| Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. | |
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MedLine Citation:
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PMID: 19542735 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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 <or=2.5 microg/l every 8 weeks (group A, 17 patients); if 2.5-5 microg/l every 6 weeks (group B, 15 patients); and if >5 microg/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<or=2.5 microg/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:
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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 |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of endocrinological investigation Volume: 32 ISSN: 1720-8386 ISO Abbreviation: J. Endocrinol. Invest. Publication Date: 2009 Mar |
Date Detail:
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Created Date: 2009-06-22 Completed Date: 2009-09-02 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7806594 Medline TA: J Endocrinol Invest Country: Italy |
Other Details:
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Languages: eng Pagination: 202-9 Citation Subset: IM |
Affiliation:
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Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples, Naples, Italy. gaelomba@unina.it |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00499993 |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acromegaly
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drug therapy*,
etiology Adenoma / drug therapy Adult Aged Algorithms Antineoplastic Agents / administration & dosage, adverse effects Delayed-Action Preparations / administration & dosage, adverse effects Female Gels / administration & dosage, adverse effects Growth Hormone-Secreting Pituitary Adenoma / drug therapy Humans Male Middle Aged Peptides, Cyclic / administration & dosage*, adverse effects Somatostatin / administration & dosage, adverse effects, analogs & derivatives* Treatment Outcome Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Delayed-Action Preparations; 0/Gels; 0/Peptides, Cyclic; 118992-92-0/lanreotide; 51110-01-1/Somatostatin |
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