ACC.24 - In an actual-use study, >90% of consumers correctly identified their eligibility for nonprescription access to low-dose rosuvastatin by using a novel web application. This therapy was overall safe and led to a 36% reduction in LDL-c.

This summary is based on the presentation of Steven Nissen, MD (Cleveland, OH, USA) at the ACC.24 Scientific Session - Outcomes After Technology Assisted Nonprescription Rosuvastatin Administration: The TACTiC Trial.

Introduction and methods

A minority of primary prevention patients eligible for statin therapy actually receive treatment. Previous attempts to solve this problem through nonprescription statins did not receive regulatory approval due to concerns about inappropriate use by consumers for whom statins could be unnecessary or even unsafe.

In the TACTiC (Technology-Assisted Self-Selection in Consumers) trial, the safety and efficacy of a novel technology-assisted self-selection tool embedded in a web application (developed as Software as a Medical Device based on FDA guidance) to qualify participants for initial and ongoing nonprescription access to low-dose rosuvastatin (5 mg) were assessed. This prospective, multicenter, single-arm, actual-use evaluation, phase 3 study was conducted in the US and recruited individuals with no medical background through advertisements for a study on heart health or lowering cholesterol.

To determine eligibility, the web application prompted participants to enter their demographic information, concomitant medications, cholesterol levels, and blood pressure, after which the tool calculated the 10-year ASCVD risk score (pooled cohort equations) based on the 2018 Cholesterol Treatment Guidelines. This resulted in 3 possible outcomes: “Do Not Use,” “Ask a Doctor” or “OK to Use.” Only individuals with one of the latter 2 outcomes were enrolled (n=1196). Eligibility was also assessed by a clinician, who had no knowledge of the participant’s self-assessment.

After enrollment, participants entered a 6-month use period, during which they received an up to a 90-day supply of rosuvastatin 5 mg and could reorder if the computer-aided self-assessment confirmed they still met guidelines for safe and effective use.

The 3 coprimary endpoints were: (1) proportion of participants whose initial self-selection was concordant with the clinician assessment (success was defined as 95%CI lower bound >85%; (2) proportion of participants whose final self-assessment (at 6 months) was concordant with the clinician assessment (success was defined as 95%CI lower bound >85%); and (3) mean percent change in LDL-c from baseline to 6 months (success was defined as 95%CI lower bound for LDL-c reduction >15%).

Main results

• At baseline, the mean LDL-c level was 139.6 mg/dL (SD: 28.3) and median clinician-calculated 10-year risk of ASCVD was 10.1% (IQR: 7.3%–14.0%). 
• The initial self-selection was correct for 1085 participants, resulting in a concordance between the participant and clinician of 90.7% (95%CI: 88.9%–92.3%).
• During the 6-month treatment period, the concordance of the final use assessment was 98.1% (95%CI: 97.1%–98.8%).
• The mean LDL-c change from baseline to 6 months was –35.5% (95%CI: –36.6% to –34.3%), with 84.5% of the participants showing an LDL-c reduction >20%.
• The final mean LDL-c level was 88.1 mg/dL (SD: 25), which was an absolute reduction from baseline of 51.4 mg/dL (SD: 29).
• The frequency of adverse events was 52.9% (myalgia: 4.1%), and the frequency of adverse events leading to study drug discontinuation was 7.1% (none of which led to withdrawal from the trial). Serious adverse events occurred in 27 participants (2.3%), but none were deemed to be related to the study drug.

Conclusion

In this actual-use study, >90% of consumers correctly identified their eligibility for statin therapy by using a novel technology-assisted web application. The nonprescription use of low-dose rosuvastatin led to a 36% reduction in LDL-c and was overall safe.

- Our reporting is based on the information provided at the ACC.24 Scientific Session -

The findings of this study were simultaneously published in J Am Coll Cardiol.