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

European Journal of Endocrinology

Volumn 154, Issue 2, 2006, Pages 213-220

  Biering, H ^a   Saller, B ^b   Bauditz, J ^a   Pirlich, M ^a   Rudolph, B ^a   Johne, A ^a   Buchfelder, M ^c   Mann, K ^d   Droste, M ^e   Schreiber, I ^b   Lochs, H ^a   Strasburger, Christian J ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b PFIZER INC   (United States)

^c UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^d UNIVERSITY OF DUISBURG ESSEN   (Germany)

^e NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMINOTRANSFERASE; OCTREOTIDE; PEGVISOMANT; SOMATOMEDIN; SOMATOSTATIN;

ACROMEGALY; ADULT; AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; BILE DUCT OBSTRUCTION; CHOLELITHIASIS; CHRONIC HEPATITIS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERANCE; ENZYME DEFECT; FEMALE; GERMANY; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; IMPAIRED GLUCOSE TOLERANCE; LIVER BIOPSY; LIVER FUNCTION TEST; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; ORAL GLUCOSE TOLERANCE TEST; POSTMARKETING SURVEILLANCE; PREVALENCE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; REVIEW; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT WITHDRAWAL; VASCULAR FIBROSIS;

ACROMEGALY; ADULT; ALANINE TRANSAMINASE; ASPARTATE AMINOTRANSFERASES; FEMALE; HEPATITIS, CHRONIC; HISTOCYTOCHEMISTRY; HUMAN GROWTH HORMONE; HUMANS; INSULIN-LIKE GROWTH FACTOR I; MALE; RECEPTORS, SOMATOTROPIN; RETROSPECTIVE STUDIES;

EID: 33644594740     PISSN: 08044643     EISSN: None     Source Type: Journal    
DOI: 10.1530/eje.1.02079     Document Type: Review

References (25)

