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Atorvastatin/simvastatin Hepatotoxicity: 6 case reports

Three men and three women aged 39–78 years developed hepatotoxicity during treatment with atorvastatin and simvastatin [see table; routes and therapeutic indications not stated].

Patient characteristics Patient/ sex/age (y) 1/M/63 2/M/78 3/F/39 4/M/58 5/F/60 6/F52 a

Drug (dose)

Duration of treatment to diagnosis (d)

Outcome

simvastatin (20mg) simvastatin (20mg) atorvastatin (10mg) simvastatin (20mg) atorvastatin (40mg) atorvastatin (10mg)

90 92

liver transplantation death

120

death

28a

positive rechallenge positive rechallenge positive rechallenge

30a 30a

second treatment

The patients were diagnosed with drug-induced liver injury associated with simvastatin 20mg (3 patients), atorvastatin 10mg (2) or atorvastatin 40mg (1). In three patients, the duration of treatment prior to diagnosis ranged from 90–120 days. Liver tests revealed AST, ALT, ALP and bilirubin levels that were 1.9–45, 1.8–38, 1.1–5.5 and 10–26.6 times the upper limit of normal (ULN), respectively. Two patients died, one patient underwent liver transplantation and three patients were rechallenged with the same drug. These patients developed similar patterns of liver injury 28–30 days after rechallenge, with AST, ALT, ALP and bilirubin levels 2.8–35, 2.9–57, 1.5–4.2 and 1.2–2.0 times the ULN, respectively. Causality was assessed as highly probable (5 patients) or possible (1), based on the International Consensus Criteria (RUCAM). Bjornsson E, et al. Hepatotoxicity associated with statins: Reports of idiosyncratic liver injury post-marketing. Journal of Hepatology 56: 374-380, No. 2, Feb 2012. Available from: URL: http://dx.doi.org/10.1016/j.jhep.2011.07.023 803068634 Iceland

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Reactions 31 Mar 2012 No. 1395