Background: The German Pegvisomant Observational Study (GPOS) was created immediately after marketing authorisation was received in Germany for Somavert®(pegvisomant) for the treatment of patients with acromegaly. In August 2006, the database underwent its fifth interim analysis of 263 patients, the vast majority of whom previously had insufficient disease control with other treatment modalities. The GPOS documents both safety and efficacy aspects of the treatment of patients with acromegaly by the first growth hormone-receptor antagonist, pegvisomant. This treatment led to normalization of disease activity in most patients, had favourable effects on glucose metabolism and improved signs and symptoms of the disorder. The safety profile indicates that pegvisomant treatment is well tolerated, and tumour growth is noted to occur at the same rate as for somatostatin analogue treatment. Transaminase elevations occurred in 16 of the 263 patients but spontaneously resolved in eight of them and promptly normalised in five patients who discontinued treatment. GPOS is presently the largest database of pegvisomant-treated patients, and it comprises more than 87% of all patients treated with pegvisomant in Germany. Conclusions: The GPOS database provides important information about treatment modalities, safety and efficacy of pegvisomant in patients with acromegaly.

Keywords:
Acromegaly, Pegvisomant, Surveillance database, Insulin-like growth factor-I, IGF-I, Normalization rate
1.
Schreiber I, Buchfelder M, Droste M, Forssmann K, Mann K, Saller B, Strasburger CJ, the German Pegvisomant Investigators: Treatment of acromegaly with the GH receptor antagonist pegvisomant in clinical practice: safety and efficacy evaluation from the German Pegvisomant Observational Study. Eur J Endocrinol 2007;156:75–82.
2.
Brabant G, von zur Mühlen A, Wüster C, Ranke M, Kratzsch J, Kiess W, Ketelslegers JM, Wilhelmsen L, Hulten L, Saller B, Mattson A, Wilde J, Schemer R, Kann P: Serum IGF-I reference values for an automated chemiluminescence immunoassay system: results from a multicentre study. Horm Res 2003;60:53–60.
3.
Elmlinger MW, Kuhnel W, Weber MM, Ranke MB: Reference ranges for two automated chemiluminescent assays for serum insulin-like growth factor I (IGF-I) and IGF-binding protein 3 (IGFBP-3). Clin Chem Lab Med 2004;42(6):654–664.
4.
Trainer PJ, Drake WM, Katznelson L, Freda PU, Herman-Bonert V, van der Lely AJ, Dimaraki EV, Stewart PM, Friend KE, Vance ML, Besser GM, Scarlett JA, Thorner MO, Parkinson C, Klibanski A, Powell JS, Barkan AL, Sheppard MC, Malsonado M, Rose DR, Clemmons DR, Johannsson G, Bengtsson BA, Stavrou S, Kleinberg DL, Cook DM, Phillips LS, Bidlingmaier M, Strasburger CJ, Hackett S, Zib K, Bennett WF, Davis RJ: Treatment of acromegaly with the growth hormone-receptor antagonist pegvisomant. N Engl J Med 2000;342:1171–1177.
5.
van der Lely AJ, Hutson RK, Trainer PJ, Besser GM, Barkan AL, Katznelson L, Klibanski A, Herman-Bonert V, Melmed S, Vance ML, Freda PU, Stewart PM, Friend KE, Clemmons DR, Johannsson G, Stavrou S, Cook DM, Phillips LS, Strasburger CJ, Hackett S, Zib KA, Davis RJ, Scarlett JA, Thorner MO: Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist. Lancet 2001;358:1754–1759.
6.
Biering H, Saller B, Bauditz J, Pirlich M, Rudolph B, Johne A, Buchfelder M, Mann K, Droste M, Schreiber I, Lochs H, Strasburger CJ: Elevated transaminases during medical treatment of acromegaly: A review of the German pegvisomant surveillance experience and a report of a patient with histologically proven chronic mild active hepatitis. Eur J Endocrinol 2006;154:1–9.
7.
Besser GM, Burman P, Daly AF: Predictors and rates of treatment-resistant tumor growth in acromegaly. Eur J Endocrinol 2005;153:187–193.
© 2007 S. Karger AG, Basel
2007
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.