1. Holdaway IM, Rajasoorya RC & Gamble GD. Factors influencing mortality in acromegaly. Journal of Clinical Endocrinology and Metabolism 2004 89 667-674.
2. Trainer PJ, Drake WM, Perry LA, Taylor NF, Besser GM & Monson JP. Modulation of cortisol metabolism by the growth hormone receptor antagonist pegvisomant in patients with acromegaly. Journal of Clinical Endocrinology and Metabolism 2001 86 2989-2992.
3. Parkinson C, Drake WM, Wieringa G, Yates AP, Besser GM & Trainer PJ. Serum lipoprotein changes following IGF-I normalization using a growth hormone receptor antagonist in acromegaly. Clinical Endocrinology 2002 56 303-311.
4. Sesmilo G, Fairfield WP, Katznelson L, Pulaski K, Freda PU, Bonert V, Dimaraki E, Stavrou S, Vance ML, Hayden D & Klibanski A. Cardiovascular risk factors in acromegaly before and after normalization of serum IGF-I levels with the GH antagonist pegvisomant. Journal of Clinical Endocrinology and Metabolism 2002 87 1692-1699.
5. Parkinson C, Kassem M, Heickendorff L, Flyvbjerg A & Trainer PJ. Pegvisomant-induced serum insulin-like growth factor-I normalization in patients with acromegaly returns elevated markers of bone turnover to normal. Journal of Clinical Endocrinology and Metabolism 2003 88 5650-5655.
6. World Health Organization, Definition, diagnosis and classification of diabetes mellitus and its complications. In Report of a World Health Organization Consultation, part I: Diagnosis and Classification of Diabetes Mellitus. Geneva: World Health Organization, 1999.
7. van der Lely AJ, Lamberts SW, Barkan A, Pandya N, Besser G, Trainer PJ, Bonert V, Melmed S, Clemmons DR, Rose R, Vance ML, Thorner M, Zib K, Davis RJ, Bennett WF & Scarlett JAA. A six-week, double blind, placebo controlled study of a growth hormone antagonist B2036-PEG (Trovert™) in acromegalic patients. Proceedings of the 80th Annual Meeting of the Endocrine Society, New Orleans, LA, USA, 1988. Abstract OR4-1.
8. 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. New England Journal of Medicine 2000 342 1171-1177.
9. 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.
10. CDER. Center for Drug Evaluation and Research Approval Package for: application number 21-106. Medical review(s) (for pegvisomant). Center for Drug Evaluation and Research, Food and Drug Administration web site 2003. Available at: http://www.fda.gov/cder/foi/nda/2003/21-106_Somavert_Medr_P1.pdf. Accessed 23 July 2003.
11. Drake WM, Parkinson C, Besser GM & Trainer PJ. Clinical use of a growth hormone receptor antagonist in the treatment of acromegaly. Trends in Endocrinology and Metabolism 2001 12 408-413.
12. Harris JM & Chess RB. Effect of pegylation on pharmaceuticals. Nature Reviews Drug Discovery 2003 2 214-221.
13. Flyvbjerg A, Bennett WF, Rasch R, Kopchick JJ & Scarlett JA. Inhibitory effect of a growth hormone receptor antagonist (G120K-PEG) on renal enlargement, glomerular hypertrophy, and urinary albumin excretion in experimental diabetes in mice. Diabetes 1999 48 377-382.
14. Segev Y, Landau D, Rasch R, Flyvbjerg A & Phillip M. Growth hormone receptor antagonism prevents early renal changes in non-obese diabetic mice. Journal of the American Society of Nephrology 1999 10 2374-2381.
15. Parkinson C, Drake WM, Roberts ME, Meeran K, Besser GM & Trainer PJ. A comparison of the effects of pegvisomant and octreotide on glucose, insulin, gastrin, cholecystokinin, and pancreatic polypeptide responses to oral glucose and a standard mixed meal. Journal of Clinical Endocrinology and Metabolism 2002 87 1797-1804.
16. Rizza RA, Mandarino LJ & Gerich JE. Effects of growth hormone on insulin action in man. Mechanisms of insulin resistance, impaired suppression of glucose production, and impaired stimulation of glucose utilization. Diabetes 1982 31 663-669.
17. Rosenfeld RG, Wilson DM, Dollar LA, Bennett A & Hintz RL. Both human pituitary growth hormone and recombinant DNA-derived human growth hormone cause insulin resistance at a postreceptor site. Journal of Clinical Endocrinology and Metabolism 1982 54 1033-1038.
18. Roelfsema F & Frolich M. Glucose tolerance and plasma immunoreactive insulin levels in acromegalics before and after selective transsphenoidal surgery. Clinical Endocrinology 1985 22 531-537.
19. Biering H, Knappe G, Gerl H & Lochs H. Diabetes-Häufigkeit bei Akromegalie und Cushing-Syndrom. Acta Medica Austriaca 2000 27 27-31.
20. Rose DR & Clemmons DR. Growth hormone receptor antagonist improves insulin resistance in acromegaly. Growth Hormone and IGF Research 2002 12 418-424.
21. Drake WM, Rowles SV, Roberts ME, Fode FK, Besser GM, Monson JP & Trainer PJ. Insulin sensitivity and glucose tolerance improve in patients with acromegaly converted from depot octreotide to pegvisomant. European Journal of Endocrinology 2003 149 521-527.
22. Hui JM, Sud A, Farrell GC, Bandara P, Byth K, Kench JG, McCaughan GW & George J. Insulin resistance is associated with chronic hepatitis C virus infection and fibrosis progression. Gastroenterology 2003 125 1695-1704.
23. Nelson DR, Lim HL, Marousis CG, Fang JW, Davis GL, Shen L, Urdea MS, Kolberg JA & Lau JY. Activation of tumor necrosis factor-alpha system in chronic hepatitis C virus infection. Digestive Diseases and Sciences 1997 42 2487-2494.
24. Hotamisligil GS, Murray DL, Choy LN & Spiegelman BM. Tumor necrosis factor alpha inhibits signaling from the insulin receptor. PNAS 1994 91 4854-4858.
25. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF & Turner RC. Homeostasis model assessment (HOMA): insulin resistance and β-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985 28 412-419.