Tadalafil for the treatment of pulmonary arterial hypertension

Abstract

Background: Tadalafil, a long-acting phosphodiesterase-5 inhibitor (PDE-5) is the most recent oral agent to receive FDA approval for the treatment of pulmonary arterial hypertension (PAH). Objective: With several new agents emerging for the treatment of PAH, this article reviews tadalafil, the compound and its properties, clinical evidence supporting its use, and the role of tadalafil in the current treatment approach for patients with PAH. Methods: A broad PubMed literature search was performed to identify the most current data on the use of tadalafil for PAH. Results: Tadalafil received FDA approval in 2009 following the recently published pivotal trial that demonstrated that the use of tadalafil 40 mg once daily was well tolerated, improved exercise capacity and quality of life measures and reduced time to clinical worsening in PAH patients. As the second PDE-5 inhibitor to gain approval for PAH, clinical properties such as its long half-life leading to once-daily dosing and possibly improved compliance, as well as potential cost benefit, may distinguish tadalafil from sildenafil in the widespread treatment of PAH.

Keywords::

• phosphodiesterase-5 inhibitor
• pulmonary arterial hypertension
• tadalafil

Notes

Strength of recommendation A: Strong recommendation; B: Moderate recommendation; C: Weak recommendation; D: Negative recommendation; I: No recommendation possible (inconclusive); E/A: Strong recommendation on the basis of expert opinion only; E/B: Moderate recommendation on the basis of expert opinion only; E/C: Weak recommendation on the basis of expert opinion only; E/D: Negative recommendation on the basis of expert opinion only.

Reprinted with permission from [10].

Reprinted with permission from Galie N, et al. Tadalafil therapy for pulmonary arterial hypertension. Circulation 2009;119:2894-903 [28].