Efficacy and safety of Nintedanib in idiopathic pulmonary fibrosis: A systematic review and meta-analysis

Abstract

Background: Idiopathic pulmonary fibrosis (IPF) is a progressive, potentially fatal lung disorder characterized by scarring, leading to reduced lung function and respiratory failure. Nintedanib, a tyrosine kinase inhibitor, shows potential in slowing IPF progression, but uncertainties remain about its long-term efficacy and safety.

Objective: To evaluate the efficacy and safety of Nintedanib in idiopathic pulmonary fibrosis.

Methods: A comprehensive literature search was conducted across PubMed, Cochrane, Scopus, Embase, and ClinicalTrials.gov from inception to August 2024, selecting studies based on predefined eligibility criteria. Dichotomous outcomes were pooled as risk ratios (RR) and continuous outcomes as mean differences (MD), both with 95% confidence intervals (CI), using random-effects models to account for potential heterogeneity. Heterogeneity was assessed using I² and X² statistics, with a p-value of <0.05 considered statistically significant. All calculations were performed using RevMan 5.4.

Results: This meta-analysis included 4 randomized controlled trials with 1,665 patients, 79.7% of whom were male smokers. There was no significant difference in IPF progression (RR=0.61, 95% CI 0.34-1.08, I²=41%) or in nasopharyngitis (RR=0.82, 95% CI 0.62-1.08, I²=0%), cough (RR=0.98, 95% CI 0.71-1.33, I²=0%), bronchitis (RR=0.90, 95% CI 0.63-1.28, I²=0%), respiratory infections (RR=1.01, 95% CI 0.59-1.75, I²=0%), dyspnea (RR=0.68, 95% CI 0.46-1.00, I²=0%), or cardiac disorders (RR=0.89, 95% CI 0.50-1.58, I²=0%), indicating nintedanib does not notably alter these risks. However, nintedanib significantly increased gastrointestinal adverse events, potentially affecting adherence and quality of life.

Conclusion: Nintedanib shows promise in slowing disease progression but carries a higher risk of adverse events. Limited sample sizes and short follow-up necessitate larger studies to confirm its efficacy and safety.

Keywords: Idiopathic pulmonary fibrosis; Meta-analysis; Nintedanib; Tyrosine kinase inhibitor.