AI Article Synopsis
- The COVID-STEROID 2 trial examined the effects of different doses of dexamethasone on adults with severe COVID-19 hypoxemia, revealing potential differences in treatment outcomes between patients from Europe and India.
- An analysis of secondary outcomes highlighted variations in mortality rates and days free from life support, suggesting poorer outcomes for Indian patients versus their European counterparts.
- Despite these findings, the evidence of treatment effect differences is considered weak, indicating that the observed variations could be coincidental rather than meaningful.
Article Abstract
Background: In the COVID-STEROID 2 trial there was suggestion of heterogeneity of treatment effects (HTE) between patients enrolled from Europe vs. India on the primary outcome. Whether there was HTE for the remaining patient-centred outcomes is unclear.
Methods: In this analysis of the COVID-STEROID 2 trial, which compared 12 mg vs. 6 mg dexamethasone in adults with COVID-19 and severe hypoxemia, we evaluated HTE by geographical region (Europe vs. India) for secondary outcomes with analyses adjusted for stratification variables. Results are presented as risk differences (RDs) or mean differences (MDs) with 99% confidence intervals (CIs) and P-values from interaction tests.
Findings: There were differences in mortality at day 28 (RD for Europe -8.3% (99% CI: -17.7 to 1.0) vs. India 0.1% (99% CI: -10.0 to 10.0)), mortality at day 90 (RD for Europe -7.4% (99% CI: -17.1 to 2.0) vs. India -1.4% (99% CI: -12.8 to 9.8)), mortality at day 180 (RD for Europe -6.7% (99% CI: -16.4 to 2.9) vs. India -1.0% (99% CI: -12.3 to 10.3)), and number of days alive without life support at day 90 (MD for Europe 6.1 days (99% CI: -1.3 to 13.4) vs. India 1.7 days (99% CI: -8.4 to 11.8)). For serious adverse reactions, the direction was reversed (RD for Europe -1.0% (99% CI: -7.1 to 5.2) vs. India -5.3% (99% CI: -16.2 to 5.0).
Interpretation: Our analysis suggests higher dose dexamethasone may have less beneficial effects for patients in India as compared with those in Europe; however, the evidence is weak, and this could represent a chance finding.
Funding: None for this analysis. The COVID STEROID 2 trial was funded by The Novo Nordisk Foundation and supported by Rigshospitalet's Research Council.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10794101 | PMC |
| http://dx.doi.org/10.1016/j.lansea.2023.100293 | DOI Listing |
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