Treating to target patients with primary hyperlipidaemia: comparison of the effects of ATOrvastatin and ROSuvastatin (the ATOROS study)

Objectives: In a 24-week, open-label, randomized, parallel-group study, we compared the efficacy and metabolic effects, beyond low density lipoprotein cholesterol ( LDL-C)-lowering, of atorvastatin ( ATV) and rosuvastatin ( RSV) in cardiovascular disease-free subjects with primary hyperlipidaemia, treated to an LDL-C target ( 130 free mg/dL). Methods: After a 6-week dietary lead-in period, patients were randomized to RSV 10 mg/day ( n = 60) or ATV 20 mg/ day ( n = 60). After 6 weeks on treatment the dose of the statin was increased ( to RSV 20 mg/ day or ATV 40 mg/ day) if the treatment goal was not achieved. A control group of healthy volunteers ( n = 60) was also included for the validation of baseline serum and urinary laboratory parameters. The primary outcome was the percentage of patients reaching the LDL-C goal; secondary outcomes were changes in lipid and non-lipid metabolic parameters. Results: A total of 45 patients ( 75.0%) in the RSV-treated group and 43 ( 71.7%) in the ATV-treated group achieved the treatment target at the initial dose. Both regimens were generally well tolerated and there were no withdrawals due to treatment-related serious adverse events. Similar significant reductions in total cholesterol, LDL-C, apolipoprotein ( apo) B, triglycerides, apoB/apoA1 ratio, fibrinogen and high-sensitivity C-reactive protein levels were seen. RSV had a significant high density lipoprotein cholesterol ( HDL-C)-raising effect and showed a trend towards increasing apoA1 levels. Glycaemic control and renal function parameters were not influenced by statin therapy. ATV, but not RSV, showed a significant hypouricaemic effect. Conclusions: RSV and ATV were equally efficacious in achieving LDL-C treatment goals in patients with primary hyperlipidaemia at the initial dose and following dose titration. RSV seems to have a significantly higher HDL-C-raising effect, while ATV lowers serum uric acid levels.