Real-life effectiveness and tolerability of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer’s disease: the EMBRACE study

Abstract

Objective:

To assess the real-life effectiveness and tolerability of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer’s disease (AD) in Canada.

Research design and methods:

Eighteen-month observational, prospective, multi-center, open-label study conducted on AD patients with Standardized Mini-Mental State Examination (SMMSE) score of 10–26 and Global Deterioration Scale (GDS) score of 4–6. Patients were treated with the rivastigmine transdermal patch (Exelon patch) 5 cm² (4.6 mg/24 hours) or 10 cm² (9.5 mg/24 hours), once daily.

Main outcome measures:

Primary outcome was change in SMMSE from baseline to 18 months. Secondary outcomes included change in SMMSE at 6 and 12 months and change in GDS, Assessment of Patient Ability (APA-C), Overall Patient Assessment Rating (OPAR), caregiver-reported compliance and treatment satisfaction at 6, 12, and 18 months.

Results:

Among the 1204 patients enrolled, 969 were included in the ITT analysis. Mean (SD) age was 80.2 (8.00) years, disease duration was 0.6 (1.26) years, 62.0% of patients were women, 80.4% were living in the community, and 69.3% were treatment naïve. Mean (SD) baseline SMMSE and GDS scores were 21.8 (3.98) and 4.2 (0.61), respectively. Over 18 months of treatment there were no clinically significant changes in SMMSE and GDS. The majority of patients showed improvement or no change in GDS, APA-C and OPAR over 18 months. The proportion with reported improvement in GDS, APA-C and OPAR was higher than the proportion that deteriorated. Compliance improved from baseline to 18 months and for 88.2% of patients caregivers preferred the transdermal patch to oral medications.

Conclusions:

The rivastigmine transdermal patch is effective in maintaining cognitive function over 18 months of treatment in patients with mild-to-moderate AD. The safety profile was comparable to the data in the Canadian product monograph. Lack of a comparator group is a potential limitation of the study.

Keywords::

• Alzheimer’s
• Effectiveness
• Rivastigmine transdermal patch
• Tolerability

Transparency

Declaration of funding

The study was funded by Novartis Pharmaceuticals Canada Inc.

Declaration of financial/other relationships

S.G. served as a steering committee member for the current study from 2008 to 2012. He is also a member of a scientific board and has been an investigator with Novartis. No honorarium was received for development of this manuscript. A.R. served as a steering committee member for the current study from 2008 to 2012. He has also received honoraria for participation in scientific advisory boards and for consultant work for Novartis and other pharmaceutical companies with products in the field of dementia management. He has served as an investigator in clinical trials sponsored by Novartis and other pharmaceutical companies with products in the field of dementia management. No honorarium was received for development of this manuscript. S.C. served as a steering committee member for the current study from 2008 to 2012. She has received honoraria from Novartis and other pharmaceutical companies for work done as a speaker, consultant, and advisor on the topic of dementia treatment. Her research site has received study grants from Novartis and other pharmaceutical companies for conducting clinical trial protocols involving anti-dementia drugs. No honorarium was received for development of this manuscript. S.B. served as a steering committee member for the current study from 2008 to 2012. She has also received compensation in the past year for ad hoc consulting from Pfizer, GE Healthcare and CME honoraria from Pfizer and Novartis. Her research unit has received contract research funds from Roche, Pfizer and Elan. No honorarium was received for development of this manuscript. J.S. has received honoraria as a consultant for Novartis. He is the CEO and CSO of JSS Medical Research that provided support in the form of medical writing. He has participated on advisory boards and as an investigator and consultant for companies working in the field of dementia and Alzheimer’s disease. D.C., F.d.T. and R.S. are employees of Novartis Pharmaceuticals Canada Inc.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Notes

*Exelon and Exelon patch are registered trade names of Novartis

^†Exelon and Exelon patch are registered tradenames of Novartis