Clinical study on effects and safety of Ezetimibe combination with Atorvastatin therapy in patients with hypercholesterolemia

Objective To evaluate the effects and safety of Ezetimibe combination with Atorvastatin therapy on hypercholesterolemic patients without reaching objective low-density cholesterol(LDL-C) level with only Atorvastatin. Methods Patients who hadn't reached objective LDL-C level with 6 weeks' Atorvastatin therapy(20mg /d) were randomly divided into two groups: 28 patients with 20mg/d Atorvastatin(monotherapy group),and 33 patients with 20mg/d Atorvastatin plus 10mg/d Ezetimibe(combination group) for the course of the 6 weeks.The following parameters were measured,including serum cholesterol(TC),Triglyceride(TG),low-density cholesterol(LDL-C),high-density cholesterol(HDL-C),C reactive protein(CRP) and ankle brachial index(ABI),and the side effects were compared. Results Compared with baseline levels,the levels of TC,TG,LDL-C were significantly reduced after 6 weeks in both groups.The level of TC,TG and LDL-C in combination group were lower than in monotherapy group.Regulating range of HDL-C had no difference in both groups.The reduction of the level and the reaching standard rate of the LDL-C in combination group was higher than in monotherapy group.The level of HDL-C was higher than baseline levels in combination group,and this change was not showed in monotherapy group.No differences were noticed in CRP and ABI in both groups. Conclusions The findings indicate that Ezetimibe combination Atorvastatin therapy are more effective and safe to improve the lipoprotein level in patients who haven't reached objective level than Atorvastatin only.But the Ezetimibe effects on improving inflammation and atherosclerosis are needed further studying.