Abstract
Introduction
The aim of this study was to assess caregiver preference and treatment compliance with oral and transdermal medications in a “real-world” setting in patients with mild-to-moderate Alzheimer’s disease (AD) in South Korea.
Methods
Real-world evaluation of compliance and preference in Alzheimer’s disease treatment (RECAP) was a 24-week, multicenter, prospective, non-interventional study in patients with AD treated with oral or transdermal therapy. Here, we report data from patients living in South Korea. Eligible patients were grouped into one of two treatment cohorts: oral (donepezil, galantamine, rivastigmine, or memantine) or transdermal (rivastigmine patch). Caregiver preference, patient compliance, and physician preference were assessed at week 24 (end of the study). Safety was assessed by reported adverse events (AEs).
Results
A total of 398 patients were enrolled (oral 51.8%; transdermal 48.2%) and 79.4% completed the study. Caregivers of patients that were exposed to either the oral or transdermal monotherapy showed a preference for the treatment to which the patients were exposed (both p < 0.0001). However, caregivers of patients that were exposed to both forms of treatments reported a higher preference for transdermal monotherapy (65.9%; p < 0.0041). Patients in both treatment cohorts showed good compliance, with an overall mean (SD) score of 8.84 (1.514) (a median of 9). Of the 15 participating physicians, eight indicated their preference for transdermal therapy and seven preferred oral therapy at week 24. A total of 133 (33.4%) patients reported at least one AE during the study period (oral: 60 patients; transdermal: 73 patients).
Conclusion
The study showed higher caregiver preference for transdermal monotherapy over oral monotherapy when patients with AD were exposed to both forms of treatment and good patient compliance for both oral and transdermal treatments.
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Acknowledgements
The present study was a part of the larger [real-world evaluation of compliance and preference in Alzheimer’s disease treatment (RECAP)] regional observational study. The manuscript was published in Clinical Interventions in Aging. This study was funded by Novartis Pharma AG, Basel, Switzerland. The article processing charges for this publication were funded by Novartis Korea Ltd., South Korea. The study results were presented as a poster presentation at the Korean Neurological Association, 2014. All authors participated in the analysis and interpretation of data and critical revision of the manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published.
The authors thank Suchitra Jagannathan (Novartis Ireland Ltd., Dublin) and K. Ananda Krishna (Novartis Healthcare Pvt. Ltd., India) for medical writing assistance and incorporating subsequent revisions. The authors also thank all the clinical investigators and study coordinators at the participating centers and all the patients who participated in the study.
Disclosures
Kang Joon Lee, Seong-Jin Cho, Byeong Chae Kim, and Jae-Hong Lee declare that they have no conflict of interest. Minseok Park is employee of Novartis Korea Ltd.
Compliance with Ethics Guidelines
The study protocol was approved by the appropriate independent ethics committee or institutional review board at each study center (Inje University Ilsan Paik Hospital, Gachon University Gil Medical Center, Chonnam National University Hospital, and Asan Medical Center). The study was conducted in accordance with applicable guidelines (STROBE and GPP) and ethical principles of the Declaration of Helsinki of 1964, as revised in 2008. All medications were prescribed in compliance with the marketing authorization defined in a previous non-interventional study (Article 2[c] EU Directive 2001/20/EC). The patients participated in this study after providing written informed consent or, where applicable, such consent was provided by a legally acceptable representative of the patient. Patients were free to withdraw their consent to participate at any stage during the study.
Data Availability
The datasets during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Lee, K.J., Cho, SJ., Kim, B.C. et al. Caregiver Preference and Treatment Compliance in Patients with Mild-to-Moderate Alzheimer’s Disease in South Korea: RECAP Study Results. Adv Ther 34, 481–494 (2017). https://doi.org/10.1007/s12325-016-0465-8
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DOI: https://doi.org/10.1007/s12325-016-0465-8
Keywords
- Alzheimer’s disease
- Caregiver preference
- Cholinesterase inhibitors
- Rivastigmine
- Transdermal patch