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Comprehensive Analysis of Statin Trials for Secondary Stroke Prevention

Review various landmark statin trials for secondary stroke prevention across different risk levels, focusing on simvastatin and atorvastatin effectiveness and outcomes. Includes SPARCL trial findings and benefits of statin therapy in stroke patients with diabetes.

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Comprehensive Analysis of Statin Trials for 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 * Treatment effect from Cox proportional hazards models with prespecified adjustment for geographical region, entry event, time since entry event, gender, and baseline age. Years Since Randomization 5 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 *Adjusted for entry event, time since entry event, gender, age, and geographic region Years Since Randomization Callahan A, Welch KMA, Amarenco P, et al.

  8. 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.

  9. 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.

  10. SPARCL: Ischemic andHemorrhagicStroke 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.

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

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