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Report of the National Lipid Association's Statin Safety Task Force


The American Journal of Cardiology
Volume 97, Issue 8, Supplement 1 , 17 April 2006, Pages S95-S97

Benefit versus Risk in Statin Treatment

John R. Guyton MD,

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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Related: A German study on the cost-effectiveness of statins concluded that statins were cost effective in preventing first heart attacks (primary prevention) and less so in secondary prevention.

Related: the economics of statins




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