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The Nose Knows
A few weeks ago I stumbled upon a two-sentence blurb in a pediatric newsletter summarizing the results of a study comparing the chemical profile of infant body odor with that of postpubertal adolescents. The investigators found that, not surprisingly, the smell of the chemical constituents wafting from babies was more appealing than that emanating from sweaty teenagers. I quickly moved on to the next blurb hoping to find something I hadn’t already experienced or figured out on my own.
But, as I navigated through the rest of my day filled with pickleball, bicycling, and the smell of home-cooked food, something about that study of body odor nagged at me. Who had funded that voyage into the obvious? Were my tax dollars involved? Had I been duped by some alleged nonprofit that had promised my donation would save lives or at least ameliorate suffering? Finally, as the sun dipped below the horizon, my curiosity got the best of me and I searched out the original study. Within minutes I fell down a rabbit hole into the cavernous world of odor science.
Having had zero experience in this niche field, I was amazed at the lengths to which these German odor investigators had gone to analyze the chemicals on and around their subjects. Just trying to ensure that materials and microclimates in the experimental environment were scent-free was a heroic effort. There was “Mono-trap sampling of volatiles, followed by thermodesorption-comprehensive gas chromatography, and time of flight-mass spectrometry analysis.” There were graphs and charts galore. This is serious science, folks. However, they still use the abbreviation “BO” freely, just as I learned to do in junior high. And, in some situations, the investigators relied on the observation of a panel of trained human sniffers to assess the detection threshold and the degree of pleasantness.
Ultimately, the authors’ conclusion was “sexual maturation coincides with changes in body odor chemical composition. Whether those changes explain differences in parental olfactory perception needs to be determined in future studies.” Again, no surprises here.
Exhausted by my venture into the realm of odor science, I finally found the answer to my burning question. The study was supported by the German Research Foundation and the European Union. Phew! Not on my nickel.
Lest you think that I believe any investigation into the potential role of smell in our health and well-being is pure bunk, let me make it clear that I think the role of odor detection is one of the least well-studied and potentially most valuable areas of medical research. Having had one family tell me that their black lab had twice successfully “diagnosed” their pre-verbal child’s ear infection (which I confirmed with an otoscope and the tympanic membrane was intact) I have been keenly interested in the role of animal-assisted diagnosis.
If you also have wondered whether you could write off your pedigreed Portuguese Water Dog as an office expense, I would direct you to an article titled “Canine olfactory detection and its relevance to medical detection.” The authors note that there is some evidence of dogs successfully alerting physicians to Parkinson’s disease, some cancers, malaria, and COVID-19, among others. However, they caution that the reliability is, in most cases, not of a quality that would be helpful on a larger scale.
I can understand the reasons for their caution. However, from my own personal experience, I am completely confident that I can diagnose strep throat by smell, sometimes simply on opening the examination room door. My false-positive rate over 40 years of practice is zero. Of course I still test and, not surprisingly, my false-negative rate is nothing to brag about. However, if a dog can produce even close to my zero false negative with a given disease, that information is valuable and suggests that we should be pointing the odor investigators and their tool box of skills in that direction. I’m pretty sure we don’t need them to dig much deeper into why babies smell better than teenagers.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
A few weeks ago I stumbled upon a two-sentence blurb in a pediatric newsletter summarizing the results of a study comparing the chemical profile of infant body odor with that of postpubertal adolescents. The investigators found that, not surprisingly, the smell of the chemical constituents wafting from babies was more appealing than that emanating from sweaty teenagers. I quickly moved on to the next blurb hoping to find something I hadn’t already experienced or figured out on my own.
But, as I navigated through the rest of my day filled with pickleball, bicycling, and the smell of home-cooked food, something about that study of body odor nagged at me. Who had funded that voyage into the obvious? Were my tax dollars involved? Had I been duped by some alleged nonprofit that had promised my donation would save lives or at least ameliorate suffering? Finally, as the sun dipped below the horizon, my curiosity got the best of me and I searched out the original study. Within minutes I fell down a rabbit hole into the cavernous world of odor science.
Having had zero experience in this niche field, I was amazed at the lengths to which these German odor investigators had gone to analyze the chemicals on and around their subjects. Just trying to ensure that materials and microclimates in the experimental environment were scent-free was a heroic effort. There was “Mono-trap sampling of volatiles, followed by thermodesorption-comprehensive gas chromatography, and time of flight-mass spectrometry analysis.” There were graphs and charts galore. This is serious science, folks. However, they still use the abbreviation “BO” freely, just as I learned to do in junior high. And, in some situations, the investigators relied on the observation of a panel of trained human sniffers to assess the detection threshold and the degree of pleasantness.
Ultimately, the authors’ conclusion was “sexual maturation coincides with changes in body odor chemical composition. Whether those changes explain differences in parental olfactory perception needs to be determined in future studies.” Again, no surprises here.
Exhausted by my venture into the realm of odor science, I finally found the answer to my burning question. The study was supported by the German Research Foundation and the European Union. Phew! Not on my nickel.
Lest you think that I believe any investigation into the potential role of smell in our health and well-being is pure bunk, let me make it clear that I think the role of odor detection is one of the least well-studied and potentially most valuable areas of medical research. Having had one family tell me that their black lab had twice successfully “diagnosed” their pre-verbal child’s ear infection (which I confirmed with an otoscope and the tympanic membrane was intact) I have been keenly interested in the role of animal-assisted diagnosis.
If you also have wondered whether you could write off your pedigreed Portuguese Water Dog as an office expense, I would direct you to an article titled “Canine olfactory detection and its relevance to medical detection.” The authors note that there is some evidence of dogs successfully alerting physicians to Parkinson’s disease, some cancers, malaria, and COVID-19, among others. However, they caution that the reliability is, in most cases, not of a quality that would be helpful on a larger scale.
I can understand the reasons for their caution. However, from my own personal experience, I am completely confident that I can diagnose strep throat by smell, sometimes simply on opening the examination room door. My false-positive rate over 40 years of practice is zero. Of course I still test and, not surprisingly, my false-negative rate is nothing to brag about. However, if a dog can produce even close to my zero false negative with a given disease, that information is valuable and suggests that we should be pointing the odor investigators and their tool box of skills in that direction. I’m pretty sure we don’t need them to dig much deeper into why babies smell better than teenagers.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
A few weeks ago I stumbled upon a two-sentence blurb in a pediatric newsletter summarizing the results of a study comparing the chemical profile of infant body odor with that of postpubertal adolescents. The investigators found that, not surprisingly, the smell of the chemical constituents wafting from babies was more appealing than that emanating from sweaty teenagers. I quickly moved on to the next blurb hoping to find something I hadn’t already experienced or figured out on my own.
But, as I navigated through the rest of my day filled with pickleball, bicycling, and the smell of home-cooked food, something about that study of body odor nagged at me. Who had funded that voyage into the obvious? Were my tax dollars involved? Had I been duped by some alleged nonprofit that had promised my donation would save lives or at least ameliorate suffering? Finally, as the sun dipped below the horizon, my curiosity got the best of me and I searched out the original study. Within minutes I fell down a rabbit hole into the cavernous world of odor science.
Having had zero experience in this niche field, I was amazed at the lengths to which these German odor investigators had gone to analyze the chemicals on and around their subjects. Just trying to ensure that materials and microclimates in the experimental environment were scent-free was a heroic effort. There was “Mono-trap sampling of volatiles, followed by thermodesorption-comprehensive gas chromatography, and time of flight-mass spectrometry analysis.” There were graphs and charts galore. This is serious science, folks. However, they still use the abbreviation “BO” freely, just as I learned to do in junior high. And, in some situations, the investigators relied on the observation of a panel of trained human sniffers to assess the detection threshold and the degree of pleasantness.
Ultimately, the authors’ conclusion was “sexual maturation coincides with changes in body odor chemical composition. Whether those changes explain differences in parental olfactory perception needs to be determined in future studies.” Again, no surprises here.
Exhausted by my venture into the realm of odor science, I finally found the answer to my burning question. The study was supported by the German Research Foundation and the European Union. Phew! Not on my nickel.
Lest you think that I believe any investigation into the potential role of smell in our health and well-being is pure bunk, let me make it clear that I think the role of odor detection is one of the least well-studied and potentially most valuable areas of medical research. Having had one family tell me that their black lab had twice successfully “diagnosed” their pre-verbal child’s ear infection (which I confirmed with an otoscope and the tympanic membrane was intact) I have been keenly interested in the role of animal-assisted diagnosis.
If you also have wondered whether you could write off your pedigreed Portuguese Water Dog as an office expense, I would direct you to an article titled “Canine olfactory detection and its relevance to medical detection.” The authors note that there is some evidence of dogs successfully alerting physicians to Parkinson’s disease, some cancers, malaria, and COVID-19, among others. However, they caution that the reliability is, in most cases, not of a quality that would be helpful on a larger scale.
I can understand the reasons for their caution. However, from my own personal experience, I am completely confident that I can diagnose strep throat by smell, sometimes simply on opening the examination room door. My false-positive rate over 40 years of practice is zero. Of course I still test and, not surprisingly, my false-negative rate is nothing to brag about. However, if a dog can produce even close to my zero false negative with a given disease, that information is valuable and suggests that we should be pointing the odor investigators and their tool box of skills in that direction. I’m pretty sure we don’t need them to dig much deeper into why babies smell better than teenagers.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
No Increased Stroke Risk After COVID-19 Bivalent Vaccine
TOPLINE:
, a new study of Medicare beneficiaries showed.
METHODOLOGY:
- The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
- A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
- The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
- The mean age of participants was 74 years, and 56% were female.
TAKEAWAY:
- There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
- Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
- There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).
IN PRACTICE:
“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”
SOURCE:
Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.
LIMITATIONS:
Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.
DISCLOSURES:
This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.
A version of this article appeared on Medscape.com.
TOPLINE:
, a new study of Medicare beneficiaries showed.
METHODOLOGY:
- The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
- A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
- The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
- The mean age of participants was 74 years, and 56% were female.
TAKEAWAY:
- There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
- Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
- There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).
IN PRACTICE:
“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”
SOURCE:
Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.
LIMITATIONS:
Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.
DISCLOSURES:
This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.
A version of this article appeared on Medscape.com.
TOPLINE:
, a new study of Medicare beneficiaries showed.
METHODOLOGY:
- The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
- A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
- The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
- The mean age of participants was 74 years, and 56% were female.
TAKEAWAY:
- There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
- Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
- There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).
IN PRACTICE:
“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”
SOURCE:
Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.
LIMITATIONS:
Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.
DISCLOSURES:
This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.
A version of this article appeared on Medscape.com.
Tarlatamab Shows Promise in Tackling Previously Treated SCLC
The investigational bispecific T-cell engager tarlatamab achieved durable responses and clinically meaningful survival outcomes in patients with small-cell lung cancer (SCLC), particularly at lower doses, according to a follow-up analysis of the phase 1 DeLLphi-300 trial.
Most patients with central nervous system tumors also sustained tumor shrinkage long after receiving radiotherapy, providing “encouraging evidence” of the new agent’s intracranial activity, said study presenter Horst-Dieter Hummel, MD, Comprehensive Cancer Center Mainfranken, Würzburg, Germany.
The research was presented at the European Lung Cancer Congress 2024 on March 22.
Data from the phase 1 and phase 2 DeLLphi trials, published last year, showed the compound achieved “encouraging clinical activity” in pretreated patients, said Dr. Hummel.
