Murgle Psychiatric Clinic Faculty of Medicine, University of Ljubljana University Psychiatric Hospital Ljubljana, Ljubljana, Slovenia.
Psychogeriatrics. 2012 Sep;12(3):165-71. doi: 10.1111/j.1479-8301.2011.00400.x.
The majority of available data on safety and tolerability issues regarding cholinesterase inhibitors used for the treatment of Alzheimer's disease has been available for orally administered formulations. The objective of this prospective, 24 week, observational, non-interventional post-marketing surveillance study was to evaluate the safety and tolerability, as well as the efficacy, of the rivastigmine transdermal patch formulation in newly diagnosed patients with Alzheimer's dementia in naturalistic conditions.
Safety and tolerability assessment included the monitoring and recording of adverse events and withdrawals at any time during the study. The efficacy parameter was determined based on the score of the Mini-Mental State Examination.
Out of the 433 patients, 11 patients (2.54%) suffered serious adverse events. Non-serious adverse events were reported in 179 patients (41.34%). As adverse event is defined as any untoward medical occurrence that may present during treatment with a pharmaceutical product but that does not necessarily have a causal relationship with this treatment. The most common adverse event in the present study was a decline in the Mini-Mental State Examination score in 97 patients (22.40%). The second most common non-serious adverse event was a skin reaction in 61 patients (14.09%). Treatment with rivastigmine continued in 139 cases (32.10%) and was discontinued in 40 cases (9.24%). The median Mini-Mental State Examination score observed at the time of inclusion was 21.0, and after 6 months, it was 22.0 (W 63441; P < 0.001). Because of several limitations, the open-label design of the present study necessitates caution when interpreting the results.
The results of this study suggest that the rivastigmine transdermal patch is safe and tolerable for Alzheimer's dementia patients in naturalistic conditions.
关于用于治疗阿尔茨海默病的胆碱酯酶抑制剂的安全性和耐受性问题，大多数可用数据均来自口服制剂。本前瞻性、24 周、观察性、非干预性上市后监测研究的目的是评估在自然环境下新诊断为阿尔茨海默病痴呆症的患者使用利伐斯的明透皮贴片制剂的安全性和耐受性，以及疗效。
安全性和耐受性评估包括在研究期间的任何时间监测和记录不良事件和停药情况。疗效参数基于简易精神状态检查的评分确定。
在 433 例患者中，有 11 例（2.54%）发生严重不良事件。有 179 例（41.34%）报告了非严重不良事件。由于不良事件被定义为任何在药物治疗期间可能发生的不良医学事件，但不一定与该治疗有因果关系。本研究中最常见的不良事件是 97 例（22.40%）简易精神状态检查评分下降。第二常见的非严重不良事件是 61 例（14.09%）皮肤反应。利伐斯的明继续治疗的有 139 例（32.10%），停止治疗的有 40 例（9.24%）。纳入时观察到的简易精神状态检查评分中位数为 21.0，6 个月后为 22.0（W 63441；P < 0.001）。由于存在一些局限性，本研究的开放标签设计在解释结果时需要谨慎。
本研究结果表明，利伐斯的明透皮贴片在自然环境下对阿尔茨海默病痴呆症患者是安全且耐受良好的。
