Document Detail

Combined treatment for acromegaly with long-acting somatostatin analogs and pegvisomant: long-term safety for up to 4.5 years (median 2.2 years) of follow-up in 86 patients.
MedLine Citation:
PMID:  19141604     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: We previously reported on the efficacy, safety, and quality of life (QoL) of long-acting somatostatin analogs (SSA) and (twice) weekly pegvisomant (PEG-V) in acromegaly and improvement after the addition of PEG-V to long-acting SSA. OBJECTIVE: To assess the long-term safety in a larger group of acromegalic patients over a larger period of time: 29.2 (1.2-57.4) months (mean (range)). DESIGN: Pegvisomant was added to SSA monotherapy in 86 subjects (37 females), to normalize serum IGF1 concentrations (n=63) or to increase the QoL. The median dosage was 60.0 (20-200) mg weekly. RESULTS: After a mean treatment period of 29.2 months, 23 patients showed dose-independent PEG-V related transient liver enzyme elevations (TLEE). TLEE occurred only once during the continuation of combination therapy, but discontinuation and re-challenge induced a second episode of TLEE. Ten of these patients with TLEE also suffered from diabetes mellitus (DM). In our present series, DM had a 2.28 odds ratio (CI 1.16-9.22; p=0.03) higher risk for developing TLEE. During the combined therapy, a clinical significant decrease in tumor size by more than 20% was observed in 14 patients. Two of these patients were previously treated by pituitary surgery, 1 with additional radiotherapy and all other patients received primary medical treatment. CONCLUSION: Long-term combined treatment with SSA and twice weekly PEG-V up to more than 4 years seems to be safe. Patients with both acromegaly and DM have a 2.28 higher risk of developing TLEE. Clinical significant tumor shrinkage was observed in 14 patients during combined treatment.
S J C M M Neggers; W W de Herder; J A M J L Janssen; R A Feelders; A J van der Lely
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Publication Detail:
Type:  Journal Article     Date:  2009-01-13
Journal Detail:
Title:  European journal of endocrinology / European Federation of Endocrine Societies     Volume:  160     ISSN:  1479-683X     ISO Abbreviation:  Eur. J. Endocrinol.     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-03-31     Completed Date:  2009-04-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9423848     Medline TA:  Eur J Endocrinol     Country:  England    
Other Details:
Languages:  eng     Pagination:  529-33     Citation Subset:  IM    
Department of Medicine, Erasmus University, Erasmus MC, Rotterdam, The Netherlands.
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MeSH Terms
Acromegaly / drug therapy*
Aged, 80 and over
Diabetes Complications / physiopathology
Drug Therapy, Combination
Follow-Up Studies
Human Growth Hormone / adverse effects,  analogs & derivatives*,  therapeutic use
Liver Function Tests
Middle Aged
Octreotide / therapeutic use
Peptides, Cyclic / therapeutic use
Receptors, Somatotropin / antagonists & inhibitors*
Somatostatin / adverse effects,  analogs & derivatives*,  therapeutic use*
Young Adult
Reg. No./Substance:
0/Peptides, Cyclic; 0/Receptors, Somatotropin; 0/pegvisomant; 118992-92-0/lanreotide; 12629-01-5/Human Growth Hormone; 51110-01-1/Somatostatin; 83150-76-9/Octreotide

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