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Comparative Study
. 2021 Sep 14;78(11):1114-1123.
doi: 10.1016/j.jacc.2021.06.048.

Technology-Assisted Self-Selection of Candidates for Nonprescription Statin Therapy

Steven E Nissen  1 , Howard G Hutchinson  2 , Tracy Y Wang  3 , Christie M Ballantyne  4 , Sara Travis  5 , Melanie Morris  2 , William Miller  5 , Jennifer Hynson  5 , Kathy Wolski  6 , Paul M Ridker  7
Affiliations
Free article
Comparative Study

Technology-Assisted Self-Selection of Candidates for Nonprescription Statin Therapy

Steven E Nissen et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Although statins reduce cardiovascular morbidity and mortality, only about one-half of eligible patients receive treatment. Safe and appropriate consumer access to statins could have a significant positive public health impact.

Objectives: This study compares the concordance between a participant and clinician assessment of eligibility for statin therapy using a technology-assisted approach.

Methods: A total of 500 participants, 83 with limited literacy, completed an at-home Web-based application to assess appropriateness for treatment with rosuvastatin 5 mg. The Web application is designed to assess eligibility for a moderate-intensity statin based on current guidelines and deny access to individuals with contraindications to rosuvastatin. Subsequently, participants visited a research site where clinicians, blinded to the information the participant entered, performed an independent Web application assessment. The Web application is programmed for 1 of 3 rosuvastatin treatment outcomes: "OK to use," "not right for you," or "ask a doctor." The primary endpoint was the percent of participants whose self-selected eligibility for nonprescription rosuvastatin was concordant with clinician assessment.

Results: For the primary endpoint, participant selection for statin therapy was concordant with clinician selection in 481 (96.2%) of 500 participants (95% confidence interval: 94.1%-97.7%), of whom 23 (4.6%) were deemed appropriate and 458 (91.6%) were deemed inappropriate for treatment. Discordance was due to incorrect self-selection ("OK to use") in 3 cases, incorrect rejection ("not right for you") in 14 cases and an incorrect "ask a doctor" outcome in 2 cases.

Conclusions: The use of a technology-assisted approach to consumer self-selection for statin therapy resulted in participant self-selection that showed substantial agreement with clinician selection.

Keywords: Web application; consumer self-selection; nonprescription statins.

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Conflict of interest statement

Funding Support and Author Disclosures This work was funded by AstraZeneca Pharmaceuticals. The sponsor was centrally involved in the study design and reviewed the manuscript, but the final decisions on content were made by the lead author after consultation with the other academic coauthors (Dr Nissen). Dr Nissen reports that the Cleveland Clinic Center for Clinical Research has received funding to perform clinical trials from AbbVie, AstraZeneca, Amgen, Eli Lilly, Esperion, Medtronic, MyoKardia, Novartis, Pfizer, and Silence Therapeutics—he is involved in these clinical trials, but receives no personal remuneration for his participation; and has served as a consultant for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction. Dr Hutchinson and Ms Morris are employees of AstraZeneca. Dr Wang has received research grants to the Duke Clinical Research Institute from Abbott, AstraZeneca, Bristol Myers Squibb, Boston Scientific, CryoLife, Chiesi, Merck, Portola, and Regeneron; and has received consulting honoraria from AstraZeneca, Bristol Myers Squibb, CryoLife, and Novartis. Dr Ballantyne has received grants to his institution from Akcea, Amgen, Esperion, Ionis, Novartis, Regeneron, and the American Heart Association; and has served as a consultant for Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Corvidia, Esperion, Genentech, Gilead, Matinas BioPharma Inc., New Amsterdam, Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi-Synthelabo. Ms Travis, Dr Miller, and Ms Hynson are employees of Concentrics Research. Dr Ridker has reported that during the course of this project he received unrelated investigator-initiated research grant support from Novartis, Kowa, Amarin, Pfizer, and the National Heart, Lung, and Blood Institute; and has served as a consultant to Corvidia, Novartis, Flame, Agepha, Inflazome, AstraZeneca, Janssen, Civi Biopharm, SOCAR, Novo Nordisk, Uptton, Omeicos, and Boehringer Ingelheim. Ms Wolski has reported that she has no relationships relevant to the contents of this paper to disclose.

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