Study design

Design:

post hoc subgroup analysis of a randomised placebo-controlled trial (Action in Diabetes and Vascular disease: preterAx and diamicroN-MR Controlled Evaluation [ADVANCE] study). ClinicalTrials.gov NCT00145925.

Allocation:

{concealed}*.†

Blinding:

blinded (patients and outcome adjudication committee).†

Study question

Setting:

{215 centres in 20 countries in Asia, Australasia, Europe, and North America}.*

Patients:

11 140 patients ⩾55 years of age (mean age 66 y, 57% men) who had type 2 diabetes and ⩾1 additional risk factor for cardiovascular events. 847 patients (7.6%) had atrial fibrillation (AF). Patients requiring long-term insulin were excluded.

Intervention:

fixed combination of perinodopril and indapamide (2 mg/0.625 mg for 3 mo, then 4 mg/1.25 mg) (n = 5569), or placebo (n = 5571).

Outcomes:

all-cause mortality, cardiovascular (CV) mortality, major cardiac events, major cerebral events, and heart failure.

Follow-up period:

mean 4.3 years.

Patient follow-up:

94% (100% in intention-to-treat analysis).

Main results

At baseline, …