Abstract
Despite the clinical benefit of statin therapy and the numerous strategies used to improve adherence, no strategy has used direct communication of genetic test results to the patient as an adherence and persistence motivator. We investigated in a real-world setting the effect of a process of providing KIF6 test results and risk information directly to 647 tested patients on 6-month statin adherence (proportion of days covered (PDC)) and persistence compared with concurrent non-tested matched controls. Adjusted 6-month statin PDC was significantly greater in tested patients: 0.77 (95% confidence interval (CI) 0.72–0.82) vs controls 0.68 (95% CI 0.63–0.73), P<0.0001. Significantly more tested patients were adherent (PDC⩾0.80) (63.4% (59.6–67.1%) vs 45.0% (41.1–48.8%), P<0.0001) and persisted on therapy (69.1% (65.4–72.5%) vs 53.3% (49.4–57.1%), P<0.0001). Similar results were observed in a secondary comparison with 779 unmatched patients who declined testing. The Additional KIF6 Risk Offers Better Adherence to Statins trial provides the first evidence that pharmacogenetic testing may modify patient adherence.
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Acknowledgements
We thank the following individuals for their contributions to AKROBATS: Bryan Dechairo, PhD, MBA, for facilitating the partnership with Celera; the Medco Research Institute nursing staff whose efforts made this trial possible; Eryn Bilynsky, RN and Dmitri Kekos for providing clinical support and data quality assurance; and Ghada Hamid for trial management. This research was funded by Medco Health Solutions. Celera Corporation provided genetic testing services, but did not contribute to funding. The sponsors provided review and approval of the manuscript.
Author contributions
Drs Herrera and Charland had access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. The authors were responsible for the design and conduct of the study; for collection, management, analysis, and interpretation of the data; and for preparation and review of the manuscript. Study concept and design: Charland, Agatep, Herrera, Frueh, Devlin, Superko and Stanek. Acquisition of data: Charland, Agatep, Herrera, Ryvkin and Shabbeer. Analysis and interpretation of data: Charland, Agatep, Herrera, Schrader, Ryvkin, Shabbeer and Stanek. Drafting of manuscript: Charland, Agatep, Schrader and Stanek. Critical revision of the manuscript for important intellectual content: Charland, Agatep, Herrera, Schrader, Frueh, Ryvkin, Devlin, Superko, Shabbeer and Stanek. Statistical analysis: Herrera, Ryvkin, Charland, Agatep and Stanek. Obtaining funding: Charland, Frueh, Devlin, Superko and Stanek. Administrative, technical, or material support: Charland, Agatep, Herrera, Schrader, Ryvkin and Stanek. Supervision: Charland, Agatep and Stanek.
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Dr Charland has received research grants regarding lipid management from Abbott Laboratories, received consulting fees from Mountain Solutions and was employed by Medco Research Institute, LLC/An Express Scripts Company. Drs Herrera, Schrader, Frueh and Stanek and Ms Agatep and Ryvkin were employed by Medco Research Institute, LLC/An Express Scripts Company. Drs Devlin and Superko are employed by Celera Corporation, which markets the KIF6 test used in this study and is available by physician order. Dr Shabbeer was previously employed by Celera Corporation and is currently employed by Ariosa Diagnostics.
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Previous meeting presentation: The data in this article were presented as a moderated poster at the ACC.12 61st Annual Scientific Session and Expo Meeting, 26 March 2012, Chicago, IL, USA.
Supplementary Information accompanies the paper on the The Pharmacogenomics Journal website
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Charland, S., Agatep, B., Herrera, V. et al. Providing patients with pharmacogenetic test results affects adherence to statin therapy: results of the Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS) trial. Pharmacogenomics J 14, 272–280 (2014). https://doi.org/10.1038/tpj.2013.27
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DOI: https://doi.org/10.1038/tpj.2013.27
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