@article {KreuterOA4962, author = {Michael Kreuter and Ulrich Costabel and Luca Richeldi and Vincent Cottin and Daniel Wachtlin and Susanne Stowasser and Martin Kolb}, title = {Effect of baseline statin use on benefit of nintedanib}, volume = {48}, number = {suppl 60}, elocation-id = {OA4962}, year = {2016}, doi = {10.1183/13993003.congress-2016.OA4962}, publisher = {European Respiratory Society}, abstract = {Background: The anti-inflammatory and antioxidant effects of statins may attenuate lung function decline in patients with idiopathic pulmonary fibrosis (IPF) yet their potential effect in combination with antifibrotic treatment is unknown. The two replicate Phase III INPULSIS{\textregistered} trials showed that nintedanib 150 mg twice daily significantly reduced the annual rate of decline in forced vital capacity (FVC) in patients with IPF.Aim: To assess the impact of statin use at baseline on lung function decline in patients treated with nintedanib or placebo in the INPULSIS{\textregistered} trials.Methods: A post-hoc subgroup analysis of patients receiving versus not receiving statins at baseline was conducted using pooled data from both INPULSIS{\textregistered} trials.Results: 312 patients (nintedanib 192; placebo 120) were receiving statins at baseline and 749 (nintedanib 446; placebo 303) were not. Baseline characteristics were mostly similar between the subgroups; but patients taking statins were older and a higher proportion had cardiovascular comorbidities. The rate of decline in FVC with nintedanib and placebo, respectively, was -78.9 and -187.6 mL/year in patients receiving statins and -127.9 and -237.9 mL/year in patients not receiving statins. The absolute treatment effect of nintedanib was similar in both these subgroups: 108.7 mL/year (95\% CI: 45.3, 172.2) and 110.0 mL/year (95\% CI: 69.7, 150.4), respectively.Conclusion: In subgroup analyses of pooled data from the INPULSIS{\textregistered} trials, FVC decline was numerically lower in patients taking versus not taking statins at baseline. The treatment effect of nintedanib was similar in both subgroups. The potential impact of statins on clinical outcomes in IPF needs validation in prospective clinical trials.}, issn = {0903-1936}, URL = {https://erj.ersjournals.com/content/48/suppl_60/OA4962}, eprint = {https://erj.ersjournals.com/content}, journal = {European Respiratory Journal} }