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Use of an internet app to determine eligibility and access to a statin without a prescription could expand the numbers of primary prevention patients taking these drugs and lead to a reduction in subsequent major cardiovascular events, a new trial suggests. 

In the TACTiC trial, use of the app was successful in identifying qualifying individuals and resulted in an average 35% reduction in low-density lipoprotein (LDL) cholesterol after 6 months of treatment with rosuvastatin 5 mg.

"Less than half of individuals who are eligible to take statins for primary prevention of cardiovascular disease are not receiving these drugs," lead investigator of the TACTiC trial, Steven Nissen, MD, reported. 

"We have shown that this technology can allow people to self-select for statin use, and results in the right individuals taking the drugs, while preventing those that do not need a statin or should not take a statin from accessing them," he said. 

"I am terribly troubled by the fact that we have a class of lifesaving drugs that are not being used by half the population who could benefit from them," Nissen concluded. "This is addressing primary prevention. We are generally getting our secondary prevention patients treated, but we really are not getting the job done with primary prevention. Our hope is that if this is approved by the regulatory agency, it will allow some of these patients to be treated." 

The trial was presented on April 8 at the American College of Cardiology's Annual Scientific Session in Atlanta, Georgia. It was also simultaneously published online in the Journal of the American College of Cardiology.

In his presentation, Nissen, who is chief academic officer in the Heart, Vascular, and Thoracic Institute at Cleveland Clinic, Ohio, noted that the US Food and Drug Administration (FDA) has not allowed over-the-counter (OTC) use of statins because of concerns about inappropriate use by consumers for whom statins could be unnecessary or unsafe.

The aim of the current study was to evaluate whether the use of an app could identify appropriate individuals for access to OTC statins. 

The app tested was developed based on FDA guidance and calculates the 10-year cardiovascular disease risk score and suitability for statin use on the basis of an individual inputting information on cholesterol and blood pressure levels, concomitant medications, and previous cardiovascular events. 

If users did not know their cholesterol and blood pressure levels, they were given instructions on how to get this information. The app would then give one of three results: that a statin (rosuvastatin 5 mg) was indicated, was not appropriate, or that the individual should talk to their doctor (if they needed a higher dose).

Patients who had been identified as suitable for a statin were then able to set up an account and purchase an initial 90-day supply of 5-mg daily rosuvastatin, which could be reordered going forward. 

Recruited from advertisements, the trial enrolled 1196 participants; they had a median age of 63 years, and 40% were women. After taking the self-assessment, participants were then interviewed by a blinded clinician who determined whether they met the criteria for statin therapy. At the end of the treatment phase, they were scheduled for a final virtual visit and again interviewed by a clinician. 

The concordance between the self-assessment and the clinician assessment was high, showing agreement in 90.7% at baseline and 98.1% of cases at the final treatment phase assessment, respectively. 

Participants also experienced a significant 35% reduction in LDL cholesterol at 6 months from a baseline average of 140 mg/dL. Nissen estimated that this could translate into a 20% reduction in major adverse cardiovascular events if maintained over the long-term. 

Compliance with LDL retesting was 83.8% for the full population and 92.9% for those qualified at all reassessments. Adherence based on pill counts was 95.1%, and compliance with Ask a Doctor and Do Not Use warnings were 83% and 80%, respectively. Instances of noncompliance were not associated with a significant safety risk, and no participants experienced a Stop Use warning.

There were no serious adverse events related to statin use, but 3% of patients discontinued treatment because of musculoskeletal disorders. 

Nissen pointed out that limitations of the study included uncertainty on long-term statin adherence, and only participants who could read and understand English and who had internet access were enrolled.

'Empowering Patients'

Designated discussant at the ACC's late-breaking clinical trial session Thomas Maddox, MD, professor of medicine at Washington University School of Medicine, St Louis, Missouri, described the study as "a w ell-executed trial in a really important area." 

He said it was "a great example of how there is an important bidirectional conversation that needs to happen between our clinicians and our regulators."

Though Maddox acknowledged that the FDA has appropriate concerns about making statins available OTC and the potential safety effects that could occur, he said this trial "is working very hard to address these concerns," and "will be a model on how we continue this conversation to provide better care for our patients." 

Maddox also noted that this technology could empower patients to take more control of their health. 

"Going through this process will get them thinking about cardiac risk and measures they can take to reduce it," he said. "I applaud the investigators of this study in helping us with that goal." 

But Maddox pointed out some additional limitations. Noting that 75% of the individuals enrolled had a college education and very few had limited literacy, he asked "Are we really reaching the right people here?" 

He also questioned whether the approach put an unnecessary burden on the patient to have to get laboratory cholesterol values, and they also needed some fluency in regard to their medical history. 

Nissen responded that the program "could not possibly get to all the population that should be treated but are not being treated, but it is a potential way to close the gap to some reasonable extent."

He added: "Yes, people have to be able to use the internet and access an app and not everybody can do that. While this will by no means eliminate the problem, it is a step in the right direction." 

The study was funded by AstraZeneca. Nissen reports grant support from AstraZeneca.