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FDA OKs Benralizumab for Asthma in Children as Young as 6 Years
Benralizumab is now approved by the US Food and Drug Administration (FDA) for the treatment of asthma in children older than 6 years.
Marketed as Fasenra, the medication first was approved in 2017 for patients aged 12 years or older.
AstraZeneca, which markets the drug, announced the approval for younger patients on April 11.
The expanded indication was supported by a study that showed that the drug functions in the same way with younger children and their adolescent peers. The safety and tolerability were also consistent with the known profile of the medicine, the company said.
For children who weigh ≥ 35 kg, the recommended dose is 30 mg. For patients aged 6-11 years who weigh < 35 kg, a new 10-mg dose will be available, according to the announcement.
The drug, a monoclonal antibody that depletes eosinophils by binding to interleukin 5 receptor alpha on eosinophils, is administered by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks.
Benralizumab should not be used to treat acute asthma symptoms. Hypersensitivity reasons have occurred after administration of the drug. The most common adverse reactions include headache and pharyngitis.
A version of this article appeared on Medscape.com.
Benralizumab is now approved by the US Food and Drug Administration (FDA) for the treatment of asthma in children older than 6 years.
Marketed as Fasenra, the medication first was approved in 2017 for patients aged 12 years or older.
AstraZeneca, which markets the drug, announced the approval for younger patients on April 11.
The expanded indication was supported by a study that showed that the drug functions in the same way with younger children and their adolescent peers. The safety and tolerability were also consistent with the known profile of the medicine, the company said.
For children who weigh ≥ 35 kg, the recommended dose is 30 mg. For patients aged 6-11 years who weigh < 35 kg, a new 10-mg dose will be available, according to the announcement.
The drug, a monoclonal antibody that depletes eosinophils by binding to interleukin 5 receptor alpha on eosinophils, is administered by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks.
Benralizumab should not be used to treat acute asthma symptoms. Hypersensitivity reasons have occurred after administration of the drug. The most common adverse reactions include headache and pharyngitis.
A version of this article appeared on Medscape.com.
Benralizumab is now approved by the US Food and Drug Administration (FDA) for the treatment of asthma in children older than 6 years.
Marketed as Fasenra, the medication first was approved in 2017 for patients aged 12 years or older.
AstraZeneca, which markets the drug, announced the approval for younger patients on April 11.
The expanded indication was supported by a study that showed that the drug functions in the same way with younger children and their adolescent peers. The safety and tolerability were also consistent with the known profile of the medicine, the company said.
For children who weigh ≥ 35 kg, the recommended dose is 30 mg. For patients aged 6-11 years who weigh < 35 kg, a new 10-mg dose will be available, according to the announcement.
The drug, a monoclonal antibody that depletes eosinophils by binding to interleukin 5 receptor alpha on eosinophils, is administered by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks.
Benralizumab should not be used to treat acute asthma symptoms. Hypersensitivity reasons have occurred after administration of the drug. The most common adverse reactions include headache and pharyngitis.
A version of this article appeared on Medscape.com.
An App for ED?
Little blue pill meets a little blue light.
A digital application can improve erectile function, according to new research presented at the European Association of Urology (EAU) Annual Congress on April 8, 2024.
Researchers developed a 12-week, self-managed program to treat erectile dysfunction (ED). The program is delivered to patients’ mobile devices and encourages users to do cardiovascular training, pelvic floor exercises, and physiotherapy. It also provides information about ED, sexual therapy, and stress management.
“The treatment of ED through physical activity and/or lifestyle changes is recommended in current European guidelines but is not well established in clinical practice,” according to the researchers.
App or Waitlist
The app, known as Kranus Edera, was created by Kranus Health. It is available by prescription in Germany and France.
To study the effectiveness of the app, investigators conducted a randomized controlled trial at the University Hospital Münster in Germany.
The study included 241 men who had scores of 21 or less on the International Index of Erectile Function (IIEF-5).
About half of the participants were randomly assigned to get the app. The rest were placed on a waiting list for the technology and served as a control group.
Men who received the app also reported gains in measures of quality of life (20.5 vs −0.04) and patient activation (11.1 vs 0.64).
Nearly nine in 10 people who used the app did so several times per week, the researchers reported.
Sabine Kliesch, MD, with University Hospital Münster, led the study, which was presented at a poster session on April 8 at the EAU Congress in Paris.
Fully Reimbursed in Germany
In Germany, Kranus Edera has been included on a government list of digital health apps that are fully reimbursed by insurers, partly based on the results of the clinical trial. The cost there is €235 (about $255).
Patients typically notice improvements in 2-4 weeks, according to the company’s website. Patients who are taking a phosphodiesterase-5 enzyme inhibitor for ED may continue taking the medication, although they may no longer need it or they may be able to reduce the dose after treatment with the app, it says.
