Horst Olschewski, MD; H. Ardeschir Ghofrani, MD; Thomas Schmehl, PhD; Jörg Winkler, MD; Heinrike Wilkens, MD; Marius M. Höper, MD; Jürgen Behr, MD; Franz-Xaver Kleber, MD; Werner Seeger, MD; for the German PPH Study Group*
Acknowledgments: The authors thank Saskia Diehl and Friederike Rohlfing for data preparation and illustrations; Ralph Wiedemann and Xavier Lopes-Ribeiro for technical assistance; Wolfgang Pabst and Dr. R.H. Bödeker, Institute for Medical Statistics, Justus-Liebig-University Gieβen, for the statistics; and Mary Kay Steen-Mueller, MD, for carefully reviewing the manuscript.
Grant Support: By the PPH e.V., gemeinnütziger Selbsthilfe- und Förderverein, and Deutsche Forschungsgemeinschaft, SFB 547.
Requests for Single Reprints: Werner Seeger, MD, Department of Internal Medicine II, Justus-Liebig-University, Klinikstrasse 36, D-35392 Gieβen, Germany; e-mail, email@example.com.
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Current Author Addresses: Drs. Olschewski, Ghofrani, Schmehl, and Seeger: Department of Internal Medicine II, Justus-Liebig-University, Klinikstrasse 36, D-35392 Gieβen, Germany.
Dr. Winkler: Department of Pneumology, University Clinic, Johannesallee 32, D-04103 Leipzig, Germany.
Dr. Wilkens: Department of Pneumology, University Clinics of Saarland, Im Gelände, D-66421 Homburg/Saar, Germany.
Dr. Höper: Department of Pneumology, Medical School, Carl-Neuberg-Strasse 1, D-30625 Hannover, Germany.
Dr. Behr: Department of Pneumology, University Clinic Groβhadern, Marchioninistrasse 15, D-81377 Munich, Germany.
Dr. Kleber: Department of Internal Medicine, Accident Clinic, Rapsweg 55, D-12683 Berlin, Germany.
Author Contributions: Conception and design: H. Olschewski, H.A. Ghofrani, W. Seeger.
Analysis and interpretation of the data: H. Olschewski, H.A. Ghofrani, T. Schmehl, M.M. Höper, F.-X. Kleber, W. Seeger.
Drafting of the article: H. Olschewski, W. Seeger.
Critical revision of the article for important intellectual content: H. Olschewski, H.A. Ghofrani, M.M. Höper, F.-X. Kleber.
Final approval of the article: H. Olschewski, H.A. Ghofrani, J. Winkler, H. Wilkens, M.M. Höper, J. Behr, W. Seeger.
Provision of study materials or patients: H. Olschewski, H.A. Ghofrani, J. Winkler, H. Wilkens, M.M. Höper, J. Behr, F.-X. Kleber, W. Seeger.
Statistical expertise: H. Olschewski, T. Schmehl.
Administrative, technical, or logistic support: T. Schmehl, J. Winkler, W. Seeger.
Collection and assembly of data: H. Olschewski, H.A. Ghofrani, T. Schmehl, J. Winkler, H. Wilkens, M.M. Höper, J. Behr, F.-X. Kleber.
Inhaled aerosolized iloprost, a stable prostacyclin analogue, has been considered a selective pulmonary vasodilator in the management of pulmonary hypertension.
To assess the efficacy of inhaled iloprost in the treatment of life-threatening pulmonary hypertension.
Open, uncontrolled, multicenter study.
Intensive care units and pulmonary hypertension clinics at six university hospitals in Germany.
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).
Inhaled iloprost, 6 to 12 times daily (50 to 200 µg/d).
Right-heart catheterization and distance walked in 6 minutes at baseline and after 3 months of therapy.
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 µg/d).
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.
*For additional members of the German PPH Study Group, see the Appendix.
Horst Olschewski, H. Ardeschir Ghofrani, Thomas Schmehl, Jörg Winkler, Heinrike Wilkens, Marius M. Höper, et al. Inhaled Iloprost To Treat Severe Pulmonary Hypertension: An Uncontrolled Trial. Ann Intern Med. 2000;132:435–443. doi: 10.7326/0003-4819-132-6-200003210-00003
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Published: Ann Intern Med. 2000;132(6):435-443.
Pulmonary Hypertension, Pulmonary/Critical Care.
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