PMID- 12853530
OWN - NLM
STAT- MEDLINE
DCOM- 20030805
LR  - 20190514
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 124
IP  - 1
DP  - 2003 Jul
TI  - Effects of the dual endothelin receptor antagonist bosentan in patients with 
      pulmonary arterial hypertension: a 1-year follow-up study.
PG  - 247-54
AB  - STUDY OBJECTIVES: We report on the long-term safety and efficacy of bosentan 
      treatment in patients with pulmonary arterial hypertension (PAH). BACKGROUND: In 
      a preceding study, bosentan was well tolerated and significantly improved the 
      exercise capacity and hemodynamics of patients with PAH after 12 weeks of 
      treatment. DESIGN: The present study was an open-label extension to the preceding 
      double-blind, placebo-controlled study of 32 patients with PAH (primary or 
      associated with scleroderma) who received bosentan or placebo at 125 mg bid for 3 
      to 7 months. PATIENTS: Twenty-nine of the original 32 patients received bosentan 
      for an additional year (62.5 mg bid for 4 weeks and then 125 mg bid). 
      INTERVENTIONS: Study end points included long-term safety, 6-min walk distance at 
      week 4, modified New York Heart Association (NYHA) functional class of PAH at 
      month 12, and the occurrence of withdrawal due to clinical worsening. Additional 
      exploratory analyses included a walk test at month 6 for 19 patients and 
      hemodynamic assessment at month 12 for 11 patients. RESULTS: At month 6, assessed 
      patients continuing bosentan treatment maintained the improvement in walk 
      distance observed at the end of the previous study (mean +/- SEM, 60 +/- 11 m), 
      and patients starting bosentan treatment improved their walk distance by 45 +/- 
      13 m. Long-term treatment with bosentan for > 1 year was associated with an 
      improvement in hemodynamic parameters and modified NYHA functional class. 
      Overall, bosentan treatment was well tolerated. No patient underwent 
      transplantation or died. CONCLUSIONS: Long-term treatment with bosentan is safe 
      and has sustained benefits on exercise capacity and hemodynamics in patients with 
      PAH.
FAU - Sitbon, Olivier
AU  - Sitbon O
AD  - Service de Pneumologie Reanimation Respiratoire, Hopital Antoine Beclere, 157, 
      Avenue de la Porte Trivaux, F-92141 Clamart Cedex, France. 
      olivier.sitbon@abc.ap-hop-paris.fr
FAU - Badesch, David B
AU  - Badesch DB
FAU - Channick, Richard N
AU  - Channick RN
FAU - Frost, Adaani
AU  - Frost A
FAU - Robbins, Ivan M
AU  - Robbins IM
FAU - Simonneau, Gerald
AU  - Simonneau G
FAU - Tapson, Victor F
AU  - Tapson VF
FAU - Rubin, Lewis J
AU  - Rubin LJ
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Endothelin Receptor Antagonists)
RN  - 0 (Sulfonamides)
RN  - Q326023R30 (Bosentan)
SB  - IM
MH  - Adult
MH  - Antihypertensive Agents/*therapeutic use
MH  - Bosentan
MH  - Double-Blind Method
MH  - Endothelin Receptor Antagonists
MH  - Exercise Tolerance
MH  - Female
MH  - Follow-Up Studies
MH  - Hemodynamics/physiology
MH  - Humans
MH  - Hypertension, Pulmonary/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Sulfonamides/*therapeutic use
MH  - Time Factors
EDAT- 2003/07/11 05:00
MHDA- 2003/08/06 05:00
CRDT- 2003/07/11 05:00
PHST- 2003/07/11 05:00 [pubmed]
PHST- 2003/08/06 05:00 [medline]
PHST- 2003/07/11 05:00 [entrez]
AID - S0012-3692(15)36017-7 [pii]
AID - 10.1378/chest.124.1.247 [doi]
PST - ppublish
SO  - Chest. 2003 Jul;124(1):247-54. doi: 10.1378/chest.124.1.247.