Using Changes in Attributable Risk to Predict Long-Term Efficacy of Simvastatin Treatment

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Abstract

It is a common perception that coronary heart disease (CHD) deaths will decline by 2% for every 1% decrease in serum total cholesterol (TC). We investigated the changes in serum TC concentrations obtained with simvastatin, an inhibitor of hydroxymethylglutaryl-C0A reductase, in 70 hypercholesterolemic subjects. Although simvastatin reduced serum TC concentrations by 30% after 6 months, calculations from age- and risk-related TC quintiles show that the absolute difference in attributable CHD deaths would be just >1%. These results are reminiscent of the experience from several large prospective primary drug trials that demonstrated impressive relative benefit ratios but much smaller absolute differences (<2%) in CHD endpoints between the treated and untreated groups. This epidemiologically based approach of assessing efficacy and potential long-term benefit of a lipid-lowering drug may be more appropriate and potentially less misleading than just the percentage change of TC (or other lipoproteins) so frequently reported in short-term drug trials.

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Vermaak, W. J. H., Ubbink, J. B., Ungerer, J. P. J., Marais, A. D., Firth, J., Van Lathem, J. M., & Becker, P. J. (1992). Using Changes in Attributable Risk to Predict Long-Term Efficacy of Simvastatin Treatment. Clinical Chemistry, 38(10), 2033–2037. https://doi.org/10.1093/clinchem/38.10.2033

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