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. Author manuscript; available in PMC: 2014 Nov 1.
Published in final edited form as: J Am Geriatr Soc. 2013 Nov;61(11):2027–2037. doi: 10.1111/jgs.12513

Table 1. Randomized clinical trials (RCTs) conducted between 2002 – 2012 to study blood pressure control in older adults with diabetes mellitus type 2 (DM).

Study (Author, Year) Country Sample Size, Participants, Treatment Design, Length Primary Outcome(s) Results
ACCORD (Cushman et al., 2010) U.S. & Canada N = 10,251 (4,733 for blood pressure control study) Mean age 62 ± 7 Adults 40 – 79 years 1617 were ≥65 years Patients with type 2 DM for 10 years, mean baseline SBP 139 mmHg, and 37% had cardiovascular disease (CVD) Intensive therapy of blood pressure <120 mmHg versus standard therapy of blood pressure <140mmHg Randomized clinical trial (RCT), mean duration 4.7 years Primary composite (nonfatal MI, nonfatal stroke, or cardiovascular [CV] death) No significant difference in CV or all cause death Nonsignificant reduction in primary outcome (298 events versus 237 events; P=0.20) Significant reduction in stroke (36 versus 62 events; P=0.01) No age interaction for primary outcome (age ≥65 years)
ADVANCE (Patel et al., 2007) Various countries N=11,140 Mean age 62 ± 6.9 55 years or older 6601 were ≥65 years Patients with type 2 DM for 8 years, mean entry blood pressure 145 mmHg and 32% with CVD Combination of perindopril and indapamide versus placebo Mean SBP reduction was 5.6 mmHg and DBP was 2.2 mmHg RCT, mean duration 4.3 years Not designed for treating to target blood pressure Composite of combined major macrovascular events (CV death, nonfatal MI or stroke) and major microvascular events (new or worse nephropathy, or retinopathy) Nonsignificant reduction in macrovascular events (480 versus 520;P=16) Reduction in cardiovascular death (211 versus 257 events; HR 0.82, P=0.03) Reduction in composite outcome (536 versus 592 events) for adults ≥65 years
UKPDS (Holman et al., 2008) U.K. N=1,148 for blood pressure study (884 for post-trial monitoring) Mean age 56.4 ± 8.1 at 10 year follow-up Adults 26 – 65 years Patients with new type 2 DM and 7.5% with CVD Tight blood pressure <150 mmHg versus less-tight blood pressure <180mmHg Differences disappeared after 2 years RCT, mean duration 15.4 years (8 yrs post-trial) Any DM related endpoint (includes death from any cause, macrovascular and microvascular complications) No reductions for Stroke, MI or death from any cause Significant reduction for peripheral vascular disease (141 versus 82 events; P=0.02)

ACCORD = Action to Control Cardiovascular Risk in Diabetes

ADVANCE = Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation. Industry sponsored.

UKPDS = United Kingdom Prospective Diabetes Study

SBP= systolic blood pressure; DBP = diastolic blood pressure