University of Copenhagen, Gentofte Hospital, Department of Cardiology, Niels Andersensvej 65, 2900, Hellerup, Denmark.
Expert Opin Drug Saf. 2010 Jan;9(1):189-99. doi: 10.1517/14740330903514105.
Dronedarone is developed for treatment of atrial fibrillation (AF) or flutter (AFL). It is a noniodinized amiodarone analogue and believed to be without the adverse effects of amiodarone. However, long-term adverse effects are not yet well investigated.
This is a review of seven studies on dronedarone.
DAFNE established an effective dose to be 400 mg b.i.d. ADONIS and EURIDIS showed significant prevention of AF/AFL recurrence hazard ratio (HR 0.78 and 0.73) compared to placebo. In ATHENA, cardiovascular death/hospitalization was significantly reduced (HR 0.76) in patients with AF and additional risk factors. ANDROMEDA was stopped because dronedarone increased early mortality (HR 2.13) in advanced heart failure (HF). ERATO found that dronedarone significantly reduced heart rate compared to placebo in patients with AF. DIONYSOS showed that amiodarone was superior to dronedarone to maintain sinus rhythm in patients with AF/AFL.
Dronedarone is superior to placebo but less efficient than amiodarone in maintaining sinus rhythm in patients with a history of AF. In patients with AF and risk factors dronedarone reduces cardiovascular mortality and morbidity, but in patients with severe HF dronedarone significantly increases mortality.
多非利特是为治疗心房颤动（AF）或房扑（AFL）而开发的。它是非碘胺类胺碘酮类似物，据信没有胺碘酮的不良影响。然而，长期的不良影响尚未得到很好的研究。
本篇综述涵盖了七项关于多非利特的研究。
DAFNE 确定了 400mg 每日两次的有效剂量。ADONIS 和 EURIDIS 研究表明，与安慰剂相比，多非利特显著降低了 AF/AFL 复发的风险比（HR 0.78 和 0.73）。在 ATHENA 研究中，患有 AF 并有其他危险因素的患者的心血管死亡/住院风险显著降低（HR 0.76）。ANDROMEDA 研究因多非利特在晚期心力衰竭（HF）患者中增加早期死亡率（HR 2.13）而提前终止。ERATO 研究发现，与安慰剂相比，多非利特可显著降低 AF 患者的心率。DIONYSOS 研究表明，胺碘酮在维持 AF/AFL 患者窦性节律方面优于多非利特。
多非利特在维持 AF 病史患者的窦性节律方面优于安慰剂，但效率不如胺碘酮。在有 AF 危险因素的患者中，多非利特可降低心血管死亡率和发病率，但在严重 HF 患者中，多非利特显著增加了死亡率。
