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Nintedanib tolerable for patients with idiopathic pulmonary fibrosis

Nintedanib appeared safe and tolerable for patients with idiopathic pulmonary fibrosis, according to study results.

Proper management of adverse events reduced the risk for dose reduction or treatment discontinuation, results showed.

Tamera Corte, MD, of Royal Prince Alfred Hospital, Camperdown in New South Wales, Australia, and colleagues used pooled data from the randomized, placebo-controlled INPULSIS trials to assess the safety and tolerability of nintedanib (Boehringer Ingelheim) in patients with idiopathic pulmonary fibrosis, a progressive disease characterized by dyspnea and loss of lung function. The analysis included 1,061 patients, of whom 638 received 150 mg twice-daily nintedanib and 423 received placebo.

Results showed a greater percentage of patients assigned nintedanib required at least one dose reduction to 100 mg twice daily (27.9% vs. 3.8%) or treatment interruption (23.7% vs. 9.9%). More patients assigned nintedanib discontinued treatment due to adverse events (19.3% vs. 13%).

Diarrhea was the most common adverse event, occurring in 62.4% of patients assigned nintedanib and 18.4% of those assigned placebo; 4.4% of patients assigned nintedanib discontinued medication prematurely due to diarrhea.

“In general, elevations in hepatic enzymes and total bilirubin were uncommon and returned to normal following dose reduction or treatment interruption,” Corte and colleagues wrote. “The dosing regimen utilized and the recommendations given for the management of adverse events, including symptomatic measures and hepatic enzyme monitoring, were successful in minimizing permanent treatment discontinuations. Physicians, nurses and patients will benefit from clear instructions on how to monitor patients and manage adverse events that may be associated with treatment with nintedanib.” – by Jeff Craven

Disclosure: Corte reports paid consultant roles and advisory board roles with, contributions to educational materials for, travel compensation from and educational grants from Actelion, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and InterMune. Please see the full study for a list of all other researchers’ relevant financial disclosures.