TY - JOUR

T1 - ОПЫТ КЛИНИЧЕСКОГО ПРИМЕНЕНИЯ ОТЕЧЕСТВЕННОГО АНТИАРИТМИЧЕСКОГО ПРЕПАРАТА III КЛАССА ДЛЯ МЕДИКАМЕНТОЗНОЙ КАРДИОВЕРСИИ ФИБРИЛЛЯЦИИ И ТРЕПЕТАНИЯ ПРЕДСЕРДИЙ:

T2 - РЕЗУЛЬТАТЫ МНОГОЦЕНТРОВОГО ИССЛЕДОВАНИЯ. ЧАСТЬ 2: ОЦЕНКА БЕЗОПАСНОСТИ ЛЕЧЕНИЯ

AU - Миронов, Н.Ю.

AU - Юричева, Ю.А.

AU - Влодзяновский, В.В.

AU - Соколов, С.Ф.

AU - Дзаурова, Х.М.

AU - Голицын, С.П.

AU - Шубик, Юрий Викторович

AU - Ривин, Алексей Евгеньевич

AU - Медведев, Михаил Маркович

AU - Пархомчук, Д.С.

AU - Барыбин, А.Е.

AU - Баландин, А.Е.

AU - Баталов, Р.Е.

AU - Терехов, Д.В.

AU - Евстифеев, И.В.

AU - Кильдеев, И.Р.

AU - Пятаева, О.В.

AU - Зенин, С.А.

N1 - Funding Information: Funding: The study was performed with the support of the National Medical Research Center of Cardiology. Publisher Copyright: © 2021 Stolichnaya Izdatelskaya Kompaniya. All rights reserved.

PY - 2021/11/3

Y1 - 2021/11/3

N2 - 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.

AB - 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.

KW - Antiarrhythmic drugs

KW - Atrial fibrillation

KW - Atrial flutter

KW - Cardioversion

KW - Effectiveness

KW - Management

KW - Restoration of sinus rhythm

KW - Rhythm control

KW - Safety

KW - CARDIOVERSION

KW - DESIGN

KW - NIFERIDIL

KW - PREVALENCE

KW - RATIONALE

KW - antiarrhythmic drugs

KW - atrial fibrillation

KW - atrial flutter

KW - cardioversion

KW - effectiveness

KW - management

KW - restoration of sinus rhythm

KW - rhythm control

KW - safety

KW - Rhythm control

KW - Antiarrhythmic drugs

KW - Effectiveness

KW - Atrial fibrillation

KW - Cardioversion

KW - Management

KW - Restoration of sinus rhythm

KW - Atrial flutter

KW - Safety

UR - http://www.scopus.com/inward/record.url?scp=85119904921&partnerID=8YFLogxK

UR - https://www.mendeley.com/catalogue/358d6e53-c2ec-3fa6-a563-10078a11d0d2/

U2 - 10.20996/1819-6446-2021-10-06

DO - 10.20996/1819-6446-2021-10-06

M3 - статья

VL - 17

SP - 668

EP - 673

JO - Rational Pharmacotherapy in Cardiology

JF - Rational Pharmacotherapy in Cardiology

SN - 1819-6446

IS - 5

ER -