Conventional time-to-first-event analyses cannot incorporate recurrent hospitalizations and patient well-being in a single outcome. To overcome this limitation, we tested an integrated measure that includes days lost from death and hospitalization, and additional days of full health lost through diminished well-being. The effect of dapagliflozin on this integrated measure was assessed in the DAPA-HF trial, which examined the efficacy of dapagliflozin, compared with placebo, in patients with NYHA class II-IV HF and a LVEF ≤40%. Over 360 days, patients in the dapagliflozin group (n=2,127) lost 10.6±1.0 [mean±SE] (2.9%) of potential follow-up days through cardiovascular death and HF hospitalization, compared with 14.4±1.0 days (4.0%) in the placebo group (n=2,108), and this component of all measures of days lost accounted for the greatest between-treatment difference [-3.8 (95%CI -6.6 to -1.0) days]. Patients receiving dapagliflozin also had fewer days lost to death and hospitalization from all causes, versus placebo [15.5±1.1 days (4.3%) vs. 20.3±1.1 days (5.6%)]. When additional days of full health lost (i.e., adjusted for KCCQ-OSS) were added, total days lost were 110.6±1.6 (30.7%) with dapagliflozin vs.116.9±1.6 days (32.5%) with placebo]. The difference in all measures between the two groups increased over time; i.e., days lost by death and hospitalization -0.9 days (-0.7%) at 120 days, -2.3 days (-1.0%) at 240 days, and -4.8 days (-1.3%) at 360 days. Dapagliflozin reduced the total days of potential full health lost due to death, hospitalizations, and impaired well-being, and this benefit increased over time during the first year.

中文翻译：

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DAPA-HF 中的达格列净以及因死亡、住院和健康受损而丧失完全健康的天数

传统的首次事件发生时间分析无法将反复住院和患者健康状况纳入单一结果。为了克服这一限制，我们测试了一项综合措施，其中包括因死亡和住院而损失的天数，以及因幸福感下降而损失的额外完全健康天数。 DAPA-HF 试验评估了达格列净对这一综合指标的影响，该试验检查了达格列净与安慰剂相比，对 NYHA II-IV 级 HF 且 LVEF ≤ 40% 的患者的疗效。在 360 天的时间里，达格列净组 (n=2,127) 的患者因心血管死亡和心力衰竭住院而损失了 10.6±1.0 [平均值±SE] (2.9%) 的潜在随访天数，而这一天数为 14.4±1.0 天 (4.0%)在安慰剂组 (n=2,108) 中，所有损失天数测量中的这一组成部分占治疗间差异最大 [-3.8 (95% CI -6.6 至 -1.0) 天]。与安慰剂相比，接受达格列净的患者因各种原因死亡和住院的天数也更少[15.5±1.1 天 (4.3%) 对比 20.3±1.1 天 (5.6%)]。当添加额外的完全健康损失天数（即根据 KCCQ-OSS 进行调整）时，达格列净组损失的总天数为 110.6±1.6 天（30.7%），而安慰剂组损失的总天数为 116.9±1.6 天（32.5%）]。两组之间所有指标的差异随着时间的推移而增加；即，死亡和住院损失的天数在 120 天时为 -0.9 天 (-0.7%)，在 240 天时为 -2.3 天 (-1.0%)，在 360 天时为 -4.8 天 (-1.3%)。达格列净减少了因死亡、住院和健康受损而导致的潜在完全健康损失的总天数，并且这种益处在第一年随着时间的推移而增加。