Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial

Nilesh J Goswami,¹ Mitch DeKoven,² Andreas Kuznik,³ Jack Mardekian,³ Michelle R Krukas,² Larry Z Liu,^3,4 Patrick Bailey,¹ Cynthia Deitrick,⁵ John Vincent<sup>3

1</sup>Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; ²Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; ³Pfizer Inc, New York, NY, USA; ⁴Weill Cornell Medical College, Cornell University, New York, NY, USA; ⁵Prairie Heart Education and Research Cooperative, Springfield, IL, USA

Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment.
Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program) randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm). After data linkage, 53 control patients and 155 intervention patients were included in the analysis.
Results: Mean age was 67.8 years (control) and 69.5 years (intervention); 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day); for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24) and for the intervention group was 0.84 (SD, 0.22). For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2) compared with 150.9 days (SD, 50.9) for the intervention group. New users had fewer persistent days (control 111.4 days, SD, 69.6 days; intervention 112.0 days, SD, 58.8 days) compared with continuing users. The Cox proportional hazards model of the risk of discontinuation with index therapy was not significantly different between the intervention and control groups (hazard ratio 0.83, P = 0.55).
Conclusion: The integrated intervention program did not significantly improve atorvastatin adherence relative to usual care in the studied patient population.

Keywords: adherence, randomized clinical trial, atorvastatin