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TROPHY

TROPHY. TR ial O f P reventing HY pertension. High-normal BP increases CV risk. Incidence of CV events in women. 10. High-normal BP 130–139/85–89 mm Hg. 8. Cumulative incidence (%) and 95% CI. 6. Normal BP 120–129/80–84 mm Hg. 4. 2. Optimal BP <120/<80 mm Hg. 0. 0. 2. 4. 6.

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TROPHY

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  1. TROPHY TRial Of Preventing HYpertension

  2. High-normal BP increases CV risk Incidence of CV events in women 10 High-normal BP130–139/85–89 mm Hg 8 Cumulative incidence (%) and 95% CI 6 Normal BP 120–129/80–84 mm Hg 4 2 Optimal BP <120/<80 mm Hg 0 0 2 4 6 8 10 12 Time (years) Framingham Heart Study Vasan RS et al. N Engl J Med. 2001;345:1291-7.

  3. TROPHY: Background • Framingham, MRFIT, and other studies indicate that prehypertension is a strong predictor of excessive cardiovascular risk • These data illustrate the need to identify and potentially treat patients with prehypertension • Hypertension (HTN) is a progressive and self-accelerating condition • Vascular abnormalities occur long before the onset of clinical disease Julius S et al. N Engl J Med. 2006;354:1685-97.

  4. TROPHY: Study objectives • TROPHY evaluated 2 years of treatment with candesartan in individuals with prehypertension* • Primary objective: • Determine if the incidence of HTN can be reduced for up to 2 years after discontinuation of active treatment • Secondary objective: • Evaluate the incidence of HTN during 2 years of treatment with candesartan or placebo Julius S et al. N Engl J Med. 2006;354:1685-97. *Average BP 130–139/≤89 mm Hg; or ≤139/85–89 mm Hg

  5. TROPHY: Study design Patients with untreated prehypertensionAges 30–65 years N = 772 RandomizedDouble-blindYears 1 & 2 Candesartan 16 mg qd n = 391 Placebo n = 381 PlaceboYears 3 & 4 Study end points: Development of HTN at years 2 and 4 Julius S et al. N Engl J Med. 2006;354:1685-97.

  6. TROPHY: Baseline characteristics N = 772 Julius S et al. N Engl J Med. 2006;354:1685-97.

  7. TROPHY: Baseline laboratory values N = 772 Julius S et al. N Engl J Med. 2006;354:1685-97.

  8. TROPHY: Reduction in new-onset hypertension 16%* 66%* N = 772 Candesartan vs Placebo Placebo only ‡ † *Relative risk reduction†P < 0.001; ‡P = 0.007 Julius S et al. N Engl J Med. 2006;354:1685-97.

  9. TROPHY: Reduction in new-onset hypertension N = 772 100 Candesartan vs placebo Placebo only RRR 16%HR = 0.84 (0.75–0.95)P = 0.007 80 60 Cumulative incidence (%) 40 RRR 66%HR = 0.34 (0.25–0.44)P < 0.001 20 0 0 1 2 3 4 Study year Placebo Candesartan 16 mg qd Number of patients without HTN Candesartan Placebo 391 381 356 269 309 184 191 118 127 85 Julius S et al. N Engl J Med. 2006;354:1685-97.

  10. After 2 years:↓SBP ~10 mm Hg At study end: ↓SBP 2.0 mm Hg (P = 0.037) TROPHY: Blood pressure by treatment group SBP (mm Hg) Difference (mm Hg) 140 30 130 120 0 -10 Candesartan vs Placebo Placebo only -20 90 0 0 6 12 18 24 30 36 42 48 Time (months) Placebo Candesartan SBP difference Julius S et al. N Engl J Med. 2006;354:1685-97.

  11. TROPHY: Incidence of adverse events Julius S et al. N Engl J Med. 2006;354:1685-97.

  12. TROPHY: Summary • Efficacy • Candesartan significantly delayed new-onset HTN vs placebo: • Relative risk reduction: 66% (year 2); 16% (year 4) • Absolute reduction of new-onset HTN: 26.8% (year 2); 9.8% (year 4) • New-onset HTN at 2 years: 13.6% vs 40.4% • Safety • Candesartan was safe and well tolerated • Serious AE rates: 3.5% (candesartan) vs 5.9% (placebo) Julius S et al. N Engl J Med. 2006;354:1685-97.

  13. TROPHY: Implications • Vascular abnormalities occur long before the onset of clinical disease • Aggressive BP-lowering with candesartan can reduce the incidence of HTN in prehypertensive patients at risk for CV disease Julius S et al. N Engl J Med. 2006;354:1685-97.

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