Safety and effectiveness of the association ezetimibe-statin (E-S) versus high dose rosuvastatin after acute coronary syndrome: the SAFE-ES study

Ann Cardiol Angeiol (Paris). 2014 Sep;63(4):222-7. doi: 10.1016/j.ancard.2014.04.018. Epub 2014 May 2.

Abstract

Background: Statin therapy is a cornerstone therapy for secondary prevention after acute coronary syndrome (ACS). However, the use of these drugs can be limited by side effects, mainly muscular pain. Ezetimibe is a newer lipid-lowering agent, with fewer side effects.

Aims: The present study was designed to compare a commercially available association of ezetimibe and simvastatin (E-S) to high dose Rosuvastatin on cholesterol and muscular enzyme levels and occurrence of muscular pain.

Methods: All consecutive ACS statin-naïve patients with LDL cholesterol (LDL-C)>100mg/dL randomly received either high dose statin (Rosuvastatin 20mg) or E-S 10/40-mg. All patients had one-month follow-up with biological testing and clinical examination. We compared the two groups on the biological efficiency and incidence of muscular pain.

Results: One hundred and twenty-eight patients were randomized; 64 received E-S and 64 Rosuvastatin. In the two groups, the lowering of LDL-C level (Δ=51%) at one month was significant (P<0.01) without any difference in the rate of lowering on LDL-C or HDL-C suggesting that E-S is as effective as high dose Rosuvastatin (P=0.77 and P=0.99). The rate of patients reaching the objective of LDL-C<100mg/dL (45%) and LDL-C<70mg/dL (51%) was not different in the two clusters (P=0.65). Incidence of muscular pain was 15% higher in patients treated with Rosuvastatin (P=0.01) without any difference on CPK level (P=0.6).

Conclusion: Using an association of E-S in an effective alternative strategy to high dose Rosuvastatin with a lower incidence of muscular pain, which might impact adherence to medication after ACS.

Keywords: Acute coronary syndrome; Douleurs musculaires; Ezetimibe; Muscular pain; Syndrome coronarien aigu.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Coronary Syndrome / drug therapy*
  • Anticholesteremic Agents / administration & dosage*
  • Anticholesteremic Agents / adverse effects
  • Azetidines / administration & dosage*
  • Azetidines / adverse effects
  • Drug Therapy, Combination
  • Ezetimibe
  • Female
  • Fluorobenzenes / administration & dosage*
  • Fluorobenzenes / adverse effects
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
  • Male
  • Middle Aged
  • Prospective Studies
  • Pyrimidines / administration & dosage*
  • Pyrimidines / adverse effects
  • Rosuvastatin Calcium
  • Sulfonamides / administration & dosage*
  • Sulfonamides / adverse effects

Substances

  • Anticholesteremic Agents
  • Azetidines
  • Fluorobenzenes
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyrimidines
  • Sulfonamides
  • Rosuvastatin Calcium
  • Ezetimibe