IMPACT trial results should not change current standard of care of 100 days for cytomegalovirus prophylaxis

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12 Citations (Scopus)

Abstract

The results of the IMPACT trial showed a significant reduction in cytomegalovirus disease with 200-day valganciclovir prophylaxis compared to the standard 100-day regimen with the same drug. These results may have the potential to change the standard of care in most transplant centers. However, we have concerns with the design, execution and statistical analysis of this trial. Our study aimed to describe each of these issues and to provide possible solutions for the better understanding of the IMPACT trial. We conclude that the IMPACT trial does not have the strength of evidence to change current clinical practice of 100-day cytomegalovirus prophylaxis. Further, based on all available evidence, we consider that another clinical trial to test 200-day CMV prophylaxis is not necessary. The authors evaluate the results of the IMPACT trial and opine that it does not have the strength of evidence to change current clinical practice of 100-day cytomegalovirus prophylaxis. See editorial by Snydman on page 6 and letter by Humar on page 177.

Original languageEnglish (US)
Pages (from-to)18-21
Number of pages4
JournalAmerican Journal of Transplantation
Volume11
Issue number1
DOIs
StatePublished - Jan 1 2011

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Standard of Care
Cytomegalovirus
Clinical Trials
Transplants
Pharmaceutical Preparations

Keywords

  • Cytomegalovirus
  • prophylaxis
  • valganciclovir

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

Cite this

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title = "IMPACT trial results should not change current standard of care of 100 days for cytomegalovirus prophylaxis",
abstract = "The results of the IMPACT trial showed a significant reduction in cytomegalovirus disease with 200-day valganciclovir prophylaxis compared to the standard 100-day regimen with the same drug. These results may have the potential to change the standard of care in most transplant centers. However, we have concerns with the design, execution and statistical analysis of this trial. Our study aimed to describe each of these issues and to provide possible solutions for the better understanding of the IMPACT trial. We conclude that the IMPACT trial does not have the strength of evidence to change current clinical practice of 100-day cytomegalovirus prophylaxis. Further, based on all available evidence, we consider that another clinical trial to test 200-day CMV prophylaxis is not necessary. The authors evaluate the results of the IMPACT trial and opine that it does not have the strength of evidence to change current clinical practice of 100-day cytomegalovirus prophylaxis. See editorial by Snydman on page 6 and letter by Humar on page 177.",
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N2 - The results of the IMPACT trial showed a significant reduction in cytomegalovirus disease with 200-day valganciclovir prophylaxis compared to the standard 100-day regimen with the same drug. These results may have the potential to change the standard of care in most transplant centers. However, we have concerns with the design, execution and statistical analysis of this trial. Our study aimed to describe each of these issues and to provide possible solutions for the better understanding of the IMPACT trial. We conclude that the IMPACT trial does not have the strength of evidence to change current clinical practice of 100-day cytomegalovirus prophylaxis. Further, based on all available evidence, we consider that another clinical trial to test 200-day CMV prophylaxis is not necessary. The authors evaluate the results of the IMPACT trial and opine that it does not have the strength of evidence to change current clinical practice of 100-day cytomegalovirus prophylaxis. See editorial by Snydman on page 6 and letter by Humar on page 177.

AB - The results of the IMPACT trial showed a significant reduction in cytomegalovirus disease with 200-day valganciclovir prophylaxis compared to the standard 100-day regimen with the same drug. These results may have the potential to change the standard of care in most transplant centers. However, we have concerns with the design, execution and statistical analysis of this trial. Our study aimed to describe each of these issues and to provide possible solutions for the better understanding of the IMPACT trial. We conclude that the IMPACT trial does not have the strength of evidence to change current clinical practice of 100-day cytomegalovirus prophylaxis. Further, based on all available evidence, we consider that another clinical trial to test 200-day CMV prophylaxis is not necessary. The authors evaluate the results of the IMPACT trial and opine that it does not have the strength of evidence to change current clinical practice of 100-day cytomegalovirus prophylaxis. See editorial by Snydman on page 6 and letter by Humar on page 177.

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