Nova SE University, Fort Lauderdale, FL, USA.
Int J Clin Pract. 2010 Jan;64(2):188-93. doi: 10.1111/j.1742-1241.2009.02253.x.
To compare the safety and tolerability of switching patients with mild-to-moderate Alzheimer's disease from donepezil to either rivastigmine capsule or transdermal patch.
Three studies investigated the switch from donepezil to rivastigmine; study US13 was a 26-week, single-arm, immediate-switch study; US18 was a 26-week, sequential cohort study (both studies evaluated rivastigmine capsules 3-12 mg/day); study US38 was a 25-week, randomised, parallel-group, open-label study which investigated switch (immediate or after 7 days' withdrawal) from donepezil to rivastigmine transdermal patch (4.6 mg/24 hr). Safety outcomes included adverse events (AEs), discontinuations caused by AEs and serious AEs (SAEs).
Patient groups receiving rivastigmine patch (n = 261) or capsules (n = 331) had mean +/- SD ages of 77.3 +/- 8.0 and 78.1 +/- 7.8 years, dementia durations of 3.9 +/- 2.6 and 3.6 +/- 2.2 years and Mini-Mental State Examination scores of 18.3 +/- 4.00 and 17.9 +/- 4.4 respectively. Overall, 184 (70.5%) and 276 (83.4%) patients experienced at least one AE, and 23 (8.8%) and 55 (16.6%) patients experienced an SAE with the rivastigmine patch and capsules respectively. Of the patients who experienced an AE, 10 (3.8%) and 109 (32.9%) experienced nausea, and 11 (4.2%) and 80 (24.1%) experienced vomiting with the rivastigmine patch and capsules respectively. Discontinuations because of AEs occurred in 64 (19.3%) patients receiving capsules and 38 (14.6%) patients in the transdermal patch group. The most common reasons for discontinuation with the transdermal patch were application site reaction and disease progression, and nausea and vomiting with the capsules.
The rivastigmine transdermal patch appears to have better tolerability than rivastigmine capsules, with fewer gastrointestinal AEs and discontinuations because of these AEs. Simple daily rotation of patch location will likely reduce the frequency of skin reactions. This post hoc analysis was carried out by Novartis Pharmaceuticals Corporation. Data for the analysis were collected from the US13 study (CENA713B US13), the US18 study (CENA713B US18) and the US38 study (CENA713D US38).
比较轻度至中度阿尔茨海默病患者从使用多奈哌齐转换为使用利斯的明胶囊或利美尼定透皮贴剂的安全性和耐受性。
有 3 项研究调查了从多奈哌齐转换为利斯的明的情况；研究 US13 是一项 26 周的单臂、即刻转换研究；研究 US18 是一项 26 周的序贯队列研究（这两项研究均评估了利斯的明胶囊 3-12 mg/天）；研究 US38 是一项 25 周、随机、平行组、开放性研究，旨在调查从多奈哌齐转换为利斯的明透皮贴剂（4.6 mg/24 小时）的即刻或停药 7 天后的转换（即转换）。安全性结局包括不良事件（AE）、因 AE 而停药和严重 AE（SAE）。
接受利斯的明贴剂（n = 261）或胶囊（n = 331）的患者平均年龄为 77.3 ± 8.0 岁和 78.1 ± 7.8 岁，痴呆持续时间为 3.9 ± 2.6 年和 3.6 ± 2.2 年，简易精神状态检查量表评分为 18.3 ± 4.00 和 17.9 ± 4.4。总体而言，184（70.5%）和 276（83.4%）例患者至少发生了 1 次 AE，23（8.8%）和 55（16.6%）例患者分别发生了 SAE。在发生 AE 的患者中，10（3.8%）和 109（32.9%）例患者出现恶心，11（4.2%）和 80（24.1%）例患者出现呕吐，分别为利斯的明贴剂和胶囊。因 AE 而停药的患者分别有 64（19.3%）例和 38（14.6%）例在透皮贴剂组。因皮肤反应和疾病进展而停药是最常见的原因，而胶囊组最常见的停药原因是恶心和呕吐。
利斯的明透皮贴剂的耐受性似乎优于利斯的明胶囊，胃肠道不良事件更少，因这些不良事件而停药的情况也更少。简单地每天更换贴剂位置可能会降低皮肤反应的频率。这是由诺华制药公司进行的事后分析。分析数据来自 US13 研究（CENA713B US13）、US18 研究（CENA713B US18）和 US38 研究（CENA713D US38）。
