Self-reported Gastrointestinal Side Effects of Antifibrotic Drugs in Dutch Idiopathic Pulmonary Fibrosis patients

Abstract

PurposeIdiopathic pulmonary fibrosis (IPF) is an inexorably progressive disease, which has a great impact on patients’ lives. Pirfenidone and nintedanib are approved and recommended antifibrotic drugs for patients with IPF. The aim of this study was to evaluate self-reported gastrointestinal side effects of antifibrotic drugs in 176 Dutch IPF patients.MethodsA cross-sectional web-based anonymous survey about complaints and side effects was conducted among IPF patients in the Netherlands. Logistic regression was used to quantify whether pirfenidone and nintedanib caused complaints of nausea, vomiting, diarrhoea, appetite loss, weight loss or loss of taste or smell perception.ResultsThe questionnaire was completed by 176 IPF patients, 71 of whom used pirfenidone and 85 nintedanib, while 20 patients did not use any antifibrotic drugs. Nintedanib users reported complaints of diarrhoea, vomiting, weight loss and loss of appetite (p < 0.01). Nausea was a significant adverse reaction (p < 0.05). Pirfenidone caused increased appetite loss (p < 0.01) and the risk of weight loss (p < 0.05). The increase in loss of appetite and weight loss did not differ significantly between the two drugs.ConclusionThe current study showed that nintedanib causes a significant increase in diarrhoea, vomiting, weight loss and loss of appetite, while pirfenidone led to loss of appetite. Our results suggest new avenues regarding dietary recommendations for IPF patients.

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“…In case of incessant diarrhoea, the next step may be rehydration and anti-diarrhoeal medication, for example loperamide, and in case of constant nausea, anti-emetics. Furthermore, antacids are recommended for indigestion [41]. Although there is no 'one-size-fits-all' policy for persistent side effects, supervised dose reduction and re-titration may be required once the symptoms have subsided.…”

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“…These have been well documented in prior studies; in the INPULSIS trials, 62.4% of patients noted diarrhea associated with nintedanib therapy, compared to 18.4% of patients receiving placebo 4 . In a study by Proesmans et al, evaluating subjective gastrointestinal side effects of patients on antifibrotic therapies, nintedanib (48.3%) users noted a significant increase in diarrhea, weight loss, vomiting, and loss of appetite compared to placebo (11.4%) [ 52 ]. Pirfenidone (40.3%) users also noted loss of appetite and weight loss [ 52 ].…”

“…In a study by Proesmans et al, evaluating subjective gastrointestinal side effects of patients on antifibrotic therapies, nintedanib (48.3%) users noted a significant increase in diarrhea, weight loss, vomiting, and loss of appetite compared to placebo (11.4%) [ 52 ]. Pirfenidone (40.3%) users also noted loss of appetite and weight loss [ 52 ]. Both nintedanib and pirfenidone have also been associated with elevations in liver-associated enzymes, as well [ 52 ].…”

“…Pirfenidone (40.3%) users also noted loss of appetite and weight loss [ 52 ]. Both nintedanib and pirfenidone have also been associated with elevations in liver-associated enzymes, as well [ 52 ]. Cottin et al evaluated the long-term safety of pifenidone through the results of the PASSPORT trial, a prospective observational study of 1009 IPF patients in Europe treated with pirfenidone [ 53 ].…”

“…As such, it is paramount to identify ways to attenuate these ADRs. Dietary interventions have been suggested, to include the use of a BRAT (bananas rice applesauce toast) diet, therapeutic intervention with antimotility or antiemetic agents such as loperamide or ondansetron, respectively, and attention to improved oral hydration [ 52 ]. Dose adjustments, through either dose reductions or interruptions in antifibrotic therapy, have also been noted to attenuate gastrointestinal adverse effects and decrease the discontinuation of therapy [ 52 ].…”