Background and importance Idiopathic pulmonary fibrosis (IPF) is a progressive disease with a poor prognosis. Nintedanib and pirfenidone are the only drugs indicated for this pathology. In pivotal clinical trials these drugs reduced the decline in forced vital capacity (FVC), which is consistent with a slowing of disease progression.
Aim and objectives Evaluation of the effectiveness and safety of nintedanib and pirfenidone in IPF in a second-level hospital.
Material and methods A descriptive study was designed in patients diagnosed with IPF treated with nintedanib or pirfenidone for at least 11 months. The following data were recorded: sex, age, dose, duration of treatment, initial FVC, FVC at 12 and 24 months, and death from any cause. The Electronic Medical Record (Selene), outpatient pharmacy software Farmatools and IBM SPSS Statistics were used. Patient data were collected between 1 January 2015 and 1 September 2021. To evaluate the effectiveness, the decline in FVC was used as the main variable. Dose reduction, time until dose reduction, and treatment discontinuation were used to evaluate safety.
Results Thirty patients were included: 23 (76.7%) men and 7 (23.3%) women, mean age 67 (49–83) years. A total of 16 (53.3%) patients received nintedanib and 14 (46.7%) pirfenidone. Mean duration of treatment was 2.8 (0.9–5) years. Mean FVC at the beginning of treatment was 2.47 L (95% CI ±0.71 L) and at 12 months the mean FVC was 2.40 L (95% CI ±0.65 L). In 16 patients it was possible to record a second FVC measurement at 24 months with a mean of 2.26 L (95% CI ±0.65 L). Death was recorded in 10 (33.3%) patients (5 (50%) in the nintedanib group and 5 (50%) in the pirfenidone group). Of all the patients, 6 (20.0%) had to reduce the dose (4 (66.7%) in the nintedanib group and 2 (33.3%) in the pirfenidone group). The mean treatment time until dose reduction was 6 (1–19) months. Four (13.3%) patients discontinued treatment due to adverse effects, all with nintedanib.
Conclusion and relevance FVC decreased slightly after 1 year of antifibrotic treatment and followed the same pace for 2 years. These results were comparable to those obtained in the pivotal clinical trials.
The safety of the treatment is acceptable, although one-fifth part of the patients had to reduce the dose due to adverse effects, and at least 1 in 10 patients had to abandon the treatment due to intolerance.
Conflict of interest No conflict of interest
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