PMID- 16946127
OWN - NLM
STAT- MEDLINE
DCOM- 20070110
LR  - 20231024
IS  - 1073-449X (Print)
IS  - 1073-449X (Linking)
VI  - 174
IP  - 11
DP  - 2006 Dec 1
TI  - Randomized study of adding inhaled iloprost to existing bosentan in pulmonary 
      arterial hypertension.
PG  - 1257-63
AB  - RATIONALE: Small, open-label studies suggest that combinations of existing 
      therapies may be effective for pulmonary arterial hypertension (PAH). OBJECTIVE: 
      To evaluate the safety and efficacy of adding inhaled iloprost, a prostacyclin 
      analog, to the endothelin receptor antagonist bosentan in patients with PAH. 
      METHODS: In a randomized, multicenter, double-blind trial, inhaled iloprost (5 
      mug) or placebo was added to stable monotherapy with bosentan for 12 wk. Efficacy 
      endpoints included change from baseline in 6-min-walk distance (6-MWD), modified 
      New York Heart Association (NYHA) functional class, hemodynamic parameters, and 
      time to clinical worsening. MEASUREMENTS AND MAIN RESULTS: A total of 67 patients 
      with PAH (55% idiopathic PAH, 45% associated PAH, 94% NYHA class III, and mean 
      baseline 6-MWD of 335 m) were randomized. At Week 12, patients receiving iloprost 
      had a mean increase in 6-MWD of 30 m (p = 0.001); placebo patients had a mean 
      6-MWD increase of 4 m (p = 0.69), with a placebo-adjusted difference of +26 m (p 
      = 0.051). NYHA status improved by one class in 34% of iloprost versus 6% of 
      placebo patients (p = 0.002). Iloprost delayed the time to clinical worsening (p 
      = 0.0219). Improvements were noted in postinhalation placebo-adjusted change in 
      mean pulmonary artery pressure (-8 mm Hg; p < 0.001) and pulmonary vascular 
      resistance (-254 dyn x s x cm(-5); p < 0.001). Combination therapy was well 
      tolerated. CONCLUSIONS: Within the limitations of a relatively small sample size, 
      results of this study demonstrate that the addition of inhaled iloprost in 
      patients with PAH with reduced exercise capacity on bosentan monotherapy is safe 
      and efficacious.
FAU - McLaughlin, Vallerie V
AU  - McLaughlin VV
AD  - The University of Michigan Health System, Ann Arbor, Michigan, USA. 
      vmclaugh@umich.edu
FAU - Oudiz, Ronald J
AU  - Oudiz RJ
FAU - Frost, Adaani
AU  - Frost A
FAU - Tapson, Victor F
AU  - Tapson VF
FAU - Murali, Srinivas
AU  - Murali S
FAU - Channick, Richard N
AU  - Channick RN
FAU - Badesch, David B
AU  - Badesch DB
FAU - Barst, Robyn J
AU  - Barst RJ
FAU - Hsu, Henry H
AU  - Hsu HH
FAU - Rubin, Lewis J
AU  - Rubin LJ
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20060831
PL  - United States
TA  - Am J Respir Crit Care Med
JT  - American journal of respiratory and critical care medicine
JID - 9421642
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Sulfonamides)
RN  - 0 (Vasodilator Agents)
RN  - JED5K35YGL (Iloprost)
RN  - Q326023R30 (Bosentan)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antihypertensive Agents/*therapeutic use
MH  - Bosentan
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hypertension, Pulmonary/*drug therapy/physiopathology
MH  - Iloprost/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Sulfonamides/*therapeutic use
MH  - Vasodilator Agents/*therapeutic use
EDAT- 2006/09/02 09:00
MHDA- 2007/01/11 09:00
CRDT- 2006/09/02 09:00
PHST- 2006/09/02 09:00 [pubmed]
PHST- 2007/01/11 09:00 [medline]
PHST- 2006/09/02 09:00 [entrez]
AID - 200603-358OC [pii]
AID - 10.1164/rccm.200603-358OC [doi]
PST - ppublish
SO  - Am J Respir Crit Care Med. 2006 Dec 1;174(11):1257-63. doi: 
      10.1164/rccm.200603-358OC. Epub 2006 Aug 31.