The majority (>90%) of participants using a novel web application appropriately qualified for treatment with a nonprescription statin, closely matching results of a clinician assessment of eligibility, according to results from the TACTiC study, presented during a Late-Breaking Clinical Trial session at ACC.24 and simultaneously published in JACC. This is the first experiment with a prescription statin to show that consumers could self-select correctly and take statins appropriate without requiring clinical qualification and prescription.

In this prospective, actual-use study, 1,196 participants (median age 63, 39.6% women, 79.3% White, 11.7% Black, and 4.1% with limited literacy) interacted with the Technology Assisted Self-Selection (TASS) Web Application to assess eligibility for a statin. Their median calculated 10-year risk of atherosclerotic cardiovascular disease was 10.1%. Participants were prompted to enter demographic information, cholesterol values, blood pressure and concomitant medications. Based on their answers, the TASS app provided one of three possible outcomes for statin use: "Do Not Use," "Ask a Doctor" or "Ok to Use." Participants who received an outcome of ask a doctor or they could use a statin continued in the study and virtually met with a clinician to review their results and initiate a six-month treatment course of low dose (5 mg) rosuvastatin.

For the co-primary endpoints, results showed there was high concordance (90.7%) between the TASS app outcome and the clinician assessment, and 98.1% had a concordant final use outcome during treatment. The co-primary endpoint of mean percentage change in LDL-C was –35.5% (starting at 139.6 mg/dL at baseline). The final LDL-C was 88.1 mg/dL, an absolute reduction of 51.4 mg/dL. Serious adverse events occurred in 27 participants (2.3%), including one sudden death, but none were determined to be related to the study.

Adherence was high at 95% based on pill count of direct delivery of nonprescription statin and persistence was 98.5% over the six-month study.

"Although statins reduce adverse cardiovascular outcomes, less than half of eligible patients receive treatment," wrote study authors Steven E. Nissen, MD, MACC, et al. "Multiple past attempts to address this problem through over-the-counter statins were unsuccessful in achieving regulatory approval due to concerns about inappropriate self-selection by consumers for whom statins could be unnecessary or unsafe." The authors point to this study's findings as the first step in assuaging those concerns.