Acute hemodynamic response in relation to plasma vardenafil levels in patients with pulmonary hypertension

British Journal of Clinical Pharmacology, 05/10/2012

Vardenafil causes rapid changes in cardiopulmonary hemodynamics, and there is a correlation between plasma vardenafil drug concentration and the acute changes in mPAP as well as PVR in patients with PH.

Methods

  • Sixteen patients with PH (aged 29–85 years), received one single oral dose of vardenafil (5, 10, or 20 mg).
  • The hemodynamic effect was assessed over a 60–min period.
  • Vardenafil plasma concentrations were measured after 15, 30, 45, and 60 min using liquid chromatography–tandem mass spectrometry.

Results

  • At 60 min a reduction in mPAP with a median percent decrease of –20.3% (range –48.3 to 3.0; p < 0.001) and an increase in cardiac output and the cardiac index with a median percent change of 10.6% (range –25.0 to 88.1; p = 0.015) and 12.1% (range –24.0 to 94.4; p = 0.01) respectively was observed.
  • The pulmonary vascular resistance (PVR) was reduced with a median percent decrease of –28.9% (range –61.5 to –5.9; p < 0.001), and pulmonary selectivity was reflected by a median percent reduction of –16.9% (range –49.0 to 16.5; p = 0.002; n = 14) in the PVR/systemic vascular resistance ratio.
  • There was a correlation between the plasma concentrations of vardenafil and change in mPAP (r = –0.579, p = 0.019), and between vardenafil concentrations and change in PVR (r = –0.662, p = 0.005).

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