Background: The efficacy and safety of high versus medium doses of glucocorticoids for the treatment of patients with COVID‐19 has shown mixed outcomes in controlled trials and observational studies. We aimed to evaluate the effectiveness of methylprednisolone 250 mg bolus versus dexamethasone 6 mg in patients with severe COVID‐19.Methods: A randomised, open‐label, controlled trial was conducted between February and August 2021 at four hospitals in Spain. The trial was suspended after the first interim analysis since the investigators considered that continuing the trial would be futile. Patients were randomly assigned in a 1:1 ratio to receive dexamethasone 6 mg once daily for up to 10 days or methylprednisolone 250 mg once daily for 3 days.Results: Of the 128 randomised patients, 125 were analysed (mean age 60 ± 17 years; 82 males [66%]). Mortality at 28 days was 4.8% in the 250 mg methylprednisolone group versus 4.8% in the 6 mg dexamethasone group (absolute risk difference, 0.1% [95% CI, −8.8 to 9.1%]; p = 0.98). None of the secondary outcomes (admission to the intensive care unit, non‐invasive respiratory or high‐flow oxygen support, additional immunosuppressive drugs, or length of stay), or prespecified sensitivity analyses were statistically significant. Hyperglycaemia was more frequent in the methylprednisolone group at 27.0 versus 8.1% (absolute risk difference, −18.9% [95% CI, −31.8 to ‐ 5.6%]; p = 0.007).Conclusions: Among severe but not critical patients with COVID‐19, 250 mg/d for 3 days of methylprednisolone compared with 6 mg/d for 10 days of dexamethasone did not result in a decrease in mortality or intubation.

Objectives: To determine the prevalence and incidence of scleroderma renal crisis (SRC) in patients with SSc over two time periods and to identify factors influencing potential epidemiological changes. Methods: A total of 1939 SSc patients were categorized based on their diagnostic date. The ‘historical cohort’ (HC) included patients diagnosed before 31 December 2002, while the ‘contemporary cohort’ (CC) included those diagnosed afterwards. Epidemiological differences in SRC between both cohorts were investigated in the overall SSc series, and according to cutaneous subsets and antibody profile. If differences were present, the factors involved were assessed. Results: Forty-four patients developed SRC (prevalence rate: 2.3%), first-year incidence: 2.09 events per 100 person-years. Patients with diffuse cutaneous subset (dcSSc) (8.1%), anti-RNA polymerase III positive antibodies (12.0%) or anti-topo I positive antibodies (4.3%) had a higher prevalence of SRC than those with limited cutaneous subset (lcSSc) (0.9%) or anti-centromere-positive antibodies (0.7%). SRC prevalence decreased over time (HC vs CC) in the overall SSc series (3.7% vs 1.3%; P = 0.001), definite-SSc cohort (3.9% vs 1.4%; P = 0.002) and lcSSc (1.8% vs 0.3%; P = 0.013), but not in dcSSc or by antibody profile. Factors independently associated with the CC included older age at SSc diagnosis, increased prevalence of early SSc and very early SSc subsets, tobacco exposure and higher medication use of calcium channel blockers, renin–angiotensin–aldosterone system inhibitors, specific vasodilators and immunosuppressants. Conclusions: This study provides compelling evidence of a significant decline in SRC prevalence and cumulative incidence over time in SSc patients, particularly in definite-SSc patients and lcSSc patients. Factors associated with the CC are described.

Aim: To analyse the importance of inflammation in the disease burden and prognosis of patients with type 2 diabetes (T2DM) and atrial fibrillation (AF). We assessed these patients according to their neutrophil-to-lymphocyte ratio (NLR) values, examining their baseline characteristics and their prognosis at one year of follow-up based on a prospective AF registry in Spain (Sumamos-FA-SEMI). Methods: A prospective, multicentre, observational study of patients with AF (Sumamos-FA-SEMI) was conducted. We categorised the patients into four groups according to the presence of T2DM and NLR levels with a reference cut-off point of three. We compared the characteristics of the four groups and evaluated the prognosis using the mean values of all-cause mortality and all-cause mortality plus readmissions during a year of follow-up. Results: We analysed 1071 patients, 482 of whom had T2DM. This group had significantly higher rates of obesity and comorbidities. Groups with an NLR greater than three points had a higher prevalence of cancer, lower HDL cholesterol levels, and more albuminuria. Other inflammatory markers, such as C-reactive protein, were also higher in these groups. Regarding prognosis, groups (both with and without T2DM) with an NLR greater than three had significantly higher mortality, with a higher probability in those without T2DM (HR 3.58, 95% CI: 1.99–6.43, p < 0.00). In terms of mortality and readmissions, only the group without T2DM and with an NLR greater than three had significantly higher mortality (HR 2.19, 95% CI: 1.51–3.19, p < 0.00). Conclusions: Among atrial fibrillation patients, the combination of T2DM and high inflammation (NLR) was linked to higher comorbidity, worse metabolic and kidney disease, and the poorest prognosis. Surprisingly, the highest risk of readmission or death was in non-T2DM patients with higher NLR levels, suggesting that T2DM treatments may mitigate risk.