Human clinical trials have started for an experimental HIV vaccine that uses the same kind of mRNA technology found in Moderna’s successful COVID-19 vaccine, the drug company has announced.

The first vaccinations were given Jan. 27 at George Washington University School of Medicine and Health Sciences, Washington, the company said in a news release. Phase I trials will also be run at the Hope Clinic of Emory Vaccine Center, Atlanta, the Fred Hutchinson Cancer Research Center, Seattle, and the University of Texas Health Science Center, San Antonio.

The vaccine is designed to prompt white blood cells to turn into antibodies that can neutralize HIV, ABC News reported. A booster shot to work with the HIV vaccine is also being studied.

For 4 decades, the human immunodeficiency virus has managed to dodge the immune system’s attempts to destroy it. Scientists have not been able to develop a vaccine, though they have made advancements in treatments, such as long-acting injectables for pre- and post-exposure prevention and treatment. HIV can lead to AIDS, which can be fatal.

The release said 56 healthy HIV-negative adults are taking part in the clinical trial, with 48 getting one or two doses of the mRNA vaccine and 32 also getting the booster. Eight people will just get the booster. All of them will be monitored for up to 6 months after receiving a final dose.

The immunogens – antigens that elicit an immune response – that are being tested were developed by the International AIDS Vaccine Initiative (IAVI) and Scripps Research. They will be delivered using the same messenger RNA (mRNA) technology in Moderna’s successful COVID-19 vaccine, the news release said.

About 1.2 million people in the United States had HIV at the end of 2019, according to the CDC, with more than 36,000 people being diagnosed in 2019.

The World Health Organization says 37.7 million people in the world had HIV in 2020.

“We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” Mark Feinberg, MD, president and CEO of IAVI, said in the news release. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine.”

A version of this article first appeared on WebMD.com.

Human clinical trials have started for an experimental HIV vaccine that uses the same kind of mRNA technology found in Moderna’s successful COVID-19 vaccine, the drug company has announced.

The first vaccinations were given Jan. 27 at George Washington University School of Medicine and Health Sciences, Washington, the company said in a news release. Phase I trials will also be run at the Hope Clinic of Emory Vaccine Center, Atlanta, the Fred Hutchinson Cancer Research Center, Seattle, and the University of Texas Health Science Center, San Antonio.

The vaccine is designed to prompt white blood cells to turn into antibodies that can neutralize HIV, ABC News reported. A booster shot to work with the HIV vaccine is also being studied.

For 4 decades, the human immunodeficiency virus has managed to dodge the immune system’s attempts to destroy it. Scientists have not been able to develop a vaccine, though they have made advancements in treatments, such as long-acting injectables for pre- and post-exposure prevention and treatment. HIV can lead to AIDS, which can be fatal.

The release said 56 healthy HIV-negative adults are taking part in the clinical trial, with 48 getting one or two doses of the mRNA vaccine and 32 also getting the booster. Eight people will just get the booster. All of them will be monitored for up to 6 months after receiving a final dose.

The immunogens – antigens that elicit an immune response – that are being tested were developed by the International AIDS Vaccine Initiative (IAVI) and Scripps Research. They will be delivered using the same messenger RNA (mRNA) technology in Moderna’s successful COVID-19 vaccine, the news release said.

About 1.2 million people in the United States had HIV at the end of 2019, according to the CDC, with more than 36,000 people being diagnosed in 2019.

The World Health Organization says 37.7 million people in the world had HIV in 2020.

“We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” Mark Feinberg, MD, president and CEO of IAVI, said in the news release. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine.”

A version of this article first appeared on WebMD.com.

Human clinical trials have started for an experimental HIV vaccine that uses the same kind of mRNA technology found in Moderna’s successful COVID-19 vaccine, the drug company has announced.

The first vaccinations were given Jan. 27 at George Washington University School of Medicine and Health Sciences, Washington, the company said in a news release. Phase I trials will also be run at the Hope Clinic of Emory Vaccine Center, Atlanta, the Fred Hutchinson Cancer Research Center, Seattle, and the University of Texas Health Science Center, San Antonio.

The vaccine is designed to prompt white blood cells to turn into antibodies that can neutralize HIV, ABC News reported. A booster shot to work with the HIV vaccine is also being studied.

For 4 decades, the human immunodeficiency virus has managed to dodge the immune system’s attempts to destroy it. Scientists have not been able to develop a vaccine, though they have made advancements in treatments, such as long-acting injectables for pre- and post-exposure prevention and treatment. HIV can lead to AIDS, which can be fatal.

The release said 56 healthy HIV-negative adults are taking part in the clinical trial, with 48 getting one or two doses of the mRNA vaccine and 32 also getting the booster. Eight people will just get the booster. All of them will be monitored for up to 6 months after receiving a final dose.

The immunogens – antigens that elicit an immune response – that are being tested were developed by the International AIDS Vaccine Initiative (IAVI) and Scripps Research. They will be delivered using the same messenger RNA (mRNA) technology in Moderna’s successful COVID-19 vaccine, the news release said.

About 1.2 million people in the United States had HIV at the end of 2019, according to the CDC, with more than 36,000 people being diagnosed in 2019.

The World Health Organization says 37.7 million people in the world had HIV in 2020.

“We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” Mark Feinberg, MD, president and CEO of IAVI, said in the news release. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine.”

A version of this article first appeared on WebMD.com.

Immune checkpoint inhibitors (ICIs) are at least as effective in patients with advanced non–small cell lung cancer (NSCLC) and mild preexisting interstitial lung disease (ILD) as in those without ILD. However, the risk of checkpoint inhibitor pneumonitis (CIP) is higher in patients with the dual diagnoses and they need careful monitoring when introducing an ICI, a systematic review and meta-analysis indicated.

“Patients with preexisting ILD, especially symptomatic ILD, are frequently excluded from clinical trials so almost all the patients [we analyzed] were diagnosed with mild preexisting ILD,” said Yuan Cheng, MD, Peking University First Hospital, Beijing, China.

“At this stage, we think that mild ILD is not a contraindication to the use of anti-programmed death-1 (PD-1) and anti-programmed death-ligand 1 (PD-L1) treatment for patients with NSCLC but whether ICIs can be used in patients with moderate to severe ILD needs further study,” she added.

The study was published online Jan. 10 in the journal CHEST.
 

Ten studies

A total of 179 patients from 10 studies were included in the review and meta-analysis. Among these, six were retrospective case-control studies, one was a retrospective noncontrolled study and three were prospective, noncontrolled clinical trials. “All the included studies were from East Asian countries,” the authors noted.

Preexisting ILD was diagnosed by use of CT or high-resolution CT. The mean age of patients was 71 years (range, 33-85 years), 87% were male and 96% of the cohort had a history of smoking. Approximately one-quarter of patients with ILD had usual interstitial pneumonitis (UIP); about the same percentage had possible UIP; one-third were diagnosed with inconsistent UIP; 14% had nonspecific interstitial pneumonia (NSIP); and 6% had indeterminate UIP.

Patients received ICIs either as first-, second-, or third-line or higher therapy and all were treated with ICI monotherapy by way of either nivolumab (Opdivo), pembrolizumab (Keytruda), or atezolizumab (Tecentriq). About 10% of patients had a PD-L1 tumor proportion score (TPS) of less than 1%, one-quarter had a PD-L1 TPS of 1%-49%, and approximately two-thirds had a TPS of 50% or greater.
 

Objective response rates

Some 35% of patients with both NSCLC and preexisting ILD achieved an objective response rate (ORR) to ICI therapy and almost two-thirds of patients achieved disease control. However, there was considerable heterogeneity in ORRs between the studies where it ranged from 5.9% to 70%, the authors cautioned.

On meta-analysis, the pooled ORR was 34% (95% confidence interval, 20%-47%) but again, with significant heterogeneity (I2 = 75.9%). However, on meta-analysis of eligible studies, patients with NSCLC who had preexisting ILD were 99% more likely to achieve an ORR compared to those without ILD (odds ratio, 1.99; 95% CI, 1.31-3.00), the investigators pointed out.

The disease control rate (DCR) also varied considerably between studies from a low of 33.3% to a high of 100%, they added. On meta-analysis, the pooled DCR was 66% (95% CI, 56%-75%). “Meanwhile, in patients without preexisting ILD, the crude ORR and pooled ORR were 24.3% and 24% (95% CI, 17%-31%), respectively” – again with significant heterogeneity between studies (I2 = 87.4%).

In contrast to the ORR, there was no difference in the DCR between the two groups, with no evidence of heterogeneity. There were no significant differences between the two groups in either median progression-free survival (PFS) or overall survival (OS). In patients with NSCLC and preexisting ILD, median PFS ranged from 1.4 to 8 months whereas median OS ranged from 15.6 to 27.8 months.

For those without preexisting ILD, the median PFS ranged from 2.3 to 8.1 months while median OS ranged from 17.4 to 25.5 months.
 

ICI safety

In patients with NSCLC and preexisting ILD, the incidence of immune-related adverse events (irAes) of any grade was 56.7%, whereas the incidence of irAEs grade 3 and higher was 27.7%. “Among the 179 patients included in the studies, 45 developed any grade of CIP, corresponding to a crude incidence of 25.1%,” the authors noted – very similar to the pooled incidence of 27% on meta-analysis.

The pooled incidence of grade 3 and higher CIP in the same group of patients was 15%. The median time from initiation of ICIs to the development of CIP ranged from 31 to 74 days, but 88% of patients who developed CIP improved with appropriate treatment. In patients with NSCLC who did not have ILD, the pooled incidence of CIP was 10% (95% CI, 6%-13%), again with significant heterogeneity between studies (I2 = 78.8%). “Generally, CIP can be managed through ICI discontinuation with or without steroid administration,” the authors noted.

However, even if most CIP can be easily managed, “the incidence of severe CIP is higher [in NSCLC patients with preexisting ILD] than in other populations,” Dr. Chen observed. “So patients with preexisting ILD should be closely monitored during ICI therapy,” she added.

Indeed, compared with patients without preexisting ILD, grade 3 or higher CIP in patients with the dual diagnosis was significantly higher at an OR of 3.23 (95%, 2.06-5.06), the investigators emphasized.

A limitation to the review and systematic meta-analysis included the fact that none of the studies analyzed were randomized clinical trials and most of the studies were retrospective and had several other shortcomings.
 

Umbrella diagnosis

Asked to comment on the review, Karthik Suresh, MD, associate professor of medicine, Johns Hopkins University, Baltimore, pointed out that ILD is really an “umbrella” diagnosis that a few hundred diseases fit under, so the first question he and members of his multidisciplinary team ask is: What is the nature of the ILD in this patient? What is the actual underlying etiology?

It could, for example, be that the patient has undergone prior chemotherapy or radiation therapy and has developed ILD as a result, as Dr. Suresh and his coauthor, Jarushka Naidoo, MD, Sidney Kimmel Comprehensive Cancer Center, Baltimore, pointed out in their paper on how to approach patients with preexisting lung disease to avoid ICI toxicities. “We’ll go back to their prior CT scans and can see the ILD has been there for years – it’s stable and the patient’s lung function is not changing,” Dr. Suresh related to this news organization.

“That’s a very different story from a [patients] whom there are new interstitial changes, who are progressing and who are symptomatic,” he noted. Essentially, what Dr. Suresh and his team members want to know is: What is the specific subdiagnosis of this disease, how severe is it, and is it progressing? Then they need to take the tumor itself into consideration.

“Some tumors have high PD-L1 expression, others have low PD-L1 expression so response to immunotherapy is usually very different based on tumor histology,” Dr. Suresh pointed out. Thus, the next question that needs to be addressed is: What is the expected response of the tumor to ICI therapy? If a tumor is exquisitely sensitive to immunotherapy, “that changes the game,” Dr. Suresh said, “whereas with other tumors, the oncologist might say there may be some benefit but it won’t be dramatic.”

The third risk factor for ICI toxicity that needs to be evaluated is the patient’s general cardiopulmonary status – for example, if a patient has mild, even moderate, ILD but is still walking 3 miles a day, has no heart problems, and is doing fine. Another patient with the same severity of disease in turn may have mild heart failure, be relatively debilitated, and sedentary: “Performance status also plays a big role in determining treatment,” Dr. Suresh emphasized.

The presence of other pulmonary conditions such as chronic obstructive pulmonary disease – common in patients with NSCLC – has to be taken into account, too. Lastly, clinicians need to ask themselves if there are any alternative therapies that might work just as well if not better than ICI therapy for this particular patient. If the patient has had genomic testing, results might indicate that the tumor has a mutation that may respond well to targeted therapies. “We put all these factors out on the table,” Dr. Suresh said.

“And you obviously have to involve the patient, too, so they understand the risks of ICI therapy and together we decide, ‘Yes, this patient with ILD should get immunotherapy or no, they should not,’ “ he said.  

The study had no specific funding. The study authors and Dr. Suresh have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Immune checkpoint inhibitors (ICIs) are at least as effective in patients with advanced non–small cell lung cancer (NSCLC) and mild preexisting interstitial lung disease (ILD) as in those without ILD. However, the risk of checkpoint inhibitor pneumonitis (CIP) is higher in patients with the dual diagnoses and they need careful monitoring when introducing an ICI, a systematic review and meta-analysis indicated.

“Patients with preexisting ILD, especially symptomatic ILD, are frequently excluded from clinical trials so almost all the patients [we analyzed] were diagnosed with mild preexisting ILD,” said Yuan Cheng, MD, Peking University First Hospital, Beijing, China.

“At this stage, we think that mild ILD is not a contraindication to the use of anti-programmed death-1 (PD-1) and anti-programmed death-ligand 1 (PD-L1) treatment for patients with NSCLC but whether ICIs can be used in patients with moderate to severe ILD needs further study,” she added.

The study was published online Jan. 10 in the journal CHEST.
 

Ten studies

A total of 179 patients from 10 studies were included in the review and meta-analysis. Among these, six were retrospective case-control studies, one was a retrospective noncontrolled study and three were prospective, noncontrolled clinical trials. “All the included studies were from East Asian countries,” the authors noted.

Preexisting ILD was diagnosed by use of CT or high-resolution CT. The mean age of patients was 71 years (range, 33-85 years), 87% were male and 96% of the cohort had a history of smoking. Approximately one-quarter of patients with ILD had usual interstitial pneumonitis (UIP); about the same percentage had possible UIP; one-third were diagnosed with inconsistent UIP; 14% had nonspecific interstitial pneumonia (NSIP); and 6% had indeterminate UIP.

Patients received ICIs either as first-, second-, or third-line or higher therapy and all were treated with ICI monotherapy by way of either nivolumab (Opdivo), pembrolizumab (Keytruda), or atezolizumab (Tecentriq). About 10% of patients had a PD-L1 tumor proportion score (TPS) of less than 1%, one-quarter had a PD-L1 TPS of 1%-49%, and approximately two-thirds had a TPS of 50% or greater.
 

Objective response rates

Some 35% of patients with both NSCLC and preexisting ILD achieved an objective response rate (ORR) to ICI therapy and almost two-thirds of patients achieved disease control. However, there was considerable heterogeneity in ORRs between the studies where it ranged from 5.9% to 70%, the authors cautioned.

On meta-analysis, the pooled ORR was 34% (95% confidence interval, 20%-47%) but again, with significant heterogeneity (I2 = 75.9%). However, on meta-analysis of eligible studies, patients with NSCLC who had preexisting ILD were 99% more likely to achieve an ORR compared to those without ILD (odds ratio, 1.99; 95% CI, 1.31-3.00), the investigators pointed out.

