Background and Importance Nintedanib and pirfenidone are the only drugs indicated for the treatment of c (IPF). Both drugs have diarrhoea in 62.4% and 18.8%, respectively, described in the Summary of Product Characteristics(SmPC) as a frequent adverse effect(AE).
In case of diarrhea, it is recommended to reduce the dose or stop treatment.
Aim and Objectives To analyse the frequency of appearance of diarrhoea of the treatment with pirfenidone and nintedanib described in SmPC with that of the patients in the study and to describe the action carried out.
Material and Methods Retrospective observational study between January 2017 and August 2022 in which IPF patients treated with nintedanib or pirfenidone were included.
The following variables were collected: age, sex, drug, duration of treatment, withdrawal reason, existence of diarrhoea and severity according to medical evaluation and, if necessary, the corrective action taken (dose reduction, treatment discontinuation or control of the AE with another drug).
For statistical analysis, mean, median and standard deviation(SD) were performed. The odds ratio (OR) was calculated with the data obtained and those described in the SmPC of each medication.
Results Thirty patients were included with a mean ± SD age of 72 ± 8 years, of which 23.3%(7) were women. 80.0%(24) received treatment with nintedanib (duration range: 37 and 1953 days), and 20.0%(6) were treated with pirfenidone (duration range: 124 and 1073 days).
Of the patients treated with pirfenidone, 83.0%(5) discontinued treatment (none due to EA). 17%(1) had mild diarrhoea that was controlled with loperamide.
66.7%(16) of nintedanib patients presented diarrhoea (7 severe, 7 moderate, and 2 mild). Of these, 37.5%(6) were treated with loperamide maintaining the dose, 18.7%(3) discontinued treatment, and 43.8%(7) underwent a dose reduction. This adjustment allowed treatment to continue in 71.4%(5/7) of the patients. The OR of diarrhoea in study patients, compared to described in SmPC, with nintedanib was 1.21 CI95 (0.51-2.86) and with pirfenidone was 0.86 CI95 (0.10-7.47).
Conclusion and Relevance The appearance of diarrhoea in both drugs is very frequent. No statistically significant differences were observed in the frequency of onset of diarrhoea in patients at our hospital compared to those described in the SmPC.
In most cases diarrhoea was controlled by dose reduction or loperamide administration.
Conflict of Interest No conflict of interest
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