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.Dear Editor, dear Reviewers, Thank you for the thoughtful and constructive review of our paper. We carefully read your comments and suggestions, and we modified the manuscript accordingly.Please find enclosed a point-by-point response as well as a marked and clean copy of the revised manuscript.While we hope that you will find the revised version of the manuscript acceptable for publication as "Original Article" in Respiratory Medicine we will be happy to respond to outstanding comments and questions, should they occur.Best regards, Prof. Enrico Clini Reviewer 1We thank the Reviewer for the precise reviewing process of our work. We have welcomed all of her/his comments and we have tried to emend the manuscript accordingly. Major comments Reviewer 1's comment 1Did the authors calculate the power of the study (e.g. number of patients needed to respond to the main aim) before its start? This does not seem to be mentioned along the paper.
Background: Persistent hypercapnia after COPD exacerbation is associated with excess mortality and early rehospitalization. High Flow Nasal cannula (HFNC), may be theoretically an alternative to long-term noninvasive ventilation (NIV), since physiological studies have shown a reduction in PaCO2 level after few hours of treatment. In this clinical study we assessed the acceptability of HFNC and its effectiveness in reducing the level of PaCO 2 in patients recovering from an Acute Hypercapnic Respiratory Failure (AHRF) episode. We also hypothesized that the response in CO 2 clearance is dependent on baseline level of hypercapnia. Methods: Fifty COPD patients recovering from an acute exacerbation and with persistent hypercapnia, despite having attained a stable pH (i.e. pH > 7,35 and PaCO 2 > 45 mmHg on 3 consecutive measurements), were enrolled and treated with HFNC for at least 8 h/day and during the nighttime Results: HFNC was well tolerated with a global tolerance score of 4.0 ± 0.9. When patients were separated into groups with or without COPD/OSA overlap syndrome, the "pure" COPD patients showed a statistically significant response in terms of PaCO 2 decrease (p = 0.044). In addition, the subset of patients with a lower pH at enrolment were those who responded best in terms of CO 2 clearance (score test for trend of odds, p = 0.0038). Conclusions: HFNC is able to significantly decrease the level of PaCO 2 after 72 h only in "pure" COPD patients, recovering from AHRF. No effects in terms of CO2 reduction were found in those with overlap syndrome. The present findings will help guide selection of the best target population and allow a sample size calculation for future long-term randomized control trials of HFNC vs NIV. Trial registration: This study is registered with www. clinicaltrials.gov with identifier number NCT03759457.
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