Aim Evaluating the efficacy and safety of early administration of antirecurrence antiarrhythmic therapy (AAT) following restoration of sinus rhythm (SR) with refralon.Aim Evaluating the efficacy and safety of early administration of antirecurrence antiarrhythmic therapy (AAT) following restoration of sinus rhythm (SR) with refralon.Material and methods The study included 247 patients with atrial fibrillation/atrial flutter (AF/AFL) (142 men) who underwent pharmacological cardioversion (PCV) with refralon. A 4-step schedule of drug administration was used (successive intravenous infusions at doses of 5, 5, 10, and 10 µg/kg; maximum total dose was 30 µg/kg). Patients who recovered SR and had no contraindications were prescribed antirecurrence AAT in the early (≤24 h; n=101) or delayed (≥24 h; n=95) period. Lappaconitine hydrobromide, propafenone, and sotalol were administered orally as the antirecurrence therapy. The decision on the time of initiating ATT and the choice of the drug and its dose was taken by the attending physician individually. The safety criteria included a prolonged PQ interval >200 ms; second- or third-degree atrioventricular block; QRS complex duration >120 ms; QT prolongation >500 ms; and heartbeat pauses >3 s. The efficacy criteria included the absence of sustained recurrence of AF/AFL after initiation of AAT and the duration of hospitalization after PCV. Patients were followed up during the study until they were discharged from the hospital.Results SR was recovered in 229 (92.7 %) patients. In the group of early AAT initiation, a PQ duration >200 ms was observed in 8 (7.9 %) patients, whereas in the group of delayed AAT initiation, in 7 patients (7.4 %; p=1.000). A wide QRS complex >120 ms was recorded in 1 (1.1 %) patient of the delayed AAT initiation group and in none of the patients of the early AAT initiation group (p=0.485). Ventricular arrhythmogenic effects and QT prolongation >500 ms were not detected in any patient. Numbers of early AF recurrence did not differ in the groups of early and delayed AAT initiation: 6 (5.9 %) vs. 5 (5.3 %), respectively (p=1.000). Median duration of hospitalization after PCV was 4 days in the group of early AAT initiation and 5 days in the group of delayed AAT initiation (р=0.009).Conclusion Early initiation of the refralon AAT does not increase the risk of drug adverse effects and reduces the duration of stay in the hospital.
Introduction:
Niferidil is a new Russian class III antiarrhythmic drug, which in clinical trials has shown a high efficiency of restoration of sinus rhythm (SR) in persistent AF (87%), not inferior to electrical cardioversion. Currently, a three-stage scheme of drug administration is used (10 μg / kg - 10 μg / kg - 10 μg / kg). In a number of patients, SR is restored before the end of the first dose of the drug, which indicates the effectiveness of an even lower dose (5 μg / kg) of the drug, which has not been studied in clinical trials.
Objective:
To evaluate the effectiveness and safety of the modified protocol of niferidil administration in patients with paroxysmal AF.
Methods:
Included 87 patients with paroxysmal, 42 of them were men, mean age 63 [57;70]. After exclusion of contraindications, all patients received niferidil according to the following scheme. The initial dose of niferidil was 5 μg/kg of body weight, if AF did not terminate after 15 minutes (min.), niferidil was additionally administered at a dose of 5 μg/kg (total dose of 10 μg/kg). If SR was not restored patients received subsequent injections of niferidil 10 μg/kg, each after 15 min. (maximal total dose of 30 μg/kg). Injections were discontinued in case of SR restoration, QTc>500ms or proarrhythmia. All patients underwent continuous ECG monitoring within 24 hours to assess effectiveness and safety of niferidil.
Results:
SR was restored in 81 out of 87 patients (cumulative effectiveness of niferidil in doses up to 30 μg / kg was 93,1 %. 49,4 % of them restored SR after administration of 5 μg/kg dose, 66 (77 %) - after 10 μg/kg dose, 77 (88,5 %) - after 20 μg/kg dose, 81 (93,1 %) - after 30 μg/kg dose. In none of the cases was there any development of life-threatening ventricular arrhythmias. Prolongation of the QTc>500 ms was recorded in 14 patients (16%). Bradyarrhythmias after SR recovery were reported in 6 patients (6,8 %). In all cases sinus bradycardia was asymptomatic.
Conclusions:
The modified protocol of cardioversion allows SR to be restored in a significant number of AF patient’s lower doses of niferidil. The drug is highly effective in the treatment of paroxysmal AF, while in almost half of the cases, SR is restored after the administration after drug dose - 5 μg / kg. None of the patients developed Torsades de pointes.
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