Inhaled low-dose iloprost for pulmonary hypertension: a prospective, multicenter, open-label study

Clinical Cardiology, 04/17/2012

Low–dose iloprost inhalation significantly improved exercise capacity and functional status in patients with pulmonary hypertension (PH). It was well tolerated. The improvement of hemodynamics was confirmed in patients with WHO–FCI–II but not in patients with WHO–FCIII–IV, suggesting the importance of early treatment in patients with advanced disease stages.

Methods

  • 62 patients with PH were enrolled and initiated with neubulizedlow–dose iloprost (2.5 μg per inhalation, 6× daily) for 24 weeks in 13 medical centers in China.
  • Efficacy endpoints included changes in 6–minute walk distance (6MWD), World Health Organization functional class (WHO–FC), and hemodynamic parameters.

Results

  • Fourteen patients (22.6%) prematurely discontinued the study: 8 due to clinical worsening (6 in WHO–FCIII–IV at baseline), 4 because of protocol change, and 2 patients lost during follow–up.
  • In the remaining 48 patients, 6MWD was increased from 356 ± 98 meters to 414 ± 99 meters (P < 0.001) and WHO–FC improved significantly (P = 0.006) after 24–week inhalation therapy.
  • Cardiac output, cardiac index, and mixed venous oxygen saturation improved significantly compared with baseline (n = 34, P < 0.05).
  • Most of the hemodynamic parameters improved significantly in patients in WHO–FC II (P < 0.05) but not in patients in WHO–FCIII–IV.

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