Key Points:
- Nonprescription statin access may help statin-eligible patients receive appropriate treatment.
- This prospective, actual-use study employed a Web App for participants to self-qualify for guideline-appropriate moderate intensity statin initiation use, and found that this technology had high accuracy in making clinician-concordant statin determinations and led to a significant reduction in participant LDL.
Statins are the most studied drug in history. Despite their proven safety and effectiveness in reducing cardiovascular risk, more than half of statin-eligible patients are not currently on guideline-recommended therapy. Over the counter (OTC) statin therapy is one option to improve uptake, but there are concerns about inappropriate use by consumers. On April 8, 2024, the principal results of “Outcomes After Technology Assisted Nonprescription Rosuvastatin Administration: The TACTiC Trial” were presented at ACC Scientific Sessions 2024 with simultaneous publication in JACC. The purpose of this study was to determine whether a novel Technology-Assisted Self-Selection tool embedded within a Web Application (Web App) that allows consumers to qualify for nonprescription access to low dose rosuvastatin (5 mg) could safely and effectively connect patients with statin treatment.
This prospective, actual-use trial screened English-proficient adults age 20-75 with internet access who responded to a study advertisement. Ad responders were given access to the Web App which collected self-reported health information and calculated 10-year ASVD risk, and then made one of three final determinations about low-dose statin initiation based on 2018 guidelines: “Ok to Use”, “Ask a Doctor”, or “Do Not Use.” Participants who the Web App deemed that a statin was not indicated or who needed a high intensity statin could not continue. Those who were deemed “Ok to Use” or who were told to “Ask a Doctor” and then returned to the Web App to indicate physician approval could continue on in the study. After an independent statin eligibility assessment by a blinded HCP via a virtual visit, eligible participants then paid for and were mailed the drug. They then had to retake the assessment to refill the drug, after which their LDL was retested, and another independent assessment by an HCP was performed. The co-primary endpoints were concordance between the Web App and the HCP assessments as well as LDL reduction.
Overall, 1196 patients were enrolled. The mean age was 63 years, 60% were male and 12 % were Black. The mean LDL-C was 140 and median 10-year ASCVD risk was 10.1%. Concordance between Web App and HCP assessment for the initial self-selection was 90.7% (95% CI 88.9, 92.3). Concordance with the final use assessment was 98.1% (97, 98.8). The mean change in LDL-C was -35.5% (-36.6, -34.3). LDL-C retesting compliance was 84%, pill count-based adherence was 95%. Compliance with the “Ask a Doctor” and “Do Not Use” warnings were 83% and 80%, respectively, and no safety signal was identified with non-compliance. Limitations in this study include a 6-month study period, self-selection of participants motivated to respond to the study advertisement, and lack of non-English language options.
Dr. Steven E. Nissen MD, MACC of the Cleveland Clinic Center for Clinical Research, concluded: “With less than half of eligible primary prevention patients receiving statins, innovative approaches to close this treatment gap are needed. The use of a Web App to qualify for a nonprescription statin has the potential to expand access and reduce subsequent major cardiovascular events.”
