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Landmark Statin Trials Across the Spectrum of Risk: Secondary Stroke Prevention

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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Landmark Statin Trials Across the Spectrum of Risk: Secondary Stroke Prevention

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  1. Landmark Statin Trials Across the Spectrum of Risk: Secondary Stroke Prevention

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. SPARCL: Multivariable Cox RegressionModel Baseline Characteristics Goldstein LB er al. Neurology. 2008;70:2364-2370.

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