Clinical Drug Investigation

, Volume 23, Issue 3, pp 153–165

Atorvastatin versus Bezafibrate in Mixed Hyperlipidaemia

Randomised Clinical Trial of Efficacy and Safety (the ATOMIX Study)
  • Emilio Ros
  • Josefina Oliván
  • José M. Mostaza
  • Miquel Vilardell
  • Xavier Pintó
  • Fernando Civeira
  • A. Hernández
  • Pedro Marqués da Silva
  • A. Rodriguez-Botaro
  • Daniel Zambón
  • Joan Lima
  • José A. Gómez-Gerique
  • Cristina Díaz
  • Rosa Arístegui
  • José M. Sol
  • Gonzalo Hernández
Original Research Article

DOI: 10.2165/00044011-200323030-00002

Cite this article as:
Ros, E., Oliván, J., Mostaza, J.M. et al. Clin. Drug Investig. (2003) 23: 153. doi:10.2165/00044011-200323030-00002

Abstract

Objective: Combined hyperlipidaemia is a common and highly atherogenic lipid phenotype with multiple lipoprotein abnormalities that are difficult to normalise with single-drug therapy. The ATOMIX multicentre, controlled clinical trial compared the efficacy and safety of atorvastatin and bezafibrate in patients with diet-resistant combined hyperlipidaemia.

Patients and study design: Following a 6-week placebo run-in period, 138 patients received atorvastatin 10mg or bezafibrate 400mg once daily in a randomised, double-blind, placebo-controlled trial. To meet predefined low-density lipoprotein-cholesterol (LDL-C) target levels, atorvastatin dosages were increased to 20mg or 40mg once daily after 8 and 16 weeks, respectively.

Results: After 52 weeks, atorvastatin achieved greater reductions in LDL-C than bezafibrate (percentage decrease 35 vs 5; p < 0.0001), while bezafibrate achieved greater reductions in triglyceride than atorvastatin (percentage decrease 33 vs 21; p < 0.05) and greater increases in high-density lipoprotein-cholesterol (HDL-C) [percentage increase 28 vs 17; p < 0.01 ]. Target LDL-C levels (according to global risk) were attained in 62% of atorvastatin recipients and 6% of bezafibrate recipients, and triglyceride levels <200 mg/dL were achieved in 52% and 60% of patients, respectively. In patients with normal baseline HDL-C, bezafibrate was superior to atorvastatin for raising HDL-C, while in those with baseline HDL-C <35 mg/dL, the two drugs raised HDL-C to a similar extent after adjustment for baseline values. Both drugs were well tolerated.

Conclusion: The results show that atorvastatin has an overall better efficacy than bezafibrate in concomitantly reaching LDL-C and triglyceride target levels in combined hyperlipidaemia, thus supporting its use as monotherapy in patients with this lipid phenotype.

Copyright information

© Adis Data Information BV 2003

Authors and Affiliations

  • Emilio Ros
    • 1
  • Josefina Oliván
    • 2
  • José M. Mostaza
    • 3
  • Miquel Vilardell
    • 4
  • Xavier Pintó
    • 5
  • Fernando Civeira
    • 6
  • A. Hernández
    • 7
  • Pedro Marqués da Silva
    • 8
  • A. Rodriguez-Botaro
    • 2
  • Daniel Zambón
    • 1
  • Joan Lima
    • 4
  • José A. Gómez-Gerique
    • 9
  • Cristina Díaz
    • 10
  • Rosa Arístegui
    • 10
  • José M. Sol
    • 10
  • Gonzalo Hernández
    • 10
  1. 1.Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)Hospital Clinic i ProvincialBarcelonaSpain
  2. 2.Hospital Virgen MacarenaSevilleSpain
  3. 3.Hospital Carlos IIIMadridSpain
  4. 4.Hospital Vall d’HebrónBarcelonaSpain
  5. 5.Hospital de BellvitgeBarcelonaSpain
  6. 6.Hospital Miguel ServetZaragozaSpain
  7. 7.Hospital Doctor PesetValenciaSpain
  8. 8.Hospital Santa MartaLisbonPortugal
  9. 9.Central Laboratory, Biochemistry Service, Fundación Jiménez DíazMadridSpain
  10. 10.R & D DepartmentPfizerSpain
  11. 11.Lipid Clinic, Nutrition & Dietetics ServiceHospital Clinic i ProvincialBarcelonaSpain