The initial phase 1 DeLLphi study found that after a median follow-up of 8.7 months, the immunotherapy led to a disease control rate of 51.4%, a median progression-free survival of 3.7 months, and median overall survival of 13.2 months.
At the meeting, Dr. Hummel reported longer-term outcomes from the phase 1 study over a median of 12.1 months as well as intracranial activity in patients who received clinically relevant doses of tarlatamab, defined as ≥ 10 mg.
The 152 patients included in the analysis had a median of two prior lines of therapy; 76.3% had undergone radiotherapy, and 63.2% had received immunotherapy. Liver metastases were present in 42.1% of patients, and 25.0% had brain metastases.
Doses varied among participants, with 76 patients (50.0%) receiving 100 mg, 32 (21.0%) receiving 100 mg via extended intravenous infusion, 17 (11.2%) receiving 10 mg, and 8 (5.3%) receiving 30 mg.
The overall objective response rate was 25.0%, with a median duration of response of 11.2 months. Among patients given the 10-mg dose, the objective response rate was higher, at 35.3%, as was the median duration of response, at 14.9 months.
Tarlatamab was associated with a median overall survival of 17.5 months, with 57.9% of patients alive at 12 months. Patients receiving the 10 mg dose had a better median overall survival of 20.3 months.
Of the 16 patients with analyzable central nervous system tumors, 62.5% experienced tumor shrinkage by ≥ 30% and 87.5% experienced intracranial disease control, which lasted for a median of 7.4 months.
In this follow-up study, tarlatamab demonstrated “clinically meaningful survival outcomes in patients with previously treated SCLC, particularly with the 10 mg dose,” Dr. Hummel concluded in his presentation.
No new safety signals emerged, though almost all patients did experience tarlatamab-related adverse events (94.8% for doses > 10 mg and 100% of patients with 10 mg doses). Overall, 66.4% of the total cohort experienced cytokine release syndrome of any grade, and 11.8% developed immune effector cell-associated neurotoxicity syndrome.
Discontinuation due to treatment-related adverse events occurred in 9 patients overall, and adverse events that led to dose interruption or reduction occurred in 32 patients overall.
“After many efforts at DLL3 targeting, we finally have an agent that shows activity and efficacy, and with convincing data,” said Jessica Menis, MD, a medical oncologist at the oncology department of the University Hospital of Verona, Italy, who was not involved in the study. The intracranial activity of tarlatamab “needs to be further evaluated in untreated patients,” Dr. Menis noted, because the study included only patients with stable, treated brain metastases.
And given the high rates of adverse events, Dr. Menis cautioned that adverse event management “will be a challenge.”
On X (Twitter), Tom Newsom-Davis, MBBS, PhD, a consultant in medical oncology at Chelsea and Westminster Hospital, London, said that tarlatamab is “not a straightforward drug to use,” highlighting the occurrence of cytokine release syndrome.
“But in this significantly pretreated population and in this hard-to-treat tumor type,” the rate and duration of responses seen with the extended follow-up are ‘impressive’,” he added.
DeLLphi-300, 301, and 304 were funded by Amgen Inc. Dr. Hummel declared relationships with several companies, including Amgen, Bristol Myers Squibb, AstraZeneca, Celgene, Merck, Novartis, Daiichi Sankyo, and Roche. Dr. Menis declared relationships with AstraZeneca, BMS, MSD, Roche, and Novartis.
A version of this article appeared on Medscape.com.
The investigational bispecific T-cell engager tarlatamab achieved durable responses and clinically meaningful survival outcomes in patients with small-cell lung cancer (SCLC), particularly at lower doses, according to a follow-up analysis of the phase 1 DeLLphi-300 trial.
Most patients with central nervous system tumors also sustained tumor shrinkage long after receiving radiotherapy, providing “encouraging evidence” of the new agent’s intracranial activity, said study presenter Horst-Dieter Hummel, MD, Comprehensive Cancer Center Mainfranken, Würzburg, Germany.
The research was presented at the European Lung Cancer Congress 2024 on March 22.
Data from the phase 1 and phase 2 DeLLphi trials, published last year, showed the compound achieved “encouraging clinical activity” in pretreated patients, said Dr. Hummel.
The initial phase 1 DeLLphi study found that after a median follow-up of 8.7 months, the immunotherapy led to a disease control rate of 51.4%, a median progression-free survival of 3.7 months, and median overall survival of 13.2 months.
At the meeting, Dr. Hummel reported longer-term outcomes from the phase 1 study over a median of 12.1 months as well as intracranial activity in patients who received clinically relevant doses of tarlatamab, defined as ≥ 10 mg.
The 152 patients included in the analysis had a median of two prior lines of therapy; 76.3% had undergone radiotherapy, and 63.2% had received immunotherapy. Liver metastases were present in 42.1% of patients, and 25.0% had brain metastases.
Doses varied among participants, with 76 patients (50.0%) receiving 100 mg, 32 (21.0%) receiving 100 mg via extended intravenous infusion, 17 (11.2%) receiving 10 mg, and 8 (5.3%) receiving 30 mg.
The overall objective response rate was 25.0%, with a median duration of response of 11.2 months. Among patients given the 10-mg dose, the objective response rate was higher, at 35.3%, as was the median duration of response, at 14.9 months.
Tarlatamab was associated with a median overall survival of 17.5 months, with 57.9% of patients alive at 12 months. Patients receiving the 10 mg dose had a better median overall survival of 20.3 months.
Of the 16 patients with analyzable central nervous system tumors, 62.5% experienced tumor shrinkage by ≥ 30% and 87.5% experienced intracranial disease control, which lasted for a median of 7.4 months.
In this follow-up study, tarlatamab demonstrated “clinically meaningful survival outcomes in patients with previously treated SCLC, particularly with the 10 mg dose,” Dr. Hummel concluded in his presentation.
No new safety signals emerged, though almost all patients did experience tarlatamab-related adverse events (94.8% for doses > 10 mg and 100% of patients with 10 mg doses). Overall, 66.4% of the total cohort experienced cytokine release syndrome of any grade, and 11.8% developed immune effector cell-associated neurotoxicity syndrome.
Discontinuation due to treatment-related adverse events occurred in 9 patients overall, and adverse events that led to dose interruption or reduction occurred in 32 patients overall.
“After many efforts at DLL3 targeting, we finally have an agent that shows activity and efficacy, and with convincing data,” said Jessica Menis, MD, a medical oncologist at the oncology department of the University Hospital of Verona, Italy, who was not involved in the study. The intracranial activity of tarlatamab “needs to be further evaluated in untreated patients,” Dr. Menis noted, because the study included only patients with stable, treated brain metastases.
And given the high rates of adverse events, Dr. Menis cautioned that adverse event management “will be a challenge.”
On X (Twitter), Tom Newsom-Davis, MBBS, PhD, a consultant in medical oncology at Chelsea and Westminster Hospital, London, said that tarlatamab is “not a straightforward drug to use,” highlighting the occurrence of cytokine release syndrome.
“But in this significantly pretreated population and in this hard-to-treat tumor type,” the rate and duration of responses seen with the extended follow-up are ‘impressive’,” he added.
DeLLphi-300, 301, and 304 were funded by Amgen Inc. Dr. Hummel declared relationships with several companies, including Amgen, Bristol Myers Squibb, AstraZeneca, Celgene, Merck, Novartis, Daiichi Sankyo, and Roche. Dr. Menis declared relationships with AstraZeneca, BMS, MSD, Roche, and Novartis.
A version of this article appeared on Medscape.com.
The investigational bispecific T-cell engager tarlatamab achieved durable responses and clinically meaningful survival outcomes in patients with small-cell lung cancer (SCLC), particularly at lower doses, according to a follow-up analysis of the phase 1 DeLLphi-300 trial.
Most patients with central nervous system tumors also sustained tumor shrinkage long after receiving radiotherapy, providing “encouraging evidence” of the new agent’s intracranial activity, said study presenter Horst-Dieter Hummel, MD, Comprehensive Cancer Center Mainfranken, Würzburg, Germany.
The research was presented at the European Lung Cancer Congress 2024 on March 22.
Data from the phase 1 and phase 2 DeLLphi trials, published last year, showed the compound achieved “encouraging clinical activity” in pretreated patients, said Dr. Hummel.
The initial phase 1 DeLLphi study found that after a median follow-up of 8.7 months, the immunotherapy led to a disease control rate of 51.4%, a median progression-free survival of 3.7 months, and median overall survival of 13.2 months.
At the meeting, Dr. Hummel reported longer-term outcomes from the phase 1 study over a median of 12.1 months as well as intracranial activity in patients who received clinically relevant doses of tarlatamab, defined as ≥ 10 mg.
The 152 patients included in the analysis had a median of two prior lines of therapy; 76.3% had undergone radiotherapy, and 63.2% had received immunotherapy. Liver metastases were present in 42.1% of patients, and 25.0% had brain metastases.
Doses varied among participants, with 76 patients (50.0%) receiving 100 mg, 32 (21.0%) receiving 100 mg via extended intravenous infusion, 17 (11.2%) receiving 10 mg, and 8 (5.3%) receiving 30 mg.
The overall objective response rate was 25.0%, with a median duration of response of 11.2 months. Among patients given the 10-mg dose, the objective response rate was higher, at 35.3%, as was the median duration of response, at 14.9 months.
Tarlatamab was associated with a median overall survival of 17.5 months, with 57.9% of patients alive at 12 months. Patients receiving the 10 mg dose had a better median overall survival of 20.3 months.
Of the 16 patients with analyzable central nervous system tumors, 62.5% experienced tumor shrinkage by ≥ 30% and 87.5% experienced intracranial disease control, which lasted for a median of 7.4 months.
In this follow-up study, tarlatamab demonstrated “clinically meaningful survival outcomes in patients with previously treated SCLC, particularly with the 10 mg dose,” Dr. Hummel concluded in his presentation.
No new safety signals emerged, though almost all patients did experience tarlatamab-related adverse events (94.8% for doses > 10 mg and 100% of patients with 10 mg doses). Overall, 66.4% of the total cohort experienced cytokine release syndrome of any grade, and 11.8% developed immune effector cell-associated neurotoxicity syndrome.
Discontinuation due to treatment-related adverse events occurred in 9 patients overall, and adverse events that led to dose interruption or reduction occurred in 32 patients overall.
“After many efforts at DLL3 targeting, we finally have an agent that shows activity and efficacy, and with convincing data,” said Jessica Menis, MD, a medical oncologist at the oncology department of the University Hospital of Verona, Italy, who was not involved in the study. The intracranial activity of tarlatamab “needs to be further evaluated in untreated patients,” Dr. Menis noted, because the study included only patients with stable, treated brain metastases.
And given the high rates of adverse events, Dr. Menis cautioned that adverse event management “will be a challenge.”
On X (Twitter), Tom Newsom-Davis, MBBS, PhD, a consultant in medical oncology at Chelsea and Westminster Hospital, London, said that tarlatamab is “not a straightforward drug to use,” highlighting the occurrence of cytokine release syndrome.
“But in this significantly pretreated population and in this hard-to-treat tumor type,” the rate and duration of responses seen with the extended follow-up are ‘impressive’,” he added.
DeLLphi-300, 301, and 304 were funded by Amgen Inc. Dr. Hummel declared relationships with several companies, including Amgen, Bristol Myers Squibb, AstraZeneca, Celgene, Merck, Novartis, Daiichi Sankyo, and Roche. Dr. Menis declared relationships with AstraZeneca, BMS, MSD, Roche, and Novartis.
A version of this article appeared on Medscape.com.
