title: Can intensive lipid-lowering therapy with statins ameliorate atherosclerosis in Japanese patients? Rationale and design of the JART study.
abstract: OBJECTIVE
  In Japan, heart disease and cerebral ischemic disease are major causes of death. A decrease in the level of low-density lipoprotein cholesterol (LDL-C) through intensive treatment with statins positively correlates with a reduction in the volume of plaques in patients with cardiovascular disease. The METEOR trial, evaluating the effect of rosuvastatin on carotid intima-media thickness (IMT), was conducted only in Europe and the US. Here we planned another trial, the Justification for Atherosclerosis Regression Treatment (JART) study, to clarify the efficacy of intensive lipid-lowering therapy with rosuvastatin in Japanese with atherosclerosis.
  
  
  RESULTS
  Four hundred patients with hypercholesterolemia (LDL-C >or=140 mg/dL) and a maximum IMT of >or=1.1 mm will be treated for 24 months either with intensive lipid-lowering therapy with rosuvastatin (target LDL-C levels: 80 mg/dL for primary prevention, and 70 mg/dL for secondary prevention) or conventional lipid-lowering therapy with pravastatin (target LDL-C level: complying with JASGL2007). The primary endpoint will be the percent change of mean-IMT and the objectives of the study are to compare the two protocols.
  
  
  CONCLUSIONS
  The JART trial is a prospective, randomized, open-label, blinded end-point evaluation, multi-center, parallel-group, comparative study to examine the regressive effect of intensive lipid-lowering therapy with statins on atherosclerosis by evaluating IMT in the Japanese population.
authors.affiliation: Department of Medicine and Biological Science, Gunma University Graduate School of Medicine, Maebashi, Japan. mkuraba@med.gunma-u.ac.jp
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kurabayashi
authors.forename: Ichiro
authors.initials: I
authors.lastname: Sakuma
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Kawamori
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Daida
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Yamazaki
authors.forename: Masayuki
authors.initials: M
authors.lastname: Yoshida
authors.forename: Mitsumasa
authors.initials: M
authors.lastname: Hata
authors.forename: Izuru
authors.initials: I
authors.lastname: Masuda
authors.forename: Kohei
authors.initials: K
authors.lastname: Kaku
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Yokoi
authors.forename: Junji
authors.initials: J
authors.lastname: Kishimoto
authors.forename: Ryuji
authors.initials: R
authors.lastname: Nohara
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005464:Fluorobenzenes / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D017035:Pravastatin / Q000627:therapeutic use*; D011446:Prospective Studies; D011743:Pyrimidines / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome; D017539:Tunica Intima / Q000187:drug effects*; D017540:Tunica Media / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D005464:Fluorobenzenes; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D017035:Pravastatin