2. Design features of included trials for type 1 diabetics, by date trial initiated or earliest publication.
Design feature | Larsen | Chase | EUCLID | DIRECT | RASS | AdDIT | |
DIRECT Prevent 1 | DIRECT Protect 1 | ||||||
Year trial initiated | 1985 | 1993a | 1997a | 2001 | 2001 | 2002a | 2009 |
Definition of "hypertension," SBP/DBP, mmHg |
> 150/90 | ≥ 141/90 | > 155/90 | > 130/85 | > 130/85 | > 135/85 or antihypertensive medication | na |
Primary outcome, parent trial | Blood‐retinal barrier leakage |
AER | AER | Diabetic retinopathy | Diabetic retinopathy | Nephropathy |
ACR |
Type of interventions: | |||||||
More control | ACEi | ACEi | ACEi | ARB | ARB | ARB or ACEi | ACEi |
Less control | None | Placebo | Placebo | Placebo | Placebo | Placebo | Placebo |
Blood pressure target: | |||||||
More control | Reduce MABP by ≥ 5 mmHg | None | DBP < 75 mmHg | None | None | < 130/80, mmHg | na |
Less control | None | None | DBP < 75 mmHg | None | None | < 130/80, mmHg | na |
Other randomized intervention(s) | None | None | None | None | None | None | Statin vs placebo |
Method of DR diagnosis/classification | Photos read by masked observer. | Fundus exam + photos read by ophthalmologist. | Photos read centrally.b | Photos read centrally.c | Photos read centrally.c | Photos read centrally.d | Photos read centrally. |
aDate of earliest publication. bAarhus, Denmark. cImperial College (London) Retinopathy Grading Centre. dWisconsin Ocular Epidemiology Reading Center.
ACEi, angiotensin converting enzyme inhibitor ACR, albumin/creatinine ratio AER, albumin ejection rate ARB, angiotensin receptor blocker DBP, diastolic blood pressure, mmHg DR, diabetic retinopathy MABP, mean arterial blood pressure, mmHg na, information not found in study publications NPDR, non‐proliferative diabetic retinopathy SBP, systolic blood pressure, mmHg