A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimer's disease: a post hoc analysis.
OBJECTIVE
To investigate the tolerability and efficacy of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer's disease receiving concomitant memantine.


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.


METHODS
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.


CONCLUSIONS
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.
Farlow
Martin R
MR
Department of Neurology, Indiana University School of Medicine, Indianapolis, IN 46202, USA. mfarlow@iupui.edu
Alva
Gus
G
Meng
Xiangyi
X
Olin
Jason T
JT
D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000473:pathology; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D000077265:Donepezil; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007189:Indans / Q000008:administration & dosage; D008297:Male; D008559:Memantine / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000009:adverse effects; D048448:Phenylcarbamates / Q000008:administration & dosage* / Q000009:adverse effects; D010880:Piperidines / Q000008:administration & dosage; D000068836:Rivastigmine; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D002800:Cholinesterase Inhibitors; D007189:Indans; D018696:Neuroprotective Agents; D048448:Phenylcarbamates; D010880:Piperidines; D000077265:Donepezil; D000068836:Rivastigmine; D008559:Memantine