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

 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.

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PII: S0016-5085(09)00915-9

doi:10.1053/j.gastro.2009.06.006

© 2009 AGA Institute. Published by Elsevier Inc. All rights reserved.