Refralon (niferidil) is a new class III antiarrhythmic agent for pharmacological cardioversion for persistent atrial fibrillation and atrial flutter

Maykov, E. B.; Shubik, Yuri V.; Mironov, N. Yu.; Sokolov, S F; Golitsyn, S. P.; Rozenshtraukh, L. V.; Chazov, E. I.

doi:10.17116/terarkh201587138-48

Cited by 15 publications

(4 citation statements)

References 22 publications

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“… Refralon/Niferidil: New class III antiarrhythmic agent developed in Russia for pharmacological cardioversion. It blocks I kur and prolongs atrial and ventricular action potential and refractory period [ 148 ]. In a study of this drug efficacy and safety, there was relief of paroxysmal AF in 95% of the cases, and while in 5% that had a prolongation of the QTc, none of the patients developed Torsade de pointes after administration of the drug [ 149 ].…”

Section: Rhythm Control In Atrial Fibrillation: Toward a Translationa...mentioning

confidence: 99%

Tic-Tac: A Translational Approach in Mechanisms Associated with Irregular Heartbeat and Sinus Rhythm Restoration in Atrial Fibrillation Patients

Parra-Lucares,

Villa,

Romero-Hernández

et al. 2023

IJMS

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Atrial fibrillation (AF) is a prevalent cardiac condition predominantly affecting older adults, characterized by irregular heartbeat rhythm. The condition often leads to significant disability and increased mortality rates. Traditionally, two therapeutic strategies have been employed for its treatment: heart rate control and rhythm control. Recent clinical studies have emphasized the critical role of early restoration of sinus rhythm in improving patient outcomes. The persistence of the irregular rhythm allows for the progression and structural remodeling of the atria, eventually leading to irreversible stages, as observed clinically when AF becomes permanent. Cardioversion to sinus rhythm alters this progression pattern through mechanisms that are still being studied. In this review, we provide an in-depth analysis of the pathophysiological mechanisms responsible for maintaining AF and how they are modified during sinus rhythm restoration using existing therapeutic strategies at different stages of clinical investigation. Moreover, we explore potential future therapeutic approaches, including the promising prospect of gene therapy.

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Section: Rhythm Control In Atrial Fibrillation: Toward a Translationa...mentioning

confidence: 99%

Tic-Tac: A Translational Approach in Mechanisms Associated with Irregular Heartbeat and Sinus Rhythm Restoration in Atrial Fibrillation Patients

Parra-Lucares,

Villa,

Romero-Hernández

et al. 2023

IJMS

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“…Согласно текущим рекомендациям, тактика контроля ритма у пациентов с пароксизмальной ФП включает назначение антиаритмических препаратов (ААП) или выполнение катетерной абляции с изоляцией устьев легочных вен (ЛВ) [2,3]. В настоящее время в арсенале врачей появились высокоэффективные ААП, которые позволяют восстанавливать синусовый ритм у пациентов даже с персистирующей и дли-тельно персистирующей ФП [4,5]. Однако препараты для профилактики рецидивов значительно уступают катетерным методам лечения.…”

Section: результатыunclassified

Potential risk factors of atrial fibrillation recurrence after cryoballoon ablation

Новиков

Mironov

et al. 2022

Kardiologiia

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Aim To identify risk factors for recurrence of atrial fibrillation (AF) following cryoballoon ablation (CBA).Material and methods This prospective study included patients with paroxysmal AF who had undergone CBA (141 patients, median age 60 years, 3% men). The evaluation prior to CBA included clinical instrumental parameters (electrocardiography (ECG), 24-h ECG monitoring, echocardiography, contrast-enhanced cardiac multispiral computed tomography). Also, possible intraoperative indexes that could affect the CBA effectivity, were evaluated. The postoperative follow-up duration was 12 months. Effectivity was assessed during in-person visits at 3, 6, and 12 months, when questioning of patients and 24-h ECG monitoring were performed. CBA was considered ineffective if the patient had recurrences of any atrial tachyarrhythmia longer than 30 sec after the end of the 3-month “blind” period.Results During the 12-month follow-up, recurrences of atrial tachyarrhythmia were observed in 46 (32.6 %) patients. Patients with ineffective CBA more frequently had AF during the first 3 months (71.7 % vs. 11.6 %; р<0.001). Such patients had a history of multiple ineffective treatments with antiarrhythmic drugs (AAD), common pulmonary venous (PV) collector (41.3 % vs. 20.0 %; р=0.008), and stroke/recurrent ischemic attacks (15.2 % vs. 5.2 %; р=0.047). Multifactorial regression analysis showed that the factors of AF recurrence included common PV collector (relative risk (RR) 2.35; 95 % confidence interval (CI) 1.29–4.25; р=0.005), multiple ineffective AADs (RR 1.42; 95 % CI 1.08–1.86; р=0.011), and early AF recurrence (RR 7.57; 95 % CI 3.84–14.90; р<0.001).Conclusion Common PV collector and multiple ineffective AADs are risk factors of ineffective CBA. Early recurrences during the first 3 postoperative months are a significant risk factor of long-term AF recurrences.

