A multicentre, open-label, observational local study to evaluate the low-density lipoprotein cholesterol-lowering effect of ezetimibe as prescribed in daily routine practice in the South African population

OBJECTIVE The study examined the efficacy, safety and tolerability of co-administering the cholesterol absorption inhibitor, ezetimibe 10 mg with ongoing statin therapy in hypercholesterolaemic patients. PATIENTS AND METHODS I n this multicentre, open-label, observational study, hypercholesterolaemic patients (from 44 South African specialty practices) on statin therapy were screened and after meeting the inclusion criteria, all received ezetimibe (10 mg/day) in addition to their ongoing statin therapy for four weeks. RESULTS In 358 patients, ezetimibe co-administered with ongoing statin therapy significantly reduced the low-density lipoprotein cholesterol (LDL-C) level by an additional 21.9% in the total population. In the secondary-prevention patients (category 1 cardiovascular risk according to ESC guidelines adopted for South Africa), an additional 20.4% reduction was observed, and a 25.5% additional reduction for the primary-prevention patients (category 2 cardiovascular risk according to ESC guidelines adopted for South Africa). These results were consistent across gender, race, age, statin brand and dose subgroups. Ezetimibe co-administered with ongoing statin therapy also increased the number of patients reaching their LDL-C goals according to their risk category (2.5 mmol/l for category 1 patients and 3.0 mmol/l for category 2 patients). Ezetimibe-plus-statin therapy was well tolerated, with a good safety profile. CONCLUSION Ezetimibe co-administered with ongoing statin therapy consistently produced significant additional improvements in LDL-C levels and goal attainment. This was observed for the whole population as well as for the two risk categories. The addition of ezetimibe to ongoing statin therapy may be considered for patients not achieving their LDL-C goals on conventional statin therapy.