Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina 27705, USA.
J Clin Psychiatry. 2012 May;73(5):661-8. doi: 10.4088/JCP.12m07648.
The objective of this analysis is to present the safety profile of selegiline transdermal system (STS) in clinical practice after US Food and Drug Administration approval by analyzing reported postmarketing adverse events (AEs).
Deidentified data were obtained on AEs, regardless of causality, as collected and compiled in the pharmaceutical company's adverse event collection systems/databases after the launch of STS in the United States. All reports of hypertensive crisis, suicide attempts, and STS overdoses were carefully examined to independently determine relation of the AE to STS.
From April 2006 to October 2010, a total of 3,155 AEs in 1,516 patients were reported (5.2% of the total exposures; N = 29,141), regardless of causality. The most frequently reported categories of AEs were general disorders (no. of AEs = 1,037, 3.6%) and central nervous system (CNS) disorders (no. of AEs = 574, 2.0%). A total of 266 reports (0.9%) were classified as serious AEs; CNS disorders (no. of AEs = 71, 26.7%) and cardiac and vascular disorders (no. of AEs = 44, 16.5%) were most common. There were 13 self-reports of possible hypertensive events or hypertension, although objective clinical data were not submitted in any of these cases. Thirteen drug-drug interactions (0.04%) were reported, and 5 were classified as serious.
The most commonly reported AEs were application site reactions and insomnia. Very few patients reported a hypertensive event, and there were no objectively confirmed reports of hypertensive crisis with food at any STS dose. Therapeutic doses of STS appear to have a safety profile in clinical practice that is consistent with that observed in clinical trials. However, given the relatively modest exposure numbers, continued safety monitoring is recommended.
通过分析报告的上市后不良事件（AE），展示 STS 在获得美国食品和药物管理局批准后的临床实践中的安全性概况。
从 STS 在美国上市后，从制药公司的不良事件收集系统/数据库中获得了与因果关系无关的 AEs 上市后数据。仔细检查了所有高血压危象、自杀企图和 STS 过量的报告，以独立确定 AE 与 STS 的关系。
2006 年 4 月至 2010 年 10 月，共报告了 1516 例患者的 3155 例 AE（5.2%的总暴露；N = 29141），无论因果关系如何。报告最多的 AE 类别是一般疾病（AE 数量为 1037 例，3.6%）和中枢神经系统（CNS）疾病（AE 数量为 574 例，2.0%）。共有 266 例报告（0.9%）被归类为严重 AE；CNS 疾病（AE 数量为 71 例，26.7%）和心血管疾病（AE 数量为 44 例，16.5%）最为常见。有 13 例可能发生高血压事件或高血压的自我报告，尽管在这些病例中均未提交客观的临床数据。报告了 13 例药物相互作用（0.04%），其中 5 例被归类为严重。
报告最多的 AE 是用药部位反应和失眠。很少有患者报告高血压事件，在任何 STS 剂量下，均未报告食物引起的高血压危象的客观确认报告。治疗剂量的 STS 在临床实践中的安全性概况与临床试验观察到的一致。但是，鉴于相对较小的暴露数量，建议继续进行安全性监测。
