Citation

Seibert J, Tracik F, Articus K, Spittler S. Neuropsychiatr. Dis. Treat. 2012; 8: 141-147.

Copyright

(Copyright © 2012, Dove Press)

DOI

10.2147/NDT.S29116

PMID

unavailable

Abstract

BACKGROUND: Oral cholinesterase inhibitors at doses efficacious for the treatment of Alzheimer's disease (AD) are often prematurely discontinued due to gastrointestinal side effects. In controlled clinical trials, transdermal rivastigmine demonstrated less such effects at similar efficacy. The current study aimed to verify the validity of this data in daily practice.

METHODS: This was a prospective, multicenter, observational study on transdermal rivastigmine in Germany. Eligible patients were those with AD who had not yet been treated with rivastigmine. Outcome measures were changes in clock-drawing test, Mini-Mental State Examination (MMSE), Caregiver Burden Scale, Clinical Global Impression (CGI), physicians' assessments of tolerability, and the incidence of adverse events (AEs) over 4 months of treatment.

RESULTS: In 257 centers 1113 patients were enrolled; 614 women and 499 men, mean age 76.5 years. In 58% of patients AD was treated for the first time and in 42% therapy was switched to transdermal rivastigmine, mostly due to lack of tolerability (13.6%) or effectiveness (26.9%). After 4 months, 67.4% of patients were on the target dose of 9.5 mg/day and 21.8% were still on 4.6 mg/day. MMSE significantly improved in patients with and without pretreatment (ΔMMSE, 0.9 ± 3.4 and 0.8 ± 3.4, respectively, both P, 0.001); the CGI score improved in 60.9% and 61.3% of patients, respectively. Overall 11.7% of patients had AEs, mainly affecting the skin or the gastrointestinal tract; in 1.1% of cases AEs were serious; 14.7% of patients discontinued therapy, 6.0% due to AEs. With rivastigmine treatment the percentage of patients taking psychotropic comedication decreased, particularly in first-time treated rivastigmine patients (from 27.1% to 22.6%; P, 0.001).

CONCLUSION: Results were in line with data from controlled clinical trials. Switching from any other oral acetylcholinesterase inhibitor to transdermal rivastigmine may improve cognition. © 2012 Seibert et al, publisher and licensee Dove Medical Press Ltd.

Language: en

Keywords

adult; human; suicide; female; male; injury; Germany; kidney disease; article; major clinical study; vomiting; mental disease; controlled study; clinical practice; antidepressant agent; neuroleptic agent; drug intoxication; citalopram; mirtazapine; sertraline; venlafaxine; hallucination; quetiapine; Alzheimer disease; nutritional deficiency; drug fatality; drug efficacy; risperidone; drug tolerability; nausea; drug withdrawal; multicenter study; restlessness; erythema; respiratory tract disease; neurologic disease; cholinesterase inhibitor; metabolic disorder; heart disease; pruritus; immunopathology; gastrointestinal disease; Alzheimer's disease; thorax disease; dizziness; drug dose reduction; observational study; validity; contact dermatitis; Mini Mental State Examination; skin disease; outcome assessment; treatment duration; drug substitution; Clinical Global Impression scale; clinical assessment tool; ear disease; inner ear disease; mediastinum disease; urinary tract disease; rivastigmine; pipamperone; transdermal patch; recommended drug dose; drug dose escalation; melperone; Caregiver Burden Scale; clock drawing test; Rivastigmine patch; soft tissue disease; subcutaneous tissue disorder; Treatment practice