PMID- 27708114
OWN - NLM
STAT- MEDLINE
DCOM- 20170615
LR  - 20220330
IS  - 1468-3296 (Electronic)
IS  - 0040-6376 (Print)
IS  - 0040-6376 (Linking)
VI  - 72
IP  - 2
DP  - 2017 Feb
TI  - Effect of statins on disease-related outcomes in patients with idiopathic 
      pulmonary fibrosis.
PG  - 148-153
LID - 10.1136/thoraxjnl-2016-208819 [doi]
AB  - BACKGROUND: 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. 
      METHODS: 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). RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION NUMBERS: NCT01366209, NCT00287729 and 
      NCT00287716.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://www.bmj.com/company/products-services/rights-and-licensing/.
FAU - Kreuter, Michael
AU  - Kreuter M
AD  - 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.
AD  - Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
FAU - Bonella, Francesco
AU  - Bonella F
AD  - Interstitial and Rare Lung Disease Unit, Ruhrlandklinik, University Hospital, 
      University of Duisburg-Essen, Essen, Germany.
FAU - Maher, Toby M
AU  - Maher TM
AUID- ORCID: 0000-0001-7192-9149
AD  - NIHR Biomedical Research Unit, Royal Brompton Hospital, London, UK.
FAU - Costabel, Ulrich
AU  - Costabel U
AD  - Interstitial and Rare Lung Disease Unit, Ruhrlandklinik, University Hospital, 
      University of Duisburg-Essen, Essen, Germany.
FAU - Spagnolo, Paolo
AU  - Spagnolo P
AD  - Section of Respiratory Diseases, Department of Cardiac, Thoracic and Vascular 
      Sciences, University of Padova, Padova, Italy.
FAU - Weycker, Derek
AU  - Weycker D
AD  - Policy Analysis Inc. (PAI), MINERVA Health Economics Network, Ltd., Brookline, 
      Massachusetts, USA.
FAU - Kirchgaessler, Klaus-Uwe
AU  - Kirchgaessler KU
AD  - F. Hoffmann-La Roche Ltd, Basel, Switzerland.
FAU - Kolb, Martin
AU  - Kolb M
AD  - Department of Medicine, Pathology & Molecular Medicine, Firestone Institute for 
      Respiratory Health, McMaster University, Hamilton, Ontario, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT01366209
SI  - ClinicalTrials.gov/NCT00287729
SI  - ClinicalTrials.gov/NCT00287716
GR  - CDA 13-017/HX/HSRD VA/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20161005
PL  - England
TA  - Thorax
JT  - Thorax
JID - 0417353
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Pyridones)
RN  - D7NLD2JX7U (pirfenidone)
SB  - IM
CIN - Thorax. 2017 Feb;72 (2):101-102. PMID: 27789650
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Disease Progression
MH  - Double-Blind Method
MH  - Female
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use
MH  - Idiopathic Pulmonary Fibrosis/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Pyridones/*therapeutic use
MH  - Risk Factors
MH  - Treatment Outcome
PMC - PMC5284334
OTO - NOTNLM
OT  - Idiopathic pulmonary fibrosis
COIS- MKr and his institution have received unrestricted grants and personal fees from 
      InterMune International AG which became a wholly owned subsidiary of Roche in 
      2014, F. Hoffmann-La Roche Ltd and Boehringer Ingelheim. FB has received speaker 
      fees, advisory board honoraria or grants from InterMune International AG which 
      became a wholly owned subsidiary of Roche in 2014, Boehringer Ingelheim, Gilead, 
      Serendex, Centocor and F. Hoffmann-La Roche Ltd. TMM is supported by a National 
      Institute for Health Research Clinician Scientist Fellowship (NIHR Ref: 
      CS:-2013-13-017). He has received research grants from GlaxoSmithKline, UCB and 
      Novartis; and consulting and speaker fees from AstraZeneca, Bayer, Biogen Idec, 
      Boehringer Ingelheim, Cipla, Dosa, GlaxoSmithKline, Lanthio, InterMune 
      International AG which became a wholly owned subsidiary of Roche in 2014, F. 
      Hoffmann-La Roche Ltd, Sanofi-Aventis, Takeda and UCB. UC has received grants, 
      personal fees and non-financial support from Boehringer Ingelheim. He has 
      received grants, personal fees and non-financial support from Intermune 
      International AG which became a wholly owned subsidiary of Roche in 2014, and 
      personal fees from F. Hoffmann-La Roche Ltd, Bayer, Gilead, GlaxoSmithKline, UCB, 
      Biogen and Centocor (all outside the submitted work). PS has received consulting 
      fees from InterMune International AG which became a wholly owned subsidiary of 
      Roche in 2014, F. Hoffmann-La Roche Ltd and Santhera Pharmaceuticals Ltd, and 
      personal fees from Boehringer Ingelheim and Novartis. DW is an employee of Policy 
      Analysis Inc. (PAI), which received funding from F. Hoffmann-La Roche Ltd for 
      this study. K-UK is an employee of F. Hoffmann-La Roche Ltd, Basel, Switzerland. 
      MKo has served as site Principal Investigator in industry-sponsored clinical 
      trials (Centocor, Roche, Sanofi and Boehringer Ingelheim) and is funded by the 
      Canadian Institute for Health Research. He has served and/or serves on the 
      Pulmonary Fibrosis Foundation Medical Advisory Board and on Advisory Boards for 
      Boehringer Ingelheim, Roche Canada, GlaxoSmithKline, AstraZeneca, Vertex, Genoa, 
      Gilead, Janssen and Prometic.
EDAT- 2016/10/07 06:00
MHDA- 2017/06/16 06:00
PMCR- 2017/01/31
CRDT- 2016/10/07 06:00
PHST- 2016/04/22 00:00 [received]
PHST- 2016/07/27 00:00 [revised]
PHST- 2016/08/08 00:00 [accepted]
PHST- 2016/10/07 06:00 [pubmed]
PHST- 2017/06/16 06:00 [medline]
PHST- 2016/10/07 06:00 [entrez]
PHST- 2017/01/31 00:00 [pmc-release]
AID - thoraxjnl-2016-208819 [pii]
AID - 10.1136/thoraxjnl-2016-208819 [doi]
PST - ppublish
SO  - Thorax. 2017 Feb;72(2):148-153. doi: 10.1136/thoraxjnl-2016-208819. Epub 2016 Oct 
      5.