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Benefit versus Risk in Statin Treatment

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Am J Cardiol. 2006 Apr 17;97(8A):S95-7.

Benefit versus Risk in Statin Treatment.

Guyton JR.

Duke University Medical Center, Durham, North Carolina, USA.

The Statin Safety Assessment Conference of the National Lipid

Association (NLA), reported in this supplement to The American

Journal of Cardiology, provides a comprehensive evaluation of old and

new experience on adverse events associated with the 3-hydroxy-3-

methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins.

To place these in context, one can express both the risk of side

effects and the benefits for cardiovascular disease in terms of

events per person-year of statin treatment.

The mortality risk from fatal rhabdomyolysis is approximately 0.3 per

100,000 person-years, and the risks of nonfatal rhabdomyolysis and of

putative statin-attributable peripheral neuropathy are approximately

3 and 12 events, respectively, per 100,000 person-years.

Reports of acute liver failure and acute or chronic kidney disease

give lower rate estimates that, even when corrected for

underreporting, are approximately equal to the background rates of

these conditions in the general population, lending scant support for

statin-attributable etiology.

In contrast, the benefit of statin use is to avert several hundred

deaths and several hundred cases each of heart and brain infarction

per 100,000 person-years in appropriately treated high-risk patients.

Although population estimates such as these are useful, they must be

translated repeatedly to individual patient-provider encounters,

where clinical skill and art must combine with scientific evidence.

The continued publication of individual case reports and small

randomized trials among groups of patients with potential side

effects should be encouraged.

Statins should not be used in situations where minimal benefit is

expected, as safety data and risk-benefit analysis must be meshed

with guidelines that help the clinician decide whom to treat and how

aggressively to treat.

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