slide source: lipids online slide library anglo-scandinavian cardiac outcomes trial (ascot) design...

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Slide Source: Lipids Online Slide Library www.lipidsonline.org Anglo-Scandinavian Cardiac Outcomes Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design 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 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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Page 1: Slide Source: Lipids Online Slide Library  Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design Sever PS et al. J Hypertens 2001;19:1139–1147

Slide Source:Lipids Online Slide Librarywww.lipidsonline.org

Anglo-Scandinavian Cardiac Outcomes Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) DesignTrial (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

Page 2: Slide Source: Lipids Online Slide Library  Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design Sever PS et al. J Hypertens 2001;19:1139–1147

Slide Source:Lipids Online Slide Librarywww.lipidsonline.org

ASCOT Entry CriteriaASCOT 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)

Page 3: Slide Source: Lipids Online Slide Library  Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design Sever PS et al. J Hypertens 2001;19:1139–1147

Slide Source:Lipids Online Slide Librarywww.lipidsonline.org

0

50

100

150

200

250

mg/

dl

TC

Baseline 1 Year

LDL-C HDL-C

ASCOT: Lipid Changes with AtorvastatinASCOT: Lipid Changes with Atorvastatin

Sever PS et al. Lancet 2003;361:1149–1158.Reprinted with permission from Elsevier Science.

TG

3 Years

Page 4: Slide Source: Lipids Online Slide Library  Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design Sever PS et al. J Hypertens 2001;19:1139–1147

Slide Source:Lipids Online Slide Librarywww.lipidsonline.org

0

1

2

3

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Cum

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ive

Incid

ence

(%)

Years

ASCOT: Primary Endpoint—Nonfatal MI ASCOT: Primary Endpoint—Nonfatal MI and Fatal CHDand Fatal CHD

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5

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

36%36%reductionreduction

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.

Page 5: Slide Source: Lipids Online Slide Library  Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design Sever PS et al. J Hypertens 2001;19:1139–1147

Slide Source:Lipids Online Slide Librarywww.lipidsonline.org

0

1

2

3

Cum

ulat

ive

Incid

ence

(%)

Years

ASCOT: Secondary Endpoint—Fatal MI ASCOT: Secondary Endpoint—Fatal MI and Nonfatal Strokeand Nonfatal Stroke

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5

Atorvastatin 10 mg Number of events 89Placebo Number of events 121

27%27%reductionreduction

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.

Page 6: Slide Source: Lipids Online Slide Library  Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Design Sever PS et al. J Hypertens 2001;19:1139–1147

Slide Source:Lipids Online Slide Librarywww.lipidsonline.org

0

2

4

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12

Cum

ulat

ive

Incid

ence

(%)

Years

ASCOT: Secondary Endpoint—All CV ASCOT: Secondary Endpoint—All CV Events and ProceduresEvents and Procedures

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5

Atorvastatin 10 mg Number of events 389Placebo Number of events 486

21%21%reductionreduction

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.