Web-based evaluations can accurately help consumers determine if they should be taking a particular nonprescription statin, according to new data published in the Journal of the American College of Cardiology.
While statins have a track record of reducing cardiovascular morbidity and mortality, only about one-half of eligible patients receive treatment, according to the study's authors.
"To expand access to statins, several attempts to provide over-the-counter availability of these drugs have been undertaken, but all failed to achieve regulatory approval due to the inability to demonstrate that consumers could appropriately self-select for treatment,” wrote lead author Steven E. Nissen, MD, with the department of cardiovascular medicine at Cleveland Clinic, and colleagues.
The CREST (Consumer Rosuvastatin Electronic Self-Selection Trial) included 500 participants who completed a web-based application in their home to assess the appropriateness of treatment with a 5 mg dose of rosuvastatin. Eighty-three participants had "limited literacy."
Nissen et al. noted that their study's primary endpoint was the percent of participants whose self-selected eligibility for nonprescription rosuvastatin was concordant with clinician assessment.
The application is intended to measure eligibility for a moderate-intensity statin based on the current guidelines, denying access to individuals who have contraindications to rosuvastatin. Participants responded to multiple questions about their medical history. At the end, one of three possible self-selection outcomes was obtained for treatment with rosuvastatin: “OK to use,” “not right for you” or “ask a doctor."
Each person then visited a research site where clinicians, blinded to the information the participant entered, performed an independent assessment.
In the study, concordance between self-selection and clinician assessment occurred in 481 (96.2%) of the 500 participants. While the statin was deemed appropriate for 23 (4.6%) of those 481 participants, it was considered inappropriate for another 458 (91.6%).
The authors found that a concordant outcome without mitigation was attained in 480 (96.0%) of participants. In the limited literacy subgroup, 80 (96.4%) of 83 participants reached a concordant outcome, with an “OK to use” result being reached in 7.2% of the subgroup.
“This outcome is potentially important because limited literacy consumers may have less access to health care providers and may benefit from enhanced efforts to deliver medications directly,” the authors wrote.
The primary reason that participants were considered not to be a good fit for using rosuvastatin was that they were already taking a cholesterol-lowering medication. Low risk scores and age were also common reasons.
"A novel approach using technology-assisted self-selection was successful in overcoming a significant barrier to the development of a nonprescription statin by ensuring that a high percentage of ineligible consumers were denied access and that only those with an appropriate level of risk were deemed eligible to access this medication," the group concluded.
Read the full study here.