Technology-Assisted Self-Selection for Nonprescription Statin Therapy

Podcast Transcript

Announcer:

Welcome to Cleveland Clinic Cardiac Consult, brought to you by The Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic.

Steven Nissen, MD:

I'm Dr. Steve Nissen, and I'm a cardiologist at the Cleveland Clinic. And I'd like to talk to you about a recent publication that we had about a new approach to non-prescription statins. Now, please keep in mind that there have been five previous efforts to get approval from the FDA for over-the-counter statins. And all of them were rejected by the FDA at various stages of development. And the problem is that the people who wanted to take statins over-the-counter were what we call the worried well. They were people who really didn't have a good indication for statins, but they wanted to protect themselves somehow. And it just didn't work out because the wrong people were getting the medications.

Steven Nissen, MD:

So what did we do? Working with AstraZeneca, we have developed a web app. We call this technology assisted self selection for statins. And the drug we chose was the very small dose, the five milligram dose of rosuvastatin. Five milligrams of rosuvastatin is actually pretty effective. It lowers LDL cholesterol by about 40%. And the way it works with this app is a patient is directed to go online, and they fill out all the information that's part of the ACC/AHA risk calculator. The program then calculates their risk and determines whether they meet the eligibility criteria to get a statin, a moderate-intensity statin, and that they have no contraindications to a statin. If they meet those criteria, then they're deemed eligible for a statin. And the idea of this program is that then the drug will be directly shipped to their home, they won't go into a pharmacy and buy it, and every 90 days they can renew it.

Steven Nissen, MD:

Now, why do this? We know that about half the people that should be taking statins, that are eligible by the current guidelines, are actually not on the drugs. That costs a lot of lives, and a lot of heart attacks and a lot of strokes. We thought it made sense to create wider availability of a statin, in this case, rosuvastatin, by using a screening program that rejects people who should not take the drug and accepts people who should.

Steven Nissen, MD:

We tested this approach in a 500 patient trial. It was published just recently in the Journal of the American College of Cardiology. And well over 95% of the time, the program and the patient got the right answer compared with a clinician's assessment of whether or not they were eligible to take a statin. No other effort at non-prescription statins has come anywhere near this level of precision. And so we think we have the right approach. We're going to go forward with the development and we hope that we can make these drugs more widely available to people that have less accessibility. Imagine somebody that's in rural Montana, where the nearest physician is a long way away. Lots of people, people in the inner city that have less access to healthcare, where having a non-prescription access to statins could be really important. And we're going to go forward with the development of this. Thank you for your attention.

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