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SCIENTIFIC STATEMENT:
Prevention of Torsade de Pointes in Hospital Settings
ACC 2009 Advocacy Position Statement: Principles for Comparative Effectiveness Research
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J Am Coll Cardiol, 2003; 41:2119-2125, doi:10.1016/S0735-1097(03)00463-7
© 2003 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: CLINICAL TRIAL

Beraprost therapy for pulmonary arterial hypertension

Robyn J. Barst, MD, FACC*,*, Michael McGoon, MD{dagger}, Vallerie McLaughlin, MD, FACC{ddagger}, Victor Tapson, MD, FCCP§, Ronald Oudiz, MD, FACC||, Shelley Shapiro, MD, Ivan M. Robbins, MD#, Richard Channick, MD**, David Badesch, MD{dagger}{dagger}, Barry K. Rayburn, MD, FACC{ddagger}{ddagger}, Robin Flinchbaugh, BS§§, Jeff Sigman, BA§§, Carl Arneson, MStat§§, Roger Jeffs, PhD§§ Beraprost Study Group

* Columbia University College of Physicians and Surgeons, New York, New York, USA
{dagger} Mayo Clinic, Rochester, Minnesota, USA
{ddagger} Rush Presbyterian-St. Luke’s Medical Center, Chicago, Illinois, USA
§ Duke University Medical Center, Durham, North Carolina, USA
|| Research and Education Institute at Harbor-UCLA Medical Center, Torrance, California, USA
USC Medical Center, Los Angeles, California, USA
# Vanderbilt University Medical Center, Nashville, Tennessee, USA
** University of California-San Diego Medical Center, La Jolla, California, USA
{dagger}{dagger} University of Colorado Health Sciences Center, Denver, Colorado, USA
{ddagger}{ddagger} University of Alabama at Birmingham, Birmingham, Alabama, USA
§§ United Therapeutics Corporation, Research Triangle Park, North Carolina, USA

Manuscript received July 3, 2002; revised manuscript received October 3, 2002, accepted November 19, 2002.

* Reprint requests and correspondence: Dr. Robyn J. Barst, Columbia University College of Physicians and Surgeons, 3959 Broadway BHN 2-255, New York, New York 10032, USA.
rjb3{at}columbia.edu

OBJECTIVES: The purpose of this study was to assess the safety and efficacy of the oral prostacyclin analogue beraprost sodium during a 12-month double-blind, randomized, placebo-controlled trial in patients with pulmonary arterial hypertension (PAH).

BACKGROUND: Pulmonary arterial hypertension is a progressive disease that ultimately causes right heart failure and death. Despite the risks from its delivery system, continuous intravenous epoprostenol remains the most efficacious treatment currently available.

METHODS: A total of 116 patients with World Health Organization (WHO) functional class II or III primary pulmonary hypertension or PAH related to either collagen vascular diseases or congenital systemic to pulmonary shunts were enrolled. Patients were randomized to receive the maximal tolerated dose of beraprost sodium (median dose 120 µg four times a day) or placebo for 12 months. The primary end point was disease progression; i.e., death, transplantation, epoprostenol rescue, or >25% decrease in peak oxygen consumption (VO2). Secondary end points included exercise capacity assessed by 6-min walk test and peak VO2, Borg dyspnea score, hemodynamics, symptoms of PAH, and quality of life.

RESULTS: Patients treated with beraprost exhibited less evidence of disease progression at six months (p = 0.002), but this effect was not evident at either shorter or longer follow-up intervals. Similarly, beraprost-treated patients had improved 6-min walk distance at 3 months by 22 m from baseline and at 6 months by 31 m (p = 0.010 and 0.016, respectively) compared with placebo, but not at either 9 or 12 months. Drug-related adverse events were common and were related to the disease and/or expected prostacyclin adverse events.

CONCLUSIONS: These data suggest that beneficial effects may occur during early phases of treatment with beraprost in WHO functional class II or III patients but that this effect attenuates with time.

Abbreviations and Acronyms
  PAH = pulmonary arterial hypertension
  PPH = primary pulmonary hypertension
  QID = four times daily
  VCO2 = minute CO2 output
  VE = minute ventilation
  VE/VCO2 = ventilatory equivalent for CO2
  VO2 = oxygen consumption
  WHO = World Health Organization




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