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Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design

Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design. Multicenter trial with 2 treatment comparisons

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Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design

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  1. Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design • Multicenter trial with 2 treatment comparisons • A prospective, randomized, open, blinded endpoint (PROBE) design comparing 2 antihypertensive regimens in hypertensive men and women without known CHD who had 3 other CV risk factors (n=19,342) • A double-blind, placebo-controlled trial of atorvastatin 10 mg/d in the subsample of patients with total cholesterol 250 mg/dL (n=10,305) • Primary endpoint: nonfatal MI (including silent MI) or CHD death • Planned follow-up average of 5 yr; lipid-lowering arm stopped early at median follow-up of 3.3 yr Sever PS et al. J Hypertens 2001;19:1139–1147. | Sever PS et al. Lancet 2003;361:1149–1158.

  2. ASCOT Entry Criteria • No treated angina or prior MI • Age: 40–79 yr • Blood pressure • Untreated: SBP 160 and/or DBP 100 mm Hg • Treated: SBP 140 and/or DBP 90 mm Hg • 3 CV risk factors: • Smoking  ECG abnormalities • LVH  NIDDM • Family Hx  PVD • Age 55 yr  Hx CVA • Male sex  TC/HDL-C 6 • Microalbuminuria/proteinuria • TG 400 mg/dL • TC 250 mg/dL (in lipid-lowering arm) Sever PS et al. J Hypertens 2001;19:1139–1147. | Sever PS et al. Lancet 2003;361:1149–1158.

  3. ASCOT: Lipid Changes with Atorvastatin Baseline 1 Year 3 Years mg/dl TC LDL-C HDL-C TG Sever PS et al. Lancet 2003;361:1149–1158. Reprinted with permission from Elsevier Science.

  4. ASCOT: Primary Endpoint—Nonfatal MI and Fatal CHD Atorvastatin 10 mg Number of events 100 Placebo Number of events 154 36%reduction Cumulative Incidence (%) HR = 0.64 (0.50–0.83); p = 0.0005 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Years Sever PS et al. Lancet 2003;361:1149–1158. Reprinted with permission from Elsevier Science.

  5. ASCOT: Secondary Endpoint—Fatal MI and Nonfatal Stroke Atorvastatin 10 mg Number of events 89 Placebo Number of events 121 27%reduction Cumulative Incidence (%) HR = 0.73 (0.56–0.96); p = 0.0236 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Years Sever PS et al. Lancet 2003;361:1149–1158. Reprinted with permission from Elsevier Science.

  6. ASCOT: Secondary Endpoint—All CV Events and Procedures Atorvastatin 10 mg Number of events 389 Placebo Number of events 486 21%reduction Cumulative Incidence (%) HR = 0.79 (0.69–0.90); p = 0.0005 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Years Sever PS et al. Lancet 2003;361:1149–1158. Reprinted with permission from Elsevier Science.

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