Web app can help patients determine if they qualify for a statin without a prescription
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Key takeaways:
- More than 90% of participants using an app correctly self-selected for over-the-counter statin use.
- Almost all who received the statin used it correctly, and LDL declined more than 35% among statin users.
ATLANTA — New results from the TACTiC trial show the promise of technology to help individuals appropriately determine if they qualify for statin therapy without a prescription.
“With less than half of eligible primary prevention patients receiving statins, innovative approaches to close this treatment gap are needed,” Steven E. Nissen, MD, MACC, chief academic offer in the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute and the Lewis and Patricia Dickey Chair in Cardiovascular Medicine at Cleveland Clinic, said during a presentation at the American College of Cardiology Scientific 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.”
Findings from TACTiC demonstrate that individuals can appropriately self-select and self-manage statin treatment with the assistance of a dedicated web app. Moreover, those who were given access to a statin without a prescription had a 35% reduction in LDL, on average, 6 months after starting treatment, Nissen, a member of the Healio | Cardiology Today Editorial Board, said here.
The study was simultaneously published in the Journal of the American College of Cardiology.
Utilizing technology
“Multiple past attempts to address this problem through over-the-counter statins were unsuccessful in achieving regulatory approval. There were major concerns about inappropriate use by consumers for whom statins could be unnecessary or unsafe,” Nissen said.
TACTiC aimed to address this problem using a novel technology-assisted self-selection web app to qualify consumers for nonprescription access to rosuvastatin 5 mg.
Researchers collaborated with AstraZeneca to create a system to make nonprescription stains available to the general population based on eligibility criteria without requiring a doctor visit or prescription.
First, participants responded to an ad and completed a medical assessment using the online web-based app, answering questions about demographics, medication use, medical history, and cholesterol and BP levels. Based on their responses, participants were given one of three prompts: “OK to Use,” “Ask a Doctor” or “Do Not Use.” Only participants who received “OK to Use” or “Ask a Doctor,” with subsequent confirmation, were eligible to purchase statin therapy. Participants could order up to a 90-day supply of rosuvastatin 5 mg (Crestor, AstraZeneca) daily, which they paid for and was shipped directly to their home, according to a press release from Cleveland Clinic. Patients who needed a high-intensity statin were directed to a physician.
Enrolled participants were then interviewed virtually by a clinician who determined whether they met the criteria for statin therapy. Participants then entered the study’s 6-month treatment phase, requiring them to reorder medicine and take an abbreviated web app assessment before each reorder to ensure they continued to meet safe use requirements, according to the press release. In this phase, participants were also prompted to have their LDL levels retested.
At the end of the treatment phase, participants were scheduled for a final virtual interview with a clinician.
“This was a complicated trial,” Nissen said.
The web app was developed based on FDA guidance. The web app calculates the 10-year ASCVD risk score, using the Pooled Cohort Equations in the 2018 American Heart Association/ACC/Multisociety Guideline on the Management of Blood Cholesterol
and a proposed drug facts label for rosuvastatin.
Key findings
For TACTiC, the researchers enrolled 1,196 participants (mean age, 63 years; 39% women; 79% white) who had the ability to read and understand English and had access to the internet. Mean baseline LDL was 140 mg/dL and median 10-year ASCVD risk was 10%.
Among the cohort, 90.7% (95% CI, 88.9-92.3) correctly self-selected for statin use compared with assessment by a clinician. Among those who entered the 6-month treatment phase, 98.1% (95% CI, 97.1-98.8) of participants correctly used the statin.
Patients had a high level of adherence: 93% retested and achieved a clinically meaningful 35.5% (95% CI, –36.3 to –34.3) reduction in LDL, Nissen said here.
“So patients self-selected accurately, they took the drug correctly and they got really meaningful reduction in LDL. The trial met its three primary endpoints,” Nissen told Healio.
Adverse events leading to rosuvastatin discontinuation occurred in 7.1%, but none led to withdrawal from the trial. The most common adverse event was musculoskeletal disorders (3.1%).
Nissen noted several limitations of the trial, including its 6-month duration and enrollment of only participants who could read and understand English and use the internet.
Next steps
“This is not designed to replace patients seeing doctors,” Nissen told Healio. For example, there are people living in rural areas who have poor access to physicians. “We think that a very low dose of a statin would be effective and safe for nonprescription access. And we showed that it was.”
During a discussion of the trial, Thomas M. Maddox, MD, MSc, professor of cardiology at Washington University School of Medicine in St. Louis, said this trial emphasizes the need for the health care system to meet patients in a digital way.
“The FDA had very appropriate concerns about making this medication available over the counter and potential safety effects that can occur. I think [this trial] will be a model about how we continue this conversation to provide better care for our patients,” Maddox said.
While Nissen acknowledged the difficulty in targeting everyone who should be treated with a statin, “this is potentially a way to close that gap to some reasonable extent.”
“The next step is to see whether the regulators agree. We’ve made the case for a unique way to deliver a nonprescription medication.”
Reference:
- Cleveland Clinic-Led Trial Finds Web App Technology Effective in Determining Access to Cholesterol-Lowering Drugs Without Prescription. https://newsroom.clevelandclinic.org/2024/04/08/cleveland-clinic-led-trial-finds-web-app-technology-effective-in-determining-access-to-cholesterol-lowering-drugs-without-prescription. Published April 8, 2024. Accessed April 8, 2024.
- Nissen SE, et al. J Am Coll Cardiol. 2024;doi:10.1016/j.jacc.2024.03.388.
Perspective
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Himabindu Vidula, MD, MS, FACC
As Dr. Nissen noted, although statins reduce CV outcomes, less than half of eligible patients are actually receiving the treatment. Therefore, we really need innovative approaches such as this one to think about how we are going to bridge and close this treatment gap. The use of this web app to qualify for a nonprescription statin really has the potential to expand access and reduced subsequent adverse CV events.
Overall, the web app was easy to use. Overall, the results demonstrate that the use of this app allows consumers to select for this nonprescription statin correctly, confirm eligibility, use the drug properly and obtain a large reduction in their LDL cholesterol. Adverse events were uncommon and none led to withdrawal from the trial.
So, as we try to put this study into context, we need to remember that undertreatment is most common in women and racial/ethnic minority groups, and also in those without health insurance. Increasing access through this type of web app could reduce the societal burden of CVD.
There were some limitations of the study ... but I think that those can be easily bridged by making this technology available in public spaces ... so that more people can use it. We still need some further testing in patients who have limited literacy. And, we also need longer follow-up to examine adherence. But overall, I think that this is a very promising approach.
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Nissen SE, et al. Joint American College of Cardiology/Journal of the American Medical Association Late-breaking clinical trials IV. Presented at: American College of Cardiology Scientific Session; April 6-8, 2024; Atlanta.
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