Are there any trough efficacy data available for the effect of Ventavis?
A. The AIR trial compared the effect of 3 months of inhaled iloprost versus placebo and evaluated changes in walk distance at peak and trough levels. When walk distance was measured immediately prior to inhalation, the improvement compared to placebo was approximately 60% of the effect seen at 30 minutes after inhalation. The improvement in NYHA Functional Class was significant (P=0.03) and was not dependent upon peak/trough levels.1,3 To assess “long-term” effects, hemodynamics before inhalation (expected trough condition) and at the end of inhalation (expected peak condition) at week 12 were compared with the pre-inhalation values obtained at baseline.
A. The AIR trial compared the effect of 3 months of inhaled iloprost versus placebo and evaluated changes in walk distance at peak and trough levels. When walk distance was measured immediately prior to inhalation, the improvement compared to placebo was approximately 60% of the effect seen at 30 minutes after inhalation. The improvement in NYHA Functional Class was significant (p=0.03) and was not dependent upon peak/trough levels.1,3 To assess “long-term” effects, hemodynamics before inhalation (expected trough condition) and at the end of inhalation (expected peak condition) at week 12 were compared with the pre-inhalation values obtained at baseline. A significant improvement was observed for mPAP, PVR, and SvO2 at the peak measurement in the iloprost group (p < 0.05). At 12 weeks, patients were stable compared with baseline for trough values.