Pratt Craig M, Reiffel James A, Ellenbogen Kenneth A, Naccarelli Gerald V, Kowey Peter R
Methodist DeBakey Heart & Vascular Center, 6565 Fannin Street, F1001, Houston, TX 77030, USA.
Am Heart J. 2009 Aug;158(2):163-169.e1-3. doi: 10.1016/j.ahj.2009.05.024.
Atrial fibrillation (AF) continues to be one of the most common cardiac problems, placing an expanding burden on the public health system. In several circumstances, AF can increase the risk of stroke and heart failure. Current pharmacologic treatment options are associated with the potential for significant adverse events, which often outweigh the benefits of achieving sinus rhythm. There is evidence to suggest antiarrhythmic benefits of omega-3 polyunsaturated fatty acids; however, the data are not conclusive. This study is designed to further assess the effect of prescription omega-3 ethyl esters (P-OM3) in the prevention of recurrent AF in patients with AF without (significant) structural heart disease.
This trial is a 6-month randomized, double-blind, placebo-controlled, parallel-study design. Patients with confirmed symptomatic paroxysmal or persistent AF (5:1 ratio) will be randomized to receive either 4 g/d P-OM3 (Lovaza; GlaxoSmithKline, Research Triangle Park, NC) or placebo. The primary end point is the first recurrence of symptomatic AF among patients with paroxysmal AF. Secondary end points include the first recurrence of symptomatic AF among all patients. Safety will be assessed regularly.
This is the first randomized blinded trial to assess the antiarrhythmic effects of 4 g/d P-OM3 in paroxysmal AF.
心房颤动（AF）仍然是最常见的心脏问题之一，给公共卫生系统带来日益沉重的负担。在多种情况下，AF会增加中风和心力衰竭的风险。目前的药物治疗选择存在发生重大不良事件的可能性，这些不良事件往往超过实现窦性心律的益处。有证据表明ω-3多不饱和脂肪酸具有抗心律失常作用；然而，数据并不确凿。本研究旨在进一步评估处方用ω-3乙酯（P-OM3）对无（明显）结构性心脏病的AF患者预防AF复发的效果。
本试验采用为期6个月的随机、双盲、安慰剂对照、平行研究设计。确诊为有症状的阵发性或持续性AF的患者（比例为5:1）将被随机分组，分别接受4g/d P-OM3（Lovaza；葛兰素史克公司，北卡罗来纳州三角研究园）或安慰剂治疗。主要终点是阵发性AF患者中首次出现有症状的AF复发。次要终点包括所有患者中首次出现有症状的AF复发。将定期评估安全性。
这是第一项评估4g/d P-OM3对阵发性AF抗心律失常作用的随机双盲试验。