Kranus also has virtual treatments for incontinence in women and voiding dysfunction.
The app is meant to save doctors time by providing patients with detailed explanations and guidance within the app itself, said Laura Wiemer, MD, senior medical director of Kranus.
The app’s modules help reinforce guideline-recommended approaches to the treatment of ED “in playful ways with awards, motivational messages, and individual adjustments to help achieve better adherence and compliance of the patient,” Dr. Wiemer told this news organization.
Kranus plans to expand to the United States in 2024, she said.
A version of this article appeared on Medscape.com.
Little blue pill meets a little blue light.
A digital application can improve erectile function, according to new research presented at the European Association of Urology (EAU) Annual Congress on April 8, 2024.
Researchers developed a 12-week, self-managed program to treat erectile dysfunction (ED). The program is delivered to patients’ mobile devices and encourages users to do cardiovascular training, pelvic floor exercises, and physiotherapy. It also provides information about ED, sexual therapy, and stress management.
“The treatment of ED through physical activity and/or lifestyle changes is recommended in current European guidelines but is not well established in clinical practice,” according to the researchers.
App or Waitlist
The app, known as Kranus Edera, was created by Kranus Health. It is available by prescription in Germany and France.
To study the effectiveness of the app, investigators conducted a randomized controlled trial at the University Hospital Münster in Germany.
The study included 241 men who had scores of 21 or less on the International Index of Erectile Function (IIEF-5).
About half of the participants were randomly assigned to get the app. The rest were placed on a waiting list for the technology and served as a control group.
Men who received the app also reported gains in measures of quality of life (20.5 vs −0.04) and patient activation (11.1 vs 0.64).
Nearly nine in 10 people who used the app did so several times per week, the researchers reported.
Sabine Kliesch, MD, with University Hospital Münster, led the study, which was presented at a poster session on April 8 at the EAU Congress in Paris.
Fully Reimbursed in Germany
In Germany, Kranus Edera has been included on a government list of digital health apps that are fully reimbursed by insurers, partly based on the results of the clinical trial. The cost there is €235 (about $255).
Patients typically notice improvements in 2-4 weeks, according to the company’s website. Patients who are taking a phosphodiesterase-5 enzyme inhibitor for ED may continue taking the medication, although they may no longer need it or they may be able to reduce the dose after treatment with the app, it says.
Kranus also has virtual treatments for incontinence in women and voiding dysfunction.
The app is meant to save doctors time by providing patients with detailed explanations and guidance within the app itself, said Laura Wiemer, MD, senior medical director of Kranus.
The app’s modules help reinforce guideline-recommended approaches to the treatment of ED “in playful ways with awards, motivational messages, and individual adjustments to help achieve better adherence and compliance of the patient,” Dr. Wiemer told this news organization.
Kranus plans to expand to the United States in 2024, she said.
A version of this article appeared on Medscape.com.
Little blue pill meets a little blue light.
A digital application can improve erectile function, according to new research presented at the European Association of Urology (EAU) Annual Congress on April 8, 2024.
Researchers developed a 12-week, self-managed program to treat erectile dysfunction (ED). The program is delivered to patients’ mobile devices and encourages users to do cardiovascular training, pelvic floor exercises, and physiotherapy. It also provides information about ED, sexual therapy, and stress management.
“The treatment of ED through physical activity and/or lifestyle changes is recommended in current European guidelines but is not well established in clinical practice,” according to the researchers.
App or Waitlist
The app, known as Kranus Edera, was created by Kranus Health. It is available by prescription in Germany and France.
To study the effectiveness of the app, investigators conducted a randomized controlled trial at the University Hospital Münster in Germany.
The study included 241 men who had scores of 21 or less on the International Index of Erectile Function (IIEF-5).
About half of the participants were randomly assigned to get the app. The rest were placed on a waiting list for the technology and served as a control group.
Men who received the app also reported gains in measures of quality of life (20.5 vs −0.04) and patient activation (11.1 vs 0.64).
Nearly nine in 10 people who used the app did so several times per week, the researchers reported.
Sabine Kliesch, MD, with University Hospital Münster, led the study, which was presented at a poster session on April 8 at the EAU Congress in Paris.
Fully Reimbursed in Germany
In Germany, Kranus Edera has been included on a government list of digital health apps that are fully reimbursed by insurers, partly based on the results of the clinical trial. The cost there is €235 (about $255).
Patients typically notice improvements in 2-4 weeks, according to the company’s website. Patients who are taking a phosphodiesterase-5 enzyme inhibitor for ED may continue taking the medication, although they may no longer need it or they may be able to reduce the dose after treatment with the app, it says.
Kranus also has virtual treatments for incontinence in women and voiding dysfunction.
The app is meant to save doctors time by providing patients with detailed explanations and guidance within the app itself, said Laura Wiemer, MD, senior medical director of Kranus.
