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1 Hannover Medical School, Hannover, 2 Klinikum Grosshadern, Munich, 3 University of Dresden, Dresden, 4 University of the Saarland, Homburg, 5 University of Heidelberg, Heidelberg, 6 University of Leipzig, Leipzig, 7 University of Regensburg, Regensburg, 8 University of Freiburg, Freiburg, and 9 Dept of Medicine, University Hospital Eppendorf, Hamburg, Germany.
CORRESPONDENCE: M. M. Hoeper, Hannover Medical School, Dept of Respiratory Medicine, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Fax: 49 5115328536. E-mail: hoeper.marius{at}mh-hannover.de
Keywords: Endothelin-receptor antagonists, prostaglandins, pulmonary hypertension
Received: May 1, 2006
Accepted June 22, 2006
Addition of inhaled iloprost to bosentan may have beneficial effects in patients with idiopathic pulmonary arterial hypertension (IPAH). A multicentre, open, randomised, controlled trial was performed to assess the safety and efficacy of inhaled iloprost in patients with IPAH who had already been treated with bosentan.
The trial was terminated early after a futility analysis predicted failure with respect to the predetermined sample size. At that time, 40 patients were randomised to receive either bosentan alone (control group) or bosentan plus inhaled iloprost (combination group) for a 12-week period.
The primary end-point, change in 6-min walking distance, was not met (mean changes +1 m and -9 m in the control and combination group, respectively). These results may have been skewed by three outliers in the iloprost group who presented with severe clinical worsening. None of the secondary end-points including functional class, peak oxygen uptake, and time to clinical worsening differed significantly between groups.
The current study failed to show a positive effect of adding inhaled iloprost to bosentan in idiopathic pulmonary arterial hypertension patients. Further studies involving larger sample sizes and long-term follow-up are needed to determine the efficacy of adding inhaled iloprost to bosentan in patients with idiopathic pulmonary arterial hypertension.
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