FROM ELCC 2024
FDA OKs First-in-Class Agent for Pulmonary Arterial Hypertension
The US Food and Drug Administration (FDA) has approved sotatercept (Winrevair, Merck), for the treatment of adults with pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group 1, to increase exercise capacity, improve WHO functional class, and reduce the risk for clinical worsening events.
“Sotatercept added to background therapy has the potential to become a new standard-of-care option for patients with pulmonary arterial hypertension,” added coinvestigator Aaron B. Waxman, MD, PhD, executive director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital, Boston.
The approval was based on results of the phase 3 STELLAR study, a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which, 323 patients with PAH (WHO Group 1, functional class II or III) were randomly assigned 1:1 to add sotatercept or placebo to stable background therapy.
The results showed that sotatercept, administered subcutaneously every 3 weeks for 24 weeks, improved average 6-minute walk distance from baseline by a significant and clinically meaningful 40.8 meters compared with placebo for the trial’s primary efficacy endpoint (P < .001).
Sotatercept also led to significant improvement in multiple secondary outcome measures, including:
- Reduction in the risk for death from any cause or PAH clinical worsening events by 84% vs background therapy alone (number of events: 9 vs 42; hazard ratio [HR], 0.16; P < .001)
- Improvement in FC from baseline at 24 weeks in 29% of patients compared with 14% of patients treated with placebo (P < .001)
- Improvement in pulmonary vascular resistance (PVR), with an average 235 dyn/sec/cm5 reduction in PVR from baseline (P < .001)
- Improvement from baseline in N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels. The median treatment difference in NT-proBNP between sotatercept and placebo was -442 pg/mL (P < .001)
The results were reported last year at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, with simultaneous publication in The New England Journal of Medicine.
Sotatercept injection may be administered by patients or caregivers with guidance, training, and follow-up from a healthcare provider. The recommended starting dose is 0.3 mg/kg. The recommended target dose is 0.7 mg/kg every 3 weeks.
Sotatercept may increase hemoglobin, may lead to erythrocytosis, and may decrease platelet count and lead to severe thrombocytopenia. Treatment should not be initiated if platelet count is < 50,000/mm3.
Hemoglobin and platelets should be monitored before each dose of sotatercept for the first five doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required.
Full prescribing information is available online.
Merck estimates that sotatercept will be available for dispensing by select specialty pharmacies in the United States by the end of April 2024.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved sotatercept (Winrevair, Merck), for the treatment of adults with pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group 1, to increase exercise capacity, improve WHO functional class, and reduce the risk for clinical worsening events.
“Sotatercept added to background therapy has the potential to become a new standard-of-care option for patients with pulmonary arterial hypertension,” added coinvestigator Aaron B. Waxman, MD, PhD, executive director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital, Boston.
The approval was based on results of the phase 3 STELLAR study, a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which, 323 patients with PAH (WHO Group 1, functional class II or III) were randomly assigned 1:1 to add sotatercept or placebo to stable background therapy.
The results showed that sotatercept, administered subcutaneously every 3 weeks for 24 weeks, improved average 6-minute walk distance from baseline by a significant and clinically meaningful 40.8 meters compared with placebo for the trial’s primary efficacy endpoint (P < .001).
Sotatercept also led to significant improvement in multiple secondary outcome measures, including:
- Reduction in the risk for death from any cause or PAH clinical worsening events by 84% vs background therapy alone (number of events: 9 vs 42; hazard ratio [HR], 0.16; P < .001)
- Improvement in FC from baseline at 24 weeks in 29% of patients compared with 14% of patients treated with placebo (P < .001)
- Improvement in pulmonary vascular resistance (PVR), with an average 235 dyn/sec/cm5 reduction in PVR from baseline (P < .001)
- Improvement from baseline in N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels. The median treatment difference in NT-proBNP between sotatercept and placebo was -442 pg/mL (P < .001)
The results were reported last year at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, with simultaneous publication in The New England Journal of Medicine.
Sotatercept injection may be administered by patients or caregivers with guidance, training, and follow-up from a healthcare provider. The recommended starting dose is 0.3 mg/kg. The recommended target dose is 0.7 mg/kg every 3 weeks.
Sotatercept may increase hemoglobin, may lead to erythrocytosis, and may decrease platelet count and lead to severe thrombocytopenia. Treatment should not be initiated if platelet count is < 50,000/mm3.
Hemoglobin and platelets should be monitored before each dose of sotatercept for the first five doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required.
Full prescribing information is available online.
Merck estimates that sotatercept will be available for dispensing by select specialty pharmacies in the United States by the end of April 2024.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved sotatercept (Winrevair, Merck), for the treatment of adults with pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group 1, to increase exercise capacity, improve WHO functional class, and reduce the risk for clinical worsening events.
“Sotatercept added to background therapy has the potential to become a new standard-of-care option for patients with pulmonary arterial hypertension,” added coinvestigator Aaron B. Waxman, MD, PhD, executive director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital, Boston.
The approval was based on results of the phase 3 STELLAR study, a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which, 323 patients with PAH (WHO Group 1, functional class II or III) were randomly assigned 1:1 to add sotatercept or placebo to stable background therapy.
The results showed that sotatercept, administered subcutaneously every 3 weeks for 24 weeks, improved average 6-minute walk distance from baseline by a significant and clinically meaningful 40.8 meters compared with placebo for the trial’s primary efficacy endpoint (P < .001).
Sotatercept also led to significant improvement in multiple secondary outcome measures, including:
- Reduction in the risk for death from any cause or PAH clinical worsening events by 84% vs background therapy alone (number of events: 9 vs 42; hazard ratio [HR], 0.16; P < .001)
- Improvement in FC from baseline at 24 weeks in 29% of patients compared with 14% of patients treated with placebo (P < .001)
- Improvement in pulmonary vascular resistance (PVR), with an average 235 dyn/sec/cm5 reduction in PVR from baseline (P < .001)
- Improvement from baseline in N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels. The median treatment difference in NT-proBNP between sotatercept and placebo was -442 pg/mL (P < .001)
The results were reported last year at the joint scientific sessions of the American College of Cardiology and the World Heart Federation, with simultaneous publication in The New England Journal of Medicine.
Sotatercept injection may be administered by patients or caregivers with guidance, training, and follow-up from a healthcare provider. The recommended starting dose is 0.3 mg/kg. The recommended target dose is 0.7 mg/kg every 3 weeks.
Sotatercept may increase hemoglobin, may lead to erythrocytosis, and may decrease platelet count and lead to severe thrombocytopenia. Treatment should not be initiated if platelet count is < 50,000/mm3.
Hemoglobin and platelets should be monitored before each dose of sotatercept for the first five doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required.
Full prescribing information is available online.
Merck estimates that sotatercept will be available for dispensing by select specialty pharmacies in the United States by the end of April 2024.
A version of this article appeared on Medscape.com.
Lung Cancer Screening Unveils Hidden Health Risks
The reason is because the low-dose CT scans used for screening cover the lower neck down to the upper abdomen, revealing far more anatomy than simply the lungs.
In fact, lung cancer screening can provide information on three of the top 10 causes of death worldwide: ischemic heart disease, chronic obstructive pulmonary disease, and, of course, lung cancer.
With lung cancer screening, “we are basically targeting many birds with one low-dose stone,” explained Jelena Spasic MD, PhD, at the European Lung Cancer Congress (ELCC) 2024.
Dr. Spasic, a medical oncologist at the Institute for Oncology and Radiology of Serbia in Belgrade, was the discussant on a study that gave an indication on just how useful screening can be for other diseases.
The study, dubbed 4-IN-THE-LUNG-RUN trial (4ITLR), is an ongoing prospective trial in six European countries that is using lung cancer screening scans to also look for coronary artery calcifications, a marker of atherosclerosis.
Usually, coronary calcifications are considered incidental findings on lung cancer screenings and reported to subjects’ physicians for heart disease risk assessment.
The difference in 4ITLR is that investigators are actively looking for the lesions and quantifying the extent of calcifications.
It’s made possible by the artificial intelligence-based software being used to read the scans. In addition to generating reports on lung nodules, it also automatically calculates an Agatston score, a quantification of the degree of coronary artery calcification for each subject.
At the meeting, which was organized by the European Society for Clinical Oncology, 4ITLR investigator Daiwei Han, MD, PhD, a research associate at the Institute for Diagnostic Accuracy in Groningen, the Netherlands, reported outcomes in the first 2487 of the 24,000 planned subjects.
To be eligible for screening, participants had to be 60-79 years old and either current smokers, past smokers who had quit within 10 years, or people with a 35 or more pack-year history. The median age in the study was 68.1 years.
Overall, 53% of subjects had Agatston scores of 100 or more, indicating the need for treatment to prevent active coronary artery disease, Dr. Han said.
Fifteen percent were at high risk for heart disease with scores of 400-999, indicating extensive coronary artery calcification, and 16.2% were at very high risk, with scores of 1000 or higher. The information is being shared with participants’ physicians.
The risk of heart disease was far higher in men, who made up 56% of the study population. While women had a median Agatston score of 61, the median score for men was 211.1.
The findings illustrate the potential of dedicated cardiovascular screening within lung cancer screening programs, Dr. Han said, noting that 4ITLR will also incorporate COPD risk assessment.
The study also shows the increased impact lung cancer screening programs could have if greater use were made of the CT images to look for other diseases, Dr. Spasic said.
4ITLR is funded by the European Union’s Horizon 2020 Program. Dr. Spasic and Dr. Han didn’t have any relevant disclosures.
The reason is because the low-dose CT scans used for screening cover the lower neck down to the upper abdomen, revealing far more anatomy than simply the lungs.
In fact, lung cancer screening can provide information on three of the top 10 causes of death worldwide: ischemic heart disease, chronic obstructive pulmonary disease, and, of course, lung cancer.
With lung cancer screening, “we are basically targeting many birds with one low-dose stone,” explained Jelena Spasic MD, PhD, at the European Lung Cancer Congress (ELCC) 2024.
Dr. Spasic, a medical oncologist at the Institute for Oncology and Radiology of Serbia in Belgrade, was the discussant on a study that gave an indication on just how useful screening can be for other diseases.
The study, dubbed 4-IN-THE-LUNG-RUN trial (4ITLR), is an ongoing prospective trial in six European countries that is using lung cancer screening scans to also look for coronary artery calcifications, a marker of atherosclerosis.
Usually, coronary calcifications are considered incidental findings on lung cancer screenings and reported to subjects’ physicians for heart disease risk assessment.
The difference in 4ITLR is that investigators are actively looking for the lesions and quantifying the extent of calcifications.
It’s made possible by the artificial intelligence-based software being used to read the scans. In addition to generating reports on lung nodules, it also automatically calculates an Agatston score, a quantification of the degree of coronary artery calcification for each subject.
At the meeting, which was organized by the European Society for Clinical Oncology, 4ITLR investigator Daiwei Han, MD, PhD, a research associate at the Institute for Diagnostic Accuracy in Groningen, the Netherlands, reported outcomes in the first 2487 of the 24,000 planned subjects.
To be eligible for screening, participants had to be 60-79 years old and either current smokers, past smokers who had quit within 10 years, or people with a 35 or more pack-year history. The median age in the study was 68.1 years.
Overall, 53% of subjects had Agatston scores of 100 or more, indicating the need for treatment to prevent active coronary artery disease, Dr. Han said.
Fifteen percent were at high risk for heart disease with scores of 400-999, indicating extensive coronary artery calcification, and 16.2% were at very high risk, with scores of 1000 or higher. The information is being shared with participants’ physicians.