The app’s modules help reinforce guideline-recommended approaches to the treatment of ED “in playful ways with awards, motivational messages, and individual adjustments to help achieve better adherence and compliance of the patient,” Dr. Wiemer told this news organization.
Kranus plans to expand to the United States in 2024, she said.
A version of this article appeared on Medscape.com.
Can AI Tool Improve Dx of Ear Infections?
TOPLINE:
Researchers have developed a tool that uses artificial intelligence (AI) to identify acute otitis media in children based on otoscopic videos. It may improve diagnosis of ear infections in primary care settings, the developers said.
METHODOLOGY:
- The developers relied on otoscopic videos of the tympanic membrane captured on smartphones connected to scopes.
- Their analysis focused on 1151 videos from 635 children, most younger than 3 years old, who were seen for sick or well visits at outpatient clinics in Pennsylvania from 2018 to 2023.
- The tool was trained to differentiate between patients who did and did not have acute otitis media.
TAKEAWAY:
- Out of an original pool of 1561 videos, 410 were excluded due to obstruction by cerumen. In the remaining videos, experts identified acute otitis media in 305 videos (26.5%) and no acute otitis media in 846 videos (73.5%).
- The tool achieved a sensitivity of 93.8% and specificity of 93.5%, with bulging of the tympanic membrane being the most indicative feature of acute otitis media, present in 100% of diagnosed cases, according to the researchers.
- Feedback from 60 parents was largely positive, with 80% wanting the tool to be used during future visits.
IN PRACTICE:
Based on the diagnostic accuracy of clinicians in other studies, “The algorithm exhibited higher accuracy than pediatricians, primary care physicians, and advance practice clinicians and, accordingly, could reasonably be used in these settings to aid with decisions regarding treatment,” the authors of the study wrote. “More accurate diagnosis of [acute otitis media] may help reduce unnecessary prescriptions of antimicrobials in young children,” they added.
Studies directly comparing the performance of the tool vs clinicians are still needed, however, according to an editorial accompanying the journal article.
“While the data from this study show the model’s accuracy (94%) is superior to historical accuracy of clinicians in diagnosing acute otitis media (84% or less), these data come from different studies not using the same definition for accuracy,” wrote Hojjat Salmasian, MD, MPH, PhD, and Lisa Biggs, MD, with Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania. “If we assume the model is confirmed to be highly accurate and free from bias, this model could truly transform care for patients with suspected acute otitis media.”
SOURCE:
Alejandro Hoberman, MD, with the University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, was the corresponding author of the study. It was published online in JAMA Pediatrics .
LIMITATIONS:
The study used convenience sampling and did not include external validation of the tool. The researchers lacked information about participant demographics and the reason for their clinic visit.
DISCLOSURES:
Three authors of the study are listed as inventors on a patent for a tool to diagnose acute otitis media. Two authors with Dcipher Analytics disclosed fees from the University of Pittsburgh for their work on an application programming interface during the study. The research was supported by the Department of Pediatrics at the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
This article was created 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.
TOPLINE:
Researchers have developed a tool that uses artificial intelligence (AI) to identify acute otitis media in children based on otoscopic videos. It may improve diagnosis of ear infections in primary care settings, the developers said.
METHODOLOGY:
- The developers relied on otoscopic videos of the tympanic membrane captured on smartphones connected to scopes.
- Their analysis focused on 1151 videos from 635 children, most younger than 3 years old, who were seen for sick or well visits at outpatient clinics in Pennsylvania from 2018 to 2023.
- The tool was trained to differentiate between patients who did and did not have acute otitis media.
TAKEAWAY:
- Out of an original pool of 1561 videos, 410 were excluded due to obstruction by cerumen. In the remaining videos, experts identified acute otitis media in 305 videos (26.5%) and no acute otitis media in 846 videos (73.5%).
- The tool achieved a sensitivity of 93.8% and specificity of 93.5%, with bulging of the tympanic membrane being the most indicative feature of acute otitis media, present in 100% of diagnosed cases, according to the researchers.
- Feedback from 60 parents was largely positive, with 80% wanting the tool to be used during future visits.
IN PRACTICE:
Based on the diagnostic accuracy of clinicians in other studies, “The algorithm exhibited higher accuracy than pediatricians, primary care physicians, and advance practice clinicians and, accordingly, could reasonably be used in these settings to aid with decisions regarding treatment,” the authors of the study wrote. “More accurate diagnosis of [acute otitis media] may help reduce unnecessary prescriptions of antimicrobials in young children,” they added.
Studies directly comparing the performance of the tool vs clinicians are still needed, however, according to an editorial accompanying the journal article.
“While the data from this study show the model’s accuracy (94%) is superior to historical accuracy of clinicians in diagnosing acute otitis media (84% or less), these data come from different studies not using the same definition for accuracy,” wrote Hojjat Salmasian, MD, MPH, PhD, and Lisa Biggs, MD, with Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania. “If we assume the model is confirmed to be highly accurate and free from bias, this model could truly transform care for patients with suspected acute otitis media.”
