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Cards研究 糖尿病
 

Cards研究 糖尿病

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    Cards研究 糖尿病 Cards研究 糖尿病 Presentation Transcript

    • Collaborative Atorvastatin Diabetes Study (CARDS)
      • 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
      Colhoun HM et al. Lancet 2004;364:685-696. Patient Population
      • 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
      2838 patients 4-year follow-up Atorvastatin 10 mg (n=1428) Double-blind placebo (n=1410)
    • CARDS: Patient Baseline Characteristics Colhoun HM et al. Lancet 2004;364:685-696. Reprinted with permission from Elsevier. Placebo (n = 1410) Atorvastatin (n = 1428) Age Mean (SD) years 61.8 (8.0) 61.5 (8.3) <60 529 (38%) 558 (39%) 60–70 708 (50%) 703 (49%) >70 173 (12%) 167 (12%) Women 453 (32%) 456 (32%) White ethnicity 1326 (94%) 1350 (95%) BMI Mean (SD), kg/m 2 28.8 (3.5) 28.7 (3.6) Obese (BMI >30 kg/m 2 ) 538 (38%) 515 (36%)
    • CARDS: Patient Baseline Lipids * Median (interquartile range) Colhoun HM et al. Lancet 2004;364:685-696. Reprinted with permission from Elsevier. Placebo (n = 1410) Mean (SD) Atorvastatin (n = 1428) Mean (SD) Total cholesterol (mg/dL) (mmol/L) 207 (32) 5.35 (0.82) 207 (32) 5.36 (0.83) LDL cholesterol (mg/dL) (mmol/L) 117 (27) 3.02 (0.70) 118 (28) 3.04 (0.72) HDL cholesterol (mg/dL) (mmol/L) 55 (13) 1.42 (0.34) 54 (12) 1.39 (0.32) Triglycerides * (mg/dL) (mmol/L) 148 (104–212) 1.67 (1.17–2.40) 150 (106–212) 1.70 (1.20–2.40)
    • CARDS: Lipid Levels by Treatment Total Cholesterol (mg/dL) Average difference 26%, 54 mg/dL; P<0.0001 Median TC (mg/dL)* Years of Study Median LDL-C (mg/dL)* Years of Study LDL Cholesterol (mg/dL) Average difference 40%, 46 mg/dL; P<0.0001 Atorvastatin Atorvastatin Placebo Placebo Colhoun HM et al. Lancet 2004;364:685-696. Reprinted with permission from Elsevier. 0 1 2 3 4 4.5 0 1 2 3 4 4.5
    • CARDS: Effect of Atorvastatin on the Primary Endpoint: Major CV Events Including Stroke Cumulative Hazard, (%) Years 0 1 2 3 4 Relative Risk Reduction 37% (95% CI, 17–52) P = 0.001 1410 1428 1351 1392 Placebo Atorvastatin 4.75 1306 1361 1022 1074 651 694 305 328 Placebo 127 events Atorvastatin 83 events 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. Type of Event Patients (%) with Event Placebo (n = 1410) Atorvastatin 10 mg (n = 1428) Serious adverse event possibly associated with study drug 20 (1.1%) 19 (1.1%) Discontinued for AE 145 (10%) 122 (9%) Rhabdomyolysis 0 0 Myopathy AE report 1 (0.1%) 1 (0.1%) CPK  10  ULN 10 (0.7%) 2 (0.1%) ALT  3  ULN 14 (1%) 17 (1%) AST  3  ULN 4 (0.3%) 6 (0.4%)
    • Primary Prevention Trials of Lipid-Altering Therapy Including Patients with 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. * By history † Prospective trial in diabetic subjects; others are subgroup analyses ‡ Mean 30 mg/d § Type 1 or 2 diabetes Trial Diabetic, * n Total N in Study Lipid-Altering Drug, mg/d CHD* Risk vs Placebo in Diabetic Patients, % CARDS † 2,838 2,838 Atorvastatin 10 – 37 (p=.001) AFCAPS 155 6,605 Lovastatin 20–40 ‡ – 44 (NS) HPS § 2,912 7,150 Simvastatin 40 – 33 (p=.0003) ASCOT 2,532 10,305 Atorvastatin 10 – 16 (NS) PROSPER 623 5,804 Pravastatin 40 +27 (NS) HHS 135 4,081 Gemfibrozil 1200 – 68 (NS)
    • Secondary Prevention Trials of Lipid-Altering Therapy Including Patients with Diabetes Bays H et al. Future Cardiology 2005;1:39-59. | Pyörälä K et al. Diabetes Care 1997;20:614-620. | Haffner SM et al. Arch Intern Med 1999;159:2661-2667. | Goldberg RB et al. Circulation 1998;98:2513-2519. | Keech A et al. Diabetes Care 2003;26:2713-2721. | Serruys PWJC et al. JAMA 2002;287:3215-3222. | HPS Collaborative Group. Lancet 2003;361:2005-2016. | Wanner C. Presented at ASN annual meeting, 2004. | Rubins HB et al. Arch Intern Med 2002;162:2597-2604. | DAIS Investigators. Lancet 2001;357:905-910. *Includes stroke in 4D and VA-HIT † By history ‡ By history or glucose  126 mg/dL § Type 1 or 2 diabetes ¶ Prospective trial in diabetic subjects; others are subgroup analyses || Angiographic study Trial Diabetic, n Total N in Study Lipid-Altering Drug, mg/d CHD * Risk vs Placebo in Diabetic Patients, % 4S Reanalysis 202 † 483 ‡ 4,444 Simvastatin 20–40 – 55 (p=.002) –42 (p=.001) CARE 586 † 4,159 Pravastatin 40 – 25 (p=.05) LIPID 1,077 ‡ 9,014 Pravastatin 40 – 19 (NS) LIPS § 202 † 1,677 Fluvastatin 80 – 47 (p=.04) HPS § 3,051 † 13,386 Simvastatin 40 – 18 (p=.002) 4D ¶ 1,255 † 1,255 Atorvastatin 20 – 8 (NS) VA-HIT 769 ‡ 2,351 Gemfibrozil 1,200 – 32 (p=.004) DAIS ¶ || 418 † 418 Fenofibrate 200 – 23 (NS)