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https://www.readbyqxmd.com/read/27876247/effect-of-pirfenidone-on-mortality-pooled-analyses-and-meta-analyses-of-clinical-trials-in-idiopathic-pulmonary-fibrosis
#1
Steven D Nathan, Carlo Albera, Williamson Z Bradford, Ulrich Costabel, Ian Glaspole, Marilyn K Glassberg, David R Kardatzke, Monica Daigl, Klaus-Uwe Kirchgaessler, Lisa H Lancaster, David J Lederer, Carlos A Pereira, Jeffrey J Swigris, Dominique Valeyre, Paul W Noble
BACKGROUND: In clinical trials of idiopathic pulmonary fibrosis, rates of all-cause mortality are low. Thus prospective mortality trials are logistically very challenging, justifying the use of pooled analyses or meta-analyses. We did pooled analyses and meta-analyses of clinical trials of pirfenidone versus placebo to determine the effect of pirfenidone on mortality outcomes over 120 weeks. METHODS: We did a pooled analysis of the combined patient populations of the three global randomised phase 3 trials of pirfenidone versus placebo-Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary Fibrosis: Research of Efficacy and Safety Outcomes (CAPACITY 004 and 006; trial durations 72-120 weeks) and Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND 016; 52 weeks)-for all-cause mortality, treatment-emergent all-cause mortality, idiopathic-pulmonary-fibrosis-related mortality, and treatment-emergent idiopathic-pulmonary-fibrosis-related mortality at weeks 52, 72, and 120...
November 19, 2016: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/27708114/effect-of-statins-on-disease-related-outcomes-in-patients-with-idiopathic-pulmonary-fibrosis
#2
Michael Kreuter, Francesco Bonella, Toby M Maher, Ulrich Costabel, Paolo Spagnolo, Derek Weycker, Klaus-Uwe Kirchgaessler, Martin Kolb
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)...
October 5, 2016: Thorax
https://www.readbyqxmd.com/read/27590145/jnk-inhibition-reduces-lung-remodeling-and-pulmonary-fibrotic-systemic-markers
#3
Jos L J van der Velden, Ying Ye, James D Nolin, Sidra M Hoffman, David G Chapman, Karolyn G Lahue, Sarah Abdalla, Peng Chen, Yong Liu, Brydon Bennett, Nasreen Khalil, Donna Sutherland, William Smith, Gerald Horan, Mahmoud Assaf, Zebulun Horowitz, Rajesh Chopra, Randall M Stevens, Maria Palmisano, Yvonne M W Janssen-Heininger, Peter H Schafer
BACKGROUND: Lung remodeling and pulmonary fibrosis are serious, life-threatening conditions resulting from diseases such as chronic severe asthma and idiopathic pulmonary fibrosis (IPF). Preclinical evidence suggests that JNK enzyme function is required for key steps in the pulmonary fibrotic process. However, a selective JNK inhibitor has not been investigated in translational models of lung fibrosis with clinically relevant biomarkers, or in IPF patients. METHODS: The JNK inhibitor CC-930 was evaluated in the house dust mite-induced fibrotic airway mouse model, in a phase I healthy volunteer pharmacodynamic study, and subsequently in a phase II multicenter study of mild/moderate IPF (n = 28), with a 4-week, placebo-controlled, double-blind, sequential ascending-dose period (50 mg QD, 100 mg QD, 100 mg BID) and a 52-week open-label treatment-extension period...
December 2016: Clinical and Translational Medicine
https://www.readbyqxmd.com/read/27566376/pirfenidone-clinical-trials-and-clinical-practice-in-patients-with-idiopathic-pulmonary-fibrosis
#4
REVIEW
Masashi Bando
Pirfenidone is an oral drug that exerts not only anti-fibrotic activity but also pleiotropic effects, such as anti-inflammatory and anti-oxidative effects. Because it suppresses reduction in vital capacity and improves progression-free survival, it was approved in October 2008 in Japan for the first time in the world as an anti-fibrotic agent for treatment of idiopathic pulmonary fibrosis (IPF). In October 2014, the agent was approved in the U.S., based on the results of the ASCEND study. Today, it is commercially available in 38 countries worldwide...
