Department of Medicine, Division of Cardiology, Columbia University Vagelos College of Physicians & Surgeons, New York, NY.
Penn State Heart and Vascular Institute, Penn State University, Hershey.
Am J Med. 2022 Jul;135(7):822-827. doi: 10.1016/j.amjmed.2022.02.019. Epub 2022 Mar 14.
Determining if a medication is effective should be easy: Either the condition is or is not improved. However, the truth is often more complex than that, including in the antiarrhythmic drug (AAD) management of atrial fibrillation. In clinical trials, AAD efficacy is usually determined by the time to first atrial fibrillation recurrence. Another AAD efficacy endpoint, in patients with cardiac implantable electrical devices, is a reduction of atrial fibrillation burden. Other cardiovascular outcomes have included hospitalization, heart failure, and cardiovascular or total mortality. In clinical practice AADs, for atrial fibrillation, are prescribed to reduce symptoms/improve quality of life, which usually correlate with reduced atrial fibrillation frequency, duration, and beneficial hemodynamic effects in certain patient subgroups. Time to first recurrence is not a reliable predictor of clinical efficacy endpoints in practice. This article presents a review for the practitioner of AAD efficacy endpoints in clinical trials versus those in clinical practice and why such differences are present.
要么病情得到改善,要么没有改善。然而,事实往往比这更复杂,包括抗心律失常药物(AAD)在心房颤动管理中的应用。在临床试验中,AAD 的疗效通常通过首次心房颤动复发的时间来确定。另一个 AAD 疗效终点是在有心脏植入式电子设备的患者中减少心房颤动负担。其他心血管结局包括住院、心力衰竭以及心血管或全因死亡率。在临床实践中,AAD 被开用于治疗心房颤动,以减轻症状/改善生活质量,这通常与某些患者亚组中减少心房颤动频率、持续时间和有益的血液动力学效应相关。首次复发时间并不是临床疗效终点的可靠预测因素。本文为临床医生介绍了临床试验中 AAD 疗效终点与临床实践中的疗效终点,以及为什么会存在这些差异。