Ambrisentan Not Effective in Idiopathic Pulmonary Fibrosis
Increased risk of disease progression, respiratory hospitalizations with ambrisentan treatment
TUESDAY, May 7 (HealthDay News) -- The endothelin A receptor-selective antagonist ambrisentan is not effective for reducing the rate of idiopathic pulmonary fibrosis (IPF) progression, according to a study published in the May 7 issue of the Annals of Internal Medicine.
To examine whether ambrisentan reduces the rate of IPF progression, Ganesh Raghu, M.D., from the University of Washington in Seattle, and colleagues randomized patients (aged 40 to 80 years) with IPF, with minimal or no honeycombing on high-resolution computed tomography scans, to receive ambrisentan (10 mg/day) or placebo.
Noting that interim analysis indicated a low likelihood of showing efficacy for the end point by the scheduled end of the study, the researchers terminated the study after enrollment of 492 patients (75 percent of intended enrollment; mean duration of exposure to study medication, 34.7 weeks). There was a significantly increased likelihood of meeting the prespecified criteria for disease progression among the ambrisentan-treated versus placebo-treated patients (27.4 percent versus 17.2 percent; hazard ratio, 1.74). The decline in lung function was seen in 16.7 percent of ambrisentan-treated patients and in 11.7 percent of placebo-treated patients (P = 0.11). Respiratory hospitalizations were significantly higher in the ambrisentan group than the placebo group (13.4 versus 5.5 percent, respectively). There was a nonsignificant difference in the number of deaths between the two groups (7.9 percent of ambrisentan-treated and 3.7 percent of placebo-treated patients; P = 0.10).
"Ambrisentan was not effective in treating IPF and may be associated with an increased risk for disease progression and respiratory hospitalizations," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Gilead Sciences, which funded the study.