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Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial
Intensive Care Medicine ( IF 27.1 ) Pub Date : 2021-11-10 , DOI: 10.1007/s00134-021-06573-1
Anders Granholm 1, 2 , Marie Warrer Munch 1, 2 , Sheila Nainan Myatra 3 , Bharath Kumar Tirupakuzhi Vijayaraghavan 4, 5, 6 , Maria Cronhjort 7 , Rebecka Rubenson Wahlin 7 , Stephan M Jakob 8 , Luca Cioccari 8 , Maj-Brit Nørregaard Kjær 1, 2 , Gitte Kingo Vesterlund 1, 2 , Tine Sylvest Meyhoff 1, 2 , Marie Helleberg 9 , Morten Hylander Møller 1, 2 , Thomas Benfield 10 , Balasubramanian Venkatesh 11 , Naomi E Hammond 11, 12 , Sharon Micallef 11 , Abhinav Bassi 6 , Oommen John 6, 13 , Vivekanand Jha 6, 13, 14 , Klaus Tjelle Kristiansen 15 , Charlotte Suppli Ulrik 16 , Vibeke Lind Jørgensen 17 , Margit Smitt 18 , Morten H Bestle 19, 20 , Anne Sofie Andreasen 21 , Lone Musaeus Poulsen 22 , Bodil Steen Rasmussen 2, 23 , Anne Craveiro Brøchner 2, 24 , Thomas Strøm 25, 26 , Anders Møller 27 , Mohd Saif Khan 28 , Ajay Padmanaban 4 , Jigeeshu Vasishtha Divatia 3 , Sanjith Saseedharan 29 , Kapil Borawake 30 , Farhad Kapadia 31 , Subhal Dixit 32 , Rajesh Chawla 33 , Urvi Shukla 34 , Pravin Amin 35 , Michelle S Chew 36 , Christian Aage Wamberg 37 , Christian Gluud 38, 39 , Theis Lange 40 , Anders Perner 1, 2
Affiliation  

Purpose

We compared dexamethasone 12 versus 6 mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial. In the primary, conventional analyses, the predefined statistical significance thresholds were not reached. We conducted a pre-planned Bayesian analysis to facilitate probabilistic interpretation.

Methods

We analysed outcome data within 90 days in the intention-to-treat population (data available in 967 to 982 patients) using Bayesian models with various sensitivity analyses. Results are presented as median posterior probabilities with 95% credible intervals (CrIs) and probabilities of different effect sizes with 12 mg dexamethasone.

Results

The adjusted mean difference on days alive without life support at day 28 (primary outcome) was 1.3 days (95% CrI −0.3 to 2.9; 94.2% probability of benefit). Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90. Probabilities of benefit on days alive without life support and days alive out of hospital at day 90 were 85 and 95.7%, respectively. Results were largely consistent across sensitivity analyses, with relatively low probabilities of clinically important harm with 12 mg on all outcomes in all analyses.

Conclusion

We found high probabilities of benefit and low probabilities of clinically important harm with dexamethasone 12 mg versus 6 mg daily in patients with COVID-19 and severe hypoxaemia on all outcomes up to 90 days.



中文翻译:


地塞米松 12 mg 与 6 mg 用于治疗 COVID-19 和严重低氧血症的患者:对 COVID STEROID 2 试验进行预先计划的二次贝叶斯分析


 目的


我们在国际随机、盲法 COVID STEROID 2 试验中,对 2019 年冠状病毒病 (COVID-19) 和严重低氧血症患者每天服用 12 毫克地塞米松与服用 6 毫克地塞米松长达 10 天进行了比较。在主要的常规分析中,未达到预定义的统计显着性阈值。我们进行了预先计划的贝叶斯分析以促进概率解释。

 方法


我们使用贝叶斯模型和各种敏感性分析,分析了意向治疗人群 90 天内的结果数据(数据来自 967 至 982 名患者)。结果以 95% 可信区间 (CrIs) 的中后验概率和 12 mg 地塞米松不同效应大小的概率表示。

 结果


第 28 天无生命支持的存活天数(主要结果)的调整后平均差异为 1.3 天(95% CrI -0.3 至 2.9;受益概率为 94.2%)。调整后的严重不良反应相对风险和获益概率为0.85(0.63至1.16;84.1%),第28天死亡率为0.87(0.73至1.03;94.8%),第90天为0.88(0.75至1.02;95.1%)。没有生命支持的存活天数和第 90 天出院存活天数的获益概率分别为 85% 和 95.7%。敏感性分析的结果基本一致,所有分析中所有结果的 12 mg 造成临床重要危害的可能性相对较低。

 结论


我们发现,对于患有严重低氧血症的 COVID-19 患者,在长达 90 天的所有结局中,每日 12 毫克地塞米松与每日 6 毫克地塞米松相比,获益的可能性较高,而产生临床重要危害的可能性较低。

更新日期:2021-11-10
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