Ambrisentan and tadalafil as initial combination therapy for pulmonary arterial hypertension: clinical effect and haemodynamic changes. An Italian multicenter retrospective analysis

Background: Initial combination treatment with ambrisentan and tadalafil (up-front therapy) offers clinical benefits in pulmonary arterial hypertension (PAH) and reduces the risk of clinical failure compared with monotherapy in naive patients. Aims: To assess the efficacy of 12 month up-front therapy with ambrisentan and tadalafil to improve hemodynamic changes in incident PAH patients. Methods: This is a multicentre retrospective analysis of real-world Italian clinical data in 56 patients with newly diagnosed PAH. Clinical evaluation, including demographics, medical history, World Health Organization (WHO) functional class, 6-minutes walk distance (6MWD), and right heart catheterization (RHC) were collected from medical records at baseline and 12 month of follow up. Results: WHO functional class at baseline was: II in 12 patients, III in 38 and IV in 6. Over a median follow-up period of 12 months, 53 (95%) patients are still alive, 6 (11%) of whom received parenteral prostanoids. Ambrisentan-tadalafil association was a associated with significant improvements in WHO-functional class (2.2±0.8 vs 2.8±0.6, p Conclusion: This study shows that initial combination with oral medications ambrisentan and tadalafil offers clinical benefits, and significant haemodynamic improvement in newly diagnosed PAH patients.