Evidence map›Paper›PMID 28091703›Full record

Trial reportEuropean journal of clinical pharmacology2017

Bolus application of landiolol and esmolol: comparison of the pharmacokinetic and pharmacodynamic profiles in a healthy Caucasian group.

Günther Krumpl, Ivan Ulc, Michaela Trebs, Pavla Kadlecová, Juri Hodisch

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01652898 (A Single Centre Prospective, Randomized, Double Blind, Crossover, Three-treatment Periods PK, PD, Safety and Tolerability Study to Compare Bolus Administration of AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers After a Pilot Phase of AOP LDLA202 Safety and Local Tolerability Assessment.), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01652898 phase1completednot on this map

A Single Centre Prospective, Randomized, Double Blind, Crossover, Three-treatment Periods PK, PD, Safety and Tolerability Study to Compare Bolus Administration of AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers After a Pilot Phase of AOP LDLA202 Safety and Local Tolerability Assessment.

TypeinterventionalSponsorAOP Orphan Pharmaceuticals AGRan2012 to 2012Enrolled12ConditionsHealthyArmsLDLA202, ONO LDL50, Esmolol hydrochloride
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Landiolol is effective and safe in paediatric supraventricular tachycardia: evidence from a European prospective multicentre open-label phase III study (LANDI-PED).Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
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  6. Observational
  7. Review
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  15. Review
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  20. Acute rate control in atrial fibrillation: an urgent need for the clinician.European heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Günther KrumplMRN Medical Research Network GmbH, Postgasse 11/22, A-1010, Vienna, Austria. g.krumpl@medresnet.com.
Ivan UlcCenter for Pharmacology and Analysis s.r.o, Prague, Czech Republic.
Michaela TrebsAOP Orphan Pharmaceuticals AG, Wien, Austria.
Pavla KadlecováAprova s.r.o, Prague, Czech Republic.
Juri HodischAOP Orphan Pharmaceuticals AG, Wien, Austria.
AOP Orphan (Austria) · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of this prospective study was to compare in non-Asian subjects the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of two short-acting cardioselective β1-adrenergic antagonists, landiolol and esmolol, after administration of three different bolus dosages. MATERIALS AND

methodsWe conducted a single-center, prospective, double-blinded, randomized study in three cross-over periods with 12 healthy subjects (7 women and 5 men, mean age of 24.5 ± 6.9 years) each receiving three doses of landiolol (0.1, 0.2, and 0.3 mg/kg BW) either in a newly developed concentrate i.v. formulation (Rapibloc® 20 mg/2 mL concentrate) or a lyophilized formulation, or three doses of esmolol (0.5, 1, and 1.5 mg/kg BW) in an i.v. formulation (Brevibloc® 100 mg/10 mL). PK and PD parameters, safety, and tolerability were assessed.

findingsResults of the two landiolol formulations were reported previously and were similar. For the landiolol concentrate formulation and esmolol, maximum blood concentrations were rapidly reached (mean t IMPLICATIONS: Heart rate reduction induced by a new liquid formulation of landiolol occurred faster, was more pronounced, and lasted longer than the effects of corresponding standard esmolol doses. Both agents reduced systolic blood pressure to a comparable degree, but the blood pressure decrease lasted longer after esmolol infusion. The local tolerance and safety profiles of the two formulations were similar. In summary, compared to esmolol, landiolol shows a more prominent and pronounced bradycardic effect in relation to its blood pressure-lowering effect, an action profile that might be of specific advantage in the perioperative setting.

trial registrationNCT01652898 and 2012-002127-14. https://clinicaltrials.gov/ct2/show/NCT01652898?term=landiolol&rank=7.

Indexed as

White PeopleAdrenergic beta-AntagonistsAdultDouble-Blind MethodFemaleHumansMaleMorpholinesPropanolaminesProspective StudiesUreaYoung AdultAdrenergic beta-AntagonistsesmolollandiololMorpholinesPropanolaminesUreaCardioselective β-blockerEsmololLandiololPharmacodynamicsPharmacokinetics

Identifiers

PMID28091703
OpenAlexW2577421764

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.