Inhaled iloprost to treat severe pulmonary hypertension. An uncontrolled trial. German PPH Study Group

Ann Intern Med. 2000 Mar 21;132(6):435-43. doi: 10.7326/0003-4819-132-6-200003210-00003.


Background: Inhaled aerosolized iloprost, a stable prostacyclin analogue, has been considered a selective pulmonary vasodilator in the management of pulmonary hypertension.

Objective: To assess the efficacy of inhaled iloprost in the treatment of life-threatening pulmonary hypertension.

Design: Open, uncontrolled, multicenter study.

Setting: Intensive care units and pulmonary hypertension clinics at six university hospitals in Germany.

Patients: 19 patients who had progressive right-heart failure despite receiving maximum conventional therapy (12 with primary pulmonary hypertension, 3 with pulmonary hypertension related to collagen vascular disease without lung fibrosis, and 4 with secondary pulmonary hypertension).

Intervention: Inhaled iloprost, 6 to 12 times daily (50 to 200 microg/d).

Measurements: Right-heart catheterization and distance walked in 6 minutes at baseline and after 3 months of therapy.

Results: During the first 3 months of therapy, New York Heart Association functional class improved in 8 patients and was unchanged in 7 patients. Four patients died, 3 of right-heart failure and 1 of sepsis. The acute hemodynamic response to inhaled iloprost was predominant pulmonary vasodilatation with little systemic effect at baseline and at 3 months (data available for 12 patients). Hemodynamic variables were improved at 3 months, and the distance walked in 6 minutes improved by 148 m (95% CI, 4.5 to 282 m; P = 0.048). Of the 15 patients who continued to use inhaled iloprost, 8 stopped: Four had lung transplantation, 1 switched to intravenous prostacyclin therapy, and 3 died. Seven patients are still receiving inhaled iloprost (mean +/-SD) duration of therapy, 536 +/- 309 days; mean dosage, 164 +/- 38 microg/d).

Conclusions: Inhaled iloprost may offer a new therapeutic option for improvement of hemodynamics and physical function in patients with life-threatening pulmonary hypertension and progressive right-heart failure that is refractory to conventional therapy.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adult
  • Aged
  • Exercise Tolerance / drug effects
  • Female
  • Follow-Up Studies
  • Heart Failure / drug therapy
  • Heart Failure / etiology
  • Hemodynamics / drug effects
  • Humans
  • Hypertension, Pulmonary / drug therapy*
  • Hypertension, Pulmonary / etiology
  • Hypertension, Pulmonary / physiopathology
  • Iloprost / administration & dosage*
  • Iloprost / adverse effects
  • Male
  • Middle Aged
  • Pulmonary Gas Exchange / drug effects
  • Statistics, Nonparametric
  • Treatment Outcome
  • Vasodilator Agents / administration & dosage*
  • Vasodilator Agents / adverse effects


  • Vasodilator Agents
  • Iloprost