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