A new study led by the Cleveland Clinic suggests that a technology-enabled web application could help consumers better determine whether they qualify for statin drugs without a prescription.

During the study period, 1,196 participants used the web application and more than 90% self-selected statin use based on current guidelines compared to clinician assessment. Of the consumers who then entered the six-month treatment phase, 98% used the drug correctly and achieved a 35% reduction in LDL (low-density lipoprotein) cholesterol, also known as “bad” cholesterol.

These findings demonstrate that consumers can better self-select and self-manage statin treatment with the help of dedicated web applications, potentially expanding access to this important class of medicines.

Results from the “Technically Assisted Nonprescription Rosuvastatin Administration: Results from the TACTiC Study” were presented today at the Current Scientific Sessions of the American College of Cardiology’s 73rd Annual Scientific Sessions and simultaneously published online in the Journal of the American College of Cardiology. I did.

“Less than half of individuals eligible for statins in the United States are currently receiving treatment. This innovative approach to drug delivery will help more people who need these lifesaving drugs. This is an important step forward,” said Stephen E. Nissen, MD, lead author of the study and chief academic officer of the Department of Heart, Vascular, and Thoracic Medicine. Cleveland Clinic Research Institute. “If approved by the FDA, this technology-based approach has the potential to expand access to drugs known to reduce serious adverse cardiovascular events.”

Statin drugs are the first-line drugs for preventing cardiovascular disease and are effective in lowering blood cholesterol levels. Numerous studies have shown that statins reduce the risk of stroke, heart attack, and death when given to appropriate patients, including those with pre-existing heart disease and those without a history of cardiovascular events.

In the TACTiC trial, AstraZeneca (study sponsor) collaborated with academic researchers to create a system that made non-prescription statins available to the general public based on eligibility criteria, without the need for a doctor’s visit or prescription. Participants first underwent a medical evaluation using an online web-based application, where they had to answer questions about demographics, medication use, medical history, and cholesterol and blood pressure levels.

Based on their responses to the survey, participants were given a choice of whether statins were “OK to use,” statins “should not be used,” or if they needed further advice, they “should talk to their doctor.” One of three answers was given. Only those who were cleared to use statins or needed to consult a doctor (those who confirmed that they had consulted a doctor) were eligible to purchase the drug. Participants could order up to 90 days’ worth of rosuvastatin at doses of 5 mg per day, which would be shipped directly to their homes.

Enrolled participants were then interviewed by a clinician to determine whether they met criteria for statin therapy without knowing their responses or recommendations from the web-based self-assessment. Participants then enter the 6-month treatment phase of the study, reorder their medication, and undergo an abbreviated web app assessment with each reorder to ensure it continues to meet safe use requirements. That was required. At this stage, participants were also asked to have their LDL cholesterol retested. At the end of the treatment phase, a final virtual visit was scheduled and the clinician interviewed again.

The first sub-primary outcome, first correct self-selection, was achieved by 90.7% of participants. For the second co-primary endpoint, 98.1% of patients entering the 6-month treatment period demonstrated appropriate utilization. Cholesterol retesting demonstrated that participants were able to lower their LDL by 35.5%. Adverse events leading to study drug discontinuation occurred in 7.1%, but none led to study discontinuation.

“To improve cardiovascular health, we need to make preventive care available to everyone,” Dr. Nissen said. “The TACTiC trial will ensure that non-prescription statin options are properly dosed through the guidance of his technology-enabled web application, empowering those who have difficulty accessing preventive treatment and those seeking more convenient options.” We are proving that it can be done.”

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

Dr. Nissen has served as a consultant to numerous pharmaceutical companies, including AbbVie, AstraZeneca, Amgen, Arrowhead, Bristol-Myers Squibb, Eli Lilly, Esperion, Medtronic, Myocardia, New Amsterdam Pharmaceuticals, Novartis, Pfizer, and Silence. I have overseen clinical trials for therapeutics. . However, we do not accept honoraria, consulting fees, or other compensation from commercial organizations.