SOURCE:
Alejandro Hoberman, MD, with the University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, was the corresponding author of the study. It was published online in JAMA Pediatrics .
LIMITATIONS:
The study used convenience sampling and did not include external validation of the tool. The researchers lacked information about participant demographics and the reason for their clinic visit.
DISCLOSURES:
Three authors of the study are listed as inventors on a patent for a tool to diagnose acute otitis media. Two authors with Dcipher Analytics disclosed fees from the University of Pittsburgh for their work on an application programming interface during the study. The research was supported by the Department of Pediatrics at the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
This article was created 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.
TOPLINE:
Researchers have developed a tool that uses artificial intelligence (AI) to identify acute otitis media in children based on otoscopic videos. It may improve diagnosis of ear infections in primary care settings, the developers said.
METHODOLOGY:
- The developers relied on otoscopic videos of the tympanic membrane captured on smartphones connected to scopes.
- Their analysis focused on 1151 videos from 635 children, most younger than 3 years old, who were seen for sick or well visits at outpatient clinics in Pennsylvania from 2018 to 2023.
- The tool was trained to differentiate between patients who did and did not have acute otitis media.
TAKEAWAY:
- Out of an original pool of 1561 videos, 410 were excluded due to obstruction by cerumen. In the remaining videos, experts identified acute otitis media in 305 videos (26.5%) and no acute otitis media in 846 videos (73.5%).
- The tool achieved a sensitivity of 93.8% and specificity of 93.5%, with bulging of the tympanic membrane being the most indicative feature of acute otitis media, present in 100% of diagnosed cases, according to the researchers.
- Feedback from 60 parents was largely positive, with 80% wanting the tool to be used during future visits.
IN PRACTICE:
Based on the diagnostic accuracy of clinicians in other studies, “The algorithm exhibited higher accuracy than pediatricians, primary care physicians, and advance practice clinicians and, accordingly, could reasonably be used in these settings to aid with decisions regarding treatment,” the authors of the study wrote. “More accurate diagnosis of [acute otitis media] may help reduce unnecessary prescriptions of antimicrobials in young children,” they added.
Studies directly comparing the performance of the tool vs clinicians are still needed, however, according to an editorial accompanying the journal article.
“While the data from this study show the model’s accuracy (94%) is superior to historical accuracy of clinicians in diagnosing acute otitis media (84% or less), these data come from different studies not using the same definition for accuracy,” wrote Hojjat Salmasian, MD, MPH, PhD, and Lisa Biggs, MD, with Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania. “If we assume the model is confirmed to be highly accurate and free from bias, this model could truly transform care for patients with suspected acute otitis media.”
SOURCE:
Alejandro Hoberman, MD, with the University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, was the corresponding author of the study. It was published online in JAMA Pediatrics .
LIMITATIONS:
The study used convenience sampling and did not include external validation of the tool. The researchers lacked information about participant demographics and the reason for their clinic visit.
DISCLOSURES:
Three authors of the study are listed as inventors on a patent for a tool to diagnose acute otitis media. Two authors with Dcipher Analytics disclosed fees from the University of Pittsburgh for their work on an application programming interface during the study. The research was supported by the Department of Pediatrics at the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
This article was created 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.
FDA Approves Drug to Reduce Accidental Food Allergies
The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.
Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.
, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.
“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release.
The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.
More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%).
The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.
Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.
, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.
“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release.
The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.
More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%).
The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.
Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.
, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.
“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release.
The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.
More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%).
The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.
A version of this article appeared on Medscape.com.
Obesity’s Effect on Neonatal Outcomes Is Dose Dependent
TOPLINE:
Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.
METHODOLOGY:
- Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
- They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
- 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.
TAKEAWAY:
- Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
- Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
- Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
- With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
- Obesity also was associated with increased risk for grade III-IV (RR), 4.58 for class III obesity) and (RR, 3.76).
IN PRACTICE:
“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported.
SOURCE:
Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland.
DISCLOSURES:
The researchers had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.
METHODOLOGY:
- Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
- They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
- 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.
TAKEAWAY:
- Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
- Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
- Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
- With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
- Obesity also was associated with increased risk for grade III-IV (RR), 4.58 for class III obesity) and (RR, 3.76).
IN PRACTICE:
“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported.
SOURCE:
Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland.
DISCLOSURES:
The researchers had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.
METHODOLOGY:
- Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
- They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
- 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.
TAKEAWAY:
- Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
- Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
- Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
- With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
- Obesity also was associated with increased risk for grade III-IV (RR), 4.58 for class III obesity) and (RR, 3.76).
IN PRACTICE:
“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported.
SOURCE:
Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland.
DISCLOSURES:
The researchers had no conflicts of interest to disclose.