The risk of heart disease was far higher in men, who made up 56% of the study population. While women had a median Agatston score of 61, the median score for men was 211.1.
The findings illustrate the potential of dedicated cardiovascular screening within lung cancer screening programs, Dr. Han said, noting that 4ITLR will also incorporate COPD risk assessment.
The study also shows the increased impact lung cancer screening programs could have if greater use were made of the CT images to look for other diseases, Dr. Spasic said.
4ITLR is funded by the European Union’s Horizon 2020 Program. Dr. Spasic and Dr. Han didn’t have any relevant disclosures.
The reason is because the low-dose CT scans used for screening cover the lower neck down to the upper abdomen, revealing far more anatomy than simply the lungs.
In fact, lung cancer screening can provide information on three of the top 10 causes of death worldwide: ischemic heart disease, chronic obstructive pulmonary disease, and, of course, lung cancer.
With lung cancer screening, “we are basically targeting many birds with one low-dose stone,” explained Jelena Spasic MD, PhD, at the European Lung Cancer Congress (ELCC) 2024.
Dr. Spasic, a medical oncologist at the Institute for Oncology and Radiology of Serbia in Belgrade, was the discussant on a study that gave an indication on just how useful screening can be for other diseases.
The study, dubbed 4-IN-THE-LUNG-RUN trial (4ITLR), is an ongoing prospective trial in six European countries that is using lung cancer screening scans to also look for coronary artery calcifications, a marker of atherosclerosis.
Usually, coronary calcifications are considered incidental findings on lung cancer screenings and reported to subjects’ physicians for heart disease risk assessment.
The difference in 4ITLR is that investigators are actively looking for the lesions and quantifying the extent of calcifications.
It’s made possible by the artificial intelligence-based software being used to read the scans. In addition to generating reports on lung nodules, it also automatically calculates an Agatston score, a quantification of the degree of coronary artery calcification for each subject.
At the meeting, which was organized by the European Society for Clinical Oncology, 4ITLR investigator Daiwei Han, MD, PhD, a research associate at the Institute for Diagnostic Accuracy in Groningen, the Netherlands, reported outcomes in the first 2487 of the 24,000 planned subjects.
To be eligible for screening, participants had to be 60-79 years old and either current smokers, past smokers who had quit within 10 years, or people with a 35 or more pack-year history. The median age in the study was 68.1 years.
Overall, 53% of subjects had Agatston scores of 100 or more, indicating the need for treatment to prevent active coronary artery disease, Dr. Han said.
Fifteen percent were at high risk for heart disease with scores of 400-999, indicating extensive coronary artery calcification, and 16.2% were at very high risk, with scores of 1000 or higher. The information is being shared with participants’ physicians.
The risk of heart disease was far higher in men, who made up 56% of the study population. While women had a median Agatston score of 61, the median score for men was 211.1.
The findings illustrate the potential of dedicated cardiovascular screening within lung cancer screening programs, Dr. Han said, noting that 4ITLR will also incorporate COPD risk assessment.
The study also shows the increased impact lung cancer screening programs could have if greater use were made of the CT images to look for other diseases, Dr. Spasic said.
4ITLR is funded by the European Union’s Horizon 2020 Program. Dr. Spasic and Dr. Han didn’t have any relevant disclosures.
FROM ELCC 2024
Is Melatonin a Valuable Resource or Children’s Health Risk?
For Courtney Stinson, ensuring her daughter’s comfort is a constant battle against the challenges of congenital myopathy. At 9 years old, she relies on a ventilator to breathe, has multiple respiratory treatments daily, and is under the constant care of rotating skilled caregivers. Last year alone, she endured 36 doctor appointments.
To ease her daughter’s struggles with sleep, and after consulting a pediatrician, Ms. Stinson turned to melatonin, a hormone naturally produced by the body to manage sleep. She gave her daughter a low dose of melatonin and saw significant improvement in her ability to settle down, especially when her mind raced.
“She would have such a hard time sleeping when everything is swirling in her head,” said Ms. Stinson, a mother of two who lives in Milan, Michigan. “It’s really been helpful when her brain is moving 100 miles an hour.”
Melatonin is sold without a prescription as a sleep aid in the form of a supplement.
Recent data from the CDC illustrates one of these drawbacks: a significant surge in accidental melatonin ingestion among young children over the past 2 decades.
Between 2012 and 2021, poison center calls related to pediatric melatonin exposures skyrocketed by 530%, while emergency department visits for unsupervised melatonin ingestion by infants and young children surged by 420% from 2009 to 2020, according to the CDC report.
Between 2019 and 2022, an estimated 10,930 emergency room visits were linked to 295 cases of children under the age of 6 ingesting melatonin. These incidents accounted for 7.1% of all emergency department visits for medication exposures in this age group, according to the report.
The share of U.S. adults using melatonin increased from 0.4% during 1999 to 2000 to 2.1% during 2017 to 2018.
Doctors say the escalating number of melatonin-related incidents underscores the need for increased awareness and safety measures to protect young children from unintentional overdose, which can cause nausea, vomiting, diarrhea, dizziness, and confusion.
“I do think there is a safe way to use it in certain children, but it should only be used under the guidance of a physician,” said Laura Sterni, MD, director of the Johns Hopkins Pediatric Sleep Center. “There are dangers to using it without that guidance.”
Almost 1 in 5 Children Use Melatonin
Nearly 1 in 5 school-age children and preteens take melatonin for sleep, according to research published last year in JAMA Pediatrics, which also found that 18% of children between 5 and 9 take the supplement.
The American Academy of Sleep Medicine issued a warning in 2022 advising parents to approach the sleep aid with caution.
“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” M. Adeel Rishi, MD, vice chair of the Academy of Sleep Medicine’s Public Safety Committee, warned on the academy’s site. “Instead of turning to melatonin, parents should work on encouraging their children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches.”
What’s the Best Way to Give Kids Melatonin?
Melatonin has been found to work well for children with attention deficit hyperactive disorder (ADHD), autism spectrum disorder, or other conditions like blindness that can hinder the development of a normal circadian rhythm.
But beyond consulting a pediatrician, caregivers whose children are otherwise healthy should consider trying other approaches to sleep disruption first, Dr. Sterni said, and things like proper sleep hygiene and anxiety should be addressed first.
“Most sleep problems in children really should be managed with behavioral therapy alone,” she said. “To first pull out a medication to treat that I think is the wrong approach.”
Sterni also recommends starting with the lowest dose possible, which is 0.5 milligrams, with the help of pediatrician. It should be taken 1 to 2 hours before bedtime and 2 hours after their last meal, she said.
But she notes that because melatonin is sold as a supplement and is not regulated by the FDA, it is impossible to know the exact amount in each dose.
According to JAMA, out of 25 supplements of melatonin, most of the products contained up to 50% more melatonin than what was listed.
Dangers of Keeping It Within Reach
One of the biggest dangers for children is that melatonin is often sold in the form of gummies or chewable tablets — things that appeal to children, said Jenna Wheeler, MD, a pediatric critical care doctor at Orlando Health Arnold Palmer Hospital for Children.
Because it is sold as a supplement, there are no child-safe packaging requirements.
“From a critical care standpoint, just remember to keep it up high, not on the nightstand or in a drawer,” Dr. Wheeler said. “A child may eat the whole bottle, thinking, ‘This is just like fruits snacks.’ ”
She noted that the amount people need is often lower than what they buy at the store, and that regardless of whether it is used in proper amounts, it is not meant to be a long-term supplement — for adults or for children.
“Like with anything that’s out there, it’s all about how it’s used,” Dr. Wheeler said. “The problem is when kids get into it accidentally or when it’s not used appropriately.”
A version of this article appeared on WebMD.com.
For Courtney Stinson, ensuring her daughter’s comfort is a constant battle against the challenges of congenital myopathy. At 9 years old, she relies on a ventilator to breathe, has multiple respiratory treatments daily, and is under the constant care of rotating skilled caregivers. Last year alone, she endured 36 doctor appointments.
To ease her daughter’s struggles with sleep, and after consulting a pediatrician, Ms. Stinson turned to melatonin, a hormone naturally produced by the body to manage sleep. She gave her daughter a low dose of melatonin and saw significant improvement in her ability to settle down, especially when her mind raced.
“She would have such a hard time sleeping when everything is swirling in her head,” said Ms. Stinson, a mother of two who lives in Milan, Michigan. “It’s really been helpful when her brain is moving 100 miles an hour.”
Melatonin is sold without a prescription as a sleep aid in the form of a supplement.
Recent data from the CDC illustrates one of these drawbacks: a significant surge in accidental melatonin ingestion among young children over the past 2 decades.
Between 2012 and 2021, poison center calls related to pediatric melatonin exposures skyrocketed by 530%, while emergency department visits for unsupervised melatonin ingestion by infants and young children surged by 420% from 2009 to 2020, according to the CDC report.
Between 2019 and 2022, an estimated 10,930 emergency room visits were linked to 295 cases of children under the age of 6 ingesting melatonin. These incidents accounted for 7.1% of all emergency department visits for medication exposures in this age group, according to the report.
The share of U.S. adults using melatonin increased from 0.4% during 1999 to 2000 to 2.1% during 2017 to 2018.
Doctors say the escalating number of melatonin-related incidents underscores the need for increased awareness and safety measures to protect young children from unintentional overdose, which can cause nausea, vomiting, diarrhea, dizziness, and confusion.
“I do think there is a safe way to use it in certain children, but it should only be used under the guidance of a physician,” said Laura Sterni, MD, director of the Johns Hopkins Pediatric Sleep Center. “There are dangers to using it without that guidance.”
Almost 1 in 5 Children Use Melatonin
Nearly 1 in 5 school-age children and preteens take melatonin for sleep, according to research published last year in JAMA Pediatrics, which also found that 18% of children between 5 and 9 take the supplement.
The American Academy of Sleep Medicine issued a warning in 2022 advising parents to approach the sleep aid with caution.
“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” M. Adeel Rishi, MD, vice chair of the Academy of Sleep Medicine’s Public Safety Committee, warned on the academy’s site. “Instead of turning to melatonin, parents should work on encouraging their children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches.”
What’s the Best Way to Give Kids Melatonin?
Melatonin has been found to work well for children with attention deficit hyperactive disorder (ADHD), autism spectrum disorder, or other conditions like blindness that can hinder the development of a normal circadian rhythm.
But beyond consulting a pediatrician, caregivers whose children are otherwise healthy should consider trying other approaches to sleep disruption first, Dr. Sterni said, and things like proper sleep hygiene and anxiety should be addressed first.
“Most sleep problems in children really should be managed with behavioral therapy alone,” she said. “To first pull out a medication to treat that I think is the wrong approach.”
Sterni also recommends starting with the lowest dose possible, which is 0.5 milligrams, with the help of pediatrician. It should be taken 1 to 2 hours before bedtime and 2 hours after their last meal, she said.
But she notes that because melatonin is sold as a supplement and is not regulated by the FDA, it is impossible to know the exact amount in each dose.
According to JAMA, out of 25 supplements of melatonin, most of the products contained up to 50% more melatonin than what was listed.
Dangers of Keeping It Within Reach
One of the biggest dangers for children is that melatonin is often sold in the form of gummies or chewable tablets — things that appeal to children, said Jenna Wheeler, MD, a pediatric critical care doctor at Orlando Health Arnold Palmer Hospital for Children.
Because it is sold as a supplement, there are no child-safe packaging requirements.
