Effectiveness of low-intensity atorvastatin 5 mg and ezetimibe 10 mg combination therapy compared with moderate-intensity atorvastatin 10 mg monotherapy: A randomized, double-blinded, multi-center, phase III study

Abstract

Background: We compared the efficacy and safety of low-intensity atorvastatin and ezetimibe combination therapy with moderate-intensity atorvastatin monotherapy in patients requiring cholesterol-lowering therapy.

Methods: At 19 centers in Korea, 290 patients were randomized to 4 groups: atorvastatin 5 mg and ezetimibe 10 mg (A5E), ezetimibe 10 mg (E), atorvastatin 5 mg (A5), and atorvastatin 10 mg (A10). Clinical and laboratory examinations were performed at baseline, and at 4-week and 8-week follow-ups. The primary endpoint was percentage change from baseline in low-density lipoprotein (LDL) cholesterol levels at the 8-week follow-up. Secondary endpoints included percentage changes from baseline in additional lipid parameters.

Results: Baseline characteristics were similar among the study groups. At the 8-week follow-up, percentage changes in LDL cholesterol levels were significantly greater in the A5E group (49.2%) than in the E (18.7%), A5 (27.9%), and A10 (36.4%) groups. Similar findings were observed regarding the percentage changes in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B levels. Triglyceride levels were also significantly decreased in the A5E group than in the E group, whereas high-density lipoprotein levels substantially increased in the A5E group than in the E group. In patients with low- and intermediate-cardiovascular risk, 93.3% achieved the target LDL cholesterol levels in the A5E group, 40.0% in the E group, 66.7% in the A5 group, and 92.9% in the A10 group. In addition, 31.4% of patients in the A5E group, 8.1% in E, 9.7% in A5, and 7.3% in the A10 group reached the target levels of both LDL cholesterol < 70 mg/dL and reduction of LDL ≥ 50% from baseline.

Conclusions: The addition of ezetimibe to low-intensity atorvastatin had a greater effect on lowering LDL cholesterol than moderate-intensity atorvastatin alone, offering an effective treatment option for cholesterol management, especially in patients with low and intermediate risks.

Figure 1.

Study flow diagram.

Figure 2.

Percentage changes in lipid profile at 8-wk follow-up. A10 = atorvastatin 10 mg, A5 = atorvastatin 5 mg, A5E = atorvastatin 5 mg and ezetimibe 10 mg, E = ezetimibe 10 mg, HDL-C = high-density lipoprotein cholesterol, LDL-C = low-density lipoprotein cholesterol, NS = not significant (P ≥ .05), TG = triglyceride. ****P < .0001; ***P < .001; **P < .01; *P < .05.

Figure 3.

Achievement of target low-density lipoprotein cholesterol goal according to the cardiovascular risk category at 8-wk follow-up. A10 = atorvastatin 10 mg, A5 = atorvastatin 5 mg, A5E = atorvastatin 5 mg and ezetimibe 10 mg, E = ezetimibe 10 mg, NS = not significant (P ≥ .05). ****P < .0001; ***P < .001; **P < .01; *P < .05.