American Journal of Cardiology
Volume 104, Issue 1 , Pages 29-35 , 1 July 2009

Safety and Efficacy of Achieving Very Low Low-Density Lipoprotein Cholesterol Levels With Rosuvastatin 40 mg Daily (from the ASTEROID Study)

  • Stephen D. Wiviott, MD

      Affiliations

    • Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
    • Corresponding Author InformationCorresponding author: Tel: 617-278-0145; fax: 617-734-7329
    • ,
  • Satishkumar Mohanavelu, MS

      Affiliations

    • Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
    • ,
  • Joel S. Raichlen, MD

      Affiliations

    • AstraZeneca, Wilmington, Delaware
    • ,
  • Valerie A. Cain, MS

      Affiliations

    • AstraZeneca, Wilmington, Delaware
    • ,
  • Steven E. Nissen, MD

      Affiliations

    • Cardiovascular Division, Cleveland Clinic, Cleveland, Ohio
    • ,
  • Peter Libby, MD

      Affiliations

    • Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts

Received 2 October 2008 ,Revised 20 February 2009 ,Accepted 20 February 2009.

References 

  1. Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267–1278
  2. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM, Kastelein JJ, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195–2207
  3. Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006;295:1556–1565
  4. Iso H, Naito Y, Kitamura A, Sato S, Kiyama M, Takayama Y, et al. Serum total cholesterol and mortality in a Japanese population. J Clin Epidemiol. 1994;47:961–969
  5. Neaton JD, Blackburn H, Jacobs D, Kuller L, Lee DJ, Sherwin R, et al. Multiple Risk Factor Intervention Trial Research Group (Serum cholesterol level and mortality findings for men screened in the Multiple Risk Factor Intervention Trial). Arch Intern Med. 1992;152:1490–1500
  6. Stemmermann GN, Chyou PH, Kagan A, Nomura AM, Yano K Honolulu (Hawaii) Heart Program. Serum cholesterol and mortality among Japanese-American men. Arch Intern Med. 1991;151:969–972
  7. LaRosa JC, Grundy SM, Kastelein JJ, Kostis JB, Greten H. Safety and efficacy of atorvastatin-induced very low-density lipoprotein cholesterol levels in patients with coronary heart disease (a post hoc analysis of the Treating to New Targets [TNT] study). Am J Cardiol. 2007;100:747–752
  8. Wiviott SD, Cannon CP, Morrow DA, Ray KK, Pfeffer MA, Braunwald E. Can low-density lipoprotein be too low? (The safety and efficacy of achieving very low low-density lipoprotein with intensive statin therapy: a PROVE IT-TIMI 22 substudy). J Am Coll Cardiol. 2005;46:1411–1416
  9. Amarenco P, Bogousslavsky J, Callahan A, Goldstein LB, Hennerici M, Rudolph AE, et al. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006;355:549–559
  10. Grundy SM, Cleeman JI, Merz CN, Brewer HB, Clark LT, Hunninghake DB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. J Am Coll Cardiol. 2004;44:720–732
  11. LaRosa JC, SM G, Kastelein JJ, JB K. Safety and efficacy of very low LDL-C levels: a post-hoc analysis of the TNT study. Circulation. 2005;112:662–663
  12. Libby P, Aikawa M. Effects of statins in reducing thrombotic risk and modulating plaque vulnerability. Clin Cardiol. 2003;26:11–14
  13. Morrow DA, de Lemos JA, Sabatine MS, Wiviott SD, Blazing MA, Shui A, et al. Clinical relevance of C-reactive protein during follow-up of patients with acute coronary syndromes in the Aggrastat-to-Zocor trial. Circulation. 2006;114:281–288
  14. Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, et al. C-reactive protein levels and outcomes after statin therapy. N Engl J Med. 2005;352:20–28
  15. Ridker PM, Fonseca FA, Genest J, Gotto AM, Kastelein JJ, Khurmi NS, et al. Baseline characteristics of participants in the JUPITER trial, a randomized placebo-controlled primary prevention trial of statin therapy among individuals with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein. Am J Cardiol. 2007;100:1659–1664
  16. Pasternak RC, Smith SC, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. Stroke. 2002;33:2337–2341
  17. Pfeffer MA, Keech A, Sacks FM, Cobbe SM, Tonkin A, Byington RP, et al. Safety and tolerability of pravastatin in long-term clinical trials: prospective Pravastatin Pooling (PPP) Project. Circulation. 2002;105:2341–2346
  18. Newman CB, Palmer G, Silbershatz H, Szarek M. Safety of atorvastatin derived from analysis of 44 completed trials in 9,416 patients. Am J Cardiol. 2003;92:670–676
  19. Shepherd J, Hunninghake DB, Stein EA, Kastelein JJ, Harris S, Pears J, et al. Safety of rosuvastatin. Am J Cardiol. 2004;94:882–888
  20. Shepherd J, Vidt DG, Miller E, Harris S, Blasetto J. Safety of rosuvastatin: update on 16,876 rosuvastatin-treated patients in a multinational clinical trial program. Cardiology. 2007;107:433–443
  21. LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005;352:1425–1435
  22. Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004;350:1495–1504
  23. Ballantyne CM, Raichlen JS, Nicholls SJ, Erbel R, Tardif JC, Brener SJ, et al. Effect of rosuvastatin therapy on coronary artery stenoses assessed by quantitative coronary angiography: a study to evaluate the effect of rosuvastatin on intravascular ultrasound-derived coronary atheroma burden. Circulation. 2008;117:2458–2466

 The ASTEROID Study was sponsored by AstraZeneca, Wilmington, Delaware. Dr. Wiviott has received honoraria for speaking at Continuing Medical Education programs and consultant fees from AstraZeneca (Wilmington, Delaware), Pfizer (New York, New York), and Merck-Schering Plough (Whitehouse Station, New Jersey). Dr. Raichlen and Ms. Cain are employees of AstraZeneca (Wilmington, Delaware). Dr. Nissen has received research support from AstraZeneca (Wilmington, Delaware), Eli Lilly (Indianapolis, Indiana), Pfizer (New York, New York), Takeda (Osaka, Japan), Daiichi Sankyo (Parsippany, New Jersey), and Sanofi-Aventis (Bridgewater, New Jersey). Dr. Nissen has consulted for a number of pharmaceutical companies without financial compensation. All honoraria, consulting fees, or other payments from any for-profit entity are paid directly to charity, so that neither income nor any tax deduction is received. Dr. Libby does not accept payments from pharmaceutical companies; he serves as an unpaid consultant, speaker, and clinical trial participant for AstraZeneca (Wilmington, Delaware), Merck (Whitehouse Station, New Jersey), Pfizer (New York, New York), and Schering Plough (Kenilworth, New Jersey).

PII: S0002-9149(09)00659-6

doi: 10.1016/j.amjcard.2009.02.040

American Journal of Cardiology
Volume 104, Issue 1 , Pages 29-35 , 1 July 2009

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