Important clinical trials that influenced revised blood pressure guidelines
| Trial | Outcomes | Key conclusions |
|---|---|---|
| Systolic BP goal < 150 mm Hg | ||
| SHEP21 (1991) | Cardiovascular events: RR 0.64, 95% CI 0.50–0.82, P = .0003 Heart failure: RR 0.51, 95% CI 0.37–0.7, P < .001 Strokes: RR 0.64, 95% CI 0.50–0.82, P = .0003 | Hypertension treatment significantly reduced fatal and nonfatal risk of stroke in patients older than 60 with systolic BP above 160 mm Hg |
| HYVET21 (2003) | Stroke events: HR 0.47, 95% CI 0.24–0.93 Stroke mortality: HR 0.57; 95% CI 0.25–1.32 Cardiovascular mortality: HR 1.13, 95% CI 0.66–1.94 Total mortality: HR 1.23, 95% CI 0.75–2.01 | Hypertension treatment in patients older than 80 significantly reduced fatal and nonfatal strokes but may increase stroke and cardiovascular mortality |
| Systolic BP goal < 140 mm Hg | ||
| FEVER22 (2005) | Average systolic blood pressure 4.2 mm Hg lower in treated group than in placebo group All cardiovascular events: HR 0.73, P = .0002 Coronary events: HR 0.68, P = .015 Heart failure: HR 0.70, P = .26 | Hypertension treatment in Chinese participants age ≥ 50 with baseline SBP of 140–180 mm Hg produced only a modest reduction in SBP but substantially reduced cardiovascular events |
| JATOS23 (2008) | Standard vs intensive treatment SBP > 160 mm Hg SBP: 135.9 vs 145.6 mm Hg (P < .001) Primary end points: morbidity (P = .99), mortality (P = .81) | A 2-year trial of intensive treatment in Japanese participants age 65 and older with hypertension (SPB > 160 mm Hg) found no significant difference between standard- and intensive-treatment groups in primary end points |
| VALISH24 (2010) | Strict vs moderate BP control (< 140 mm Hg vs between 140 and 150 mm Hg) Primary end points: cardiovascular events: HR 0.89, 95% CI 0.60–1.34 SBP: 136.6 vs 142.0 mm Hg (P < .001) | A 3-year trial comparing strict vs moderate treatment in reducing cardiovascular mortality and morbidity in elderly patients (ages 70–84) with hypertension (mean SBP = 169.5 mm Hg) found no significant difference between the groups in primary outcome end points |
BP = blood pressure; CI = 95% confidence interval; FEVER = Felodipine Event Reduction Study; HYVET = Hypertension in the Very Elderly Trial; HR = hazard ratio; JATOS = Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients; RR = relative risk; SBP = systolic blood pressure; SHEP = Systolic Hypertension in the Elderly Program; VALISH = Valsartan in Elderly Isolated Systolic Hypertension study