British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Eur J Heart Fail. 2023 Nov;25(11):2078-2090. doi: 10.1002/ejhf.3000. Epub 2023 Sep 1.
Chronic obstructive pulmonary disease (COPD) is common in heart failure with a mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and is associated with worse outcomes. In a pre-specified analysis of DELIVER, we investigated the relationship between COPD status and outcomes, and the efficacy and safety of dapagliflozin, compared with placebo, according to COPD status.
Patients with severe pulmonary disease (including COPD) were excluded from the trial. The primary outcome was a composite of cardiovascular death or worsening heart failure. Of the 6261 patients with data on baseline COPD status, 694 (11.1%) had a known history of this condition. The risk of the primary endpoint was higher in patients with mild-to-moderate COPD compared with those without COPD (adjusted hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.08-1.51). The benefit of dapagliflozin on the primary outcome was consistent irrespective of COPD status (no COPD: HR 0.82 [95% CI 0.72-0.93]; COPD: HR 0.82 [95% CI 0.62-1.10]; p = 0.98). Consistent effects were observed for heart failure, cardiovascular, and all-cause hospitalization, and deaths, and composites of these. Dapagliflozin, as compared with placebo, improved the Kansas City Cardiomyopathy Questionnaire scores from baseline to 8 months to a similar extent in patients with and without mild-to-moderate COPD (p ≥ 0.63). Adverse events and treatment discontinuation were not more frequent with dapagliflozin than with placebo irrespective of COPD status.
Mild-to-moderate COPD is common in patients with HFmrEF/HFpEF and is associated with worse outcomes. The beneficial effects of dapagliflozin compared with placebo on clinical events and symptoms were consistent, regardless of COPD status.
ClinicalTrials.gov NCT03619213.
慢性阻塞性肺疾病（COPD）在射血分数轻度降低或保留的心力衰竭（HFmrEF/HFpEF）中较为常见，并且与更差的结局相关。在 DELIVER 的一项预先指定的分析中，我们根据 COPD 状况，研究了 COPD 状况与结局之间的关系，以及达格列净与安慰剂相比的疗效和安全性。
该试验排除了严重肺部疾病（包括 COPD）患者。主要结局是心血管死亡或心力衰竭恶化的复合终点。在有基线 COPD 状况数据的 6261 名患者中，有 694 名（11.1%）有这种疾病的已知病史。与无 COPD 的患者相比，轻度至中度 COPD 患者的主要终点风险更高（调整后的危害比 [HR] 1.28，95%置信区间 [CI] 1.08-1.51）。达格列净对主要结局的益处与 COPD 状况无关（无 COPD：HR 0.82 [95%CI 0.72-0.93]；COPD：HR 0.82 [95%CI 0.62-1.10]；p=0.98）。在心力衰竭、心血管和全因住院以及死亡以及这些的复合终点方面，也观察到了一致的效果。与安慰剂相比，达格列净在有和没有轻度至中度 COPD 的患者中，从基线到 8 个月，同样程度地改善了堪萨斯城心肌病问卷评分（p≥0.63）。无论 COPD 状况如何，与安慰剂相比，达格列净的不良事件和停药发生率都没有更高。
HFmrEF/HFpEF 患者中轻度至中度 COPD 较为常见，并且与更差的结局相关。与安慰剂相比，达格列净的有益效果在临床事件和症状方面是一致的，而与 COPD 状况无关。
ClinicalTrials.gov NCT03619213。
