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Clinical Pharmacology
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Hemodynamic assessments obtained at week 12 before inhalation in both groups (at least 2 hours after a previous dose, trough) and after inhalation in the iloprost group (approximately 15 minutes after a dose, peak), are shown in Table 2. The relationship between hemodynamic changes and clinical effects is unknown.
Table 2: Hemodynamic Parameters Before and After Iloprost Inhalation: Change from Baseline to Week 12
| Baseline | Mean (± SD) change from baseline at Week 12 | ||||
| Parameter | Iloprost | Placebo | Iloprost | Placebo | |
| Before Inhalation |
After Inhalation | ||||
| PVR (dyn•s•cm-5) | 1029 ± 390 | 1041 ± 493 | -9 ± 275 (n=76) |
-239 ± 279 (n=70) |
+96 ± 323 (n=77) |
| mPAP (mmHg) | 53 ± 12 | 54 ± 14 | -0.2 ± 7.3 (n=93) |
-4.6 ± 9.3 (n=90) |
-0.1 ± 6.9 (n=82) |
| CO (L/min) | 3.8 ± 1.1 | 3.8 ± 0.9 | +0.1 ± 0.9 (n=91) |
+0.5 ± 1.1 (n=89) |
-0.2 ± 0.8 (n=80) |
| SVO2 (%) | 60 ± 8 | 60±8 | -1.1 ± 7.6 (n=72) |
+1.8 ± 8.3 (n=70) |
-3.2 ± 6.7 (n=63) |
In a small, randomized, double-blind, placebo-controlled study (the STEP trial), 34 patients treated with bosentan 125 mg bid for at least 16 weeks tolerated the addition of inhaled iloprost (up to 5 mcg 6 to 9 times per day during waking hours). The mean daily inhaled dose was 27 mcg and the mean number of inhalations per day was 5.6.
Generic Name: Iloprost
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