User login
No short-term death risk in elderly after COVID-19 vaccines
and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).
Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.
“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”
“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.
“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
Potential risks
Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.
As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients
Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
Health authorities investigate
In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.
They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.
In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).
The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.
The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.
The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.
In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.
“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
Population-wide study
Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.
They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.
The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.
Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.
The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.
and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).
Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.
“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”
“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.
“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
Potential risks
Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.
As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients
Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
Health authorities investigate
In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.
They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.
In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).
The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.
The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.
The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.
In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.
“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
Population-wide study
Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.
They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.
The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.
Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.
The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.
and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).
Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.
“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”
“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.
“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
Potential risks
Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.
As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients
Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
Health authorities investigate
In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.
They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.
In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).
The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.
The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.
The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.
In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.
“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
Population-wide study
Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.
They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.
The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.
Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.
The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.
FROM EUGMS 2021
Omega-3s tame inflammation in elderly COVID-19 patients
results of a small randomized controlled trial suggest.
Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.
The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.
Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.
In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.
“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.
Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
‘Eicosanoid storm’
In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.
“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”
Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
Trial details
In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.
Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.
Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.
All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.
Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.
Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
Inflammatory markers improve
As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.
“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.
As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.
The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
AFib concerns
In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”
The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.
“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”
The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
results of a small randomized controlled trial suggest.
Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.
The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.
Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.
In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.
“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.
Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
‘Eicosanoid storm’
In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.
“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”
Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
Trial details
In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.
Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.
Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.
All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.
Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.
Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
Inflammatory markers improve
As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.
“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.
As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.
The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
AFib concerns
In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”
The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.
“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”
The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
results of a small randomized controlled trial suggest.
Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.
The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.
Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.
In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.
“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.
Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
‘Eicosanoid storm’
In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.
“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”
Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
Trial details
In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.
Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.
Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.
All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.
Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.
Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
Inflammatory markers improve
As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.
“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.
As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.
The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
AFib concerns
In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”
The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.
“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”
The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EUGMS
Staff education cuts psychotropic drug use in long-term care
The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.
The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.
There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.
“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.
Heavy drug use
Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.
To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.
Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).
Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.
The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.
Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
Short-term benefit
As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.
By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.
Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.
In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.
Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).
“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.
The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
Randomized design
In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”
“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.
Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.
Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.
Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”
Dr. Aalto and Dr. Ryg had no disclosures.
The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.
The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.
There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.
“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.
Heavy drug use
Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.
To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.
Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).
Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.
The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.
Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
Short-term benefit
As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.
By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.
Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.
In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.
Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).
“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.
The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
Randomized design
In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”
“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.
Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.
Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.
Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”
Dr. Aalto and Dr. Ryg had no disclosures.
The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.
The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.
There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.
“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.
Heavy drug use
Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.
To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.
Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).
Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.
The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.
Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
Short-term benefit
As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.
By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.
Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.
In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.
Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).
“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.
The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
Randomized design
In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”
“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.
Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.
Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.
Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”
Dr. Aalto and Dr. Ryg had no disclosures.
FROM EUGMS 2021