Arya Anita, Silberbauer John, Teichman Sam L, Milner Peter, Sulke Neil, Camm A John
Eastbourne District General Hospital, King's Drive, Eastbourne BN21 2UD, UK.
Europace. 2009 Apr;11(4):458-64. doi: 10.1093/europace/eun384. Epub 2009 Jan 26.
ATI-2042 (budiodarone) is a chemical analogue of amiodarone with a half life of 7 h. It is electrophysiologically similar to amiodarone, but may not have metabolic and interaction side effects. The sophisticated electrocardiograph logs of advanced DDDRP pacemakers were used to monitor the efficacy of ATI-2042. The aim of this study was to determine the preliminary efficacy and safety of ATI-2042 in patients with paroxsymal atrial fibrillation (PAF) and pacemakers.
Six women with AF burden (AFB) between 1 and 50% underwent six sequential 2-week study periods. Patients received 200 mg bid of ATI-2042 during Period 2 (p2), 400 mg bid during p3, 600 mg bid during p4, 800 mg bid during p5, and no drug during baseline and washout (p1 and p6). Pacemaker data for the primary outcome measure AFB were downloaded during each period. Mean AFB decreased between baseline and all doses: AFB at baseline (SD) was 20.3 +/- 14.6% and mean AFB at 200 mg bid was 5.2 +/- 4.2%, at 400 mg bid 5.2 +/- 5.2%, at 600 mg bid 2.8 +/- 3.4%, and at 800 mg bid 1.5 +/- 0.5%. The mean reductions in AFB at all doses of ATI-2042 were statistically significant (P < 0.005). Atrial fibrillation burden increased in washout. Atrial fibrillation episodes tended to increase with ATI-2042, but this was offset by substantial decreases in episode duration. ATI-2042 was generally well tolerated.
ATI-2042 effectively reduced AFB over all doses studied by reducing mean episode duration. A large-scale study will be required to confirm this effect.
ATI-2042（布地碘酮）是胺碘酮的化学类似物，半衰期为7小时。其在电生理方面与胺碘酮相似，但可能没有代谢和相互作用方面的副作用。采用先进的DDDRP起搏器的精密心电图记录来监测ATI-2042的疗效。本研究的目的是确定ATI-2042在阵发性心房颤动（PAF）患者和起搏器患者中的初步疗效和安全性。
6名房颤负荷（AFB）在1%至50%之间的女性患者接受了6个连续的为期2周的研究阶段。患者在第2阶段（p2）接受每日两次200mg的ATI-2042，第3阶段（p3）每日两次400mg，第4阶段（p4）每日两次600mg，第5阶段（p5）每日两次800mg，在基线期和洗脱期（p1和p6）不服用药物。在每个阶段下载用于主要结局指标AFB的起搏器数据。基线期与所有剂量之间的平均AFB均下降：基线期（标准差）AFB为20.3±14.6%，每日两次200mg时平均AFB为5.2±4.2%，每日两次400mg时为5.2±5.2%，每日两次600mg时为2.8±3.4%，每日两次800mg时为1.5±0.5%。所有剂量的ATI-2042使AFB平均降低均具有统计学意义（P<0.005）。洗脱期房颤负荷增加。房颤发作次数倾向于随ATI-2042增加，但发作持续时间大幅缩短抵消了这一增加。ATI-一般耐受性良好。
ATI-2042通过缩短平均发作持续时间，在所有研究剂量下均有效降低了AFB。需要进行大规模研究来证实这一效果。
