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

Circ J. 2019 Dec 25;84(1):33-42. doi: 10.1253/circj.CJ-19-0661. Epub 2019 Dec 6.

Abstract

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.

Keywords: Atrial fibrillation; Atrial flutter; Cardioselective β-blockers; Landiolol; Tachyarrhythmia.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Atrial Fibrillation* / drug therapy
  • Atrial Fibrillation* / pathology
  • Atrial Fibrillation* / physiopathology
  • Atrial Flutter* / drug therapy
  • Atrial Flutter* / pathology
  • Atrial Flutter* / physiopathology
  • Humans
  • Middle Aged
  • Morpholines / administration & dosage*
  • Morpholines / adverse effects
  • Morpholines / pharmacokinetics*
  • Pilot Projects
  • Prospective Studies
  • Urea / administration & dosage
  • Urea / adverse effects
  • Urea / analogs & derivatives*
  • Urea / pharmacokinetics

Substances

  • Morpholines
  • landiolol
  • Urea