
To the Editor: In reporting the results of the INPULSIS-1 and INPULSIS-2 trials, Richeldi et al. (May 29 issue) 1 describe the use of nintedanib in the treatment of idiopathic pulmonary fibrosis. In the same issue, King et al. 2 report the results of the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND) study of the use of pirfenidone for this condition. In the two INPULSIS trials, a significant and similar benefit with nintedanib versus placebo was observed with respect to the primary end point, the annual rate of decline in forced vital capacity (FVC). In the ASCEND trial, the primary end point was prespecified as the change from baseline to week 52 in the percentage of the predicted FVC, but the test statistic used was based on a “cutoff point” analysis. In the secondary outcome data provided in the ASCEND trial, the mean decline from baseline in FVC over 52 weeks in the placebo group was 428 ml, as compared with an average of 150 to 200 ml per year in contemporary trials. 1,3 Can the authors provide an explanation of this inconsistency?
Male, Indoles, Pyridones, Humans, Female, Enzyme Inhibitors, Protein Kinase Inhibitors, Antifibrinolytic Agents, Idiopathic Pulmonary Fibrosis
Male, Indoles, Pyridones, Humans, Female, Enzyme Inhibitors, Protein Kinase Inhibitors, Antifibrinolytic Agents, Idiopathic Pulmonary Fibrosis
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