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(Circulation. 2006;114:1310-1314.)
© 2006 American Heart Association, Inc.

Controversies in Cardiovascular Medicine

Is it appropriate to make statins available over the counter?

Over-The-Counter Statins Are Worth Considering in Primary Prevention of Cardiovascular Disease

Antonio M. Gotto, Jr, MD, DPhil

From Weill Medical College, Cornell University, New York, NY.

Correspondence to A.M. Gotto, Jr, c/o Jesse Jou, Weill Medical College, Cornell University, 445 E 69th St, Olin Hall 205, New York, NY 10021. E-mail amg_editorial@med.cornell.edu

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
Much has already been written outlining the advantages and disadvantages of over-the-counter (OTC) access to low-dose therapy with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, or statin, for individuals at intermediate risk for coronary heart disease (CHD).^1,2 After the United Kingdom’s approval in 2004 of an OTC, low-dose formulation of simvastatin, a pharmaceutical company in the United States reapplied to the US Food and Drug Administration (FDA) for a nonprescription preparation of lovastatin, which the FDA had first rejected in 2000.³ Previously, low-dose pravastatin also had failed to secure OTC approval. The sponsors of the application proposed that individuals who meet the following criteria may be those most likely to gain from access to OTC statin treatment: (1) those who qualify for primary prevention under the third Adult Treatment Panel (ATP III) of the National Cholesterol Education Program,⁴ (2) those with multiple (2) risk factors and a 10-year CHD risk 20%, (3) those with no contraindications to statins, and (4) those with a favorable likelihood of experiencing benefit versus risk.

Response by Barter and Rye p 1314

After reviewing the evidence to date, a joint session of the FDA’s Nonprescription Drugs Advisory and Endocrine and Metabolic Drugs Advisory committees again did not endorse the application.⁵ Despite these stumbling blocks, the appropriateness of OTC statins remains an important topic for the future of primary cardiovascular disease prevention. If further progress is to be made, advocates for OTC statins must address the concerns of the FDA panel and other critics.

	Challenges of Primary Prevention of Coronary Heart Disease

 
As sampled . . . [Full Text of this Article]

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