| Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial. | |
| | |
MedLine Citation:
|
PMID: 20410233 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
CONTEXT: Pasireotide (SOM230) is a novel multireceptor ligand somatostatin analog with affinity for somatostatin receptor subtypes sst(1-3) and sst(5). Because most GH-secreting pituitary adenomas express sst(2) and sst(5), pasireotide has the potential to be more effective than the sst(2)-preferential somatostatin analogs octreotide and lanreotide. OBJECTIVE: Our objective was to evaluate the efficacy and safety of three different doses of pasireotide in patients with acromegaly. DESIGN: We conducted a phase II, randomized, multicenter, open-label, three-way, crossover study. PATIENTS: Sixty patients with acromegaly, defined by a 2-h five-point mean GH level higher than 5 microg/liter, lack of suppression of GH to less than 1 microg/liter after oral glucose tolerance test, and elevated IGF-I for age- and sex-matched controls. Patients could have had previous surgery, radiotherapy, and/or medical therapy or no previous treatment. INTERVENTION: After treatment with octreotide 100 microg s.c. three times daily for 28 d, each patient received pasireotide 200, 400, and 600 microg s.c. twice daily in random order for 28 d. MAIN OUTCOME MEASURE: A biochemical response was defined as a reduction in GH to no more than 2.5 microg/liter and normalization of IGF-I to age- and sex-matched controls. RESULTS: After 4 wk of octreotide, 9% of patients achieved a biochemical response. After 4 wk of pasireotide 200-600 microg s.c. bid, 19% of patients achieved a biochemical response, which increased to 27% after 3 months of pasireotide; 39% of patients had a more than 20% reduction in pituitary tumor volume. Pasireotide was generally well tolerated. CONCLUSIONS: Pasireotide is a promising treatment for acromegaly. Larger studies of longer duration evaluating the efficacy and safety of pasireotide in patients with acromegaly are ongoing. |
| | |
Authors:
|
S Petersenn; J Schopohl; A Barkan; P Mohideen; A Colao; R Abs; A Buchelt; Y-Y Ho; K Hu; A J Farrall; S Melmed; B M K Biller; |
Related Documents
:
|
8127403 - Inhibition of interleukin-2-mediated lymphocyte activation in patients with cushing's s... 1319693 - The cushing syndrome induced by bronchial carcinoid tumors. 11332653 - Diagnostic findings in 95 finnish patients with common variable immunodeficiency. |
Publication Detail:
|
Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-04-21 |
Journal Detail:
|
Title: The Journal of clinical endocrinology and metabolism Volume: 95 ISSN: 1945-7197 ISO Abbreviation: J. Clin. Endocrinol. Metab. Publication Date: 2010 Jun |
Date Detail:
|
Created Date: 2010-06-07 Completed Date: 2010-07-01 Revised Date: 2010-08-02 |
Medline Journal Info:
|
Nlm Unique ID: 0375362 Medline TA: J Clin Endocrinol Metab Country: United States |
Other Details:
|
Languages: eng Pagination: 2781-9 Citation Subset: AIM; IM |
Affiliation:
|
Division of Endocrinology, Medical Center, University of Duisburg-Essen, Hufelandstrasse 55, 45122 Essen, Germany. stephan.petersenn@uni-due.de |
| Data Bank Information | |
Bank Name/Acc. No.:
|
ClinicalTrials.gov/NCT00088582 |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Acromegaly
/
drug therapy* Adolescent Adult Aged Aged, 80 and over Blood Glucose / metabolism Cross-Over Studies Dose-Response Relationship, Drug Double-Blind Method Endpoint Determination Female Human Growth Hormone / blood Humans Insulin-Like Growth Factor I / metabolism Magnetic Resonance Imaging Male Middle Aged Octreotide / adverse effects, therapeutic use Pituitary Neoplasms / pathology Somatostatin / adverse effects, analogs & derivatives*, pharmacokinetics, therapeutic use Young Adult |
| Chemical | |
Reg. No./Substance:
|
0/Blood Glucose; 0/pasireotide; 12629-01-5/Human Growth Hormone; 51110-01-1/Somatostatin; 67763-96-6/Insulin-Like Growth Factor I; 83150-76-9/Octreotide |
| Investigator | |
Investigator/Affiliation:
|
Thierry Brue / ; Philippe Caron / ; Phillipe Chanson / ; Ross Cuneo / ; Angel Díaz / ; Ezio Ghigo / ; Rolf Gaillard / ; Irene Halperin / ; David Kleinberg / ; Vincent Rohmer / ; J A Romijn / ; Jean-Louis Schlienger / ; Paul Stewart / ; Antoine Tabarin / ; Peter J Trainer / ; A J van der Lely / ; Mary Lee Vance / |
| Comments/Corrections | |
Comment In:
|
Nat Rev Endocrinol. 2010 Aug;6(8):417 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Deoxyribonucleic Acid Methylation and Gene Expression of PPARGC1A in Human Muscle Is Influenced by H...
Next Document: New insights into thyroglobulin pathophysiology revealed by the study of a family with congenital go...