Cleveland Clinic-Led Trial Finds Web App Technology Effective in Determining Access to Cholesterol-Lowering Drugs Without Prescription

Findings from a new Cleveland Clinic-led study suggest that a technology-assisted web application can help consumers appropriately determine if they qualify for a statin drug without a prescription.

During the trial, 1,196 participants used the web application and more than 90% correctly self-selected for statin use based on current guidelines compared with assessment by a clinician. Among those who then entered a six-month treatment phase,98% of consumers correctly used the drug, achieving a 35% reduction in LDL (low density lipoprotein) cholesterol – also known as "bad" cholesterol. 

These findings demonstrate that consumers can appropriately self-select and self-manage statin treatment with the assistance of a dedicated web application, potentially allowing expanded access to this important class of medications.

Findings from the “Outcomes After Technology Assisted Nonprescription Rosuvastatin Administration: The TACTiC Trial” were presented today during a late-breaking science session at the American College of Cardiology’s 73rdAnnual Scientific Session and simultaneously published online in the Journal of the American College of Cardiology. 

“Less than half of individuals in the United States who are eligible to receive statins are currently receiving treatment. This innovative approach to drug delivery is an important step forward in making these life-saving medications more available to the people who need them,” said the study’s lead author Steven E. Nissen, M.D., Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic. “If approved by the FDA, this technology-based approach could expand access to drugs that we know can reduce major adverse cardiovascular events.”

Statin medications are first-line drugs for the prevention of cardiovascular disease that work by lowering cholesterol levels in the blood. Statins have been shown in many studies to reduce the risk of stroke, heart attack and death when administered to the right patients, including patients with pre-existing heart disease as well as those without a history of cardiovascular events. 

In the TACTiC trial, AstraZeneca (the study sponsor)collaborated with academic researchers to create a system to make non-prescription statins available to the general population based on eligibility criteria without requiring a doctor visit or prescription. Participants first took a medical assessment using an online web-based application, where they were required to answer questions regarding their demographics, medication use, medical history, and cholesterol and blood pressure levels.

Based on their responses to the questionnaire, participants were given one of three answers: “Ok to use” statins, “should not use” statins or “should ask a doctor” for further advice. Only those who were given the green light that they could use statins or should ask a doctor (and confirmed that they had spoken to a doctor) were eligible to purchase medication. Participants could order up to a 90-day supply of rosuvastatin at a dose of 5 mg daily, which was shipped directly to their home.

Enrolled participants were then interviewed by a clinician who determined, without knowledge of the responses or recommendations from the web-based self-assessment, whether they met the criteria for statin therapy. Participants then entered the study’s six-month treatment phase, requiring them to reorder medicine and take an abbreviated web-app assessment prior to each reorder to ensure they continued to meet safe use requirements. During this phase, participants were also asked to have their LDL cholesterol retested. At the end of the treatment phase, they were scheduled for a final virtual visit and again interviewed by a clinician.

The first co-primary outcome, correct initial self-selection, was achieved in 90.7%of participants. For the second co-primary endpoint, in those who entered the six-month treatment period, 98.1% demonstrated appropriate use. Retesting of cholesterol demonstrated that participants were able to lower their LDL by 35.5%.Adverse events leading to study drug discontinuation occurred in 7.1% with none leading to withdrawal from the trial.

“Improving cardiovascular health requires increasing access to preventive care for everyone,” Dr. Nissen said. “The TACTiC Trial demonstrates that with the guidance of a technology-assisted web application, a non-prescription statin option can be properly administered and empower those who have difficulty accessing preventive care or want a more convenient option.”

The TACTiC trial was funded by AstraZeneca. It was designed by the sponsor, academic investigators, and Concentrics Research, a contract research organization specializing in consumer healthcare. The study design was reviewed by the Food and Drug Administration and overseen by an academic advisory group composed of experts in lipid management, epidemiology, and public health. The Cleveland Clinic Center for Clinical Research (C5Research) served as the academic coordinating center and independently reviewed participant outcomes to determine suitability for treatment with a statin.

Dr. Nissen has served as a consultant for many pharmaceutical companies and has overseen clinical trials for AbbVie, AstraZeneca, Amgen, Arrowhead, Bristol Myers Squibb, Eli Lilly, Esperion, Medtronic, MyoKardia, New Amsterdam Pharmaceuticals, Novartis, Pfizer, and Silence Therapeutics. However, he does not accept honoraria, consulting fees or other compensation from commercial entities.