Ruaro Barbara, Gandin Ilaria, Pozzan Riccardo, Tavano Stefano, Bozzi Chiara, Hughes Michael, Kodric Metka, Cifaldi Rossella, Lerda Selene, Confalonieri Marco, Baratella Elisa, Confalonieri Paola, Salton Francesco
Pulmonology Unit, Department of Medical Surgical and Health Sciences, University Hospital of Cattinara, University of Trieste, 34149 Trieste, Italy.
Biostatistics Unit, Department of Medical Sciences, University of Trieste, 34149 Trieste, Italy.
Pharmaceuticals (Basel). 2023 Feb 16;16(2):307. doi: 10.3390/ph16020307.
Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a median survival of ~3 years. Nintedanib (NTD) has been shown to be useful in controlling interstitial lung disease (ILD) in IPF. Here we describe the experience of NTD use in IPF in a real-life setting. Objective. Our objective was to examine the safety profile and efficacy of nintedanib even in subjects treated with anticoagulants. Clinical data of patients with IPF treated with NTD at our center were retrospectively evaluated at baseline and at 6 and 12 months after the introduction of NTD. The following parameters were recorded: IPF clinical features, NTD tolerability, and pulmonary function tests (PFT) (i.e., Forced Vital Capacity (FVC) and carbon monoxide diffusing capacity (DLCO)). In total, 56 IPF patients (34% female and 66% male, mean onset age: 71 ± 11 years, mean age at baseline: 74 ± 9 years) treated with NTD were identified. At enrollment, HRCT showed an UIP pattern in 45 (80%) and a NSIP in 11 (20%) patients. For FVC and FEV1 we found no significant change between baseline and 6 months, but for DLCO we observed a decrease ( = 0.012). We identified a significant variation between baseline and 12 months for FEV1 ( = 0.039) and for DLCO ( = 0.018). No significant variation was observed for FVC. In the cohort, 18 (32%) individuals suspended NTD and 10 (18%) reduced the dosage. Among individuals that suspended the dosage, 14 (78%) had gastrointestinal (GI) collateral effects (i.e., diarrhea being the most common complaint (67%), followed by nausea/vomiting (17%) and weight loss (6%). Bleeding episodes have also not been reported in patients taking anticoagulant therapy. (61%). One patient died within the first 6 months and two subjects died within the first 12 months. In a real-life clinical scenario, NTD may stabilize the FVC values in IPF patients. However, GI side effects are frequent and NTD dose adjustment may be necessary to retain the drug in IPF patients. This study confirms the safety of NTD, even in patients treated with anticoagulant drugs.
特发性肺纤维化（IPF）是一种罕见的严重疾病，中位生存期约为3年。尼达尼布（NTD）已被证明可有效控制IPF中的间质性肺疾病（ILD）。在此，我们描述在实际临床环境中使用NTD治疗IPF的经验。目的。我们的目的是即使在接受抗凝治疗的患者中，也能研究尼达尼布的安全性和有效性。在引入NTD之前、之后6个月和12个月时，对我们中心接受NTD治疗的IPF患者的临床数据进行回顾性评估。记录以下参数：IPF临床特征、NTD耐受性和肺功能测试（PFT）（即用力肺活量（FVC）和一氧化碳弥散量（DLCO））。共确定了56例接受NTD治疗的IPF患者（女性34%，男性66%，平均发病年龄：71±11岁，基线时平均年龄：74±9岁）。入组时，高分辨率CT（HRCT）显示45例（80%）患者为寻常型间质性肺炎（UIP）模式，11例（20%）患者为非特异性间质性肺炎（NSIP）模式。对于FVC和第一秒用力呼气容积（FEV1），我们发现基线和6个月之间无显著变化，但对于DLCO，我们观察到下降（P = 0.012）。我们发现基线和12个月之间FEV1（P = 0.039）和DLCO（P = 0.018）有显著变化。FVC未观察到显著变化。在该队列中，18例（32%）患者停用NTD，10例（18%）患者减少剂量。在停药的患者中，14例（78%）有胃肠道（GI）副作用（即腹泻是最常见的主诉（67%），其次是恶心/呕吐（17%）和体重减轻（6%））。接受抗凝治疗的患者也未报告出血事件。（61%）。1例患者在最初6个月内死亡，2例患者在最初12个月内死亡。在实际临床情况下，NTD可能会使IPF患者的FVC值稳定。然而，胃肠道副作用很常见，可能需要调整NTD剂量以维持IPF患者用药。本研究证实了NTD的安全性，即使在接受抗凝药物治疗的患者中也是如此。
