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.
Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine, Japan.
Koji
K
Ikeda
Tomosaburo
T
Takahashi
Hiroyuki
H
Yamada
Kiyoaki
K
Matsui
Takahisa
T
Sawada
Takashi
T
Nakamura
Hiroaki
H
Matsubara
D000368:Aged; D058070:Asymptomatic Diseases; D015415:Biomarkers / Q000097:blood; D002340:Carotid Artery Diseases / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D017536:Carotid Artery, Common / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000378:metabolism; D059168:Carotid Intima-Media Thickness; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D007564:Japan; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D015415:Biomarkers; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; D014280:Triglycerides; C108475:pitavastatin