دورية أكاديمية

A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension.

التفاصيل البيبلوغرافية
العنوان: A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension.
المؤلفون: Barst RJ; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA., Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, Groves BM, Tapson VF, Bourge RC, Brundage BH, Koerner SK, Langleben D, Keller CA, Murali S, Uretsky BF, Clayton LM, Jöbsis MM, Blackburn SD, Shortino D, Crow JW
مؤلفون مشاركون: Primary Pulmonary Hypertension Study Group
المصدر: The New England journal of medicine [N Engl J Med] 1996 Feb 01; Vol. 334 (5), pp. 296-301.
نوع المنشور: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
اللغة: English
بيانات الدورية: Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Print ISSN: 0028-4793 (Print) Linking ISSN: 00284793 NLM ISO Abbreviation: N Engl J Med Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Boston, Massachusetts Medical Society.
مواضيع طبية MeSH: Epoprostenol/*administration & dosage , Hypertension, Pulmonary/*drug therapy , Platelet Aggregation Inhibitors/*administration & dosage, Adult ; Anticoagulants/therapeutic use ; Drug Administration Schedule ; Epoprostenol/adverse effects ; Exercise Tolerance/drug effects ; Female ; Hemodynamics/drug effects ; Humans ; Hypertension, Pulmonary/mortality ; Hypertension, Pulmonary/therapy ; Infusions, Intravenous ; Male ; Platelet Aggregation Inhibitors/adverse effects ; Prospective Studies ; Survival Analysis ; Treatment Outcome ; Vasodilator Agents/therapeutic use
مستخلص: 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/liter/min; 95 percent confidence interval, -7.6 to -2.3 mm Hg/liter/min; 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.
التعليقات: Comment in: N Engl J Med. 1996 May 30;334(22):1477; author reply 1477-8. (PMID: 8618595)
فهرسة مساهمة: Investigator: E Horn; J Kirkpatrick; K Wynne; W Knight; D Georgiou; J Beckman; WR Clarke; D Ralph; P Schrader; EJ Caldwell; W Williams; B Vogel; NA Ettinger; D Canfield; NS Hill; C Carlisle; A Hinderliter; PW Willis; AE Frost; K Chafizedah; D Ross; D Claire; E Shalit; B Edwards; C Severson; K Kosberg; T Tokaraczyk; L Kaufman; H Hartle; WR Summer; B deBoisblanc; B Everett; A Krichman
المشرفين على المادة: 0 (Anticoagulants)
0 (Platelet Aggregation Inhibitors)
0 (Vasodilator Agents)
DCR9Z582X0 (Epoprostenol)
تواريخ الأحداث: Date Created: 19960201 Date Completed: 19960201 Latest Revision: 20231024
رمز التحديث: 20240627
DOI: 10.1056/NEJM199602013340504
PMID: 8532025
قاعدة البيانات: MEDLINE
الوصف
تدمد:0028-4793
DOI:10.1056/NEJM199602013340504