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Landmark Statin Trials Across the Spectrum of Risk: Secondary Stroke Prevention . Simvastatin in Patients With Prior Cerebrovascular Disease: HPS. 29.8. 24.7*. Simvastatin. Placebo. 10.3. 10.4. (N=488). N=406. N=169. N=170. Major Vasular Events. Stroke. *29% RRR, p =0.001

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simvastatin in patients with prior cerebrovascular disease hps
Simvastatin in Patients With Prior Cerebrovascular Disease: HPS

29.8

24.7*

Simvastatin

Placebo

10.3

10.4

(N=488)

N=406

N=169

N=170

Major Vasular Events

Stroke

*29% RRR, p=0.001

Heart Protection Study Collaborative Group. Lancet. 2004;363:757-767.

sparcl trial of secondary stroke prevention study design
SPARCL Trial of Secondary StrokePrevention: Study Design

Double-Blind Period

Patient Population

Atorvastatin 80 mg/day

  • 205 sites worldwide
  • Previously documented stroke or TIA within 6 months
  • No history of CHD
  • LDL-C levels ≥100 mg/dL and ≤190 mg/dL

4731 Patients

Pravastatin 40 mg

540 Primary End Points

Primary End Point Time to the First Occurrence of a Fatal or Nonfatal Stroke

SPARCL Investigators. Cerebrovasc Dis. 2003;16:389-395.

sparcl primary end point time to fatal or nonfatal stroke
SPARCL Primary End Point: Time to Fatal or Nonfatal Stroke

16%

Placebo

Placebo (n= 2366)Mean LDL-C = 128 mg/dL (3.3 mmol/L)

16%RR

Atorvastatin

12%

Fatal or Non-Fatal Stroke, %

Atorvastatin 80 mg (n= 2635)Mean LDL-C = 73 mg/dL (1.9 mmol/L)

8%

4%

Adjusted HR (95% CI)* = 0.84 (0.71, 0.99), p = 0.03

0%

0

1

2

3

4

5

6

Years Since Randomization

* Treatment effect from Cox proportional hazards models with prespecified adjustment for geographical region, entry event, time since entry event, gender, and baseline age.

Amarenco P et al. N Engl J Med. 2006;355:549-559.

sparcl secondary end point time to major coronary event
SPARCL Secondary End Point:Time to Major Coronary Event

8%

Placebo

Atorvastatin

6%

35%RR

4%

Major Coronary Event, %

2%

Adjusted HR (95% CI)* = 0.65 (0.49, 0.87), p = 0.003

0%

0

1

2

3

4

5

6

Years Since Randomization

5

* Treatment effect from Cox proportional hazards models with prespecified adjustment for geographical region, entry event, time since entry event, gender, and baseline age.

Amarenco P et al. N Engl J Med. 2006;355:549-559.

sparcl benefit risk
SPARCL: Benefit/Risk

P=0.002

P = 0.03

17.2%

Major Coronary Event

Ischemic Stroke

Hemorrhagic Stroke

Unclassified Stroke

14.1%

13.1%

11.2%

Incidence (%)

Atorvastatinn = 2365

Placebon = 2366

Atorvastatinn = 2365

Placebon = 2366

Stroke

Stroke and Major Coronary Events

AmarencoP. Exp Op Pharmacotherapy. 2007;8:2789-2797.

effect of atorvastatin on stroke in sparcl patients with diabetes
Effect of Atorvastatin on Stroke In SPARCL Patients with Diabetes

100

Atorvastatin 80 mg

Placebo

90

Percentage of Patients Free of EndPoints

RR: 30%

80

HR = 0.70 (95% CI, 0.50, 0.98), P = 0.0387*

Log-rank P = 0.0377

70

0

1

2

3

4

5

6

Years Since Randomization

*Adjusted for entry event, time since entry event, gender, age, and geographic region

Callahan A, Welch KMA, Amarenco P, et al.

sparcl stroke in patients with carotid stenosis
SPARCL: Stroke in Patients With Carotid Stenosis

100

Atorvastatin

Placebo

90

Patients Free of Fatal or Non-Fatal Stroke, %

RR: 33%

80

HR=0.67 (95% CI 0.47, 0.94), P=.02*

70

0

1

2

3

4

5

Years Since Randomization

* Adjusted for entry event, time since entry event, gender, age, and geographical region.

Sillesen H et al. Stroke. 2008;39;3297-3302.

sparcl carotid endarterectomy in patients w ith carotid stenosis
SPARCL: Carotid Endarterectomy inPatients with Carotid Stenosis

100

Atorvastatin (n=16/493)

Placebo (n=37/514)

98

RR: 56%

Patients Free of Carotid Endarterectomy, %

96

94

HR=0.44 (95% CI 0.24, 0.79), P=.006

92

0

1

2

3

4

5

Years Since Randomization

* Adjusted for entry event, time since entry event, gender, age, and geographical region.

Sillesen H et al. Stroke. 2008;39;3297-3302.

sparcl prespecified and post hoc analyses
SPARCL: Prespecified andPost-Hoc Analyses

*Treatmenteffectfrom Cox proportionalhazardsmodelswithpre-specifiedadjustment for geographicalregion, entry event, time since entry event,gender, and baselineage.

HR, hazard ratio; CI, confidence interval.

The SPARCL Investigators: N Engl J Med: 2006;355:549-559.

sparcl ischemic and hemorrhagic stroke post hoc analysis
SPARCL: Ischemic and Hemorrhagic Stroke Post hoc Analysis

Placebo: Ischemic

Atorvastatin: Ischemic

Placebo: Hemorrhagic

Atorvastatin: Hemorrhagic

Fatal and Nonfatal Stroke

16

Ischemic: HR (95% CI = 0.79 (0.66, 0.95)

12

Ischemic or Hemorrhagic Stroke (%)

8

4

Hemorrhagic: HR (95% CI = 1.68 (1.09, 2.59)

0

Unadjusted HR

0

1

2

3

4

5

6

Years Since Randomization

Goldstein LB et al. Neurology. 2008 ;70:2364-2370.

sparcl multivariable cox regression model baseline characteristics
SPARCL: Multivariable Cox RegressionModel Baseline Characteristics

Goldstein LB er al. Neurology. 2008;70:2364-2370.