[Achievement of blood lipid target levels with Ezetimibe/Simvastatin in patients with atherosclerosis and/or diabetes mellitus--an Austrian observational study].

BACKGROUND: In patients at risk for cardiovascular complications, established LDL cholesterol (LDL-C) target levels are frequently not achieved using standard statin therapy regimens. The additional lipid-lowering efficacy of the fixed combination ezetimibe/simvastatin was evaluated in a countrywide non-interventional observational study in Austria.
METHODS: About 3,156 subjects with clinically manifest atherosclerosis and/or diabetes at high cardiovascular risk and with LDL-C-levels >113 mg/dl under statin therapy met the inclusion criteria and 2,903 of these patients were treated by primary care physicians, in hospitals and in rehabilitation centers with 10 mg ezetimibe and 10-40 mg simvastatin daily in a fixed-combination tablet (Inegy).
RESULTS: During the follow-up period of 4-12 weeks, LDL-C levels were reduced by a median of 27-31% of baseline values (mean 153.1 +/- 33.5 mg/dl) mainly regardless of previous statin therapy (rosuvastatin, atorvastatin, simvastatin, pravastatin, fluvastatin, and lovastatin) and dosing (pooled median values). LDL-C reduction correlated proportional with baseline LDL-C values and increased with increasing simvastatin dosage. Overall, 45.3% (10/10 mg), 43.9% (10/20 mg) and 62.7% (10/40 mg ezetimibe/simvastatin) achieved LDL-C target levels of <100 mg/dl.
CONCLUSIONS: The fixed combination therapy with ezetimibe/simvastatin showed a clinically significant additional lipid-lowering potential as compared with established statin monotherapies and enabled more patients at cardiovascular risk to reach the LDL-C target level of <100 mg/dl.