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ASTEROID

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

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ASTEROID

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  1. ASTEROID AStudy To evaluate the Effect of Rosuvastatin On Intravascular ultrasound- Derived coronary atheroma burden

  2. ASTEROID: Background and hypothesis • Aggressive lipid modification has demonstrated regression and/or reduced progression of stenotic lesions by quantitative coronary angiography • IVUS trials have shown a halting of progression of atherosclerosis during statin treatment; however, none have provided convincing evidence of regression • Does very aggressive statin treatment with rosuvastatin 40 mg, designed to simultaneously  LDL-C and  HDL-C, result in regression of coronary atherosclerosis? Nissen SE et al. JAMA. 2006;295:1556-65.

  3. ASTEROID: Study design Multicenter, open-label, blinded end point IVUS assessment at baseline and study end Angiographic CAD (>20% luminal narrowing*) Statin-naive N = 507 Rosuvastatin 40 mg qd for 24 months Completed trialN = 349 • Primary efficacy parameters: • Change in % atheroma volume of target vessel • Change in total atheroma volume in most diseased 10-mm segment *Patients with >50% luminal narrowing were excluded Nissen SE et al. JAMA. 2006;295:1556-65.

  4. ASTEROID: Baseline characteristics N = 349 Nissen SE et al. JAMA. 2006;295:1556-65.

  5. ASTEROID: Baseline characteristics N = 349 Nissen SE et al. JAMA. 2006;295:1556-65.

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

  7. ASTEROID: Treatment effect on primary efficacy parameters P < 0.001 P < 0.001 % mm3 Nissen SE et al. JAMA. 2006;295:1556-65.

  8. ASTEROID: Treatment-emergent adverse events N = 507 Patients (%) 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) 63 patients withdrew for adverse events,62 withdrew for other reasons*Causes of death: Renal failure (1), sudden cardiac death (2), gastric carcinoma (1) Nissen SE et al. JAMA. 2006;295:1556-65.

  9. ASTEROID: Drug discontinuations N = 507 Patients (%) 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) 63 patients withdrew for adverse events,62 withdrew for other reasons*Angina, CHF, arrhythmias, other ischemic events Nissen SE et al. JAMA. 2006;295:1556-65.

  10. Relationship between ↓LDL-C and atheroma burden Data from recent IVUS trials 1.8 REVERSALPravastatin CAMELOTPlacebo 1.2 Median Δ in percent atheroma volume (%) 0.6 A-PlusPlacebo REVERSAL Atorvastatin 0 –0.6 ASTEROID Rosuvastatin r2 = 0.97 P < 0.001 –1.2 0 60 70 80 90 100 110 120 Mean LDL-C (mg/dL) Nissen SE et al. JAMA. 2006;295:1556-65.

  11. ASTEROID: Summary • Aggressive statin treatment with rosuvastatin (40 mg) achieved significant changes in lipid levels • LDL-C lowered to 60.8 mg/dL (53.2%) • HDL-C raised to 49 mg/dL (14.7%) • These changes were associated with significant regression of coronary atherosclerosis assessed via prespecified IVUS end points • Benefits were also observed in all prespecified subgroups (including age, sex, BMI, history of diabetes) Nissen SE et al. JAMA. 2006;295:1556-65.

  12. ASTEROID: Implications • Aggressive lipid-modulating strategies in patients with CAD can reverse the atherosclerotic disease process • Therapies designed to simultaneously lower LDL-C while raising HDL-C have the potential to substantially reduce atheroma burden Nissen SE et al. JAMA. 2006;295:1556-65.Blumenthal R et al. JAMA. 2006;295:1583-4.

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