title: Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J).
abstract: BACKGROUND
  A previous study reported that amlodipine retarded coronary plaque progression in patients with coronary artery disease. The goal of this multicenter study was to determine which calcium-channel blockers (CCBs) other than amlodipine attenuated the progression of plaque volume (PV) accessed by intravascular ultrasound (IVUS).
  
  
  RESULTS
  ALPS-J was a prospective, randomized open-label study conducted at 5 centers. Patients who had hypertension and were scheduled for coronary intervention were enrolled. Subjects were randomly assigned to receive 16 mg/day of azelnidipine or 5mg/day of amlodipine administered for 48 weeks. The primary endpoint was the percent change in coronary PV measured by IVUS. Between 2007 and 2009, 199 patients were enrolled; 115 had evaluable IVUS images at both baseline and after 48 weeks of treatment. Blood pressure significantly reduced to 128/68 mmHg at follow-up. The lipid profiles in the 2 groups were comparable (low-density lipoprotein cholesterol: 97 mg/dl). The %change in PV showed a significant regression of 4.67 and 4.85% in the azelnidipine and amlodipine groups, respectively. The upper limit of the 95% confidence interval of the mean difference in %change PV between the 2 groups (0.18%, 95% confidence interval 4.62 to 4.98%) did not exceed the pre-defined non-inferiority margin of 6.525%.
  
  
  CONCLUSIONS
  ALPS-J demonstrated that azelnidipine was not inferior to amlodipine for primary efficacy. In addition to standard medical therapy, dihydropyridine CCBs will retard PV progression in hypertensive patients.
authors.affiliation: Departments of Cardiology, Juntendo University School of Medicine.
authors.forename: Takahiko
authors.initials: T
authors.lastname: Kojima
authors.forename: Katsumi
authors.initials: K
authors.lastname: Miyauchi
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yokoyama
authors.forename: Ken
authors.initials: K
authors.lastname: Yokoyama
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kurata
authors.forename: Satoru
authors.initials: S
authors.lastname: Suwa
authors.forename: Masaki
authors.initials: M
authors.lastname: Kawamura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tamura
authors.forename: Shinya
authors.initials: S
authors.lastname: Okazaki
authors.forename: Kenji
authors.initials: K
authors.lastname: Inoue
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Fujiwara
authors.forename: Masataka
authors.initials: M
authors.lastname: Sumiyoshi
authors.forename: Kosei
authors.initials: K
authors.lastname: Tanimoto
authors.forename: Yuji
authors.initials: Y
authors.lastname: Nakazato
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Yamagami
authors.forename: Takafumi
authors.initials: T
authors.lastname: Hiro
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Komiyama
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Daida
mesh_terms: D017311:Amlodipine / Q000008:administration & dosage* / Q000627:therapeutic use; D001383:Azetidinecarboxylic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004095:Dihydropyridines / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D006973:Hypertension / Q000150:complications*; D008055:Lipids / Q000097:blood; D058226:Plaque, Atherosclerotic / Q000188:drug therapy; D018084:Ultrasonography, Interventional
chemical_list: D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D008055:Lipids; D017311:Amlodipine; D001383:Azetidinecarboxylic Acid; C061679:azelnidipine