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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