Preliminary results of a prospective randomized study comparing the efficacy and safety of refralon and amiodarone in cardioversion in patients with paroxysmal atrial fibrillation and flutter

Gagloeva, D. A.; Dzaurova, Kh. M.; Zelberg, M. A.; Mironov, N. Yu.; Yuricheva, Yu. A.; Sokolov, S. F.; Krymukova, M. A.; Salpagarova, A. I.; Dulaev, L. O.; Pevzner, D. V.; Golitsyn, S. P.

doi:10.15829/1728-8800-2023-3527

Cited by 4 publications

(1 citation statement)

References 7 publications

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“…Moreover, results of a blind randomized study comparing refralon (cavutilide) and amiodarone in paroxysmal AF/AFL showed that the effectiveness of the minimum dose of refralon (5 mcg/kg) (56.7%) did not significantly differ from the efficacy of the maximum amiodarone dose (1200 mg/day) (57.1%). The administration of refralon at a maximum dose of 30 mcg/kg allowed SR to recover in 96.7% of patients, which significantly exceeds the effectiveness of amiodarone [24]. In addition, the use of cavutilide at a dose of 5 mcg/kg is accompanied by a lesser degree of QT interval prolongation and its rapid normalization.…”

Section: Discussionmentioning

confidence: 96%

Intravenous Cavutilide for Pharmacological Conversion of Paroxysmal and Persistent Atrial Fibrillation in Patients with Heart Failure

Beliaeva,

Dzaurova,

Yuricheva

et al. 2023

JCDD

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This work aimed to study the efficacy and safety of the class III antiarrhythmic agent cavutilide (Niferidil, Refralon) for pharmacological cardioversion in patients with paroxysmal and persistent atrial fibrillation (AF) and heart failure (HF). Methods and Results: In this retrospective cohort study, 58 patients with stable HF (aged 69 [61;73] years, 30 males, 78% with persistent AF) and 274 patients without HF (aged 63 [57;70] years, 196 males, 56% with persistent AF) were included. The median AF duration in the group with HF was 35.5 [10.6;124] days, and that in the group without HF was 14.5 [3.6;90] days. All patients received 5–30 µg/kg cavutilide intravenously in one to four (if needed) boluses of 5–5–10–10 µg/kg at 15 min intervals. Subsequent boluses were not administered if the patient’s sinus rhythm (SR) was restored or if bradycardia, QT prolongation > 500 ms or evidence of proarrhythmia was observed. Holter electrocardiogram monitoring was started before infusion and was continued for 24 h. The main criterion for an antiarrhythmic effect was sinus rhythm restoration within 24 h of the initial bolus. Results: Cavutilide converted AF to SR in 37.9% of patients with HF after bolus 1 (5 µg/kg), in 58.6% after bolus 2 (cumulative dose = 10 µg/kg), in 74% of cases after bolus 3 (cumulative dose = 20 µg/kg) and in 92.8% of cases after bolus 4 (cumulative dose = 30 µg/kg). Cavutilide was effective in 89% of cases with persistent AF with a median duration of 70.5 [30;159] days and in 92% of cases with paroxysmal AF with a median duration of 36 [24;102] h. In the group of patients without HF, the effectiveness of bolus 1 was 36.9%, that of the bolus 2 was 58%, that of the bolus 3 was 77% and that of the bolus 4 was 90.1%. Cavutilide restored SR in 90% of patients with persistent AF with a median duration of 82.5 [28;180] days and in 90% of cases with paroxysmal AF with a median duration of 50 [24;120] h. No statistically significant difference in the probability of SR restoration or the effectiveness of each bolus of cavutilide was found between patients with and without HF. The median time to restoration of SR in patients with HF was 23 [11;55] min, and that in patients without HF was 22 [10;45] min (p = 0.424). No cases of symptomatic/severe bradycardia were observed in either group. QT prolongation over 500 ms after cavutilide injection was registered in 19% of patients without HF and in 15.5% of those with HF (p = 0.58). Short runs of Torsade de pointes tachycardia occurred in one patient (0.4%) without HF after 10 µg cavutilide administration and were successfully treated with MgSO4. Conclusions: Cavutilide demonstrated a high likelihood of AF conversion to SR in paroxysmal (92%) and persistent (89%) arrhythmia and HF. Concomitant HF and its severity do not affect the efficacy and safety of cavutilide.

