Study Shows Use of Technology Can Help Ensure Safe and Effective Access to Non-Prescription Statins

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In an effort to make cholesterol-lowering medications available without a prescription, researchers at a top American hospital, Cleveland Clinic, found that a novel web-based application is nearly as accurate as a clinician’s assessment in determining who qualifies for statin use. The study was published this week in the Journal of the American College of Cardiology.

According to the World Health Organization, cardiovascular disease is the leading cause of death globally, with an estimated 17.9 million people dying in 2019. Cardiovascular disease includes hypertension, coronary heart disease, heart failure, stroke and/or congenital heart defects. More than 17 million people with cardiovascular disease have coronary heart disease, which is a build-up of fatty plaques in the arteries supplying the heart muscles. The problem is particularly acute for minorities. According to the U.S. Department of Health and Human Services Office of Minority Health, for example, African Americans are 30 percent more likely to die from heart disease than Caucasians, yet statin use is significantly lower.
Statin medications are first-line drugs for the prevention of cardiovascular disease that work by lowering cholesterol levels in the blood. Statins have been shown in many studies to reduce the risk of stroke, heart attack and death when administered to the right patients, both with a history of cardiovascular disease and without.

“Despite scientific evidence showing that statins can prevent a first heart attack or stroke, access remains a critical barrier, with only about one-half of eligible patients receiving treatment, highlighting the need to make these drugs more widely available,” said Steven Nissen, M.D., Chief Academic Officer of the Heart, Vascular and Thoracic Institute at Cleveland Clinic, and the study’s lead author.

Previous attempts to create nonprescription statins have failed, mostly by failing to demonstrate that consumers who should not take statins would not have access to over-the-counter treatment. In this study, a total of 500 participants, 83 with limited literacy, completed an at-home web-based application to assess appropriateness for treatment with 5 milligrams of rosuvastatin. The web application is programmed for 1 of 3 treatment outcomes: “Ok to use,” “not right for you,” or “ask a doctor.”

Subsequently, participants visited a research site where clinicians, blinded to the information the participant entered, performed an independent assessment. Results showed that participant selection for statin therapy was the same as the clinician selection in 481 (96.2%) of 500 participants. 23 were deemed appropriate and 458 were deemed inappropriate for treatment.

“This study was successful in making certain that the wrong people would not get these drugs, and is an encouraging step forward in the pursuit of a non-prescription statin,” said Nissen.

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