Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial).
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 12860216 · doi:10.1016/s0002-9149(03)00530-7
What was done
In a 6-week, parallel-group, open-label, multicenter randomized controlled trial (STELLAR Trial), 2,431 adults with hypercholesterolemia (LDL cholesterol 160 to <250 mg/dL, triglycerides <400 mg/dL) were randomized after a dietary lead-in period to receive rosuvastatin (10, 20, 40, or 80 mg), atorvastatin (10, 20, 40, or 80 mg), simvastatin (10, 20, 40, or 80 mg), or pravastatin (10, 20, or 40 mg). The primary objective was comparing LDL cholesterol reduction across dose ranges; secondary objectives included other lipid modifications and achievement of NCEP ATP III and European LDL cholesterol goals.
What was found
Across dose ranges at 6 weeks, rosuvastatin 10 to 80 mg reduced LDL cholesterol by a mean of 8.2% more than atorvastatin 10 to 80 mg, 26% more than pravastatin 10 to 40 mg, and 12% to 18% more than simvastatin 10 to 80 mg (all p < 0.001). Rosuvastatin raised HDL cholesterol by +7.7% to +9.6% compared with +2.1% to +6.8% in comparator groups. Rosuvastatin reduced total cholesterol significantly more than all comparators (p < 0.001) and triglycerides significantly more than simvastatin and pravastatin (p < 0.001). NCEP ATP III LDL goals were met by 82% to 89% of patients on rosuvastatin 10 to 40 mg versus 69% to 85% on atorvastatin 10 to 80 mg; European goals (<3.0 mmol/L) were achieved by 79% to 92% versus 52% to 81%, respectively. Drug tolerability was similar across treatments.
Why it matters
This head-to-head trial demonstrated superior milligram-for-milligram and dose-range lipid-lowering efficacy of rosuvastatin over atorvastatin, simvastatin, and pravastatin for short-term LDL cholesterol reduction and goal attainment.
Limits
The trial had an open-label design, had a short duration of 6 weeks, and evaluated surrogate lipid markers rather than cardiovascular morbidity or mortality outcomes. The study population was restricted to hypercholesterolemic adults within specific LDL and triglyceride ranges.
Cited by
- supports Rosuvastatin is approximately twice as potent as atorvastatin milligram for milligram.