A version of this article appeared on Medscape.com.
e-Cigarettes Best Nicotine Gum for Smoking Cessation
UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
TOPLINE:
and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers.
METHODOLOGY:
- The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
- They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.
TAKEAWAY:
- At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
- At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
- Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
- In the varenicline group, 8.8% experienced nausea.
- No serious adverse events were reported.
IN PRACTICE:
“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary.
SOURCE:
Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine.
LIMITATIONS:
The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.
The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.
More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.
Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.
DISCLOSURES:
The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.
A version of this article appeared on Medscape.com.
UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
TOPLINE:
and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers.
METHODOLOGY:
- The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
- They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.
TAKEAWAY:
- At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
- At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
- Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
- In the varenicline group, 8.8% experienced nausea.
- No serious adverse events were reported.
IN PRACTICE:
“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary.
SOURCE:
Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine.
LIMITATIONS:
The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.
The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.
More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.
Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.
DISCLOSURES:
The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.
A version of this article appeared on Medscape.com.
UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.
TOPLINE:
and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers.
METHODOLOGY:
- The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
- They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.
TAKEAWAY:
- At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
- At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
- Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
- In the varenicline group, 8.8% experienced nausea.
- No serious adverse events were reported.
IN PRACTICE:
“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary.
SOURCE:
Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine.
LIMITATIONS:
The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.
The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.
More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.
Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.
DISCLOSURES:
The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.
A version of this article appeared on Medscape.com.
HPV Vax Tied to Lower Odds of Cervical Lesion Progression
TOPLINE:
Among women with cervical intraepithelial neoplasia grade 2 (CIN2), vaccination against human papillomavirus (HPV) before age 20 is associated with lower odds of progression.
METHODOLOGY:
- Researchers analyzed data from 7904 women in Denmark who were undergoing active surveillance for CIN2 between 2007 and 2020.
- CIN2 lesions on their own. Removing them can increase the risk for during subsequent pregnancies, the researchers noted.
- Nearly half of the women had received at least one dose of an HPV vaccine at least 1 year before the diagnosis of cervical dysplasia.
TAKEAWAY:
- During 28 months of follow-up, the risk for progression was 22.9% for women vaccinated before age 15, 31.5% for women vaccinated between ages 15 and 20, and 37.6% for women who were not vaccinated.
- Women vaccinated before age 15 had a 35% lower risk for progression than unvaccinated women, after adjusting for cytology, income, and education (adjusted relative risk, 0.65; 95% CI, 0.57-0.75).
- Cervical cancer developed in 0.37% of the unvaccinated women and 0.13% of the vaccinated women.
- All cases of cervical cancer in the vaccinated group occurred in women who received the vaccine after age 20.
IN PRACTICE:
“These findings suggest that HPV vaccination status may be used to identify women at higher risk for progression, thereby enabling risk stratification at the time of CIN2 diagnosis,” the researchers wrote.
SOURCE:
Louise Krog, BscMed, with Aarhus University, Aarhus, Denmark, was the corresponding author of the study. The research was published online in the American Journal of Obstetrics & Gynecology.
LIMITATIONS:
The study authors had limited information about potential confounders such as smoking, immunosuppressive conditions, and the age at which patients became sexually active.
DISCLOSURES:
The study was funded by the Danish Cancer Society, the Carpenter Axel Kastrup-Nielsen’s Memorial Fund, and the Dagmar Marshall’s Fund. Co-authors disclosed ties to AstraZeneca, Roche, and Hologic.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women with cervical intraepithelial neoplasia grade 2 (CIN2), vaccination against human papillomavirus (HPV) before age 20 is associated with lower odds of progression.
METHODOLOGY:
- Researchers analyzed data from 7904 women in Denmark who were undergoing active surveillance for CIN2 between 2007 and 2020.
- CIN2 lesions on their own. Removing them can increase the risk for during subsequent pregnancies, the researchers noted.
- Nearly half of the women had received at least one dose of an HPV vaccine at least 1 year before the diagnosis of cervical dysplasia.
TAKEAWAY:
- During 28 months of follow-up, the risk for progression was 22.9% for women vaccinated before age 15, 31.5% for women vaccinated between ages 15 and 20, and 37.6% for women who were not vaccinated.
- Women vaccinated before age 15 had a 35% lower risk for progression than unvaccinated women, after adjusting for cytology, income, and education (adjusted relative risk, 0.65; 95% CI, 0.57-0.75).
- Cervical cancer developed in 0.37% of the unvaccinated women and 0.13% of the vaccinated women.
- All cases of cervical cancer in the vaccinated group occurred in women who received the vaccine after age 20.
IN PRACTICE:
“These findings suggest that HPV vaccination status may be used to identify women at higher risk for progression, thereby enabling risk stratification at the time of CIN2 diagnosis,” the researchers wrote.
