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Original Research |

Inhaled Iloprost To Treat Severe Pulmonary Hypertension: An Uncontrolled Trial

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, German PPH Study Group*
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From Justus-Liebig-University, Gieβen; University Clinic, Leipzig; University Clinics of Saarland, Homburg/Saar; Medical School, Hannover; University Clinic Groβhadern, Munich; and Accident Clinic, Berlin, Germany.

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, werner.seeger@innere.med.uni-giessen.de.

Requests To Purchase Bulk Reprints (minimum, 100 copies): the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints@mail.acponline.org.

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.

Ann Intern Med. 2000;132(6):435-443. doi:10.7326/0003-4819-132-6-200003210-00003
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Progressive right-heart failure is the ultimate cause of death for most patients with primary pulmonary hypertension. The prognosis is particularly poor for patients with New York Heart Association functional class IV disease and severely increased central venous pressure (1). Prostacyclin was the first drug shown to be life-saving in a controlled study of primary pulmonary hypertension (2). However, the lack of pulmonary selectivity of the vasodilatory effect and consequent systemic side effects limit the usefulness of prostacyclin (3). Patients with severe arterial hypotension and preexistent shunt areas in the lung often cannot tolerate intravenous prostacyclin (46). Inhaled nitric oxide has pulmonary selectivity, but its vasodilatory potency in the pulmonary vasculature is lower than that of prostacyclin (78). Because nitric oxide has a short half-life, interruption of nitric oxide inhalation may provoke an immediate rebound hypertensive crisis (910).

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Grahic Jump Location
Hemodynamic response at baseline and after 3 months of therapy with aerosolized iloprost.striped barswhite barsPVRSVRPPP

Pretherapy ( ) and post-therapy ( ) values (+SE) are given for 12 patients for whom complete data were available on hemodynamics at baseline and after 3 months of therapy. A single inhalation of iloprost, 8.4 to 10.5 µg, nebulized within 12 to 15 minutes was given. Mean pulmonary artery pressure, cardiac index, pulmonary vascular resistance, central venous pressure, mean systemic artery pressure, heart rate, systemic vascular resistance, and the ratio of pulmonary vascular resistance ( ) to systemic vascular resistance ratio ( ) were significantly changed by inhalation of iloprost * < 0.05 for differences in values from baseline to 3 months; † < 0.001; ‡ < 0.01, by exact Wilcoxon matched-pair signed-rank test. NS = not significant.

Grahic Jump Location




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Summary for Patients

Inhaled Iloprost to Treat Severe Pulmonary Hypertension

The summary below is from the full report titled “Inhaled Iloprost To Treat Severe Pulmonary Hypertension. An Uncontrolled Trial.”. It is in the 21 March 2000 issue of Annals of Internal Medicine (volume 132, pages 435-443). The authors are H. Olschewski, H.A. Ghofrani, T. Schmehl, J. Winkler, H. Wilkens, M.M. Höper, J. Behr, F.-X. Kleber, and W. Seeger, for the German PPH Study Group.


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