UKPDS 38, 1998 [5] |
1,148 Hypertensive participants with T2DM aged with 25–65 yr |
Median 8.4 yr |
Active: 159/94 |
144/82 (target: <150/85) |
154/87 (target: <180/105) |
Reduced risk for diabetes related any end points risk by 24% with active control |
Control: 160/94 |
Deaths related to diabetes risk by 32%, stroke risk by 44%, and heart failure risk by 56% |
Microvascular end points risk by 37% |
No benefit in all-cause mortality |
HOT, 1998 [24] |
18,790 Hypertensive participants including 1,501 with T2DM |
Mean 3.8 yr |
170/105 |
DBP: 81.1 in target DBP ≤80 |
DBP: 85.2 in target DBP ≤90 |
No benefit in CV event in overall participants |
DBP: 83.2 in target DBP ≤85 |
In participants with diabetes, increased major CV event risk by 2.06-fold in target DBP ≤90 compared with ≤80; Increased CV mortality risk by 3.0-fold in target DBP ≤90 compared with ≤80 |
ADVANCE, 2007 [25] |
11,140 With T2DM aged with 55 yr and older with prior CVD or CV risk factors |
Mean 4.3 yr |
Active: 145/81 |
136/73 |
140/73 |
Reduced risk of major macrovascular or microvascular event by 9%, death from CV disease by 18%, death from any cause by 14% |
Control: 145/81 |
Subgroup analysis of INVEST, 2010 [26] |
6,400 Participants of the 22,576 participants in INVEST aged at least 50 yr with T2DM and CAD |
16,893 Patient-yr |
Active: 144/85 |
Active SBP: 121.5 (SBP category <130) |
Uncontrolled: SBP 146.1 (SBP category ≥140) |
No benefit in adverse CV outcome including all-cause death, nonfatal myocardial infarction, or nonfatal stroke in active control of SBP compared with usual control |
Usual: 149/85 |
Usual SBP 131.2 (SBP category 130–140) |
Increased risk of adverse CV outcome in uncontrolled SBP group compared with usual control by 1.46-fold |
Uncontrolled: 159/86 |
Increased risk of all-cause mortality in active control compared with usual control by 1.15-fold when extended follow-up |
ACCORD-BP, 2010 [20] |
4,733 Participants with T2DM aged 40–79 yr with prior CVD or 55–79 yr with CV risk factors |
Mean 4.7 yr |
Active: 139.0/75.9 |
119.3/64.4 (target SBP: <120) |
135/70.5 (target SBP: 130–140) |
No benefit in primary composite outcome including nonfatal MI, nonfatal stroke, and CV death |
Control: 139.4/76.0 |
Reduced risk of stroke by 41% with active control |
SAEs more common in intensive group, particularly hypotension, elevated serum creatinine and electrolyte imbalance |
SPRINT-eligible ACCORD-BP, 2017 [23] |
SPRINT-eligible 1,284 participants of the 4,733 participants in ACCORD-BP aged at least 75 yr with T2DM or clinical CVD or subclnical CVD or high CV risk |
- |
Active: 139.8 |
SBP: 120.1 (target SBP: <120) |
SBP: 133.5 (target SBP: <140) |
Reduced risk of composite of CV death, nonfatal MI, nonfatal stroke, any revascularization, and HF by 21% |
Control: 140.8 |
Reduced risk of CV death, nonfatal MI, and nonfatal stroke by 31% |
More frequent treatment-related adverse events in active control |