EFFICACY AND SAFETY OF LOW-INTENSITY PITAVASTATIN 1MG AND EZETIMIBE 10MG COMBINATION THERAPY IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA : A RANDOMIZED, DOUBLE-BLINDED, MULTI-CENTER, PHASE III STUDY

초록

Background and Aims: Several studies have investigated low-intensity statin therapy in combination with ezetimibe; however, none have evaluated a fixeddose combination containing pitavastatin 1mg and ezetimibe 10mg. We evaluated the efficacy and safety of pitavastatin 1 mg with ezetimibe 10 mg versus pitavastatin 1 mg alone Methods: A randomized, double-blind, active-control, multicenter, phase 3 clinical trial was conducted. Overall, 129 patients with hypercholesterolemia from 14 clinical trial sites in Korea were randomly assigned in 1:1 ratio to a test (pitavastatin 1 mg + ezetimibe 10 mg) or control (pitavastatin 1 mg) group. Participants received their assigned drug orally for 8 weeks. Efficacy and safety were assessed at week 4 and 8. The primary endpoint was the percentage change from baseline in LDL-C at week 8. Statistical analyses were performed using the mixed-effect model repeated measure analysis. Results: The test group demonstrated significantly enhanced LDL-C reduction compared to the control group, -43.86% in test group and -29.09% in control group (LS mean difference -14.77%[-19.3770, -10.1713], p<0.0001). The test group also demonstrated superior efficacy in LDL-C treatment target achievement rate, as well as in several lipid parameters, including TC, Non-HDL-C, LDLC/HDL-C ratio and Apolipoprotein B as well. Treatment-emergent adverse event rates following drug administration were 9.52% in the test group and 24.24% in the control group (p=0.0263). No serious adverse drug reactions occurred in either group. Conclusions: Pitavastatin 1 mg and ezetimibe 10 mg combination therapy substantially enhanced lipid levels compared to pitavastatin 1 mg monotherapy, with enhanced safety. The addition of ezetimibe 10 mg to low-intensity pitavastatin 1 mg represents an effective and well-tolerated treatment option for patients with primary hypercholesterolemia.