A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation or Flutter

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.

Start Date01 Oct 2004

Sponsor / Collaborator

Solvay Pharmaceuticals, Inc.

100 Clinical Results associated with Tedisamil Sesquifumarate

100 Translational Medicine associated with Tedisamil Sesquifumarate

100 Patents (Medical) associated with Tedisamil Sesquifumarate

Literatures (Medical) associated with Tedisamil Sesquifumarate

01 Jul 2023·American journal of cardiovascular drugs : drugs, devices, and other interventions

Bayesian Network Meta-analysis of Randomized Controlled Trials on the Efficacy of Antiarrhythmics in the Pharmacological Cardioversion of Paroxysmal Atrial Fibrillation.

Review

Author: Santangelo, Sara ; Cristiani, Lorenzo ; Guglielmo, Nicola ; Orso, Daniele ; Copetti, Roberto ; Cilenti, Francesco ; Bove, Tiziana

PURPOSESince atrial fibrillation (AF) is one of the major arrhythmias managed in hospitals worldwide, it has a major impact on public health. The guidelines agree on the desirability of cardioverting paroxysmal AF episodes. This meta-analysis aims to answer the question of which antiarrhythmic agent is most effective in cardioverting a paroxysmal AF.MATERIALS AND METHODSA systematic review and Bayesian network meta-analysis, searching MEDLINE, Embase, and CINAHL, were performed, including randomized controlled trials (RCTs) enrolling a population of unselected adult patients with a paroxysmal AF that compared at least two pharmacological regimes to restore the sinus rhythm or a cardioversion agent against a placebo. The main outcome was efficacy in restoring sinus rhythm.RESULTSSixty-one RCTs (7988 patients) were included in the quantitative analysis [deviance information criterion (DIC) 272.57; I² = 3%]. Compared with the placebo, the association verapamil-quinidine shows the highest SUCRA rank score (87%), followed by antazoline (86%), vernakalant (85%), tedisamil at high dose (i.e., 0.6 mg/kg; 80%), amiodarone-ranolazine (80%), lidocaine (78%), dofetilide (77%), and intravenous flecainide (71%). Taking into account the degree of evidence of each individual comparison between pharmacological agents, we have drawn up a ranking of pharmacological agents from the most effective to the least effective.CONCLUSIONSIn comparing the antiarrhythmic agents used to restore sinus rhythm in the case of paroxysmal AF, vernakalant, amiodarone-ranolazine, flecainide, and ibutilide are the most effective medications. The verapamil-quinidine combination seems promising, though few RCTs have studied it. The incidence of side effects must be taken into account in the choice of antiarrhythmic in clinical practice.CLINICAL TRIAL REGISTRATIONPROSPERO: International prospective register of systematic reviews, 2022, CRD42022369433 (Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022369433 ).

01 Jul 2020·Annals of Emergency MedicineQ1 · MEDICINE

Pharmacologic Cardioversion of Recent-Onset Atrial Fibrillation and Flutter in the Emergency Department: A Systematic Review and Network Meta-analysis

Q1 · MEDICINE

Review

Author: deSouza, Ian S ; Carmelli, Guy ; Sinert, Richard ; Benabbas, Roshanak ; Sexton, Theresa ; Tadrous, Mina

