Aim. To study the pharmacokinetics and effect on hemodynamic parameters of the original and a generic nebivolol in healthy volunteers in the fasting state. Material and methods. 18 healthy volunteers were included into the randomized open study on cross-balanced design. They received single dose (5 mg) of two compared preparations of nebivolol under fasting condition. The concentration of unchanged nebivolol in blood plasma was determined by gas chromatography-tandem mass spectrometry. Calculation of pharmacokinetic parameters and assessment of the hemodynamic were performed. Results. The concentrations of nebivolol after the original and generic drugs intake did not differ significantly in any time point (AUC 0-∞ 41.09±46.82 vs 47.16±66.58 ng•hr/mL and T 1/2 30.84±10.78 vs 29.59±12.08 hours, respectively). Blood pressure reduction was slightly more pronounced when taking generic nebivolol, while the reduction in heart rate at 2 and 4 hours -after original nebivolol intake. Conclusion. A comparative pharmacokinetic study of the genetic nebivolol showed its bioequivalence to the original drug. The effect on hemodynamic parameters with single dose (5 mg) of generic and original nebivolol in healthy volunteers was comparable.
The purpose of this article is to discuss the issues related to the treatment of patients with paroxysmal and persistent atrial fibrillation (AF). The article discusses the indications for patients with radiofrequency catheter (RFC) ablation of the mouths of the pulmonary veins and based on the results of randomized clinical trials analyzed the clinical effects of this procedure, depending on the type of AF. The article discusses the initiation of antiarrhythmic therapy and the duration of its application after RFC.
Currently pulmonary veins isolation becomes one of the approaches for invasive treatment of paroxysmal atrial fibrillation (AF). One of difficult and unexplored problems associated with this procedure is management of patients in postoperative period (especially early) which is often complicated by frequent early recurrence of atrial tachyarrhythmias. The purpose of this study was to assess effectiveness and safety of IC antiarrhythmic drug propafenone for prevention of arrhythmia recurrence in the early postoperative period compared with placebo. Taking into account the inclusion and exclusion criteria 120 patients with paroxysmal AF were included and randomized and underwent radiofrequency ablation of pulmonary veins; 112 patients successfully finished the study. More than 57% of patients had early postoperative atrial tachyarrhythmias (AT) most of which were new and regular. Reduction of incidence of post-ablation AT during blanking period in propafenone group was clinically significant what was confirmed by patient’s diary and ECG-monitoring. Propafenone treatment within this period reduce the need for hospitalization or cardioversion without putting patient at risk of serious side effects associated with its prolonged use.
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