ACCORD BP 2010.

Study characteristics
Methods	Multicentre, 2 × 2 factorial design, ITT strategy. Participants and investigators were not blinded to blood pressure goals. All participants in the ACCORD BP trial were randomly assigned to intensive or standard glycaemic control, and were also randomly assigned to intensive or standard blood pressure control. Follow‐up: 4–8 years (mean 4.7 years)
Participants	Men and women with type 2 diabetes mellitus and a glycated haemoglobin level ≥ 7.5%, aged 40–79 years with CVD, or 55–79 years with anatomical evidence of a substantial amount of atherosclerosis, albuminuria, or LVH, or ≥ 2 additional risk factors for CVD (dyslipidaemia, hypertension, smoking, or obesity). Participants with SBP of 130–180 mmHg who were taking ≤ 3 antihypertensive medications and who had the equivalent of a 24‐hour protein excretion rate < 1.0 g were also eligible for the blood pressure trial. Exclusion criteria: BMI > 45, sCR level > 1.5 mg/dL, and other serious illness. Baseline characteristics of 1531 participants (% or mean): men/women: 63%/37%; age: 62 (SD 8) years; age ≥ 75 years: 7%; SBP: 138 (SD 16) mmHg; DBP: 74 (SD 11) mmHg; current smoker: 13%; ethnic group: white: 62%, non‐white: 38%. Types of drugs at 1 year: thiazides: 51%; ACEIs/ARBs: 84%; CCB: 26%; BB: 57%; other: 28%. Previous cardiovascular condition: IHD: 86%; stroke: 20%. Countries: USA, Canada
Interventions	Standard target: SBP < 140 mmHg Lower (intensive) target: SBP < 120 mmHg
Outcomes	Primary outcome: first occurrence of a major cardiovascular event, defined as the composite of non‐fatal MI, non‐fatal stroke, or cardiovascular death. Secondary outcomes included: combination of the primary outcome plus revascularization or hospitalization for CHF; combination of a fatal coronary event, non‐fatal MI, or unstable angina; non‐fatal MI; fatal or non‐fatal stroke; non‐fatal stroke; death from any cause; death from cardiovascular causes; and hospitalization or death due to heart failure.
Funding sources	Supported by contracts from the NHLBI. The NIDDK, the National Institute on Aging, the National Eye Institute, and the Centers for Disease Control and Prevention also contributed funding. General Clinical Research Centers provided support at many sites. Several companies provided study medications.
Declarations of interest	Drs Bigger, Buse, Byington, Corson, Cushman, Cutler, Evans, Friedewald, Gerstein, Goff, Grimm, Ismail‐Beigi, Katz, Peterson, and Probstfield declared different types of relationships with NIH institutions and pharmaceutical companies (consultancy, grants, honoraria).
Notes	The glycaemia ACCORD trial was stopped on 6 February 2008. Blood pressures achieved at the end of the trial were as follows: standard target: SBP 133.5 (SD 0.4) mmHg; lower target: SBP 119.3 (SD) 0.4 mmHg. A public repository provided individual participant data from people with hypertension with established CVD for use in this systematic review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed centrally on the study's Web site with the use of permuted blocks to maintain concealment of future study‐group assignments" (pp. 1575–85).
Allocation concealment (selection bias)	Low risk	Quote: "Randomization was performed centrally on the study's Web site with the use of permuted blocks to maintain concealment of future study‐group assignments" (pp. 1575–85).
Blinding of participants and personnel (performance bias) All outcomes	High risk	The study design was not compatible with blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "ACCORD utilized a centralized adjudication process for all deaths, and hospitalizations for myocardial infarction and strokes. Upon identification of a potential outcome, clinical site staff obtained medical records or details regarding the case. Personal identifiers and information that may have alerted adjudicators to treatment assignment (e.g. A1C values) were masked by the clinical site and the medical records sent to the Coordinating Center" (pp. 1575–85; Appendix 1).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Consort diagram (section 2) (pp. 1575–85; Appendix 1).
Selective reporting (reporting bias)	Low risk	No reporting bias (protocol was checked).
Other bias	Unclear risk	Subgroup of participants with basal CVD not predefined.