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A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimer disease: A post hoc analysis

Authors

Farlow, Martin R., Alva, Gus, Meng, Xiangyi, Olin, Jason T.

Journal

Current Medical Research and Opinion, Volume: 26, No.: 2, Pages.: 263-269

Year of Publication

2010

Abstract

Objective: To investigate the tolerability and efficacy of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer’s disease receiving concomitant memantine. Research design and methods: Post hoc analysis of a 25-week, randomized, prospective, open-label, parallel-group study. Patients receiving donepezil were switched to rivastigmine patches (4.6 mg/24 h) immediately or following a 7-day withdrawal for 4 weeks (core phase), before titrating up to 9.5 mg/24 h for a further 20-week extension phase. Prior memantine therapy was continued throughout. Clinical trial registration: clinicaltrials.gov. NCT00428389. Main outcome measures: Tolerability (adverse events [AEs], serious AEs [SAEs] and discontinuations) and efficacy (cognition, global functioning and activities of daily living [ADLs]) were assessed for the rivastigmine transdermal patch, with or without concomitant memantine. Results: Overall, 135 and 126 patients received rivastigmine with and without memantine, respectively. Of these, 122 (90.4%) and 118 (93.7%) patients with and without memantine, respectively, completed the core phase; 120 and 114 patients, respectively, entered the extension phase, and 90 (75.0%) and 86 (75.4%) completed the study. The incidences of AEs (73.3 vs. 67.5%) and SAEs (10.4 vs. 7.1%) were both slightly larger in patients receiving concomitant memantine, but the differences were not statistically significant (95% CIs: -5.2, 16.9 and -3.6, 10.1 for AEs and SEAs, respectively). The incidence of gastrointestinal AEs was low in both groups. Discontinuation due to AEs was higher in patients who received memantine (17.0 vs. 11.9%). Changes in cognitive and global function were similar between groups. ADL scores worsened in both groups; significantly more in those treated with memantine. Conclusion: Use of the rivastigmine transdermal patch in patients on established memantine appears to be well-tolerated, with only modest, non-significant increases in AEs compared with monotherapy, and did not seem to affect cognition or global functioning adversely. (PsycINFO Database Record (c) 2012 APA, all rights reserved). (journal abstract)

Bibtex Citation

@article{Farlow_2009, doi = {10.1185/03007990903434914}, url = {http://dx.doi.org/10.1185/03007990903434914}, year = 2009, month = {nov}, publisher = {Informa Healthcare}, volume = {26}, number = {2}, pages = {263--269}, author = {Martin R. Farlow and Gus Alva and Xiangyi Meng and Jason T. Olin}, title = {A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimer's disease: a post hoc analysis}, journal = {Current Medical Research and Opinion} }

Keywords

adverse, alzheimer’s disease, concomitant memantine, drug therapy, effects, memantine, patients, rivastigmine, rivastigmine transdermal patches, safety, tolerability

Countries of Study

USA

Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime