Clinical Drug Investigation

, Volume 19, Issue 5, pp 327–334

Additional Efficacy of Milligram-Equivalent Doses of Atorvastatin over Simvastatin

  • Marjel van Dam
  • Dick C. G. Basart
  • Charles Janus
  • Rolf Zwertbroek
  • Han A. M. Spierenburg
  • Hans A. Werner
  • A. C. Bredero
  • Peter J. Lansberg
  • Carla J. Jonker
  • Mieke D. Trip
  • Martin H. Prins
  • John J. P. Kastelein
Clinical Use

DOI: 10.2165/00044011-200019050-00002

Cite this article as:
Dam, M.., Basart, D.C.G., Janus, C. et al. Clin. Drug Investig. (2000) 19: 327. doi:10.2165/00044011-200019050-00002

Abstract

Objectives: This single-blind, multicentre study in a large cohort of hypercholesterolaemic patients with or without coronary heart disease (CHD) was designed to evaluate the additional low density lipoprotein cholesterol (LDL-C)— lowering effect of atorvastatin over milligram-equivalent doses of simvastatin.

Methods: 378 patients treated with either simvastatin 20 or 40mg, with baseline LDL-C values >2.6 mmol/L, were randomised to four groups: patients on 20mg simvastatin were randomised to either simvastatin 20mg (n = 129) or atorvastatin 20mg (n = 124), and patients on 40mg simvastatin were randomised to simvastatin 40mg (n = 64) or atorvastatin 40mg (n = 61). The investigator was blinded for study medication during the 8-week treatment phase, the patient was not. Lipid profiles were measured at screening, randomisation and at study completion. The primary efficacy parameter was the relative change in LDL-C level within and between groups. Statistical significance was assessed with analysis of variance.

Results: No major differences in baseline patient characteristics were found with regard to demographic variables, vital signs, cardiovascular risk factors, concomitant medication or lipid profiles. The mean (±SD) relative decreases of LDL-C from baseline were: 14.0 ± 14.1% for atorvastatin 20mg (n = 107) versus 3.3 ± 14.1% for simvastatin 20mg (n = 108) [p = 0.0001], and 14.7 ± 15.2% for atorvastatin 40mg (n = 55) versus 2.9 ± 12.7% for simvastatin 40mg (n = 54) [p = 0.0001]. The relative change of LDL-C from baseline in the overall atorvastatin group (n = 162) versus the overall simvastatin group (n = 162) was 14.2 ± 14.4% versus 3.2 ± 13.6% (p = 0.0001). This involved an additional decrease of 11% in the atorvastatin versus the simvastatin group. The percentage of high risk patients according to the European Atherosclerosis Society/National Cholesterol Education Program (EAS/NCEP) who initially did not meet these goals but reached them at week 8, was 48/34% (for atorvastatin 20mg) versus 20/14% (for simvastatin 20mg) [p = 0.005 and p = 0.007, respectively], and 58/18% (for atorvastatin 40mg) versus 24/10% (for simvastatin 40mg) [p = 0.005 and not significant, respectively].

Conclusion: Our results indicated that patients with hypercholesterolaemia on simvastatin 20 or 40mg who are switched to a milligram-equivalent dose of atorvastatin, will reach significantly lower LDL-C values within 8 weeks of treatment, with a greater percentage of high risk patients reaching their EAS or NCEP targets.

Copyright information

© Adis International Limited 2000

Authors and Affiliations

  • Marjel van Dam
    • 1
  • Dick C. G. Basart
    • 2
  • Charles Janus
    • 2
  • Rolf Zwertbroek
    • 3
  • Han A. M. Spierenburg
    • 4
  • Hans A. Werner
    • 4
  • A. C. Bredero
    • 5
  • Peter J. Lansberg
    • 6
  • Carla J. Jonker
    • 7
  • Mieke D. Trip
    • 1
  • Martin H. Prins
    • 8
  • John J. P. Kastelein
    • 1
  1. 1.Department of Vascular MedicineAcademic Medical CentreAmsterdamThe Netherlands
  2. 2.Department of CardiologyWestfries GasthuisHoornThe Netherlands
  3. 3.Department of Internal MedicineWestfries GasthuisHoornThe Netherlands
  4. 4.Department of CardiologySchieland HospitalSchiedamThe Netherlands
  5. 5.Department of CardiologyDiakonessenhuisUtrechtThe Netherlands
  6. 6.Department of Internal MedicineSlotervaart HospitalAmsterdamThe Netherlands
  7. 7.Parke-Davis BVHoofddorpThe Netherlands
  8. 8.Department of Clinical Epidemiology and BiostatisticsAcademic Medical CenterAmsterdamThe Netherlands

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