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A Patel
Dr A Patel, University of Sydney, Sydney, New South Wales, Australia; [email protected]
STUDY DESIGN
Design:
randomised controlled trial (Action in Diabetes and Vascular disease: preterAx and diamicroN-MR Controlled Evaluation [ADVANCE]).
Allocation:
concealed.*
Blinding:
blinded (outcome assessors, {patients, clinicians, data collectors, data analysts, and manuscript writers}).*[dagger]
STUDY QUESTION
Setting:
215 centres in 20 countries in Asia, Australasia, Europe, and North America.
Patients:
11 140 patients [= or >, slanted]55 years of age (mean age 66 y, 57% men) who were diagnosed with type 2 diabetes mellitus at [= or >, slanted]30 years of age and had [= or >, slanted]1 of the following: history of major cardiovascular disease or risk factor for cardiovascular disease (ie, history of major microvascular disease, current cigarette smoking, total cholesterol >6.0 mmol/l, high-density lipoprotein cholesterol <1.0 mmol/l, urinary albumin-creatinine ratio 30-300 μg/mg, diagnosis of type 2 diabetes [= or >, slanted]10 years previously, or age [= or >, slanted]65 y). Exclusion criteria included definite indication for an angiotensin-converting enzyme inhibitor other than perindopril at a maximum dose of 4 mg/day or for long-term insulin therapy; and definite indication for, or contraindication to, any of the study treatments.
Intervention:
patients who tolerated and adhered to the study treatment during a 6-week run in period were randomised to...