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dc.contributor.authorBjörnsson, Einar
dc.contributor.authorJacobsen, Elin I
dc.contributor.authorKalaitzakis, Evangelos
dc.date.accessioned2012-08-09T14:35:24Z
dc.date.available2012-08-09T14:35:24Z
dc.date.issued2012-02
dc.date.submitted2012-08-10
dc.identifier.citationJ. Hepatol. 2012, 56(2):374-80en_GB
dc.identifier.issn0168-8278
dc.identifier.pmid21889469
dc.identifier.doi10.1016/j.jhep.2011.07.023
dc.identifier.urihttp://hdl.handle.net/2336/237986
dc.descriptionTo access publisher full text version of this article. Please click on the hyperlink in Additional Links field.en_GB
dc.description.abstractAIMS: Limited data exist on drug-induced liver injury (DILI) associated with statins. METHODS: Reports on adverse reactions suspected to be due to statins received by the Swedish Adverse Drug Reactions Advisory Committe 1988-2010 were analyzed. Only cases with >5×upper limit of normal (ULN) in aminotransferases and/or alkaline phosphatase >2×ULN were included. RESULTS: The most common types of ADRs suspected were DILI in 124/217 (57%) cases. A total of 73/124 (59%) cases had at least possible relationship, median age 64 years (57-73), 55% males, whereas 25/124 cases (20%) were excluded due to mild elevations of liver tests and 26 due to unlikely relationship and/or lack of data. A statin-related DILI episode was reported in 1.2/100,000 users. Atorvastatin was implicated in 30/73 (41%) cases, simvastatin in 28 (38%), fluvastatin (15%), and others. Two patients died of acute liver failure, one underwent liver transplantation and 25 (34%) had jaundice. Three patients were rechallenged with the same statin producing similar patterns of liver injury. The median duration of therapy was 90 days (30-120), 120 (39-248) for atorvastatin, and 75 (30-150) for simvastatin (NS). Cholestatic/mixed injury was more common with atorvastatin, 17/30 (56%) than with simvastatin, 7/28 (24%) (p=0.018). CONCLUSIONS: Idiosyncratic liver injury associated with statins is rare but can be severe. After recovery, a similar pattern of liver injury can be reproduced on re-exposure. Most patients experience liver injury 3-4 months after start of therapy. Atorvastatin is mostly associated with cholestatic liver injury whereas hepatocellular injury is more common with simvastatin.
dc.language.isoenen
dc.relation.urlhttp://dx.doi.org/10.1016/j.jhep.2011.07.023en_GB
dc.rightsArchived with thanks to Journal of hepatologyen_GB
dc.subject.meshAdverse Drug Reaction Reporting Systemsen_GB
dc.subject.meshAgeden_GB
dc.subject.meshDrug-Induced Liver Injuryen_GB
dc.subject.meshFemaleen_GB
dc.subject.meshHeptanoic Acidsen_GB
dc.subject.meshHumansen_GB
dc.subject.meshHydroxymethylglutaryl-CoA Reductase Inhibitorsen_GB
dc.subject.meshMaleen_GB
dc.subject.meshMiddle Ageden_GB
dc.subject.meshPyrrolesen_GB
dc.subject.meshSimvastatinen_GB
dc.subject.meshSwedenen_GB
dc.subject.meshTime Factorsen_GB
dc.titleHepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing.en
dc.typeArticleen
dc.contributor.departmentLandspitali National University Hospital, Reykjavik, Icelanden_GB
dc.identifier.journalJournal of hepatologyen_GB
dc.rights.accessNational Consortium - Landsaðganguren
dc.type.categoryMelting, Lyfjafræðingaren_GB
html.description.abstractAIMS: Limited data exist on drug-induced liver injury (DILI) associated with statins. METHODS: Reports on adverse reactions suspected to be due to statins received by the Swedish Adverse Drug Reactions Advisory Committe 1988-2010 were analyzed. Only cases with >5×upper limit of normal (ULN) in aminotransferases and/or alkaline phosphatase >2×ULN were included. RESULTS: The most common types of ADRs suspected were DILI in 124/217 (57%) cases. A total of 73/124 (59%) cases had at least possible relationship, median age 64 years (57-73), 55% males, whereas 25/124 cases (20%) were excluded due to mild elevations of liver tests and 26 due to unlikely relationship and/or lack of data. A statin-related DILI episode was reported in 1.2/100,000 users. Atorvastatin was implicated in 30/73 (41%) cases, simvastatin in 28 (38%), fluvastatin (15%), and others. Two patients died of acute liver failure, one underwent liver transplantation and 25 (34%) had jaundice. Three patients were rechallenged with the same statin producing similar patterns of liver injury. The median duration of therapy was 90 days (30-120), 120 (39-248) for atorvastatin, and 75 (30-150) for simvastatin (NS). Cholestatic/mixed injury was more common with atorvastatin, 17/30 (56%) than with simvastatin, 7/28 (24%) (p=0.018). CONCLUSIONS: Idiosyncratic liver injury associated with statins is rare but can be severe. After recovery, a similar pattern of liver injury can be reproduced on re-exposure. Most patients experience liver injury 3-4 months after start of therapy. Atorvastatin is mostly associated with cholestatic liver injury whereas hepatocellular injury is more common with simvastatin.


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