| Long-Term Safety of Pegvisomant in Patients with Acromegaly: Comprehensive Review of 1288 Subjects in ACROSTUDY. | |
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MedLine Citation:
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PMID: 22362824 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Context:Pegvisomant is a GH receptor antagonist. The ACROSTUDY is a global safety surveillance study of long-term treatment of acromegaly with pegvisomant.Objective:The objective of the study was to monitor long-term safety and treatment outcomes.Design:ACROSTUDY is open to all patients with acromegaly who are treated with pegvisomant. We report an interim analysis of data captured from 1288 subjects enrolled before a database freeze of December 31, 2009.Setting:This was a global noninterventional surveillance study.Main Outcome Measure(s):Long-term monitoring of safety, including central magnetic resonance imaging (MRI) reading and treatment outcomes, was measured.Results:Subjects (n = 1288) were treated with pegvisomant for a mean of 3.7 yr and followed up in ACROSTUDY for a mean of 2.1 yr. A total of 1147 adverse events (AE) were recorded in 477 subjects (37%), among which 192 AE in 124 subjects (9.6%) were considered to be related to pegvisomant. Serious AE were recorded in 159 subjects (12.3%), whereas pegvisomant-related Serious AE were recorded in 26 subjects (2%). No deaths (15 subjects; 1.2%) were attributed to pegvisomant use. The incidence of increase in pituitary tumor size in the subset with confirmed MRI increases on central reading represented 3.2% of the overall cohort with at least two available MRI (n = 936). Injection-site reactions were reported in 28 cases (2.2%). In 30 patients (2.5%), an elevated aspartate aminotransferase or alanine aminotransferase of more than 3 times the upper level of normality was reported. There were no reports of liver failure. After 5 yr of pegvisomant treatment, 63.2% of subjects had normal IGF-I levels at a mean dose of 18 mg/d.Conclusions:Data entered and evaluated in ACROSTUDY indicate that pegvisomant is an effective and safe medical treatment in patients with acromegaly. The reported low incidence of pituitary tumor size increase, liver enzyme elevations, and lipodystrophy at the injection site are reassuring. |
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Authors:
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A J van der Lely; Beverly M K Biller; Thierry Brue; Michael Buchfelder; Ezio Ghigo; Roy Gomez; Judith Hey-Hadavi; Frida Lundgren; Natasa Rajicic; Christian J Strasburger; Susan M Webb; Maria Koltowska-Häggström |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-2-22 |
Journal Detail:
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Title: The Journal of clinical endocrinology and metabolism Volume: - ISSN: 1945-7197 ISO Abbreviation: - Publication Date: 2012 Feb |
Date Detail:
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Created Date: 2012-2-24 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0375362 Medline TA: J Clin Endocrinol Metab Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Department of Medicine (A.J.v.d.L.), Erasmus University Medical Center, 3000 CA Rotterdam, The Netherlands; Harvard Medical School (B.M.K.B.), Massachusetts General Hospital, Boston, Massachusetts 02114; Department of Endocrinology (T.B.), Centre de Référence des Maladies Rares d'Origine Hypophysaire, Hôpital de la Timone, Assistance Publique-Hôpitaux de Marseille and Faculté de Médecine de Marseille, Aix-Marseille Université, 13331 Marseille, France; Department of Neurosurgery (M.B.), Neurochirurgische Klinik, 91054 Erlangen, Germany; Department of Endocrinology (E.G.), University of Turin, 10126 Turin, Italy; European Medical Affairs (R.G.), Pfizer, 1050 Brussels, Belgium; Medicines Development Group (J.H.-H., N.R.), Clinical Affairs, Pfizer Inc., New York, New York 10017; ACROSTUDY (F.L., M.K.-H.), Pfizer Health AB, 191 90 Sollentuna, Sweden; Division of Clinical Endocrinology (C.J.S.), Department of Medicine, Campus Charité-Mitte, 10117 Berlin, Germany; and Departments of Endocrinology and Medicine (S.M.W.), Hospital Sant Pau, IIB-Sant Pau, Centro de Investigación Biomédica en Red de Enfermedades Raras Unit 747, Instituto de Salud Carlos III; Universitat Autònoma de Barcelona, 08025 Barcelona, Spain. |
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