title: Co-administration of ketoconazole to tacrolimus-treated kidney transplant recipients: a prospective randomized study.
abstract: BACKGROUND
  Since the introduction of calcineurin inhibitors, there has been a significant improvement in the results of solid organ transplantation, including graft and patient survival. However, high cost, chronic nephrotoxicity and other side effects stand as major challenges for long-term use of these drugs. The long-term safety and financial benefits of the combination ketoconazole-cyclosporine previously studied. However, data about the effect of the addition of ketoconazole addition to tacrolimus-treated patients are scarce. Therefore, this study was conducted to evaluate the safety and financial impact of that combination.
  
  
  METHODS
  The subjects of this work included 70 live-donor stable kidney transplant recipients receiving tacrolimus. Their age ranged from 16 to 45 years. Among them, 54 were males and 16 were females. All of them were 6 months or more post-transplantation. Patients were randomly divided into two equal groups. Group I patients initially received ketoconazole 100 mg/day in addition to their usual treatment, while group II patients were considered a control. Patients were followed-up for 6 months.
  
  
  RESULTS
  Concomitant ketoconazole-tacrolimus resulted in marked reduction of tacrolimus dose (by 58.7%) and cost (by 56.9%). It also resulted in significant improvement in graft function and fungal skin infection, in addition to a decrease of gastrointestinal episodes and hospitalization.
  
  
  CONCLUSIONS
  We conclude that ketoconazole-tacrolimus combination in kidney transplant recipients is safe, has outstanding impact on treatment costs and improves patient and graft outcome.
authors.affiliation: Nephrology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
authors.forename: Khalid Farouk
authors.initials: KF
authors.lastname: el-Dahshan
authors.forename: Mohamed Adel
authors.initials: MA
authors.lastname: Bakr
authors.forename: Ahmed Farouk
authors.initials: AF
authors.lastname: Donia
authors.forename: Ali el-Sayed
authors.initials: Ael-S
authors.lastname: Badr
authors.forename: Mohamed Abdel-Kader
authors.initials: MA
authors.lastname: Sobh
mesh_terms: D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage*; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007654:Ketoconazole / Q000008:administration & dosage*; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage
chemical_list: D000935:Antifungal Agents; D007166:Immunosuppressive Agents; D003404:Creatinine; D007654:Ketoconazole; D016559:Tacrolimus