4.5 Article

Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: A single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial

期刊

JOURNAL OF HEART AND LUNG TRANSPLANTATION
卷 30, 期 9, 页码 990-996

出版社

ELSEVIER SCIENCE INC
DOI: 10.1016/j.healun.2011.02.017

关键词

lung transplantation; valganciclovir; cytomegalovirus; bronchiolitis obliterans syndrome

资金

  1. Roche Pharmaceuticals
  2. National Heart Lung and Blood Institute [SCCOR 1P50-HL084917-01, K24-091140-01]
  3. National Institutes of Health [KL2RR024127]
  4. American Society of Transplantation

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BACKGROUND: The optimal approach to cytomegalovirus (CMV) prevention after lung transplantation is controversial. We recently completed a prospective, randomized, placebo-controlled study of CMV prevention in lung transplantation that demonstrated the short-term efficacy and safety of extending valganciclovir prophylaxis to 12 months vs 3 months of therapy. In the current analysis, we monitored a single-center subset of patients enrolled in the CMV prevention trial to determine if extended prophylaxis conferred a sustained long-term benefit and to assess its hematologic safety. METHODS: The sub-analysis included 38 randomized patients from Duke University Medical Center. All patients underwent consistent serial serum CMV monitoring and surveillance bronchoscopies. CMV was defined by viremia (>= 500 CMV DNA copies/ml) or pneumonitis. The safety assessment included a review of all complete blood counts obtained from transplant onward. RESULTS: During a mean follow-up of 3.9 years in each group, extended-course compared with short-course prophylaxis provided a sustained protective benefit with a lifetime CMV incidence of 12% vs 55%, respectively (hazard ratio, 0.13; 95% confidence interval, 0.03-0.61; p = 0.009), an effect that persisted after adjustment for clinical risk factors. Patients in each group underwent a comparable number of peripheral blood draws and bronchoscopies. Post-transplant white blood cell, neutrophil, and platelet counts were similar between each treatment group during the course of follow-up. CONCLUSION: Extending valganciclovir prophylaxis to 12 months provides a durable long-term CMV protective benefit compared with short-course therapy, without increasing adverse hematologic effects. J Heart Lung Transplant 2011;30:990-6 (C) 2011 International Society for Heart and Lung Transplantation. All rights reserved.

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