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Low-Dose, Over-the-Counter Statins May Be Safe, Effective Aid in Preventing Heart Disease for Americans at Moderate Risk, Says Weill Cornell Dean

Dr. Antonio Gotto's Editorial, in a Leading Cardiology Journal, Finds Low-Dose Statins' Benefits Outweigh Risks

NEW YORK (Sep 17, 2004)

Cholesterol-busting statin medications have revolutionized the prevention and treatment of coronary heart disease (CHD), the leading killer of American men and women.

But a recent move by the British government toward approval of low-dose, over-the-counter (OTC) simvastatin (Zocor®) has raised heated debate here in the U.S.

Now, in his editorial in the September 15 issue of the American Journal of Cardiology, Dr. Antonio M. Gotto, Jr., Professor of Medicine and the Stephen and Suzanne Weiss Dean of Weill Cornell Medical College in New York City, says the proven effectiveness and good safety record of statin medications argues for a similar move in the U.S.

"OTC availability of low-dose statin therapy may be a viable complement to therapeutic lifestyle changes in certain intermediate-risk, primary-prevention patients," he writes.

Soaring obesity rates and an aging population are placing more Americans at risk for high cholesterol and cardiovascular disease than ever before. And while a good diet and regular exercise can help keep cholesterol down, it's often not enough.

That's where the statin family of medications — drugs like simvastatin, atorvastatin (Lipitor®), lovastatin (Mevacor®) and pravastatin (Pravachol®) — come in, with doctors writing millions of prescriptions for the cholesterol-lowering drugs each year.

In his editorial, Dr. Gotto cites three large-scale, randomized, placebo-controlled clinical trials that support the effectiveness of statin medications for preventing heart attacks in people who have never had one (that is, primary prevention). One of these studies, in fact, showed that patients who received lovastatin benefited from the treatment, despite having a level of heart disease risk that was "significantly lower than any treatment threshold currently recommended for lipid-lowering drugs in the context of primary prevention."

It's primary prevention — not active treatment of disease — that the U.K. government had in mind when it authorized the move to an OTC statin.

As Dr. Gotto writes, OTC low-dose statins may be most useful for middle-aged individuals with two or more risk factors for CHD and an "intermediate" risk of developing the disease over the following 10 years.

Safety is always of concern whenever drugs move from the prescription pad to over-the-counter. But in his review of available data, Dr. Gotto finds that, "in doses used in clinical trials, the statins have a good safety record, and one may assume that lower doses would be even safer."

Elevated risks for rhabdomyolysis, a serious muscle disorder, did prompt the recall of cerivastatin (Baycol®) in 2001. According to Dr. Gotto, studies suggest this risk may be unique to cerivastatin. Muscle toxicity is a known side effect of all statins, but other statins have a much lower risk for this side effect, especially at lower doses.

"There is clearly a desire for complementary approaches to lifestyle therapy" in fighting high cholesterol, Dr. Gotto writes, even though high cholesterol remains undertreated in the U.S. Researchers will need to investigate the impact of OTC statins in the fight against heart disease.

In this context, he adds, "the United Kingdom's decision to permit OTC statins makes the debate a timely and important one for the United States."

Dr. Gotto is a consultant with the following companies with interests in cholesterol drugs: AstraZeneca; Bristol-Myers Squibb Co.; Kowa; Merck & Co, Inc.; Merck-Schering Plough; Novartis; Pfizer, Inc.; and Reliant Pharmaceuticals.