PMID- 11985913
OWN - NLM
STAT- MEDLINE
DCOM- 20020517
LR  - 20211223
IS  - 0735-1097 (Print)
IS  - 0735-1097 (Linking)
VI  - 39
IP  - 9
DP  - 2002 May 1
TI  - Effects of beraprost sodium, an oral prostacyclin analogue, in patients with 
      pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled 
      trial.
PG  - 1496-502
AB  - OBJECTIVES: The purpose of this study was to assess the efficacy and safety of 
      beraprost sodium, an orally active prostacyclin analogue, in New York Heart 
      Association (NYHA) functional class II and III patients with pulmonary arterial 
      hypertension (PAH). BACKGROUND: Pulmonary arterial hypertension is a 
      life-threatening disease for which continuous intravenous infusion of 
      prostacyclin has been proven effective. However, this treatment is associated 
      with serious complications arising from the complex delivery system. METHODS: In 
      this double-blind, placebo-controlled study, 130 patients with PAH were 
      randomized to the maximal tolerated dose of beraprost (median dose 80 microg four 
      times a day) or to placebo for 12 weeks. The primary end point was the change in 
      exercise capacity assessed by the 6-min walk test. Secondary end points included 
      changes in Borg dyspnea index, cardiopulmonary hemodynamics and NYHA functional 
      class. RESULTS: Patients treated with beraprost improved exercise capacity and 
      symptoms. The difference between treatment groups in the mean change of 6-min 
      walking distance at week 12 was 25.1 m (95% confidence interval [CI]: 1.8 to 
      48.3, p = 0.036). The difference in the mean change of Borg dyspnea index was 
      -0.94 (95% CI: -1.63 to -0.24, p = 0.009). In the sub-group of patients with 
      primary pulmonary hypertension, the difference in the mean change of 6-min 
      walking distance was 46.1 m (95% CI: 3.0 to 89.3, p = 0.035). Cardiopulmonary 
      hemodynamics and NYHA functional class had no statistically significant changes. 
      Drug-related adverse events were common in the titration phase and decreased in 
      the maintenance period. CONCLUSIONS: Beraprost improves exercise capacity and 
      symptoms in NYHA functional class II and III patients with PAH and, in 
      particular, in those with primary pulmonary hypertension.
FAU - Galie, Nazzareno
AU  - Galie N
AD  - Institute of Cardiology, University of Bologna, Bologna, Italy. 
      n.galie@bo.nettuno.it
FAU - Humbert, Marc
AU  - Humbert M
FAU - Vachiery, Jean-Luc
AU  - Vachiery JL
FAU - Vizza, Carmine Dario
AU  - Vizza CD
FAU - Kneussl, Meinhard
AU  - Kneussl M
FAU - Manes, Alessandra
AU  - Manes A
FAU - Sitbon, Olivier
AU  - Sitbon O
FAU - Torbicki, Adam
AU  - Torbicki A
FAU - Delcroix, Marion
AU  - Delcroix M
FAU - Naeije, Robert
AU  - Naeije R
FAU - Hoeper, Marius
AU  - Hoeper M
FAU - Chaouat, Ari
AU  - Chaouat A
FAU - Morand, Sophie
AU  - Morand S
FAU - Besse, Bruno
AU  - Besse B
FAU - Simonneau, Gerald
AU  - Simonneau G
CN  - Arterial Pulmonary Hypertension and Beraprost European (ALPHABET) Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
RN  - 0 (Vasodilator Agents)
RN  - 35E3NJJ4O6 (beraprost)
RN  - DCR9Z582X0 (Epoprostenol)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Double-Blind Method
MH  - Dyspnea/etiology
MH  - Epoprostenol/administration & dosage/*analogs & 
      derivatives/*pharmacology/therapeutic use
MH  - Exercise Tolerance/*drug effects
MH  - Female
MH  - Heart Failure/classification/complications/physiopathology
MH  - Hemodynamics/drug effects
MH  - Humans
MH  - Hypertension, Pulmonary/complications/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Vasodilator Agents/administration & dosage/*pharmacology/therapeutic use
EDAT- 2002/05/03 10:00
MHDA- 2002/05/23 10:01
CRDT- 2002/05/03 10:00
PHST- 2002/05/03 10:00 [pubmed]
PHST- 2002/05/23 10:01 [medline]
PHST- 2002/05/03 10:00 [entrez]
AID - S0735109702017862 [pii]
AID - 10.1016/s0735-1097(02)01786-2 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2002 May 1;39(9):1496-502. doi: 10.1016/s0735-1097(02)01786-2.