OBJECTIVES: To review and analyse evidence for the comparative cholesterol-lowering efficacy of ezetimibe-statin combination therapy versus statin monotherapy in adults with primary hypercholesterolemia.  METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched to identify parallel-group, randomised controlled trials of ezetimibe-statin combination therapy versus statin monotherapy, published between January 1993 and March 2010.  Studies were selected using predefined criteria including minimum treatment of 4 weeks.  Two reviewers conducted screening of articles, critical appraisal and data extraction, with a third reviewer resolving disagreements.  Study quality was assessed using the Cochrane Collaboration ‘risk of bias’ assessment tool.  The difference between treatments in mean percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) and proportion of patients attaining LDL-C treatment goal was analysed.  Data were combined by pair-wise, direct comparison random effects meta-analysis, with heterogeneity assessed using the I2 statistic.  RESULTS: Fifteen articles met selection criteria; 13 studies involving over 5000 patients could be included in the meta-analyses.  Data on simvastatin, atorvastatin and rosuvastatin were analysed.  There was a significantly greater percentage reduction in LDL-C levels in patients treated with ezetimibe-statin combination therapy compared with those treated with statin monotherapy (weighted mean difference: 14.11% [95% CI: 16.13, 12.1], p<0.001), similarly, a greater proportion of patients achieved LDL-C goal when treated with ezetimibe-statin combination therapy compared with those treated with statin monotherapy (odds ratio 2.38 [95% CI: 1.89, 2.94], p<0.001).  The proportion of patients achieving LDL-C goal ranged from 12-83% (median 60%) in ezetimibe-statin arms of studies and from 2-52% (median 23%) in the statin monotherapy arms.  CONCLUSIONS: The results indicate that ezetimibe-statin combination therapy is significantly more effective in reducing LDL-C levels than increasing the statin monotherapy dose, thereby enabling more patients to achieve their LDL-C goal.