September 2016: Respiratory Investigation
https://www.readbyqxmd.com/read/27050871/antacid-therapy-and-disease-outcomes-in-idiopathic-pulmonary-fibrosis-a-pooled-analysis
#5
Michael Kreuter, Wim Wuyts, Elisabetta Renzoni, Dirk Koschel, Toby M Maher, Martin Kolb, Derek Weycker, Paolo Spagnolo, Klaus-Uwe Kirchgaessler, Felix J F Herth, Ulrich Costabel
BACKGROUND: Gastro-oesophageal reflux disease is a potential risk factor for the development and progression of idiopathic pulmonary fibrosis (IPF). We aimed to investigate the effect of antacid therapy on disease progression in patients randomly assigned to placebo through analysis of three large, phase 3 trials of pirfenidone in IPF. METHODS: Patients with IPF from the placebo groups of three trials of pirfenidone (CAPACITY 004, CAPACITY 006, and ASCEND) were included in this post-hoc analysis...
May 2016: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/26968970/effect-of-continued-treatment-with-pirfenidone-following-clinically-meaningful-declines-in-forced-vital-capacity-analysis-of-data-from-three-phase-3-trials-in-patients-with-idiopathic-pulmonary-fibrosis
#6
RANDOMIZED CONTROLLED TRIAL
Steven D Nathan, Carlo Albera, Williamson Z Bradford, Ulrich Costabel, Roland M du Bois, Elizabeth A Fagan, Robert S Fishman, Ian Glaspole, Marilyn K Glassberg, Kenneth F Glasscock, Talmadge E King, Lisa Lancaster, David J Lederer, Zhengning Lin, Carlos A Pereira, Jeffrey J Swigris, Dominique Valeyre, Paul W Noble, Athol U Wells
BACKGROUND: The assessment of treatment response in idiopathic pulmonary fibrosis (IPF) is complicated by the variable clinical course. We examined the variability in the rate of disease progression and evaluated the effect of continued treatment with pirfenidone in patients who experienced meaningful progression during treatment. METHODS: The source population included patients enrolled in the ASCEND and CAPACITY trials (N=1247). Pearson's correlation coefficients were used to characterise the relationship between changes in FVC during consecutive 6-month intervals in the placebo population...
May 2016: Thorax
https://www.readbyqxmd.com/read/26869678/recombinant-human-pentraxin-2-therapy-in-patients-with-idiopathic-pulmonary-fibrosis-safety-pharmacokinetics-and-exploratory-efficacy
#7
Bernt van den Blink, Marlous R Dillingh, Leo C Ginns, Lake D Morrison, Matthijs Moerland, Marlies Wijsenbeek, Elizabeth G Trehu, Brian J Bartholmai, Jacobus Burggraaf
Abnormal fibrogenic repair response upon alveolar injury is believed to play an important role in the pathogenesis of idiopathic pulmonary fibrosis (IPF). PRM-151 (recombinant human pentraxin-2, also known as serum amyloid P), has been shown to reduce fibrosis in preclinical lung fibrosis models, and was well tolerated with a favourable pharmacokinetic profile in an earlier single-dose phase I study.A randomised, double-blind, placebo-controlled, multiple ascending dose trial was performed to assess the tolerability and pharmacokinetic and pharmacodynamic characteristics of multiple doses of PRM-151 in IPF patients...
March 2016: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/26835133/safety-of-pirfenidone-in-patients-with-idiopathic-pulmonary-fibrosis-integrated-analysis-of-cumulative-data-from-5-clinical-trials
#8
Lisa Lancaster, Carlo Albera, Williamson Z Bradford, Ulrich Costabel, Roland M du Bois, Elizabeth A Fagan, Robert S Fishman, Ian Glaspole, Marilyn K Glassberg, Talmadge E King, David J Lederer, Zhengning Lin, Steven D Nathan, Carlos A Pereira, Jeffrey J Swigris, Dominique Valeyre, Paul W Noble
BACKGROUND: Pirfenidone is an oral antifibrotic agent that has been shown to reduce the decline in lung function in patients with idiopathic pulmonary fibrosis (IPF). We performed an integrated analysis of safety data from five clinical trials evaluating pirfenidone in patients with IPF. METHODS: All patients treated with pirfenidone in the three multinational Phase 3 studies (CAPACITY (studies 004 and 006), ASCEND (study 016)) and two ongoing open-label studies (study 002 and study 012 (RECAP)) were included in the analysis...