The disease control rate (DCR) also varied considerably between studies from a low of 33.3% to a high of 100%, they added. On meta-analysis, the pooled DCR was 66% (95% CI, 56%-75%). “Meanwhile, in patients without preexisting ILD, the crude ORR and pooled ORR were 24.3% and 24% (95% CI, 17%-31%), respectively” – again with significant heterogeneity between studies (I2 = 87.4%).

In contrast to the ORR, there was no difference in the DCR between the two groups, with no evidence of heterogeneity. There were no significant differences between the two groups in either median progression-free survival (PFS) or overall survival (OS). In patients with NSCLC and preexisting ILD, median PFS ranged from 1.4 to 8 months whereas median OS ranged from 15.6 to 27.8 months.

For those without preexisting ILD, the median PFS ranged from 2.3 to 8.1 months while median OS ranged from 17.4 to 25.5 months.
 

ICI safety

In patients with NSCLC and preexisting ILD, the incidence of immune-related adverse events (irAes) of any grade was 56.7%, whereas the incidence of irAEs grade 3 and higher was 27.7%. “Among the 179 patients included in the studies, 45 developed any grade of CIP, corresponding to a crude incidence of 25.1%,” the authors noted – very similar to the pooled incidence of 27% on meta-analysis.

The pooled incidence of grade 3 and higher CIP in the same group of patients was 15%. The median time from initiation of ICIs to the development of CIP ranged from 31 to 74 days, but 88% of patients who developed CIP improved with appropriate treatment. In patients with NSCLC who did not have ILD, the pooled incidence of CIP was 10% (95% CI, 6%-13%), again with significant heterogeneity between studies (I2 = 78.8%). “Generally, CIP can be managed through ICI discontinuation with or without steroid administration,” the authors noted.

However, even if most CIP can be easily managed, “the incidence of severe CIP is higher [in NSCLC patients with preexisting ILD] than in other populations,” Dr. Chen observed. “So patients with preexisting ILD should be closely monitored during ICI therapy,” she added.

Indeed, compared with patients without preexisting ILD, grade 3 or higher CIP in patients with the dual diagnosis was significantly higher at an OR of 3.23 (95%, 2.06-5.06), the investigators emphasized.

A limitation to the review and systematic meta-analysis included the fact that none of the studies analyzed were randomized clinical trials and most of the studies were retrospective and had several other shortcomings.
 

Umbrella diagnosis

Asked to comment on the review, Karthik Suresh, MD, associate professor of medicine, Johns Hopkins University, Baltimore, pointed out that ILD is really an “umbrella” diagnosis that a few hundred diseases fit under, so the first question he and members of his multidisciplinary team ask is: What is the nature of the ILD in this patient? What is the actual underlying etiology?

It could, for example, be that the patient has undergone prior chemotherapy or radiation therapy and has developed ILD as a result, as Dr. Suresh and his coauthor, Jarushka Naidoo, MD, Sidney Kimmel Comprehensive Cancer Center, Baltimore, pointed out in their paper on how to approach patients with preexisting lung disease to avoid ICI toxicities. “We’ll go back to their prior CT scans and can see the ILD has been there for years – it’s stable and the patient’s lung function is not changing,” Dr. Suresh related to this news organization.

“That’s a very different story from a [patients] whom there are new interstitial changes, who are progressing and who are symptomatic,” he noted. Essentially, what Dr. Suresh and his team members want to know is: What is the specific subdiagnosis of this disease, how severe is it, and is it progressing? Then they need to take the tumor itself into consideration.

“Some tumors have high PD-L1 expression, others have low PD-L1 expression so response to immunotherapy is usually very different based on tumor histology,” Dr. Suresh pointed out. Thus, the next question that needs to be addressed is: What is the expected response of the tumor to ICI therapy? If a tumor is exquisitely sensitive to immunotherapy, “that changes the game,” Dr. Suresh said, “whereas with other tumors, the oncologist might say there may be some benefit but it won’t be dramatic.”

The third risk factor for ICI toxicity that needs to be evaluated is the patient’s general cardiopulmonary status – for example, if a patient has mild, even moderate, ILD but is still walking 3 miles a day, has no heart problems, and is doing fine. Another patient with the same severity of disease in turn may have mild heart failure, be relatively debilitated, and sedentary: “Performance status also plays a big role in determining treatment,” Dr. Suresh emphasized.

The presence of other pulmonary conditions such as chronic obstructive pulmonary disease – common in patients with NSCLC – has to be taken into account, too. Lastly, clinicians need to ask themselves if there are any alternative therapies that might work just as well if not better than ICI therapy for this particular patient. If the patient has had genomic testing, results might indicate that the tumor has a mutation that may respond well to targeted therapies. “We put all these factors out on the table,” Dr. Suresh said.

“And you obviously have to involve the patient, too, so they understand the risks of ICI therapy and together we decide, ‘Yes, this patient with ILD should get immunotherapy or no, they should not,’ “ he said.  

The study had no specific funding. The study authors and Dr. Suresh have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Immune checkpoint inhibitors (ICIs) are at least as effective in patients with advanced non–small cell lung cancer (NSCLC) and mild preexisting interstitial lung disease (ILD) as in those without ILD. However, the risk of checkpoint inhibitor pneumonitis (CIP) is higher in patients with the dual diagnoses and they need careful monitoring when introducing an ICI, a systematic review and meta-analysis indicated.

“Patients with preexisting ILD, especially symptomatic ILD, are frequently excluded from clinical trials so almost all the patients [we analyzed] were diagnosed with mild preexisting ILD,” said Yuan Cheng, MD, Peking University First Hospital, Beijing, China.

“At this stage, we think that mild ILD is not a contraindication to the use of anti-programmed death-1 (PD-1) and anti-programmed death-ligand 1 (PD-L1) treatment for patients with NSCLC but whether ICIs can be used in patients with moderate to severe ILD needs further study,” she added.

The study was published online Jan. 10 in the journal CHEST.
 

Ten studies

A total of 179 patients from 10 studies were included in the review and meta-analysis. Among these, six were retrospective case-control studies, one was a retrospective noncontrolled study and three were prospective, noncontrolled clinical trials. “All the included studies were from East Asian countries,” the authors noted.

Preexisting ILD was diagnosed by use of CT or high-resolution CT. The mean age of patients was 71 years (range, 33-85 years), 87% were male and 96% of the cohort had a history of smoking. Approximately one-quarter of patients with ILD had usual interstitial pneumonitis (UIP); about the same percentage had possible UIP; one-third were diagnosed with inconsistent UIP; 14% had nonspecific interstitial pneumonia (NSIP); and 6% had indeterminate UIP.

Patients received ICIs either as first-, second-, or third-line or higher therapy and all were treated with ICI monotherapy by way of either nivolumab (Opdivo), pembrolizumab (Keytruda), or atezolizumab (Tecentriq). About 10% of patients had a PD-L1 tumor proportion score (TPS) of less than 1%, one-quarter had a PD-L1 TPS of 1%-49%, and approximately two-thirds had a TPS of 50% or greater.
 

Objective response rates

Some 35% of patients with both NSCLC and preexisting ILD achieved an objective response rate (ORR) to ICI therapy and almost two-thirds of patients achieved disease control. However, there was considerable heterogeneity in ORRs between the studies where it ranged from 5.9% to 70%, the authors cautioned.

On meta-analysis, the pooled ORR was 34% (95% confidence interval, 20%-47%) but again, with significant heterogeneity (I2 = 75.9%). However, on meta-analysis of eligible studies, patients with NSCLC who had preexisting ILD were 99% more likely to achieve an ORR compared to those without ILD (odds ratio, 1.99; 95% CI, 1.31-3.00), the investigators pointed out.

The disease control rate (DCR) also varied considerably between studies from a low of 33.3% to a high of 100%, they added. On meta-analysis, the pooled DCR was 66% (95% CI, 56%-75%). “Meanwhile, in patients without preexisting ILD, the crude ORR and pooled ORR were 24.3% and 24% (95% CI, 17%-31%), respectively” – again with significant heterogeneity between studies (I2 = 87.4%).

In contrast to the ORR, there was no difference in the DCR between the two groups, with no evidence of heterogeneity. There were no significant differences between the two groups in either median progression-free survival (PFS) or overall survival (OS). In patients with NSCLC and preexisting ILD, median PFS ranged from 1.4 to 8 months whereas median OS ranged from 15.6 to 27.8 months.

For those without preexisting ILD, the median PFS ranged from 2.3 to 8.1 months while median OS ranged from 17.4 to 25.5 months.
 

ICI safety

In patients with NSCLC and preexisting ILD, the incidence of immune-related adverse events (irAes) of any grade was 56.7%, whereas the incidence of irAEs grade 3 and higher was 27.7%. “Among the 179 patients included in the studies, 45 developed any grade of CIP, corresponding to a crude incidence of 25.1%,” the authors noted – very similar to the pooled incidence of 27% on meta-analysis.

The pooled incidence of grade 3 and higher CIP in the same group of patients was 15%. The median time from initiation of ICIs to the development of CIP ranged from 31 to 74 days, but 88% of patients who developed CIP improved with appropriate treatment. In patients with NSCLC who did not have ILD, the pooled incidence of CIP was 10% (95% CI, 6%-13%), again with significant heterogeneity between studies (I2 = 78.8%). “Generally, CIP can be managed through ICI discontinuation with or without steroid administration,” the authors noted.

However, even if most CIP can be easily managed, “the incidence of severe CIP is higher [in NSCLC patients with preexisting ILD] than in other populations,” Dr. Chen observed. “So patients with preexisting ILD should be closely monitored during ICI therapy,” she added.

Indeed, compared with patients without preexisting ILD, grade 3 or higher CIP in patients with the dual diagnosis was significantly higher at an OR of 3.23 (95%, 2.06-5.06), the investigators emphasized.

A limitation to the review and systematic meta-analysis included the fact that none of the studies analyzed were randomized clinical trials and most of the studies were retrospective and had several other shortcomings.
 

Umbrella diagnosis

Asked to comment on the review, Karthik Suresh, MD, associate professor of medicine, Johns Hopkins University, Baltimore, pointed out that ILD is really an “umbrella” diagnosis that a few hundred diseases fit under, so the first question he and members of his multidisciplinary team ask is: What is the nature of the ILD in this patient? What is the actual underlying etiology?

It could, for example, be that the patient has undergone prior chemotherapy or radiation therapy and has developed ILD as a result, as Dr. Suresh and his coauthor, Jarushka Naidoo, MD, Sidney Kimmel Comprehensive Cancer Center, Baltimore, pointed out in their paper on how to approach patients with preexisting lung disease to avoid ICI toxicities. “We’ll go back to their prior CT scans and can see the ILD has been there for years – it’s stable and the patient’s lung function is not changing,” Dr. Suresh related to this news organization.

“That’s a very different story from a [patients] whom there are new interstitial changes, who are progressing and who are symptomatic,” he noted. Essentially, what Dr. Suresh and his team members want to know is: What is the specific subdiagnosis of this disease, how severe is it, and is it progressing? Then they need to take the tumor itself into consideration.

“Some tumors have high PD-L1 expression, others have low PD-L1 expression so response to immunotherapy is usually very different based on tumor histology,” Dr. Suresh pointed out. Thus, the next question that needs to be addressed is: What is the expected response of the tumor to ICI therapy? If a tumor is exquisitely sensitive to immunotherapy, “that changes the game,” Dr. Suresh said, “whereas with other tumors, the oncologist might say there may be some benefit but it won’t be dramatic.”

The third risk factor for ICI toxicity that needs to be evaluated is the patient’s general cardiopulmonary status – for example, if a patient has mild, even moderate, ILD but is still walking 3 miles a day, has no heart problems, and is doing fine. Another patient with the same severity of disease in turn may have mild heart failure, be relatively debilitated, and sedentary: “Performance status also plays a big role in determining treatment,” Dr. Suresh emphasized.

The presence of other pulmonary conditions such as chronic obstructive pulmonary disease – common in patients with NSCLC – has to be taken into account, too. Lastly, clinicians need to ask themselves if there are any alternative therapies that might work just as well if not better than ICI therapy for this particular patient. If the patient has had genomic testing, results might indicate that the tumor has a mutation that may respond well to targeted therapies. “We put all these factors out on the table,” Dr. Suresh said.

“And you obviously have to involve the patient, too, so they understand the risks of ICI therapy and together we decide, ‘Yes, this patient with ILD should get immunotherapy or no, they should not,’ “ he said.  

The study had no specific funding. The study authors and Dr. Suresh have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Intravenous ketamine is effective for treating depression but is inferior to electroconvulsive therapy (ECT), new research suggests.

In the first head-to-head trial, ECT was more effective than intravenous ketamine in hospitalized patients with severe depression, with higher remission rates and a greater reduction in symptoms.

However, ketamine led to remission in nearly half of participants and is a “valuable” option for treating severe depression, particularly in younger patients, the investigators noted.

The high rate of remission for ketamine infusion “indicates that it definitely can be used in a clinical setting, but it is more probable that a patient will achieve remission with ECT compared to ketamine,” principal investigator Pouya Movahed Rad, MD, PhD (pharmacology), senior consultant and researcher in psychiatry, Lund (Sweden) University, said in an interview.

Results of the KetECT study were recently published online in the International Journal of Neuropsychopharmacology.
 

Primary focus on remission

The parallel, open-label, noninferiority study included 186 patients aged 18-85 years who were hospitalized with severe unipolar depression and had a score of at least 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS).

Participants were randomly allocated (1:1) to thrice-weekly infusions of racemic ketamine (0.5 mg/kg over 40 minutes) or ECT. All patients continued to take their antidepressant medication during the study. The primary outcome was remission, defined as a MADRS score of 10 or less.  

Results showed the remission rate was significantly higher in the ECT group than in the ketamine group (63% vs. 46%, respectively; P = .026). The 95% confidence interval of the difference in remission rates was estimated between 2% and 30%. 

Both ketamine and ECT required a median of six treatment sessions to induce remission.

Post-hoc analysis indicated that age was a factor in the findings. In the ECT group, remission was significantly more likely in older patients (51-85 years), compared with younger patients (18-50 years), with remission rates of 77% and 50%, respectively.

But the opposite was true in the ketamine group, with significantly higher remission rates in younger versus older patients (61% vs. 37%).

The study results also support the safety and efficacy of ketamine in patients with psychotic depression, which was present in 15% of patients in the ECT group and 18% of those in the ketamine group.

In this subgroup, half of patients with psychotic depression remitted after ketamine, with no indications of adverse reactions particular for these patients. The remission rate with ECT was 79%.

During the 12-month follow-up period, rate of relapse among remitters was similar at 64% in the ECT group and 70% in the ketamine group (log rank P = .44).
 

Let the patient decide

As expected, ECT and ketamine had distinct side effect profiles. Subjectively reported prolonged amnesia was more common with ECT and reports of dissociative side effects, anxiety, blurred vision, euphoria, vertigo, and diplopia (double vision) were more common with ketamine. 

“Dissociative symptoms were, as expected, observed during treatment with ketamine, but they were brief and in the majority of cases mild and tolerable,” Dr. Movahed Rad said.

The investigators noted that participating study sites all had long-time experience with ECT but no experience administering ketamine.

“Staffs, and some patients, were familiar with side effects common to ECT but were less prepared for the adverse psychological effects of ketamine. This, and knowing ECT was available after the study, probably contributed to the higher dropout rate in the ketamine group,” they wrote.

If both ECT and ketamine are available, “the patient’s preference should, of course, be taken in account when choosing treatment,” said Dr. Movahed Rad.

