• Drugs in R&D · Sep 2014

    Multicenter Study Clinical Trial

    A multicenter, open-label study of an intravenous short-acting β1-adrenergic receptor antagonist landiolol hydrochloride for coronary computed tomography angiography by 16-slice multi-detector computed tomography in Japanese patients with suspected ischemic cardiac disease.

    • Masaharu Hirano, Akira Yamashina, Kazuhiro Hara, Yuji Ikari, Masahiro Jinzaki, Misako Iino, Takuhiro Yamaguchi, Mitsunobu Tanimoto, Sachio Kuribayashi, and Landiolol Hydrochloride Study Group.
    • Department of Cardiology, Tokyo Medical University, 6-7-1, Nishi-shinjuku, Shinjuku, Tokyo, 160-0023, Japan, m-hirano@tokyo-med.ac.jp.
    • Drugs R D. 2014 Sep 1; 14 (3): 185-94.

    BackgroundDuring coronary computed tomography (CT) angiography (CCTA), β-blockers (β-adrenergic receptor antagonists) have commonly been used to lower heart rate and improve image quality.ObjectivesThe aim of this study was to investigate the image quality-improving effect as well as the heart rate-lowering effect of landiolol hydrochloride (an intravenous short-acting β1-adrenergic receptor antagonist) in CCTA by 16-slice multi-detector CT (MDCT).MethodsA total of 39 subjects suspected of having ischemic cardiac disease and requiring CCTA received 0.125 mg/kg of landiolol hydrochloride to study the efficacy and safety of landiolol hydrochloride in a multicenter open-label clinical study. The endpoint was the diagnosable proportion (proportion of subjects whose coronary stenosis was diagnosable).ResultsThe diagnosable proportions for the reconstruction images at mid-diastole were 56.0 %. The diagnosable proportions for the optimal reconstruction images were 65.4 %. The mean heart rate-lowering effect was observed soon after administration of landiolol hydrochloride; the peak of the effect was reached in 3-5 min, and the effect wore off in 30 min after completion of administration. The mean heart rate-lowering proportion at that time was -14.46 ± 8.4 %.ConclusionsLandiolol hydrochloride was confirmed to reduce heart rate significantly and rapidly after intravenous injection and this suggests that the study drug is a safe and useful agent for improving the image quality of CCTA by 16-slice MDCT.

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