Gastroenterology
Volume 137, Issue 3 , Pages 856-864.e1 , September 2009

Intravenous N-Acetylcysteine Improves Transplant-Free Survival in Early Stage Non-Acetaminophen Acute Liver Failure

  • William M. Lee

      Affiliations

    • Division of Digestive and Liver Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas
    • Corresponding Author InformationReprint requests William M. Lee, MD, Division of Digestive and Liver Diseases, The University of Texas Southwestern Medical Center at Dallas, 5959 Harry Hines Boulevard, HP.4.420, Dallas, Texas 75390-8887. fax: (214) 645-6114
    • ,
  • Linda S. Hynan

      Affiliations

    • Department of Clinical Sciences (Biostatistics) and Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas
    • ,
  • Lorenzo Rossaro

      Affiliations

    • University of California Davis, Sacramento, California
    • ,
  • Robert J. Fontana

      Affiliations

    • Division of Gastroenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan
    • ,
  • R. Todd Stravitz

      Affiliations

    • Section of Hepatology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia
    • ,
  • Anne M. Larson

      Affiliations

    • Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Washington, Seattle, Washington
    • ,
  • Timothy J. Davern II

      Affiliations

    • Division of Gastroenterology, Department of Internal Medicine, University of California, San Francisco, California
    • ,
  • Natalie G. Murray

      Affiliations

    • Division of Gastroenterology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas
    • ,
  • Timothy McCashland

      Affiliations

    • Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Nebraska, Omaha, Nebraska
    • ,
  • Joan S. Reisch

      Affiliations

    • Division of Digestive and Liver Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas
    • ,
  • Patricia R. Robuck

      Affiliations

    • National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health; and the Acute Liver Failure Study Group Investigators (see Appendix for list of participating members and institutions)
    • ,
  • Acute Liver Failure Study Group

Received 15 October 2008 ,Accepted 2 June 2009.

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 Conflict of interest The authors disclose no conflicts. The statistical analysis of the entire data sets pertaining to efficacy (specifically primary and major secondary efficacy end points) and safety (specifically, serious adverse events as defined in federal guidelines) have been confirmed independently by a biostatistician who is not employed by the corporate entity. The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and analysis. This was a randomized clinical trial (ClinicalTrials.gov number NCT00004467).

 Funding The study was supported by the following grants: R-03 DK52827, R-01 DK58369, and U-01 DK58369 from the National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, and FD-R-001661 from the Orphan Products Division, United States Food and Drug Administration. Additional funding was provided by the Stephen Tips Fund of the Northwestern Medical Foundation and the Jeanne Roberts and Rollin and Mary Ella King Funds of the Southwestern Medical Foundation. This study was performed under IND #56925, filed with the Food and Drug Administration. The N-acetylcysteine used in the trial was supplied initially by Apothecon/Geneva Pharmaceuticals (Princeton, NJ), a division of Bristol Myers Squibb, and after April 2003 was supplied by Cumberland Pharmaceuticals (Nashville, TN). No additional support, data analysis, or input of any kind was provided by these companies.

 To view this article’s video abstract, go to the AGA's YouTube Channel.

PII: S0016-5085(09)00915-9

doi: 10.1053/j.gastro.2009.06.006

Gastroenterology
Volume 137, Issue 3 , Pages 856-864.e1 , September 2009

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