乌鸦传媒

ATLANTA -- The vast majority of people correctly identified their own need for a statin using a web tool and took the drug appropriately without a prescription, according to an actual use study, supporting the safety of approval for nonprescription use.

Self-selection to take 5-mg rosuvastatin (Crestor) based on the app's advice matched clinician selection in 90.7% (95% CI 88.9-92.3) of cases, and 98.1% used the statin correctly, Steven E. Nissen, MD, of the Cleveland Clinic, reported at the American College of Cardiology (ACC) annual meeting. The findings also appeared in the .

Participants' LDL cholesterol dropped by 35.5% at 6 months from a baseline average of 140 mg/dL.

If the FDA were to approve nonprescription use and individuals continued on their statin longer term, such improvements in cholesterol would be expected to reduce risk of mortality and morbidity from atherosclerotic disease by more than 20%, Nissen noted at an ACC press conference.

"With less than half of eligible primary prevention patients receiving statins, innovative approaches to close this treatment gap are needed," he told attendees at the late-breaking clinical trial session. "The use of a web app to qualify for a nonprescription statin has the potential to expand access and reduce subsequent major cardiovascular events."

The findings paralleled those from a 2021 study by the same group, showing 96% concordance between the app and physicians, which was welcome news after five prior attempts to make various statins available without prescription had failed, largely over inability to get only the right patients on the drug.

"Most of them didn't even get to an FDA panel because they failed early in the development," Nissen told 乌鸦传媒. "They used the drug facts label that you get when you buy something over the counter, and that doesn't work."

He chalked up the success of the nonprescription strategy for rosuvastatin to use of the web app. "It's because we've got the technology now."

The web app is being developed under an FDA pathway for software as a medical device to determine eligibility for a statin. It calculates 10-year atherosclerotic cardiovascular disease (ASCVD) risk score with the Pooled Cohort Equation and the proposed drug facts label for nonprescription rosuvastatin. Users also input cholesterol levels, concomitant medications, and medical history of relevant cardiovascular disease and events.

Individuals deemed eligible get an "OK to use" message, while those with possible contraindications or who need a high-intensity statin are told to "Ask a doctor" or "Do not use."

The TACTiC study included 1,196 participants (median age 63, 39.6% women) who completed the web app assessment and got the OK to use statins or confirmed they had asked a doctor about use. Most of the people who completed the web app assessment got a "Do not use" message and were not enrolled (10,332 of 12,624). Those who worked for a healthcare-related company or had ever been employed as a healthcare professional were also excluded.

Study participants could set up an account and buy up to a 90-day supply of 5-mg daily rosuvastatin for shipment directly to their home. Participants were then interviewed by a clinician blinded to app assessments who determined if they met criteria for statin therapy. During the 6-month study phase, patients had to take an abbreviated web-app assessment to reorder medicine and get their LDL cholesterol re-tested. Afterward, they had a final virtual visit to be interviewed by a clinician for determination of appropriateness of use.

ACC session study discussant Thomas M. Maddox, MD, of the Washington University School of Medicine in St. Louis, raised several concerns: About three-quarters of the study population had a college education. Only about 4% of patients had limited literacy. "So are we really reaching that 50% [of statin-eligible nonusers], which I would imagine is overrepresented in terms of less education, less literacy?" he posited.

Also, individuals need to enter their cholesterol values to complete the assessment, so "does this platform put an unnecessary degree of burden on the patient to collect information?" Maddox asked. "That speaks to potential access issues. They also need some fluency in their medical history. Do they know they have artery disease and other things that are part of that screening platform?"

Equity is also a concern as patients who don't use digital and information tools wouldn't be able to access this drug, he suggested.

Nissen noted that a finger-prick blood test for cholesterol at a pharmacy can provide the information needed to complete that section of the assessment. However, he agreed that, while a "step in the right direction, it by no means can eliminate the problem. ... We're really not getting the job done with primary prevention. And our hope would be that if this is approved by the regulatory agency, that it will allow these patients to, at least some of them, to be treated."

Such a strategy might be good for rural areas where it's not easy to see a provider or just those who don't like to see doctors, he told 乌鸦传媒.

Undertreatment is also more common in women, in racial and ethnic minority groups, and in those without health insurance, noted ACC press conference study discussant Himabindu Vidula, MD, of the University of Pennsylvania in Philadelphia.

"There were some limitations of the study, including the fact that participants who did not have access to the internet or could not read English or were not willing to use the technology wouldn't be able to use this," she said. "But I think that those can be easily bridged by making this technology available in public spaces such as grocery stores, convenience stores, [and] drug stores so that more people can use it."

All of the findings cleared the FDA-defined criteria for success. Adherence based on pill counts was 95.1%, which Nissen called remarkable and potentially due to a motivated participant cohort.

No participants got a stop use warning. No adverse events clearly related to the statin occurred, other than myalgias in 4.1%.

Nissen noted that longer-term assessment of adherence and nonprescription use are needed. "Is it a 5-year study? No. But every patient that should be on a statin that's not, even for a modest period of time, makes a difference."

Kathryn Berlacher, MD, of the University of Pittsburgh, called the findings hopeful, not just for statin use but for a variety of avenues for primary and secondary prevention.

"We've also seen in a completely non-cardiac realm of the mini pill and progesterone for over-the-counter use for birth control," she told 乌鸦传媒. "Now thinking about a nonprescription way to have rosuvastatin, which, to be honest, is one of my favorite preventive medicines, is really terrific. ... It should be the beginning of a number of other ways that we do this -- in hypertension and a variety of other aspects of primary prevention and secondary prevention."

Comment