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Collaborative Atorvastatin Diabetes Study (CARDS). Atorvastatin 10 mg (n=1428). Patient Population. Type 2 diabetes mellitus Men and women 40–75 years of age Primary CHD and stroke prevention LDL-C 160 mg/dL ( 4.14 mmol/L) TG 600 mg/dL ( 6.78 mmol/L) 1 additional RF
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Collaborative Atorvastatin Diabetes Study (CARDS) Atorvastatin 10 mg (n=1428) Patient Population • Type 2 diabetes mellitus • Men and women 40–75 years of age • Primary CHD and stroke prevention • LDL-C 160 mg/dL (4.14 mmol/L) • TG 600 mg/dL (6.78 mmol/L) • 1 additional RF • HTN (or on HTN treatment) • Retinopathy • Albuminuria • Current smoking 2838 patients 4-year follow-up Double-blind placebo (n=1410) • Primary endpoint: time to first major CV event (CHD death, nonfatal MI, unstable angina, resuscitated cardiac arrest, coronary revascularization, stroke • Secondary endpoints: total mortality, any CV endpoint, lipids, and lipoproteins Colhoun HM et al. Lancet 2004;364:685-696.
CARDS: Patient Baseline Characteristics Colhoun HM et al. Lancet 2004;364:685-696. Reprinted with permission from Elsevier.
CARDS: Patient Baseline Lipids *Median (interquartile range) Colhoun HM et al. Lancet 2004;364:685-696. Reprinted with permission from Elsevier.
0 0 1 1 2 2 3 3 4 4 4.5 4.5 CARDS: Lipid Levels by Treatment Total Cholesterol (mg/dL)Average difference 26%,54 mg/dL; P<0.0001 LDL Cholesterol (mg/dL)Average difference 40%,46 mg/dL; P<0.0001 Placebo Placebo Median LDL-C (mg/dL)* Atorvastatin Median TC (mg/dL)* Atorvastatin Years of Study Years of Study Colhoun HM et al. Lancet 2004;364:685-696. Reprinted with permission from Elsevier.
CARDS: Effect of Atorvastatin on the Primary Endpoint: Major CV Events Including Stroke Relative Risk Reduction 37% (95% CI, 17–52)P = 0.001 Placebo127 events Cumulative Hazard, (%) Atorvastatin83 events 0 1 2 3 4 4.75 Years PlaceboAtorvastatin 14101428 13511392 13061361 10221074 651694 305328 Colhoun HM et al. Lancet 2004;364:685-696. Reprinted with permission from Elsevier.
CARDS: Adverse and Serious Adverse Events Colhoun HM et al. Lancet 2004;364:685-696.
Primary Prevention Trials of Lipid-Altering Therapy Including Patients with Diabetes * By history † Prospective trial in diabetic subjects; others are subgroup analyses ‡ Mean 30 mg/d § Type 1 or 2 diabetes Bays H et al. Future Cardiology 2005;1:39-59. | Colhoun HM et al. Lancet 2004;364:685-696. | Downs JR et al. JAMA 1998;279:1615-1622. | HPS Collaborative Group. Lancet 2003;361:2005-2016. | Sever PS et al. Lancet 2003;361:1149-1158. | Shepherd J et al. Lancet 2002;360:1623-1630. | Koskinen P et al. Diabetes Care 1992;15:820-825.
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