吡非尼酮用于特发性肺纤维化患者预防和管理潜在不良事件的真实世界实践模式
Real-World Practice Patterns for Prevention and Management of Potential Adverse Events with Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.
作者信息
Wencel Mark L, Haselkorn Tmirah, Limb Susan L, Stauffer John L, Morgenthien Elizabeth, Raimundo Karina, LaCamera Peter P
机构信息
Via Christi Health, Wichita, KS, USA.
EpiMetrix, Inc., Los Altos, CA, USA.
出版信息
Pulm Ther. 2018 Jun;4(1):103-114. doi: 10.1007/s41030-018-0056-8. Epub 2018 May 29.
INTRODUCTION
Pirfenidone is an oral antifibrotic agent approved for idiopathic pulmonary fibrosis (IPF). Real-world data on adverse event (AE) management for pirfenidone are limited. Strategies for managing potential antifibrotic therapy AEs were examined in a sample of US pulmonologists.
METHODS
An online, self-administered survey was fielded to pulmonologists between April 10 and May 17, 2017. Pulmonologists were included if they spent > 20% of their time in direct patient care and had ≥ 5 patients with IPF on antifibrotic therapy. Participants answered questions regarding initiation of pirfenidone, dose titration, and management of potential AEs.
RESULTS
A total of 169 pulmonologists participated. Gastrointestinal (GI) intolerance was the most important factor in implementing alternative titration schedules for pirfenidone. Approximately three-quarters of pulmonologists recommended the standard titration scheme for starting treatment; however, a range of titration schedules up to 8 weeks were described, with a 4-week schedule being most common. Pulmonologists reported that most patients treated with alternative titration schedules could achieve the full dose of pirfenidone. Pulmonologists who were most effective at mitigating pirfenidone-related GI AEs by advising dosing at mealtimes more frequently recommended taking pirfenidone during a substantial meal than pulmonologists who were less effective. For photosensitivity AEs, pulmonologists recommended sunscreen use, sun avoidance, wearing a hat, and ultraviolet protection factor clothing.
CONCLUSIONS
Pulmonologists reported that alternative titration schedules for initiating pirfenidone were common and can aid in maintaining the full dose. Proposed strategies to ameliorate pirfenidone-related GI and photosensitivity AEs included taking pirfenidone during a substantial meal and minimizing sun exposure, respectively.
FUNDING
F. Hoffmann-La Roche Ltd./Genentech, Inc. Plain language summary available for this article.
引言
吡非尼酮是一种口服抗纤维化药物，已被批准用于特发性肺纤维化（IPF）。关于吡非尼酮不良事件（AE）管理的真实世界数据有限。在美国肺科医生样本中研究了管理潜在抗纤维化治疗AE的策略。
方法
2017年4月10日至5月17日对肺科医生进行了一项在线自我管理调查。如果肺科医生将超过20%的时间用于直接患者护理且有≥5名接受抗纤维化治疗的IPF患者，则纳入研究。参与者回答了有关吡非尼酮起始、剂量滴定和潜在AE管理的问题。
结果
共有169名肺科医生参与。胃肠道（GI）不耐受是实施吡非尼酮替代滴定方案的最重要因素。大约四分之三的肺科医生推荐标准滴定方案开始治疗；然而，描述了长达8周的一系列滴定方案，其中4周方案最为常见。肺科医生报告说，大多数采用替代滴定方案治疗的患者可以达到吡非尼酮的全剂量。通过更频繁地建议在进餐时给药来最有效地减轻吡非尼酮相关GI AE的肺科医生比效果较差的肺科医生更推荐在丰盛餐食期间服用吡非尼酮。对于光敏性AE，肺科医生推荐使用防晒霜、避免日晒、戴帽子和穿着具有紫外线防护系数的衣物。
结论
肺科医生报告说，起始吡非尼酮的替代滴定方案很常见，并且有助于维持全剂量。提出的改善吡非尼酮相关GI和光敏性AE的策略分别包括在丰盛餐食期间服用吡非尼酮和尽量减少阳光照射。
资助
F. Hoffmann-La Roche Ltd./Genentech, Inc. 本文提供通俗易懂的摘要。
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