The effect of long-term danazol prophylaxis on liver function in hereditary angioedema-a longitudinal study.
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, gammaGT, 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.
Farkas
Henriette
H
Department of Internal Medicine, Semmelweis University, Budapest, Hungary. farkash@kut.sote.hu
Czaller
Ibolya
I
Csuka
Dorottya
D
Vas
Anikó
A
Valentin
Szilvia
S
Varga
Lilian
L
Széplaki
Gábor
G
Jakab
László
L
Füst
George
G
Prohászka
Zoltán
Z
Harmat
George
G
Visy
Beata
B
Karádi
István
I
D054179:Angioedemas, Hereditary / Q000188:drug therapy* / Q000235:genetics; D056735:Autoimmune Lymphoproliferative Syndrome / Q000188:drug therapy* / Q000235:genetics; D003174:Complement C1 Inactivator Proteins / Q000235:genetics; D050718:Complement C1 Inhibitor Protein / Q000235:genetics; D003613:Danazol / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008107:Liver Diseases / Q000503:physiopathology / Q000517:prevention & control*; D008111:Liver Function Tests; D008137:Longitudinal Studies
D003174:Complement C1 Inactivator Proteins; D050718:Complement C1 Inhibitor Protein; C469952:SERPING1 protein, human; D003613:Danazol