Background: Nintedanib has been investigated as a treatment for IPF in three randomized, placebo-controlled, 52-week trials: the Phase 2 TOMORROW trial and the two replicate Phase 3 INPULSIS™ trials. Compared with placebo, nintedanib 150 mg twice daily reduced the decline in forced vital capacity (FVC), consistent with a slowing of disease progression. Mortality was a secondary endpoint in all three trials; however, the trials were not powered to show a between-group difference. Our aim was to obtain a more precise estimate of the effect of nintedanib 150 mg twice daily on mortality using pooled data from the TOMORROW and INPULSIS™ trials.
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