6. Design features of trials for hypertensive type 2 diabetic participants, by date trial initiated or earliest publication.
Characteristic | UKPDS/HDS | ABCD (2) | Steno‐2 | Rachmani 2002 | ADDITION‐Europe | ADVANCE/AdRem | DEMAND | BENEDICT | HINTS | J‐DOIT3 |
Year trial initiated | 1987 | 1991 | 1992 | 1995 | 2001 | 2002 | 2002 | 2003a | 2006 | 2006 |
Definition of "hypertension", SBP/DBP, mmHg, or otherb |
≥ 160/95 or antihypertensive medication | DBP ≥ 90 | ≥ 160/95 (≥ 135/85) |
> 140/90 or antihypertensive medication | > 135/85 | > 140/90 or antihypertensive medication | ≥ 130/85 or antihypertensive medication | na | > 140/90 or antihypertensive medication | > 130/80 |
Primary outcome, parent study | Macro‐ and microvascular complications | 24‐hour creatinine clearance | Nephropathy | eGFR | Death, CVD events | Macro‐ and microvascular complications | GFR | Microalbuminuria | BP control | Macrovascular diabetic complications |
Type of intervention: | ||||||||||
More BP control | ACEi or β blocker |
ACEi or CCA | Intensive intervention |
Patient participation in education and care | Stepped antihypertensive medication | ACEi or diuretic | ACEi or CCB | ACEi, ndCCB, or combination | Nurse management |
"Intensive intervention" |
Less BP control | No ACEi or β blocker |
Placebo | Conventional treatment | Standard care | Routine care | Placebo | CCB or placebo | Placebo | Usual care | Conventional intervention |
Blood pressure target: | ||||||||||
More BP control | < 150/85 mmHg | DBP < 75 mmHg | < 140/85 (< 130/80c) |
< 130/85 mmHg | ≤ 120/80 mmHg | na | < 120/80 mmHg | < 120/80 mmHg | ≤ 140/80 mmHg | ≤ 120/75 mmHg |
Less BP control | < 180/105 mmHg | DBP 80 to 89 mmHg | < 160/95 (< 135/85c) |
na | ≤ 135/85 mmHg | na | < 120/80 mmHg | < 120/80 mmHg | ≤ 140/80 mmHg | ≤ 130/80 mmHg |
Other randomized intervention(s) | Intense glucose control vs standard | None | None | None | Intense glucose and cholesterol control vs standard | Intense glucose control vs standard | None | ndCCB vs placebo | None | None |
Method of DR diagnosis | Photos graded centrally. | Photos graded centrally.d | Photos graded centrally.e | Fundus exams | Photos graded centrally.e |
Photos graded centrally.f | Fundus exams + photos | Fundus exams + photos | Diagnosis in electronic chart | Fundus exams + records |
aDate of earliest publication. bAs defined by investigators. cFrom 2000. dWisconsin Fundus Photograph Reading Center. eBaseline photos taken up to 3 months before/after randomization. fAdRem Sub‐study Coordination Centre, Utrecht, the Netherlands.
ACEi, angiotensin converting enzyme inhibitor BP, blood pressure (systolic/diastolic) or other CCA, calcium channel antagonist CCB, calcium channel blocker CVD, cardiovascular disease DBP, diastolic blood pressure, mmHg DR, diabetic retinopathy eGFR, estimated glomerular filtration rate GFR, glomerular filtration rate na, information not found in study publications ndCCBs, non‐dihydropyridine calcium channel blockers SBP, systolic blood pressure, mmHg