1. Observational, Multicenter Study on the Efficacy, Tolerability, and Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis Older than 80 Years.
- Author
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Mondoni, Michele, Alfano, Fausta, Varone, Francesco, Muscato, Giuseppe, Conti, Caterina, Saderi, Laura, Chiesa, Amerigo, Di Marco, Fabiano, Vancheri, Carlo, Richeldi, Luca, Centanni, Stefano, and Sotgiu, Giovanni
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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 ,HOSPITAL care evaluation - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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