“From a critical care standpoint, just remember to keep it up high, not on the nightstand or in a drawer,” Dr. Wheeler said. “A child may eat the whole bottle, thinking, ‘This is just like fruits snacks.’ ”
She noted that the amount people need is often lower than what they buy at the store, and that regardless of whether it is used in proper amounts, it is not meant to be a long-term supplement — for adults or for children.
“Like with anything that’s out there, it’s all about how it’s used,” Dr. Wheeler said. “The problem is when kids get into it accidentally or when it’s not used appropriately.”
A version of this article appeared on WebMD.com.
For Courtney Stinson, ensuring her daughter’s comfort is a constant battle against the challenges of congenital myopathy. At 9 years old, she relies on a ventilator to breathe, has multiple respiratory treatments daily, and is under the constant care of rotating skilled caregivers. Last year alone, she endured 36 doctor appointments.
To ease her daughter’s struggles with sleep, and after consulting a pediatrician, Ms. Stinson turned to melatonin, a hormone naturally produced by the body to manage sleep. She gave her daughter a low dose of melatonin and saw significant improvement in her ability to settle down, especially when her mind raced.
“She would have such a hard time sleeping when everything is swirling in her head,” said Ms. Stinson, a mother of two who lives in Milan, Michigan. “It’s really been helpful when her brain is moving 100 miles an hour.”
Melatonin is sold without a prescription as a sleep aid in the form of a supplement.
Recent data from the CDC illustrates one of these drawbacks: a significant surge in accidental melatonin ingestion among young children over the past 2 decades.
Between 2012 and 2021, poison center calls related to pediatric melatonin exposures skyrocketed by 530%, while emergency department visits for unsupervised melatonin ingestion by infants and young children surged by 420% from 2009 to 2020, according to the CDC report.
Between 2019 and 2022, an estimated 10,930 emergency room visits were linked to 295 cases of children under the age of 6 ingesting melatonin. These incidents accounted for 7.1% of all emergency department visits for medication exposures in this age group, according to the report.
The share of U.S. adults using melatonin increased from 0.4% during 1999 to 2000 to 2.1% during 2017 to 2018.
Doctors say the escalating number of melatonin-related incidents underscores the need for increased awareness and safety measures to protect young children from unintentional overdose, which can cause nausea, vomiting, diarrhea, dizziness, and confusion.
“I do think there is a safe way to use it in certain children, but it should only be used under the guidance of a physician,” said Laura Sterni, MD, director of the Johns Hopkins Pediatric Sleep Center. “There are dangers to using it without that guidance.”
Almost 1 in 5 Children Use Melatonin
Nearly 1 in 5 school-age children and preteens take melatonin for sleep, according to research published last year in JAMA Pediatrics, which also found that 18% of children between 5 and 9 take the supplement.
The American Academy of Sleep Medicine issued a warning in 2022 advising parents to approach the sleep aid with caution.
“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” M. Adeel Rishi, MD, vice chair of the Academy of Sleep Medicine’s Public Safety Committee, warned on the academy’s site. “Instead of turning to melatonin, parents should work on encouraging their children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches.”
What’s the Best Way to Give Kids Melatonin?
Melatonin has been found to work well for children with attention deficit hyperactive disorder (ADHD), autism spectrum disorder, or other conditions like blindness that can hinder the development of a normal circadian rhythm.
But beyond consulting a pediatrician, caregivers whose children are otherwise healthy should consider trying other approaches to sleep disruption first, Dr. Sterni said, and things like proper sleep hygiene and anxiety should be addressed first.
“Most sleep problems in children really should be managed with behavioral therapy alone,” she said. “To first pull out a medication to treat that I think is the wrong approach.”
Sterni also recommends starting with the lowest dose possible, which is 0.5 milligrams, with the help of pediatrician. It should be taken 1 to 2 hours before bedtime and 2 hours after their last meal, she said.
But she notes that because melatonin is sold as a supplement and is not regulated by the FDA, it is impossible to know the exact amount in each dose.
According to JAMA, out of 25 supplements of melatonin, most of the products contained up to 50% more melatonin than what was listed.
Dangers of Keeping It Within Reach
One of the biggest dangers for children is that melatonin is often sold in the form of gummies or chewable tablets — things that appeal to children, said Jenna Wheeler, MD, a pediatric critical care doctor at Orlando Health Arnold Palmer Hospital for Children.
Because it is sold as a supplement, there are no child-safe packaging requirements.
“From a critical care standpoint, just remember to keep it up high, not on the nightstand or in a drawer,” Dr. Wheeler said. “A child may eat the whole bottle, thinking, ‘This is just like fruits snacks.’ ”
She noted that the amount people need is often lower than what they buy at the store, and that regardless of whether it is used in proper amounts, it is not meant to be a long-term supplement — for adults or for children.
“Like with anything that’s out there, it’s all about how it’s used,” Dr. Wheeler said. “The problem is when kids get into it accidentally or when it’s not used appropriately.”
A version of this article appeared on WebMD.com.
Systematic Viral Testing in Emergency Departments Has Limited Benefit for General Population
Routine use of rapid respiratory virus testing in the emergency department (ED) appears to show limited benefit among patients with signs and symptoms of acute respiratory infection (ARI), according to a new study.
Rapid viral testing wasn’t associated with reduced antibiotic use, ED length of stay, or rates of ED return visits or hospitalization. However, testing was associated with a small increase in antiviral prescriptions and a small reduction in blood tests and chest x-rays.
“Our interest in studying the benefits of rapid viral testing in emergency departments comes from a commitment to diagnostic stewardship — ensuring that the right tests are administered to the right patients at the right time while also curbing overuse,” said lead author Tilmann Schober, MD, a resident in pediatric infectious disease at McGill University and Montreal Children’s Hospital.
“Following the SARS-CoV-2 pandemic, we have seen a surge in the availability of rapid viral testing, including molecular multiplex panels,” he said. “However, the actual impact of these advancements on patient care in the ED remains uncertain.”
The study was published online on March 4, 2024, in JAMA Internal Medicine).
Rapid Viral Testing
Dr. Schober and colleagues conducted a systematic review and meta-analysis of 11 randomized clinical trials to understand whether rapid testing for respiratory viruses was associated with patient treatment in the ED.
In particular, the research team looked at whether testing in patients with suspected ARI was associated with decreased antibiotic use, ancillary tests, ED length of stay, ED return visits, hospitalization, and increased influenza antiviral treatment.
Among the trials, seven studies included molecular testing, and eight used multiplex panels, including influenza and respiratory syncytial virus (RSV), influenza/RSV/adenovirus/parainfluenza, or a panel of 15 or more respiratory viruses. No study evaluated testing for SARS-CoV-2. The research team reported risk ratios (RRs) and risk difference estimates.
In general, routine rapid viral testing was associated with higher use of influenza antivirals (RR, 1.33) and lower use of chest radiography (RR, 0.88) and blood tests (RR, 0.81). However, the magnitude of these effects was small. For instance, to achieve one additional viral prescription, 70 patients would need to be tested, and to save one x-ray, 30 patients would need to be tested.
“This suggests that, while statistically significant, the practical impact of these secondary outcomes may not justify the extensive effort and resources involved in widespread testing,” Dr. Schober said.
In addition, there was no association between rapid testing and antibiotic use (RR, 0.99), urine testing (RR, 0.95), ED length of stay (0 h), return visits (RR, 0.93), or hospitalization (RR, 1.01).
Notably, there was no association between rapid viral testing and antibiotic use in any prespecified subgroup based on age, test method, publication date, number of viral targets, risk of bias, or industry funding, the authors said. They concluded that rapid virus testing should be reserved for patients for whom the testing will change treatment, such as high-risk patients or those with severe disease.
“It’s crucial to note that our study specifically evaluated the impact of systematic testing of patients with signs and symptoms of acute respiratory infection. Our findings do not advocate against rapid respiratory virus testing in general,” Dr. Schober said. “There is well-established evidence supporting the benefits of viral testing in certain contexts, such as hospitalized patients, to guide infection control practices or in specific high-risk populations.”
Future Research
Additional studies should look at testing among subgroups, particularly those with high-risk conditions, the study authors wrote. In addition, the research team would like to study the implementation of novel diagnostic stewardship programs as compared with well-established antibiotic stewardship programs.
“Acute respiratory tract illnesses represent one of the most common reasons for being evaluated in an acute care setting, especially in pediatrics, and these visits have traditionally resulted in excessive antibiotic prescribing, despite the etiology of the infection mostly being viral,” said Suchitra Rao, MBBS, associate professor of pediatrics at the University of Colorado School of Medicine and associate medical director of infection prevention and control at Children’s Hospital Colorado, Aurora.
Dr. Rao, who wasn’t involved with this study, has surveyed ED providers about respiratory viral testing and changes in clinical decision-making. She and colleagues found that providers most commonly changed clinical decision-making while prescribing an antiviral if influenza was detected or withholding antivirals if influenza wasn’t detected.
“Multiplex testing for respiratory viruses and atypical bacteria is becoming more widespread, with newer-generation platforms having shorter turnaround times, and offers the potential to impact point-of-care decision-making,” she said. “However, these tests are expensive, and more studies are needed to explore whether respiratory pathogen panel testing in the acute care setting has an impact in terms of reduced antibiotic use as well as other outcomes, including ED visits, health-seeking behaviors, and hospitalization.”
For instance, more recent studies around SARS-CoV-2 with newer-generation panels may make a difference, as well as multiplex panels that include numerous viral targets, she said.
“Further RCTs are required to evaluate the impact of influenza/RSV/SARS-CoV-2 panels, as well as respiratory pathogen panel testing in conjunction with antimicrobial and diagnostic stewardship efforts, which have been associated with improved outcomes for other rapid molecular platforms, such as blood culture identification panels,” Rao said.
The study was funded by the Research Institute of the McGill University Health Center. Dr. Schober reported no disclosures, and several study authors reported grants or personal fees from companies outside of this research. Dr. Rao disclosed no relevant relationships.
A version of this article appeared on Medscape.com .
Routine use of rapid respiratory virus testing in the emergency department (ED) appears to show limited benefit among patients with signs and symptoms of acute respiratory infection (ARI), according to a new study.
Rapid viral testing wasn’t associated with reduced antibiotic use, ED length of stay, or rates of ED return visits or hospitalization. However, testing was associated with a small increase in antiviral prescriptions and a small reduction in blood tests and chest x-rays.
“Our interest in studying the benefits of rapid viral testing in emergency departments comes from a commitment to diagnostic stewardship — ensuring that the right tests are administered to the right patients at the right time while also curbing overuse,” said lead author Tilmann Schober, MD, a resident in pediatric infectious disease at McGill University and Montreal Children’s Hospital.
“Following the SARS-CoV-2 pandemic, we have seen a surge in the availability of rapid viral testing, including molecular multiplex panels,” he said. “However, the actual impact of these advancements on patient care in the ED remains uncertain.”
The study was published online on March 4, 2024, in JAMA Internal Medicine).
Rapid Viral Testing
Dr. Schober and colleagues conducted a systematic review and meta-analysis of 11 randomized clinical trials to understand whether rapid testing for respiratory viruses was associated with patient treatment in the ED.
In particular, the research team looked at whether testing in patients with suspected ARI was associated with decreased antibiotic use, ancillary tests, ED length of stay, ED return visits, hospitalization, and increased influenza antiviral treatment.
Among the trials, seven studies included molecular testing, and eight used multiplex panels, including influenza and respiratory syncytial virus (RSV), influenza/RSV/adenovirus/parainfluenza, or a panel of 15 or more respiratory viruses. No study evaluated testing for SARS-CoV-2. The research team reported risk ratios (RRs) and risk difference estimates.
