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					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.
                                                                   Slide Source:
Lancet 2003;361:1149–1158.                                         Lipids Online Slide Library
                                                                   www.lipidsonline.org
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.
                                                                   Slide Source:
Lancet 2003;361:1149–1158.                                         Lipids Online Slide Library
                                                                   www.lipidsonline.org
ASCOT: Lipid Changes with Atorvastatin

                       Baseline               1 Year       3 Years
      250

      200

      150

      100

        50

          0
                    TC            LDL-C            HDL-C    TG

Sever PS et al. Lancet 2003;361:1149–1158.                       Slide Source:
                                                                 Lipids Online Slide Library
Reprinted with permission from Elsevier Science.                 www.lipidsonline.org
    ASCOT: Primary Endpoint—Nonfatal MI
    and Fatal CHD
                           4
Cumulative Incidence (%)


                                       Atorvastatin 10 mg    Number of events 100
                                       Placebo               Number of events 154

                           3                                                           36%
                                                                                       reduction
                           2


                           1
                                                 HR = 0.64 (0.50–0.83); p = 0.0005
                           0
                           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.                                        Slide Source:
                                                                                      Lipids Online Slide Library
    Reprinted with permission from Elsevier Science.                                  www.lipidsonline.org
    ASCOT: Secondary Endpoint—Fatal MI
    and Nonfatal Stroke
                           3
Cumulative Incidence (%)


                                       Atorvastatin 10 mg    Number of events   89
                                       Placebo               Number of events 121
                                                                                        27%
                           2                                                            reduction



                           1

                                                 HR = 0.73 (0.56–0.96); p = 0.0236
                           0
                           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.                                         Slide Source:
                                                                                       Lipids Online Slide Library
    Reprinted with permission from Elsevier Science.                                   www.lipidsonline.org
    ASCOT: Secondary Endpoint—All CV Events
    and Procedures
                           12
Cumulative Incidence (%)


                                   Atorvastatin 10 mg   Number of events 389
                                   Placebo              Number of events 486
                           10
                                                                                       21%
                           8                                                           reduction

                           6

                           4

                           2
                                             HR = 0.79 (0.69–0.90); p = 0.0005
                           0
                           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.                                       Slide Source:
                                                                                     Lipids Online Slide Library
    Reprinted with permission from Elsevier Science.                                 www.lipidsonline.org

				
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posted:10/27/2011
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