Successful use of weekly pegvisomant administration in patients with acromegaly.

2.50
Hdl Handle:
http://hdl.handle.net/10541/69755
Title:
Successful use of weekly pegvisomant administration in patients with acromegaly.
Authors:
Higham, Claire E; Thomas, J; Bidlingmaier, M; Drake, William M; Trainer, Peter J
Abstract:
Context Clinical trials using 80 mg once-weekly pegvisomant in active acromegaly led to a 30% fall in serum IGF-I. Subsequent studies demonstrated that daily administration of up to 40 mg/day achieved an IGF-I within reference range in 97% of patients. Pegvisomant has a half-life of >70hrs suggesting weekly dosing may be possible but using higher doses than in the initial trials. Objective To determine the efficacy of weekly dosing of pegvisomant. Design A two-center, open-label prospective study in patients with acromegaly converted from a stable daily dose of pegvisomant (median dose 15 mg daily [range 10-20 mg od], IGF-I normal for 3 months prior to inclusion) to twice-weekly (week 0-16) followed by once-weekly (week 16-32) administration. Results Seven patients (4M, age 57+/-7 yrs, 6/7 prior trans-sphenoidal surgery, 7/7 prior radiotherapy) were recruited. Six patients completed the twice-weekly and five patients both the twice-weekly and once-weekly administration. Headaches led to 2 patient withdrawals at 0 + 24 weeks. Mean pre-dose serum IGF-I levels remained stable with the different administration regimens (IGF-I baseline 145+/-39 ng/ml, twice-weekly 124+/-39 ng/ml and once-weekly 127+/-22 ng/ml) and all values were within age adjusted IGF-I reference range. Pegvisomant dose was reduced in 2 patients and 5 opted to continue weekly administration at trial termination. Safety and QOL parameters remained stable. Conclusions Twice and once-weekly administration of pegvisomant is effective in controlling serum IGF-I levels in acromegaly and although not formally assessed, continuation of weekly dosing in 5 patients at study conclusion suggests patient preference for this regimen.
Affiliation:
C Higham, Endocrinology, Christie Hospital, Manchester, M20 4BX, United Kingdom.
Citation:
Successful use of weekly pegvisomant administration in patients with acromegaly. 2009: Eur. J. Endocrinol.
Journal:
European Journal of Endocrinology
Issue Date:
1-May-2009
URI:
http://hdl.handle.net/10541/69755
DOI:
10.1530/EJE-08-0990
PubMed ID:
19411301
Type:
Article
Language:
en
ISSN:
1479-683X
Appears in Collections:
All Christie Publications ; Endocrinology

Full metadata record

DC FieldValue Language
dc.contributor.authorHigham, Claire E-
dc.contributor.authorThomas, J-
dc.contributor.authorBidlingmaier, M-
dc.contributor.authorDrake, William M-
dc.contributor.authorTrainer, Peter J-
dc.date.accessioned2009-06-05T09:25:47Z-
dc.date.available2009-06-05T09:25:47Z-
dc.date.issued2009-05-01-
dc.identifier.citationSuccessful use of weekly pegvisomant administration in patients with acromegaly. 2009: Eur. J. Endocrinol.en
dc.identifier.issn1479-683X-
dc.identifier.pmid19411301-
dc.identifier.doi10.1530/EJE-08-0990-
dc.identifier.urihttp://hdl.handle.net/10541/69755-
dc.description.abstractContext Clinical trials using 80 mg once-weekly pegvisomant in active acromegaly led to a 30% fall in serum IGF-I. Subsequent studies demonstrated that daily administration of up to 40 mg/day achieved an IGF-I within reference range in 97% of patients. Pegvisomant has a half-life of >70hrs suggesting weekly dosing may be possible but using higher doses than in the initial trials. Objective To determine the efficacy of weekly dosing of pegvisomant. Design A two-center, open-label prospective study in patients with acromegaly converted from a stable daily dose of pegvisomant (median dose 15 mg daily [range 10-20 mg od], IGF-I normal for 3 months prior to inclusion) to twice-weekly (week 0-16) followed by once-weekly (week 16-32) administration. Results Seven patients (4M, age 57+/-7 yrs, 6/7 prior trans-sphenoidal surgery, 7/7 prior radiotherapy) were recruited. Six patients completed the twice-weekly and five patients both the twice-weekly and once-weekly administration. Headaches led to 2 patient withdrawals at 0 + 24 weeks. Mean pre-dose serum IGF-I levels remained stable with the different administration regimens (IGF-I baseline 145+/-39 ng/ml, twice-weekly 124+/-39 ng/ml and once-weekly 127+/-22 ng/ml) and all values were within age adjusted IGF-I reference range. Pegvisomant dose was reduced in 2 patients and 5 opted to continue weekly administration at trial termination. Safety and QOL parameters remained stable. Conclusions Twice and once-weekly administration of pegvisomant is effective in controlling serum IGF-I levels in acromegaly and although not formally assessed, continuation of weekly dosing in 5 patients at study conclusion suggests patient preference for this regimen.en
dc.languageENG-
dc.language.isoenen
dc.subjectPegvisomanten
dc.subjectAcromegalyen
dc.titleSuccessful use of weekly pegvisomant administration in patients with acromegaly.en
dc.typeArticleen
dc.contributor.departmentC Higham, Endocrinology, Christie Hospital, Manchester, M20 4BX, United Kingdom.en
dc.identifier.journalEuropean Journal of Endocrinologyen

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