Abstract

Background. Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease. Nintedanib (NTD) has been demonstrated to be useful in controlling interstitial lung disease (ILD) in IPF (1). Objective. Our goal was to evaluate the safety profile and efficacy of NTD, including in patients treated with oral anticoagulants. Methods. Clinical data of IPF patients were retrospectively studied at baseline (T0) and at 6 (T6) and 12 (T12) months after the introduction of NTD. We assessed the following parameters: clinical characteristics, tolerability of NTD and pulmonary function tests. Results. We evaluated data from 64 IPF patients (31% women and 69% men, mean age of onset: 73 ± 10 years, mean age at baseline: 72±8 years). At enrollment, HRCT showed UIP pattern in 49 (77%) and NSIP in 15 (23%) patients. We observed from T0 to both T6 and T12 no significant change for FVC (p=0.06). From T0 to T12, we identified a significant change for DLCO (p=0.02). In the 46 (72%) patients that took anticoagulant therapy no bleeding episodes were reported. In addition, we observed that 18 (29%) individuals discontinued NTD, and 12 (19%) reduced the dosage. Regarding the causes of NTD discontinuation, 14 (78%) had gastrointestinal (GI) symptoms, specifically 75% of patients had diarrhea, 18% nausea/vomiting and 7% weight loss. Three patients died during the study follow-up (T12). Conclusions. Our study confirms that NTD can stabilize FVC values in IPF patients. We present the safety of NTD in patients treated with anticoagulant drugs. We emphasize that dose adjustment of NTD can be helpful in gastrointestinal disorders. References. Ruaro B, et al. Front Pharmacol. 2022;13:1027332.