Effect of intensive statin therapy on regression of carotid intima-media thickness in patients with subclinical carotid atherosclerosis (a prospective, randomized trial: PEACE (Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-lowering Therapy) study)

BACKGROUND: Atherosclerosis often advances before symptoms appear. It remains uncertain whether intensive cholesterol-lowering therapy with statin is beneficial when compared with moderate cholesterol-lowering therapy in patients with subclinical carotid atherosclerosis. METHODS: The PEACE study was a prospective, randomized, open-labeled, blinded end points, two-arm parallel treatment group comparison study conducted at 15 centers in Japan. A total of 303 patients with carotid intima-media thickness (CIMT) thickening (>1.1 mm) whose low-density lipoprotein cholesterol (LDL-C) level was more than 100 mg/dl were enrolled, in which 223 patients completed the 12 months' follow-up study. Patients were randomly assigned to receive either moderate (target LDL-C; 100 mg/dl) or intensive (target LDL-C; 80 mg/dl) cholesterol-lowering therapy with pitavastatin. The primary end point was the change in mean far wall common CIMT. RESULTS: LDL-C level declined to 89.4 ± 20 mg/dl in the intensive group, while it declined to 95.1 ± 22.5 mg/dl in the moderate group at 12 months' follow-up (p < 0.05 between the groups). The change in mean CIMT was -0.024 (95% confidence interval -0.046 to -0.0014) mm/year (p < 0.05 vs. baseline) in the intensive group, and -0.0078 (95% confidence interval -0.028 to 0.012) mm/year (p = 0.4406 vs. baseline) in the moderate group. However, there was no significant difference in the change in mean far wall common CIMT between the groups (p = 0.29). CONCLUSIONS: Intensive cholesterol-lowering therapy did not show superior effects on the progression of CIMT to moderate cholesterol-lowering therapy, whereas only intensive cholesterol-lowering therapy regressed the carotid atherosclerosis over one year.