2016: BMJ Open Respiratory Research
https://www.readbyqxmd.com/read/26647432/pirfenidone-for-idiopathic-pulmonary-fibrosis-analysis-of-pooled-data-from-three-multinational-phase-3-trials
#9
Paul W Noble, Carlo Albera, Williamson Z Bradford, Ulrich Costabel, Roland M du Bois, Elizabeth A Fagan, Robert S Fishman, Ian Glaspole, Marilyn K Glassberg, Lisa Lancaster, David J Lederer, Jonathan A Leff, Steven D Nathan, Carlos A Pereira, Jeffrey J Swigris, Dominique Valeyre, Talmadge E King
Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression.All patients randomised to pirfenidone 2403 mg·day(-1) or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol...
January 2016: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/26346347/nintedanib-evidence-for-its-therapeutic-potential-in-idiopathic-pulmonary-fibrosis
#10
REVIEW
Minoru Inomata, Yasuhiko Nishioka, Arata Azuma
Idiopathic pulmonary fibrosis (IPF) is a progressive disease with poor prognosis. The molecular mechanisms involved in the progression of IPF are not fully understood; however, the platelet-derived growth factor (PDGF)/PDGF receptor pathway is thought to play a critical role in fibrogenesis of the lungs. Other growth factors, including fibroblast growth factor and vascular endothelial growth factor, are also thought to contribute to the pathogenesis of pulmonary fibrosis. Nintedanib is an inhibitor of multiple tyrosine kinases, including receptors for PDGF, fibroblast growth factor, and vascular endothelial growth factor...
2015: Core Evidence
https://www.readbyqxmd.com/read/25856121/sensitivity-analyses-of-the-change-in-fvc-in-a-phase-3-trial-of-pirfenidone-for-idiopathic-pulmonary-fibrosis
#11
RANDOMIZED CONTROLLED TRIAL
David J Lederer, Williamson Z Bradford, Elizabeth A Fagan, Ian Glaspole, Marilyn K Glassberg, Kenneth F Glasscock, David Kardatzke, Talmadge E King, Lisa H Lancaster, Steven D Nathan, Carlos A Pereira, Steven A Sahn, Jeffrey J Swigris, Paul W Noble
BACKGROUND: FVC outcomes in clinical trials on idiopathic pulmonary fibrosis (IPF) can be substantially influenced by the analytic methodology and the handling of missing data. We conducted a series of sensitivity analyses to assess the robustness of the statistical finding and the stability of the estimate of the magnitude of treatment effect on the primary end point of FVC change in a phase 3 trial evaluating pirfenidone in adults with IPF. METHODS: Source data included all 555 study participants randomized to treatment with pirfenidone or placebo in the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND) study...
July 2015: Chest
https://www.readbyqxmd.com/read/25604027/pirfenidone-a-review-of-its-use-in-idiopathic-pulmonary-fibrosis
#12
REVIEW
Esther S Kim, Gillian M Keating
Pirfenidone (Esbriet®) is an orally administered, synthetic, pyridone compound that is approved for the treatment of adults with mild to moderate idiopathic pulmonary fibrosis (IPF) in the EU, and for the treatment of IPF in the USA. This article summarizes pharmacological, efficacy and tolerability data relevant to the use of pirfenidone in these indications. In the randomized, double-blind, placebo-controlled, multinational CAPACITY trials in patients with mild to moderate IPF, a significant reduction in the rate of decline in forced vital capacity (FVC) was seen with pirfenidone versus placebo in study 004 but not in study 006...
February 2015: Drugs
https://www.readbyqxmd.com/read/24836312/a-phase-3-trial-of-pirfenidone-in-patients-with-idiopathic-pulmonary-fibrosis
#13
RANDOMIZED CONTROLLED TRIAL
Talmadge E King, Williamson Z Bradford, Socorro Castro-Bernardini, Elizabeth A Fagan, Ian Glaspole, Marilyn K Glassberg, Eduard Gorina, Peter M Hopkins, David Kardatzke, Lisa Lancaster, David J Lederer, Steven D Nathan, Carlos A Pereira, Steven A Sahn, Robert Sussman, Jeffrey J Swigris, Paul W Noble
BACKGROUND: In two of three phase 3 trials, pirfenidone, an oral antifibrotic therapy, reduced disease progression, as measured by the decline in forced vital capacity (FVC) or vital capacity, in patients with idiopathic pulmonary fibrosis; in the third trial, this end point was not achieved. We sought to confirm the beneficial effect of pirfenidone on disease progression in such patients. METHODS: In this phase 3 study, we randomly assigned 555 patients with idiopathic pulmonary fibrosis to receive either oral pirfenidone (2403 mg per day) or placebo for 52 weeks...
May 29, 2014: New England Journal of Medicine
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