SOURCE:
Louise Krog, BscMed, with Aarhus University, Aarhus, Denmark, was the corresponding author of the study. The research was published online in the American Journal of Obstetrics & Gynecology.
LIMITATIONS:
The study authors had limited information about potential confounders such as smoking, immunosuppressive conditions, and the age at which patients became sexually active.
DISCLOSURES:
The study was funded by the Danish Cancer Society, the Carpenter Axel Kastrup-Nielsen’s Memorial Fund, and the Dagmar Marshall’s Fund. Co-authors disclosed ties to AstraZeneca, Roche, and Hologic.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women with cervical intraepithelial neoplasia grade 2 (CIN2), vaccination against human papillomavirus (HPV) before age 20 is associated with lower odds of progression.
METHODOLOGY:
- Researchers analyzed data from 7904 women in Denmark who were undergoing active surveillance for CIN2 between 2007 and 2020.
- CIN2 lesions on their own. Removing them can increase the risk for during subsequent pregnancies, the researchers noted.
- Nearly half of the women had received at least one dose of an HPV vaccine at least 1 year before the diagnosis of cervical dysplasia.
TAKEAWAY:
- During 28 months of follow-up, the risk for progression was 22.9% for women vaccinated before age 15, 31.5% for women vaccinated between ages 15 and 20, and 37.6% for women who were not vaccinated.
- Women vaccinated before age 15 had a 35% lower risk for progression than unvaccinated women, after adjusting for cytology, income, and education (adjusted relative risk, 0.65; 95% CI, 0.57-0.75).
- Cervical cancer developed in 0.37% of the unvaccinated women and 0.13% of the vaccinated women.
- All cases of cervical cancer in the vaccinated group occurred in women who received the vaccine after age 20.
IN PRACTICE:
“These findings suggest that HPV vaccination status may be used to identify women at higher risk for progression, thereby enabling risk stratification at the time of CIN2 diagnosis,” the researchers wrote.
SOURCE:
Louise Krog, BscMed, with Aarhus University, Aarhus, Denmark, was the corresponding author of the study. The research was published online in the American Journal of Obstetrics & Gynecology.
LIMITATIONS:
The study authors had limited information about potential confounders such as smoking, immunosuppressive conditions, and the age at which patients became sexually active.
DISCLOSURES:
The study was funded by the Danish Cancer Society, the Carpenter Axel Kastrup-Nielsen’s Memorial Fund, and the Dagmar Marshall’s Fund. Co-authors disclosed ties to AstraZeneca, Roche, and Hologic.
A version of this article appeared on Medscape.com.
Fivefold Increase in Vaping During Adolescent Pregnancies
TOPLINE:
, according to research published online on December 13 in JAMA Network Open.
METHODOLOGY:
- Researchers analyzed data from the 2016-2021 Pregnancy Risk Assessment Monitoring System.
- They focused on 10,428 adolescents aged 10-19 years who had had a singleton birth and provided information about their use of e-cigarettes or cigarettes.
TAKEAWAY:
- Whereas the researchers found a roughly fivefold increase in the exclusive use of e-cigarettes, the percentage of patients using only cigarettes decreased from 9.2% in 2017 to 3.2% in 2021.
- The percentage of patients who both vaped and smoked fluctuated between 0.6% and 1.6%.
- The rate of small-for-gestational-age (SGA) births for adolescents who did not smoke or vape (12.9%) did not differ significantly from that among adolescents who exclusively used e-cigarettes (16.8%) or those who used both cigarettes and e-cigarettes (17.6%).
- The researchers found use of cigarettes only was associated with a significantly higher rate of SGA births: 24.6%.
IN PRACTICE:
“Exclusive e-cigarette use and dual use of cigarettes and e-cigarettes did not seem to be statistically significantly associated with SGA birth in our analysis, but this finding should be interpreted with caution given the low prevalence of use and the limited sample size,” the study authors wrote.
SOURCE:
Xiaozhong Wen, MD, PhD, with the Jacobs School of Medicine and Biomedical Sciences at the State University of New York at Buffalo, was the corresponding author of the study.
LIMITATIONS:
Participants may have underreported their use of e-cigarettes and cigarettes because of fears of social stigma. The researchers lacked information about vaping in the first and second trimesters, exposure to secondhand smoke, cannabis use, and diet.
DISCLOSURES:
The research was supported by the National Institute on Drug Abuse; the Food and Drug Administration Center for Tobacco Products; the National Heart, Lung, and Blood Institute; and the American Heart Association. A study coauthor has received grants from Pfizer and personal fees from Johnson & Johnson, the World Health Organization, and the Campaign for Tobacco-Free Kids.
A version of this article appeared on Medscape.com.
TOPLINE:
, according to research published online on December 13 in JAMA Network Open.
METHODOLOGY:
- Researchers analyzed data from the 2016-2021 Pregnancy Risk Assessment Monitoring System.
