Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.
Rollins School of Public Health and the Emory Vaccine Center, Emory University School of Medicine, Atlanta, GA, USA.
Adv Ther. 2022 Oct;39(10):4723-4741. doi: 10.1007/s12325-022-02267-2. Epub 2022 Aug 12.
To compare the mortality of hospitalized patients with COVID-19 between those that required supplemental oxygen and received dexamethasone with a comparable set of patients who did not receive dexamethasone.
We utilized the Premier Health Database to identify hospitalized adult patients with COVID-19 from July 1, 2020-January 31, 2021. Index date was when patients first initiated oxygen therapy. The primary endpoint was in-hospital mortality for patients receiving dexamethasone versus those not receiving dexamethasone 1-day pre- to 1-day post-index period. Secondary endpoints included 28-day mortality, time to in-hospital mortality, progression to invasive mechanical ventilation or death, time to discharge, and proportion discharged alive by day 28. Twenty-three models using weighting, matching, stratification, and regression were deployed through the concept of frequentist model average (FMA) to estimate the effect of dexamethasone on all-cause mortality up to the 28-day hospitalization period.
A total of 1,208,881 patients with COVID-19 were screened; as an inpatient 255,216 used oxygen, and 251,536 were included in the analysis. In the dexamethasone group, odds of in-hospital mortality were higher than those of the comparator (FMA: odds ratio [OR] 1.15, 95% CI 1.08, 1.22). Using a best fit model, OR for in-hospital mortality was non-significant for the dexamethasone group compared with the comparator (OR 1.02, 95% CI 0.92, 1.14). Dexamethasone treatment was associated with poorer outcomes versus the comparator group across the majority of secondary endpoints, except for number of days in hospital, which was lower in the dexamethasone group versus the comparator group (mean difference - 2.14, 95% CI - 2.43, - 1.47).
Hospitalized adult patients with COVID-19 who required supplemental oxygen and received dexamethasone did not have a survival benefit versus similar patients not receiving dexamethasone. The dexamethasone group was not associated with favorable responses for outcomes such as progression to death or mechanical ventilation and time to in-hospital death.
比较 COVID-19 住院患者中需要补充氧气并接受地塞米松治疗与未接受地塞米松治疗的可比患者的死亡率。
我们利用 Premier Health 数据库从 2020 年 7 月 1 日至 2021 年 1 月 31 日期间确定 COVID-19 的住院成年患者。索引日期是患者首次开始吸氧的日期。主要终点是接受地塞米松治疗的患者与未接受地塞米松治疗的患者在索引前 1 天至后 1 天的住院死亡率。次要终点包括 28 天死亡率、住院死亡率时间、进展为有创机械通气或死亡、出院时间以及第 28 天前出院存活的比例。通过频繁主义模型平均（FMA）的概念部署了 23 个使用加权、匹配、分层和回归的模型，以估计地塞米松对 28 天住院期间全因死亡率的影响。
共筛选出 1208811 例 COVID-19 患者；255216 例住院患者使用氧气，251536 例患者纳入分析。在地塞米松组，住院死亡率的几率高于对照组（FMA：比值比[OR]1.15，95%CI1.08，1.22）。使用最佳拟合模型，与对照组相比，地塞米松组的住院死亡率的 OR 无统计学意义（OR1.02，95%CI0.92，1.14）。与对照组相比，地塞米松组在大多数次要终点上的预后较差，除住院天数外，地塞米松组的住院天数低于对照组（平均差异-2.14，95%CI-2.43，-1.47）。
需要补充氧气并接受地塞米松治疗的 COVID-19 住院成年患者与未接受地塞米松治疗的相似患者相比，生存获益无差异。地塞米松组与死亡或机械通气进展和住院死亡率时间等结局的有利反应无关。
