A COMPARISON OF CONTINUOUS INTRAVENOUS EPOPROSTENOL (PROSTACYCLIN) WITH CONVENTIONAL THERAPY FOR PRIMARY PULMONARY-HYPERTENSION

Background. Primary pulmonary hypertension is a progressive disease fo r which no treatment has been shown in a prospective, randomized trial to improve survival. Methods. We conducted a 12-week prospective, ran domized, multicenter open trial comparing the effects of the continuou s 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 w as improved in the 41 patients treated with epoprostenol (median dista nce 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 com parison of the treatment groups). Indexes of the quality of life were improved only in the epoprostenol group (P < 0.01). Hemodynamics impro ved at 12 weeks in the epoprostenoltreated patients. The changes in me an pulmonary-artery pressure for the epoprostenol and control groups w ere -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, resp ectively (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 minut e; P < 0.001). Eight patients died during the study, all of whom had b een randomly assigned to conventional therapy (P = 0.003). Serious com plications included four episodes of catheter-related sepsis and one t hrombotic event. Conclusions. As compared with conventional therapy, t he continuous intravenous infusion of epoprostenol produced symptomati c and hemodynamic improvement, as well as improved survival in patient s with severe primary pulmonary hypertension. (C) 1996, Massachusetts Medical Society.