In general, routine rapid viral testing was associated with higher use of influenza antivirals (RR, 1.33) and lower use of chest radiography (RR, 0.88) and blood tests (RR, 0.81). However, the magnitude of these effects was small. For instance, to achieve one additional viral prescription, 70 patients would need to be tested, and to save one x-ray, 30 patients would need to be tested.
“This suggests that, while statistically significant, the practical impact of these secondary outcomes may not justify the extensive effort and resources involved in widespread testing,” Dr. Schober said.
In addition, there was no association between rapid testing and antibiotic use (RR, 0.99), urine testing (RR, 0.95), ED length of stay (0 h), return visits (RR, 0.93), or hospitalization (RR, 1.01).
Notably, there was no association between rapid viral testing and antibiotic use in any prespecified subgroup based on age, test method, publication date, number of viral targets, risk of bias, or industry funding, the authors said. They concluded that rapid virus testing should be reserved for patients for whom the testing will change treatment, such as high-risk patients or those with severe disease.
“It’s crucial to note that our study specifically evaluated the impact of systematic testing of patients with signs and symptoms of acute respiratory infection. Our findings do not advocate against rapid respiratory virus testing in general,” Dr. Schober said. “There is well-established evidence supporting the benefits of viral testing in certain contexts, such as hospitalized patients, to guide infection control practices or in specific high-risk populations.”
Future Research
Additional studies should look at testing among subgroups, particularly those with high-risk conditions, the study authors wrote. In addition, the research team would like to study the implementation of novel diagnostic stewardship programs as compared with well-established antibiotic stewardship programs.
“Acute respiratory tract illnesses represent one of the most common reasons for being evaluated in an acute care setting, especially in pediatrics, and these visits have traditionally resulted in excessive antibiotic prescribing, despite the etiology of the infection mostly being viral,” said Suchitra Rao, MBBS, associate professor of pediatrics at the University of Colorado School of Medicine and associate medical director of infection prevention and control at Children’s Hospital Colorado, Aurora.
Dr. Rao, who wasn’t involved with this study, has surveyed ED providers about respiratory viral testing and changes in clinical decision-making. She and colleagues found that providers most commonly changed clinical decision-making while prescribing an antiviral if influenza was detected or withholding antivirals if influenza wasn’t detected.
“Multiplex testing for respiratory viruses and atypical bacteria is becoming more widespread, with newer-generation platforms having shorter turnaround times, and offers the potential to impact point-of-care decision-making,” she said. “However, these tests are expensive, and more studies are needed to explore whether respiratory pathogen panel testing in the acute care setting has an impact in terms of reduced antibiotic use as well as other outcomes, including ED visits, health-seeking behaviors, and hospitalization.”
For instance, more recent studies around SARS-CoV-2 with newer-generation panels may make a difference, as well as multiplex panels that include numerous viral targets, she said.
“Further RCTs are required to evaluate the impact of influenza/RSV/SARS-CoV-2 panels, as well as respiratory pathogen panel testing in conjunction with antimicrobial and diagnostic stewardship efforts, which have been associated with improved outcomes for other rapid molecular platforms, such as blood culture identification panels,” Rao said.
The study was funded by the Research Institute of the McGill University Health Center. Dr. Schober reported no disclosures, and several study authors reported grants or personal fees from companies outside of this research. Dr. Rao disclosed no relevant relationships.
A version of this article appeared on Medscape.com .
Routine use of rapid respiratory virus testing in the emergency department (ED) appears to show limited benefit among patients with signs and symptoms of acute respiratory infection (ARI), according to a new study.
Rapid viral testing wasn’t associated with reduced antibiotic use, ED length of stay, or rates of ED return visits or hospitalization. However, testing was associated with a small increase in antiviral prescriptions and a small reduction in blood tests and chest x-rays.
“Our interest in studying the benefits of rapid viral testing in emergency departments comes from a commitment to diagnostic stewardship — ensuring that the right tests are administered to the right patients at the right time while also curbing overuse,” said lead author Tilmann Schober, MD, a resident in pediatric infectious disease at McGill University and Montreal Children’s Hospital.
“Following the SARS-CoV-2 pandemic, we have seen a surge in the availability of rapid viral testing, including molecular multiplex panels,” he said. “However, the actual impact of these advancements on patient care in the ED remains uncertain.”
The study was published online on March 4, 2024, in JAMA Internal Medicine).
Rapid Viral Testing
Dr. Schober and colleagues conducted a systematic review and meta-analysis of 11 randomized clinical trials to understand whether rapid testing for respiratory viruses was associated with patient treatment in the ED.
In particular, the research team looked at whether testing in patients with suspected ARI was associated with decreased antibiotic use, ancillary tests, ED length of stay, ED return visits, hospitalization, and increased influenza antiviral treatment.
Among the trials, seven studies included molecular testing, and eight used multiplex panels, including influenza and respiratory syncytial virus (RSV), influenza/RSV/adenovirus/parainfluenza, or a panel of 15 or more respiratory viruses. No study evaluated testing for SARS-CoV-2. The research team reported risk ratios (RRs) and risk difference estimates.
In general, routine rapid viral testing was associated with higher use of influenza antivirals (RR, 1.33) and lower use of chest radiography (RR, 0.88) and blood tests (RR, 0.81). However, the magnitude of these effects was small. For instance, to achieve one additional viral prescription, 70 patients would need to be tested, and to save one x-ray, 30 patients would need to be tested.
“This suggests that, while statistically significant, the practical impact of these secondary outcomes may not justify the extensive effort and resources involved in widespread testing,” Dr. Schober said.
In addition, there was no association between rapid testing and antibiotic use (RR, 0.99), urine testing (RR, 0.95), ED length of stay (0 h), return visits (RR, 0.93), or hospitalization (RR, 1.01).
Notably, there was no association between rapid viral testing and antibiotic use in any prespecified subgroup based on age, test method, publication date, number of viral targets, risk of bias, or industry funding, the authors said. They concluded that rapid virus testing should be reserved for patients for whom the testing will change treatment, such as high-risk patients or those with severe disease.
“It’s crucial to note that our study specifically evaluated the impact of systematic testing of patients with signs and symptoms of acute respiratory infection. Our findings do not advocate against rapid respiratory virus testing in general,” Dr. Schober said. “There is well-established evidence supporting the benefits of viral testing in certain contexts, such as hospitalized patients, to guide infection control practices or in specific high-risk populations.”
Future Research
Additional studies should look at testing among subgroups, particularly those with high-risk conditions, the study authors wrote. In addition, the research team would like to study the implementation of novel diagnostic stewardship programs as compared with well-established antibiotic stewardship programs.
“Acute respiratory tract illnesses represent one of the most common reasons for being evaluated in an acute care setting, especially in pediatrics, and these visits have traditionally resulted in excessive antibiotic prescribing, despite the etiology of the infection mostly being viral,” said Suchitra Rao, MBBS, associate professor of pediatrics at the University of Colorado School of Medicine and associate medical director of infection prevention and control at Children’s Hospital Colorado, Aurora.
Dr. Rao, who wasn’t involved with this study, has surveyed ED providers about respiratory viral testing and changes in clinical decision-making. She and colleagues found that providers most commonly changed clinical decision-making while prescribing an antiviral if influenza was detected or withholding antivirals if influenza wasn’t detected.
“Multiplex testing for respiratory viruses and atypical bacteria is becoming more widespread, with newer-generation platforms having shorter turnaround times, and offers the potential to impact point-of-care decision-making,” she said. “However, these tests are expensive, and more studies are needed to explore whether respiratory pathogen panel testing in the acute care setting has an impact in terms of reduced antibiotic use as well as other outcomes, including ED visits, health-seeking behaviors, and hospitalization.”
For instance, more recent studies around SARS-CoV-2 with newer-generation panels may make a difference, as well as multiplex panels that include numerous viral targets, she said.
“Further RCTs are required to evaluate the impact of influenza/RSV/SARS-CoV-2 panels, as well as respiratory pathogen panel testing in conjunction with antimicrobial and diagnostic stewardship efforts, which have been associated with improved outcomes for other rapid molecular platforms, such as blood culture identification panels,” Rao said.
The study was funded by the Research Institute of the McGill University Health Center. Dr. Schober reported no disclosures, and several study authors reported grants or personal fees from companies outside of this research. Dr. Rao disclosed no relevant relationships.
A version of this article appeared on Medscape.com .
New Infant RSV Antibody Treatment Shows Strong Results
The new RSV antibody treatment for babies has been highly effective in its first season, according to a first look at data from four children’s hospitals.
Babies who received the new preventive treatment for RSV shortly after birth were 90% less likely to be severely sickened with the potentially deadly respiratory illness, according to the new estimate published by the Centers for Disease Control and Prevention. It is the first real-world evaluation of Beyfortus (the generic name is nirsevimab), which was approved by the Food and Drug Administration last July.
RSV is a seasonal illness that affects more people — particularly infants and the elderly — in the fall and winter. Symptoms are usually mild in healthy adults, but infants are particularly at risk of getting bronchiolitis, which results in exhausting wheezing and coughing in babies due to swelling in their airways and lungs. Babies who are hospitalized may need fluids and medical devices to help them breathe.
RSV peaked this season from November to January, with more than 10,000 monthly diagnoses reported to the CDC.
The new CDC analysis was conducted among about 700 babies hospitalized for severe respiratory problems from October to the end of February. Among the babies in the study, 407 were diagnosed with RSV and 292 tested negative. The researchers found that 1% of babies in the study who were diagnosed with RSV had received Beyfortus, while the remaining babies who were positive for the virus had not.
Among the babies hospitalized for other severe respiratory problems, 18% had received Beyfortus. Overall, just 59 babies among the nearly 700 in the study received Beyfortus, perhaps reflecting the short supply of the medicine the first season it was available. The report authors noted that babies in the study who did receive Beyfortus also tended to have high-risk medical conditions.
The number of babies nationwide who received Beyfortus during this first season of availability is unclear, but a January CDC survey showed that 4 in 10 parents said their babies under 8 months old had received the treatment. The Wall Street Journal reported recently that a shortage last fall resulted from underestimated demand and from production plans that were set before the CDC decided to recommend that all infants under 8 months old receive Beyfortus if their mothers did not get a maternal vaccine that can protect infants from RSV.
Both the antibody treatment for infants and the maternal vaccine were shown in clinical trials to be about 80% effective at preventing severe illness stemming from RSV.
The authors of the latest CDC report concluded that “this early estimate supports the current nirsevimab recommendation for the prevention of severe RSV disease in infants. Infants should be protected by maternal RSV vaccination or infant receipt of nirsevimab.”
A version of this article appeared on WebMD.com.
The new RSV antibody treatment for babies has been highly effective in its first season, according to a first look at data from four children’s hospitals.
Babies who received the new preventive treatment for RSV shortly after birth were 90% less likely to be severely sickened with the potentially deadly respiratory illness, according to the new estimate published by the Centers for Disease Control and Prevention. It is the first real-world evaluation of Beyfortus (the generic name is nirsevimab), which was approved by the Food and Drug Administration last July.
RSV is a seasonal illness that affects more people — particularly infants and the elderly — in the fall and winter. Symptoms are usually mild in healthy adults, but infants are particularly at risk of getting bronchiolitis, which results in exhausting wheezing and coughing in babies due to swelling in their airways and lungs. Babies who are hospitalized may need fluids and medical devices to help them breathe.
