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Analysis of Efficacy and Safety in Patients Aged 65–75 Years at Randomization

Collaborative Atorvastatin Diabetes Study (CARDS)

¹ Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K
² Pfizer, New York, New York
³ The Middlesex Hospital, University College London, London, U.K
⁴ The Conway Institute, University College Dublin, Dublin, Ireland
⁵ Department of Medicine, Manchester Royal Infirmary, University of Manchester, Manchester, U.K
⁶ Department of Epidemiology and Public Health, Royal Free and University College Medical School, London, U.K
⁷ Centre for Diabetes and Metabolic Medicine, Barts and The London Queen Mary’s School of Medicine and Dentistry, London, U.K

Address correspondence and reprint requests to Professor H.A.W. Neil, Division of Public Health and Primary Health Care, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, U.K. E-mail: andrew.neil{at}wolfson.ox.ac.uk

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).

RESEARCH DESIGN AND 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.

Abbreviations: CARDS, Collaborative Atorvastatin Diabetes Study • CPK, creatinine phosphokinase • CTT, Cholesterol Treatment Trialists’ • CVD, cardiovascular disease • NNT, number of patients needed to treat • ULN, upper limit of normal

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