Efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis patients: a systematic review and meta-analysis of randomised controlled trials

BMJ Open. 2021 Dec 31;11(12):e050004. doi: 10.1136/bmjopen-2021-050004.

Abstract

Objectives: Idiopathic pulmonary fibrosis (IPF) has been defined as a distinctive type of chronic fibrotic disease, characterised by a progressive decline in lung function and a common histological pattern of interstitial pneumonia. To analyse the efficacy and safety of pirfenidone in the treatment of IPF, a systematic review and meta-analysis was performed.

Design: This is a meta-analysis study.

Participants: Patients were diagnosed as IPF.

Interventions: Use of pirfenidone.

Primary and secondary outcome: Progression-free survival (PFS), acute exacerbation and worsening of IPF and Impact on adverse events.

Measures: The inverse variance method for the random-effects model was used to summarise the dichotomous outcomes, risk ratios and 95% CIs.

Results: A total of 9 randomised controlled trials with 1011 participants receiving pirfenidone and 912 controls receiving placebo were summarised. The pooled result suggested a statistically significant difference inall-cause mortality after pirfenidone use, with a summarised relative ratio of 0.51 (p<0.01). Longer PFS was observed in patients receiving pirfenidone compared with those who were given placebo (p<0.01). The IPF groups presented a high incidence of adverse events with a pooled relative ratio of 3.89 (p<0.01).

Conclusions: Pirfenidone can provide survival benefit for patients with IPF. Pirfenidone treatment was also associated with a longer PFS, a lower incidence of acute exacerbation and worsening of IPF.

Keywords: adult thoracic medicine; respiratory medicine (see thoracic medicine); thoracic medicine.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Humans
  • Idiopathic Pulmonary Fibrosis* / drug therapy
  • Lung Diseases, Interstitial* / diagnosis
  • Progression-Free Survival
  • Pyridones / adverse effects
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Vital Capacity

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Pyridones
  • pirfenidone