A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimers disease

A post hoc analysis

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

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Objective: To investigate the tolerability and efficacy of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimers 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 (4.6mg/24h) immediately or following a 7-day withdrawal for 4 weeks (core phase), before titrating up to 9.5mg/24h 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.

Original languageEnglish
Pages (from-to)263-269
Number of pages7
JournalCurrent Medical Research and Opinion
Volume26
Issue number2
DOIs
StatePublished - Feb 2010

Fingerprint

Rivastigmine
Transdermal Patch
Memantine
Alzheimer Disease
Cognition
Activities of Daily Living
Incidence

Keywords

  • Alzheimers disease
  • Memantine
  • Rivastigmine
  • Switch
  • Transdermal patch

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{e298d2b79cce40069d0f5d44d2084f1c,
title = "A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimers disease: A post hoc analysis",
abstract = "Objective: To investigate the tolerability and efficacy of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimers 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 (4.6mg/24h) immediately or following a 7-day withdrawal for 4 weeks (core phase), before titrating up to 9.5mg/24h 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.",
keywords = "Alzheimers disease, Memantine, Rivastigmine, Switch, Transdermal patch",
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T1 - A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimers disease

T2 - A post hoc analysis

AU - Farlow, Martin

AU - Alva, Gus

AU - Meng, Xiangyi

AU - Olin, Jason T.

PY - 2010/2

Y1 - 2010/2

N2 - Objective: To investigate the tolerability and efficacy of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimers 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 (4.6mg/24h) immediately or following a 7-day withdrawal for 4 weeks (core phase), before titrating up to 9.5mg/24h 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.

AB - Objective: To investigate the tolerability and efficacy of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimers 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 (4.6mg/24h) immediately or following a 7-day withdrawal for 4 weeks (core phase), before titrating up to 9.5mg/24h 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.

KW - Alzheimers disease

KW - Memantine

KW - Rivastigmine

KW - Switch

KW - Transdermal patch

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