Dual cholesterol inhibition with ezetimibe/simvastatin in pre-treated hypercholesterolaemic patients with coronary heart disease or diabetes mellitus: prospective observational cohort studies in clinical practice

Objective: Patients with primary hypercholesterolaemia and concomitant coronary heart disease (CHD) and/or diabetes mellitus (DM), who are at particularly high risk of cardiovascular events such as stroke or myocardial infarction, benefit from aggressive lipid lowering strategies. The present studies investigated the incremental efficacy and safety of dual cholesterol inhibition with ezetimibe/simvastatin in such high-risk patients pre-treated with statins but not reaching the 100 mg/dL (2.6 mmol/L) low density cholesterol (LDL-C) cholesterol threshold in the primary care setting. Methods: Two open-label, prospective, non-randomised, observational studies (study 1 with n = 19194 patients, predominantly with CHD; study 2 with n = 19484 patients, predominantly with DM). Patients received - almost all after statin pre-treatment - ezetimibe 10 mg plus simvastatin 10 mg (study 1:15%, study 2: 16%), 20 mg (in 68% each), 40 mg (12%/10%) or 80 mg (1%/1%) as fixed dose combinations over 3 months (dosage at investigator's discretion). Results: Mean LDL-C was reduced by 28%/27% (study 1 / study 2) compared with baseline values (on statin monotherapy). Mean total cholesterol was decreased by 22% in each study, mean triglycerides by 16/17%, and mean high density cholesterol (HDL-C) was increased by 9/10%. Adverse events were reported in 0.3% and 0.2% of patients, respectively. Conclusion: Dual cholesterol inhibition with ezetimibe/simvastatin was effective and well tolerated under real practice conditions in high-risk patients with CHD and/or DM.