根据心力衰竭持续时间分析达格列净的患者特征、结局及效果：DELIVER试验的一项预设分析
Patient Characteristics, Outcomes, and Effects of Dapagliflozin According to the Duration of Heart Failure: A Prespecified Analysis of the DELIVER Trial.
作者信息
Kondo Toru, Jering Karola S, Borleffs C Jan Willem, de Boer Rudolf A, Claggett Brian L, Desai Akshay S, Dobreanu Dan, Inzucchi Silvio E, Hernandez Adrian F, Janssens Stefan P, Jhund Pardeep S, Kosiborod Mikhail N, Lam Carolyn S P, Langkilde Anna Maria, Martinez Felipe A, Petersson Magnus, Vinh Pham Nguyen, Vaduganathan Muthiah, Solomon Scott D, McMurray John J V
机构信息
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (T.K., P.S.J., J.J.V.M.).
Department of Cardiology, Nagoya University Graduate School of Medicine, Japan (T.K.).
出版信息
Circulation. 2023 Apr 4;147(14):1067-1078. doi: 10.1161/CIRCULATIONAHA.122.062918. Epub 2023 Mar 6.
BACKGROUND
How patient characteristics and outcomes vary according to the duration of heart failure (HF) is unknown in individuals with mildly reduced or preserved ejection fraction. We compared these, and the efficacy and safety of dapagliflozin, according to the time from diagnosis of HF in a prespecified analysis of the DELIVER trial (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure).
METHODS
HF duration was categorized as ≤6 months, >6 to 12 months, >1 to 2 years, >2 to 5 years, or >5 years. The primary outcome was the composite of worsening HF or cardiovascular death. The effect of treatment was examined by HF duration category.
RESULTS
The number of patients in each category was as follows: 1160 (≤6 months), 842 (>6 to 12 months), 995 (>1 to 2 years), 1569 (>2 to 5 years), and 1692 (>5 years). Patients with longer-duration HF were older and had more comorbidities with worse symptoms. The rate of the primary outcome (per 100 person-years) increased with HF duration: ≤6 months, 7.3 (95% CI, 6.3 to 8.4); >6 to 12 months, 7.1 (6.0 to 8.5); >1 to 2 years, 8.4 (7.2 to 9.7); >2 to 5 years, 8.9 (7.9 to 9.9); and >5 years, 10.6 (9.5 to 11.7). Similar trends were seen for other outcomes. The benefit of dapagliflozin was consistent across HF duration category: the hazard ratio for the primary outcome in the ≤6-month group was 0.67 (95% CI, 0.50 to 0.91); >6 to 12 months, 0.78 (0.55 to 1.12); >1 to 2 years, 0.81 (0.60 to 1.09); >2 to 5 years, 0.97 (0.77 to 1.22); and >5 years, 0.78 (0.64 to 0.96; =0.41). The absolute benefit was greatest in longest-duration HF; the number needed to treat for HF >5 years was 24 versus 32 for ≤6 months.
CONCLUSIONS
Patients with longer-duration HF were older, had more comorbidities and symptoms, and had higher rates of worsening HF and death. The benefits of dapagliflozin were consistent across HF duration. Even patients with long-standing HF and generally mild symptoms are not stable, and it is not too late for such patients to benefit from a sodium-glucose cotransporter 2 inhibitor.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT03619213.
背景
在射血分数轻度降低或保留的个体中，患者特征和结局如何随心力衰竭（HF）持续时间而变化尚不清楚。在DELIVER试验（达格列净评估改善射血分数保留的心力衰竭患者生活）的一项预先指定分析中，我们根据HF诊断后的时间比较了这些情况，以及达格列净的疗效和安全性。
方法
HF持续时间分为≤6个月、>6至12个月、>1至2年、>2至5年或>5年。主要结局是HF恶化或心血管死亡的复合结局。按HF持续时间类别检查治疗效果。
结果
各类别患者数量如下：1160例（≤6个月）、842例（>6至12个月）、995例（>1至2年）、1569例（>2至5年）和1692例（>5年）。HF持续时间较长的患者年龄较大，合并症更多，症状更严重。主要结局发生率（每100人年）随HF持续时间增加：≤6个月，7.3（95%CI，6.3至8.4）；>6至12个月，7.1（6.0至8.5）；>1至2年，8.4（7.2至9.7）；>2至5年，8.9（7.9至9.9）；>5年，10.6（9.5至11.7）。其他结局也观察到类似趋势。达格列净的益处贯穿HF持续时间类别始终：≤6个月组主要结局的风险比为0.67（95%CI，0.50至0.91）；>6至12个月，0.78（0.55至1.12）；>1至2年，0.81（0.60至1.09）；>2至5年，0.97（0.77至1.22）；>5年，0.78（0.64至0.96；P=0.41）。绝对益处在HF持续时间最长的患者中最大；HF>5年的治疗所需人数为24，而≤6个月的为32。
结论
HF持续时间较长的患者年龄较大，合并症和症状更多，HF恶化和死亡发生率更高。达格列净的益处在HF持续时间方面是一致的。即使是患有长期HF且症状通常较轻的患者也不稳定，此类患者从钠-葡萄糖协同转运蛋白2抑制剂中获益也为时不晚。
注册
网址：https://www.
临床试验
gov；唯一标识符：NCT03619213。
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