Effect of intravenous pulses of methylprednisolone 250 mg versus dexamethasone 6 mg in hospitalised adults with severe COVID ‐19 pneumonia: An open‐label randomised trial

Producción CientíficaBackground: 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

Combining heart rate and systolic blood pressure to improve risk stratification in older patients with heart failure: Findings from the RICA Registry

Objectives: Heart rate (HR) and systolic blood pressure (SBP) are independent prognostic variables in patients with heart failure (HF). We evaluated if combining HR and SBP could improve prognostic assessment in older patients. Methods: Variables associated with all-cause mortality and readmission for HF during 9 months of follow-up were analyzed from the Spanish Heart Failure Registry (RICA). HR and SBP values were stratified in three combined groups. Results: We evaluated 1551 patients, 82 years and 56% women. Using HR strata of < 70 and ≥ 70 bpm we found mortality rates of 9.8 and 13.6%, respectively (hazard ratio 1.0 and 1.35). For SBP ≥ 140, 120–140 and < 120 mm Hg, mortality rates were 8.2, 10.4 and 20.3%. respectively (hazard ratio 1.0, 1.34 and 2.76). Using combined strata of HR < 70 bpm and SBP ≥ 140 mm Hg (n = 176; low-risk), HR < 70 and SBP < 140 + HR ≥ 70 and SBP < 120 (n = 1089; moderate-risk) and HR ≥ 70 and SBP < 120 (n = 286; high-risk) we found mortality rates of 4.5%, 11.0% and 24.0%, respectively. Multivariate Cox regression for all-cause mortality shows for low-, middle- and high-risk groups was 1 (reference), 1.93 (95% CI: 0.93–3.99, p = 0.077) and 4.32 (95% CI: 2.04–9.14, p < 0.001). BMI, NYHA, MDRD, hypertension and sodium were also independent prognostic factors. Conclusions: The combination provides better risk discrimination than use of HR and SBP alone and may provide a simple and reliable tool for risk assessment for older HF patients in clinical practice

Standardized incidence ratios and risk factors for cancer in patients with systemic sclerosis: Data from the Spanish Scleroderma Registry (RESCLE)

Aim: Patients with systemic sclerosis (SSc) are at increased risk of cancer, a growing cause of non-SSc-related death among these patients. We analyzed the increased cancer risk among Spanish patients with SSc using standardized incidence ratios (SIRs) and identified independent cancer risk factors in this population. Material and methods: Spanish Scleroderma Registry data were analyzed to determine the demographic characteristics of patients with SSc, and logistic regression was used to identify cancer risk factors. SIRs with 95% confidence intervals (CIs) relative to the general Spanish population were calculated. Results: Of 1930 patients with SSc, 206 had cancer, most commonly breast, lung, hematological, and colorectal cancers. Patients with SSc had increased risks of overall cancer (SIR 1.48, 95% CI 1.36-1.60; P < 0.001), and of lung (SIR 2.22, 95% CI 1.77-2.73; P < 0.001), breast (SIR 1.31, 95% CI 1.10-1.54; P = 0.003), and hematological (SIR 2.03, 95% CI 1.52-2.62; P < 0.001) cancers. Cancer was associated with older age at SSc onset (odds ratio [OR] 1.22, 95% CI 1.01-1.03; P < 0.001), the presence of primary biliary cholangitis (OR 2.35, 95% CI 1.18-4.68; P = 0.015) and forced vital capacity <70% (OR 1.8, 95% CI 1.24-2.70; P = 0.002). The presence of anticentromere antibodies lowered the risk of cancer (OR 0.66, 95% CI 0.45-0.97; P = 0.036). Conclusions: Spanish patients with SSc had an increased cancer risk compared with the general population. Some characteristics, including specific autoantibodies, may be related to this increased risk

Combining heart rate and systolic blood pressure to improve risk stratification in older patients with heart failure: Findings from the RICA Registry

Objectives: Heart rate (HR) and systolic blood pressure (SBP) are independent prognostic variables in patients with heart failure (HF). We evaluated if combining HR and SBP could improve prognostic assessment in older patients. Methods: Variables associated with all-cause mortality and readmission for HF during 9 months of follow-up were analyzed from the Spanish Heart Failure Registry (RICA). HR and SBP values were stratified in three combined groups. Results: We evaluated 1551 patients, 82 years and 56% women. Using HR strata of <70 and ≥70 bpm we found mortality rates of 9.8 and 13.6%, respectively (hazard ratio 1.0 and 1.35). For SBP ≥ 140, 120-140 and <120 mm Hg, mortality rates were 8.2, 10.4 and 20.3%. respectively (hazard ratio 1.0, 1.34 and 2.76). Using combined strata of HR < 70 bpm and SBP ≥ 140 mm Hg (n = 176; low-risk), HR < 70 and SBP < 140 + HR ≥ 70 and SBP < 120 (n = 1089; moderate-risk) and HR ≥ 70 and SBP < 120 (n = 286; high-risk) we found mortality rates of 4.5%, 11.0% and 24.0%, respectively. Multivariate Cox regression for all-cause mortality shows for low-, middle- and high-risk groups was 1 (reference), 1.93 (95% CI: 0.93-3.99, p = 0.077) and 4.32 (95% CI: 2.04-9.14, p < 0.001). BMI, NYHA, MDRD, hypertension and sodium were also independent prognostic factors. Conclusions: The combination provides better risk discrimination than use of HR and SBP alone and may provide a simple and reliable tool for risk assessment for older HF patients in clinical practice