Circulation. 1997 Oct 21;96(8):2625-32. doi: 10.1161/01.cir.96.8.2625.
Atrial fibrillation and paroxysmal supraventricular tachycardia are common disorders of the heart rhythm for which antiarrhythmic drug therapy is commonly prescribed. The Atrial Fibrillation Investigation with Bidisomide (AFIB) study was a randomized, placebo-controlled clinical trial designed to accomplish three goals in a single protocol: (1) to determine the efficacy of the antiarrhythmic drug bidisomide in the treatment of these two arrhythmias; (2) to establish the appropriate dose range for bidisomide; and (3) to detect an adverse mortality effect of bidisomide if one were present in patients with atrial fibrillation.
In this clinical trial, 1227 patients with atrial fibrillation and 187 with paroxysmal supraventricular tachycardia were randomly assigned to bidisomide (200, 400, or 600 mg BID) or placebo; patient groups with each arrhythmia were analyzed separately. Symptomatic recurrences of atrial fibrillation and paroxysmal supraventricular tachycardia were documented with the use of transtelephonic ECG monitoring. The time to the first symptomatic arrhythmia recurrence was measured in each patient and compared among treatment groups. Among the atrial fibrillation patients, there was no significant difference in the time to first symptomatic recurrence between the placebo group and any of the three bidisomide treatment groups; the hazard ratios (placebo:treatment) were 1.19, 1.03, and 1.14 for bidisomide 200, 400, and 600 mg BID, respectively. Among paroxysmal supraventricular tachycardia patients, there was a similar lack of a significant treatment effect; the hazard ratios were 1.30, 1.93, and 1.59 for bidisomide 200, 400, and 600 mg BID, respectively. In the primary safety analysis of mortality, 3 of 493 patients taking placebo died, compared with 9 of 488 patients taking one of the two higher doses of bidisomide (P>.10).
Bidisomide in the doses tested did not have a clinically important antiarrhythmic effect. The AFIB study provided a novel clinical trial design to test antiarrhythmic drugs for both safety and efficacy.
心房颤动和阵发性室上性心动过速是常见的心律失常疾病，通常会开具抗心律失常药物进行治疗。比地索胺心房颤动研究（AFIB）是一项随机、安慰剂对照的临床试验，旨在通过单一方案实现三个目标：（1）确定抗心律失常药物比地索胺治疗这两种心律失常的疗效；（2）确定比地索胺的合适剂量范围；（3）如果心房颤动患者存在比地索胺的不良死亡率影响则进行检测。
在这项临床试验中，1227例心房颤动患者和187例阵发性室上性心动过速患者被随机分配接受比地索胺（200、400或600毫克，每日两次）或安慰剂治疗；每种心律失常的患者组分别进行分析。通过电话心电图监测记录心房颤动和阵发性室上性心动过速的症状性复发情况。测量每位患者首次出现症状性心律失常复发的时间，并在各治疗组之间进行比较。在心房颤动患者中，安慰剂组与三个比地索胺治疗组中任何一组相比，首次出现症状性复发的时间均无显著差异；比地索胺200、400和600毫克每日两次的风险比（安慰剂：治疗组）分别为1.19、1.03和1.14。在阵发性室上性心动过速患者中，同样缺乏显著的治疗效果；比地索胺200、400和600毫克每日两次的风险比分别为1.30、1.93和1.59。在死亡率的主要安全性分析中，493例服用安慰剂的患者中有3例死亡，而488例服用两种较高剂量比地索胺之一的患者中有9例死亡（P>.10）。
所测试剂量的比地索胺没有临床上重要的抗心律失常作用。AFIB研究提供了一种新颖的临床试验设计，用于测试抗心律失常药物的安全性和疗效。
