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

Masaharu Hirano, Akira Yamashina, Kazuhiro Hara, Yuji Ikari, Masahiro Jinzaki, Misako Iino, Takuhiro Yamaguchi, Mitsunobu Tanimoto, Sachio Kuribayashi

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objectives and Background: 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.

Original languageEnglish
Pages (from-to)53-62
Number of pages10
JournalClinical Drug Investigation
Volume34
Issue number1
DOIs
Publication statusPublished - 2014

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Adrenergic Antagonists
Adrenergic Receptors
Heart Diseases
Placebos
Heart Rate
Computer-Assisted Image Processing
Computed Tomography Angiography
landiolol
Diastole
Coronary Stenosis
Intravenous Injections

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

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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. / Hirano, Masaharu; Yamashina, Akira; Hara, Kazuhiro; Ikari, Yuji; Jinzaki, Masahiro; Iino, Misako; Yamaguchi, Takuhiro; Tanimoto, Mitsunobu; Kuribayashi, Sachio.

In: Clinical Drug Investigation, Vol. 34, No. 1, 2014, p. 53-62.

Research output: Contribution to journalArticle

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abstract = "Objectives and Background: 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.",
author = "Masaharu Hirano and Akira Yamashina and Kazuhiro Hara and Yuji Ikari and Masahiro Jinzaki and Misako Iino and Takuhiro Yamaguchi and Mitsunobu Tanimoto and Sachio Kuribayashi",
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T1 - 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

AU - Hirano, Masaharu

AU - Yamashina, Akira

AU - Hara, Kazuhiro

AU - Ikari, Yuji

AU - Jinzaki, Masahiro

AU - Iino, Misako

AU - Yamaguchi, Takuhiro

AU - Tanimoto, Mitsunobu

AU - Kuribayashi, Sachio

PY - 2014

Y1 - 2014

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AB - Objectives and Background: 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.

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