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Original Article
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Volume 334:296-301 February 1, 1996 Number 5
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A Comparison of Continuous Intravenous Epoprostenol (Prostacyclin) with Conventional Therapy for Primary Pulmonary Hypertension
Robyn J. Barst, M.D., Lewis J. Rubin, M.D., Walker A. Long, M.D., Michael D. McGoon, M.D., Stuart Rich, M.D., David B. Badesch, M.D., Bertron M. Groves, M.D., Victor F. Tapson, M.D., Robert C. Bourge, M.D., Bruce H. Brundage, M.D., Spencer K. Koerner, M.D., David Langleben, M.D., Cesar A. Keller, M.D., Srinivas Murali, M.D., Barry F. Uretsky, M.D., Linda M. Clayton, Pharm.D., Maria M. Jöbsis, B.A., Shelmer D. Blackburn, B.A., Denise Shortino, M.S., James W. Crow, Ph.D., for The Primary Pulmonary Hypertension Study Group

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ABSTRACT

Background Primary pulmonary hypertension is a progressive disease for which no treatment has been shown in a prospective, randomized trial to improve survival.

Methods We conducted a 12-week prospective, randomized, multicenter open trial comparing the effects of the continuous intravenous infusion of epoprostenol (formerly called prostacyclin) plus conventional therapy with those of conventional therapy alone in 81 patients with severe primary pulmonary hypertension (New York Heart Association functional class III or IV).

Results Exercise capacity was improved in the 41 patients treated with epoprostenol (median distance walked in six minutes, 362 m at 12 weeks vs. 315 m at base line), but it decreased in the 40 patients treated with conventional therapy alone (204 m at 12 weeks vs. 270 m at base line; P<0.002 for the comparison of the treatment groups). Indexes of the quality of life were improved only in the epoprostenol group (P<0.01).

Hemodynamics improved at 12 weeks in the epoprostenol-treated patients. The changes in mean pulmonary-artery pressure for the epoprostenol and control groups were -8 percent and +3 percent, respectively (difference in mean change, -6.7 mm Hg; 95 percent confidence interval, -10.7 to -2.6 mm Hg; P<0.002), and the mean changes in pulmonary vascular resistance for the epoprostenol and control groups were -21 percent and +9 percent, respectively (difference in mean change, -4.9 mm Hg per liter per minute; 95 percent confidence interval, -7.6 to -2.3 mm Hg per liter per minute; P<0.001). Eight patients died during the study, all of whom had been randomly assigned to conventional therapy (P = 0.003). Serious complications included four episodes of catheter-related sepsis and one thrombotic event.

Conclusions As compared with conventional therapy, the continuous intravenous infusion of epoprostenol produced symptomatic and hemodynamic improvement, as well as improved survival in patients with severe primary pulmonary hypertension.


Source Information

From the Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York (R.J.B.); the Department of Medicine, University of Maryland, Baltimore (L.J.R.); the Department of Pediatrics, University of North Carolina, Chapel Hill (W.A.L.); the Department of Medicine, Mayo Medical Center, Rochester, Minn. (M.D.M.); the Department of Medicine, University of Illinois at Chicago (S.R.); the Department of Medicine, University of Colorado Health Sciences Center, Denver (D.B.B., B.M.G.); the Department of Medicine, Duke University Medical Center, Durham, N.C. (V.F.T.); the Department of Medicine, University of Alabama, Birmingham (R.C.B.); the Department of Medicine, Harbor–UCLA Medical Center, Torrance, Calif. (B.H.B.); the Department of Medicine, Cedars–Sinai Medical Center, Los Angeles (S.K.K.); the Department of Medicine, Sir Mortimer B. Davis Jewish General Hospital, McGill University, Montreal (D.L.); the Department of Medicine, Baylor College of Medicine, Houston (C.A.K.); the Department of Medicine, Presbyterian–University Hospital, University of Pittsburgh, Pittsburgh (S.M., B.F.U.); and the Medical Division, Burroughs Wellcome, Research Triangle Park, N.C. (L.M.C., M.M.J., S.D.B., D.S., J.W.C.).

Address reprint requests to Dr. Barst at the Division of Pediatric Cardiology, Department of Pediatrics, BH 262N, Columbia University College of Physicians and Surgeons, 3959 Broadway, New York, NY 10032.

Full Text of this Article


Related Letters:

Intravenous Epoprostenol for Primary Pulmonary Hypertension
Schulze-Neick I., Lange P. E., Haas N. A., Higenbottam T., Barst R. J., Rubin L. J.
Extract | Full Text  
N Engl J Med 1996; 334:1477-1478, May 30, 1996. Correspondence

Epoprostenol (Prostacyclin) Therapy in Primary Pulmonary Hypertension
Botney M., Rich S., McLaughlin V. V.
Extract | Full Text  
N Engl J Med 1998; 338:1773-1774, Jun 11, 1998. Correspondence

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