title: [Clinical efficacy and safety of prolonged use of the valganciclovir for the treatment of cytomegalovirus disease in patients after kidney transplantation].
abstract: Cytomegalovirus infection is particularly dangerous for patients undergoing solid organs transplantation. Among these patients cytomegalovirus disease (CMV) may occur. CMV disease is associated with increased mortality, organ damage and reduced graft survival. THE AIM OF THE STUDY was to determine the clinical outcomes (clinical efficacy and safety profile) for the use of valganciclovir administered for 200 days compared to standard period of 100 days in the prevention of cytomegalovirus disease in seronegative patients after kidney transplantation from infected donor (high risk patients).
  
  
  METHODS
  A systematic review of literature published during the period: 1st January 1966-31st October 2010, was performed in order to assess the efficacy and safety of valganciclovir in the treatment of cytomegalovirus disease. Databases MEDLINE (PubMed), EMBASE and Cochrane were searched.
  
  
  RESULTS
  A systematic review yielded 1 randomized and 3 nonrandomized clinical trials. 200 days prophylaxis with valganciclovir significantly decreased a risk of: cytomegalovirus disease, CMV viral load, opportunistic infections; percentage of patients with high viral load was also significantly decreased compared to 100 days therapy. The safety profile of extended therapy was similar to that observed within 100 days prophylaxis. The higher risk of leucopenia in the 200 days than 100 days group was the only one adverse event that met statistical significance. The results of non-randomized trials were comparable to those mentioned above.
  
  
  CONCLUSIONS
  Prolonged prophylaxis of cytomegalovirus till 200 days in high-risk patients (D+/B-) is safe and provides significant therapeutic benefits.
authors.affiliation: Uniwersytet Jagielloński w Krakowie, Wydział Nauk o Zdrowiu, Instytut Zdrowia Publicznego, Zaklad Gospodarki Lekiem. pawel.kawalec@uj.edu.pl
authors.forename: Paweł
authors.initials: P
authors.lastname: Kawalec
authors.forename: Monika
authors.initials: M
authors.lastname: Szkultecka-Debek
authors.forename: Justyna
authors.initials: J
authors.lastname: Maks
authors.forename: Anna
authors.initials: A
authors.lastname: Paszulewicz
authors.forename: Aneta
authors.initials: A
authors.lastname: Kaweczyńska-Lasoń
authors.forename: Andrzej
authors.initials: A
authors.lastname: Pilc
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage*; D003586:Cytomegalovirus Infections / Q000209:etiology / Q000517:prevention & control*; D004334:Drug Administration Schedule; D015774:Ganciclovir / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D016030:Kidney Transplantation / Q000009:adverse effects*; D016896:Treatment Outcome; D000077562:Valganciclovir; D019562:Viral Load / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir