title: A randomized, double-blind, placebo-controlled, phase III study of the short-acting β1-adrenergic receptor blocker landiolol hydrochloride for coronary computed tomography angiography in Japanese patients with suspected ischemic cardiac disease.
abstract: OBJECTIVE
  The objective of this study was to investigate the image quality-improving and heart rate-lowering effects of landiolol hydrochloride (a short-acting β1-adrenergic receptor blocker) on coronary computed tomography angiography (CCTA). During CCTA, β-adrenergic receptor blockers have been commonly used to lower heart rate and improve image quality.
  
  
  METHODS
  A total of 258 subjects suspected of having ischemic cardiac disease and requiring CCTA were randomized to either a landiolol hydrochloride 0.125 mg/kg group or placebo group to study the efficacy and safety of landiolol hydrochloride in a multicenter, double-blind, randomized parallel study. The primary endpoint was the diagnosable proportion (proportion of subjects whose coronary stenosis was diagnosable).
  
  
  RESULTS
  The diagnosable proportions about the reconstruction images at mid-diastole were 68.2 and 38.2 % in the landiolol hydrochloride and placebo group, respectively, indicating significant superiority of landiolol hydrochloride over placebo (p < 0.0001). The diagnosable proportions about the optimal reconstruction images were 81.4 and 54.2 % in the landiolol hydrochloride and placebo group, respectively, indicating significant superiority of landiolol hydrochloride over placebo (p < 0.0001). The mean heart rate-lowering effect was first observed soon after administration of landiolol hydrochloride, was most marked at 3-5 min, and disappeared 30 min after completion of administration. The mean heart rate-lowering proportion at that time was -19.1 ± 8.1 % and -5.9 ± 9.7 % in the landiolol hydrochloride and placebo groups, respectively, showing a significantly higher proportion in the landiolol hydrochloride group.
  
  
  CONCLUSIONS
  Landiolol hydrochloride was confirmed to significantly and rapidly lower heart rate after intravenous injection, suggesting that it is a safe and useful agent for improving the image quality of CCTA.
authors.affiliation: Department of Cardiology, Tokyo Medical University, 6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan, m-hirano@tokyo-med.ac.jp.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Hirano
authors.forename: Akira
authors.initials: A
authors.lastname: Yamashina
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Hara
authors.forename: Yuji
authors.initials: Y
authors.lastname: Ikari
authors.forename: Masahiro
authors.initials: M
authors.lastname: Jinzaki
authors.forename: Misako
authors.initials: M
authors.lastname: Iino
authors.forename: Takuhiro
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Mitsunobu
authors.initials: M
authors.lastname: Tanimoto
authors.forename: Sachio
authors.initials: S
authors.lastname: Kuribayashi
mesh_terms: D061605:Administration, Intravenous; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D017023:Coronary Angiography / Q000379:methods*; D023921:Coronary Stenosis / Q000175:diagnosis*; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007089:Image Enhancement / Q000379:methods; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D014057:Tomography, X-Ray Computed / Q000379:methods*; D014508:Urea / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology
chemical_list: D000319:Adrenergic beta-Antagonists; D009025:Morpholines; C077049:landiolol; D014508:Urea