Kang Jieun, Chung Man Pyo, Park Moo Suk, Oh In Jae, Lee Heung Bum, Kim Young Whan, Park Jong Sun, Uh Soo Taek, Kim Yun Seong, Jegal Yangjin, Song Jin Woo
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Ilsan Paik Hospital, Goyang-si, South Korea.
Samsung Medical Center, Department of Pulmonary and Critical Care Medicine, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Front Pharmacol. 2023 Jan 10;13:1025947. doi: 10.3389/fphar.2022.1025947. eCollection 2022.
Pirfenidone, an antifibrotic medication approved for the treatment of idiopathic pulmonary fibrosis (IPF), often requires dose reduction owing to adverse events. In this study, we evaluated if pirfenidone's reduced dose has any impact on clinical outcomes in patients with IPF. We used the data of a prospective post-marketing study of pirfenidone conducted at 10 hospitals in South Korea from 2014 to 2017. Dose reduction was defined when the pirfenidone dose was temporarily or permanently reduced to manage adverse events or when the treatment dose failed to reach the standard dose. Study patients were classified based on the most frequently administered dose during 48-week follow-up-1800 mg, 1,200 mg, and <1,200 mg/days. The following clinical outcomes were compared between the groups: death, hospitalization, acute exacerbation, pulmonary function decline, and changes in severity of dyspnea and cough. The median follow-up duration in all 143 patients was 11 months. During the study period, 70.6% experienced at least one dose reduction. Patients treated with standard-dose pirfenidone tended to be young and had the lowest diffusing capacity. Pulmonary function changes did not differ depending on the pirfenidone dose. The three groups were not significantly different in terms of the proportion of death, hospitalization, and acute exacerbation. The symptom changes were also similar between the groups. Reduced doses did not negatively impact clinical outcomes compared with the standard-dose pirfenidone in patients with IPF. Dose reduction may be a useful method to manage adverse events while maintaining therapeutic efficacy.
吡非尼酮是一种被批准用于治疗特发性肺纤维化（IPF）的抗纤维化药物，由于不良事件，常常需要减少剂量。在本研究中，我们评估了吡非尼酮的减量是否对IPF患者的临床结局有任何影响。我们使用了2014年至2017年在韩国10家医院进行的一项吡非尼酮上市后前瞻性研究的数据。当吡非尼酮剂量为临时或永久减少以处理不良事件，或治疗剂量未达到标准剂量时，定义为剂量减少。根据48周随访期间最常使用的剂量将研究患者分类——1800毫克、1200毫克和<1200毫克/天。比较了各组之间的以下临床结局：死亡、住院、急性加重、肺功能下降以及呼吸困难和咳嗽严重程度的变化。所有143例患者的中位随访时间为11个月。在研究期间，70.6%的患者经历了至少一次剂量减少。接受标准剂量吡非尼酮治疗的患者往往较年轻，且弥散能力最低。肺功能变化并不因吡非尼酮剂量而异。三组在死亡、住院和急性加重的比例方面没有显著差异。各组之间的症状变化也相似。与标准剂量吡非尼酮相比，减量对IPF患者的临床结局没有负面影响。减少剂量可能是一种在维持治疗效果的同时处理不良事件的有用方法。
