OTC statin treatment could help stem the cardiovascular disease epidemic

Making statin treatment available without a prescription could help the fight against heart disease, says Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Director of the Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health at The Mount Sinai Medical Center.

Writing in the September 1 edition of The American Journal of Cardiology, Dr. Fuster notes that a nonprescription statin program could provide patients with a tool of proved benefit in cardiovascular risk prevention. Educating the public and encouraging patient involvement in their own health care has repeatedly shown to be an effective means of improving disease prevention.

“There could be an enormous health benefit to making nonprescription statins available and enhancing patients' involvement in their own care,” said Dr. Fuster, who has served as president of the World Heart Federation.

Dr. Fuster's recommendation comes at a time when heart disease is reaching epidemic proportions in the United States and remains the leading cause of death in this country. Cholesterol is a primary risk factor for heart disease. The number of Americans estimated to have coronary heart disease is expected to more than double by 2050, according to the editorial.

“Even though statins have been available for 20 years, and have proven to be safe and effective in lowering cholesterol, many patients throughout the world still do not get this treatment,” said Dr. Fuster. “We have made only limited progress tackling coronary heart disease, and we need additional approaches to prevent this epidemic from continuing.”

Several studies have found that any reduction in low density lipoprotein (LDL) cholesterol levels results in coronary heart disease risk reduction. Research has also shown that taking statins can reduce LDL levels by as much as 24% and that when patients are introduced to cholesterol-lowering therapies, they become motivated to learn about other lifestyle modifications that can help keep lipid levels under control, such as diet and exercise.

There are more than 23 million people in the U.S. without coronary heart disease but with risk factors for developing the disease. A significant proportion of these patients are candidates for lipid-lowering therapy and could benefit by taking statin drugs, but are currently not on treatment, said Dr. Fuster. It is this moderate risk population that could directly benefit from the greater access and education a nonprescription statin would provide.

Dr. Fuster notes in his editorial that any proposal for nonprescription statins is an opportunity to educate the public about how to protect themselves from heart disease. Any over-the-counter statin therapy should be accompanied by lifestyle changes, including eating a heart-healthy diet, exercising, enrolling in a smoking cessation program, getting cholesterol tests, and discussing cholesterol management with physicians, he explained. “To realize this potential,” Dr. Fuster said, “sponsors of nonprescription statin proposals must continue the development of improved product labeling and educational messages and to demonstrate their effectiveness in driving appropriate consumer behavior.”