RSV peaked this season from November to January, with more than 10,000 monthly diagnoses reported to the CDC.
The new CDC analysis was conducted among about 700 babies hospitalized for severe respiratory problems from October to the end of February. Among the babies in the study, 407 were diagnosed with RSV and 292 tested negative. The researchers found that 1% of babies in the study who were diagnosed with RSV had received Beyfortus, while the remaining babies who were positive for the virus had not.
Among the babies hospitalized for other severe respiratory problems, 18% had received Beyfortus. Overall, just 59 babies among the nearly 700 in the study received Beyfortus, perhaps reflecting the short supply of the medicine the first season it was available. The report authors noted that babies in the study who did receive Beyfortus also tended to have high-risk medical conditions.
The number of babies nationwide who received Beyfortus during this first season of availability is unclear, but a January CDC survey showed that 4 in 10 parents said their babies under 8 months old had received the treatment. The Wall Street Journal reported recently that a shortage last fall resulted from underestimated demand and from production plans that were set before the CDC decided to recommend that all infants under 8 months old receive Beyfortus if their mothers did not get a maternal vaccine that can protect infants from RSV.
Both the antibody treatment for infants and the maternal vaccine were shown in clinical trials to be about 80% effective at preventing severe illness stemming from RSV.
The authors of the latest CDC report concluded that “this early estimate supports the current nirsevimab recommendation for the prevention of severe RSV disease in infants. Infants should be protected by maternal RSV vaccination or infant receipt of nirsevimab.”
A version of this article appeared on WebMD.com.
The new RSV antibody treatment for babies has been highly effective in its first season, according to a first look at data from four children’s hospitals.
Babies who received the new preventive treatment for RSV shortly after birth were 90% less likely to be severely sickened with the potentially deadly respiratory illness, according to the new estimate published by the Centers for Disease Control and Prevention. It is the first real-world evaluation of Beyfortus (the generic name is nirsevimab), which was approved by the Food and Drug Administration last July.
RSV is a seasonal illness that affects more people — particularly infants and the elderly — in the fall and winter. Symptoms are usually mild in healthy adults, but infants are particularly at risk of getting bronchiolitis, which results in exhausting wheezing and coughing in babies due to swelling in their airways and lungs. Babies who are hospitalized may need fluids and medical devices to help them breathe.
RSV peaked this season from November to January, with more than 10,000 monthly diagnoses reported to the CDC.
The new CDC analysis was conducted among about 700 babies hospitalized for severe respiratory problems from October to the end of February. Among the babies in the study, 407 were diagnosed with RSV and 292 tested negative. The researchers found that 1% of babies in the study who were diagnosed with RSV had received Beyfortus, while the remaining babies who were positive for the virus had not.
Among the babies hospitalized for other severe respiratory problems, 18% had received Beyfortus. Overall, just 59 babies among the nearly 700 in the study received Beyfortus, perhaps reflecting the short supply of the medicine the first season it was available. The report authors noted that babies in the study who did receive Beyfortus also tended to have high-risk medical conditions.
The number of babies nationwide who received Beyfortus during this first season of availability is unclear, but a January CDC survey showed that 4 in 10 parents said their babies under 8 months old had received the treatment. The Wall Street Journal reported recently that a shortage last fall resulted from underestimated demand and from production plans that were set before the CDC decided to recommend that all infants under 8 months old receive Beyfortus if their mothers did not get a maternal vaccine that can protect infants from RSV.
Both the antibody treatment for infants and the maternal vaccine were shown in clinical trials to be about 80% effective at preventing severe illness stemming from RSV.
The authors of the latest CDC report concluded that “this early estimate supports the current nirsevimab recommendation for the prevention of severe RSV disease in infants. Infants should be protected by maternal RSV vaccination or infant receipt of nirsevimab.”
A version of this article appeared on WebMD.com.
Smoking Cessation Before Age 40 Years Brings Great Benefits
Chronic smoking remains a major cause of premature mortality on a global scale. Despite intensified efforts to combat this scourge, a quarter of deaths among middle-aged adults in Europe and North America are attributed to it. However, over the past decades, antismoking campaigns have borne fruit, and many smokers have quit before the age of 40 years, enabling some case-control studies.
Among those abstainers who made the right choice, the excess mortality attributable to smoking over a lifetime would be reduced by 90% compared with controls who continued smoking. The estimated benefit is clear, but the analysis lacks nuance. Is smoking cessation beneficial even at older ages? If so, is the effect measurable in terms of magnitude and speed of the effect? An article published online in The New England Journal of Medicine Evidence provided some answers to these questions.
Four-Cohort Meta-Analysis
The study was a meta-analysis of individual data collected within four national cohort studies that were linked to each country’s death registry. Two of these studies were nationally representative. The National Health Interview Survey involved a sample of US citizens living in the community, aged 20-79 years, who were included annually in the cohort between 1997 and 2018. The second, the Canadian Community Health Survey, included subjects in the same age group, with samples analyzed between 2000 and 2014.
In Norway, three cohort studies conducted between 1974 and 2003, in which participants aged 25-79 years were included, were combined to form the Norwegian Health Screening Survey. These were the Counties Study (1974-1988), the 40 Years Study (1985-1999), and the Cohort of Norway (1994-2003), respectively. The fourth cohort was established through recruitment via the UK Biobank, with adults aged 40-73 years invited to participate in the survey. The data analysis ultimately covered a relatively heterogeneous total population of 1.48 million adults, all from high-income countries and followed for 15 years. It relied on the Cox proportional hazards model applied to each study, considering smoker vs nonsmoker status, as well as the time elapsed since smoking cessation (less than 3 years, between 3 and 9 years, or at least 10 years). Statistical adjustments made in the context of multivariate Cox analysis considered age, education, alcohol consumption, and obesity.
Excess Mortality Confirmed
At the end of follow-up, 122,697 deaths were recorded. The comparison of smokers and nonsmokers confirmed smoking-related excess mortality, with adjusted hazard ratios (HRs) estimated at 2.80 for women and 2.70 for men. Smoking shortened life expectancy in the 40- to 79-year-age group by 12 years for women and 13 years for men, in terms of overall mortality. In terms of smoking-attributable specific mortality, the corresponding figures reached 24 and 26 years, respectively. Respiratory diseases ranked highest in both sexes (HR, 7.6 for women and 6.3 for men), followed by cardiovascular diseases (HR, 3.1 for women and 2.9 for men) and cancers (HR, 2.8 for women and 3.1 for men).
The Earlier, the Better
Smoking cessation halves overall excess mortality. Above all, quitting before age 40 years brings overall mortality back to the level of nonsmokers as early as the third year after quitting. The excess mortality decreases even more as the cessation period is prolonged, even after age 40 years. Thus, cessation ≥ 10 years in smokers aged 40-49 years almost cancels out overall excess mortality (-99% in women, -96% in men). The trend is almost as favorable in the older age group (50-59 years), with corresponding figures of -95% and -92%, respectively.
Long-term survival increases in the early years after cessation, especially if it occurs at a younger age, but the benefit remains tangible even in older smokers. Thus, cessation of less than 3 years, effective in patients aged 50-59 years, reduces overall excess mortality by 63% in women and 54% in men. In patients aged 60-79 years, the figures are -40% and -33%, respectively.
Naturally, the earlier the cessation, the greater the number of years gained. It is 12 years for cessation before age 40 years, reduced to 6 years for cessation between 40 and 49 years, and 2.5 years when it is even later (50-59 years). These quantitative results are approximate, given the methodology (a meta-analysis) and some heterogeneity in the studies, as well as the multitude of potential confounding factors that have not all been considered. Nevertheless, the results probably contain a kernel of truth, and their optimistic implications should be highlighted to encourage smokers to abstain, even older ones. Better late than never, even if the benefit of cessation is maximal when it occurs as early as possible, knowing that a minimum of 3 years of cessation would be sufficient to gain years of life.
This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Chronic smoking remains a major cause of premature mortality on a global scale. Despite intensified efforts to combat this scourge, a quarter of deaths among middle-aged adults in Europe and North America are attributed to it. However, over the past decades, antismoking campaigns have borne fruit, and many smokers have quit before the age of 40 years, enabling some case-control studies.
Among those abstainers who made the right choice, the excess mortality attributable to smoking over a lifetime would be reduced by 90% compared with controls who continued smoking. The estimated benefit is clear, but the analysis lacks nuance. Is smoking cessation beneficial even at older ages? If so, is the effect measurable in terms of magnitude and speed of the effect? An article published online in The New England Journal of Medicine Evidence provided some answers to these questions.
Four-Cohort Meta-Analysis
The study was a meta-analysis of individual data collected within four national cohort studies that were linked to each country’s death registry. Two of these studies were nationally representative. The National Health Interview Survey involved a sample of US citizens living in the community, aged 20-79 years, who were included annually in the cohort between 1997 and 2018. The second, the Canadian Community Health Survey, included subjects in the same age group, with samples analyzed between 2000 and 2014.
In Norway, three cohort studies conducted between 1974 and 2003, in which participants aged 25-79 years were included, were combined to form the Norwegian Health Screening Survey. These were the Counties Study (1974-1988), the 40 Years Study (1985-1999), and the Cohort of Norway (1994-2003), respectively. The fourth cohort was established through recruitment via the UK Biobank, with adults aged 40-73 years invited to participate in the survey. The data analysis ultimately covered a relatively heterogeneous total population of 1.48 million adults, all from high-income countries and followed for 15 years. It relied on the Cox proportional hazards model applied to each study, considering smoker vs nonsmoker status, as well as the time elapsed since smoking cessation (less than 3 years, between 3 and 9 years, or at least 10 years). Statistical adjustments made in the context of multivariate Cox analysis considered age, education, alcohol consumption, and obesity.
Excess Mortality Confirmed
At the end of follow-up, 122,697 deaths were recorded. The comparison of smokers and nonsmokers confirmed smoking-related excess mortality, with adjusted hazard ratios (HRs) estimated at 2.80 for women and 2.70 for men. Smoking shortened life expectancy in the 40- to 79-year-age group by 12 years for women and 13 years for men, in terms of overall mortality. In terms of smoking-attributable specific mortality, the corresponding figures reached 24 and 26 years, respectively. Respiratory diseases ranked highest in both sexes (HR, 7.6 for women and 6.3 for men), followed by cardiovascular diseases (HR, 3.1 for women and 2.9 for men) and cancers (HR, 2.8 for women and 3.1 for men).
The Earlier, the Better
Smoking cessation halves overall excess mortality. Above all, quitting before age 40 years brings overall mortality back to the level of nonsmokers as early as the third year after quitting. The excess mortality decreases even more as the cessation period is prolonged, even after age 40 years. Thus, cessation ≥ 10 years in smokers aged 40-49 years almost cancels out overall excess mortality (-99% in women, -96% in men). The trend is almost as favorable in the older age group (50-59 years), with corresponding figures of -95% and -92%, respectively.
Long-term survival increases in the early years after cessation, especially if it occurs at a younger age, but the benefit remains tangible even in older smokers. Thus, cessation of less than 3 years, effective in patients aged 50-59 years, reduces overall excess mortality by 63% in women and 54% in men. In patients aged 60-79 years, the figures are -40% and -33%, respectively.
Naturally, the earlier the cessation, the greater the number of years gained. It is 12 years for cessation before age 40 years, reduced to 6 years for cessation between 40 and 49 years, and 2.5 years when it is even later (50-59 years). These quantitative results are approximate, given the methodology (a meta-analysis) and some heterogeneity in the studies, as well as the multitude of potential confounding factors that have not all been considered. Nevertheless, the results probably contain a kernel of truth, and their optimistic implications should be highlighted to encourage smokers to abstain, even older ones. Better late than never, even if the benefit of cessation is maximal when it occurs as early as possible, knowing that a minimum of 3 years of cessation would be sufficient to gain years of life.
