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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


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Langleben, 2002 - Terbogrel vs Placebo

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Simmoneau, 2002 - Treprostinil vs Placebo

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Badesch, 2000 - Epoprostenol vs control

Barst, 1996 - Epoprostenol vs control

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See also:

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

    BREATHE-1 (Rubin) study, 2002

    Facebook    pdf : Bosentan - All mecanism for pulmonary hypertension

    Treatments

    Studied treatment Bosentan 125 or 250 mg twice daily (after 4 weeks of 62.5 mg of bosentan twice daily)
    Control treatment Placebo

    Patients

    Patients patients with pulmonary arterial hypertension (primary or associated with connective-tissue disease)

    Method and design

    Randomized effectives 144 / 69 (studied vs. control)
    Blinding double blind
    Follow-up duration 16 weeks
    Primary endpoint six-minute walk distance


    Results

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

    Hospitalization for any reason

    6 / 144
    9 / 69
    0,32 [0,12;0,86]

    All cause death

    1 / 144
    2 / 69
    classic 0,24 [0,02;2,60]
    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 6 / 144 (4,2%) 9 / 69 (13,0%) 0,32 [0,12;0,86]   10044 
    All cause death 1 / 144 (0,7%) 2 / 69 (2,9%) 0,24 [0,02;2,60]   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 4,17% 13,04% -88,8‰
    All cause death 6,94‰ 2,90% -22,0‰

    Meta-analysis of all similar trials:

    All mecanism in pulmonary hypertension for all patients



    Reference(s)

    Trials register # NA
    • Rubin LJ, Badesch DB, Barst RJ, Galie N, Black CM, Keogh A, Pulido T, Frost A, Roux S, Leconte I, Landzberg M, Simonneau G. . N Engl J Med 2002;346:896-903 - 10.1056/NEJMoa012212
      Pubmed | Hubmed | Fulltext

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