麻豆传媒

A web app helped people determine whether they should be on a statin with high concordance to physicians' determinations, a study showed, supporting the potential for non-prescription self-selection.

The app's advice on taking 5-mg rosuvastatin matched clinician selection in 96.2% (95% CI 94.1%-97.7%) of a broad population, with 4.6% deemed appropriate for use, Steven Nissen, MD, of the Cleveland Clinic Heart and Vascular Institute, and colleagues reported in the .

Most of the discordance was from the app telling patients a statin wasn't right for them (14 cases), which is a lost opportunity but poses no inherent risk, the researchers noted. Only three of those cases out of the 500 patients in the study got an incorrect "OK to use" result from the app, and none of them were at increased risk of adverse events.

"Is it that much of a stretch to imagine that patients could further access cardiovascular preventive therapies after guidance from an online decision aid?" asked an by Neha J. Pagidipati, MD, MPH, of the Duke Clinical Research Institute in Durham, North Carolina, and Eric D. Peterson, MD, MPH, of the University of Texas Southwestern in Dallas.

Only one-third of primary prevention statin candidates are on an appropriate dose of one, and the socioeconomic and racial disparities in prescribing are wide, Pagidipati and Peterson noted. "Clearly, the current approach of relying on a fragmented healthcare system to deliver consistent CV preventive care is not working for most patients."

"People may live in rural areas or they may live in minority communities where they have less access to healthcare; they may not like to see doctors," Nissen said. "Whatever the reasons may be, the hope would be we can reach more people if we make the drugs available over the counter."

Five previous efforts to take statins over the counter have failed, he noted. At the time, based on studies that showed about half of the people who would get statins over the counter were not eligible due to contraindications or low risk, he said, "I was one of the people that was very vocal in opposing over-the-counter statins."

However, the new findings are "in a completely different ball park from the previous efforts," Nissen told 麻豆传媒, noting that the FDA wants to see at least 90% success at self-selection. "We're very pleased this paradigm can work. It's a brand new approach to taking to prescription a non-prescription status."

Rather than actually over the counter, the concept is web-based qualification to receive the drug and then direct shipment from the manufacturer, he explained.

The web-based app runs people through the American College of Cardiology/American Heart Association atherosclerotic cardiovascular disease risk calculator and asks about contraindications, previous diagnoses, lab results, and family history.

On those details, people were "reasonably accurate" at recalling their medical and medication histories, the editorialists noted. Self-reports matched the response of their clinician for 81%.

The results of the web-based app didn't vary by participants' health literacy. Of the 83 participants with limited literacy, 96.4% had concordance between the physician and app, with 7.2% given the "OK to use."

The broad study population was selected as a group in which most would not be eligible for the statin.

"Although the current study helps determine whether ineligible consumers can be successfully excluded from treatment, it does not provide a robust assessment of technology-assisted self-selection in identifying patients most likely to benefit from nonprescription statin therapy," Nissen's group wrote.

Because statins remain prescription products, the study couldn't look at actual initiation of or adherence to a statin, the editorialists cautioned, calling for larger real-world implementation studies that look for adverse effects as well.

"Future studies will be required that enroll participants specifically selected for eligibility to receive nonprescription rosuvastatin to determine whether technology can improve accurate selection of these consumers and assess their adherence to treatment," the researchers agreed.

The study focused on the lowest dose of rosuvastatin, Nissen said, because "it's very effective -- reducing LDL by up to 40% -- and it has very few drug-drug interactions. So it's really well suited."

Another study is currently underway, but Nissen suggested it may be years still until the FDA might weigh in on nonprescription statin use.

Any statins other than rosuvastatin that attempt the same would have to go through a similar development process, as there wouldn't be class approval, he added.

Rosuvastatin 5 mg should cover most people, but those who need more intense statin dosing should be getting a prescription under the care of a physician, Nissen argued.

"We're getting the right drug to the right patient in a timely fashion and lowering barriers to access," he said. "And that's what makes it a reasonable public health measure that can help people."

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