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Inhaled Iloprost for Severe Pulmonary Hypertension: Clinical Outcomes
Inhaled iloprost provided a significant clinical benefit over placebo in this 12-week trial.
Iloprost, a stable analogue of prostacyclin, can improve vasodilation in patients with pulmonary hypertension (Journal Watch Cardiology May 10 2002) and, in small studies, has improved outcomes (e.g., Journal Watch Cardiology September 1 2000). In this industry-supported European study, researchers randomized 203 patients with severe pulmonary hypertension to inhaled iloprost or to placebo. Each subject had a mean pulmonary-artery pressure >30 mm Hg, could cover 50 m to 500 m on a 6-minute walk test, and was in NYHA functional class III or IV despite treatment with conventional therapy. The primary combined endpoint at 12 weeks was a 
10% increase in 6-minute walk distance and improvement by 1 NYHA functional class.
The combined endpoint was achieved by 17% of the iloprost group and 5% of the placebo group (P=0.007): Respectively, 38% and 26% achieved the walk-distance improvement (P=0.06), and 24% and 13% achieved the NYHA-class improvement (P=0.03). Improvements in pulmonary vascular resistance, the Mahler Dyspnea Index, and quality of life with iloprost were significantly better than corresponding changes with placebo. There were 4 deaths in the placebo group and 1 in the iloprost group. Overall, adverse-event rates did not differ significantly between groups.
Comment: These data show that inhaled iloprost is an effective and safe therapy for severe pulmonary hypertension. The challenges will be to determine how broad a patient population should receive this treatment, whether it will remain effective in the long term, and how much it will cost.
— Harlan M. Krumholz, MD, SM
Published in Journal Watch Cardiology September 27, 2002
Citation(s):
Olschewski H et al. for the Aerosolized Iloprost Randomized Study Group. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med 2002 Aug 1; 347:322-9.
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