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首页> 外文期刊>International journal of clinical practice >Safety and tolerability of rivastigmine transdermal patch compared with rivastigmine capsules in patients switched from donepezil: data from three clinical trials.
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Safety and tolerability of rivastigmine transdermal patch compared with rivastigmine capsules in patients switched from donepezil: data from three clinical trials.

机译：在从多奈哌齐转换的患者中，与卡巴拉汀胶囊相比，卡巴拉汀透皮贴剂的安全性和耐受性：来自三个临床试验的数据。

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OBJECTIVES: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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).
机译：目的：比较轻度至中度阿尔茨海默氏病患者从多奈哌齐改用卡巴拉汀胶囊或透皮贴剂的安全性和耐受性。方法：三项研究调查了从多奈哌齐向卡巴拉汀的转换。研究US13是一项为期26周的单臂即时转换研究。 US18是一项为期26周的连续队列研究（两项研究均评估了3-12 mg /天的rivastigmine胶囊）;研究US38是一项为期25周的随机分组平行标签开放性研究，研究了从多奈哌齐转换为卡巴拉汀透皮贴剂（4.6 mg / 24小时）（立即或撤药7天后）。安全结局包括不良事件（AE），由AE引起的停药和严重AE（SAE）。结果：接受卡巴拉汀贴片（n = 261）或胶囊（n = 331）的患者组的平均+/- SD年龄分别为77.3 +/- 8.0和78.1 +/- 7.8岁，痴呆持续时间为3.9 +/- 2.6和3.6 +/- 2.2岁，最低精神状态考试分数分别为18.3 +/- 4.00和17.9 +/- 4.4。总体而言，分别有184名（70.5％）和276名（83.4％）患者经历了至少一种AE，而23名（8.8％）和55名（16.6％）患者分别经历了卡巴拉汀和卡那汀的SAE发作。在经历过AE的患者中，分别有10例（3.8％）和109例（32.9％）经历恶心，而11例（4.2％）和80例（24.1％）经历了卡巴拉汀的呕吐。透皮贴剂组中有64名（19.3％）接受胶囊的患者和38名（14.6％）的患者因AE停药。停用透皮贴剂的最常见原因是应用部位反应和疾病进展，以及胶囊产生的恶心和呕吐。结论：卡巴拉汀明经皮贴剂比卡巴拉汀明胶囊具有更好的耐受性，胃肠道不良事件更少，并且由于这些不良事件而停药。每天简单旋转补丁位置可能会减少皮肤反应的频率。事后分析是由诺华制药公司进行的。分析数据从US13研究（CENA713B US13），US18研究（CENA713B US18）和US38研究（CENA713D US38）收集。

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