Achieving lipid goals with rosuvastatin compared with simvastatin in high risk patients in real clinical practice: a randomized, open-label, parallel-group, multi-center study: the DISCOVERY-Beta study

Toivo Laks¹, Ester Keba², Mariann Leiner³, Eero Merilind⁴, Mall Petersen⁵, Sirje Reinmets⁶, Sille Väli⁷, Terje Sööt⁸, Karin Otter⁸

¹Clinic of Internal Medicine, North-Estonia Regional Hospital, Tallinn, Estonia; ²Clinic of Internal Medicine, Viljandi County Hospital, Viljandi, Estonia; ³Mustamäe Family Doctors Centre, Tallinn, Estonia; ⁴Nõmme Family Doctors Centre, Tallinn, Estonia; ⁵Saku Health Centre, Saku, Estonia; ⁶Kristiine Family Doctors, Tallinn, Estonia; ⁷Family Doctor Sille Väli, Kuressaare, Estonia; ⁸AstraZeneca, Tallinn, Estonia

Abstract: The aim of this multi-center, open-label, randomized, parallel-group trial was to compare the efficacy of rosuvastatin with that of simvastatin in achieving the 1998 European Atherosclerosis Society (EAS) lipid treatment goals. 504 patients (≥18 years) with primary hypercholesterolemia and a 10-year cardiovascular (CV) risk >20% or history of coronary heart disease (CHD) or other established atherosclerotic disease were randomized in a 2:1 ratio to receive rosuvastatin 10 mg or simvastatin 20 mg once daily for 12 weeks. A significantly higher proportion of patients achieved 1998 EAS low-density lipoprotein cholesterol (LDL-C) goal after 12 weeks of treatment with rosuvastatin 10 mg compared to simvastatin 20 mg (64 vs 51.5%, p < 0.01). Similarly, significantly more patients achieved the 1998 EAS total cholesterol (TC) goal and the 2003 EAS LDL-C and TC goals (p < 0.001) with rosuvastatin 10 mg compared with simvastatin 20 mg. The incidence of adverse events and the proportion of patients who discontinued study treatment were similar between treatment groups. In conclusion, in the DISCOVERY-Beta Study in patients with primary hypercholesterolemia greater proportion of patients in the rosuvastatin 10 mg group achieved the EAS LDL-C treatment goal compared with the simvastatin 20 mg group. Drug tolerability was similar across both treatment groups.

Keywords: hypercholesterolemia, low-density lipoprotein cholesterol, statins, rosuvastatin, simvastatin, tolerability