Web App Could Improve Statin Therapy Without Need for Clinician Prescription

Steve Nissen, MD
Credit: Cleveland Clinic

A study examines use of a web application to improve access to nonprescription statin therapy highlights the potential of digital interventions in improving population-level health.

Results of the 6-month prospective study indicate use of the Technology Assisted Self-Selection (TASS) web application, which leveraged a digital patient questionnaire to determine if a patient was eligible for statins, was able to recommend statin therapy in concordance with clinician assessment in more than 90% of patients, with 84.5% of patients achieving an LDL-C reduction of 20% or greater.

“We think this approach can make statins available to more people who are not currently taking these important drugs,” said lead investigator Steven Nissen, MD, chief academic officer in the Heart, Vascular, and Thoracic Institute at Cleveland Clinic.² “This therapeutic approach is designed to allow access to consumers who should be treated, while preventing access to those for whom statins are not indicated or unsafe.”

One of the most impactful advancements in modern medicine, the advent of statin therapy marked a definitive change in the course of cardiovascular disease risk management. Now, decades later, statin therapy remains the cornerstone of management for elevated LDL-C. However, despite an established safety profile and reduced costs, patient adherence and access remain a persistent issue.

Named TACTIC, the current trial was launched with the intent of exploring if consumers could self-select correctly and take statins appropriately without requiring clinician qualification and a prescription. With this in mind, investigators leveraged the TASS web application.¹

According to investigators, the app incorporates the 2018 Cholesterol Treatment Guidelines users the Pooled Cohort Equations to determine 10-year cardiovascular risk and includes key components of a proposed drug facts label for nonprescription rosuvastatin. Patients were prompted to enter demographic and medical information including total cholesterol, HDL-C, LDL-C, triglycerides, systolic and diastolic blood pressure, and, when indicated, any of the risk enhancing factors cited in the guidelines. After completing the screening questionnaire, participants received an outcome of “Do Not Use,” “Ask a Doctor” or “OK to Use”.¹

The study leveraged 3 coprimary endpoints. These which were the percent of participants whose initial self-selection was concordant with the clinician assessment, the percent of participants whose final use assessment was concordant with the clinician assessment, and the percent change from baseline in LDL-C with treatment.¹

Participants were recruited for the trial through advertisements for a study about heart health or lowering cholesterol. To be eligible, patients needed to be 20 to 75 years of age and have the ability to read and understand English because the app was only in English. In total,133,744 individuals were assessed for eligibility. After exclusion of those who failed pre-screening, did not access the app, and those who received a “Do Not Use” outcome, 1196 patients who signed an informed consent were included in the study.¹

This cohort had a median age of 63 (Interquartile range, 57-68) years, 39.6% were women, 79.3% were White, 11.7% were Black, and 4.1% had limited literacy. Investigators pointed out the mean LDL-C level of the group was 139.6 (Standard Deviation [SD], 28.3) mg/dL and the median 10-year risk of atherosclerotic cardiovascular disease was 10.1% (IQR, 7.3 to 14.0).¹

Upon analysis, results indicated use of the web app self-selection resulted in an outcome concordant with clinician assessment in 90.7% (95% CI, 88.9 to 92.3) of participants and 98.1% (95% CI, 97.1 to 98.8) had a concordant final use outcome during treatment. Further analysis suggested the mean percent change in LDL-C observed among this group was 35.5% (95% CI, -36.6 to -34.3). Results of the safety analyses revealed serious adverse events occurred in 2.3% participants, but none of these were considered treatment related.¹

“Not only did participants self-select correctly, they also demonstrated they could appropriately self-administer the drug and they obtained a reduction in LDL cholesterol that was about what you’d expect with high adherence,” Nissen said.²

References:

1. Nissen SE, Hutchinson HG, Wolski K et al. A Technology-Assisted Web Application for Consumer Access to a Nonprescription Statin Medication. Presented at: American College of Cardiology (ACC.24) Annual Scientific Session. April 6 – 8, 2024. Atlanta, GA.
2. American College of Cardiology. Study shows web app effective in determining access to statins without a prescription. American College of Cardiology. April 8, 2024. Accessed April 10, 2024. https://www.acc.org/About-ACC/Press-Releases/2024/04/08/13/32/study-shows-web-app-effective-in-determining-access-to-statins-without-a-prescription.