“Ketamine should be offered if ECT is not available, or cannot be given due to excessive risks with anesthesia or other somatic risk factor. Patients who have not responded to ECT or have had unacceptable side effects should be offered ketamine infusion and vice versa,” he added.

A good alternative

Commenting on the findings, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said the data confirm ECT is highly effective for treatment-resistant depression and show that “newcomer” intravenous ketamine also performs “exceptionally well.”

“This is an extremely important study that really establishes the efficacy of ketamine in a very difficult to treat population,” added Dr. McIntyre, who was not involved in the research.

He added that this “rigorous, well-designed study addresses a critical question” about the comparative efficacy of ECT and intravenous ketamine. It also makes “quite a strong statement about the efficacy of ketamine in younger people.”

He cautioned, however, that this study represents the “first data point and, of course, is not the final word on the topic. There are other studies currently still ongoing that are also comparing ECT to IV ketamine and we’ll look forward to seeing the results.”

The fact that 15%-20% of the study patients had psychotic depression is also noteworthy, said Dr. McIntyre.

“We’ve been hesitant to use ketamine in these patients, I think for obvious reasons, but we recently published a paper showing that it is safe and very effective in these patients,” he said.

Having ketamine as a treatment option is important because the majority of patients who could benefit from ECT decline it, often because of the stigma associated with the procedure, which is often portrayed negatively in films and other media.

“I have been recommending ECT almost every day of my professional life and 98 times out of 100 people say: ‘Thanks but no thanks.’ That’s a problem because ECT is so effective,” Dr. McIntyre said.

The study was funded by the Swedish Research Council, Crafoord Foundation, Skåne Regional Council, Königska Foundation, Lions Forskningsfond Skåne, and the OM Perssons donation foundation. Dr. Movahed Rad has received lecturer honoraria from Lundbeck. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, and other companies. McIntyre is also CEO of AltMed.

A version of this article first appeared on Medscape.com.

Intravenous ketamine is effective for treating depression but is inferior to electroconvulsive therapy (ECT), new research suggests.

In the first head-to-head trial, ECT was more effective than intravenous ketamine in hospitalized patients with severe depression, with higher remission rates and a greater reduction in symptoms.

However, ketamine led to remission in nearly half of participants and is a “valuable” option for treating severe depression, particularly in younger patients, the investigators noted.

The high rate of remission for ketamine infusion “indicates that it definitely can be used in a clinical setting, but it is more probable that a patient will achieve remission with ECT compared to ketamine,” principal investigator Pouya Movahed Rad, MD, PhD (pharmacology), senior consultant and researcher in psychiatry, Lund (Sweden) University, said in an interview.

Results of the KetECT study were recently published online in the International Journal of Neuropsychopharmacology.
 

Primary focus on remission

The parallel, open-label, noninferiority study included 186 patients aged 18-85 years who were hospitalized with severe unipolar depression and had a score of at least 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS).

Participants were randomly allocated (1:1) to thrice-weekly infusions of racemic ketamine (0.5 mg/kg over 40 minutes) or ECT. All patients continued to take their antidepressant medication during the study. The primary outcome was remission, defined as a MADRS score of 10 or less.  

Results showed the remission rate was significantly higher in the ECT group than in the ketamine group (63% vs. 46%, respectively; P = .026). The 95% confidence interval of the difference in remission rates was estimated between 2% and 30%. 

Both ketamine and ECT required a median of six treatment sessions to induce remission.

Post-hoc analysis indicated that age was a factor in the findings. In the ECT group, remission was significantly more likely in older patients (51-85 years), compared with younger patients (18-50 years), with remission rates of 77% and 50%, respectively.

But the opposite was true in the ketamine group, with significantly higher remission rates in younger versus older patients (61% vs. 37%).

The study results also support the safety and efficacy of ketamine in patients with psychotic depression, which was present in 15% of patients in the ECT group and 18% of those in the ketamine group.

In this subgroup, half of patients with psychotic depression remitted after ketamine, with no indications of adverse reactions particular for these patients. The remission rate with ECT was 79%.

During the 12-month follow-up period, rate of relapse among remitters was similar at 64% in the ECT group and 70% in the ketamine group (log rank P = .44).
 

Let the patient decide

As expected, ECT and ketamine had distinct side effect profiles. Subjectively reported prolonged amnesia was more common with ECT and reports of dissociative side effects, anxiety, blurred vision, euphoria, vertigo, and diplopia (double vision) were more common with ketamine. 

“Dissociative symptoms were, as expected, observed during treatment with ketamine, but they were brief and in the majority of cases mild and tolerable,” Dr. Movahed Rad said.

The investigators noted that participating study sites all had long-time experience with ECT but no experience administering ketamine.

“Staffs, and some patients, were familiar with side effects common to ECT but were less prepared for the adverse psychological effects of ketamine. This, and knowing ECT was available after the study, probably contributed to the higher dropout rate in the ketamine group,” they wrote.

If both ECT and ketamine are available, “the patient’s preference should, of course, be taken in account when choosing treatment,” said Dr. Movahed Rad.

“Ketamine should be offered if ECT is not available, or cannot be given due to excessive risks with anesthesia or other somatic risk factor. Patients who have not responded to ECT or have had unacceptable side effects should be offered ketamine infusion and vice versa,” he added.

A good alternative

Commenting on the findings, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said the data confirm ECT is highly effective for treatment-resistant depression and show that “newcomer” intravenous ketamine also performs “exceptionally well.”

“This is an extremely important study that really establishes the efficacy of ketamine in a very difficult to treat population,” added Dr. McIntyre, who was not involved in the research.

He added that this “rigorous, well-designed study addresses a critical question” about the comparative efficacy of ECT and intravenous ketamine. It also makes “quite a strong statement about the efficacy of ketamine in younger people.”

He cautioned, however, that this study represents the “first data point and, of course, is not the final word on the topic. There are other studies currently still ongoing that are also comparing ECT to IV ketamine and we’ll look forward to seeing the results.”

The fact that 15%-20% of the study patients had psychotic depression is also noteworthy, said Dr. McIntyre.

“We’ve been hesitant to use ketamine in these patients, I think for obvious reasons, but we recently published a paper showing that it is safe and very effective in these patients,” he said.

Having ketamine as a treatment option is important because the majority of patients who could benefit from ECT decline it, often because of the stigma associated with the procedure, which is often portrayed negatively in films and other media.

“I have been recommending ECT almost every day of my professional life and 98 times out of 100 people say: ‘Thanks but no thanks.’ That’s a problem because ECT is so effective,” Dr. McIntyre said.

The study was funded by the Swedish Research Council, Crafoord Foundation, Skåne Regional Council, Königska Foundation, Lions Forskningsfond Skåne, and the OM Perssons donation foundation. Dr. Movahed Rad has received lecturer honoraria from Lundbeck. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, and other companies. McIntyre is also CEO of AltMed.

A version of this article first appeared on Medscape.com.

Intravenous ketamine is effective for treating depression but is inferior to electroconvulsive therapy (ECT), new research suggests.

In the first head-to-head trial, ECT was more effective than intravenous ketamine in hospitalized patients with severe depression, with higher remission rates and a greater reduction in symptoms.

However, ketamine led to remission in nearly half of participants and is a “valuable” option for treating severe depression, particularly in younger patients, the investigators noted.

The high rate of remission for ketamine infusion “indicates that it definitely can be used in a clinical setting, but it is more probable that a patient will achieve remission with ECT compared to ketamine,” principal investigator Pouya Movahed Rad, MD, PhD (pharmacology), senior consultant and researcher in psychiatry, Lund (Sweden) University, said in an interview.

Results of the KetECT study were recently published online in the International Journal of Neuropsychopharmacology.
 

Primary focus on remission

The parallel, open-label, noninferiority study included 186 patients aged 18-85 years who were hospitalized with severe unipolar depression and had a score of at least 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS).

Participants were randomly allocated (1:1) to thrice-weekly infusions of racemic ketamine (0.5 mg/kg over 40 minutes) or ECT. All patients continued to take their antidepressant medication during the study. The primary outcome was remission, defined as a MADRS score of 10 or less.  

Results showed the remission rate was significantly higher in the ECT group than in the ketamine group (63% vs. 46%, respectively; P = .026). The 95% confidence interval of the difference in remission rates was estimated between 2% and 30%. 

Both ketamine and ECT required a median of six treatment sessions to induce remission.

Post-hoc analysis indicated that age was a factor in the findings. In the ECT group, remission was significantly more likely in older patients (51-85 years), compared with younger patients (18-50 years), with remission rates of 77% and 50%, respectively.

But the opposite was true in the ketamine group, with significantly higher remission rates in younger versus older patients (61% vs. 37%).

The study results also support the safety and efficacy of ketamine in patients with psychotic depression, which was present in 15% of patients in the ECT group and 18% of those in the ketamine group.

In this subgroup, half of patients with psychotic depression remitted after ketamine, with no indications of adverse reactions particular for these patients. The remission rate with ECT was 79%.

During the 12-month follow-up period, rate of relapse among remitters was similar at 64% in the ECT group and 70% in the ketamine group (log rank P = .44).
 

Let the patient decide

As expected, ECT and ketamine had distinct side effect profiles. Subjectively reported prolonged amnesia was more common with ECT and reports of dissociative side effects, anxiety, blurred vision, euphoria, vertigo, and diplopia (double vision) were more common with ketamine. 

“Dissociative symptoms were, as expected, observed during treatment with ketamine, but they were brief and in the majority of cases mild and tolerable,” Dr. Movahed Rad said.

The investigators noted that participating study sites all had long-time experience with ECT but no experience administering ketamine.

“Staffs, and some patients, were familiar with side effects common to ECT but were less prepared for the adverse psychological effects of ketamine. This, and knowing ECT was available after the study, probably contributed to the higher dropout rate in the ketamine group,” they wrote.

If both ECT and ketamine are available, “the patient’s preference should, of course, be taken in account when choosing treatment,” said Dr. Movahed Rad.

“Ketamine should be offered if ECT is not available, or cannot be given due to excessive risks with anesthesia or other somatic risk factor. Patients who have not responded to ECT or have had unacceptable side effects should be offered ketamine infusion and vice versa,” he added.

A good alternative

Commenting on the findings, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, said the data confirm ECT is highly effective for treatment-resistant depression and show that “newcomer” intravenous ketamine also performs “exceptionally well.”

“This is an extremely important study that really establishes the efficacy of ketamine in a very difficult to treat population,” added Dr. McIntyre, who was not involved in the research.

He added that this “rigorous, well-designed study addresses a critical question” about the comparative efficacy of ECT and intravenous ketamine. It also makes “quite a strong statement about the efficacy of ketamine in younger people.”

He cautioned, however, that this study represents the “first data point and, of course, is not the final word on the topic. There are other studies currently still ongoing that are also comparing ECT to IV ketamine and we’ll look forward to seeing the results.”

The fact that 15%-20% of the study patients had psychotic depression is also noteworthy, said Dr. McIntyre.

“We’ve been hesitant to use ketamine in these patients, I think for obvious reasons, but we recently published a paper showing that it is safe and very effective in these patients,” he said.

Having ketamine as a treatment option is important because the majority of patients who could benefit from ECT decline it, often because of the stigma associated with the procedure, which is often portrayed negatively in films and other media.

“I have been recommending ECT almost every day of my professional life and 98 times out of 100 people say: ‘Thanks but no thanks.’ That’s a problem because ECT is so effective,” Dr. McIntyre said.

The study was funded by the Swedish Research Council, Crafoord Foundation, Skåne Regional Council, Königska Foundation, Lions Forskningsfond Skåne, and the OM Perssons donation foundation. Dr. Movahed Rad has received lecturer honoraria from Lundbeck. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, and other companies. McIntyre is also CEO of AltMed.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared the Omnipod 5 Automated Insulin Delivery System (Insulet), the third semiautomated closed-loop insulin delivery system in the United States and the first that is tubing free.

Omnipod 5 is cleared for people aged 6 years and older with type 1 diabetes. The system integrates the tubeless insulin delivery Pods with Dexcom G6 continuous glucose monitors (CGM) and a smartphone app or a separate controller device to automatically adjust insulin to minimize high and low blood glucose levels via SmartAdjust technology.

Within the app is a SmartBolus calculator that receives Dexcom CGM values every 5 minutes and automatically adjusts insulin up or down or pauses it based on predicted values for 60 minutes into the future and the individual’s customized glucose targets.

The Omnipod 5 becomes the third FDA-cleared semiautomated insulin delivery system in the United States, along with systems by Tandem and Medtronic. Others are available outside the United States. All of the currently marketed systems incorporate insulin pumps with tubing, whereas the tubeless Pods are worn directly on the body and changed every 3 days.

In a statement, JDRF, the type 1 diabetes advocacy organization, said: “Authorization of the Insulet Omnipod 5 is a huge win for the type 1 diabetes community. As the first tubeless hybrid closed-loop system to receive FDA clearance, this is a critical step forward in making day-to-day life better for people living with the disease.”

JDRF, which worked with the FDA to establish regulatory pathways for artificial pancreas technology, supported the development of the Omnipod 5 control algorithm through investigators in the JDRF Artificial Pancreas Consortium.

The Omnipod 5 will be available as a pharmacy product. It will be launched soon in limited market release and broadly thereafter.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared the Omnipod 5 Automated Insulin Delivery System (Insulet), the third semiautomated closed-loop insulin delivery system in the United States and the first that is tubing free.

Omnipod 5 is cleared for people aged 6 years and older with type 1 diabetes. The system integrates the tubeless insulin delivery Pods with Dexcom G6 continuous glucose monitors (CGM) and a smartphone app or a separate controller device to automatically adjust insulin to minimize high and low blood glucose levels via SmartAdjust technology.

Within the app is a SmartBolus calculator that receives Dexcom CGM values every 5 minutes and automatically adjusts insulin up or down or pauses it based on predicted values for 60 minutes into the future and the individual’s customized glucose targets.

The Omnipod 5 becomes the third FDA-cleared semiautomated insulin delivery system in the United States, along with systems by Tandem and Medtronic. Others are available outside the United States. All of the currently marketed systems incorporate insulin pumps with tubing, whereas the tubeless Pods are worn directly on the body and changed every 3 days.

In a statement, JDRF, the type 1 diabetes advocacy organization, said: “Authorization of the Insulet Omnipod 5 is a huge win for the type 1 diabetes community. As the first tubeless hybrid closed-loop system to receive FDA clearance, this is a critical step forward in making day-to-day life better for people living with the disease.”

JDRF, which worked with the FDA to establish regulatory pathways for artificial pancreas technology, supported the development of the Omnipod 5 control algorithm through investigators in the JDRF Artificial Pancreas Consortium.

The Omnipod 5 will be available as a pharmacy product. It will be launched soon in limited market release and broadly thereafter.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared the Omnipod 5 Automated Insulin Delivery System (Insulet), the third semiautomated closed-loop insulin delivery system in the United States and the first that is tubing free.

Omnipod 5 is cleared for people aged 6 years and older with type 1 diabetes. The system integrates the tubeless insulin delivery Pods with Dexcom G6 continuous glucose monitors (CGM) and a smartphone app or a separate controller device to automatically adjust insulin to minimize high and low blood glucose levels via SmartAdjust technology.

Within the app is a SmartBolus calculator that receives Dexcom CGM values every 5 minutes and automatically adjusts insulin up or down or pauses it based on predicted values for 60 minutes into the future and the individual’s customized glucose targets.

The Omnipod 5 becomes the third FDA-cleared semiautomated insulin delivery system in the United States, along with systems by Tandem and Medtronic. Others are available outside the United States. All of the currently marketed systems incorporate insulin pumps with tubing, whereas the tubeless Pods are worn directly on the body and changed every 3 days.

