Ambrisentan ± tadalafil in WHO functional class II/III pulmonary arterial hypertension: a guide to its use in the EU
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Ambrisentan [Volibris® (EU), Letairis® (USA)], an endothelin-1 receptor antagonist, is effective in treating WHO functional class (FC) II/III pulmonary arterial hypertension (PAH) when used as monotherapy or in combination with tadalafil (a phosphodiesterase type-5 inhibitor). In patients with idiopathic PAH or PAH associated with connective tissue diseases, ambrisentan monotherapy provided sustained clinical benefits, including improvements in exercise capacity. Clinical benefits, including a lower risk of clinical failure, were greater with initial combination treatment with ambrisentan + tadalafil than with initial monotherapy with either ambrisentan or tadalafil in patients with PAH, including those in various patient subgroups. Ambrisentan has an acceptable tolerability and safety profile with or without concomitant tadalafil. Based on the results of clinical trials, current guidelines recommend ambrisentan as initial mono- or combination treatment in patients with non-vasoreactive WHO FC class II/III PAH.
The manuscript was reviewed by: L. Sargento, Heart Failure Unit, Cardiology Department, Pulido Valente Hospital, Lisbon North Hospital Centre, Lisbon, Portugal; D. Skowasch, Department of Internal Medicine II, Division of Cardiology and Pneumology, University of Bonn, Bonn, Germany. During the peer review process, Glaxo Group Ltd, the marketing authorisation holder of ambrisentan, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with ethical standards
The preparation of this review was not supported by any external funding.
Conflict of interest
K. A. Lyseng-Williamson is a salaried employee of Adis/Springer and declares no conflict of interest. J. Behr declares having received payments for consulting and lecturing from Actelion, Bayer, Biogen, Boehringer-Ingelheim, Galapagos NV, Novartis and Roche, and having received a grant from Boehringer-Ingelheim.
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