OPEN LABEL TRIAL OF AZIMILIDE IN SUPRAVENTRICULAR ARRHYTHMIAS

杜克大学医学中心临床药理学和心脏病学部门的研究人员使用兰金临床研究单位研究房颤和其他常见心律失常患者。房颤是最常见的心律失常，需要抗心律失常药物治疗，占美国所有心律失常住院治疗的三分之一以上。房颤患者通常正常的心律被快速、不规则的心脏跳动所取代，这可能会导致胸部重击感、呼吸急促、胸痛、头晕或意识丧失。这些时期可能持续几分钟或几小时，或者可能无限期地持续，除非医生给予紧急治疗。Azimilide是一种重要的III类抗心律失常药物，可阻断快速和缓慢内向钾通道。它正在被开发为一种治疗方法，以减少房颤、房扑或两者兼而有之患者的症状性心律失常发生频率。在方案D88中，成功完成随机、安慰剂对照的阿齐利特临床试验的房颤患者接受开放标签的阿齐利特75 mg或100 mg每日治疗。已完成随访，本方案中未对其他患者进行随访。

Investigators in the Divisions of Clinical Pharmacology and Cardiology at Duke University Medical Center have used the Rankin Clinical Research Unit to study patients with atrial fibrillation and other common disorders of the heart rhythm. Atrial fibrillation is the most common disorder of the heart rhythm requiring treatment with antiarrhythmic drugs, and it accounts for over one-third of all U.S. hospitalizations for arrhythmias. Patients with atrial fibrillation have their usually normal heart rhythm replaced by periods of rapid, irregular heart beating that may cause a sense of pounding in the chest, shortness of breath, chest pain, dizziness, or loss of consciousness. These periods may last for minutes or hours, or they may last indefinitely unless acute treatment is given by a physician. Azimilide is an important investigational class III antiarrhythmic drug that blocks both rapid and slow inward potassium channels. It is being developed as a therapy to reduce the frequency of symptomatic arrhythmia occurrences in patients with atrial fibrillation, atrial flutter or both. In protocol D88 patients with atrial fibrillation who had successfully completed a randomized, placebo-controlled clinical trial of azimilide were treated with open-label azimilide75 mg or 100 mg daily. Follow-up has been completed, and no further patients are being followed in this protocol.