ACCORD 2010.

Study characteristics
Methods	Randomised and multicentre trial performed in the USA and Canada. The entire ACCORD trial enrolled 10,251 participants with type 2 diabetes mellitus considered to be at high risk. All participants were randomly assigned to either intensive or standard glycaemic control. In addition, 4733 participants were also randomly assigned (in a 2‐by‐2 factorial design) to either intensive or standard blood‐pressure control (the ACCORD blood‐pressure trial). The mean follow‐up was 4.7 years
Participants	4733 participants were included in the ACCORD BP trial. Participants were eligible if they had type 2 diabetes mellitus and a glycated haemoglobin level of 7.5% or more, and were 40 years of age or older with cardiovascular disease or 55 years of age or older with anatomical evidence of a substantial amount of atherosclerosis, albuminuria, left ventricular hypertrophy, or at least two additional risk factors for cardiovascular disease (dyslipidaemia, hypertension, smoking, or obesity). Participants with a SBP between 130 mm Hg and 180 mm Hg who were taking three or fewer antihypertensive medications and who had the equivalent of a 24‐hour protein excretion rate of less than 1.0 g were also eligible for the blood pressure trial. Exclusion criteria included a body‐mass index of more than 45, a serum creatinine level of more than 1.5 mg per dL, and other serious illness
Interventions	Systolic BP targets Intensive therapy was defined by a target SBP of less than 120 mm Hg, whereas standard therapy targeted a SBP of less than 140 mm Hg. There was no specific drug regimen to achieve the target blood pressure. However, all the antihypertensive regimens were to include drug classes that had been shown to result in a reduction in cardiovascular events among participants with diabetes
Outcomes	The primary outcome was the first occurrence of a major cardiovascular event, which was defined as the composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Prespecified secondary outcomes included the combination of the primary outcome plus revascularisation or hospitalisation for congestive heart failure, the combination of a fatal coronary event, nonfatal myocardial infarction, or unstable angina; nonfatal myocardial infarction; fatal or nonfatal stroke, nonfatal stroke, death from any cause, death from cardiovascular causes, and hospitalisation or death due to heart failure
Notes	Study supported by contracts from the National Institutes of Health and the Centers for Disease Control and Prevention.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Unclear risk	Method not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants and investigators not possible
Blinding of outcome assessment (detection bias) All outcomes	Low risk	An independent Endpoint Committee, which was blinded to the study intervention arms, reviewed all cardiovascular events.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The vital status for 5% of randomised participants was unknown at the end of the trial. Their distribution is not reported
Selective reporting (reporting bias)	High risk	The ACCORD investigators elected to restrict analysis and reporting of SAE data to events related to blood pressure medications because those were the only events collected in a consistent manner throughout the trial and subject to safety officer and DSMB review.
Other bias	Low risk	The trial was sponsored by the National Heart, Lung, and Blood Institute from the USA. No other funding reported