Statins and Monitoring of Liver Function Tests

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EDITORIAL

© 2007 Adis Data Information BV. All rights reserved.

Statins and Monitoring of Liver Function Tests Karam Kostner and Laurence G. Howes Department of Cardiology, Gold Coast Hospital, Griffith University and Bond University Medical Schools, Southport, Gold Coast, Queensland, Australia

The HMG-CoA reductase inhibitors, or ‘statins’, have been studied in numerous controlled human research trials involving hundreds of thousands of study participants and have been prescribed for millions of patients. These drugs have been shown to improve lipid blood levels and reduce the risk of atherosclerotic coronary artery disease (CAD), resulting in reduced CAD morbidity and mortality, and in several studies they have reduced overall all-cause mortality. In recent years, many patients and health professionals have questioned the safety of statins. There have been indications from the media and from clinical experience that some patients refuse to initiate statin therapy while others choose to withdraw from long-term statin treatment because of concerns about safety.[1] These concerns have arisen from information obtained from the news media, direct-to-consumer advertising and the Internet. Health professionals are also expressing concerns, perhaps out of a response to their patients’ sentiments but also because of the withdrawal of cerivastatin from the market as a result of serious adverse events, publications reporting statin-related adverse effects and the constant threat of litigation from malpractice lawyers.[2] The initiation and continuation of statin therapy involves a number of safety obligations, including the assessment and subsequent monitoring of liver function tests (LFTs). However, a recent American National Lipid Association (NLA) Task Force formed to evaluate the value and cost effectiveness of routine LFT monitoring in patients receiving sta-

tin therapy has raised serious doubts about whether such monitoring is desirable or of value. This editorial summarises the available literature regarding statins and liver toxicity and examines the question of whether LFTs should be routinely monitored with statin therapy. 1. Summary of the Liver Task Force’s Findings and Recommendations The NLA appointed a Safety Assessment Task Force to address concerns about the safety of lipidmodifying therapies and evaluate the usefulness of routine LFT monitoring. The Task Force presented their findings regarding statin safety at a meeting convened from 17 to 19 July 2005, at the Mandarin Hotel in Washington, DC, USA. The report from this meeting was published in the American Journal of Cardiology.[3] The NLA Task Force concluded that there was neither any evidence that a relationship existed between elevated serum aminotransferase levels, statin therapy and the subsequent risk of developing significant liver injury, nor that routine monitoring of LFTs identified individuals likely to develop rare cases of idiosyncratic liver failure. Therefore, they recommended that the requirement for routine LFT monitoring in patient