Document Detail


Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly.
MedLine Citation:
PMID:  19542735     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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
Related Documents :
9279515 - The results of transsphenoidal surgery for 44 consecutive acromegalic patients.
11836305 - Estrogen mini-dose replacement during gnrh agonist therapy in central precocious pubert...
11347645 - Acoustic neuromas in the elderly.
1992185 - Creutzfeldt-jakob disease in pituitary growth hormone recipients in the united states.
2299455 - Recovery of neurosensory function following orthognathic surgery.
9672795 - Long-term outcome of primary glaucoma triple procedure with adjunctive 5-fluorouracil.
Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of endocrinological investigation     Volume:  32     ISSN:  1720-8386     ISO Abbreviation:  J. Endocrinol. Invest.     Publication Date:  2009 Mar 
Date Detail:
Created Date:  2009-06-22     Completed Date:  2009-09-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7806594     Medline TA:  J Endocrinol Invest     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  202-9     Citation Subset:  IM    
Affiliation:
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.:
ClinicalTrials.gov/NCT00499993
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Acromegaly / 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:
0/Antineoplastic Agents; 0/Delayed-Action Preparations; 0/Gels; 0/Peptides, Cyclic; 118992-92-0/lanreotide; 51110-01-1/Somatostatin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  The relationship among renal injury, changed activity of renal 1-alpha hydroxylase and bone loss in ...
Next Document:  Increased clearance of cortisol by 5beta-reductase in a subgroup of women with adrenal hyperandrogen...