Safety, tolerability, and pharmacokinetics of l‐ornithine phenylacetate in patients with acute liver injury/failure and hyperammonemia
dc.contributor.author | Stravitz, R. Todd | |
dc.contributor.author | Gottfried, Michelle | |
dc.contributor.author | Durkalski, Valerie | |
dc.contributor.author | Fontana, Robert J. | |
dc.contributor.author | Hanje, A. James | |
dc.contributor.author | Koch, David | |
dc.contributor.author | Hameed, Bilal | |
dc.contributor.author | Ganger, Daniel | |
dc.contributor.author | Subramanian, Ram M. | |
dc.contributor.author | Bukofzer, Stan | |
dc.contributor.author | Ravis, William R. | |
dc.contributor.author | Clasen, Kristen | |
dc.contributor.author | Sherker, Averell | |
dc.contributor.author | Little, Lanna | |
dc.contributor.author | Lee, William M. | |
dc.date.accessioned | 2018-03-07T18:23:27Z | |
dc.date.available | 2019-05-13T14:45:23Z | en |
dc.date.issued | 2018-03 | |
dc.identifier.citation | Stravitz, R. Todd; Gottfried, Michelle; Durkalski, Valerie; Fontana, Robert J.; Hanje, A. James; Koch, David; Hameed, Bilal; Ganger, Daniel; Subramanian, Ram M.; Bukofzer, Stan; Ravis, William R.; Clasen, Kristen; Sherker, Averell; Little, Lanna; Lee, William M. (2018). "Safety, tolerability, and pharmacokinetics of l‐ornithine phenylacetate in patients with acute liver injury/failure and hyperammonemia." Hepatology 67(3): 1003-1013. | |
dc.identifier.issn | 0270-9139 | |
dc.identifier.issn | 1527-3350 | |
dc.identifier.uri | https://hdl.handle.net/2027.42/142428 | |
dc.publisher | Wiley Periodicals, Inc. | |
dc.title | Safety, tolerability, and pharmacokinetics of l‐ornithine phenylacetate in patients with acute liver injury/failure and hyperammonemia | |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | |
dc.subject.hlbsecondlevel | Internal Medicine and Specialties | |
dc.subject.hlbtoplevel | Health Sciences | |
dc.description.peerreviewed | Peer Reviewed | |
dc.description.bitstreamurl | https://deepblue.lib.umich.edu/bitstream/2027.42/142428/1/hep29621.pdf | |
dc.description.bitstreamurl | https://deepblue.lib.umich.edu/bitstream/2027.42/142428/2/hep29621-sup-0001-suppinfo1.pdf | |
dc.description.bitstreamurl | https://deepblue.lib.umich.edu/bitstream/2027.42/142428/3/hep29621_am.pdf | |
dc.identifier.doi | 10.1002/hep.29621 | |
dc.identifier.source | Hepatology | |
dc.identifier.citedreference | Conn HO, Leevy CM, Vlahcevic ZR, Rodgers JB, Maddrey WC, Seeff L, et al. Comparison of lactulose and neomycin in the treatment of chronic portal‐systemic encephalopathy. A double blind controlled trial. Gastroenterology 1977; 72: 573 ‐ 583. | |
dc.identifier.citedreference | Reuben A, Tillman H, Fontana RJ, Davern T, McGuire B, Stravitz RT, et al. Outcomes in adults with acute liver failure between 1998 and 2013: an observational cohort study. Ann Intern Med 2016; 164: 724 ‐ 732. | |
dc.identifier.citedreference | Kumar R, Shalimar, Sharma H, Prakash S, Panda SK, Khanal S, et al. Persistent hyperammonemia is associated with complications and poor outcomes in patients with acute liver failure. Clin Gastroenterol Hepatol 2012; 10: 925 ‐ 931. | |
dc.identifier.citedreference | Mpabanzi L, Jalan R. Neurological complications of acute liver failure: pathophysiological basis of current management and emerging therapies. Neurochem Int 2012; 60: 736 ‐ 742. | |
dc.identifier.citedreference | Enns GM, Berry SA, Berry GT, Rhead WJ, Brusilow SW, Hamosh A. Survival after treatment with phenylacetate and benzoate for urea‐cycle disorders. N Engl J Med 2007; 356: 2282 ‐ 2292. | |
dc.identifier.citedreference | Acharya SK, Bhatia V, Sreenivas V, Khanal S, Panda SK. Efficacy of L‐ornithine L‐aspartate in acute liver failure: a double‐blind, randomized, placebo‐controlled study. Gastroenterology 2009; 136: 2159 ‐ 2168. | |
dc.identifier.citedreference | Jalan R, Lee WM. Treatment of hyperammonemia in liver failure: a tale of two enzymes. Gastroenterology 2009; 136: 2048 ‐ 2051. | |
