Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial)☆,
Section snippets
Trial design
This randomized, parallel-group, open-label, comparator-controlled trial (4522IL/0065) was conducted in 182 United States clinical centers between April 2001 and March 2002. After discontinuation of any lipid-lowering drugs and supplements, patients entered a 6-week, dietary lead-in period in which they were instructed to follow the NCEP Step I diet.9 Patients who were compliant with the diet and met lipid criteria were randomized to 1 of 15 treatments taken orally once daily (before bedtime)
Patient characteristics
Baseline patient characteristics were very similar among groups. Table 1shows characteristics by drug assignment. Of the 2,431 patients randomized to treatment, 94% completed the 6-week trial (Figure 1). Drug compliance as assessed by tablet counts was similar among treatments, and means of tablets taken ranged from 90.5% to 95.3%.
Efficacy
According to the dose-response analyses, mean differences between the LDL cholesterol dose-response slopes of rosuvastatin 10 to 80 mg versus atorvastatin 10 to 80
Discussion
This multicenter trial, which is the largest trial of its kind to date comparing the lipid-modifying efficacy of statins, showed the greater efficacy of rosuvastatin in reducing LDL cholesterol, compared with atorvastatin, simvastatin, and pravastatin across dose ranges. The significantly greater LDL cholesterol reduction achieved with rosuvastatin 10 to 80 mg, compared with atorvastatin 10 to 80 mg, which was an average difference of 8.2% across the dose-range slopes, exceeded the predefined
Acknowledgements
We gratefully acknowledge the investigators (see Appendix), their coinvestigators and study coordinators, and the patients who participated in this trial. In addition, we wish to thank Marlies Winter, MS, and Jackie Freimor, MA, of BioScience Communications, and Donna Curtis, PhD, and Erem Latif, MS, of AstraZeneca LP (Wilmington, Delaware), for their assistance in the preparation of this manuscript.
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Cited by (0)
- ☆
This study was supported by AstraZeneca LP, Wilmington, Delaware.
- *
STELLAR = Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin.