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.
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Olschewski H, Ghofrani HA, Schmehl T, Winkler J, Wilkens H, Höper MM, 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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