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 Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfize...

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Main Authors: Goswami NJ, DeKoven M, Kuznik A, Mardekian J, Krukas MR, Liu LZ, Bailey P, Deitrick C, Vincent J
Format: Article
Language:English
Published: Dove Medical Press 2013-07-01
Series:International Journal of General Medicine
Online Access:http://www.dovepress.com/impact-of-an-integrated-intervention-program-on-atorvastatin-adherence-a13844
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author Goswami NJ
DeKoven M
Kuznik A
Mardekian J
Krukas MR
Liu LZ
Bailey P
Deitrick C
Vincent J
author_facet Goswami NJ
DeKoven M
Kuznik A
Mardekian J
Krukas MR
Liu LZ
Bailey P
Deitrick C
Vincent J
author_sort Goswami NJ
collection DOAJ
description 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 Vincent3 1Prairie 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
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spelling doaj.art-589b706377034fd9804d43037322b5462022-12-22T02:32:21ZengDove Medical PressInternational Journal of General Medicine1178-70742013-07-012013default647655Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trialGoswami NJDeKoven MKuznik AMardekian JKrukas MRLiu LZBailey PDeitrick CVincent JNilesh 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 Vincent3 1Prairie 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, atorvastatinhttp://www.dovepress.com/impact-of-an-integrated-intervention-program-on-atorvastatin-adherence-a13844
spellingShingle Goswami NJ
DeKoven M
Kuznik A
Mardekian J
Krukas MR
Liu LZ
Bailey P
Deitrick C
Vincent J
Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial
International Journal of General Medicine
title Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial
title_full Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial
title_fullStr Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial
title_full_unstemmed Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial
title_short Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial
title_sort impact of an integrated intervention program on atorvastatin adherence a randomized controlled trial
url http://www.dovepress.com/impact-of-an-integrated-intervention-program-on-atorvastatin-adherence-a13844
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