PMID- 17873492
OWN - NLM
STAT- MEDLINE
DCOM- 20080327
LR  - 20220331
IS  - 1421-9751 (Electronic)
IS  - 0008-6312 (Linking)
VI  - 109
IP  - 4
DP  - 2008
TI  - Clinical and hemodynamic effects of bosentan dose optimization in symptomatic 
      heart failure patients with severe systolic dysfunction, associated with 
      secondary pulmonary hypertension--a multi-center randomized study.
PG  - 273-80
AB  - OBJECTIVE: To evaluate the effects of bosentan on echo-derived hemodynamic 
      measurements, and clinical variables in symptomatic heart failure (HF) patients. 
      METHOD: Multi- center, double-blind, randomized (2:1), placebo-controlled study 
      comparing bosentan (8-125 mg b.i.d.) to placebo in patients with New York Heart 
      Association class IIIb-IV HF, left ventricular ejection fraction <35% and 
      systolic pulmonary artery pressure (SPAP) >40 mm Hg. Primary and secondary 
      endpoints were change from baseline to 20 weeks in SPAP and cardiac index, 
      respectively. Safety endpoints were treatment emergent adverse events (AEs), 
      change in body weight, hemoglobin, hematocrit, systolic blood pressure and 
      diuretic use. RESULTS: Ninety-four patients enrolled: 60 to bosentan, 34 to 
      placebo. There was no significant difference between the 2 arms in SPAP change 
      (0.1 +/- 11.5 mm Hg , 95% confidence limit (CL) -5.4 to 5.2, p = 0.97), cardiac 
      index shift (0.12 +/- 0.45, 95% CL -0.09 to 0.33 , p = 0.24 ) or any of the other 
      22 echocardiographic measurements obtained. Therapy-duration was longer in the 
      placebo arm, while more patients in the bosentan arm experienced adverse and 
      serious AEs. CONCLUSION: In HF patients with left ventricular dysfunction and 
      secondary pulmonary hypertension, bosentan did not provide any measurable 
      hemodynamic benefit, and was associated with more frequent AEs, requiring drug 
      discontinuation.
CI  - 2007 S. Karger AG, Basel
FAU - Kaluski, Edo
AU  - Kaluski E
AD  - Department of Cardiology, University of Medicine and Dentistry, Newark, NJ 07101, 
      USA. ekaluski@gmail.com
FAU - Cotter, Gad
AU  - Cotter G
FAU - Leitman, Marina
AU  - Leitman M
FAU - Milo-Cotter, Olga
AU  - Milo-Cotter O
FAU - Krakover, Ricardo
AU  - Krakover R
FAU - Kobrin, Isaac
AU  - Kobrin I
FAU - Moriconi, Tina
AU  - Moriconi T
FAU - Rainisio, Maurizio
AU  - Rainisio M
FAU - Caspi, Avraham
AU  - Caspi A
FAU - Reizin, Leonardo
AU  - Reizin L
FAU - Zimlichman, Reuven
AU  - Zimlichman R
FAU - Vered, Zvi
AU  - Vered Z
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20070917
PL  - Switzerland
TA  - Cardiology
JT  - Cardiology
JID - 1266406
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Sulfonamides)
RN  - Q326023R30 (Bosentan)
SB  - IM
MH  - Antihypertensive Agents/*administration & dosage
MH  - Bosentan
MH  - Double-Blind Method
MH  - Female
MH  - Heart Failure, Systolic/*complications/diagnostic imaging/*drug therapy
MH  - Humans
MH  - Hypertension, Pulmonary/*complications/drug therapy
MH  - Male
MH  - Severity of Illness Index
MH  - Sulfonamides/*administration & dosage
MH  - Treatment Outcome
MH  - Ultrasonography
MH  - Ventricular Dysfunction, Left/drug therapy
EDAT- 2007/09/18 09:00
MHDA- 2008/03/28 09:00
CRDT- 2007/09/18 09:00
PHST- 2006/12/14 00:00 [received]
PHST- 2007/02/16 00:00 [accepted]
PHST- 2007/09/18 09:00 [pubmed]
PHST- 2008/03/28 09:00 [medline]
PHST- 2007/09/18 09:00 [entrez]
AID - 000107791 [pii]
AID - 10.1159/000107791 [doi]
PST - ppublish
SO  - Cardiology. 2008;109(4):273-80. doi: 10.1159/000107791. Epub 2007 Sep 17.