STUDY OBJECTIVEWe conduct a systematic review and Bayesian network meta-analysis to indirectly compare and rank antidysrhythmic drugs for pharmacologic cardioversion of recent-onset atrial fibrillation and atrial flutter in the emergency department (ED).METHODSWe searched MEDLINE, EMBASE, and Web of Science from inception to March 2019, limited to human subjects and English language. We also searched for unpublished data. We limited studies to randomized controlled trials that enrolled adult patients with recent-onset atrial fibrillation or atrial flutter and compared antidysrhythmic agents, placebo, or control. We determined these outcomes before data extraction: rate of conversion to sinus rhythm within 4 hours, time to cardioversion, rate of significant adverse events, and rate of thromboembolism within 30 days. We extracted data according to Preferred Reporting Items for Systematic Reviews and Meta-analyses network meta-analysis and appraised selected trials with the Cochrane review handbook.RESULTSThe systematic review initially identified 640 studies; 19 met inclusion criteria. Eighteen trials that randomized 2,069 atrial fibrillation patients provided data for atrial fibrillation conversion rate outcome. Bayesian network meta-analysis using a random-effects model demonstrated that antazoline (odds ratio [OR] 24.9; 95% credible interval [CrI] 7.4 to 107.8), tedisamil (OR 12.0; 95% CrI 4.3 to 43.8), vernakalant (OR 7.5; 95% CrI 3.1 to 18.6), propafenone (OR 6.8; 95% CrI 3.6 to 13.8), flecainide (OR 6.1; 95% CrI 2.9 to 13.2), and ibutilide (OR 4.1; 95% CrI 1.8 to 9.6) were associated with increased likelihood of conversion within 4 hours compared with placebo or control. Overall quality was low, and the network exhibited inconsistency.CONCLUSIONFor pharmacologic cardioversion of recent-onset atrial fibrillation within a 4-hour ED visit, there is insufficient evidence to determine which treatment is superior. Several agents are associated with increased likelihood of conversion within 4 hours compared with placebo or control. Limited data preclude any recommendation for cardioversion of recent-onset atrial flutter. Further high-quality study is necessary.

01 Feb 2020·American Journal of Physiology-Heart and Circulatory PhysiologyQ2 · MEDICINE

Mathematical model for β₁-adrenergic regulation of the mouse ventricular myocyte contraction

Q2 · MEDICINE

Article

Author: Mullins, Paula D. ; Bondarenko, Vladimir E.

The β1-adrenergic regulation of cardiac myocyte contraction plays an important role in regulating heart function. Activation of this system leads to an increased heart rate and stronger myocyte contraction. However, chronic stimulation of the β1-adrenergic signaling system can lead to cardiac hypertrophy and heart failure. To understand the mechanisms of action of β1-adrenoceptors, a mathematical model of cardiac myocyte contraction that includes the β1-adrenergic system was developed and studied. The model was able to simulate major experimental protocols for measurements of steady-state force-calcium relationships, cross-bridge release rate and force development rate, force-velocity relationship, and force redevelopment rate. It also reproduced quite well frequency and isoproterenol dependencies for intracellular Ca2+ concentration ([Ca2+]i) transients, total contraction force, and sarcomere shortening. The mathematical model suggested the mechanisms of increased contraction force and myocyte shortening on stimulation of β1-adrenergic receptors is due to phosphorylation of troponin I and myosin-binding protein C and increased [Ca2+]i transient resulting from activation of the β1-adrenergic signaling system. The model was used to simulate work-loop contractions and estimate the power during the cardiac cycle as well as the effects of 4-aminopyridine and tedisamil on the myocyte contraction. The developed mathematical model can be used further for simulations of contraction of ventricular myocytes from genetically modified mice and myocytes from mice with chronic cardiac diseases. NEW & NOTEWORTHY A new mathematical model of mouse ventricular myocyte contraction that includes the β1-adrenergic system was developed. The model simulated major experimental protocols for myocyte contraction and predicted the effects of 4-aminopyridine and tedisamil on the myocyte contraction. The model also allowed for simulations of work-loop contractions and estimation of the power during the cardiac cycle.

100 Deals associated with Tedisamil Sesquifumarate

External Link

KEGG	Wiki	ATC	Drug Bank
D06652	Tedisamil Sesquifumarate	C01BD06	DB06200

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Atrial Fibrillation	SE	Solvay SA	-
Atrial Fibrillation	GB	Solvay SA	-
Atrial Fibrillation	ES	Solvay SA	-
Atrial Flutter	ES	Solvay SA	-
Atrial Flutter	GB	Solvay SA	-
Atrial Flutter	SE	Solvay SA	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Atrial Fibrillation	Phase 1	US	Solvay SA	-
Atrial Flutter	Phase 1	US	Solvay SA	-

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