Michael Kreuter1, Ulrich Costabel2, Luca Richeldi3, Vincent Cottin4, Marlies Wijsenbeek5, Francesco Bonella2, Elisabeth Bendstrup6, Toby M Maher7, Daniel Wachtlin8, Susanne Stowasser8, Martin Kolb9. 1. Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research, Heidelberg, Germany. 2. Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany. 3. Catholic University of the Sacred Heart, Rome, Italy. 4. Louis Pradel Hospital, Claude Bernard University Lyon 1, Lyon, France. 5. Erasmus MC, University Medical Centre, Rotterdam, the Netherlands. 6. Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark. 7. National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, United Kingdom. 8. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. 9. McMaster University, Hamilton, Ontario, Canada.
Abstract
BACKGROUND:Cardiovascular comorbidities are frequent in patients with idiopathic pulmonary fibrosis (IPF), and many patients with IPF receive treatment with statins to reduce cardiovascular risk. OBJECTIVES: We investigated whether statin use at baseline was associated with differences in disease progression in placebo-treated patients or influenced the treatment effect of nintedanib in the INPULSIS® trials. METHODS: Post-hoc subgroup analyses of patients receiving versus not receiving statins at baseline using pooled data from the INPULSIS® trials. RESULTS: At baseline, 312 patients received statins and 749 did not. The annual rates of decline in forced vital capacity (FVC) in patients treated withnintedanib and placebo, respectively, were -78.9 and -187.6 mL/year in patients who received statins at baseline, and -127.9 and -237.9 mL/year in patients who did not. The effect of nintedanib was consistent across subgroups (p = 0.9590). CONCLUSIONS: In the INPULSIS® trials, there was a numerically lower FVC decline in placebo-treated patients with IPF who received statins at baseline versus those who did not. Use of statins at baseline did not influence the treatment effect of nintedanib. Prospective data are needed to assess the impact of statins on the course of IPF.
RCT Entities:
BACKGROUND: Cardiovascular comorbidities are frequent in patients with idiopathic pulmonary fibrosis (IPF), and many patients with IPF receive treatment with statins to reduce cardiovascular risk. OBJECTIVES: We investigated whether statin use at baseline was associated with differences in disease progression in placebo-treated patients or influenced the treatment effect of nintedanib in the INPULSIS® trials. METHODS: Post-hoc subgroup analyses of patients receiving versus not receiving statins at baseline using pooled data from the INPULSIS® trials. RESULTS: At baseline, 312 patients received statins and 749 did not. The annual rates of decline in forced vital capacity (FVC) in patients treated with nintedanib and placebo, respectively, were -78.9 and -187.6 mL/year in patients who received statins at baseline, and -127.9 and -237.9 mL/year in patients who did not. The effect of nintedanib was consistent across subgroups (p = 0.9590). CONCLUSIONS: In the INPULSIS® trials, there was a numerically lower FVC decline in placebo-treated patients with IPF who received statins at baseline versus those who did not. Use of statins at baseline did not influence the treatment effect of nintedanib. Prospective data are needed to assess the impact of statins on the course of IPF.
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