Results of European post-marketing surveillance of bosentan in pulmonary hypertension
Results of European post-marketing surveillance of bosentan in pulmonary hypertension
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DOI：
10.1183/09031936.00138706
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发表时间：
2007-08-01
影响因子：
24.3
通讯作者：
Hoeper, M. M.
中科院分区：
文献类型：
--
作者：
Humbert, M.;Segal, E. S.;Hoeper, M. M.
在波生坦被批准用于治疗肺动脉高压（PAH）后，欧洲当局要求引入上市后监测系统（PMS）以获得关于其安全性特征的进一步数据。设计了一种新型、前瞻性、基于互联网的PMS，征集关于转氨酶升高、波生坦停药的医学原因和其他需要住院治疗的严重不良事件的报告。采集的数据包括人口统计学、PAH病因学、基线功能状态和PAH特异性合并用药。收集的安全性信号包括死亡、住院、严重不良事件、非预期不良事件和转氨酶升高。在30个月内，纳入了4，994例患者，占欧洲接受波生坦治疗患者的79%。总共有4，623名患者未接受过治疗;其中352名患者转氨酶升高，对应于7.6%的粗发病率和10.1%的年发病率。150例（3.2%）波生坦初治患者因转氨酶升高而停用波生坦。新的上市后监测从大多数患者中获取了目标安全性数据（“潜在安全性信号”），并证实临床实践中转氨酶水平升高的发生率和严重程度与临床试验中报告的相似。这些数据补充了随机对照临床试验的数据，并提供了关于波生坦安全性特征的重要额外信息。
After the approval of bosentan for the treatment of pulmonary arterial hypertension (PAH), European authorities required the introduction of a post-marketing surveillance, system (PMS) to obtain further data on its safety profile.A novel, prospective, internet-based PMS was designed, which solicited reports on elevated aminotransferases, medical reasons for bosentan discontinuation and other serious adverse events requiring hospitalisation. Data captured included demographics, PAH aetiology, baseline functional status and concomitant PAH-specific medications. Safety signals captured included death, hospitalisation, serious adverse events, unexpected adverse events and elevated aminotransferases.Within 30 months, 4,994 patients were included, representing 79% of patients receiving bosentan in Europe. In total, 4,623 patients were naive to treatment; of these, 352 had elevated aminotransferases, corresponding to a crude incidence of 7.6% and an annual rate of 10.1%. Bosentan was discontinued due to elevated aminotransferases in 150 (3.2%) bosentan-naive patients. Safety results were consistent across subgroups and aetiologies.The novel post-marketing surveillance captured targeted safety data ("potential safety signals") from the majority of patients and confirmed that the incidence and severity of elevated aminotransferase levels in clinical practice was similar to that reported in clinical trials. These data complement those from randomised controlled clinical trials and provide important additional information on the safety profile of bosentan.