title: [Adverse effects of longterm, continual administration of high doses of albendazole in the treatment of echinococcal disease].
abstract: OBJECTIVE
  Modern treatment of cystic echinococcosis, except for surgical treatment and percutaneous drainage of cyst considers also administration of albendazole as a type of individual therapy. However, clinicians fear of the serious adverse effects of high doses of albendazole, first of all the elevation of serum transaminases activity, very frequently results in subdosing of albendazole and wrong conclusions its efficacy and safety. The aim of this study was to investigate adverse effects of a longterm, continual administration of high doses of albendazole in the treatment of patients with echinococcal disease.
  
  
  METHODS
  A total of 42 patients (mean age 40.4 +/- 18.3 years) with echinococcal disease were included in the study. They were treated with continual administration of high doses of albendazole within the period of 4 to 6 months. The subgroups of 27 and 15 patients were treated with 15-20 mg/kg/day and with 21-25 mg/kg/day albendazole, respectively. The patients in the control group (18 with surgical treatment, 6 with percutaneous drainage of cyst) were treated with 800 mg albendazole per day (< 15 mg/kg body weight) in the cycles of 28 days (1-3 cycles) and a two-week pause between them.
  
  
  RESULTS
  In the study group adverse effects of albendazole were registered in 20 (47.6%), whereas in the control group in 6 (30.0%) of the patients. In both subgroups elevated activity of serum transaminases were found more frequently in the study group compared to the control one (35.7% vs 25%, p < 0.05), especially in the patients who were treated with higher doses of albendazole. The patients in the study group, compared to the patients in the control group had significantly higher mean activity of serum alanin aminotransferase in the course of the second and third month of the therapy (p < 0.05). Administration of albendazole due to adverse effects was stopped in 3 (7.1%) of the patients in the study group. Two (4.8%) of them had a very high activity of serum transaminases and one had a muscle pains and high activity of serum creatine kinase. After the interruption of the therapy we documented a nonnalization of serum enzyme levels in all the patients.
  
  
  CONCLUSIONS
  Longterm, continual administration of high doses of albendazole in the patients with echinococcal disease results in significant elevation of serum transaminases activity, compared to the patients treated with albendazole in the cycles, but in the majority of the patients serum transaminases activity was normalizated by the end of a 6-month period.
authors.affiliation: Vojnomedicinsak akademija, Uprava, Beograd, Srbija.
authors.forename: Miodrag
authors.initials: M
authors.lastname: Jevtić
authors.forename: Dragan
authors.initials: D
authors.lastname: Mikić
authors.forename: Gordana
authors.initials: G
authors.lastname: Arsić-Komljenović
authors.forename: Nebojsa
authors.initials: N
authors.lastname: Stanković
authors.forename: Elizabeta
authors.initials: E
authors.lastname: Ristanović
authors.forename: Goran
authors.initials: G
authors.lastname: Sjenicić
authors.forename: Snezana
authors.initials: S
authors.lastname: Janićijević-Hudomal
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015766:Albendazole / Q000008:administration & dosage / Q000009:adverse effects*; D000923:Anticestodal Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D004443:Echinococcosis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000923:Anticestodal Agents; D015766:Albendazole