COVID-19 Drugs: French Study Shows That Corticosteroids Increases Survival Rates Of Elderly Severe COVID-19 Patients
: A new study by French researchers from Université Claude Bernard, Université de Paris, Sorbonne Université, Hôpital Henri-Mondor, Centre Hospitalier de Vierzon and Centre Hospitalier Métropole Savoie has demonstrated that corticosteroids increases survival rates of elderly severe COVID-19 patients.
The study was designed to assess the effectiveness of corticosteroids among elderly patients with COVID-19 pneumonia requiring oxygen. The primary outcome was overall survival at day 14. The secondary outcome was the proportion of patients discharged from hospital to home/rehabilitation on day 14. Adverse events were abstracted from electronic health records.
Among the 267 geriatric patients from 36 hospitals in France and Luxembourg included in the analysis, 96 were assigned to the treatment group. Median age was 86; interquartile range 83 to 90 and 95% had a SARS-CoV-2 PCR-confirmed diagnosis. Use of corticosteroids was significantly associated with an increased survival (weighted hazard ratio [wHR] 0.66, 95% CI 0.44 to 0.97). There was no significant difference between the treatment and control groups regarding the proportion of patients discharged to home/rehabilitation at day 14 (wRR 1.11, 95% CI 0.68 to 1.81). Twenty-two (16.7%) patients receiving corticosteroids developed adverse events while only 11 (6.4%) from the control group did.
The study concluded that corticosteroids were associated with a significant increase the day-14 overall survival of patients over 80 years old hospitalized for severe COVID-19
This is the first study to focus on corticosteroid usage for the elderly. Previous studies on the efficacy of corticosteroids did not specifically target elderly patients. Among older patients aged over 80 years old, the RECOVERY trial found no difference in the survival of patients treated or not with dexamethasone. However, the heterogeneity in the severity of infection within the latter subgroup limited the drawing of strong conclusions
The study findings were published on a preprint server and are currently being peer reviewed. https://www.medrxiv.org/content/10.1101/2020.11.10.20226886v1
The study team looked at the rates of survival among elderly patients with COVID-19 who were administered with corticosteroids.
It is known that the aged are at a greater risk of severe disease and death caused by COVID-19. The study team states that around the world, the population over 65 years makes up 9 percent. However, among deaths due to COVID-19, 80 percent are elderly. Around 30 to 40 percent of cases of COVID-19 recorded around the world are elderly, they added. This makes this population an important concern when treating and managing COVID-19. https://onlinelibrary.wiley.com/doi/full/10.1111/jgs.16472
The WHO or World Health Organization has recommended the use of systemic (given intravenously) corticosteroids for all adult patients with severe and critical COVID-19. There are, however, very few studies that specifically look at the effectiveness of the use of these steroids among the elderly with severe COVI
Reports from the recent RECOVERY trial a research project led by Oxford University aimed at exploring COVID-19-related treatments showed that there was no difference in survival of patients who were treated with dexamethasone (a corticosteroid) compared to those who were not. However, in this RECOVERY study, there was a wide range of patients with different severities of infection, and so it was difficult to draw firm conclusions, said the study team. https://www.nejm.org/doi/10.1056/NEJMoa2021436
It should be noted that in France and some other nations, systematic use corticosteroids for patients over the age of 70 are not recommended. https://www.hcsp.fr/explore.cgi/avisrapportsdomaine?clefr=935
But due to the high risk of deaths among older patients with severe COVID-19, corticosteroids have been frequently administered to those over 80 in France since the start of the pandemic.
This research was undertaken with medical data and experiences of steroid treatment among the elderly in France to date to assess its efficacy as a treatment for severe SARS-CoV-2 infection (those with pneumonia requiring oxygen) in elderly patients.
The research was a comparative observational study that gathered all the routine care data for COVID-19 patients. For this study, data from geriatric and infectious diseases wards from 36 different hospitals in France and Luxembourg were gathered. Patients admitted between March 1 and April 30, 2020, were included in the study.
Patients in this study were all over 80 and had SARS-CoV-2 infection confirmed with polymerase chain reaction reverse transcription (PCR-RT) tests or suggestive CT-scan images. They required over 3 litres per minute of oxygen and had C-reactive protein levels over 40 mg/l (indicative of inflammation).
For this study, the survival of the patients until day 14 was the primary measure of outcome. The percentage of those who were discharged from hospital to home/rehabilitation on day 14 was also recorded. All adverse effects of therapy were recorded for analysis as well. These were recorded by one of the physicians on the team separately.
Two different treatment strategies were compared:
-First Group: Treatment group ie those receiving at least one dose of corticosteroids ≥0.4 mg/kg/day equivalent of prednisone. The participants in this group were started on corticosteroids within a “grace period” of 72h after baseline.
-Second Group: Control group those receiving standard supportive care.
For all patients, a follow-up period started at baseline. The events recorded at baseline included death, loss to follow-up, end of follow-up at least at day 14 after baseline.
The overall results of this study can be summarized as:
-A total of 267 elderly patients with severe COVID-19 were included in the analysis. The median age of the participants was 86 years (ranging between 83 and 90 years). 95 percent had confirmed PCR-RT for COVID-19.
-Of these, 96 participants were assigned to the treatment group. Of these steroid treatments was as follows:
51 (53.7%) received methylprednisolone
22 (23.2%) received prednisone
15 (15.8%) received dexamethasone
4 (4.2%) received prednisolone
3 (3.2%) received hydrocortisone
-Use of corticosteroids was associated with increased survival (weighted hazard ratio [wHR] 0.66, 95% CI 0.44 to 0.97)
-On follow up 41 patients (42.7 percent) and 86 patients (50.2 percent) died before day 14 in the treatment and control groups, respectively (Hazard ratio HR 0.76, 95% CI 0.52 to 1.09)
-Regarding the proportion of patients discharged to home/rehabilitation at day 14, both treatment and control groups had similar numbers (Weighted Relative risk wRR 1.11, 95% CI 0.68 to 1.81)
-A total of 22 (or 16.7 percent) of patients on the treatment group receiving steroids developed adverse effects, and 11 (or 6.4 percent) on the control group developed adverse effects on treatment.
-Adverse effects were as follows in treatment and control groups, respectively:
Raised blood sugar or hyperglycemia (6.1 percent vs 0.6 percent)
Heart failure (2.3 percent vs 0.6 percent)
Confusion (3 percent vs 1.2 percent)
Infections (1.5 percent vs 0 percent)
The researchers concluded that steroids were associated with a “significant increase” in by day 14 of overall survival among elderly patients over the age of 80 years who had to be hospitalized for severe COVID-19.
The study team said, “Altogether, our results support the WHO guidelines, and expand them to patients over 80 years old without contra-indication. They send a good signal for elderly, including those living in long terms care facilities or other institutions where corticosteroids could be prescribed according to an oxygen criterion, without systematic transfer to the hospital. Strengthening the therapeutic arsenal for the care of elderly with COVID-19 is critical as these patients may not fully benefit from vaccination because of the immune-senescence associated with advanced age and their exclusion from vaccine trials.” https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091
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