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- Title
Observational, Multicenter Study on the Efficacy, Tolerability, and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis Older than 80 Years.
- Authors
Mondoni, Michele; Alfano, Fausta; Varone, Francesco; Muscato, Giuseppe; Conti, Caterina; Saderi, Laura; Chiesa, Amerigo; Di Marco, Fabiano; Vancheri, Carlo; Richeldi, Luca; Centanni, Stefano; Sotgiu, Giovanni
- Abstract
Background: Idiopathic pulmonary fibrosis (IPF) primarily affects old patients. Old age is a predictor of mortality. Nintedanib, the only antifibrotic drug approved in Italy for patients aged >80 years, can slow the progression of IPF by reducing the rate of decline in forced vital capacity (FVC) and the risk of exacerbations. Objectives: The primary aim of the study was to compare the decline of FVC after 12 months of nintedanib in patients aged >80 years versus younger patients. Differences related to other functional data, safety, tolerability, hospitalizations, exacerbations, and mortality were evaluated. Methods: An observational, retrospective, multicenter study was carried out in Italy. Results: 159 (122 [76.7%] males) patients were recruited: 106 (66.7%) aged ≤80 years and 53 (33.3%) aged >80 years. FVC decline after 12 months of therapy was not significantly different (−45 mL [−170; 75] vs. −20 mL [−138; 110] mL; p: 0.51). No differences were found for other functional data. Diarrhea was the most frequent adverse event (AE). Rate and type of any AEs, permanent/temporary dose reduction, or drug discontinuation were not significantly different between patients aged ≤80 vs. >80 years. Furthermore, acute exacerbations, hospitalization, and mortality were not significantly different. Conclusions: Nintedanib is effective and safe in patients with IPF aged >80 years, and no significant differences were found when clinical outcomes were compared with those of younger patients. Thus, older age should not be a barrier for the early prescription of antifibrotic treatment in IPF patients.
- Subjects
ITALY; HOSPITAL care evaluation; DRUG efficacy; RESEARCH; IDIOPATHIC pulmonary fibrosis; DRUG tolerance; SCIENTIFIC observation; DIARRHEA; ANTI-inflammatory agents; FIBROSIS; RETROSPECTIVE studies; VITAL capacity (Respiration); TREATMENT effectiveness; DESCRIPTIVE statistics; DRUG side effects; PATIENT safety; DISEASE exacerbation; EVALUATION; OLD age
- Publication
Respiration, 2023, Vol 102, Issue 1, p25
- ISSN
0025-7931
- Publication type
Article
- DOI
10.1159/000527308