Supplementary Material for: 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
2015-09-29T00:00:00Z (GMT) by
<b><i>Aim:</i></b> To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm<sup>2</sup> and titrated to 10 cm<sup>2</sup> 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<sup>2</sup> and titrated by 2.5 cm<sup>2</sup> every 4 weeks to 10 cm<sup>2</sup>). <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> 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. <b><i>Conclusion:</i></b> The tolerability of two different titration schemes was similar in Japanese patients with AD.