United Therapeutics and Eli Lilly have announced the results of a pivotal 16-week study. The results showed that once-daily dose of tadalafil was generally well tolerated, improved exercise capacity and improved time to clinical worsening in patients with pulmonary arterial hypertension (PAH).
The randomized, double-blind, 16-week, placebo-controlled Phase 3 study followed 405 patients with PAH, either treatment-naive or taking bosentan, randomized to placebo or tadalafil 2.5 mg, 10 mg, 20 mg or 40 mg orally.
The study formed the basis of the FDA approval to market tadalafil tablets for the treatment of PAH under the brand name ADCIRCA.
Dr. Nazzareno Galie, Associate Professor of Cardiology and head of the Pulmonary Hypertension Centre at the Institute of Cardiology, said: The results of this study are encouraging for PAH clinicians and the patients they treat.