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

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

Research output: Contribution to journalArticle

8 Citations (Scopus)

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, doubleblind, 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.

Original languageEnglish
Pages (from-to)7-20
Number of pages14
JournalInternational Journal of Cardiovascular Imaging
Volume29
Issue number1 SUPPL.
DOIs
Publication statusPublished - 2013 Jun

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Heart Diseases
Placebos
Heart Rate
Safety
landiolol
Coronary Angiography
Hot Temperature
Incidence
Computed Tomography Angiography

Keywords

  • Beta-blocker
  • Computed tomography
  • Coronary artery
  • Heart rate
  • Safety

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

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

In: International Journal of Cardiovascular Imaging, Vol. 29, No. 1 SUPPL., 06.2013, p. 7-20.

Research output: Contribution to journalArticle

Jinzaki, Masahiro ; Hirano, Masaharu ; Hara, Kazuhiro ; Suzuki, Takahiko ; Yamashina, Akira ; Ikari, Yuji ; Iino, Misako ; Yamaguchi, Takuhiro ; Kuribayashi, Sachio. / 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. In: International Journal of Cardiovascular Imaging. 2013 ; Vol. 29, No. 1 SUPPL. pp. 7-20.
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AU - Suzuki, Takahiko

AU - Yamashina, Akira

AU - Ikari, Yuji

AU - Iino, Misako

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N2 - 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, doubleblind, 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.

AB - 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, doubleblind, 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.

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