Analysis of efficacy and safety in patients aged 65-75 years at randomization: Collaborative Atorvastatin Diabetes Study (CARDS).
OBJECTIVE
Rates of cardiovascular disease are highest in the elderly. Lipid-lowering statin therapy reduces the proportional risk as effectively in older patients as in younger individuals; however, limited data are available for elderly patients with type 2 diabetes. We conducted a post hoc analysis to compare the efficacy and safety of atorvastatin among 1,129 patients aged 65-75 years at randomization with 1,709 younger patients in the Collaborative Atorvastatin Diabetes Study (CARDS).


METHODS
CARDS was a randomized placebo-controlled trial of 10 mg/day atorvastatin for primary prevention of cardiovascular disease in patients aged 40-75 years with LDL cholesterol concentrations </=4.14 mmol/l followed for a median of 3.9 years. The primary end point was time to first occurrence of acute coronary heart disease events, coronary revascularizations, or stroke.


RESULTS
Atorvastatin treatment resulted in a 38% reduction in relative risk ([95% CI -58 to -8], P = 0.017) of first major cardiovascular events in older patients and a 37% reduction ([-57 to -7], P = 0.019) in younger patients. Corresponding absolute risk reductions were 3.9 and 2.7%, respectively (difference 1.2% [95% CI -2.8 to 5.3], P = 0.546); numbers needed to treat for 4 years to avoid one event were 21 and 33, respectively. All-cause mortality was reduced nonsignificantly by 22% ([-49 to 18], P = 0.245) and 37% ([-64 to 9], P = 0.98), respectively. The overall safety profile of atorvastatin was similar between age-groups.


CONCLUSIONS
Absolute and relative benefits of statin therapy in older patients with type 2 diabetes are substantial, and all patients warrant treatment unless specifically contraindicated.
Neil
H Andrew W
HA
Division of Public Health and Primary Health Care, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK. andrew.neil@wolfson.ox.ac.uk
DeMicco
David A
DA
Luo
Don
D
Betteridge
D John
DJ
Colhoun
Helen M
HM
Durrington
Paul N
PN
Livingstone
Shona J
SJ
Fuller
John H
JH
Hitman
Graham A
GA
D000328:Adult; D017677:Age Distribution; D000368:Aged; D000789:Angina, Unstable / Q000401:mortality / Q000517:prevention & control; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000069059:Atorvastatin; D003327:Coronary Disease / Q000401:mortality* / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000401:mortality*; D005260:Female; D006538:Heptanoic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000517:prevention & control; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D012307:Risk Factors; D040242:Risk Reduction Behavior; D020521:Stroke / Q000401:mortality / Q000517:prevention & control
D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D011758:Pyrroles; D000069059:Atorvastatin