Table 2. Randomized clinical trials (RCTs) of statins for older adults with and without diabetes mellitus type 2 (DM) (2002 – 2012).
| Study (Author, Year) Country | Sample Size, Participants, | Treatment | Design, Length | Primary Outcome(s) | Results |
|---|---|---|---|---|---|
| CARDS study (Colhoun et al., 2004) U.K. & Ireland | N=2838 Mean age 61.8 ± 8.3 Aged 40 – 75 years 1751 were > 60 years Patients with type2-DM Without cardiovascular disease (CVD) | Atorvastatin 10 mg versus placebo | Randomized clinical trial (RCT), mean duration 3.9 years | Primary endpoint (first event for acute coronary events, coronary revascularizations, and stroke) | Treatment reduced risk (37%) of first CVD events |
| ASPEN (Knopp et al. 2006) U.S. and multiple countries | N=2410 Mean age 61 ± 8 Adults 40 – 75 year 910 were ≥ 65 years Patients with type 2 DM, 69% with no prior vascular disease | Atorvastatin 10 mg versus placebo | RCT, mean duration 4 years | Composite primary end point | Non-significant results |
| ASCOT-LLA (Sever et al., 2005) U.K. | N=2,532 Mean age 63.8±8.4 Aged 40-79 years 1716 were > 60 years Patients with type 2 DM, having at least 3 CV risk factors | Atorvastatin 10 mg versus placebo | RCT, mean duration 3.3 years | CV events and procedures | Treatment reduced risk of major CVD events and procedures Non-significant results for subgroup of age > 60 years |
| MEGA (Nakamura et al., 2006) Japan | N=7,832 Mean age 58±7 Aged 40-70 years Patients with high lipids without CVD, 31% with DM | Pravastatin 10-20mg and diet versus diet | RCT, mean duration 5.3 years | First occurrence of coronary heart disease | Coronary heart disease events lower in treatment group (66 versus 101 events, P=0.01) Tests for interaction for age (< 60 versus ≥ 6 years) and for DM was not significant |
CARDS = Collaborative Atorvastatin Diabetes Study
ASPEN = Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in non-insulin-dependent diabetes mellitus
ASCOT-LLA = Anglo-Scandinavian Cardiac Outcomes Trial--lipid-lowering arm
MEGA = Mangement of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese