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Over-the-counter statins: a new controversy

Nature Clinical Practice Cardiovascular Medicine volume 2, pages 174–175 (2005)Cite this article

The UK recently became the first country to provide nonprescription statins, when its National Health Service approved the pharmaceutical company Merck Sharp & Dohme's application to sell 10 mg simvastatin over the counter (OTC).1 This decision was supported by the Department of Health and the Committee on Safety of Medicines. By contrast, in January of this year an FDA advisory panel overwhelmingly rejected Merck Sharp & Dohme's request to make 20 mg lovastatin available OTC in the US, because of concerns over safety, but not efficacy. This issue, however, is not over and this viewpoint highlights some of the arguments for and against the sale of OTC statin therapy.2,3

The results of the Heart Protection Study4 suggested that statin therapy should be provided to individuals with vascular disease or those at increased cardiovascular risk, irrespective of cholesterol level. In participants older than 55 years of age who had diabetes and raised cardiovascular risk but no current cardiovascular disease, statin therapy reduced risk by 24%. This reduction was similar to that in participants with established vascular disease overall. Interestingly, marked variance in baseline LDL-cholesterol levels did not affect the proportionate risk reduction provided by 40 mg simvastatin daily. These findings, along with others, helped convince the American Diabetes Association and the National Cholesterol Education Program (NCEP) to establish diabetes as a coronary artery disease equivalent. In addition, the lipid-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial5 showed that 10 mg atorvastatin decreased cardiovascular morbidity and mortality compared with placebo in hypertensive individuals with mild hypercholesterolemia. Thus, in patients with diabetes or hypertension, with no or mild hyperlipidemia and no vascular disease, low-dose statin therapy can substantially decrease cardiovascular morbidity and mortality.4,5

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  1. Professor of Medicine in the Division of Cardiology, Department of Internal Medicine, at The University of New Mexico Health Sciences Center,

    Jonathan Abrams

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Correspondence to Jonathan Abrams.

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The author declares no competing financial interests.

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Abrams, J. Over-the-counter statins: a new controversy. Nat Rev Cardiol 2, 174–175 (2005). https://doi.org/10.1038/ncpcardio0152

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