- They focused on 10,428 adolescents aged 10-19 years who had had a singleton birth and provided information about their use of e-cigarettes or cigarettes.
TAKEAWAY:
- Whereas the researchers found a roughly fivefold increase in the exclusive use of e-cigarettes, the percentage of patients using only cigarettes decreased from 9.2% in 2017 to 3.2% in 2021.
- The percentage of patients who both vaped and smoked fluctuated between 0.6% and 1.6%.
- The rate of small-for-gestational-age (SGA) births for adolescents who did not smoke or vape (12.9%) did not differ significantly from that among adolescents who exclusively used e-cigarettes (16.8%) or those who used both cigarettes and e-cigarettes (17.6%).
- The researchers found use of cigarettes only was associated with a significantly higher rate of SGA births: 24.6%.
IN PRACTICE:
“Exclusive e-cigarette use and dual use of cigarettes and e-cigarettes did not seem to be statistically significantly associated with SGA birth in our analysis, but this finding should be interpreted with caution given the low prevalence of use and the limited sample size,” the study authors wrote.
SOURCE:
Xiaozhong Wen, MD, PhD, with the Jacobs School of Medicine and Biomedical Sciences at the State University of New York at Buffalo, was the corresponding author of the study.
LIMITATIONS:
Participants may have underreported their use of e-cigarettes and cigarettes because of fears of social stigma. The researchers lacked information about vaping in the first and second trimesters, exposure to secondhand smoke, cannabis use, and diet.
DISCLOSURES:
The research was supported by the National Institute on Drug Abuse; the Food and Drug Administration Center for Tobacco Products; the National Heart, Lung, and Blood Institute; and the American Heart Association. A study coauthor has received grants from Pfizer and personal fees from Johnson & Johnson, the World Health Organization, and the Campaign for Tobacco-Free Kids.
A version of this article appeared on Medscape.com.
TOPLINE:
, according to research published online on December 13 in JAMA Network Open.
METHODOLOGY:
- Researchers analyzed data from the 2016-2021 Pregnancy Risk Assessment Monitoring System.
- They focused on 10,428 adolescents aged 10-19 years who had had a singleton birth and provided information about their use of e-cigarettes or cigarettes.
TAKEAWAY:
- Whereas the researchers found a roughly fivefold increase in the exclusive use of e-cigarettes, the percentage of patients using only cigarettes decreased from 9.2% in 2017 to 3.2% in 2021.
- The percentage of patients who both vaped and smoked fluctuated between 0.6% and 1.6%.
- The rate of small-for-gestational-age (SGA) births for adolescents who did not smoke or vape (12.9%) did not differ significantly from that among adolescents who exclusively used e-cigarettes (16.8%) or those who used both cigarettes and e-cigarettes (17.6%).
- The researchers found use of cigarettes only was associated with a significantly higher rate of SGA births: 24.6%.
IN PRACTICE:
“Exclusive e-cigarette use and dual use of cigarettes and e-cigarettes did not seem to be statistically significantly associated with SGA birth in our analysis, but this finding should be interpreted with caution given the low prevalence of use and the limited sample size,” the study authors wrote.
SOURCE:
Xiaozhong Wen, MD, PhD, with the Jacobs School of Medicine and Biomedical Sciences at the State University of New York at Buffalo, was the corresponding author of the study.
LIMITATIONS:
Participants may have underreported their use of e-cigarettes and cigarettes because of fears of social stigma. The researchers lacked information about vaping in the first and second trimesters, exposure to secondhand smoke, cannabis use, and diet.
DISCLOSURES:
The research was supported by the National Institute on Drug Abuse; the Food and Drug Administration Center for Tobacco Products; the National Heart, Lung, and Blood Institute; and the American Heart Association. A study coauthor has received grants from Pfizer and personal fees from Johnson & Johnson, the World Health Organization, and the Campaign for Tobacco-Free Kids.
A version of this article appeared on Medscape.com.
New drug reporting limit may overlook cannabis in children
TOPLINE:
, according to a research letter published online in JAMA Pediatrics.
METHODOLOGY:
- After a laboratory changed its reporting threshold for the metabolite 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) from 5 ng/mL to 15 ng/mL in 2019 to match federal standards, researchers examined the rate of false positives for the initial urine drug screen and the false-negative rate with LC-MS.
- Their study focused on 976 cannabinoid-positive drug screens conducted at a pediatric hospital between Nov. 18, 2019, and May 31, 2021, that had confirmatory LC-MS to rule out false-positive results.
- Patients had a median age of 16 years.
TAKEAWAY:
- The false-positive rate was 10.1% based on the 15 ng/mL threshold compared with 2% based on the 5 ng/mL limit of quantification.
- About 81% of samples with negative LC-MS reports had detectable concentrations of THC-COOH.
