Aunes-Jansson Maria, Edvardsson Nils, Stridh Martin, Sörnmo Leif, Frison Lars, Berggren Anders
AstraZeneca R&D, Mölndal, Sweden.
J Electrocardiol. 2013 Jan-Feb;46(1):29-35. doi: 10.1016/j.jelectrocard.2012.09.002. Epub 2012 Dec 6.
The atrial fibrillatory rate (AFR), on AZD7009 as compared to placebo, was investigated as a potential biomarker for electrophysiological effect in early antiarrhythmic drug development.
Patients with permanent AF received infusions of AZD7009 and placebo in an exploratory two-way, single-blind, randomized cross-over study. The ECG was continuously recorded, and following QRST cancellation the AFR, its standard deviation (SD), the exponential decay and the atrial electrogram amplitude were determined as 3-min averages.
The mean AFR rapidly decreased by 43% from baseline (394 ± 38 to 225 ± 61 fibrillations/min, p=0.0003) on AZD7009, but not on placebo. The SD of the AFR and the exponential decay decreased in parallel. In 2 of 8 patients, termination of AF occurred after the AFR had decreased by 58% and 53%, respectively.
The AFR may potentially serve as a biomarker of electrophysiological effects in early evaluation of rhythm control agents.
在早期抗心律失常药物研发中，研究了与安慰剂相比，AZD7009的心房颤动率（AFR）作为电生理效应潜在生物标志物的情况。
在一项探索性双向、单盲、随机交叉研究中，永久性房颤患者接受了AZD7009和安慰剂的输注。持续记录心电图，在消除QRST后，将AFR、其标准差（SD）、指数衰减和心房电图振幅确定为3分钟平均值。
在AZD7009治疗时，平均AFR较基线水平迅速下降43%（从394±38次/分钟降至225±61次/分钟，p = 0.0003），而在安慰剂治疗时未下降。AFR的SD和指数衰减平行下降。8名患者中有2名在AFR分别下降58%和53%后房颤终止。
在节律控制药物的早期评估中，AFR可能作为电生理效应的生物标志物。
