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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

pulmonary hypertension - All mecanism - all patients


Related trials

PACES (Simonneau), 2008 - Sildenafil vs Placebo

EARLY (Galie), 2008 - Bosentan vs Placebo

ARIES (Galie=, 2008 - Ambrisentan vs Placebo

COMBI (Hoeper), 2006 - Inhaled iloprost vs Placebo

Singh, 2006 - Sildenafil vs Placebo

STEP (McLaughlin), 2006 - Inhaled iloprost vs Placebo

STRIDE-2 (Barst), 2006 - Sitaxsentan vs Placebo

BREATH-5 (Galie), 2006 - Bosentan vs Placebo

SERAPH (Wilkins), 2005 - Bosentan vs Sildenafil

SUPER-1 (Galie), 2005 - Sildenafil vs Placebo

STRIDE-1 (Barst), 2004 - Sitaxsentan vs Placebo

BREATH-2 (Humbert), 2004 - Epoprostenol + Bosentan vs Epoprostenol + placebo

Sastry, 2004 - Sildenafil vs Placebo

Barst, 2003 - Beraprost vs Placebo

BREATHE-1 (Rubin), 2002 - Bosentan vs Placebo

Langleben, 2002 - Terbogrel vs Placebo

AIR (Olschewski), 2002 - Iloprost vs Placebo

ALPHABET (Galie), 2002 - Beraprost vs Placebo

Simmoneau, 2002 - Treprostinil vs Placebo

Channick, 2001 - Bosentan vs Placebo

Badesch, 2000 - Epoprostenol vs control

Barst, 1996 - Epoprostenol vs control

Rubin, 1990 - Epoprostenol vs control



See also:

  • All pulmonary hypertension clinical trials
  • All clinical trials of All mecanism
  • All clinical trials of Bosentan
  •  

    EARLY (Galie) study, 2008

    [NCT00091715] Facebook    pdf : Bosentan - All mecanism for pulmonary hypertension

    Treatments

    Studied treatment Bosentan
    Control treatment Placebo

    Patients

    Patients Patients with WHO FC II pulmonary arterial hypertension

    Method and design

    Randomized effectives 93 / 92 (studied vs. control)
    Blinding double blind
    Follow-up duration 24 weeks
    Primary endpoint pulmonary vascular resistanceand six-minute walk distance


    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    Hospitalization for any reason

    1 / 93
    3 / 92
    classic 0,33 [0,03;3,11]

    All cause death

    1 / 93
    1 / 92
    classic 0,99 [0,06;15,58]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Hospitalization for any reason 1 / 93 (1,1%) 3 / 92 (3,3%) 0,33 [0,03;3,11]   10044 
    All cause death 1 / 93 (1,1%) 1 / 92 (1,1%) 0,99 [0,06;15,58]   10044 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 10044: Galiè N, Manes A, Negro L, Palazzini M, Bacchi Reggiani ML, Branzi AEur Heart J 2009;:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Hospitalization for any reason 1,08% 3,26% -21,9‰
    All cause death 1,08% 1,09% -0,1‰

    Meta-analysis of all similar trials:

    All mecanism in pulmonary hypertension for all patients



    Reference(s)

    Trials register # NCT00091715

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