Web-based app to guide nonprescription use of statins a win in TACTiC trial

Self-selecting for nonprescription statin therapy with the help of a Web-based application leads to a high percentage of individuals correctly confirming their eligibility, using the medication appropriately, and achieving significant low-density lipoprotein cholesterol (LDL-C) reductions, according to the results of the TACTiC trial.

In the 6-month, phase III trial designed to evaluate the use of the Web app to qualify participants for treatment with 5-mg rosuvastatin without prescription, app-guided self-assessment matched clinician-assessed eligibility for initial treatment in 90.7 percent (95 percent confidence interval [CI], 88.9–92.3) of participants. [J Am Coll Cardiol 2024;doi:10.1016/j.jacc.2024.03.388]

The concordance between the app and clinician assessments was also high for the final treatment phase, wherein 98.1 percent (95 percent CI, 97.1–98.8) of participants were deemed to demonstrate appropriate statin use during the 6-month treatment period.

Consequently, mean LDL-C levels dropped by 35.5 percent (95 percent CI, –36.6 to –34.3) 6 months after starting treatment, with 84.5 percent of participants achieving LDL-C reductions that exceeded 20 percent. The final mean LDL-C was 88.1 mg/dL, an absolute reduction of 51.4 mg/dL or 1.33 mmol/L from baseline.

“With less than half of eligible primary prevention patients receiving statins, innovative approaches to close this treatment gap are needed,” lead study author Dr Steven Nissen of Cleveland Clinic Center for Clinical Research in Cleveland, Ohio, US, said in a session at ACC 2024.

“The use of a Web App to qualify for a nonprescription statin has the potential to expand access and reduce subsequent major cardiovascular events,” Nissen said in light of the findings of TACTiC.

Strong follow-through

The Web app featured a novel Technology-Assisted Self-Selection (TASS) tool developed as a medical device software based on FDA guidance. Users were required to enter their demographic, medical, laboratory, and blood pressure data. Treatment eligibility was determined by calculating the 10-year atherosclerotic cardiovascular disease (ASCVD) risk, in line with the 2018 cholesterol treatment guidelines and a proposed Drug Facts Label (DFL) for rosuvastatin.

Based on the results of the app-guided self-assessment, users were informed that they could use statins (‘OK to Use’), should ask a doctor for further advice (‘Ask a Doctor’), or could not use statins (‘Do Not Use’). Only those with ‘OK to Use’ or ‘Ask a Doctor’ outcome could qualify and enrol in TACTiC, Nissen said.

A total of 1,196 participants (median age 63.0 years, 39.6 percent women, 79.3 percent White) were included in the study. These participants were required to set up an account on the Web app, purchase a 90-day supply of 5-mg daily rosuvastatin for shipment directly to their home, and undergo LDL-C testing. A clinician blinded to app assessments interviewed the participants to determine their eligibility for statin therapy.

During treatment, participants were instructed to reorder medication to allow them to complete the 6-month study. An abbreviated Web app assessment had to be undertaken upon each reorder to help ensure continued appropriateness of treatment.

Most participants (74.0 percent) graduated college or technical school, and 4.1 percent had limited literacy (7th/8th grade reading level or below). At baseline, the mean LDL-C was 139.6 mg/dL, the median systolic blood pressure was 130 mm Hg, and the median clinician-calculated 10-year risk of ASCVD was 10.1 percent.

“The secondary endpoints showed that participants were largely adherent to dosing, LDL-C retesting, and warnings contained in the DFL,” Nissen said.

Compliance with retesting of LDL-C was 83.8 percent for the full population and 92.9 percent for those qualified at all reassessments. The vast majority of participants (95.1 percent) were adherent to treatment, as measured by pill counts, while 83 percent and 80 percent complied with ‘Ask a Doctor’ and ‘Do Not Use’ warnings, respectively.

Adverse events (AEs) occurred in 52.9 percent of participants. Commonly reported AEs included COVID-19 (9.6 percent), arthralgia (7.0 percent), headache (5.4 percent), pain in extremity (4.3 percent), and myalgia (4.1 percent), among others. AEs led to drug discontinuation in 7.1 percent of participants, with none leading to withdrawal from the trial. There were 40 serious AEs documented in 27 participants, but none of these AEs were considered related to study drug.

Curbing ASCVD burden

“We think this [Web-based] approach can make statins available to more people who are not currently taking these important drugs. 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,” Nissen said in a statement.

Facilitating access of statin treatment through nonprescription availability has the potential to ultimately reduce the societal burden of ASCVD, he pointed out.

“If approved, [the TASS tool] would represent the first treatment made available without a prescription for a chronic asymptomatic condition,” Nissen continued, adding that the resulting 35.5-percent reduction in LDL-C observed in the study is large enough to effectively reduce the incidence of ASCVD events based on the Cholesterol Treatment Trialists Collaboration.

On the other hand, Nissen acknowledged that the Web-based approach may only be limited to users who can read English, have access to the internet, and are willing to use technology. He underscored the need to come up with other approaches to provide safe access to a statin for those who are less willing or unable to use technology.