Randomized controlled trials of intensive versus standard hypertension treatment strategies
| Clinical trial . | Population . | Intensive . | Standard . | Outcomes . |
|---|---|---|---|---|
| ACCORD BP (35) | 4,733 participants with T2D aged 40–79 years with prior evidence of CVD or multiple cardiovascular risk factors | SBP target: <120 mmHg Achieved (mean) SBP/DBP: 119.3/64.4 mmHg | SBP target: 130–140 mmHg Achieved (mean) SBP/DBP: 135/70.5 mmHg | • No benefit in primary end point: composite of nonfatal MI, nonfatal stroke, and CVD death • Stroke risk reduced 41% with intensive control, not sustained through follow-up beyond the period of active treatment • Adverse events more common in intensive group, particularly elevated serum creatinine and electrolyte abnormalities |
| ADVANCE (36) | 11,140 participants with T2D aged ≥55 years with prior evidence of CVD or multiple cardiovascular risk factors | Intervention: a single-pill, fixed-dose combination of perindopril and indapamide Achieved (mean) SBP/DBP: 136/73 mmHg | Control: placebo Achieved (mean) SBP/DBP: 141.6/75.2 mmHg | • Intervention reduced risk of primary composite end point of major macrovascular and microvascular events (9%), death from any cause (14%), and death from CVD (18%) • 6-year observational follow-up found reduction in risk of death in intervention group attenuated but still significant (242) |
| HOT (37) | 18,790 participants, including 1,501 with diabetes | DBP target: ≤80 mmHg Achieved (mean): 81.1 mmHg, ≤80 group; 85.2 mmHg, ≤90 group | DBP target: ≤90 mmHg | • In the overall trial, there was no cardiovascular benefit with more intensive targets • In the subpopulation with diabetes, an intensive DBP target was associated with a significantly reduced risk (51%) of CVD events |
| SPRINT (43) | 9,361 participants without diabetes | SBP target: <120 mmHg Achieved (mean): 121.4 mmHg | SBP target: <140 mmHg Achieved (mean): 136.2 mmHg | • Intensive SBP target lowered risk of the primary composite outcome 25% (MI, ACS, stroke, heart failure, and death due to CVD) • Intensive target reduced risk of death 27% • Intensive therapy increased risks of electrolyte abnormalities and AKI |
| STEP (34) | 8,511 participants aged 60–80 years, including 1,627 with diabetes | SBP target: <130 mmHg Achieved (mean): 127.5 mmHg | SBP target: <150 mmHg Achieved (mean): 135.3 mmHg | • Intensive SBP target lowered risk of the primary composite outcome 26% (stroke, ACS [acute MI and hospitalization for unstable angina], acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes) • Intensive target reduced risk of cardiovascular death 28% • Intensive therapy increased risks of hypotension |
| Clinical trial . | Population . | Intensive . | Standard . | Outcomes . |
|---|---|---|---|---|
| ACCORD BP (35) | 4,733 participants with T2D aged 40–79 years with prior evidence of CVD or multiple cardiovascular risk factors | SBP target: <120 mmHg Achieved (mean) SBP/DBP: 119.3/64.4 mmHg | SBP target: 130–140 mmHg Achieved (mean) SBP/DBP: 135/70.5 mmHg | • No benefit in primary end point: composite of nonfatal MI, nonfatal stroke, and CVD death • Stroke risk reduced 41% with intensive control, not sustained through follow-up beyond the period of active treatment • Adverse events more common in intensive group, particularly elevated serum creatinine and electrolyte abnormalities |
| ADVANCE (36) | 11,140 participants with T2D aged ≥55 years with prior evidence of CVD or multiple cardiovascular risk factors | Intervention: a single-pill, fixed-dose combination of perindopril and indapamide Achieved (mean) SBP/DBP: 136/73 mmHg | Control: placebo Achieved (mean) SBP/DBP: 141.6/75.2 mmHg | • Intervention reduced risk of primary composite end point of major macrovascular and microvascular events (9%), death from any cause (14%), and death from CVD (18%) • 6-year observational follow-up found reduction in risk of death in intervention group attenuated but still significant (242) |
| HOT (37) | 18,790 participants, including 1,501 with diabetes | DBP target: ≤80 mmHg Achieved (mean): 81.1 mmHg, ≤80 group; 85.2 mmHg, ≤90 group | DBP target: ≤90 mmHg | • In the overall trial, there was no cardiovascular benefit with more intensive targets • In the subpopulation with diabetes, an intensive DBP target was associated with a significantly reduced risk (51%) of CVD events |
| SPRINT (43) | 9,361 participants without diabetes | SBP target: <120 mmHg Achieved (mean): 121.4 mmHg | SBP target: <140 mmHg Achieved (mean): 136.2 mmHg | • Intensive SBP target lowered risk of the primary composite outcome 25% (MI, ACS, stroke, heart failure, and death due to CVD) • Intensive target reduced risk of death 27% • Intensive therapy increased risks of electrolyte abnormalities and AKI |
| STEP (34) | 8,511 participants aged 60–80 years, including 1,627 with diabetes | SBP target: <130 mmHg Achieved (mean): 127.5 mmHg | SBP target: <150 mmHg Achieved (mean): 135.3 mmHg | • Intensive SBP target lowered risk of the primary composite outcome 26% (stroke, ACS [acute MI and hospitalization for unstable angina], acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes) • Intensive target reduced risk of cardiovascular death 28% • Intensive therapy increased risks of hypotension |
ACCORD BP, Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial; ACS, acute coronary syndrome; ADVANCE, Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation; AKI, acute kidney injury; CVD, cardiovascular disease; DBP, diastolic blood pressure; HOT, Hypertension Optimal Treatment trial; MI, myocardial infarction; SBP, systolic blood pressure; SPRINT, Systolic Blood Pressure Intervention Trial; STEP, Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients; T2D, type 2 diabetes.