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

Yu Nakamura; Christine Strohmaier; Kaoru Tamura; Naoko Kataoka; Masayuki Nakano; Shoichiro Oda; Kazuma Nishimura; Akira Homma

doi:10.1159/000439269

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

Dement Geriatr Cogn Dis Extra. 2015 Sep 29;5(3):361-74. doi: 10.1159/000439269. eCollection 2015 Sep-Dec.

Authors

Yu Nakamura¹, Christine Strohmaier², Kaoru Tamura³, Naoko Kataoka³, Masayuki Nakano⁴, Shoichiro Oda⁴, Kazuma Nishimura⁴, Akira Homma⁵

Affiliations

¹ Department of Neuropsychiatry, Faculty of Medicine, Kagawa University, Kagawa, Japan.
² Novartis Pharma AG, Basel, Switzerland.
³ Novartis Pharma K.K., Tokyo, Japan.
⁴ Ono Pharmaceutical Co., Ltd., Osaka, Japan.
⁵ Dementia Care Research and Training Center, Tokyo, Japan.

Abstract

Aim: To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm(2) and titrated to 10 cm(2) after 4 weeks) is well tolerated in Japanese patients with Alzheimer's disease (AD) as compared to 3-step titration (initiated at 2.5 cm(2) and titrated by 2.5 cm(2) every 4 weeks to 10 cm(2)).

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.

Keywords: Alzheimer's disease; Cholinesterase inhibitors; Japan; Randomized clinical trial; Rivastigmine patch; Titration scheme.