In a statement, JDRF, the type 1 diabetes advocacy organization, said: “Authorization of the Insulet Omnipod 5 is a huge win for the type 1 diabetes community. As the first tubeless hybrid closed-loop system to receive FDA clearance, this is a critical step forward in making day-to-day life better for people living with the disease.”

JDRF, which worked with the FDA to establish regulatory pathways for artificial pancreas technology, supported the development of the Omnipod 5 control algorithm through investigators in the JDRF Artificial Pancreas Consortium.

The Omnipod 5 will be available as a pharmacy product. It will be launched soon in limited market release and broadly thereafter.

A version of this article first appeared on Medscape.com.

Regular practice of a specific yoga maneuver appears to reduce susceptibility to reflex vasovagal syncope, a new study suggests.

The tadasana exercise – a movement-based contemplative practice that gradually corrects orthostatic imbalance by strengthening protective neuromuscular reflexes – practiced for just 15 minutes twice a day, was associated with the complete elimination of episodes of vasovagal syncope for many patients.

“These exercises are very easy to perform, inexpensive, and very effective. This is a very easy fix for a scary and potentially dangerous condition,” lead author Hygriv Rao, MD, said in an interview. “We are excited about these results. We thought it would work, but we did not expect it to be so effective. It seems to work for almost all patients.

“We found that, with the tadasana maneuver, episodes of full syncope, where the patient actually loses consciousness, ceased completely, and episodes of near-syncope, where the patient feels faint but does not completely pass out, were greatly reduced,” Dr. Rao added. “The actual loss of consciousness, which is the most dangerous part, is practically gone. This gives a lot of confidence to patients and their families.”

The researchers reported their initial results from a pilot study of the technique in a letter to JACC: Clinical Electrophysiology that was published online Jan. 26, 2022.

Dr. Rao, a cardiologist at the KIMS Hospitals, Hyderabad, India, explained that vasovagal syncope is a brief loss of consciousness caused by a neurologically induced drop in blood pressure caused by faulty neuromuscular reflexes.

It is typically triggered by emotional stress, prolonged standing, or getting up from a sitting position too quickly.

Very few treatments have been shown effective, with current management approaches involving avoiding triggers, increasing fluids, and if the individual feels an episode coming on, they can take steps to stop it by lying down, raising their legs, or lowering their head to increase blood flow to the brain.

“Recently, there has been a lot of interest in yoga as a preventative therapy for vasovagal syncope,” Dr. Rao noted. “We considered various yoga positions and we chose the tadasana maneuver to study in this context as it resembles exercises sometimes given to patients with vasovagal syncope but with some differences including the addition of synchronized breathing, which may help stabilize autonomic tone.”

For the tadasana maneuver, the individual stands straight with their feet together, arms by their side (against a wall if they need support), and alternatively lift the front and back part of their feet.

They first lift their toes with their weight resting on the ball of their feet, then after a few seconds they raise their heels with their weight on the front of the foot. Then after a few more seconds they lift their arms over their shoulders, stretching upward while standing on their toes.

These movements are synchronized with breathing exercises, with the individual taking a deep breath in as they lift their arms and breathing out again on lowering the arms.

“Each movement takes a few seconds, and each cycle of movements takes about 2 minutes. If this is performed 8 times, then this would take about 15 minutes. We recommend this 15-minute routine twice a day,” Dr. Rao said.

For the current study, 113 patients diagnosed with recurrent vasovagal disorder were counseled to practice standard physical maneuvers and maintain adequate hydration. Medications were prescribed at the discretion of the treating physician.

Of these, 61 patients were additionally trained to practice the tadasana maneuver and asked to practice the movement for 15 minutes twice a day. The mean durations of symptoms and follow-up in the two groups were similar. The average follow-up was about 20 months.

Results showed that episodes of both near-syncope and syncope decreased in both groups but there was a much larger reduction in the patients practicing the tadasana maneuver.

Before treatment, the 52 patients in the conventional group experienced 163 syncope or near-syncope events. At follow-up, 22 symptom recurrences occurred in 12 patients (23%). Total mean events per patient declined from 3 to 0.4.

Full syncope events in this group declined from 65 in 32 patients to 2 in 2 patients (mean per patient, 1.3 to 1), and near-syncope events fell from 98 in 34 patients to 20 in 10 patients (mean per patient, 2.0 to 0.4).

In the tadasana group, 61 patients had 378 syncope/near-syncope events before treatment; at follow-up, only 6 events occurred in 5 patients (8%). Per patient, total events declined from a mean of 6 to 0.1.

Full syncope events fell from 108 in 48 patients to 0 (mean per patient, 1.8 to 0), and near-syncope events declined from 269 in 33 patients to 6 in 5 patients (mean per patient, 4.4 to 0.1).

“This combination of exercise and breathing influences the neuromuscular reflex malfunction that occurs in vasovagal syncope,” Dr. Rao noted. “The movements focus on strengthening neuromuscular reflexes in the quadriceps and the calf muscles, which can increase the blood circulation and venous return, thus preventing blood pooling in the lower body.”

The researchers said this pilot study offers three main findings. First, both conventional therapy and conventional plus tadasana therapy appeared to benefit patients, compared with their respective baseline symptom burden. Second, application of tadasana as an adjunctive treatment was associated with fewer total event recurrences (that is, syncope and near-syncope combined), and third, tadasana was well tolerated, with no adverse events reported.

“The reduction in total events (i.e., syncope and near-syncope events), compared with pretreatment numbers, was substantial and most tadasana patients were managed without any pharmacotherapy,” the authors reported.

Dr. Rao noted that at baseline almost all patients in both groups were taking medications for the condition, but during the study these medications were reduced as fewer episodes occurred. At the end of the follow-up, 80% of the conventional group were still taking medication, compared with just 14% of those in the tadasana group.

Patients had an initial training session in person with a yoga instructor and then received follow-on training by video online. Dr. Rao said there was a very high rate of compliance, “almost 100%.”

He reports that a total of 200 patients have now been treated with this approach at his hospital with very similar results to those seen in the initial study.

This work was supported in part by a grant from the Dr Earl E. Bakken Family in support of heart-brain research. Dr. Rao disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Regular practice of a specific yoga maneuver appears to reduce susceptibility to reflex vasovagal syncope, a new study suggests.

The tadasana exercise – a movement-based contemplative practice that gradually corrects orthostatic imbalance by strengthening protective neuromuscular reflexes – practiced for just 15 minutes twice a day, was associated with the complete elimination of episodes of vasovagal syncope for many patients.

“These exercises are very easy to perform, inexpensive, and very effective. This is a very easy fix for a scary and potentially dangerous condition,” lead author Hygriv Rao, MD, said in an interview. “We are excited about these results. We thought it would work, but we did not expect it to be so effective. It seems to work for almost all patients.

“We found that, with the tadasana maneuver, episodes of full syncope, where the patient actually loses consciousness, ceased completely, and episodes of near-syncope, where the patient feels faint but does not completely pass out, were greatly reduced,” Dr. Rao added. “The actual loss of consciousness, which is the most dangerous part, is practically gone. This gives a lot of confidence to patients and their families.”

The researchers reported their initial results from a pilot study of the technique in a letter to JACC: Clinical Electrophysiology that was published online Jan. 26, 2022.

Dr. Rao, a cardiologist at the KIMS Hospitals, Hyderabad, India, explained that vasovagal syncope is a brief loss of consciousness caused by a neurologically induced drop in blood pressure caused by faulty neuromuscular reflexes.

It is typically triggered by emotional stress, prolonged standing, or getting up from a sitting position too quickly.

Very few treatments have been shown effective, with current management approaches involving avoiding triggers, increasing fluids, and if the individual feels an episode coming on, they can take steps to stop it by lying down, raising their legs, or lowering their head to increase blood flow to the brain.

“Recently, there has been a lot of interest in yoga as a preventative therapy for vasovagal syncope,” Dr. Rao noted. “We considered various yoga positions and we chose the tadasana maneuver to study in this context as it resembles exercises sometimes given to patients with vasovagal syncope but with some differences including the addition of synchronized breathing, which may help stabilize autonomic tone.”

For the tadasana maneuver, the individual stands straight with their feet together, arms by their side (against a wall if they need support), and alternatively lift the front and back part of their feet.

They first lift their toes with their weight resting on the ball of their feet, then after a few seconds they raise their heels with their weight on the front of the foot. Then after a few more seconds they lift their arms over their shoulders, stretching upward while standing on their toes.

These movements are synchronized with breathing exercises, with the individual taking a deep breath in as they lift their arms and breathing out again on lowering the arms.

“Each movement takes a few seconds, and each cycle of movements takes about 2 minutes. If this is performed 8 times, then this would take about 15 minutes. We recommend this 15-minute routine twice a day,” Dr. Rao said.

For the current study, 113 patients diagnosed with recurrent vasovagal disorder were counseled to practice standard physical maneuvers and maintain adequate hydration. Medications were prescribed at the discretion of the treating physician.

Of these, 61 patients were additionally trained to practice the tadasana maneuver and asked to practice the movement for 15 minutes twice a day. The mean durations of symptoms and follow-up in the two groups were similar. The average follow-up was about 20 months.

Results showed that episodes of both near-syncope and syncope decreased in both groups but there was a much larger reduction in the patients practicing the tadasana maneuver.

Before treatment, the 52 patients in the conventional group experienced 163 syncope or near-syncope events. At follow-up, 22 symptom recurrences occurred in 12 patients (23%). Total mean events per patient declined from 3 to 0.4.

Full syncope events in this group declined from 65 in 32 patients to 2 in 2 patients (mean per patient, 1.3 to 1), and near-syncope events fell from 98 in 34 patients to 20 in 10 patients (mean per patient, 2.0 to 0.4).

In the tadasana group, 61 patients had 378 syncope/near-syncope events before treatment; at follow-up, only 6 events occurred in 5 patients (8%). Per patient, total events declined from a mean of 6 to 0.1.

Full syncope events fell from 108 in 48 patients to 0 (mean per patient, 1.8 to 0), and near-syncope events declined from 269 in 33 patients to 6 in 5 patients (mean per patient, 4.4 to 0.1).

“This combination of exercise and breathing influences the neuromuscular reflex malfunction that occurs in vasovagal syncope,” Dr. Rao noted. “The movements focus on strengthening neuromuscular reflexes in the quadriceps and the calf muscles, which can increase the blood circulation and venous return, thus preventing blood pooling in the lower body.”

The researchers said this pilot study offers three main findings. First, both conventional therapy and conventional plus tadasana therapy appeared to benefit patients, compared with their respective baseline symptom burden. Second, application of tadasana as an adjunctive treatment was associated with fewer total event recurrences (that is, syncope and near-syncope combined), and third, tadasana was well tolerated, with no adverse events reported.

“The reduction in total events (i.e., syncope and near-syncope events), compared with pretreatment numbers, was substantial and most tadasana patients were managed without any pharmacotherapy,” the authors reported.

Dr. Rao noted that at baseline almost all patients in both groups were taking medications for the condition, but during the study these medications were reduced as fewer episodes occurred. At the end of the follow-up, 80% of the conventional group were still taking medication, compared with just 14% of those in the tadasana group.

Patients had an initial training session in person with a yoga instructor and then received follow-on training by video online. Dr. Rao said there was a very high rate of compliance, “almost 100%.”

He reports that a total of 200 patients have now been treated with this approach at his hospital with very similar results to those seen in the initial study.

This work was supported in part by a grant from the Dr Earl E. Bakken Family in support of heart-brain research. Dr. Rao disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Regular practice of a specific yoga maneuver appears to reduce susceptibility to reflex vasovagal syncope, a new study suggests.

The tadasana exercise – a movement-based contemplative practice that gradually corrects orthostatic imbalance by strengthening protective neuromuscular reflexes – practiced for just 15 minutes twice a day, was associated with the complete elimination of episodes of vasovagal syncope for many patients.

“These exercises are very easy to perform, inexpensive, and very effective. This is a very easy fix for a scary and potentially dangerous condition,” lead author Hygriv Rao, MD, said in an interview. “We are excited about these results. We thought it would work, but we did not expect it to be so effective. It seems to work for almost all patients.

“We found that, with the tadasana maneuver, episodes of full syncope, where the patient actually loses consciousness, ceased completely, and episodes of near-syncope, where the patient feels faint but does not completely pass out, were greatly reduced,” Dr. Rao added. “The actual loss of consciousness, which is the most dangerous part, is practically gone. This gives a lot of confidence to patients and their families.”

The researchers reported their initial results from a pilot study of the technique in a letter to JACC: Clinical Electrophysiology that was published online Jan. 26, 2022.

Dr. Rao, a cardiologist at the KIMS Hospitals, Hyderabad, India, explained that vasovagal syncope is a brief loss of consciousness caused by a neurologically induced drop in blood pressure caused by faulty neuromuscular reflexes.

It is typically triggered by emotional stress, prolonged standing, or getting up from a sitting position too quickly.

Very few treatments have been shown effective, with current management approaches involving avoiding triggers, increasing fluids, and if the individual feels an episode coming on, they can take steps to stop it by lying down, raising their legs, or lowering their head to increase blood flow to the brain.

“Recently, there has been a lot of interest in yoga as a preventative therapy for vasovagal syncope,” Dr. Rao noted. “We considered various yoga positions and we chose the tadasana maneuver to study in this context as it resembles exercises sometimes given to patients with vasovagal syncope but with some differences including the addition of synchronized breathing, which may help stabilize autonomic tone.”

For the tadasana maneuver, the individual stands straight with their feet together, arms by their side (against a wall if they need support), and alternatively lift the front and back part of their feet.

They first lift their toes with their weight resting on the ball of their feet, then after a few seconds they raise their heels with their weight on the front of the foot. Then after a few more seconds they lift their arms over their shoulders, stretching upward while standing on their toes.

These movements are synchronized with breathing exercises, with the individual taking a deep breath in as they lift their arms and breathing out again on lowering the arms.

“Each movement takes a few seconds, and each cycle of movements takes about 2 minutes. If this is performed 8 times, then this would take about 15 minutes. We recommend this 15-minute routine twice a day,” Dr. Rao said.

For the current study, 113 patients diagnosed with recurrent vasovagal disorder were counseled to practice standard physical maneuvers and maintain adequate hydration. Medications were prescribed at the discretion of the treating physician.

Of these, 61 patients were additionally trained to practice the tadasana maneuver and asked to practice the movement for 15 minutes twice a day. The mean durations of symptoms and follow-up in the two groups were similar. The average follow-up was about 20 months.

Results showed that episodes of both near-syncope and syncope decreased in both groups but there was a much larger reduction in the patients practicing the tadasana maneuver.

Before treatment, the 52 patients in the conventional group experienced 163 syncope or near-syncope events. At follow-up, 22 symptom recurrences occurred in 12 patients (23%). Total mean events per patient declined from 3 to 0.4.

Full syncope events in this group declined from 65 in 32 patients to 2 in 2 patients (mean per patient, 1.3 to 1), and near-syncope events fell from 98 in 34 patients to 20 in 10 patients (mean per patient, 2.0 to 0.4).

In the tadasana group, 61 patients had 378 syncope/near-syncope events before treatment; at follow-up, only 6 events occurred in 5 patients (8%). Per patient, total events declined from a mean of 6 to 0.1.

Full syncope events fell from 108 in 48 patients to 0 (mean per patient, 1.8 to 0), and near-syncope events declined from 269 in 33 patients to 6 in 5 patients (mean per patient, 4.4 to 0.1).