This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Chronic smoking remains a major cause of premature mortality on a global scale. Despite intensified efforts to combat this scourge, a quarter of deaths among middle-aged adults in Europe and North America are attributed to it. However, over the past decades, antismoking campaigns have borne fruit, and many smokers have quit before the age of 40 years, enabling some case-control studies.
Among those abstainers who made the right choice, the excess mortality attributable to smoking over a lifetime would be reduced by 90% compared with controls who continued smoking. The estimated benefit is clear, but the analysis lacks nuance. Is smoking cessation beneficial even at older ages? If so, is the effect measurable in terms of magnitude and speed of the effect? An article published online in The New England Journal of Medicine Evidence provided some answers to these questions.
Four-Cohort Meta-Analysis
The study was a meta-analysis of individual data collected within four national cohort studies that were linked to each country’s death registry. Two of these studies were nationally representative. The National Health Interview Survey involved a sample of US citizens living in the community, aged 20-79 years, who were included annually in the cohort between 1997 and 2018. The second, the Canadian Community Health Survey, included subjects in the same age group, with samples analyzed between 2000 and 2014.
In Norway, three cohort studies conducted between 1974 and 2003, in which participants aged 25-79 years were included, were combined to form the Norwegian Health Screening Survey. These were the Counties Study (1974-1988), the 40 Years Study (1985-1999), and the Cohort of Norway (1994-2003), respectively. The fourth cohort was established through recruitment via the UK Biobank, with adults aged 40-73 years invited to participate in the survey. The data analysis ultimately covered a relatively heterogeneous total population of 1.48 million adults, all from high-income countries and followed for 15 years. It relied on the Cox proportional hazards model applied to each study, considering smoker vs nonsmoker status, as well as the time elapsed since smoking cessation (less than 3 years, between 3 and 9 years, or at least 10 years). Statistical adjustments made in the context of multivariate Cox analysis considered age, education, alcohol consumption, and obesity.
Excess Mortality Confirmed
At the end of follow-up, 122,697 deaths were recorded. The comparison of smokers and nonsmokers confirmed smoking-related excess mortality, with adjusted hazard ratios (HRs) estimated at 2.80 for women and 2.70 for men. Smoking shortened life expectancy in the 40- to 79-year-age group by 12 years for women and 13 years for men, in terms of overall mortality. In terms of smoking-attributable specific mortality, the corresponding figures reached 24 and 26 years, respectively. Respiratory diseases ranked highest in both sexes (HR, 7.6 for women and 6.3 for men), followed by cardiovascular diseases (HR, 3.1 for women and 2.9 for men) and cancers (HR, 2.8 for women and 3.1 for men).
The Earlier, the Better
Smoking cessation halves overall excess mortality. Above all, quitting before age 40 years brings overall mortality back to the level of nonsmokers as early as the third year after quitting. The excess mortality decreases even more as the cessation period is prolonged, even after age 40 years. Thus, cessation ≥ 10 years in smokers aged 40-49 years almost cancels out overall excess mortality (-99% in women, -96% in men). The trend is almost as favorable in the older age group (50-59 years), with corresponding figures of -95% and -92%, respectively.
Long-term survival increases in the early years after cessation, especially if it occurs at a younger age, but the benefit remains tangible even in older smokers. Thus, cessation of less than 3 years, effective in patients aged 50-59 years, reduces overall excess mortality by 63% in women and 54% in men. In patients aged 60-79 years, the figures are -40% and -33%, respectively.
Naturally, the earlier the cessation, the greater the number of years gained. It is 12 years for cessation before age 40 years, reduced to 6 years for cessation between 40 and 49 years, and 2.5 years when it is even later (50-59 years). These quantitative results are approximate, given the methodology (a meta-analysis) and some heterogeneity in the studies, as well as the multitude of potential confounding factors that have not all been considered. Nevertheless, the results probably contain a kernel of truth, and their optimistic implications should be highlighted to encourage smokers to abstain, even older ones. Better late than never, even if the benefit of cessation is maximal when it occurs as early as possible, knowing that a minimum of 3 years of cessation would be sufficient to gain years of life.
This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Study Sounds Alert About GLP-1 RA Use and Aspiration Risk
TOPLINE:
Patients on weekly glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have high residual gastric content, a major risk factor for aspiration under anesthesia, despite following fasting guidelines before undergoing elective procedures.
METHODOLOGY:
- The increasing use of GLP-1 RAs to manage weight and hyperglycemia has sparked safety concerns because of the drugs’ association with slow gastric emptying, a major risk factor for aspiration under anesthesia.
- This cross-sectional study used gastric ultrasonography to examine the link between GLP-1 RA use and the prevalence of increased residual gastric content.
- All 124 participants (median age, 56 years; 60% women) — half of whom received once-weekly GLP-1 RAs such as semaglutide, dulaglutide, or tirzepatide — adhered to the guideline-recommended fasting duration before undergoing elective procedures under anesthesia.
- The primary outcome focused on identifying increased residual gastric content, defined by the presence of solids, thick liquids, or > 1.5 mL/kg of clear liquids on ultrasound.
- An exploratory analysis examined the association between the duration of GLP-1 RA discontinuation and increased residual gastric content.
TAKEAWAY:
- The adjusted prevalence of increased residual gastric content was 30.5% (95% CI, 9.9%-51.2%) higher in participants who received GLP-1 RA than those who did not.
- Most patients took their last dose of GLP-1 RA within 5 days before their procedure, but elevated residual gastric content persisted even after 7 days of GLP-1 RA discontinuation.
- There was also no significant association between the type of GLP-1 RA used and the prevalence of increased residual gastric content.
IN PRACTICE:
“We expect healthcare professionals will encounter these classes of drugs with increasing frequency in the perioperative period. Perioperative physicians, including anesthesiologists, surgeons, and primary care physicians, should be well-informed about the safety implications of GLP-1 RA drugs,” the authors wrote.
SOURCE:
The study was led by Sudipta Sen, MD, from the Department of Anesthesiology, Critical Care and Pain Medicine, McGovern Medical School, University of Texas Health Center at Houston, Houston, Texas, and published online in JAMA Surgery.
LIMITATIONS:
Residual gastric content, the primary outcome, served as a proxy for aspiration risk and does not have an exact threshold of volume associated with increased risk. The study did not directly evaluate aspiration events. The authors also acknowledged potential bias from unmeasured confounders owing to the observational nature of this study. A small sample size limited the ability to detect a risk difference for each additional day of drug discontinuation before surgery.
DISCLOSURES:
One of the authors reported receiving a grant from the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Patients on weekly glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have high residual gastric content, a major risk factor for aspiration under anesthesia, despite following fasting guidelines before undergoing elective procedures.
METHODOLOGY:
- The increasing use of GLP-1 RAs to manage weight and hyperglycemia has sparked safety concerns because of the drugs’ association with slow gastric emptying, a major risk factor for aspiration under anesthesia.
- This cross-sectional study used gastric ultrasonography to examine the link between GLP-1 RA use and the prevalence of increased residual gastric content.
- All 124 participants (median age, 56 years; 60% women) — half of whom received once-weekly GLP-1 RAs such as semaglutide, dulaglutide, or tirzepatide — adhered to the guideline-recommended fasting duration before undergoing elective procedures under anesthesia.
- The primary outcome focused on identifying increased residual gastric content, defined by the presence of solids, thick liquids, or > 1.5 mL/kg of clear liquids on ultrasound.
- An exploratory analysis examined the association between the duration of GLP-1 RA discontinuation and increased residual gastric content.
TAKEAWAY:
- The adjusted prevalence of increased residual gastric content was 30.5% (95% CI, 9.9%-51.2%) higher in participants who received GLP-1 RA than those who did not.
- Most patients took their last dose of GLP-1 RA within 5 days before their procedure, but elevated residual gastric content persisted even after 7 days of GLP-1 RA discontinuation.
- There was also no significant association between the type of GLP-1 RA used and the prevalence of increased residual gastric content.
IN PRACTICE:
“We expect healthcare professionals will encounter these classes of drugs with increasing frequency in the perioperative period. Perioperative physicians, including anesthesiologists, surgeons, and primary care physicians, should be well-informed about the safety implications of GLP-1 RA drugs,” the authors wrote.
SOURCE:
The study was led by Sudipta Sen, MD, from the Department of Anesthesiology, Critical Care and Pain Medicine, McGovern Medical School, University of Texas Health Center at Houston, Houston, Texas, and published online in JAMA Surgery.
LIMITATIONS:
Residual gastric content, the primary outcome, served as a proxy for aspiration risk and does not have an exact threshold of volume associated with increased risk. The study did not directly evaluate aspiration events. The authors also acknowledged potential bias from unmeasured confounders owing to the observational nature of this study. A small sample size limited the ability to detect a risk difference for each additional day of drug discontinuation before surgery.
DISCLOSURES:
One of the authors reported receiving a grant from the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Patients on weekly glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have high residual gastric content, a major risk factor for aspiration under anesthesia, despite following fasting guidelines before undergoing elective procedures.
METHODOLOGY:
- The increasing use of GLP-1 RAs to manage weight and hyperglycemia has sparked safety concerns because of the drugs’ association with slow gastric emptying, a major risk factor for aspiration under anesthesia.
- This cross-sectional study used gastric ultrasonography to examine the link between GLP-1 RA use and the prevalence of increased residual gastric content.
- All 124 participants (median age, 56 years; 60% women) — half of whom received once-weekly GLP-1 RAs such as semaglutide, dulaglutide, or tirzepatide — adhered to the guideline-recommended fasting duration before undergoing elective procedures under anesthesia.
- The primary outcome focused on identifying increased residual gastric content, defined by the presence of solids, thick liquids, or > 1.5 mL/kg of clear liquids on ultrasound.
- An exploratory analysis examined the association between the duration of GLP-1 RA discontinuation and increased residual gastric content.
TAKEAWAY:
- The adjusted prevalence of increased residual gastric content was 30.5% (95% CI, 9.9%-51.2%) higher in participants who received GLP-1 RA than those who did not.
- Most patients took their last dose of GLP-1 RA within 5 days before their procedure, but elevated residual gastric content persisted even after 7 days of GLP-1 RA discontinuation.
- There was also no significant association between the type of GLP-1 RA used and the prevalence of increased residual gastric content.
IN PRACTICE:
“We expect healthcare professionals will encounter these classes of drugs with increasing frequency in the perioperative period. Perioperative physicians, including anesthesiologists, surgeons, and primary care physicians, should be well-informed about the safety implications of GLP-1 RA drugs,” the authors wrote.
SOURCE:
The study was led by Sudipta Sen, MD, from the Department of Anesthesiology, Critical Care and Pain Medicine, McGovern Medical School, University of Texas Health Center at Houston, Houston, Texas, and published online in JAMA Surgery.
LIMITATIONS:
Residual gastric content, the primary outcome, served as a proxy for aspiration risk and does not have an exact threshold of volume associated with increased risk. The study did not directly evaluate aspiration events. The authors also acknowledged potential bias from unmeasured confounders owing to the observational nature of this study. A small sample size limited the ability to detect a risk difference for each additional day of drug discontinuation before surgery.
DISCLOSURES:
One of the authors reported receiving a grant from the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.