dc.identifier.citedreference | Mokhtarani M, Diaz GA, Rhead W, Berry SA, Lichter‐Konecki U, Feigenbaum A, et al. Elevated phenylacetic acid levels do not correlate with adverse events in patients with urea cycle disorders or hepatic encephalopathy and can be predicted based on the plasma PAA to PAGN ratio. Mol Genet Metab 2013; 110: 446 ‐ 453. | |
dc.identifier.citedreference | Jalan R, Wright G, Davies NA, Hodges SJ. L‐Ornithine phenylacetate (OP): a novel treatment for hyperammonemia and hepatic encephalopathy. Med Hypotheses 2007; 69: 1064 ‐ 1069. | |
dc.identifier.citedreference | Davies NA, Wright G, Ytrebo LM, Stadlbauer V, Fuskevag OM, Zwingmann C, et al. L‐ornithine and phenylacetate synergistically produce sustained reduction in ammonia and brain water in cirrhotic rats. Hepatology 2009; 50: 155 ‐ 164. | |
dc.identifier.citedreference | Ytrebo LM, Kristiansen RG, Maehre H, Fuskevag OM, Kalstad T, Revhaug A, et al. L‐ornithine phenylacetate attenuates increased arterial and extracellular brain ammonia and prevents intracranial hypertension in pigs with acute liver failure. Hepatology 2009; 50: 165 ‐ 174. | |
dc.identifier.citedreference | Rama Rao KV, Norenberg MD. Glutamine in the pathogenesis of hepatic encephalopathy: the trojan horse hypothesis revisited. Neurochem Res 2014; 39: 593 ‐ 598. | |
dc.identifier.citedreference | Ventura‐Cots M, Arranz JA, Simon‐Talero M, Torrens M, Blanco A, Riudor E, et al. Safety of ornithine phenylacetate in cirrhotic decompensated patients: an open‐label, dose‐escalating, single‐cohort study. J Clin Gastroenterol 2013; 47: 881 ‐ 887. | |
dc.identifier.citedreference | Ventura‐Cots M, Concepcion M, Arranz JA, Simon‐Talero M, Torrens M, Blanco‐Grau A, et al. Impact of ornithine phenylacetate (OCR‐002) in lowering plasma ammonia after upper gastrointestinal bleeding in cirrhotic patients. Therap Adv Gastroenterol 2016; 9: 823 ‐ 835. | |
dc.identifier.citedreference | Koch DG, Speiser JL, Durkalski V, Fontana RJ, Davern T, McGuire B, et al. The natural history of severe acute liver injury. Am J Gastroenterol 2017; 112: 1389 ‐ 1396. | |
dc.identifier.citedreference | Bernal W, Hall C, Karvellas CJ, Auzinger G, Sizer E, Wendon J. Arterial ammonia and clinical risk factors for encephalopathy and intracranial hypertension in acute liver failure. Hepatology 2007; 46: 1844 ‐ 1852. | |
dc.identifier.citedreference | Thibault A, Cooper MR, Figg WD, Venzon DJ, Sartor AO, Tompkins AC, et al. A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer. Cancer Res 1994; 54: 1690 ‐ 1694. | |
dc.identifier.citedreference | Thibault A, Samid D, Cooper MR, Figg WD, Tompkins AC, Patronas N, et al. Phase I study of phenylacetate administered twice daily to patients with cancer. Cancer 1995; 75: 2932 ‐ 2938. | |
dc.identifier.citedreference | Bernal W, Hyyrylainen A, Gera A, Audimoolam VK, McPhail MJ, Auzinger G, et al. Lessons from look‐back in acute liver failure? A single centre experience of 3300 patients. J Hepatol 2013; 59: 74 ‐ 80. | |
dc.identifier.citedreference | Murphy N, Auzinger G, Bernel W, Wendon J. The effect of hypertonic sodium chloride on intracranial pressure in patients with acute liver failure. Hepatology 2004; 39: 464 ‐ 470. | |
dc.identifier.citedreference | Moldave K, Meister A. Enzymic acylation of glutamine by phenylacetic acid. Biochim Biophys Acta 1957; 24: 654 ‐ 655. | |
dc.identifier.citedreference | McGuire BM, Zupanets IA, Lowe ME, Xiao X, Syplyviy VA, Monteleone J, et al. Pharmacology and safety of glycerol phenylbutyrate in healthy adults and adults with cirrhosis. Hepatology 2010; 51: 2077 ‐ 2085. | |
dc.identifier.citedreference | Zimmerman L, Jornvall H, Bergstrom J. Phenylacetylglutamine and hippuric acid in uremic and healthy subjects. Nephron 1990; 55: 265 ‐ 271. | |
dc.identifier.citedreference | Ghabril M, Zupanets IA, Vierling J, Mantry P, Rockey D, Wolf D, et al. Glycerol phenylbutyrate in patients with cirrhosis and episodic hepatic encephalopathy: a pilot study of safety and effect on venous ammonia concentration. Clin Pharmacol Drug Dev 2013; 2: 278 ‐ 284. | |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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