“This combination of exercise and breathing influences the neuromuscular reflex malfunction that occurs in vasovagal syncope,” Dr. Rao noted. “The movements focus on strengthening neuromuscular reflexes in the quadriceps and the calf muscles, which can increase the blood circulation and venous return, thus preventing blood pooling in the lower body.”

The researchers said this pilot study offers three main findings. First, both conventional therapy and conventional plus tadasana therapy appeared to benefit patients, compared with their respective baseline symptom burden. Second, application of tadasana as an adjunctive treatment was associated with fewer total event recurrences (that is, syncope and near-syncope combined), and third, tadasana was well tolerated, with no adverse events reported.

“The reduction in total events (i.e., syncope and near-syncope events), compared with pretreatment numbers, was substantial and most tadasana patients were managed without any pharmacotherapy,” the authors reported.

Dr. Rao noted that at baseline almost all patients in both groups were taking medications for the condition, but during the study these medications were reduced as fewer episodes occurred. At the end of the follow-up, 80% of the conventional group were still taking medication, compared with just 14% of those in the tadasana group.

Patients had an initial training session in person with a yoga instructor and then received follow-on training by video online. Dr. Rao said there was a very high rate of compliance, “almost 100%.”

He reports that a total of 200 patients have now been treated with this approach at his hospital with very similar results to those seen in the initial study.

This work was supported in part by a grant from the Dr Earl E. Bakken Family in support of heart-brain research. Dr. Rao disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

When 2021 began, there appeared to be light at the end of the long and dark COVID-19 pandemic. A vaccine was introduced, the “curve” had been flattened, and by spring, businesses were slowly starting to open. Whereas the medical literature of 2020 seemed to be almost entirely focused on COVID-19, medical writers, researchers, and educators seemed to slowly start turning more attention back to non–COVID-related topics in 2021.

Unfortunately, as I write this, the Omicron variant of the coronavirus is in full swing, and much of our attention has once again turned back to COVID-19. However, we are able to look back on 2021 and acknowledge a wealth of fantastic original research articles and guidelines which have improved patient care in many ways. In this annual recap of my favorite articles of the past year, I will focus on what I believe every acute care physician should read and know, as they will improve patient care.

Specifically, I have chosen articles that did not appear to gain widespread notoriety in emergency medicine but are, nevertheless, worthy of your time and attention. Note that this write-up serves as a summary only, and I encourage interested readers to peruse the full manuscripts for further details. I am limiting my recap to two articles.
 

Recommendations on difficult airway management

Emergency physicians are well trained in airway management, and a major part of that training includes the preintubation anatomic assessment of the airway. However, there are few recommendations on the physiological considerations for airway management.

A set of recommendations from the Society for Airway Management was written primarily with anesthesiologists in mind, but many of the recommendations listed below are very relevant to emergency physicians as well. The authors make recommendations for patients who are hypoxic or hypotensive prior to induction, for patients with right ventricular dysfunction, for patients with severe metabolic acidosis, and for neurologically injured patients. Some of the key pearls follow.
 

Patients with hypoxemia

• The importance of preoxygenation before intubation is once again emphasized, and this can be performed using high-flow oxygen for at least 3 minutes, or (in a cooperative patient) with eight vital capacity breaths.
• Maintenance of oxygenation during the apneic period should be continued. Apneic oxygenation can be provided with a nasal cannula at 15 liters per minute or with a high-flow nasal oxygen system at 40-70 LPM.
• For patients with significant shunt physiology or reduced functional residual capacity (for example, late pregnancy, obesity, or acute respiratory distress syndrome), preoxygenation should be performed with positive end expiratory pressure (PEEP) using noninvasive positive pressure ventilation or bag-valve mask ventilation with a PEEP valve. When higher levels of PEEP are required, an extraglottic device should be considered during preoxygenation.
• For patients with refractory hypoxemia, awake intubation to maintain spontaneous respirations should be considered.
• Patients should be preoxygenated in the upright position when possible.
• Ramped-up position (head elevated so as to bring the external auditory canal in the same horizontal line as the sternal notch) should be performed when possible in order to improve the grade of view, improve oxygenation, and reduce aspiration.

Patients with hypotension

• Patients should be screened for high risk for hemodynamic collapse prior to administration of induction medications and intubation by assessing the stroke index. A stroke index greater than 0.7 predicts a high risk. These patients should receive hemodynamic optimization (for example, intravenous fluids, administration of vasopressors) whenever possible, prior to administration of induction medications and intubation.
• Vasopressor infusions are preferable to bolus-dosed vasopressors. However, if vasopressor infusions are not possible, bolus-dosed vasopressors should be available and used to maintain systemic pressure during and after the intubation until an infusion can be started. When bolus-dosed vasopressors are used, diluted epinephrine should be considered as the vasopressor of choice in patients with depressed myocardial function.

Patients with right ventricular (RV) dysfunction

• Patients should be screened for significant RV dysfunction prior to intubation because of their high risk for hemodynamic decompensation with positive pressure ventilation.
• RV dysfunction may sometimes worsen with fluid administration. Fluid-intolerant patients may instead need RV afterload reduction with inhaled or intravenous pulmonary vasodilators.
• Patients with RV failure–induced shock should be considered for preintubation extracorporeal membrane oxygenation if available.
• Patients with RV volume overload should receive diuresis prior to intubation.
• Ventilator settings should aim to avoid hypercapnia, maintain low airway pressures, and use a higher PEEP to avoid atelectasis.

Patients with severe metabolic acidosis

• Patients with severe metabolic acidosis are at high risk for decompensation after intubation because of volume depletion and inadequate alveolar ventilation, resulting in profound acidosis.
• Patients with high minute ventilation prior to intubation should be considered for awake intubation to maintain spontaneous respirations. Otherwise, consider a spontaneous breathing mode after intubation with a high minute ventilation (that is, use a higher-than-normal respiratory rate on the ventilator in order to reproduce the preintubation minute ventilation). Apnea time should be minimized in order to minimize worsening acidosis.
• Preintubation bicarbonate boluses to prevent worsening acidosis are controversial and lack data showing any benefit.

Neurologically injured patients

• Eucapnia and normoxia should be maintained before, during, and after intubation to maintain stable cerebral blood flow.
• Hemodynamically neutral induction agents should be used.
• Patients should be positioned with the head of bed elevated to 30° upright when possible.
• Limit PEEP post intubation in order to promote venous drainage.

Evidence update for the treatment of anaphylaxis

The treatment of anaphylaxis is considered bread and butter in emergency and acute care medicine, but a great deal of what we have learned over the years is not well supported by the literature. In an article published in Resuscitation, the Anaphylaxis Working Group of the Resuscitation Council of the United Kingdom performed an evidence review regarding the emergency treatment of anaphylaxis.

A summary of key points includes:

• Anaphylaxis is defined as a systemic hypersensitivity reaction, usually rapid in onset, with potentially life-threatening compromise in airway, breathing, and/or circulation.
• The most important treatment is epinephrine (EPI), with an initial recommended dose in adults of 0.5 mg administered via the intramuscular (IM) route. Up to 10% of patients have a suboptimal response to one dose, but 98% will respond by the third dose; therefore, these authors recommend repeating the IM EPI every 5 minutes, if needed, up to three doses. There is no evidence to support any alternative or additional vasopressors, and so they should only be used if EPI is ineffective. Intravenous EPI is not recommended initially except in the perioperative setting where close monitoring can be performed. If intravenous EPI is used, the authors recommend an intravenous infusion rather than bolus dosing.
• Intravenous fluid bolus dosing is recommended in the majority of cases of anaphylaxis, regardless of presence or absence of hemodynamic compromise, because of the profound reduction in venous tone and third-spacing that typically occurs.
• Antihistamines are not recommended in early treatment. They are only effective for reversing skin manifestations of anaphylaxis (which EPI treats as well), and the sedation they produce can confound the proper ongoing evaluation of the patient. Furthermore, the use of antihistamines early in the treatment of anaphylaxis has been found to produce delays in proper use of EPI.
• Steroids are not recommended in early treatment. They help only with the late phase of inflammatory response, but despite that, there is no good evidence that they decrease the biphasic response of anaphylaxis. There is some emerging evidence that the use of steroids may actually be associated with increased morbidity even after correcting for anaphylaxis severity. The authors recommended the use of steroids in anaphylaxis only for patients with poorly controlled asthma and possibly for patients with refractory anaphylaxis. Inhaled beta-agonists are recommended in anaphylaxis only for patients with lower respiratory tract symptoms caused by anaphylaxis, but warned that the inhaled beta-agonists should not delay proper use of EPI.
• The optimal observation period before discharge for stable patients is unknown. The authors noted the recommendations of the Joint Task Force on Practice Parameters of the American Academy of Allergy, Asthma, & Immunology and the American College of Allergy, Asthma, and Immunology: Biphasic reactions were more common in patients with severe initial symptoms – for example, those requiring more than one dose of EPI; therefore, these patients are recommended to have “extended observation.” Lower-risk patients with resolved symptoms of anaphylaxis can be observed for 1 hour, which would capture 95% of biphasic reactions in this group of patients.

Summary and other honorable mentions

There you have it. My two favorite practice-changing (non–COVID-19) articles of 2021. Not surprisingly, both articles deal largely with airway and hemodynamic concerns – the ABC’s of emergency medicine. Although these bulleted pearls provide key points from these two articles, the full discussions of those key points in the articles would provide a great deal more education than I can provide in this brief write-up, and so I strongly encourage everyone to read the full articles.

I also encourage readers to peruse the following “honorable mention” articles: Stiell and colleagues published a “Best Practices Checklist” on behalf of the Canadian Association of Emergency Physicians pertaining to the management of acute atrial fibrillation and atrial flutter; and on behalf of the American Heart Association (in collaboration with several other major organizations), Gulati and colleagues published the 2021 Guideline for the Evaluation and Diagnosis of Chest Pain. Both publications show us how we should strive to manage atrial fibrillation and chest pain, respectively, in the emergency department for years to come.

Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore.

A version of this article first appeared on Medscape.com.

When 2021 began, there appeared to be light at the end of the long and dark COVID-19 pandemic. A vaccine was introduced, the “curve” had been flattened, and by spring, businesses were slowly starting to open. Whereas the medical literature of 2020 seemed to be almost entirely focused on COVID-19, medical writers, researchers, and educators seemed to slowly start turning more attention back to non–COVID-related topics in 2021.

Unfortunately, as I write this, the Omicron variant of the coronavirus is in full swing, and much of our attention has once again turned back to COVID-19. However, we are able to look back on 2021 and acknowledge a wealth of fantastic original research articles and guidelines which have improved patient care in many ways. In this annual recap of my favorite articles of the past year, I will focus on what I believe every acute care physician should read and know, as they will improve patient care.

Specifically, I have chosen articles that did not appear to gain widespread notoriety in emergency medicine but are, nevertheless, worthy of your time and attention. Note that this write-up serves as a summary only, and I encourage interested readers to peruse the full manuscripts for further details. I am limiting my recap to two articles.
 

Recommendations on difficult airway management

Emergency physicians are well trained in airway management, and a major part of that training includes the preintubation anatomic assessment of the airway. However, there are few recommendations on the physiological considerations for airway management.

A set of recommendations from the Society for Airway Management was written primarily with anesthesiologists in mind, but many of the recommendations listed below are very relevant to emergency physicians as well. The authors make recommendations for patients who are hypoxic or hypotensive prior to induction, for patients with right ventricular dysfunction, for patients with severe metabolic acidosis, and for neurologically injured patients. Some of the key pearls follow.
 

Patients with hypoxemia

• The importance of preoxygenation before intubation is once again emphasized, and this can be performed using high-flow oxygen for at least 3 minutes, or (in a cooperative patient) with eight vital capacity breaths.
• Maintenance of oxygenation during the apneic period should be continued. Apneic oxygenation can be provided with a nasal cannula at 15 liters per minute or with a high-flow nasal oxygen system at 40-70 LPM.
• For patients with significant shunt physiology or reduced functional residual capacity (for example, late pregnancy, obesity, or acute respiratory distress syndrome), preoxygenation should be performed with positive end expiratory pressure (PEEP) using noninvasive positive pressure ventilation or bag-valve mask ventilation with a PEEP valve. When higher levels of PEEP are required, an extraglottic device should be considered during preoxygenation.
• For patients with refractory hypoxemia, awake intubation to maintain spontaneous respirations should be considered.
• Patients should be preoxygenated in the upright position when possible.
• Ramped-up position (head elevated so as to bring the external auditory canal in the same horizontal line as the sternal notch) should be performed when possible in order to improve the grade of view, improve oxygenation, and reduce aspiration.

Patients with hypotension

• Patients should be screened for high risk for hemodynamic collapse prior to administration of induction medications and intubation by assessing the stroke index. A stroke index greater than 0.7 predicts a high risk. These patients should receive hemodynamic optimization (for example, intravenous fluids, administration of vasopressors) whenever possible, prior to administration of induction medications and intubation.
• Vasopressor infusions are preferable to bolus-dosed vasopressors. However, if vasopressor infusions are not possible, bolus-dosed vasopressors should be available and used to maintain systemic pressure during and after the intubation until an infusion can be started. When bolus-dosed vasopressors are used, diluted epinephrine should be considered as the vasopressor of choice in patients with depressed myocardial function.

Patients with right ventricular (RV) dysfunction

• Patients should be screened for significant RV dysfunction prior to intubation because of their high risk for hemodynamic decompensation with positive pressure ventilation.
• RV dysfunction may sometimes worsen with fluid administration. Fluid-intolerant patients may instead need RV afterload reduction with inhaled or intravenous pulmonary vasodilators.
• Patients with RV failure–induced shock should be considered for preintubation extracorporeal membrane oxygenation if available.
• Patients with RV volume overload should receive diuresis prior to intubation.
• Ventilator settings should aim to avoid hypercapnia, maintain low airway pressures, and use a higher PEEP to avoid atelectasis.

Patients with severe metabolic acidosis

• Patients with severe metabolic acidosis are at high risk for decompensation after intubation because of volume depletion and inadequate alveolar ventilation, resulting in profound acidosis.
• Patients with high minute ventilation prior to intubation should be considered for awake intubation to maintain spontaneous respirations. Otherwise, consider a spontaneous breathing mode after intubation with a high minute ventilation (that is, use a higher-than-normal respiratory rate on the ventilator in order to reproduce the preintubation minute ventilation). Apnea time should be minimized in order to minimize worsening acidosis.
• Preintubation bicarbonate boluses to prevent worsening acidosis are controversial and lack data showing any benefit.

Neurologically injured patients

• Eucapnia and normoxia should be maintained before, during, and after intubation to maintain stable cerebral blood flow.
• Hemodynamically neutral induction agents should be used.
• Patients should be positioned with the head of bed elevated to 30° upright when possible.
• Limit PEEP post intubation in order to promote venous drainage.

Evidence update for the treatment of anaphylaxis

The treatment of anaphylaxis is considered bread and butter in emergency and acute care medicine, but a great deal of what we have learned over the years is not well supported by the literature. In an article published in Resuscitation, the Anaphylaxis Working Group of the Resuscitation Council of the United Kingdom performed an evidence review regarding the emergency treatment of anaphylaxis.

