title: Effect of statins on disease-related outcomes in patients with idiopathic pulmonary fibrosis.
abstract: Data are conflicting regarding the possible effects of statins in patients with idiopathic pulmonary fibrosis (IPF). This post hoc analysis assessed the effects of statin therapy on disease-related outcomes in IPF.
  
  
  
  Patients randomised to placebo (n=624) in three controlled trials of pirfenidone in IPF (CAPACITY 004 and 006, ASCEND) were categorised by baseline statin use. Outcomes assessed during the 1-year follow-up included disease progression, mortality, hospitalisation and composite outcomes of death or ≥10% absolute decline in FVC and death or ≥50 m decline in 6-minute walk distance (6MWD).
  
  
  
  At baseline, 276 (44%) patients were statin users versus 348 (56%) non-users. Baseline characteristics were similar between groups, except statin users were older and had higher prevalence of cardiovascular disease and risk factors. In multivariate analyses adjusting for differences in baseline characteristics, statin users had lower risks of death or 6MWD decline (HR 0.69; 95% CI 0.48 to 0.99, p=0.0465), all-cause hospitalisation (HR 0.58; 95% CI 0.35 to 0.94, p=0.0289), respiratory-related hospitalisation (HR 0.44; 95% CI 0.25 to 0.80, p=0.0063) and IPF-related mortality (HR 0.36; 95% CI 0.14 to 0.95, p=0.0393) versus non-users. Non-significant treatment effects favouring statin use were observed for disease progression (HR 0.75; 95% CI 0.52 to 1.07, p=0.1135), all-cause mortality (HR 0.54; 95% CI 0.24 to 1.21, p=0.1369) and death or FVC decline (HR 0.71; 95% CI 0.48 to 1.07, p=0.1032).
  
  
  
  This post hoc analysis supports the hypothesis that statins may have a beneficial effect on clinical outcomes in IPF. Prospective clinical trials are required to validate these observations.
  
  
  
  NCT01366209, NCT00287729 and NCT00287716.
authors.affiliation: Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, and Translational Lung Research Center Heidelberg (TLRCH), Heidelberg, Germany.|Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Kreuter
authors.affiliation: Interstitial and Rare Lung Disease Unit, Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bonella
authors.affiliation: NIHR Biomedical Research Unit, Royal Brompton Hospital, London, UK.
authors.forename: Toby M
authors.identifier: 0000-0001-7192-9149
authors.initials: TM
authors.lastname: Maher
authors.affiliation: Interstitial and Rare Lung Disease Unit, Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Costabel
authors.affiliation: Section of Respiratory Diseases, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Spagnolo
authors.affiliation: Policy Analysis Inc. (PAI), MINERVA Health Economics Network, Ltd., Brookline, Massachusetts, USA.
authors.forename: Derek
authors.initials: D
authors.lastname: Weycker
authors.affiliation: F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Klaus-Uwe
authors.initials: KU
authors.lastname: Kirchgaessler
authors.affiliation: Department of Medicine, Pathology & Molecular Medicine, Firestone Institute for Respiratory Health, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Martin
authors.initials: M
authors.lastname: Kolb
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011728:Pyridones / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011728:Pyridones; C093844:pirfenidone
keywords: Idiopathic pulmonary fibrosis