Evidence map›Paper›PMID 32849964›Full record

ArticleCardiology research2020

Model-Informed Development of Sotalol Loading and Dose Escalation Employing an Intravenous Infusion.

John C Somberg, Alexander A Vinks, Min Dong, Janos Molnar

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Cardiology research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05247320 (Prospective Evaluation Analysis and Kinetics of IV Sotalol), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.8field-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.

NCT05247320 completednot on this mapstarted 2022, after this paper: background citation

Prospective Evaluation Analysis and Kinetics of IV Sotalol

TypeobservationalSponsorUniversity of UtahRan2022 to 2023Enrolled167ConditionsAtrial ArrhythmiaArmsSotalol Injection
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Safety and feasibility of intravenous sotalol loading for the prevention of ventricular arrhythmias.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Article
  7. Observational
  8. Article
  9. Article
  10. Atrial Fibrillation Management: A Comprehensive Review with a Focus on Pharmacotherapy, Rate, and Rhythm Control Strategies.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2022
    Review
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

John C SombergAmerican Institute of Therapeutics, 21 N Skokie Hwy, Suite G-3, Lake Bluff, IL 60044, USA.
Alexander A VinksDivision of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC6018, Cincinnati, OH 45229, USA.
Min DongDivision of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC6018, Cincinnati, OH 45229, USA.
Janos MolnarAmerican Institute of Therapeutics, 21 N Skokie Hwy, Suite G-3, Lake Bluff, IL 60044, USA.
American Institute for Economic Research · USCincinnati Children's Hospital Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSotalol is often employed to prevent recurrence of symptomatic atrial flutter/atrial fibrillation. Because sotalol can prolong the QT interval excessively causing ventricular arrhythmias, a 3-day in-hospital loading or dose escalation period is mandated with oral administration in the product label for patient safety. In patients with normal renal function, 3 days (five oral doses) are required to obtain steady state maximum sotalol concentration, which results in maximum QT prolongation. The aim of this study is to develop an intravenous to oral loading regime for sotalol therapy that reduces the 3-day in-hospital initiation or dose escalation with oral administration to 1 day without compromising patient safety.

methodsUsing model-informed drug development techniques, simulations were developed for initiation and dose escalation of sotalol therapy by employing an intravenous loading dose followed by oral sotalol administrations.

resultsIn patients with normal renal function, an initial 1-h loading dose of intravenous sotalol followed by two oral doses in 24 h has been developed permitting attainment of three maximum serum concentrations reflecting maximum QT prolongation in a 1-day observation period. Dosing regimens for patients with impaired renal function are also developed.

conclusionsIn patients with normal renal function, using an intravenous loading dose followed by oral administrations permits safe initiation or dose escalation of sotalol in 1 day instead of the 3-day dosing regimen with oral administration.

Indexed as

Dose escalationDose initiationIntravenous sotalolSimulationsSotalol

Identifiers

PMID32849964
PMCPMC7430892
OpenAlexW3048118830

What OpenQuestion holds

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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.