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Slide Source: Lipids Online Slide Library www.lipidsonline.org Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design Sever PS et al. J Hypertens 2001;19:1139–1147. | Sever PS et al. Lancet 2003;361:1149–1158. 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
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Slide Source: Lipids Online Slide Library www.lipidsonline.org ASCOT Entry Criteria Sever PS et al. J Hypertens 2001;19:1139–1147. | Sever PS et al. Lancet 2003;361:1149–1158. 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)
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Slide Source: Lipids Online Slide Library www.lipidsonline.org mg/dl TC Baseline1 Year LDL-CHDL-C ASCOT: Lipid Changes with Atorvastatin Sever PS et al. Lancet 2003;361:1149–1158. Reprinted with permission from Elsevier Science. TG 3 Years
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Slide Source: Lipids Online Slide Library www.lipidsonline.org Cumulative Incidence (%) Years ASCOT: Primary Endpoint—Nonfatal MI and Fatal CHD 0.00.51.01.52.02.53.03.5 Atorvastatin 10 mg Number of events100 Placebo Number of events 154 36% reduction HR = 0.64 (0.50–0.83); p = 0.0005 Sever PS et al. Lancet 2003;361:1149–1158. Reprinted with permission from Elsevier Science.
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Slide Source: Lipids Online Slide Library www.lipidsonline.org Cumulative Incidence (%) Years ASCOT: Secondary Endpoint—Fatal MI and Nonfatal Stroke 0.00.51.01.52.02.53.03.5 Atorvastatin 10 mg Number of events 89 Placebo Number of events 121 27% reduction HR = 0.73 (0.56–0.96); p = 0.0236 Sever PS et al. Lancet 2003;361:1149–1158. Reprinted with permission from Elsevier Science.
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Slide Source: Lipids Online Slide Library www.lipidsonline.org Cumulative Incidence (%) Years ASCOT: Secondary Endpoint—All CV Events and Procedures 0.00.51.01.52.02.53.03.5 Atorvastatin 10 mg Number of events389 Placebo Number of events 486 21% reduction HR = 0.79 (0.69–0.90); p = 0.0005 Sever PS et al. Lancet 2003;361:1149–1158. Reprinted with permission from Elsevier Science.
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