Paracetamol Study in Patients With Low Muscle Mass

Summary

To investigate the safety and toxicity related to paracetamol treatment in children and adults with respectively SMA and CP.

Timeline

Start

2019-02-18

Primary completion

2024-12

Completion

2024-12

Publications

• Background Kolb SJ, Kissel JT. Spinal Muscular Atrophy. Neurol Clin. 2015 Nov;33(4):831-46. doi: 10.1016/j.ncl.2015.07.004.
• Background Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
• Background Ceelie I, James LP, Gijsen V, Mathot RA, Ito S, Tesselaar CD, Tibboel D, Koren G, de Wildt SN. Acute liver failure after recommended doses of acetaminophen in patients with myopathies. Crit Care Med. 2011 Apr;39(4):678-82. doi: 10.1097/CCM.0b013e318206cc8f.
• Background Hynson JL, South M. Childhood hepatotoxicity with paracetamol doses less than 150 mg/kg per day. Med J Aust. 1999 Nov 1;171(9):497. doi: 10.5694/j.1326-5377.1999.tb123758.x. No abstract available.
• Background Orngreen MC, Zacho M, Hebert A, Laub M, Vissing J. Patients with severe muscle wasting are prone to develop hypoglycemia during fasting. Neurology. 2003 Oct 14;61(7):997-1000. doi: 10.1212/01.wnl.0000086813.59722.72.
• Background Sen, C. K. Glutathione: A key role in skeletal muscle metabolism. in Oxidative Stress in Skeletal Muscle 127-139 (Birkhäuser, Basel, 1998). doi:10.1007/978-3-0348-8958-2_8
• Background Hammarqvist F, Luo JL, Cotgreave IA, Andersson K, Wernerman J. Skeletal muscle glutathione is depleted in critically ill patients. Crit Care Med. 1997 Jan;25(1):78-84. doi: 10.1097/00003246-199701000-00016.
• Background McClain CJ, Price S, Barve S, Devalarja R, Shedlofsky S. Acetaminophen hepatotoxicity: An update. Curr Gastroenterol Rep. 1999 Feb-Mar;1(1):42-9. doi: 10.1007/s11894-999-0086-3.
• Background Caparrotta TM, Antoine DJ, Dear JW. Are some people at increased risk of paracetamol-induced liver injury? A critical review of the literature. Eur J Clin Pharmacol. 2018 Feb;74(2):147-160. doi: 10.1007/s00228-017-2356-6. Epub 2017 Oct 24.
• Background Pearce B, Grant IS. Acute liver failure following therapeutic paracetamol administration in patients with muscular dystrophies. Anaesthesia. 2008 Jan;63(1):89-91. doi: 10.1111/j.1365-2044.2007.05340.x.
• Background Forrest JA, Clements JA, Prescott LF. Clinical pharmacokinetics of paracetamol. Clin Pharmacokinet. 1982 Mar-Apr;7(2):93-107. doi: 10.2165/00003088-198207020-00001.
• Background Prescott LF. Kinetics and metabolism of paracetamol and phenacetin. Br J Clin Pharmacol. 1980 Oct;10 Suppl 2(Suppl 2):291S-298S. doi: 10.1111/j.1365-2125.1980.tb01812.x.
• Background van Rongen A, Valitalo PAJ, Peeters MYM, Boerma D, Huisman FW, van Ramshorst B, van Dongen EPA, van den Anker JN, Knibbe CAJ. Morbidly Obese Patients Exhibit Increased CYP2E1-Mediated Oxidation of Acetaminophen. Clin Pharmacokinet. 2016 Jul;55(7):833-847. doi: 10.1007/s40262-015-0357-0.
• Background Watkins PB, Kaplowitz N, Slattery JT, Colonese CR, Colucci SV, Stewart PW, Harris SC. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):87-93. doi: 10.1001/jama.296.1.87.

Drugs

Indications