Benefit-risk assessment of Rosuvastatin 10 to 40 milligrams

Am J Cardiol. 2003 Aug 21;92(4B):23K-29K. doi: 10.1016/s0002-9149(03)00779-3.


The aim of this article is to examine the benefit-risk profile of rosuvastatin at doses of 10 to 40 mg. In dyslipidemic patients, rosuvastatin produced markedly greater reductions in low-density lipoprotein (LDL) cholesterol and equivalent or greater improvements in various lipid measures, including high-density lipoprotein (HDL) cholesterol, non-HDL cholesterol, and triglycerides when compared with atorvastatin, simvastatin, and pravastatin. In addition, rosuvastatin is more effective than these statins in allowing patients to reach National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III and Joint European Societies LDL cholesterol goals. The safety profile of rosuvastatin was reviewed (as of April 2003) in 12,569 patients, representing 14,231 patient-years of treatment at doses up to 80 mg. In controlled trials, rosuvastatin 10 to 40 mg demonstrated a similar adverse event profile to those for atorvastatin 10 to 80 mg, simvastatin 10 to 80 mg, and pravastatin 10 to 40 mg. Myopathy (defined as muscle symptoms plus serum creatine kinase levels >10 times the upper limit of normal) attributed to rosuvastatin occurred in < or = 0.03% of patients receiving rosuvastatin 10 to 40 mg. No cases of rhabdomyolysis occurred in patients receiving rosuvastatin 10 to 40 mg. Clinically significant alanine aminotransferase elevations occurred in 0.2% of patients receiving rosuvastatin and those receiving atorvastatin, simvastatin, and pravastatin. Compared with other widely used statins, the benefit-risk profile of rosuvastatin 10 to 40 mg appears to be very favorable.

Publication types

  • Review

MeSH terms

  • Cholesterol, HDL / blood
  • Cholesterol, LDL / blood
  • Clinical Trials as Topic
  • Fluorobenzenes / administration & dosage*
  • Humans
  • Hyperlipidemias / drug therapy*
  • Pyrimidines*
  • Risk Assessment
  • Rosuvastatin Calcium
  • Safety
  • Sulfonamides*


  • Cholesterol, HDL
  • Cholesterol, LDL
  • Fluorobenzenes
  • Pyrimidines
  • Sulfonamides
  • Rosuvastatin Calcium