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The effect of long-term danazol prophylaxis on liver function in hereditary angioedema—a longitudinal study

  • Pharmacoepidemiology and Prescription
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Abstract

Background

Danazol is a drug most widely used for the prophylaxis of hereditary angioedema resulting from the deficiency of the C1-inhibitor. Potential hepatotoxic or liver tumor-inducing side effects of long-term danazol prophylaxis have been investigated during the follow-up of hereditary angioedema patients.

Methods

Characteristic parameters of liver function (including bilirubin, GOT, GPT, γGT, total protein, ALP, LDH), as well as findings of viral serology screens and abdominal ultrasonography—determined during years 0 and 5 of follow-up of patient groups taking/not taking danazol—have been reviewed and analyzed comparatively.

Results

From a population of 126 hereditary angioedema patients, 46 subjects taking danazol and another 46 not taking danazol fulfilled the inclusion criteria. Longitudinal follow-up did not reveal any clinically relevant difference between the liver function parameters determined in years 0 and 5 in the two groups. Abdominal ultrasound did not detect neoplastic or other potentially treatment-related alterations of the liver parenchyma. There were no discontinuations of treatment during the study.

Conclusions

Our results clearly suggest that, administered at the lowest effective dose, danazol does not induce liver injury in hereditary angioedema patients.

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Abbreviations

GOT:

Glutamate-oxaloacetate transaminase

GPT:

Glutamate-pyruvate transaminase

γGT:

Gamma-glutamyltransferase

ALP:

Alkaline phosphatase

LDH:

Lactate dehydrogenase

HAE:

Hereditary angioedema

C1-INH:

C1-inhibitor

pdhC1-INH:

Plasma-derived human C1-inhibitor concentrate

AAS:

Anabolic androgen steroid

LDL:

Low-density lipoprotein

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Acknowledgments

We thank Márta Kókai, Judit Hajas, Éva Páskuly, and Judit Bali for their excellent laboratory assistance.

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Authors and Affiliations

  1. Faculty of Medicine, 3rd Department of Internal Medicine, Semmelweis University, Kútvölgyi út 4, H-1125, Budapest, Hungary

    Henriette Farkas, Ibolya Czaller, Dorottya Csuka, Lilian Varga, Gábor Széplaki, László Jakab, George Füst, Zoltán Prohászka & István Karádi

  2. Department of Radiology, Kútvölgyi Clinical Centre, Budapest, Hungary

    Anikó Vas

  3. Central Laboratory, Kútvölgyi Clinical Centre, Budapest, Hungary

    Szilvia Valentin

  4. Heim Pál Pediatric Hospital, Budapest, Hungary

    George Harmat & Beata Visy

Authors
  1. Henriette Farkas
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  2. Ibolya Czaller
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  3. Dorottya Csuka
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Correspondence to Henriette Farkas.

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Farkas, H., Czaller, I., Csuka, D. et al. The effect of long-term danazol prophylaxis on liver function in hereditary angioedema—a longitudinal study. Eur J Clin Pharmacol 66, 419–426 (2010). https://doi.org/10.1007/s00228-009-0771-z

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  • DOI: https://doi.org/10.1007/s00228-009-0771-z

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