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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  The tolerability of two different titration schemes was similar in Japanese patients with AD.
authors.affiliation: Department of Neuropsychiatry, Faculty of Medicine, Kagawa University, Kagawa, Japan.
authors.forename: Yu
authors.initials: Y
authors.lastname: Nakamura
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Christine
authors.initials: C
authors.lastname: Strohmaier
authors.affiliation: Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Tamura
authors.affiliation: Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Kataoka
authors.affiliation: Ono Pharmaceutical Co., Ltd., Osaka, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Nakano
authors.affiliation: Ono Pharmaceutical Co., Ltd., Osaka, Japan.
authors.forename: Shoichiro
authors.initials: S
authors.lastname: Oda
authors.affiliation: Ono Pharmaceutical Co., Ltd., Osaka, Japan.
authors.forename: Kazuma
authors.initials: K
authors.lastname: Nishimura
authors.affiliation: Dementia Care Research and Training Center, Tokyo, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Homma
keywords: Alzheimer's disease; Cholinesterase inhibitors; Japan; Randomized clinical trial; Rivastigmine patch; Titration scheme