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The TR ial O f P reventing HY pertension (TROPHY)

The TR ial O f P reventing HY pertension (TROPHY). TROPHY. TROPHY – hypothesis.

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The TR ial O f P reventing HY pertension (TROPHY)

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  1. The TRial Of Preventing HYpertension (TROPHY) TROPHY

  2. TROPHY – hypothesis The TRial Of Preventing HYpertension (TROPHY) is an investigator-initiated trial to examine whether early treatment of high-normal blood pressure values (according to JNC VI) with candesartan would prevent or postpone the development of stage 1 hypertension. Julius et al,Hypertension 2004

  3. TROPHY – objectives • Primary • to determine whether treatment with candesartan 16 mg compared with placebo reduces the incidence of hypertension in subjects with high-normal BP • Secondary • evaluate reduction of BP after 2 years of treatment with candesartan 16 mg versus placebo • evaluate incidence of hypertension after 2 years of treatment with candesartan 16 mg versus placebo • evaluate quality of life during 2 years of treatment with candesartan 16 mg versus placebo Julius et al,Hypertension 2004

  4. TROPHY– inclusion criteria • Aged 30 to 65 years • Clinic BP reading of 130-139/ 89 mm Hg or  139/85-89 mm Hg Julius et al,Hypertension 2004

  5. TROPHY – study design Placebo Placebo n  400 Non-pharmacological treatment Qualifying period* Non-pharmacological treatment n  400 Candesartan cilexetil 16 mg Placebo Two Years Two Years *Clinic BP reading of 130-139/ 89 mm Hg or  139/85-89 mm Hg Julius et al,Hypertension 2004

  6. TROPHY – end point • Development of clinical hypertension • Mean clinic BP by automated device 140/90 mm Hg at 3 different clinic visits during the 4-year study period • Mean clinic BP by automated device 160/100 mm Hg at any single visit during the 4-year study period • Development of signs of target organ damage or a BP condition requiring pharmacological treatment, as judged by the investigator • Mean clinic BP by automated device 140/90 mm Hg at the 48-month visit Julius et al,Hypertension 2004

  7. TROPHY – baseline characteristics Variable Value Randomised patients, n 809 Male, n 482 Female, n 326 Age, years 49 14 BMI, kg/m2 30  5 Blood pressure, mmHg Clinic automated 134  4/85  4 Clinic regular 133  5/85  4 Measured at home 134  9/83  10 Julius et al,Hypertension 2004

  8. TROPHY: Risk of hypertension after two years with candesartan vs placebo, followed by two years of placebo vs placebo Julius S et al. N Engl J Med 2006;available at http://www.nejm.org

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