Centre for Pulmonary Hypertension, Thoraxklinik of University Hospital Heidelberg, Amalienstrasse 5, 69126, Heidelberg, Germany,
Lung. 2015 Feb;193(1):105-12. doi: 10.1007/s00408-014-9657-7. Epub 2014 Oct 16.
Two phosphodiesterase-type 5 (PDE-5) inhibitors, sildenafil and tadalafil, are approved for treatment of pulmonary arterial hypertension (PAH). It has not yet been observed if transition from sildenafil to tadalafil is beneficial in patients suffering from adverse reactions. Aim of this study was to analyze safety and long-term effects in PAH patients whose treatment was transitioned from sildenafil to tadalafil due to intolerable side-effects.
A retrospective analysis of PAH-patients who were stable on sildenafil for >3 months and transitioned to tadalafil due to adverse events was performed. Data collected included demographics, PAH-etiology, WHO-functional class, 6 min walking distance (6MWD), echocardiography, lung function tests, and NTproBNP pre-transition and 3, 6, and 12 months post-transition.
Included were 13 PAH patients (8 females mean age 64 ± 10 years) who had been on sildenafil for a mean of 12 ± 8.4 months. In six patients (46.1 %) a switch to tadalafil was feasible and resulted in tolerable side effects and a stable clinical course with improvement of symptoms, 6MWD, stable echocardiographic findings, and NTproBNP-levels during a follow-up of 11 ± 3 months. In 5 out of 13 patients (38.5 %) adverse events occurred under tadalafil as well and therapy with PDE-5 inhibitors was discontinued. In two patients (15.4 %) sildenafil-treatment could be successfully restarted after an intermittent switch to tadalafil.
The observations of this study indicate that a transition of sildenafil to tadalafil in case of intolerable side effects is a reasonable therapy option in about 50 % of the patients. These results should be verified by a larger prospective study.
两种磷酸二酯酶 5 型（PDE-5）抑制剂，西地那非和他达拉非，被批准用于治疗肺动脉高压（PAH）。尚未观察到在因不良反应而从西地那非转换为他达拉非的患者中是否有益。本研究的目的是分析因不良反应而从西地那非转换为他达拉非的 PAH 患者的安全性和长期效果。
对因不良反应而在稳定服用西地那非>3 个月后转换为他达拉非的 PAH 患者进行回顾性分析。收集的数据包括人口统计学、PAH 病因、WHO 功能分级、6 分钟步行距离（6MWD）、超声心动图、肺功能检查和 NTproBNP 转换前和转换后 3、6 和 12 个月。
包括 13 名 PAH 患者（8 名女性，平均年龄 64±10 岁），平均服用西地那非 12±8.4 个月。在 6 名患者（46.1%）中，转换为他达拉非是可行的，并且在 11±3 个月的随访期间，副作用可耐受，临床症状改善，6MWD、稳定的超声心动图发现和 NTproBNP 水平稳定。在 13 名患者中有 5 名（38.5%）在使用他达拉非时也出现了不良反应，并且停止了 PDE-5 抑制剂治疗。在 2 名患者（15.4%）中，在间歇性转换为他达拉非后，成功重新开始西地那非治疗。
本研究的观察结果表明，在因不可耐受的副作用而从西地那非转换为他达拉非是一种合理的治疗选择，约 50%的患者适用。这些结果需要通过更大的前瞻性研究来验证。
