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 Two Years Qualifying period * Placebo Non-pharmacological treatment Candesartan cilexetil 16 mg n  400 Placebo * 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 VariableValue Randomised patients, n809 Male, n482 Female, n326 Age, years49  14 BMI, kg/m 2 30  5 Blood pressure, mmHg Clinic automated134  4/85  4 Clinic regular133  5/85  4 Measured at home134  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 Time point Candesartan, n Placebo, n Relative risk (95% CI)p At two 2 years 5315466.3<0.001 At four 4 years 20824015.6<0.007 Julius S et al. N Engl J Med 2006;available at http://www.nejm.org