Analysis of Efficacy and Safety in Patients Aged 65–75 Years at Randomization
Collaborative Atorvastatin Diabetes Study (CARDS)
- H. Andrew W. Neil, DSC1,
- David A. DeMicco, PHARMD2,
- Don Luo, PHD2,
- D. John Betteridge, PHD3,
- Helen M. Colhoun, MD4,
- Paul N. Durrington, MD5,
- Shona J. Livingstone, MSC6,
- John H. Fuller, FRCP6,
- Graham A. Hitman, MD7 and
- on behalf of the CARDS Study Investigators
- 1Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K
- 2Pfizer, New York, New York
- 3The Middlesex Hospital, University College London, London, U.K
- 4The Conway Institute, University College Dublin, Dublin, Ireland
- 5Department of Medicine, Manchester Royal Infirmary, University of Manchester, Manchester, U.K
- 6Department of Epidemiology and Public Health, Royal Free and University College Medical School, London, U.K
- 7Centre 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
Abstract
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.
- 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
Footnotes
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H.A.W.N. and D.A.D. contributed equally to this work.
H.A.W.N. and P.N.D. have received research support from and have served as consultants for AstraZeneca, Merck Sharp and Dohme, Schering Plough, Solvay Health Care, and Pfizer. D.J.B. has received honoraria from and has served on an advisory board for Pfizer. H.M.C. has received honoraria from, has served on an advisory board for, and has received research support from Pfizer. J.H.F. has served as a consultant for and has received research funding from AstraZeneca, Fournier, and Pfizer. G.A.H. has received lecture fees from and has served on an advisory board for Pfizer, GlaskoSmithKline, and AstraZeneca.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.
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- Accepted August 10, 2006.
- Received May 19, 2006.
- DIABETES CARE
