A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease
Aim: To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm2 and titrated to 10 cm2 after 4 weeks) is well tolerated in Japanese patients with Alzheimer's disease (AD) as compared to 3-step titration (initiated at 2.5 cm2 and titrated by 2.5 cm2 every 4 weeks to 10...
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doaj-0e1d7e0d03c240d79b544b2869fa118c2020-11-25T02:34:40ZengKarger PublishersDementia and Geriatric Cognitive Disorders Extra1664-54642015-09-015336137410.1159/000439269439269A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's DiseaseYu NakamuraChristine StrohmaierKaoru TamuraNaoko KataokaMasayuki NakanoShoichiro OdaKazuma NishimuraAkira HommaAim: To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm2 and titrated to 10 cm2 after 4 weeks) is well tolerated in Japanese patients with Alzheimer's disease (AD) as compared to 3-step titration (initiated at 2.5 cm2 and titrated by 2.5 cm2 every 4 weeks to 10 cm2). Methods: A 24-week, multicenter, randomized, double-blind study was conducted in Japan between July 2012 and May 2014. Patients with mild to moderate AD aged 50-85 years were randomized 1:1 to 1-step or 3-step titration of the rivastigmine once-daily patch. The primary endpoint was the proportion of patients with adverse events leading to discontinuation. Results: Of 216 patients randomized, 215 (1-step, n = 107; 3-step, n = 108) were included in the safety analysis. The primary endpoint outcome was 15.0% in the 1-step group and 18.5% in the 3-step group. The observed treatment difference was −3.6% (95% confidence interval: −17.0, 9.6), falling within the prespecified acceptance range. Conclusion: The tolerability of two different titration schemes was similar in Japanese patients with AD.http://www.karger.com/Article/FullText/439269Alzheimerߣs diseaseCholinesterase inhibitorsJapanRandomized clinical trialRivastigmine patchTitration scheme |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Yu Nakamura Christine Strohmaier Kaoru Tamura Naoko Kataoka Masayuki Nakano Shoichiro Oda Kazuma Nishimura Akira Homma |
spellingShingle |
Yu Nakamura Christine Strohmaier Kaoru Tamura Naoko Kataoka Masayuki Nakano Shoichiro Oda Kazuma Nishimura Akira Homma A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease Dementia and Geriatric Cognitive Disorders Extra Alzheimerߣs disease Cholinesterase inhibitors Japan Randomized clinical trial Rivastigmine patch Titration scheme |
author_facet |
Yu Nakamura Christine Strohmaier Kaoru Tamura Naoko Kataoka Masayuki Nakano Shoichiro Oda Kazuma Nishimura Akira Homma |
author_sort |
Yu Nakamura |
title |
A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease |
title_short |
A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease |
title_full |
A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease |
title_fullStr |
A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease |
title_full_unstemmed |
A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease |
title_sort |
24-week, randomized, controlled study to evaluate the tolerability, safety and efficacy of 2 different titration schemes of the rivastigmine patch in japanese patients with mild to moderate alzheimer's disease |
publisher |
Karger Publishers |
series |
Dementia and Geriatric Cognitive Disorders Extra |
issn |
1664-5464 |
publishDate |
2015-09-01 |
description |
Aim: To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm2 and titrated to 10 cm2 after 4 weeks) is well tolerated in Japanese patients with Alzheimer's disease (AD) as compared to 3-step titration (initiated at 2.5 cm2 and titrated by 2.5 cm2 every 4 weeks to 10 cm2). Methods: A 24-week, multicenter, randomized, double-blind study was conducted in Japan between July 2012 and May 2014. Patients with mild to moderate AD aged 50-85 years were randomized 1:1 to 1-step or 3-step titration of the rivastigmine once-daily patch. The primary endpoint was the proportion of patients with adverse events leading to discontinuation. Results: Of 216 patients randomized, 215 (1-step, n = 107; 3-step, n = 108) were included in the safety analysis. The primary endpoint outcome was 15.0% in the 1-step group and 18.5% in the 3-step group. The observed treatment difference was −3.6% (95% confidence interval: −17.0, 9.6), falling within the prespecified acceptance range. Conclusion: The tolerability of two different titration schemes was similar in Japanese patients with AD. |
topic |
Alzheimerߣs disease Cholinesterase inhibitors Japan Randomized clinical trial Rivastigmine patch Titration scheme |
url |
http://www.karger.com/Article/FullText/439269 |
work_keys_str_mv |
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