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Long-Term Treatment...
Long-Term Treatment with Pegvisomant as Monotherapy in Patients with Acromegaly : Experience from Acrostudy
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- Freda, Pamela U (författare)
- Department of Medicine, Columbia University College of Physicians & Surgeons. New York, NY, USA
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- Gordon, Murray B (författare)
- Departments of Medicine and Neurosurgery, Allegheny Neuroendocrinology Center, Allegheny General Hospital Pittsburgh, PA, USA
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- Kelepouris, Nicky (författare)
- Pfizer, Collegeville, PA, USA
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- Jonsson, Peter (författare)
- Pfizer Health AB, Sollentuna, Sweden
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- Koltowska-Häggström, Maria, 1957- (författare)
- Uppsala universitet,Institutionen för kvinnors och barns hälsa,Barnendokrinologisk forskning/Gustafsson
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- van der Lely, A J (författare)
- Erasmus University Medical Center, CA Rotterdam, The Netherlands
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Department of Medicine, Columbia University College of Physicians & Surgeons New York, NY, USA Departments of Medicine and Neurosurgery, Allegheny Neuroendocrinology Center, Allegheny General Hospital Pittsburgh, PA, USA (creator_code:org_t)
- 2015
- 2015
- Engelska.
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Ingår i: Endocrine Practice. - 1530-891X .- 1934-2403. ; 21:3, s. 264-274
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.4...
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Abstract
Ämnesord
Stäng
- Objective: To evaluate use of pegvisomant, a GH receptor antagonist, as monotherapy in ACROSTUDY, a global safety surveillance study set in 14 countries (373 sites).Methods: A descriptive analysis of safety, magnetic resonance imaging (MRI) reading and treatment outcomes in 710 subjects who received at least one pegvisomant dose as monotherapy during and up to 5 years follow-up in ACROSTUDY.Results: Subjects received 5.4 yr. (mean) of pegvisomant and were followed in ACROSTUDY 3.8 yr. (mean). A total of 1255 adverse events were reported in 345 subjects (48.6%). Serious adverse events were reported in 133 (18.7%) subjects including 22 deaths, none of which were attributed to pegvisomant use. Of 670 (94%) subjects with at least one liver function test reported in ACROSTUDY, 8 (1.2%) had reported increases in transaminases > 3X ULN. No liver failure was reported. Based on central MRI reading, 12 of 542 subjects (2.2%) had a confirmed increase or increase/decrease in tumor size. Injection-site reactions were reported in 2.3%. At 5 years of therapy, IGF-1 level was reported normal in 67.5% (mean dose 17.2 mg/day) and elevated in 29.9% (mean dose 19.8 mg/day). Subjects on 20 mg per day or more rose from 36% at 3 years to 41% at 5 years of therapy.Conclusions: ACROSTUDY data indicate that pegvisomant used as sole medical therapy is safe and effective medical treatment for acromegaly. The reported low incidence of pituitary tumor size increase and liver enzyme elevations are reassuring and support the positive benefit-risk of pegvisomant therapy.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- acromegaly
- pegvisomant
- ACROSTUDY
- clinical trial
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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