A summary of key points includes:

• Anaphylaxis is defined as a systemic hypersensitivity reaction, usually rapid in onset, with potentially life-threatening compromise in airway, breathing, and/or circulation.
• The most important treatment is epinephrine (EPI), with an initial recommended dose in adults of 0.5 mg administered via the intramuscular (IM) route. Up to 10% of patients have a suboptimal response to one dose, but 98% will respond by the third dose; therefore, these authors recommend repeating the IM EPI every 5 minutes, if needed, up to three doses. There is no evidence to support any alternative or additional vasopressors, and so they should only be used if EPI is ineffective. Intravenous EPI is not recommended initially except in the perioperative setting where close monitoring can be performed. If intravenous EPI is used, the authors recommend an intravenous infusion rather than bolus dosing.
• Intravenous fluid bolus dosing is recommended in the majority of cases of anaphylaxis, regardless of presence or absence of hemodynamic compromise, because of the profound reduction in venous tone and third-spacing that typically occurs.
• Antihistamines are not recommended in early treatment. They are only effective for reversing skin manifestations of anaphylaxis (which EPI treats as well), and the sedation they produce can confound the proper ongoing evaluation of the patient. Furthermore, the use of antihistamines early in the treatment of anaphylaxis has been found to produce delays in proper use of EPI.
• Steroids are not recommended in early treatment. They help only with the late phase of inflammatory response, but despite that, there is no good evidence that they decrease the biphasic response of anaphylaxis. There is some emerging evidence that the use of steroids may actually be associated with increased morbidity even after correcting for anaphylaxis severity. The authors recommended the use of steroids in anaphylaxis only for patients with poorly controlled asthma and possibly for patients with refractory anaphylaxis. Inhaled beta-agonists are recommended in anaphylaxis only for patients with lower respiratory tract symptoms caused by anaphylaxis, but warned that the inhaled beta-agonists should not delay proper use of EPI.
• The optimal observation period before discharge for stable patients is unknown. The authors noted the recommendations of the Joint Task Force on Practice Parameters of the American Academy of Allergy, Asthma, & Immunology and the American College of Allergy, Asthma, and Immunology: Biphasic reactions were more common in patients with severe initial symptoms – for example, those requiring more than one dose of EPI; therefore, these patients are recommended to have “extended observation.” Lower-risk patients with resolved symptoms of anaphylaxis can be observed for 1 hour, which would capture 95% of biphasic reactions in this group of patients.

Summary and other honorable mentions

There you have it. My two favorite practice-changing (non–COVID-19) articles of 2021. Not surprisingly, both articles deal largely with airway and hemodynamic concerns – the ABC’s of emergency medicine. Although these bulleted pearls provide key points from these two articles, the full discussions of those key points in the articles would provide a great deal more education than I can provide in this brief write-up, and so I strongly encourage everyone to read the full articles.

I also encourage readers to peruse the following “honorable mention” articles: Stiell and colleagues published a “Best Practices Checklist” on behalf of the Canadian Association of Emergency Physicians pertaining to the management of acute atrial fibrillation and atrial flutter; and on behalf of the American Heart Association (in collaboration with several other major organizations), Gulati and colleagues published the 2021 Guideline for the Evaluation and Diagnosis of Chest Pain. Both publications show us how we should strive to manage atrial fibrillation and chest pain, respectively, in the emergency department for years to come.

Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore.

A version of this article first appeared on Medscape.com.

When 2021 began, there appeared to be light at the end of the long and dark COVID-19 pandemic. A vaccine was introduced, the “curve” had been flattened, and by spring, businesses were slowly starting to open. Whereas the medical literature of 2020 seemed to be almost entirely focused on COVID-19, medical writers, researchers, and educators seemed to slowly start turning more attention back to non–COVID-related topics in 2021.

Unfortunately, as I write this, the Omicron variant of the coronavirus is in full swing, and much of our attention has once again turned back to COVID-19. However, we are able to look back on 2021 and acknowledge a wealth of fantastic original research articles and guidelines which have improved patient care in many ways. In this annual recap of my favorite articles of the past year, I will focus on what I believe every acute care physician should read and know, as they will improve patient care.

Specifically, I have chosen articles that did not appear to gain widespread notoriety in emergency medicine but are, nevertheless, worthy of your time and attention. Note that this write-up serves as a summary only, and I encourage interested readers to peruse the full manuscripts for further details. I am limiting my recap to two articles.
 

Recommendations on difficult airway management

Emergency physicians are well trained in airway management, and a major part of that training includes the preintubation anatomic assessment of the airway. However, there are few recommendations on the physiological considerations for airway management.

A set of recommendations from the Society for Airway Management was written primarily with anesthesiologists in mind, but many of the recommendations listed below are very relevant to emergency physicians as well. The authors make recommendations for patients who are hypoxic or hypotensive prior to induction, for patients with right ventricular dysfunction, for patients with severe metabolic acidosis, and for neurologically injured patients. Some of the key pearls follow.
 

Patients with hypoxemia

• The importance of preoxygenation before intubation is once again emphasized, and this can be performed using high-flow oxygen for at least 3 minutes, or (in a cooperative patient) with eight vital capacity breaths.
• Maintenance of oxygenation during the apneic period should be continued. Apneic oxygenation can be provided with a nasal cannula at 15 liters per minute or with a high-flow nasal oxygen system at 40-70 LPM.
• For patients with significant shunt physiology or reduced functional residual capacity (for example, late pregnancy, obesity, or acute respiratory distress syndrome), preoxygenation should be performed with positive end expiratory pressure (PEEP) using noninvasive positive pressure ventilation or bag-valve mask ventilation with a PEEP valve. When higher levels of PEEP are required, an extraglottic device should be considered during preoxygenation.
• For patients with refractory hypoxemia, awake intubation to maintain spontaneous respirations should be considered.
• Patients should be preoxygenated in the upright position when possible.
• Ramped-up position (head elevated so as to bring the external auditory canal in the same horizontal line as the sternal notch) should be performed when possible in order to improve the grade of view, improve oxygenation, and reduce aspiration.

Patients with hypotension

• Patients should be screened for high risk for hemodynamic collapse prior to administration of induction medications and intubation by assessing the stroke index. A stroke index greater than 0.7 predicts a high risk. These patients should receive hemodynamic optimization (for example, intravenous fluids, administration of vasopressors) whenever possible, prior to administration of induction medications and intubation.
• Vasopressor infusions are preferable to bolus-dosed vasopressors. However, if vasopressor infusions are not possible, bolus-dosed vasopressors should be available and used to maintain systemic pressure during and after the intubation until an infusion can be started. When bolus-dosed vasopressors are used, diluted epinephrine should be considered as the vasopressor of choice in patients with depressed myocardial function.

Patients with right ventricular (RV) dysfunction

• Patients should be screened for significant RV dysfunction prior to intubation because of their high risk for hemodynamic decompensation with positive pressure ventilation.
• RV dysfunction may sometimes worsen with fluid administration. Fluid-intolerant patients may instead need RV afterload reduction with inhaled or intravenous pulmonary vasodilators.
• Patients with RV failure–induced shock should be considered for preintubation extracorporeal membrane oxygenation if available.
• Patients with RV volume overload should receive diuresis prior to intubation.
• Ventilator settings should aim to avoid hypercapnia, maintain low airway pressures, and use a higher PEEP to avoid atelectasis.

Patients with severe metabolic acidosis

• Patients with severe metabolic acidosis are at high risk for decompensation after intubation because of volume depletion and inadequate alveolar ventilation, resulting in profound acidosis.
• Patients with high minute ventilation prior to intubation should be considered for awake intubation to maintain spontaneous respirations. Otherwise, consider a spontaneous breathing mode after intubation with a high minute ventilation (that is, use a higher-than-normal respiratory rate on the ventilator in order to reproduce the preintubation minute ventilation). Apnea time should be minimized in order to minimize worsening acidosis.
• Preintubation bicarbonate boluses to prevent worsening acidosis are controversial and lack data showing any benefit.

Neurologically injured patients

• Eucapnia and normoxia should be maintained before, during, and after intubation to maintain stable cerebral blood flow.
• Hemodynamically neutral induction agents should be used.
• Patients should be positioned with the head of bed elevated to 30° upright when possible.
• Limit PEEP post intubation in order to promote venous drainage.

Evidence update for the treatment of anaphylaxis

The treatment of anaphylaxis is considered bread and butter in emergency and acute care medicine, but a great deal of what we have learned over the years is not well supported by the literature. In an article published in Resuscitation, the Anaphylaxis Working Group of the Resuscitation Council of the United Kingdom performed an evidence review regarding the emergency treatment of anaphylaxis.

A summary of key points includes:

• Anaphylaxis is defined as a systemic hypersensitivity reaction, usually rapid in onset, with potentially life-threatening compromise in airway, breathing, and/or circulation.
• The most important treatment is epinephrine (EPI), with an initial recommended dose in adults of 0.5 mg administered via the intramuscular (IM) route. Up to 10% of patients have a suboptimal response to one dose, but 98% will respond by the third dose; therefore, these authors recommend repeating the IM EPI every 5 minutes, if needed, up to three doses. There is no evidence to support any alternative or additional vasopressors, and so they should only be used if EPI is ineffective. Intravenous EPI is not recommended initially except in the perioperative setting where close monitoring can be performed. If intravenous EPI is used, the authors recommend an intravenous infusion rather than bolus dosing.
• Intravenous fluid bolus dosing is recommended in the majority of cases of anaphylaxis, regardless of presence or absence of hemodynamic compromise, because of the profound reduction in venous tone and third-spacing that typically occurs.
• Antihistamines are not recommended in early treatment. They are only effective for reversing skin manifestations of anaphylaxis (which EPI treats as well), and the sedation they produce can confound the proper ongoing evaluation of the patient. Furthermore, the use of antihistamines early in the treatment of anaphylaxis has been found to produce delays in proper use of EPI.
• Steroids are not recommended in early treatment. They help only with the late phase of inflammatory response, but despite that, there is no good evidence that they decrease the biphasic response of anaphylaxis. There is some emerging evidence that the use of steroids may actually be associated with increased morbidity even after correcting for anaphylaxis severity. The authors recommended the use of steroids in anaphylaxis only for patients with poorly controlled asthma and possibly for patients with refractory anaphylaxis. Inhaled beta-agonists are recommended in anaphylaxis only for patients with lower respiratory tract symptoms caused by anaphylaxis, but warned that the inhaled beta-agonists should not delay proper use of EPI.
• The optimal observation period before discharge for stable patients is unknown. The authors noted the recommendations of the Joint Task Force on Practice Parameters of the American Academy of Allergy, Asthma, & Immunology and the American College of Allergy, Asthma, and Immunology: Biphasic reactions were more common in patients with severe initial symptoms – for example, those requiring more than one dose of EPI; therefore, these patients are recommended to have “extended observation.” Lower-risk patients with resolved symptoms of anaphylaxis can be observed for 1 hour, which would capture 95% of biphasic reactions in this group of patients.

Summary and other honorable mentions

There you have it. My two favorite practice-changing (non–COVID-19) articles of 2021. Not surprisingly, both articles deal largely with airway and hemodynamic concerns – the ABC’s of emergency medicine. Although these bulleted pearls provide key points from these two articles, the full discussions of those key points in the articles would provide a great deal more education than I can provide in this brief write-up, and so I strongly encourage everyone to read the full articles.

I also encourage readers to peruse the following “honorable mention” articles: Stiell and colleagues published a “Best Practices Checklist” on behalf of the Canadian Association of Emergency Physicians pertaining to the management of acute atrial fibrillation and atrial flutter; and on behalf of the American Heart Association (in collaboration with several other major organizations), Gulati and colleagues published the 2021 Guideline for the Evaluation and Diagnosis of Chest Pain. Both publications show us how we should strive to manage atrial fibrillation and chest pain, respectively, in the emergency department for years to come.

Amal Mattu, MD, is a professor, vice chair of education, and codirector of the emergency cardiology fellowship in the department of emergency medicine at the University of Maryland, Baltimore.

A version of this article first appeared on Medscape.com.

Takayama et al evaluated 301 Japanese HCC patients who had a Child-Pugh score ≤ 7, no more than 3 HCC nodules (none more than 3 cm in greatest diameter), who were then randomly assigned to undergo either surgery (n=150) or RFA (n=151). The authors reported that though the median procedure duration was longer in the surgery group than in the RFA group (274 versus 40 minutes, P < 0.01) as was the median duration of hospital stay (17 days versus 10 days, P < 0.01), recurrence free survival (RFS) did not differ significantly between the groups. The median RFS was 3.5 years (95% confidence interval [CI], 2.6–5.1) in the surgery group and 3.0 years (95% CI, 2.4–5.6) in the RFA group (hazard ratio, 0.92; 95% CI, 0.67–1.25; P = 0.58). The overall survival (OS) data for this study are not yet mature.

Cao et al looked at outcomes of patients with periportal HCCs who were treated with RFA. They evaluated 233 patients who had a single nodular HCC that was ≤ 5 cm in greatest diameter who underwent RFA with or without transarterial chemoembolization (TACE) as first-line therapy. In that group, 56 patients had a periportal HCC. The authors reported that patients with periportal HCCs had worse outcomes. Local recurrence rates at 1, 3, and 5 years were significantly higher with periportal HCCs than with nonperiportal HCCs (15.7, 33.7, and 46.9% vs 6.0, 15.7, and 28.7%, respectively, P = 0.0067). The 1-, 3- and 5-year OS rates with periportal HCCs were significantly worse than with nonperiportal HCCs (81.3, 65.1 and 42.9% vs 99.3, 90.4 and 78.1%, respectively, P < 0.0001). In the subgroup of HCC ≤ 3 cm, patients with periportal HCCs showed significantly higher local recurrence rates (P = 0.0006) and OS (P < 0.0001) after RFA than patients with single nonperiportal HCCs. Subgroup analyses revealed that tumor size, periportal HCC and AFP ≥ 400ug/ml were independent prognostic factors for tumor progression after RFA. The authors concluded that periportal HCCs have a worse prognosis, and need better treatment options than are currently available.

Lee at al report a retrospective evaluation of Korean patients with HCC who were either treated with RFA or microwave ablation (MWA). Of 150 HCC patients (100 in the RFA group and 50 in the MWA group), the complete response rate, two-year survival rate, and complication rate were similar between the two groups. However, the MWA group had better one- and two-year disease-free survival than the RFA group (P = 0.035 and P = 0.032, respectively). In addition, there were fewer major complications in the MWA group (P = 0.043). In a subgroup analysis, patients with perivascular tumors, high risk of recurrence, and small tumor size (≤3 cm) were more suitable for MWA than RFA. The authors concluded that in patients with HCC, initial treatment with microwave ablation leads to better 1- and 2-year disease-free survival and a lower risk of major complications than RFA.

Takayama et al evaluated 301 Japanese HCC patients who had a Child-Pugh score ≤ 7, no more than 3 HCC nodules (none more than 3 cm in greatest diameter), who were then randomly assigned to undergo either surgery (n=150) or RFA (n=151). The authors reported that though the median procedure duration was longer in the surgery group than in the RFA group (274 versus 40 minutes, P < 0.01) as was the median duration of hospital stay (17 days versus 10 days, P < 0.01), recurrence free survival (RFS) did not differ significantly between the groups. The median RFS was 3.5 years (95% confidence interval [CI], 2.6–5.1) in the surgery group and 3.0 years (95% CI, 2.4–5.6) in the RFA group (hazard ratio, 0.92; 95% CI, 0.67–1.25; P = 0.58). The overall survival (OS) data for this study are not yet mature.

