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FDA Mulls Easier Access to Cholesterol Drugs

The journal said the government hadn't determined "the hazards" of OTC statins and hadn't measured the potential impact of long-term use of low-dose Zocor vs. long-term use of higher doses of statin drugs. "If the U.K. public is to be used in an OTC experiment, then the evidence must be collected and used for the benefit of all," The Lancet said.

For the American Journal of Cardiology, OTC statins could be a valuable therapy because clinical trial data for the cholesterol fighters, excluding Baycol, "indicate a favorable risk-benefit ratio," says an editorial written by a physician who is a consultant for several companies making statins.

An OTC statin "with demonstrated primary-prevention benefits will offer another therapeutic alternative to patients who have intermediate risk and require primary prevention," the editorial said.

The editorial pointed out that OTC statins aren't for everyone. "No argument can be made for self-medication or management without a physician's supervision" for patients with a high risk of coronary heart disease, existing heart disease or other cardiovascular ailments, the journal said. But for patients with an "intermediate risk" for heart disease, low-dose OTC statins "may be a viable approach to decrease risk" as long as the patient also improves diet, increases exercise, loses weight and makes other lifestyle adjustments.
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