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Atorvastatin associated liver disease.

A T Clarke¹, P R Mills

¹Gastroenterology Unit, Gartnavel General Hospital, Glasgow, UK. aclarke1972@ntlworld.com

Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

|June 17, 2006

Summary

Atorvastatin can cause rare but serious liver injury, with 14 reported cases and three deaths. Persistent liver function abnormalities require caution, especially in older patients.

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Area of Science:

Pharmacology
Hepatology
Drug Safety

Background:

Atorvastatin, a widely prescribed HMG-CoA reductase inhibitor for dyslipidemia.
Transient elevations in serum transaminases are common but usually benign.
Emerging evidence suggests rare, idiosyncratic hepatotoxic reactions.

Observation:

Seven cases of significant liver dysfunction associated with atorvastatin from 2002-2005.
Literature review identified an additional seven cases, totaling 14 patients.
Patients were typically over 60, with a 2:1 female-to-male ratio, presenting mixed cholestatic/hepatocellular reactions.

Findings:

Mean onset of reaction was approximately 9 weeks, with prolonged liver recovery (months).
Three deaths occurred among the 14 reported patients.

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UK Committee on Safety of Medicines reported four deaths (0.5/year) from hepatobiliary disease over 8 years.

Implications:

While rare, atorvastatin-induced acute hepatotoxicity necessitates vigilance.
Persistent liver function abnormalities warrant cautious management.
Comparison with simvastatin, which has no reported hepatobiliary fatalities, highlights potential safety concerns.