title: Safety and effectiveness of the association ezetimibe-statin (E-S) versus high dose rosuvastatin after acute coronary syndrome: the SAFE-ES study.
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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Département de cardiologie, CHU Timone, 13385 Marseille, France; Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France. Electronic address: pierre.deharo@ap-hm.fr.
authors.forename: P
authors.initials: P
authors.lastname: Deharo
authors.affiliation: Département de cardiologie, CHU Timone, 13385 Marseille, France; Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France.
authors.forename: M
authors.initials: M
authors.lastname: Pankert
authors.affiliation: Département de cardiologie, CHU Timone, 13385 Marseille, France; Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France.
authors.forename: J
authors.initials: J
authors.lastname: Quilici
authors.affiliation: Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France; Laboratoire d'hématologie, CHU Timone, 13385 Marseille, France.
authors.forename: C
authors.initials: C
authors.lastname: Grosdidier
authors.affiliation: Équipe mobile d'aide à l'investigation (EMAI), Assistance publique-Hôpitaux de Marseille, 13385 Marseille, France.
authors.forename: V
authors.initials: V
authors.lastname: Verdier
authors.affiliation: Département de cardiologie, CHU Timone, 13385 Marseille, France; Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France.
authors.forename: G
authors.initials: G
authors.lastname: Bonnet
authors.affiliation: Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France; Laboratoire d'hématologie, CHU Timone, 13385 Marseille, France.
authors.forename: P
authors.initials: P
authors.lastname: Morange
authors.affiliation: Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France; Laboratoire d'hématologie, CHU Timone, 13385 Marseille, France.
authors.forename: M-C
authors.initials: MC
authors.lastname: Alessi
authors.affiliation: Département de cardiologie, CHU Timone, 13385 Marseille, France; Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France.
authors.forename: J-L
authors.initials: JL
authors.lastname: Bonnet
authors.affiliation: Département de cardiologie, CHU Timone, 13385 Marseille, France; Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France.
authors.forename: T
authors.initials: T
authors.lastname: Cuisset
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001384:Azetidines / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D000069438:Ezetimibe
keywords: Acute coronary syndrome; Douleurs musculaires; Ezetimibe; Muscular pain; Syndrome coronarien aigu