The AIR trial 2 (n = 203) was included in a Cochrane review[Abstract] 1. This multicenter 3-month RCT compared iloprost inhalations with placebo in patients with severe (NYHA class III or IV) primary and secondary pulmonary hypertension. The primary end point was a composite of improvement in exercise capacity (distance walked in 6 minutes, 6-MWD) by at least 10% and NYHA functional class by at least 1 class in the absence of clinical deterioration and death; 16.8% in the iloprost group versus 4.9% in the placebo group achieved this endpoint (P=0.007). The treatment effect on the 6-MWD was a mean increase of 36 m in the overall population in favor of iloprost (p = 0.004) and 59 m in the subgroup of patients with primary pulmonary hypertension. As compared with base-line values, hemodynamic values were significantly improved at 12 weeks when measured after iloprost inhalation (P<0.001), were largely unchanged when measured before iloprost inhalation, and were significantly worse in the placebo group. Iloprost treatment also improved the NYHA class (P=0.03), dyspnea (P=0.015), and quality of life (P=0.026). Syncope occurred with similar frequency in the two groups but was more frequently rated as serious in the iloprost group, although this adverse effect was not associated with clinical deterioration.
Another multicenter RCT 3 included 67 patients with pulmonary artery hypertension (NYHA class III) who were symptomatic while receiving a stable dose of bosentan. At week 12, patients receiving iloprost in adjunction to bosentan had a mean increase in 6-MWD of 30 m and placebo patients had a mean 6-MWD increase of 4 m; a placebo-adjusted difference of +26 m (p = 0.051). There were also improvements in NYHA functional class (p = 0.002), time to clinical worsening (p = 0.022), postinhalation mean pulmonary artery pressure (p < 0.001), and pulmonary vascular resistance (p < 0.001). Combination therapy was well tolerated.
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