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Baseline characteristics in the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with Type 2 diabetes
M J Thomason1, H M Colhoun, S J Livingstone
1EURODIAB, Department of Epidemiology and Public Health, Royal Free and University College Medical School, London, UK. m.thomason@ucl.ac.uk
Insights
The Collaborative Atorvastatin Diabetes Study (CARDS) evaluated atorvastatin for cardiovascular event prevention in Type 2 diabetes patients. Baseline characteristics of participants were described to inform future cardiovascular risk management strategies.
Area of Science:
- Cardiology
- Endocrinology
- Clinical Trials
Background:
- Type 2 diabetes significantly increases cardiovascular disease (CVD) risk.
- Primary prevention of major cardiovascular events is crucial in diabetic populations.
- Lipid-lowering therapy is a key strategy for managing CVD risk in diabetes.
Purpose of the Study:
- To characterize baseline demographics and clinical features of patients enrolled in the CARDS trial.
- To provide a comprehensive description of participants in a randomized, placebo-controlled trial of atorvastatin for primary CVD prevention.
- To establish a foundation for analyzing the efficacy of atorvastatin in reducing cardiovascular events in Type 2 diabetes.
Main Methods:
- The Collaborative Atorvastatin Diabetes Study (CARDS) was a randomized, placebo-controlled trial.
- Inclusion criteria included Type 2 diabetes, age 40-75, no prior major cardiovascular events, and specific risk factors.
- Eligibility also required LDL-cholesterol <= 4.14 mmol/l and triglycerides <= 6.78 mmol/l.
Main Results:
- 2838 patients were randomized into the CARDS study by June 2001.
- Mean age was 62 years, with a median diabetes duration of 6 years.
- Prevalent risk factors included hypertension (79%), retinopathy (30%), and current smoking (23%).
Conclusions:
- The CARDS study provides essential data on baseline characteristics for atorvastatin's role in Type 2 diabetes.
- Findings will contribute to understanding the macrovascular and microvascular benefits of lipid lowering.
- Results are expected to influence clinical management strategies for diabetic patients at cardiovascular risk.
Aim:
To describe baseline characteristics of patients in the Collaborative AtoRvastatin Diabetes Study (CARDS), a randomized, placebo-controlled trial of lipid lowering with atorvastatin 10 mg daily for the primary prevention of major cardiovascular events in patients with Type 2 diabetes.
Methods:
The main eligibility criteria were Type 2 diabetes, age 40-75 years, no previous history of coronary heart disease, stroke or other major cardiovascular events, a documented history of at least one of retinopathy, micro- or macroalbuminuria, hypertension or current smoking, LDL-cholesterol < or = 4.14 mmol/l and triglycerides < or = 6.78 mmol/l.
Results:
Randomization of 2838 persons (909 women) into CARDS was completed in June 2001. At entry, mean age was 62 years, 12% were over 70 years old and median duration of diabetes was 6 years. Median fasting lipid levels were total cholesterol 5.4 mmol/l, LDL-cholesterol 3.1 mmol/l, HDL-cholesterol 1.4 mmol/l and triglyceride 1.7 mmol/l. There was a documented history of retinopathy in 30% of patients, micro/macroalbuminuria in 11% (additionally 17% had micro/macroalbuminuria based on two elevated pretreatment measurements of albumin-creatinine ratios), hypertension in 79% and 23% were current smokers.
Conclusion:
CARDS will contribute importantly to the evidence for the macrovascular and microvascular benefits of lipid lowering with atorvastatin in patients with Type 2 diabetes. The results are likely to have important implications for the management of patients.
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