title: A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting β1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease.
abstract: The purpose of this study was to compare the safety and efficacy of the short-acting β1-receptor blocker, landiolol hydrochloride (0.06 and 0.125-mg/kg), to placebo during coronary computed tomography angiography (CTA) in a phase 2 dose-finding study. A total of 183 patients suspected of having ischemic cardiac disease and scheduled to undergo an invasive coronary angiography were randomized to groups treated with landiolol hydrochloride (0.06 or 0.125-mg/kg) or placebo. The heart rate, safety, and the performance of coronary diagnosis using landiolol hydrochloride were evaluated in a multicenter, double-blind, randomized, parallel study. The patients' heart rates during the coronary CTA were 67.6 ± 8.7 and 62.6 ± 7.8 beats/min in the 0.06 and 0.125-mg/kg landiolol hydrochloride groups, respectively, both of which were significantly lower than the heat rate of 73.7 ± 11.8 beats/min in the placebo group (P = 0.003 and P < 0.001, respectively). No adverse events or reactions occurred at an incidence of 5 % or greater, confirming the safety of landiolol hydrochloride. The proportion of correctly classified patients was significantly higher in the 0.125-mg/kg landiolol hydrochloride group than in the placebo group (73.6 vs. 50.0 %). Landiolol hydrochloride at doses of 0.06 and 0.125-mg/kg significantly decreased the heart rate compared with a placebo. The present findings suggest that landiolol hydrochloride is safe and useful at a dose of 0.125-mg/kg to improve coronary diagnostic performance during coronary CTA.
authors.affiliation: Department of Diagnostic Radiology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan. jinzaki@rad.med.keio.ac.jp
authors.forename: Masahiro
authors.initials: M
authors.lastname: Jinzaki
authors.forename: Masaharu
authors.initials: M
authors.lastname: Hirano
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Hara
authors.forename: Takahiko
authors.initials: T
authors.lastname: Suzuki
authors.forename: Akira
authors.initials: A
authors.lastname: Yamashina
authors.forename: Yuji
authors.initials: Y
authors.lastname: Ikari
authors.forename: Misako
authors.initials: M
authors.lastname: Iino
authors.forename: Takuhiro
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Sachio
authors.initials: S
authors.lastname: Kuribayashi
mesh_terms: D058671:Adrenergic beta-1 Receptor Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D016009:Chi-Square Distribution; D017023:Coronary Angiography / Q000379:methods*; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D007275:Injections, Intravenous; D007564:Japan; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D061330:Multidetector Computed Tomography; D017202:Myocardial Ischemia / Q000000981:diagnostic imaging* / Q000503:physiopathology; D011237:Predictive Value of Tests; D013997:Time Factors; D014508:Urea / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D058671:Adrenergic beta-1 Receptor Antagonists; D009025:Morpholines; C077049:landiolol; D014508:Urea