ASTEROID

1. ASTEROID A S tudy T o evaluate the E ffect of R osuvastatin O n I ntravascular ultrasound- D erived coronary atheroma burden

4. ASTEROID: Baseline characteristics Nissen SE et al. JAMA . 2006;295:1556-65. N = 349 28.4 (25.8 – 31.4) BMI (kg/m 2 ) (interquartile range) 96.8 White (%) 70.2 Male (%) 58.5 Age mean (years)

5. ASTEROID: Baseline characteristics N = 349 Nissen SE et al. JAMA . 2006;295:1556-65. 83.7 53.3 18.3 85.1 84.2 Concomitant medications Aspirin ACEIs ARBs Nitrates β -blockers 96.0 13.2 17.2 24.6 Medical history Hypertension Diabetes ACS Prior MI Patients (%)

6. ASTEROID: Treatment effect on lipids Nissen SE et al. JAMA . 2006;295:1556-65. *P < 0.001 vs baseline n = 346 * *  53.2%  14.7%  33.8%  58.5%

7. ASTEROID: Treatment effect on primary efficacy parameters Nissen SE et al. JAMA . 2006;295:1556-65. mm 3 P < 0.001 P < 0.001 %

8. ASTEROID: Treatment -emergent adverse events Nissen SE et al. JAMA . 2006;295:1556-65. 63 patients withdrew for adverse events, 62 withdrew for other reasons * Causes of death: Renal failure (1), sudden cardiac death (2), gastric carcinoma (1) N = 507 Death* MI Stroke Creatine kinase >5x ULN Creatine kinase >10x ULN ALT >3x ULN 4 (0.8) 10 (2.0) 3 (0.6) 6 (1.2) 0 9 (1.8) Patients (%)

9. ASTEROID: Drug discontinuations Nissen SE et al. JAMA . 2006;295:1556-65. 63 patients withdrew for adverse events, 62 withdrew for other reasons * Angina, CHF, arrhythmias, other ischemic events N = 507 Musculoskeletal complaints GI complaints Neoplasms  Creatine kinase  ALT or bilirubin CV disorders * 19 (3.7) 2 (0.4) 2 (0.4) 2 (0.4) 2 (0.4) 22 (4.3) Patients (%)

10. Relationship between ↓LDL-C and atheroma burden Data from recent IVUS trials Nissen SE et al. JAMA . 2006;295:1556-65. Median Δ in percent atheroma volume (%) 1.8 – 0.6 CAMELOT Placebo REVERSAL Atorvastatin REVERSAL Pravastatin A-Plus Placebo ASTEROID Rosuvastatin r 2 = 0.97 P < 0.001 0 0.6 1.2 – 1.2 0 60 70 80 90 100 110 120 Mean LDL-C (mg/dL)