Stefania Cerri1, Matteo Monari2, Aldo Guerrieri3, Pierluigi Donatelli4, Ilaria Bassi2, Martina Garuti4, Fabrizio Luppi5, Sara Betti2, Gianpiero Bandelli2, Marco Carpano2, Maria Letizia Bacchi Reggiani6, Roberto Tonelli7, Enrico Clini8, Stefano Nava9. 1. Pneumology Unit, University Hospital of Modena Policlinico, Modena, Italy. 2. Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy. 3. Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy. 4. Department of Medical and Surgical Sciences and Post-doctoral School of Respiratory Diseases, University of Modena Reggio Emilia, Modena, Italy. 5. Cardio-Thoracic-Vascular Department, University of Milano Bicocca and Respiratory Unit, San Gerardo Hospital, Monza, Italy. 6. Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Statistical Service, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy. 7. Department of Medical and Surgical Sciences and Post-doctoral School of Respiratory Diseases, University of Modena Reggio Emilia, Modena, Italy; Clinical and Experimental Medicine PhD Program, University of Modena Reggio Emilia, Modena, Italy. 8. Pneumology Unit, University Hospital of Modena Policlinico, Modena, Italy; Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy; Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy; Department of Medical and Surgical Sciences and Post-doctoral School of Respiratory Diseases, University of Modena Reggio Emilia, Modena, Italy. 9. Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy. Electronic address: stefanava@gmail.com.
Abstract
BACKGROUND: Real-life data on the use of pirfenidone and nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF) are still scarce. METHODS: We compared the efficacy of either pirfenidone (n = 78) or nintedanib (n = 28) delivered over a 24-month period in patients with IPF, followed at two regional clinic centers in Italy, with a group of patients who refused the treatment (n = 36), and who were considered to be controls. All patients completed regular visits at 1- to 3-month intervals, where primary [forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO)] and secondary outcomes (side effects, treatment compliance, and mortality) were recorded. RESULTS: Over time, the decline in FVC and DLCO was significantly higher (p = 0.0053 and p = 0.037, respectively) in controls when compared with the combined treated group, with no significant difference between the two treated groups. Compared to patients with less advanced disease (GAP (Gender, Age, Physiology) stage I), those in GAP stages II and III showed a significantly higher decline in both FVC and DLCO irrespective of the drug taken. Side effects were similarly reported in patients receiving pirfenidone and nintedanib (5% and 7%, respectively), whereas mortality did not differ among the three groups. CONCLUSION: This real-life study demonstrated that both pirfenidone and nintedanib were equally effective in reducing the decline of FVC and DLCO versus non-treated patients after 24 months of treatment; however, patients with more advanced disease were likely to show a more rapid decline in respiratory function.
BACKGROUND: Real-life data on the use of pirfenidone and nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF) are still scarce. METHODS: We compared the efficacy of either pirfenidone (n = 78) or nintedanib (n = 28) delivered over a 24-month period in patients with IPF, followed at two regional clinic centers in Italy, with a group of patients who refused the treatment (n = 36), and who were considered to be controls. All patients completed regular visits at 1- to 3-month intervals, where primary [forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO)] and secondary outcomes (side effects, treatment compliance, and mortality) were recorded. RESULTS: Over time, the decline in FVC and DLCO was significantly higher (p = 0.0053 and p = 0.037, respectively) in controls when compared with the combined treated group, with no significant difference between the two treated groups. Compared to patients with less advanced disease (GAP (Gender, Age, Physiology) stage I), those in GAP stages II and III showed a significantly higher decline in both FVC and DLCO irrespective of the drug taken. Side effects were similarly reported in patients receiving pirfenidone and nintedanib (5% and 7%, respectively), whereas mortality did not differ among the three groups. CONCLUSION: This real-life study demonstrated that both pirfenidone and nintedanib were equally effective in reducing the decline of FVC and DLCO versus non-treated patients after 24 months of treatment; however, patients with more advanced disease were likely to show a more rapid decline in respiratory function.
Authors: Paolo Cameli; Rosa Metella Refini; Laura Bergantini; Miriana d'Alessandro; Valerio Alonzi; Carlo Magnoni; Paola Rottoli; Piersante Sestini; Elena Bargagli Journal: Front Mol Biosci Date: 2020-09-04