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A Placebo-Controlled Randomized Trial of Warfarin in Idiopathic Pulmonary Fibrosis
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A Placebo-Controlled Randomized Trial of Warfarin in Idiopathic Pulmonary Fibrosis
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Journal Article
A Placebo-Controlled Randomized Trial of Warfarin in Idiopathic Pulmonary Fibrosis
2012
Overview
Abstract
Rationale
Animal and human studies support the importance of the coagulation cascade in pulmonary fibrosis.
Objectives
In a cohort of subjects with progressive idiopathic pulmonary fibrosis (IPF), we tested the hypothesis that treatment with warfarin at recognized therapeutic doses would reduce rates of mortality, hospitalization, and declines in FVC.
Methods
This was a double-blind, randomized, placebo-controlled trial of warfarin targeting an international normalized ratio of 2.0 to 3.0 in patients with IPF. Subjects were randomized in a 1:1 ratio to warfarin or matching placebo for a planned treatment period of 48 weeks. International normalized ratios were monitored using encrypted home point-of-care devices that allowed blinding of study therapy.
Measurements and Main Results
The primary outcome measure was the composite outcome of time to death, hospitalization (nonbleeding, nonelective), or a 10% or greater absolute decline in FVC. Due to a low probability of benefit and an increase in mortality observed in the subjects randomized to warfarin (14 warfarin versus 3 placebo deaths; P = 0.005) an independent Data and Safety Monitoring Board recommended stopping the study after 145 of the planned 256 subjects were enrolled (72 warfarin, 73 placebo). The mean follow-up was 28 weeks.
Conclusions
This study did not show a benefit for warfarin in the treatment of patients with progressive IPF. Treatment with warfarin was associated with an increased risk of mortality in an IPF population who lacked other indications for anticoagulation.
Clinical trial registered with www.clinicaltrials.gov (NCT00957242).
Publisher
Oxford University Press,American Thoracic Society
Subject
/ Aged
/ Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
/ Anticoagulants - therapeutic use
/ Biological and medical sciences
/ Female
/ Hospitalization - statistics & numerical data
/ Humans
/ Idiopathic Pulmonary Fibrosis - drug therapy
/ Idiopathic Pulmonary Fibrosis - mortality
/ Idiopathic Pulmonary Fibrosis - physiopathology
/ International Normalized Ratio
/ Male
/ Pulmonary hypertension. Acute cor pulmonale. Pulmonary embolism. Pulmonary vascular diseases
