Pharmacodynamic and -kinetic Behavior of Low-, Intermediate-, and High-Dose Landiolol During Long-Term Infusion in Whites

Krumpl, Günther; Ulč, Ivan; Trebs, Michaela; Kadlecová, Pavla; Hodisch, Juri; Maurer, Gabriele D.; Husch, Bernhard

doi:10.1097/fjc.0000000000000495

Cited by 10 publications

(13 citation statements)

References 37 publications

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“…Samples were processed as previously described. 14 AF/AFL symptoms were recorded before landiolol infusion (baseline), at 16 min and at 30 min after initiation of the CI, at the end of infusion and at the end-of-study examination 1 day later.…”

Section: Methodsmentioning

confidence: 99%

Open-Label Two-Dose Pilot Study of Landiolol for the Treatment of Atrial Fibrillation/Atrial Flutter in Caucasian Patients

Stix

Wolzt

Domanovits

et al. 2019

Circ J

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Background:We investigated for the first time the suitability of landiolol, an ultra-short-acting β1-specific β-blocker, for the treatment of atrial fibrillation/atrial flutter (AF/AFL) in Caucasian patients. Methods and Results:The 20 study patients received landiolol as a continuous infusion (starting dose 40 µg/kg/min) with (B+CI) or without (CI) a preceding bolus dose (100 µg/kg/min administered over 1 min) in a prospective open-label study. The primary endpoint was the proportion of patients with sustained heart rate (HR) reduction ≥20% or to <90 beats/min within 16 min of starting the CI. Secondary endpoints were the pharmacodynamics, pharmacokinetics, AF/AFL symptoms, safety and tolerability of landiolol. At 16 min, HR was reduced in all patients treated with landiolol. The primary endpoint was met by 60% of patients in the CI group and 40% in the B+CI group without a significant group difference. Overall reduction of AF/AFL symptoms at 16 min was 72%. Safety and local tolerability of landiolol were excellent, and no serious adverse events occurred. Conclusions:Continuous infusion of landiolol with a starting dose of 40 µg/kg/min is suitable for the acute treatment of tachycardic AF/AFL in Caucasian patients. Administration of a preceding bolus seems unnecessary.

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Section: Methodsmentioning

confidence: 99%

Open-Label Two-Dose Pilot Study of Landiolol for the Treatment of Atrial Fibrillation/Atrial Flutter in Caucasian Patients

Stix

Wolzt

Domanovits

et al. 2019

Circ J

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“…The pharmacokinetic profile of landiolol has been determined in the Caucasian 8 , 9 and found similar to the Asian population ( Table 1 ).…”

Section: Clinical Dose Response and Pharmacokinetics In The Asian Andmentioning

confidence: 98%

“…Pharmacodynamic characteristics of landiolol established in animals were confirmed in humans, both in heathly volunteers and clinical trials. 8 , 9 , 10–15…”

Section: Clinical Dose Response and Pharmacokinetics In The Asian Andmentioning

confidence: 99%

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Landiolol: pharmacology and its use for rate control in atrial fibrillation in an emergency setting

Domanovits

Wolzt

Stix

2018

European Heart Journal Supplements

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This article provides new insight on landiolol, an ultra-short acting injectable betablocker, recently approved in Europe, with regard to its pharmacokinetic and pharmacodynamic profile, along with its first experience in Caucasian healthy volunteers and patients with atrial fibrillation. Landiolol as iv formulation exhibited in an emergency setting rapid rate reduction in patients with tachycardic atrial fibrillation without pronounced blood pressure drop both in caucasian and asian populations in similar manner.

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“…Landiolol, the beta-blocker used in our study, is a highly beta1-selective, ultrashort-acting beta-blocker that could be ideally suited for the treatment of critically ill patients due to its limited hypotensive effect [ 35 – 38 ].…”

Section: Introductionmentioning

confidence: 99%

Landiolol in patients with septic shock resident in an intensive care unit (LANDI-SEP): study protocol for a randomized controlled trial

Unger

Morelli

Singer

et al. 2018

Trials

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BackgroundIn patients with septic shock, the presence of an elevated heart rate (HR) after fluid resuscitation marks a subgroup of patients with a particularly poor prognosis. Several studies have shown that HR control in this population is safe and can potentially improve outcomes. However, all were conducted in a single-center setting. The aim of this multicenter study is to demonstrate that administration of the highly beta1-selective and ultrashort-acting beta blocker landiolol in patients with septic shock and persistent tachycardia (HR ≥ 95 beats per minute [bpm]) is effective in reducing and maintaining HR without increasing vasopressor requirements.MethodsA phase IV, multicenter, prospective, randomized, open-label, controlled study is being conducted. The study will enroll a total of 200 patients with septic shock as defined by The Third International Consensus Definitions for Sepsis and Septic Shock criteria and tachycardia (HR ≥ 95 bpm) despite a hemodynamic optimization period of 24–36 h. Patients are randomized (1:1) to receive either standard treatment (according to the Surviving Sepsis Campaign Guidelines 2016) and continuous landiolol infusion to reach a target HR of 80–94 bpm or standard treatment alone. The primary endpoint is HR response (HR 80–94 bpm), the maintenance thereof, and the absence of increased vasopressor requirements during the first 24 h after initiating treatment.DiscussionDespite recent studies, the role of beta blockers in the treatment of patients with septic shock remains unclear. This study will investigate whether HR control using landiolol is safe, feasible, and effective, and further enhance the understanding of beta blockade in patients with septic shock.Trial registrationEU Clinical Trials Register; EudraCT, 2017-002138-22. Registered on 8 August 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3024-6) contains supplementary material, which is available to authorized users.

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Pharmacodynamic and -kinetic Behavior of Low-, Intermediate-, and High-Dose Landiolol During Long-Term Infusion in Whites

Cited by 10 publications

References 37 publications

Open-Label Two-Dose Pilot Study of Landiolol for the Treatment of Atrial Fibrillation/Atrial Flutter in Caucasian Patients

Open-Label Two-Dose Pilot Study of Landiolol for the Treatment of Atrial Fibrillation/Atrial Flutter in Caucasian Patients

Landiolol: pharmacology and its use for rate control in atrial fibrillation in an emergency setting

Landiolol in patients with septic shock resident in an intensive care unit (LANDI-SEP): study protocol for a randomized controlled trial

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