Cao et al looked at outcomes of patients with periportal HCCs who were treated with RFA. They evaluated 233 patients who had a single nodular HCC that was ≤ 5 cm in greatest diameter who underwent RFA with or without transarterial chemoembolization (TACE) as first-line therapy. In that group, 56 patients had a periportal HCC. The authors reported that patients with periportal HCCs had worse outcomes. Local recurrence rates at 1, 3, and 5 years were significantly higher with periportal HCCs than with nonperiportal HCCs (15.7, 33.7, and 46.9% vs 6.0, 15.7, and 28.7%, respectively, P = 0.0067). The 1-, 3- and 5-year OS rates with periportal HCCs were significantly worse than with nonperiportal HCCs (81.3, 65.1 and 42.9% vs 99.3, 90.4 and 78.1%, respectively, P < 0.0001). In the subgroup of HCC ≤ 3 cm, patients with periportal HCCs showed significantly higher local recurrence rates (P = 0.0006) and OS (P < 0.0001) after RFA than patients with single nonperiportal HCCs. Subgroup analyses revealed that tumor size, periportal HCC and AFP ≥ 400ug/ml were independent prognostic factors for tumor progression after RFA. The authors concluded that periportal HCCs have a worse prognosis, and need better treatment options than are currently available.

Lee at al report a retrospective evaluation of Korean patients with HCC who were either treated with RFA or microwave ablation (MWA). Of 150 HCC patients (100 in the RFA group and 50 in the MWA group), the complete response rate, two-year survival rate, and complication rate were similar between the two groups. However, the MWA group had better one- and two-year disease-free survival than the RFA group (P = 0.035 and P = 0.032, respectively). In addition, there were fewer major complications in the MWA group (P = 0.043). In a subgroup analysis, patients with perivascular tumors, high risk of recurrence, and small tumor size (≤3 cm) were more suitable for MWA than RFA. The authors concluded that in patients with HCC, initial treatment with microwave ablation leads to better 1- and 2-year disease-free survival and a lower risk of major complications than RFA.

Takayama et al evaluated 301 Japanese HCC patients who had a Child-Pugh score ≤ 7, no more than 3 HCC nodules (none more than 3 cm in greatest diameter), who were then randomly assigned to undergo either surgery (n=150) or RFA (n=151). The authors reported that though the median procedure duration was longer in the surgery group than in the RFA group (274 versus 40 minutes, P < 0.01) as was the median duration of hospital stay (17 days versus 10 days, P < 0.01), recurrence free survival (RFS) did not differ significantly between the groups. The median RFS was 3.5 years (95% confidence interval [CI], 2.6–5.1) in the surgery group and 3.0 years (95% CI, 2.4–5.6) in the RFA group (hazard ratio, 0.92; 95% CI, 0.67–1.25; P = 0.58). The overall survival (OS) data for this study are not yet mature.

Cao et al looked at outcomes of patients with periportal HCCs who were treated with RFA. They evaluated 233 patients who had a single nodular HCC that was ≤ 5 cm in greatest diameter who underwent RFA with or without transarterial chemoembolization (TACE) as first-line therapy. In that group, 56 patients had a periportal HCC. The authors reported that patients with periportal HCCs had worse outcomes. Local recurrence rates at 1, 3, and 5 years were significantly higher with periportal HCCs than with nonperiportal HCCs (15.7, 33.7, and 46.9% vs 6.0, 15.7, and 28.7%, respectively, P = 0.0067). The 1-, 3- and 5-year OS rates with periportal HCCs were significantly worse than with nonperiportal HCCs (81.3, 65.1 and 42.9% vs 99.3, 90.4 and 78.1%, respectively, P < 0.0001). In the subgroup of HCC ≤ 3 cm, patients with periportal HCCs showed significantly higher local recurrence rates (P = 0.0006) and OS (P < 0.0001) after RFA than patients with single nonperiportal HCCs. Subgroup analyses revealed that tumor size, periportal HCC and AFP ≥ 400ug/ml were independent prognostic factors for tumor progression after RFA. The authors concluded that periportal HCCs have a worse prognosis, and need better treatment options than are currently available.

Lee at al report a retrospective evaluation of Korean patients with HCC who were either treated with RFA or microwave ablation (MWA). Of 150 HCC patients (100 in the RFA group and 50 in the MWA group), the complete response rate, two-year survival rate, and complication rate were similar between the two groups. However, the MWA group had better one- and two-year disease-free survival than the RFA group (P = 0.035 and P = 0.032, respectively). In addition, there were fewer major complications in the MWA group (P = 0.043). In a subgroup analysis, patients with perivascular tumors, high risk of recurrence, and small tumor size (≤3 cm) were more suitable for MWA than RFA. The authors concluded that in patients with HCC, initial treatment with microwave ablation leads to better 1- and 2-year disease-free survival and a lower risk of major complications than RFA.

When evaluating patients with atopic dermatitis (AD), it is essential to do a full body exam, rather than simply asking patients to roll up their sleeves to examine the antecubital fossa, advised Jonathan I. Silverberg, MD, PhD, MPH.

Dr. Silverberg, director of clinical research in the department of dermatology at George Washington University, Washington, recommends that patients with AD should be asked to gown up for clinical encounters so that their body surface area (BSA) can be assessed. “Whether you use the palmar method or use the rule of nines (a chart that divides the body into sections representing 9% BSA) ... you need to look at BSA because lesion severity in a localized area doesn’t tell you the whole story,” he said during the Revolutionizing Atopic Dermatitis virtual symposium.

He described his anecdotal experiences with patients objecting to being asked by office staff to wear a gown for exams, who often say they have never been asked by a doctor to do so, and often tell him that with previous exams, they were asked to roll up their sleeves only. But there are many patients with AD who do not have flexural disease “and if they just roll up their sleeve for an exam, you would miss the fact that they might be covered over their trunk or legs or other parts of the body,” Dr. Silverberg said. “Make a concerted effort to look not just at lesion severity but to assess body surface area. We need to assess both.”
 

Capturing the patient perspective

From a patient-reported standpoint, Dr. Silverberg favors asking patients to verbally rate the severity of their disease. Clear or almost clear? Mild, moderate, or severe? “This approach correlates beautifully with validated outcome measures for AD,” he said.

“You could use a numeric rating scale (NRS) for itch, pain, or sleep disturbance. I would argue that it’s best to use a 7-day recall period; 24 hours is too short. They may be clear yesterday but may have been bad 3 days earlier.” The NRS will soon be a reportable item on the AAD DataDerm Clinical Registry, he said, but noted that “the NRS by itself does not accurately predict the full severity of AD.”

A tool he finds useful is the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), which was developed in 2017 by an international panel of experts. “It’s free, feasible to use, and a great option for clinical practice.” Dr. Silverberg said. “It’s highly clinically relevant, but it doesn’t take into account BSA. So, BSA is a separate tool that you want to use as well.”

Another tool he mentioned is the Atopic Dermatitis Control Tool (ADCT), developed by industry in 2018. It uses six questions about AD control intended to be used during a 1-week recall period.

“To maximize efficiency, consider having patients complete patient-reported outcomes through patient portals prior to the office visit,” he advised. “Collecting this information prior to the encounter can speed up the clinical encounter and improve quality of care.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, and receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

When evaluating patients with atopic dermatitis (AD), it is essential to do a full body exam, rather than simply asking patients to roll up their sleeves to examine the antecubital fossa, advised Jonathan I. Silverberg, MD, PhD, MPH.

Dr. Silverberg, director of clinical research in the department of dermatology at George Washington University, Washington, recommends that patients with AD should be asked to gown up for clinical encounters so that their body surface area (BSA) can be assessed. “Whether you use the palmar method or use the rule of nines (a chart that divides the body into sections representing 9% BSA) ... you need to look at BSA because lesion severity in a localized area doesn’t tell you the whole story,” he said during the Revolutionizing Atopic Dermatitis virtual symposium.

He described his anecdotal experiences with patients objecting to being asked by office staff to wear a gown for exams, who often say they have never been asked by a doctor to do so, and often tell him that with previous exams, they were asked to roll up their sleeves only. But there are many patients with AD who do not have flexural disease “and if they just roll up their sleeve for an exam, you would miss the fact that they might be covered over their trunk or legs or other parts of the body,” Dr. Silverberg said. “Make a concerted effort to look not just at lesion severity but to assess body surface area. We need to assess both.”
 

Capturing the patient perspective

From a patient-reported standpoint, Dr. Silverberg favors asking patients to verbally rate the severity of their disease. Clear or almost clear? Mild, moderate, or severe? “This approach correlates beautifully with validated outcome measures for AD,” he said.

“You could use a numeric rating scale (NRS) for itch, pain, or sleep disturbance. I would argue that it’s best to use a 7-day recall period; 24 hours is too short. They may be clear yesterday but may have been bad 3 days earlier.” The NRS will soon be a reportable item on the AAD DataDerm Clinical Registry, he said, but noted that “the NRS by itself does not accurately predict the full severity of AD.”

A tool he finds useful is the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), which was developed in 2017 by an international panel of experts. “It’s free, feasible to use, and a great option for clinical practice.” Dr. Silverberg said. “It’s highly clinically relevant, but it doesn’t take into account BSA. So, BSA is a separate tool that you want to use as well.”

Another tool he mentioned is the Atopic Dermatitis Control Tool (ADCT), developed by industry in 2018. It uses six questions about AD control intended to be used during a 1-week recall period.

“To maximize efficiency, consider having patients complete patient-reported outcomes through patient portals prior to the office visit,” he advised. “Collecting this information prior to the encounter can speed up the clinical encounter and improve quality of care.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, and receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

When evaluating patients with atopic dermatitis (AD), it is essential to do a full body exam, rather than simply asking patients to roll up their sleeves to examine the antecubital fossa, advised Jonathan I. Silverberg, MD, PhD, MPH.

Dr. Silverberg, director of clinical research in the department of dermatology at George Washington University, Washington, recommends that patients with AD should be asked to gown up for clinical encounters so that their body surface area (BSA) can be assessed. “Whether you use the palmar method or use the rule of nines (a chart that divides the body into sections representing 9% BSA) ... you need to look at BSA because lesion severity in a localized area doesn’t tell you the whole story,” he said during the Revolutionizing Atopic Dermatitis virtual symposium.

He described his anecdotal experiences with patients objecting to being asked by office staff to wear a gown for exams, who often say they have never been asked by a doctor to do so, and often tell him that with previous exams, they were asked to roll up their sleeves only. But there are many patients with AD who do not have flexural disease “and if they just roll up their sleeve for an exam, you would miss the fact that they might be covered over their trunk or legs or other parts of the body,” Dr. Silverberg said. “Make a concerted effort to look not just at lesion severity but to assess body surface area. We need to assess both.”
 

Capturing the patient perspective

From a patient-reported standpoint, Dr. Silverberg favors asking patients to verbally rate the severity of their disease. Clear or almost clear? Mild, moderate, or severe? “This approach correlates beautifully with validated outcome measures for AD,” he said.

“You could use a numeric rating scale (NRS) for itch, pain, or sleep disturbance. I would argue that it’s best to use a 7-day recall period; 24 hours is too short. They may be clear yesterday but may have been bad 3 days earlier.” The NRS will soon be a reportable item on the AAD DataDerm Clinical Registry, he said, but noted that “the NRS by itself does not accurately predict the full severity of AD.”

A tool he finds useful is the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), which was developed in 2017 by an international panel of experts. “It’s free, feasible to use, and a great option for clinical practice.” Dr. Silverberg said. “It’s highly clinically relevant, but it doesn’t take into account BSA. So, BSA is a separate tool that you want to use as well.”

Another tool he mentioned is the Atopic Dermatitis Control Tool (ADCT), developed by industry in 2018. It uses six questions about AD control intended to be used during a 1-week recall period.

“To maximize efficiency, consider having patients complete patient-reported outcomes through patient portals prior to the office visit,” he advised. “Collecting this information prior to the encounter can speed up the clinical encounter and improve quality of care.”

Dr. Silverberg disclosed that he is a consultant to numerous pharmaceutical companies, and receives fees for non-CME/CE services from Eli Lilly, Leo Pharma, Pfizer, Regeneron, and Sanofi Genzyme, as well as contracted research fees from Galderma.

Takayama et al evaluated 301 Japanese HCC patients who had a Child-Pugh score ≤ 7, no more than 3 HCC nodules (none more than 3 cm in greatest diameter), who were then randomly assigned to undergo either surgery (n=150) or RFA (n=151). The authors reported that though the median procedure duration was longer in the surgery group than in the RFA group (274 versus 40 minutes, P < 0.01) as was the median duration of hospital stay (17 days versus 10 days, P < 0.01), recurrence free survival (RFS) did not differ significantly between the groups. The median RFS was 3.5 years (95% confidence interval [CI], 2.6–5.1) in the surgery group and 3.0 years (95% CI, 2.4–5.6) in the RFA group (hazard ratio, 0.92; 95% CI, 0.67–1.25; P = 0.58). The overall survival (OS) data for this study are not yet mature.

Cao et al looked at outcomes of patients with periportal HCCs who were treated with RFA. They evaluated 233 patients who had a single nodular HCC that was ≤ 5 cm in greatest diameter who underwent RFA with or without transarterial chemoembolization (TACE) as first-line therapy. In that group, 56 patients had a periportal HCC. The authors reported that patients with periportal HCCs had worse outcomes. Local recurrence rates at 1, 3, and 5 years were significantly higher with periportal HCCs than with nonperiportal HCCs (15.7, 33.7, and 46.9% vs 6.0, 15.7, and 28.7%, respectively, P = 0.0067). The 1-, 3- and 5-year OS rates with periportal HCCs were significantly worse than with nonperiportal HCCs (81.3, 65.1 and 42.9% vs 99.3, 90.4 and 78.1%, respectively, P < 0.0001). In the subgroup of HCC ≤ 3 cm, patients with periportal HCCs showed significantly higher local recurrence rates (P = 0.0006) and OS (P < 0.0001) after RFA than patients with single nonperiportal HCCs. Subgroup analyses revealed that tumor size, periportal HCC and AFP ≥ 400ug/ml were independent prognostic factors for tumor progression after RFA. The authors concluded that periportal HCCs have a worse prognosis, and need better treatment options than are currently available.

Lee at al report a retrospective evaluation of Korean patients with HCC who were either treated with RFA or microwave ablation (MWA). Of 150 HCC patients (100 in the RFA group and 50 in the MWA group), the complete response rate, two-year survival rate, and complication rate were similar between the two groups. However, the MWA group had better one- and two-year disease-free survival than the RFA group (P = 0.035 and P = 0.032, respectively). In addition, there were fewer major complications in the MWA group (P = 0.043). In a subgroup analysis, patients with perivascular tumors, high risk of recurrence, and small tumor size (≤3 cm) were more suitable for MWA than RFA. The authors concluded that in patients with HCC, initial treatment with microwave ablation leads to better 1- and 2-year disease-free survival and a lower risk of major complications than RFA.

Takayama et al evaluated 301 Japanese HCC patients who had a Child-Pugh score ≤ 7, no more than 3 HCC nodules (none more than 3 cm in greatest diameter), who were then randomly assigned to undergo either surgery (n=150) or RFA (n=151). The authors reported that though the median procedure duration was longer in the surgery group than in the RFA group (274 versus 40 minutes, P < 0.01) as was the median duration of hospital stay (17 days versus 10 days, P < 0.01), recurrence free survival (RFS) did not differ significantly between the groups. The median RFS was 3.5 years (95% confidence interval [CI], 2.6–5.1) in the surgery group and 3.0 years (95% CI, 2.4–5.6) in the RFA group (hazard ratio, 0.92; 95% CI, 0.67–1.25; P = 0.58). The overall survival (OS) data for this study are not yet mature.

