PMID- 20202971
OWN - NLM
STAT- MEDLINE
DCOM- 20110429
LR  - 20181201
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Linking)
VI  - 31
IP  - 9
DP  - 2010 May
TI  - Combination therapy with bosentan and sildenafil in Eisenmenger syndrome: a 
      randomized, placebo-controlled, double-blinded trial.
PG  - 1124-31
LID - 10.1093/eurheartj/ehq011 [doi]
AB  - AIMS: To evaluate the efficacy of combining the dual endothelin receptor 
      antagonist, bosentan, and the phosfodiesterase-5-inhibitor, sildenafil, in 
      patients with Eisenmenger syndrome. METHODS AND RESULTS: The study was a 
      randomized, placebo-controlled, double-blinded, cross-over design. Patients with 
      Eisenmenger syndrome (n = 21) were treated open label with bosentan for 9 months. 
      After 3 months, sildenafil/placebo was added for 3 months, and a cross-over was 
      performed for the last 3 months. At baseline and after 3, 6, and 9 months, 
      patients were examined with 6 min walk test, oxygen saturations, N-terminal 
      pro-brain natriuretic peptide, New York Heart Association (NYHA) classification, 
      cardiac catheterization, and magnetic resonance imaging. The primary endpoint was 
      changed in 6 min walk distance (MWD). Bosentan improved the 6 MWD (377 vs. 414 m, 
      P = 0.001), pulmonary vascular resistance (PVR) (28 vs. 22 wood, P = 0.01), and 
      pulmonary blood flow (2.6 vs. 3.5 L/min, P = 0.01). Adding sildenafil to bosentan 
      did not improve the 6 MWD significantly (21 vs. 8 m, P = 0.48), but increased 
      saturation at rest (2.9 vs. -1.8%, P < 0.01). CONCLUSION: In Eisenmenger 
      syndrome, treatment with bosentan significantly improved walking distance, 
      pulmonary blood flow, and PVR. Adding sildenafil to bosentan did not 
      significantly improve walking distance but did increase saturation at rest. 
      http://www.ClinicalTrial.gov: NCT00303004.
FAU - Iversen, Kasper
AU  - Iversen K
AD  - Department of Cardiology, Copenhagen University Hospital, Section 2014, 
      Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.
FAU - Jensen, Annette S
AU  - Jensen AS
FAU - Jensen, Tim V
AU  - Jensen TV
FAU - Vejlstrup, Niels G
AU  - Vejlstrup NG
FAU - Sondergaard, Lars
AU  - Sondergaard L
LA  - eng
SI  - ClinicalTrials.gov/NCT00303004
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100303
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 0 (Piperazines)
RN  - 0 (Purines)
RN  - 0 (Sulfonamides)
RN  - 0 (Sulfones)
RN  - BW9B0ZE037 (Sildenafil Citrate)
RN  - Q326023R30 (Bosentan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antihypertensive Agents/*administration & dosage
MH  - Bosentan
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Drug Therapy, Combination/methods
MH  - Eisenmenger Complex/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phosphodiesterase 5 Inhibitors/*administration & dosage
MH  - Piperazines/*administration & dosage
MH  - Purines/administration & dosage
MH  - Sildenafil Citrate
MH  - Sulfonamides/*administration & dosage
MH  - Sulfones/*administration & dosage
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2010/03/06 06:00
MHDA- 2011/04/30 06:00
CRDT- 2010/03/06 06:00
PHST- 2010/03/06 06:00 [entrez]
PHST- 2010/03/06 06:00 [pubmed]
PHST- 2011/04/30 06:00 [medline]
AID - ehq011 [pii]
AID - 10.1093/eurheartj/ehq011 [doi]
PST - ppublish
SO  - Eur Heart J. 2010 May;31(9):1124-31. doi: 10.1093/eurheartj/ehq011. Epub 2010 Mar 
      3.