Limits...
Dose-finding study of landiolol hydrochloride: a short-acting β1-blocker for controlling heart rate during coronary computed-tomography angiography in Japan.

Hirano M, Hara K, Ikari Y, Jinzaki M, Iino M, Hamada C, Kuribayashi S - Adv Ther (2013)

Bottom Line: Heart rate decreased rapidly after completion of landiolol hydrochloride administration in all groups, with a heart rate reduction of 15.55 ± 6.56% in Group L, 16.48 ± 7.80% in Group M, and 21.49 ± 6.13% in Group H (Group L vs Group H, P = 0.0008; Group M vs Group H, P = 0.0109).Landiolol hydrochloride showed a rapid onset and short β-blocking effect, and was most effective at a dose of 0.5 mg/kg.However, the diagnosable proportion had no significant differences among the three groups in CCTA.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Tokyo Medical University, 6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan, m-hirano@tokyo-med.ac.jp.

ABSTRACT

Introduction: Coronary computed-tomography angiography (CCTA) has high diagnostic performance, but it sometimes does not allow evaluation because of artifacts. Currently, the use of a β-blocker is recommended to prevent motion artifacts, but the β-blocker (metoprolol, propranolol, etc.) commonly used has a slow onset and long duration of action. Landiolol hydrochloride is an intravenous β1-blocker with a very short half-life. We investigated the efficacy and optimal dose of this drug for reduction of heart rate in patients undergoing CCTA.

Methods: Eighty-seven subjects with ischemic heart disease were divided into three groups to receive landiolol hydrochloride at a dose of 0.125 (Group L), 0.25 (Group M), or 0.5 mg/kg (Group H). CCTA was performed at 3-7 min after administration, and heart rate, blood pressure, and image quality were assessed.

Results: Heart rate decreased rapidly after completion of landiolol hydrochloride administration in all groups, with a heart rate reduction of 15.55 ± 6.56% in Group L, 16.48 ± 7.80% in Group M, and 21.49 ± 6.13% in Group H (Group L vs Group H, P = 0.0008; Group M vs Group H, P = 0.0109). Since there was no significant difference in heart rate during imaging among the three groups, although there was a significant difference between groups L and H and groups M and H in terms of percent change in heart rate, coronary stenosis was diagnosable in all groups with no significant difference.

Conclusion: Landiolol hydrochloride showed a rapid onset and short β-blocking effect, and was most effective at a dose of 0.5 mg/kg. However, the diagnosable proportion had no significant differences among the three groups in CCTA. Therefore, the clinically recommended dose was 0.125 mg/kg or less, considering the heart rate of patients with suspected coronary stenosis during CCTA.

Show MeSH

Related in: MedlinePlus

Flow diagram of subjects. FAS full analysis set, PPS per protocol set
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC3824371&req=5

Fig2: Flow diagram of subjects. FAS full analysis set, PPS per protocol set

Mentions: All 90 subjects enrolled in the study received the study drug, without any withdrawals or dropouts. However, two subjects did not meet the inclusion criteria, and one subject had incomplete data for assessment. As a result, 87 subjects were included in the PPS analysis set (low-dose, n = 29; medium-dose, n = 28; high-dose, n = 30) (Fig. 2). There was no significant difference among the three groups for patient baseline characteristics (Table 1).Fig. 2


Dose-finding study of landiolol hydrochloride: a short-acting β1-blocker for controlling heart rate during coronary computed-tomography angiography in Japan.

Hirano M, Hara K, Ikari Y, Jinzaki M, Iino M, Hamada C, Kuribayashi S - Adv Ther (2013)

Flow diagram of subjects. FAS full analysis set, PPS per protocol set
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3824371&req=5

Fig2: Flow diagram of subjects. FAS full analysis set, PPS per protocol set
Mentions: All 90 subjects enrolled in the study received the study drug, without any withdrawals or dropouts. However, two subjects did not meet the inclusion criteria, and one subject had incomplete data for assessment. As a result, 87 subjects were included in the PPS analysis set (low-dose, n = 29; medium-dose, n = 28; high-dose, n = 30) (Fig. 2). There was no significant difference among the three groups for patient baseline characteristics (Table 1).Fig. 2

Bottom Line: Heart rate decreased rapidly after completion of landiolol hydrochloride administration in all groups, with a heart rate reduction of 15.55 ± 6.56% in Group L, 16.48 ± 7.80% in Group M, and 21.49 ± 6.13% in Group H (Group L vs Group H, P = 0.0008; Group M vs Group H, P = 0.0109).Landiolol hydrochloride showed a rapid onset and short β-blocking effect, and was most effective at a dose of 0.5 mg/kg.However, the diagnosable proportion had no significant differences among the three groups in CCTA.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Tokyo Medical University, 6-7-1, Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan, m-hirano@tokyo-med.ac.jp.

ABSTRACT

Introduction: Coronary computed-tomography angiography (CCTA) has high diagnostic performance, but it sometimes does not allow evaluation because of artifacts. Currently, the use of a β-blocker is recommended to prevent motion artifacts, but the β-blocker (metoprolol, propranolol, etc.) commonly used has a slow onset and long duration of action. Landiolol hydrochloride is an intravenous β1-blocker with a very short half-life. We investigated the efficacy and optimal dose of this drug for reduction of heart rate in patients undergoing CCTA.

Methods: Eighty-seven subjects with ischemic heart disease were divided into three groups to receive landiolol hydrochloride at a dose of 0.125 (Group L), 0.25 (Group M), or 0.5 mg/kg (Group H). CCTA was performed at 3-7 min after administration, and heart rate, blood pressure, and image quality were assessed.

Results: Heart rate decreased rapidly after completion of landiolol hydrochloride administration in all groups, with a heart rate reduction of 15.55 ± 6.56% in Group L, 16.48 ± 7.80% in Group M, and 21.49 ± 6.13% in Group H (Group L vs Group H, P = 0.0008; Group M vs Group H, P = 0.0109). Since there was no significant difference in heart rate during imaging among the three groups, although there was a significant difference between groups L and H and groups M and H in terms of percent change in heart rate, coronary stenosis was diagnosable in all groups with no significant difference.

Conclusion: Landiolol hydrochloride showed a rapid onset and short β-blocking effect, and was most effective at a dose of 0.5 mg/kg. However, the diagnosable proportion had no significant differences among the three groups in CCTA. Therefore, the clinically recommended dose was 0.125 mg/kg or less, considering the heart rate of patients with suspected coronary stenosis during CCTA.

Show MeSH
Related in: MedlinePlus