Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.
J Am Coll Cardiol. 2018 Mar 27;71(12):1379-1390. doi: 10.1016/j.jacc.2018.01.047. Epub 2018 Mar 10.
Despite multiple examples of glucose-lowering therapies affecting heart failure (HF) risk, ascertainment of HF data in cardiovascular outcome trials of these medications has not been systematically characterized. In this review, large (n >1,000) published phase III and IV cardiovascular outcome trials evaluating glucose-lowering therapies through June 2017 were identified. Data were abstracted from publications, U.S. Food and Drug Administration advisory committee records, and U.S. Food and Drug Administration labeling documents. Overall, 21 trials including 152,737 patients were evaluated. Rates and definitions of baseline HF and incident HF were inconsistently provided. Baseline ejection fraction data were provided in 3 studies but not specific to patients with HF. No trial reported functional class, ejection fraction, or HF therapy at the time of incident HF diagnosis. HF hospitalization data were available in 15 trials, but only 2 included HF-related events within the primary composite endpoint. This systematic review highlights gaps in HF data capture within cardiovascular outcome trials of glucose-lowering therapies and outlines rationale and strategies for improving HF characterization.
尽管有多种降低血糖的治疗方法会影响心力衰竭 (HF) 的风险，但这些药物的心血管结局试验中 HF 数据的确定尚未得到系统描述。在这篇综述中，我们确定了截至 2017 年 6 月评估降血糖治疗的大型（n＞1000）已发表的 III 期和 IV 期心血管结局试验。数据从出版物、美国食品和药物管理局咨询委员会记录和美国食品和药物管理局标签文件中提取。总体而言，评估了 21 项试验，共包括 152737 名患者。HF 的基线发生率和新发 HF 的定义不一致。仅 3 项研究提供了基线射血分数数据，但并非专门针对 HF 患者。没有试验报告 HF 诊断时的功能分级、射血分数或 HF 治疗。在 15 项试验中有 HF 住院数据，但只有 2 项试验将 HF 相关事件纳入主要复合终点。这项系统综述强调了降血糖治疗的心血管结局试验中 HF 数据采集的差距，并概述了改善 HF 特征的基本原理和策略。