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“…В ходе клинических исследований 4-Нитро-N-[(1RS)-1-(4-фторфенил)-2-(1-этилпиперидин-4ил)этил] бензамида гидрохлорида (торговое название Рефралон) было показано, что частота возникновения полиморфной желудочковой тахикардии типа Torsade de pointes (TdP) -опасного нежелательного эффекта, свойственного всем блокаторам калиевых каналовне превышала 2%, что существенно ниже, чем при использовании других антиаритмических препаратов III класса (за исключением амиодарона) [8][9][10][11].…”

Section: Introductionunclassified

Safety and Effectiveness of Pharmacologic Conversion of Atrial Fibrillation and Flutter: Results of Multicenter Trial. Part II: Assessment of Safety

Mironov

Shubik

Vlodzyanovskiy

et al. 2021

Racionalʹnaâ farmakoterapiâ v kardiologii

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Aim. We aimed to assess safety and effectiveness of class III antiarrhythmic drug Refralon for conversion of atrial fibrillation (AFib) and flutter (AFl) in post-registration trial and to compare data of primary center (National medical research center in cardiology) with data of other hospitals.Material and Methods. We performed retrospective cohort study in 727 patients (451 enrolled in primary center and 276 enrolled in other hospitals) admitted between June 24, 2014 and June 24, 2019. Refralon was administered for conversion of AFib and AFl in intense care units in escalating doses (10-30 micrograms/kg) intravenously.Results. Conversion of AFib and AFl into sinus rhythm was achieved in 53,6% after administration of 10 mcg/kg dose, in 73% after administration of 20 mcg/kg dose and in 91,6% after administration of Refralon in dose up to 30 mcg/kg. No mortality and no major adverse cardiac events registered in our study. Asystole >3.0 sec observed in 5% (35 of 727) of patients): in 5% (24 of 451) of patients enrolled in primary center and in 4% (11 of 276) of patients enrolled in other hospitals; 95% confidence interval (CI) [-0.09; 0.113]. Asystole> 5.0 s observed in 1.7% of patients who further required non-urgent implantation of a permanent pacemaker due to manifestations of sinus node dysfunction. Cardiac conduction disturbances (exclusively sinus bradycardia) were registered in 7% (53 of 727) patients: in 8% (37 of 451) of patients enrolled in primary center and in 6% (17 of 276) of patients enrolled in other hospitals; 95% CI: [-0.1; 0.15]. Only 0.14% of patients had symptomatic sinus bradycardia that resolved after atropine injection. Ventricular arrhythmias (exclusively Torsade de pointes tachycardia in excessive QT interval prolongation) were registered in 1.7% (12 of 727) patients: in 2% (9 of 451) of patients in primary center and in 1% (3 of 276) of patients of other hospitals; 95% CI: [-0.06; 0.08]. QTc interval prolongation to values >500 ms documented in 19% (138 of 727) of patients: in 21% (95 of 451) of patients in primary center and in 16% (43 of 276) of patients in other hospitals; 95% CI: [-0.13; 0.24].Conclusion: In post-registration multicenter trial Refralon demonstrated good safety profile in conversion of AFib and AFl. Potential risk of TdP tachycardia mandates precautions with the use of the drug. In other hospitals Refralon did not demonstrate lower safety than in primary medical center.

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Refralon (niferidil) is a new class III antiarrhythmic agent for pharmacological cardioversion for persistent atrial fibrillation and atrial flutter

Cited by 15 publications

References 22 publications

Tic-Tac: A Translational Approach in Mechanisms Associated with Irregular Heartbeat and Sinus Rhythm Restoration in Atrial Fibrillation Patients

Tic-Tac: A Translational Approach in Mechanisms Associated with Irregular Heartbeat and Sinus Rhythm Restoration in Atrial Fibrillation Patients

Potential risk factors of atrial fibrillation recurrence after cryoballoon ablation

Safety and Effectiveness of Pharmacologic Conversion of Atrial Fibrillation and Flutter: Results of Multicenter Trial. Part II: Assessment of Safety

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