IN PRACTICE:
“Confirming THC-COOH in children’s and adolescents’ urine may be relevant at concentrations less than 15 ng/mL, particularly if child protection is pertinent,” according to the study authors.
“Confirmatory testing should be reserved for select cases and must be interpreted with caution,” they added. “Laboratories should report down to the limit of quantification on request.”
SOURCE:
Christopher J. Watson, MD, emergency medicine physician, Maine Medical Center, Portland, is the study’s corresponding author.
LIMITATIONS:
The researchers lacked information about the clinical context in which patients underwent drug screening.
DISCLOSURES:
A coauthor disclosed royalties from UpToDate outside of the study.
A version of this article appeared on Medscape.com.
TOPLINE:
, according to a research letter published online in JAMA Pediatrics.
METHODOLOGY:
- After a laboratory changed its reporting threshold for the metabolite 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) from 5 ng/mL to 15 ng/mL in 2019 to match federal standards, researchers examined the rate of false positives for the initial urine drug screen and the false-negative rate with LC-MS.
- Their study focused on 976 cannabinoid-positive drug screens conducted at a pediatric hospital between Nov. 18, 2019, and May 31, 2021, that had confirmatory LC-MS to rule out false-positive results.
- Patients had a median age of 16 years.
TAKEAWAY:
- The false-positive rate was 10.1% based on the 15 ng/mL threshold compared with 2% based on the 5 ng/mL limit of quantification.
- About 81% of samples with negative LC-MS reports had detectable concentrations of THC-COOH.
IN PRACTICE:
“Confirming THC-COOH in children’s and adolescents’ urine may be relevant at concentrations less than 15 ng/mL, particularly if child protection is pertinent,” according to the study authors.
“Confirmatory testing should be reserved for select cases and must be interpreted with caution,” they added. “Laboratories should report down to the limit of quantification on request.”
SOURCE:
Christopher J. Watson, MD, emergency medicine physician, Maine Medical Center, Portland, is the study’s corresponding author.
LIMITATIONS:
The researchers lacked information about the clinical context in which patients underwent drug screening.
DISCLOSURES:
A coauthor disclosed royalties from UpToDate outside of the study.
A version of this article appeared on Medscape.com.
TOPLINE:
, according to a research letter published online in JAMA Pediatrics.
METHODOLOGY:
- After a laboratory changed its reporting threshold for the metabolite 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) from 5 ng/mL to 15 ng/mL in 2019 to match federal standards, researchers examined the rate of false positives for the initial urine drug screen and the false-negative rate with LC-MS.
- Their study focused on 976 cannabinoid-positive drug screens conducted at a pediatric hospital between Nov. 18, 2019, and May 31, 2021, that had confirmatory LC-MS to rule out false-positive results.
- Patients had a median age of 16 years.
TAKEAWAY:
- The false-positive rate was 10.1% based on the 15 ng/mL threshold compared with 2% based on the 5 ng/mL limit of quantification.
- About 81% of samples with negative LC-MS reports had detectable concentrations of THC-COOH.
IN PRACTICE:
“Confirming THC-COOH in children’s and adolescents’ urine may be relevant at concentrations less than 15 ng/mL, particularly if child protection is pertinent,” according to the study authors.
“Confirmatory testing should be reserved for select cases and must be interpreted with caution,” they added. “Laboratories should report down to the limit of quantification on request.”
SOURCE:
Christopher J. Watson, MD, emergency medicine physician, Maine Medical Center, Portland, is the study’s corresponding author.
LIMITATIONS:
The researchers lacked information about the clinical context in which patients underwent drug screening.
DISCLOSURES:
A coauthor disclosed royalties from UpToDate outside of the study.
A version of this article appeared on Medscape.com.
Can thermal biofeedback reduce pain and anxiety?
TOPLINE:
A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.
METHODOLOGY:
- Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
- Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
- Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.
TAKEAWAY:
- Anxiety scores decreased by about 22% on average (P < .001).
- Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
- In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.
IN PRACTICE:
“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”
SOURCE:
Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.
LIMITATIONS:
The studies were open label and did not include control groups.
DISCLOSURES:
Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.
A version of this article first appeared on Medscape.com.
TOPLINE:
A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.
METHODOLOGY:
- Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
- Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
- Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.
TAKEAWAY:
- Anxiety scores decreased by about 22% on average (P < .001).
- Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
- In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.
IN PRACTICE:
“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”
SOURCE:
Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.
LIMITATIONS:
The studies were open label and did not include control groups.
DISCLOSURES:
Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.
A version of this article first appeared on Medscape.com.
TOPLINE:
A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.
METHODOLOGY:
- Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
- Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
- Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.
TAKEAWAY:
- Anxiety scores decreased by about 22% on average (P < .001).
- Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
- In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.
IN PRACTICE:
“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”
SOURCE:
Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.
LIMITATIONS:
The studies were open label and did not include control groups.
DISCLOSURES:
Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.
A version of this article first appeared on Medscape.com.