Simon T, Mary-Krause M, Chatelin A, Thuault M, Jaillon P
Service de pharmacologie, AP-HP, faculté de médecine Pierre et Marie Curie, site Saint-Antoine, Université Paris 6, 27, rue Chaligny, 75012 Paris.
Arch Mal Coeur Vaiss. 2006 Feb;99(2):109-16.
Flecainide acetate instant release (LI) has been prescribed for years in the prevention of atrial fibrillation (AF) relapse after sinus rate conversion. A new controlled-release (LP) formulation of flecainide was recently introduced. The objectives of this observational study were to evaluate the benefit/risk ratio of LI or LP flecainide treatment for prevention of AF relapse.
EPIFLEC study was an open, prospective, observational study conducted by 151 cardiologists who had prescribed either flecainide LI (group 1) to 838 patients or flecainide LP (group 2) to 214 patients or flecainide LI before LP (group 3) to 242 patients. In these patients, AF was either paroxystic (35%) or persistant (65%). Concomitant pathologies were observed in 80% of these patients (mean age 68 years) with a high incidence (50%) of hypertension. The mean duration of treatment was 6.9 +/- 6.7 months in group 1 (LI), 6.2 +/- 3.1 months in group 2 (LP) and 12.7 +/- 5.4 months in group 3 (LI-LP).
mean daily dosages of flecainide were similar among the 3 groups. Antithrombotic drugs were prescribed in 74% (group 1) to 83% (group 2) of the patients and another antiarrhythmic drug was associated to flecainide among 12 to 21% of the patients. AF relapse was observed in 171 patients in group 1 (LI), 38 patients in group 2 (LP) and 39 patients in group 3 (LI-LP). The incidence of AF relapse was compared in groups 1 and 2 at 10 months of follow-up and AF relapse probability was not significantly different between flecainide LI and LP :26 +/- 2% and 23 +/- 4% respectively (OR = 0.99, CI 95%:0.69-1.4; p = 0.96). A multivariate analysis showed that previous multiples episodes of AF, electrical shock rate conversion and history of flutter and hypertension were independent predictors of AF relapse. Among 11 deaths observed during follow-up, only 2 were cardiovascular. The most frequent non lethal cardiovascular adverse events were arrhythmias or cardiac conduction disorders and were limited to less than 5% of the patients. Only 5 supraventricular transient pro arrhythmias episodes were recorded.
this pharmaco-epidemiological study in private practice confirms that flecainide is able to prevent AF relapse in 75% of patients at 10 months and that the tolerance of the treatment is acceptable in these patients.
多年来，醋酸氟卡尼速释制剂（LI）一直被用于预防窦性心律转复后房颤（AF）复发。最近引入了一种新的氟卡尼控释制剂（LP）。本观察性研究的目的是评估LI或LP氟卡尼治疗预防AF复发的获益/风险比。
EPIFLEC研究是一项开放、前瞻性观察性研究，由151名心脏病专家进行，他们为838例患者开具了氟卡尼LI（第1组），为214例患者开具了氟卡尼LP（第2组），或为242例患者先开具氟卡尼LI后开具LP（第3组）。在这些患者中，AF为阵发性（35%）或持续性（65%）。80%的这些患者（平均年龄68岁）存在合并症，高血压发病率较高（50%）。第1组（LI）的平均治疗持续时间为6.9±6.7个月，第2组（LP）为6.2±3.1个月，第3组（LI-LP）为12.7±5.4个月。
3组中氟卡尼的平均日剂量相似。74%（第1组）至83%（第2组）的患者开具了抗血栓药物，12%至21%的患者使用了与氟卡尼联用的另一种抗心律失常药物。第1组（LI）有171例患者、第2组（LP）有38例患者、第3组（LI-LP）有39例患者出现AF复发。在随访10个月时比较了第1组和第2组AF复发的发生率，氟卡尼LI和LP之间的AF复发概率无显著差异：分别为26±2%和23±4%（OR = 0.99，95%CI：0.69 - 1.4；p = 0.96）。多因素分析显示，既往多次AF发作、电击转复以及扑动和高血压病史是AF复发的独立预测因素。在随访期间观察到的11例死亡中，只有2例是心血管原因。最常见的非致命心血管不良事件是心律失常或心脏传导障碍，且仅限于不到5%的患者。仅记录到5例室上性短暂促心律失常发作。
这项在私人诊所进行的药物流行病学研究证实，氟卡尼能够在10个月时预防75%的患者AF复发，并且这些患者对该治疗的耐受性是可以接受的。