Cao et al looked at outcomes of patients with periportal HCCs who were treated with RFA. They evaluated 233 patients who had a single nodular HCC that was ≤ 5 cm in greatest diameter who underwent RFA with or without transarterial chemoembolization (TACE) as first-line therapy. In that group, 56 patients had a periportal HCC. The authors reported that patients with periportal HCCs had worse outcomes. Local recurrence rates at 1, 3, and 5 years were significantly higher with periportal HCCs than with nonperiportal HCCs (15.7, 33.7, and 46.9% vs 6.0, 15.7, and 28.7%, respectively, P = 0.0067). The 1-, 3- and 5-year OS rates with periportal HCCs were significantly worse than with nonperiportal HCCs (81.3, 65.1 and 42.9% vs 99.3, 90.4 and 78.1%, respectively, P < 0.0001). In the subgroup of HCC ≤ 3 cm, patients with periportal HCCs showed significantly higher local recurrence rates (P = 0.0006) and OS (P < 0.0001) after RFA than patients with single nonperiportal HCCs. Subgroup analyses revealed that tumor size, periportal HCC and AFP ≥ 400ug/ml were independent prognostic factors for tumor progression after RFA. The authors concluded that periportal HCCs have a worse prognosis, and need better treatment options than are currently available.

Lee at al report a retrospective evaluation of Korean patients with HCC who were either treated with RFA or microwave ablation (MWA). Of 150 HCC patients (100 in the RFA group and 50 in the MWA group), the complete response rate, two-year survival rate, and complication rate were similar between the two groups. However, the MWA group had better one- and two-year disease-free survival than the RFA group (P = 0.035 and P = 0.032, respectively). In addition, there were fewer major complications in the MWA group (P = 0.043). In a subgroup analysis, patients with perivascular tumors, high risk of recurrence, and small tumor size (≤3 cm) were more suitable for MWA than RFA. The authors concluded that in patients with HCC, initial treatment with microwave ablation leads to better 1- and 2-year disease-free survival and a lower risk of major complications than RFA.

Takayama et al evaluated 301 Japanese HCC patients who had a Child-Pugh score ≤ 7, no more than 3 HCC nodules (none more than 3 cm in greatest diameter), who were then randomly assigned to undergo either surgery (n=150) or RFA (n=151). The authors reported that though the median procedure duration was longer in the surgery group than in the RFA group (274 versus 40 minutes, P < 0.01) as was the median duration of hospital stay (17 days versus 10 days, P < 0.01), recurrence free survival (RFS) did not differ significantly between the groups. The median RFS was 3.5 years (95% confidence interval [CI], 2.6–5.1) in the surgery group and 3.0 years (95% CI, 2.4–5.6) in the RFA group (hazard ratio, 0.92; 95% CI, 0.67–1.25; P = 0.58). The overall survival (OS) data for this study are not yet mature.

Cao et al looked at outcomes of patients with periportal HCCs who were treated with RFA. They evaluated 233 patients who had a single nodular HCC that was ≤ 5 cm in greatest diameter who underwent RFA with or without transarterial chemoembolization (TACE) as first-line therapy. In that group, 56 patients had a periportal HCC. The authors reported that patients with periportal HCCs had worse outcomes. Local recurrence rates at 1, 3, and 5 years were significantly higher with periportal HCCs than with nonperiportal HCCs (15.7, 33.7, and 46.9% vs 6.0, 15.7, and 28.7%, respectively, P = 0.0067). The 1-, 3- and 5-year OS rates with periportal HCCs were significantly worse than with nonperiportal HCCs (81.3, 65.1 and 42.9% vs 99.3, 90.4 and 78.1%, respectively, P < 0.0001). In the subgroup of HCC ≤ 3 cm, patients with periportal HCCs showed significantly higher local recurrence rates (P = 0.0006) and OS (P < 0.0001) after RFA than patients with single nonperiportal HCCs. Subgroup analyses revealed that tumor size, periportal HCC and AFP ≥ 400ug/ml were independent prognostic factors for tumor progression after RFA. The authors concluded that periportal HCCs have a worse prognosis, and need better treatment options than are currently available.

Lee at al report a retrospective evaluation of Korean patients with HCC who were either treated with RFA or microwave ablation (MWA). Of 150 HCC patients (100 in the RFA group and 50 in the MWA group), the complete response rate, two-year survival rate, and complication rate were similar between the two groups. However, the MWA group had better one- and two-year disease-free survival than the RFA group (P = 0.035 and P = 0.032, respectively). In addition, there were fewer major complications in the MWA group (P = 0.043). In a subgroup analysis, patients with perivascular tumors, high risk of recurrence, and small tumor size (≤3 cm) were more suitable for MWA than RFA. The authors concluded that in patients with HCC, initial treatment with microwave ablation leads to better 1- and 2-year disease-free survival and a lower risk of major complications than RFA.

A new study of thousands of women has found that sticking to recommended healthy dietary patterns can lessen the risk of new-onset gout.

“The identification of multiple patterns of eating that can similarly reduce a woman’s risk of incident gout in our study allows more choice for potential personalization of dietary recommendations according to culinary traditions and personal preferences to enhance adherence,” Chio Yokose, MD, of Harvard Medical School, Boston, and coauthors wrote. The study was published Jan. 31, 2022, in JAMA Internal Medicine.

OksanaKiian/Getty Images

To determine whether consistent healthy eating plays a role in preventing gout in women, the authors launched a prospective cohort study tied to the Nurses’ Health Study, an ongoing endeavor that has been questioning its participants’ food and beverage intake since 1984. Based on the 2020 to 2025 Dietary Guidelines for Americans, four healthy eating patterns were identified for assessment: the Dietary Approaches to Stop Hypertension (DASH), the Mediterranean diet, the Alternative Healthy Eating Index, and the Prudent diet, as well as the unhealthy Western dietary pattern for comparison.

Over 34 years of follow-up, the researchers identified 3,890 cases of gout among 80,039 women with an average age of 50.5 and an average body mass index (BMI) of 25.0 kg/m². Women who strongly adhered to either of the four healthy dietary patterns had a significantly lower risk of gout, especially those who stuck to DASH (multivariable hazard ratio, 0.68; 95% confidence interval, 0.61-0.76) and Prudent (HR, 0.75; 95% CI, 0.73-0.90). In contrast, women with high Western diet scores had a 49% increased risk of gout (HR, 1.49; 95% CI, 1.33-1.68), compared with those who had low scores.

After additional analysis that factored in variables like diuretic use, alcohol use, and obesity, the associations between each diet and their risk of gout persisted in almost every instance. In particular, the most DASH-adherent women with normal BMI had a 68% lower risk of gout (HR, 0.32; 95% CI, 0.26-0.38), compared with the least-adherent women who were overweight or obese. Strong DASH adherence and no diuretic use also led to a 65% gout risk reduction (HR, 0.35; 95% CI, 0.30-0.41).
 

Healthy eating offers broad benefits for gout patients

“These results are consistent with a lot of the conversations we have on a day-to-day basis with patients,” Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha, said in an interview. “But I will say, I don’t get a lot of patients coming in saying: ‘Hey, what can I do to prevent gout?’ You’re usually seeing them after the fact.”

“These results shouldn’t be confused with that,” he said. “In other words, I wouldn’t want people interpreting this study to mean diet is always a satisfactory treatment for someone with established gout. The fact of the matter is, often it’s not. We need medication to effectively treat gout. I think this and other studies like it call for future research that can look at these dietary interventions as either standalone or probably adjuvant therapies in gout treatment.”

But, he added, that doesn’t mean conversations about diet aren’t of the utmost importance for gout patients.

“That shouldn’t stop clinicians from talking to patients about dietary changes that holistically are going to have positive benefits,” he said. “By the time you meet them, gout patients often already have other health conditions: high blood pressure, diabetes, obesity. The dietary changes that these authors studied are going to have a holistic benefit that goes well beyond gout risk, and that’s important. That’s a conversation that physicians and health care providers can and should be having right now with their patients.”

The authors acknowledged their study’s limitations, including the unmeasured or residual confounding that could come with any observational study as well as these rates of gout and these dietary patterns not necessarily being representative of a random sample of American women. “Future research could examine the population contributions of diets and other risk factors for incident female gout, as done in men.”

The study was funded by the National Institutes of Health. The authors reported several potential conflicts of interest, including receiving grants from the NIH and grants and personal fees from other organizations and pharmaceutical companies. Dr. Mikuls reported receiving past funding from Horizon Therapeutics and serving for them in a consulting capacity.

A new study of thousands of women has found that sticking to recommended healthy dietary patterns can lessen the risk of new-onset gout.

“The identification of multiple patterns of eating that can similarly reduce a woman’s risk of incident gout in our study allows more choice for potential personalization of dietary recommendations according to culinary traditions and personal preferences to enhance adherence,” Chio Yokose, MD, of Harvard Medical School, Boston, and coauthors wrote. The study was published Jan. 31, 2022, in JAMA Internal Medicine.

OksanaKiian/Getty Images

To determine whether consistent healthy eating plays a role in preventing gout in women, the authors launched a prospective cohort study tied to the Nurses’ Health Study, an ongoing endeavor that has been questioning its participants’ food and beverage intake since 1984. Based on the 2020 to 2025 Dietary Guidelines for Americans, four healthy eating patterns were identified for assessment: the Dietary Approaches to Stop Hypertension (DASH), the Mediterranean diet, the Alternative Healthy Eating Index, and the Prudent diet, as well as the unhealthy Western dietary pattern for comparison.

Over 34 years of follow-up, the researchers identified 3,890 cases of gout among 80,039 women with an average age of 50.5 and an average body mass index (BMI) of 25.0 kg/m². Women who strongly adhered to either of the four healthy dietary patterns had a significantly lower risk of gout, especially those who stuck to DASH (multivariable hazard ratio, 0.68; 95% confidence interval, 0.61-0.76) and Prudent (HR, 0.75; 95% CI, 0.73-0.90). In contrast, women with high Western diet scores had a 49% increased risk of gout (HR, 1.49; 95% CI, 1.33-1.68), compared with those who had low scores.

After additional analysis that factored in variables like diuretic use, alcohol use, and obesity, the associations between each diet and their risk of gout persisted in almost every instance. In particular, the most DASH-adherent women with normal BMI had a 68% lower risk of gout (HR, 0.32; 95% CI, 0.26-0.38), compared with the least-adherent women who were overweight or obese. Strong DASH adherence and no diuretic use also led to a 65% gout risk reduction (HR, 0.35; 95% CI, 0.30-0.41).
 

Healthy eating offers broad benefits for gout patients

“These results are consistent with a lot of the conversations we have on a day-to-day basis with patients,” Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha, said in an interview. “But I will say, I don’t get a lot of patients coming in saying: ‘Hey, what can I do to prevent gout?’ You’re usually seeing them after the fact.”

“These results shouldn’t be confused with that,” he said. “In other words, I wouldn’t want people interpreting this study to mean diet is always a satisfactory treatment for someone with established gout. The fact of the matter is, often it’s not. We need medication to effectively treat gout. I think this and other studies like it call for future research that can look at these dietary interventions as either standalone or probably adjuvant therapies in gout treatment.”

But, he added, that doesn’t mean conversations about diet aren’t of the utmost importance for gout patients.

“That shouldn’t stop clinicians from talking to patients about dietary changes that holistically are going to have positive benefits,” he said. “By the time you meet them, gout patients often already have other health conditions: high blood pressure, diabetes, obesity. The dietary changes that these authors studied are going to have a holistic benefit that goes well beyond gout risk, and that’s important. That’s a conversation that physicians and health care providers can and should be having right now with their patients.”

The authors acknowledged their study’s limitations, including the unmeasured or residual confounding that could come with any observational study as well as these rates of gout and these dietary patterns not necessarily being representative of a random sample of American women. “Future research could examine the population contributions of diets and other risk factors for incident female gout, as done in men.”

The study was funded by the National Institutes of Health. The authors reported several potential conflicts of interest, including receiving grants from the NIH and grants and personal fees from other organizations and pharmaceutical companies. Dr. Mikuls reported receiving past funding from Horizon Therapeutics and serving for them in a consulting capacity.

A new study of thousands of women has found that sticking to recommended healthy dietary patterns can lessen the risk of new-onset gout.

“The identification of multiple patterns of eating that can similarly reduce a woman’s risk of incident gout in our study allows more choice for potential personalization of dietary recommendations according to culinary traditions and personal preferences to enhance adherence,” Chio Yokose, MD, of Harvard Medical School, Boston, and coauthors wrote. The study was published Jan. 31, 2022, in JAMA Internal Medicine.

OksanaKiian/Getty Images

To determine whether consistent healthy eating plays a role in preventing gout in women, the authors launched a prospective cohort study tied to the Nurses’ Health Study, an ongoing endeavor that has been questioning its participants’ food and beverage intake since 1984. Based on the 2020 to 2025 Dietary Guidelines for Americans, four healthy eating patterns were identified for assessment: the Dietary Approaches to Stop Hypertension (DASH), the Mediterranean diet, the Alternative Healthy Eating Index, and the Prudent diet, as well as the unhealthy Western dietary pattern for comparison.

Over 34 years of follow-up, the researchers identified 3,890 cases of gout among 80,039 women with an average age of 50.5 and an average body mass index (BMI) of 25.0 kg/m². Women who strongly adhered to either of the four healthy dietary patterns had a significantly lower risk of gout, especially those who stuck to DASH (multivariable hazard ratio, 0.68; 95% confidence interval, 0.61-0.76) and Prudent (HR, 0.75; 95% CI, 0.73-0.90). In contrast, women with high Western diet scores had a 49% increased risk of gout (HR, 1.49; 95% CI, 1.33-1.68), compared with those who had low scores.

After additional analysis that factored in variables like diuretic use, alcohol use, and obesity, the associations between each diet and their risk of gout persisted in almost every instance. In particular, the most DASH-adherent women with normal BMI had a 68% lower risk of gout (HR, 0.32; 95% CI, 0.26-0.38), compared with the least-adherent women who were overweight or obese. Strong DASH adherence and no diuretic use also led to a 65% gout risk reduction (HR, 0.35; 95% CI, 0.30-0.41).
 

Healthy eating offers broad benefits for gout patients

“These results are consistent with a lot of the conversations we have on a day-to-day basis with patients,” Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha, said in an interview. “But I will say, I don’t get a lot of patients coming in saying: ‘Hey, what can I do to prevent gout?’ You’re usually seeing them after the fact.”

“These results shouldn’t be confused with that,” he said. “In other words, I wouldn’t want people interpreting this study to mean diet is always a satisfactory treatment for someone with established gout. The fact of the matter is, often it’s not. We need medication to effectively treat gout. I think this and other studies like it call for future research that can look at these dietary interventions as either standalone or probably adjuvant therapies in gout treatment.”

But, he added, that doesn’t mean conversations about diet aren’t of the utmost importance for gout patients.

“That shouldn’t stop clinicians from talking to patients about dietary changes that holistically are going to have positive benefits,” he said. “By the time you meet them, gout patients often already have other health conditions: high blood pressure, diabetes, obesity. The dietary changes that these authors studied are going to have a holistic benefit that goes well beyond gout risk, and that’s important. That’s a conversation that physicians and health care providers can and should be having right now with their patients.”

The authors acknowledged their study’s limitations, including the unmeasured or residual confounding that could come with any observational study as well as these rates of gout and these dietary patterns not necessarily being representative of a random sample of American women. “Future research could examine the population contributions of diets and other risk factors for incident female gout, as done in men.”

The study was funded by the National Institutes of Health. The authors reported several potential conflicts of interest, including receiving grants from the NIH and grants and personal fees from other organizations and pharmaceutical companies. Dr. Mikuls reported receiving past funding from Horizon Therapeutics and serving for them in a consulting capacity.