Adverse Events of Pirfenidone for the Treatment of Pulmonary Fibrosis: A Meta-Analysis of Randomized Controlled Trials

Jiang, Chunguo; Huang, Hui; Liu, Jia; Wang, Yanxun; Lü, Zhiwei; Xu, Zuojun

doi:10.1371/journal.pone.0047024

Cited by 63 publications

(36 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The US Food and Drug Administration has yet to approve pirfenidone, pending the results of an ongoing large phase III U.S. multicenter clinical trial (ASCEND trial, NCT0136629). Dermatologic (photosensitivity and rash), neurologic (dizziness and fatigue) and gastro-intestinal (nausea, dyspepsia, diarrhea and anorexia) side effects have been reported with pirfenidone and should be routinely addressed [90,93]. …”

Section: Pharmacotherapymentioning

confidence: 99%

Idiopathic pulmonary fibrosis: Early detection and referral

Oldham

Noth

2014

Respiratory Medicine

View full text Add to dashboard Cite

Summary Idiopathic pulmonary fibrosis (IPF), a devastating progressive interstitial lung disease (ILD) with no known cause or cure, is the most common and deadly of the idiopathic interstitial pneumonias. With a median survival of 3–5 years following diagnosis, IPF is characterized by a progressive decline in lung function and quality of life in most patients. Vigilance among clinicians in recognizing IPF early in the disease course remains critical to properly caring for these patients, as this provides the widest range of management options. When IPF is suspected, a multidisciplinary evaluation (MDE) by a clinician, radiologist and pathologist with ILD expertise should occur, as this improves diagnostic agreement in both community and academic settings. When community MDE is not possible, or diagnostic doubt exists, referral to an ILD center should be considered. ILD center referral may also provide access specialized care, including clinical trials and lung transplantation, and should be considered for any patient with an established diagnosis of IPF.

show abstract

Section: Pharmacotherapymentioning

confidence: 99%

Idiopathic pulmonary fibrosis: Early detection and referral

Oldham

Noth

2014

Respiratory Medicine

View full text Add to dashboard Cite

show abstract

“…Jiang et al [42] reported the results of a meta-analysis to analyze the safety profile of pirfenidone for treating pulmonary fibrosis. Six-randomized controlled trials were analyzed.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Pirfenidone for the treatment of idiopathic pulmonary fibrosis

Xaubet

Serrano-Mollar

Ancochea

2013

Expert Opinion on Pharmacotherapy

View full text Add to dashboard Cite

Pirfenidone is the only anti-fibrotic drug approved for the treatment of IPF. Pirfenidone provides a meaningful clinical effect on reductions in the decrease in forced vital capacity (FVC), six-minute walk test (6MWT) distance and mortality, and it improves the progression-free survival in IPF patients with mild-to-moderate disease. Pirfenidone is well tolerated, with the most common side-effects being gastrointestinal discomfort and photosensitivity. Pirfenidone has a favorable benefit-risk profile and represents a suitable treatment option for patients with mild-to-moderate IPF.

show abstract

“…However, support in favor of pirfenidone is not unanimous, in part due to an inconsistency in the primary endpoint results of two large clinical trials, while in a pooled analysis a significant treatment effect for pirfenidone versus placebo was observed [11,15,16]. In addition, there is the perception that a rather modest treatment benefit comes at the cost of significant adverse events which are experienced by a considerable proportion of patients and which may affect treatment compliance [17]. In view of the data available at that time, pirfenidone was given a weak negative recommendation by the consensus statement of the ATS/ERS/JRS/ALAT on the diagnoses and management of IPF [1].…”

Section: Introductionmentioning

confidence: 99%

Pirfenidone in Idiopathic Pulmonary Fibrosis: Real-Life Experience from a German Tertiary Referral Center for Interstitial Lung Diseases

Oltmanns

Kahn²,

Palmowski³

et al. 2014

Respiration

View full text Add to dashboard Cite

Background: Pirfenidone is a novel antifibrotic drug for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). However, adverse events may offset treatment benefits and compliance. Objectives: To assess recent course of disease, adverse events and compliance in patients who started pirfenidone. Methods: In an observational cohort study, 63 patients with mild-to-moderate IPF who started pirfenidone between May 2011 and June 2013 were reviewed. Pulmonary function, adverse events and treatment compliance were recorded at each clinic visit. Disease progression was defined as a reduction of vital capacity ≥10% and/or diffusion capacity (DLCO) ≥15%. Results: Follow-up time on pirfenidone treatment was 11 (±7) months. Sixty-six percent of the patients continued with pirfenidone monotherapy and 34% of the patients received pirfenidone combined with corticosteroids (CCS) and/or N-acetylcysteine (NAC). There was a nonsignificant reduction in mean decline of percent predicted forced vital capacity after treatment start (0.7 ± 10.9%) compared to the pretreatment period (6.6 ± 6.7%, p = 0.098). Sixty-two percent of the patients had stable disease on pirfenidone treatment. Adverse events affected 85% of the patients, leading to discontinuation of pirfenidone in 20%. Adverse events and treatment discontinuation were seen more frequently in patients with concomitant CCS and/or NAC treatment. Conclusions: Adverse events affect the majority of patients treated with pirfenidone, but are mostly manageable with supportive measures. In this heterogeneous patient group, a nonsignificant effect of pirfenidone treatment on pulmonary function was seen, underlining the need for more data on patient selection criteria and efficacy of pirfenidone, particularly in patients with coexistent emphysema and concomitant NAC/CCS treatment.

show abstract

Adverse Events of Pirfenidone for the Treatment of Pulmonary Fibrosis: A Meta-Analysis of Randomized Controlled Trials

Cited by 63 publications

References 19 publications

Idiopathic pulmonary fibrosis: Early detection and referral

Idiopathic pulmonary fibrosis: Early detection and referral

Pirfenidone for the treatment of idiopathic pulmonary fibrosis

Pirfenidone in Idiopathic Pulmonary Fibrosis: Real-Life Experience from a German Tertiary Referral Center for Interstitial Lung Diseases

Contact Info

Product

Resources

About