a clinical trial to compare the efficacy of tadalafil in pulmonary hypertension and interstitial lung disease

Background: to determine the effects of oral tadalafil on respiratory function in patients with interstitial lung disease (ild), both with and without pulmonary hypertension (ph). methods: patients with ild-ph (who classes 2 and 3) were assigned to group a, while patients with ild without ph were assigned to group b. participants in both groups received a daily dose of 40 mg oral tadalafil as an add-on therapy to their conventional treatments for a duration of 6 months. the study outcomes included changes in forced vital capacity (fvc), total lung capacity (tlc), diffusion lung capacity for carbon monoxide (dlco), residual volume (rv), and a 6-minute walk distance (6mwd). results: of the 38 patients enrolled, 34 completed the 6-month treatment and were included in the final analysis. the mean age of participants was 50 years. at 6 months, no significant changes were observed in fvc, forced expiratory volume in 1 second (fev1), fev1/fvc ratio, and dlco. however, patients receiving tadalafil showed a significant improvement in median (interquartile range [iqr]) tlc after 6 months of treatment (77.1 [70.2-80.1] ml in group a versus 86.2 [86.3 - 93.1] ml in group b, p = 0.002) and in median (iqr) rv (83.1 [79.1 - 85.2] ml in group a versus 90.2 [86.3 - 93.1] ml in group b, p = 0.02). additionally, no significant differences were noted in pulmonary arterial pressure (pap) and 6mwd. no serious adverse effects were reported. conclusions: a 6-month therapy with tadalafil was shown to partially improve respiratory function in patients with ild, both with and without ph. this treatment demonstrated an acceptable safety profile.