaria Ambrosio, Giorgio Arnaldi, Maura Arosio, Valentina Chiarini, Renato Cozzi, Silvia Grottoli, Franco Mantero, Fausto Bogazzi, Massimo Terzolo, Patrizia Tita, P. F. Boscani, Annamaria Colao,

Neuroendocrine Tumor Research Advances

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.