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Section: Discussionmentioning

confidence: 96%

Intravenous Cavutilide for Pharmacological Conversion of Paroxysmal and Persistent Atrial Fibrillation in Patients with Heart Failure

Beliaeva,

Dzaurova,

Yuricheva

et al. 2023

JCDD

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Present and future of antiarrhythmic therapy for atrial fibrillation: A review

Tarzimanova

2024

Consilium Medicum

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Despite the emergence and active development of interventional methods for the treatment of arrhythmias, to date, the use of antiarrhythmic drugs to recover and maintain sinus rhythm is the most significant and in demand in patients with paroxysmal and persistent forms of atrial fibrillation (AF). The results of multicenter randomized clinical studies show that early antiarrhythmic therapy to recover and maintain sinus rhythm improves the prognosis for patients with AF. Currently, the most effective and safe drugs to control AF paroxysms and maintain sinus rhythm are class 1C and III agents, according to the Vaughan–Williams classification. The development of new antiarrhythmic drugs brings hope for the emergence of an effective and safe means for the control and prevention of AF, which will significantly improve the quality of life of patients and their prognosis.

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The results of I phase clinical study of class III antiarrhythmic drug, tablet form

Yuricheva,

Dzaurova,

Beliaeva

et al. 2024

SJCEM

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Aim: To evaluate the safety and tolerance of single dose or repeated doses administration of domestic class III antiarrhythmic agent Refralon (cavutilide), tablets, by healthy volunteers; and to study it’s pharmacokinetics and absolute bioavailability.Material and Methods. Healthy male volunteers, aged 18 – 45 years were included in one of 7 cohorts: 1, 2, 4 и 6 mg PO, 1 mg IV (these cohorts included 6 people each), one cohort of 12 people who took 2 mg of the drug per day for 5 days, and one cohort of 6 menfor 10 days. Drug intake/injection, blood and urine tests, sampling for pharmacokinetic analysis, assessment of vital signs, ECG registration at specified points, Holter monitoring of ECG were performed in a hospital setting.Results. The study included 48 volunteers 32 ± 7,2 years old, mean weight 74,6 ± 4,7 kg. No significant changes in blood and urine tests and vital signs in any of cohorts were registered. Among cohorts of single dose oral intake only maximum dose of 6 mg caused persistent statistically significant increase of the duration of the QT and QTc intervals. In cohort of multiple intake of 2 mg of the drug statistically significant increase of the QT/QTc duration was noted with maximum value on 9-10 days. By this time balance between absorption and elimination processes was achieved.Conclusion. Duration of the QT/QTc intervals didn’t exceed reference values during the entire study in all cohorts of oral intake of Refralon, either single dose or repeated doses administration. Significant persistent increase of the duration of the QT and QTc intervals was registered only in cohort of maximum single dose of 6 mg intake and during intake of 2 mg of Refralon daily for 5-10 days. Stationary state was achieved by 8-10 day of Refralon intake.

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Preliminary results of a prospective randomized study comparing the efficacy and safety of refralon and amiodarone in cardioversion in patients with paroxysmal atrial fibrillation and flutter

Cited by 4 publications

References 7 publications

Intravenous Cavutilide for Pharmacological Conversion of Paroxysmal and Persistent Atrial Fibrillation in Patients with Heart Failure

Intravenous Cavutilide for Pharmacological Conversion of Paroxysmal and Persistent Atrial Fibrillation in Patients with Heart Failure

Present and future of antiarrhythmic therapy for atrial fibrillation: A review

The results of I phase clinical study of class III antiarrhythmic drug, tablet form

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