PMID- 12065350
OWN - NLM
STAT- MEDLINE
DCOM- 20020827
LR  - 20190514
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 121
IP  - 6
DP  - 2002 Jun
TI  - Clinical efficacy of sitaxsentan, an endothelin-A receptor antagonist, in 
      patients with pulmonary arterial hypertension: open-label pilot study.
PG  - 1860-8
AB  - STUDY OBJECTIVES: To evaluate the safety and efficacy of sitaxsentan, an 
      endothelin-A receptor antagonist, in a 12-week, open-label trial of patients with 
      pulmonary arterial hypertension (PAH). PATIENTS: Six children and 14 adults with 
      New York Heart Association (NYHA) functional class II, III, or IV primary 
      pulmonary hypertension or PAH associated with either congenital 
      systemic-to-pulmonary shunts or collagen vascular disease were enrolled. 
      MEASUREMENTS: Sitaxsentan was administered orally at 100 to 500 mg bid for 12 
      weeks. Cardiopulmonary hemodynamics via cardiac catheterization were obtained at 
      baseline and week 12. Six-minute walk test distance was measured at baseline, 
      week 6, and week 12. RESULTS: Sitaxsentan treatment resulted in significant 
      improvement in exercise capacity as assessed by the 6-min walk distance (baseline 
      [mean +/- SD], 466 +/- 132 m; week 12, 515 +/- 141 m, n = 20, p = 0.006). Mean 
      pulmonary artery pressure and pulmonary vascular resistance index also improved 
      (63 +/- 20 to 52 +/- 22 mm Hg, n = 17, p = 0.0002; and 20 +/- 11 to 14 +/- 13 U x 
      m(2), n = 17, p = 0.008, respectively). Serious adverse events included two cases 
      of acute hepatitis (fatal in one patient). CONCLUSIONS: Patients with NYHA 
      functional class II, III, or IV PAH showed a significant improvement in exercise 
      capacity and cardiopulmonary hemodynamics over a 12-week period of treatment with 
      sitaxsentan, an endothelin-A receptor antagonist. Further investigation is 
      warranted to evaluate the safety and efficacy of sitaxsentan in patients with 
      PAH.
FAU - Barst, Robyn J
AU  - Barst RJ
AD  - Department of Pediatrics, Columbia University, College of Physicians and 
      Surgeons, New York, NY, USA.
FAU - Rich, Stuart
AU  - Rich S
FAU - Widlitz, Allison
AU  - Widlitz A
FAU - Horn, Evelyn M
AU  - Horn EM
FAU - McLaughlin, Vallerie
AU  - McLaughlin V
FAU - McFarlin, Joyce
AU  - McFarlin J
LA  - eng
GR  - RR-00645/RR/NCRR NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Endothelin Receptor Antagonists)
RN  - 0 (Isoxazoles)
RN  - 0 (Receptor, Endothelin A)
RN  - 0 (Thiophenes)
RN  - J9QH779MEM (sitaxsentan)
SB  - IM
CIN - Chest. 2003 May;123(5):1772; author reply 1772-3. PMID: 12740304
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - *Endothelin Receptor Antagonists
MH  - Exercise Tolerance/drug effects
MH  - Female
MH  - Hemodynamics/drug effects
MH  - Humans
MH  - Hypertension, Pulmonary/*drug therapy/physiopathology
MH  - Isoxazoles/pharmacology/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Receptor, Endothelin A
MH  - Thiophenes/pharmacology/*therapeutic use
EDAT- 2002/06/18 10:00
MHDA- 2002/08/28 10:01
CRDT- 2002/06/18 10:00
PHST- 2002/06/18 10:00 [pubmed]
PHST- 2002/08/28 10:01 [medline]
PHST- 2002/06/18 10:00 [entrez]
AID - S0012-3692(15)35019-4 [pii]
AID - 10.1378/chest.121.6.1860 [doi]
PST - ppublish
SO  - Chest. 2002 Jun;121(6):1860-8. doi: 10.1378/chest.121.6.1860.