Orally dissolving buprenorphine tied to severe tooth decay, FDA warns

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Orally dissolving medications containing buprenorphine are linked to severe dental problems, including total tooth loss, the U.S. Food and Drug Administration warns in a safety communication.

The oral side effects of these medications, which are used to treat opioid use disorder (OUD) and pain, include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.



Multiple cases have been reported even in patients with no history of dental problems.

The FDA is adding a warning about the risk of dental problems to the prescribing information and the patient medication guide for all buprenorphine-containing medicines dissolved in the mouth.

The FDA emphasizes, however, that buprenorphine remains “an important treatment option for OUD and pain, and the benefits of these medicines clearly outweigh the risks.”
 

More than 300 reported cases

Buprenorphine was approved in 2002 as a sublingual tablet, and in 2015 as a film to be placed inside the cheek to treat pain. Both delivery methods have been associated with dental problems.

Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious.

There may be other cases, the FDA says, as this represents only cases reported to the FDA or published in the medical literature.

The average age of the patients who developed dental problems while taking buprenorphine is 42 years, but those as young as 18 years old were also affected.

Most cases occurred in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.

In 26 cases, patients had no prior history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

Among all 305 cases reported, 113 involved two or more teeth.

The most common treatment for the dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases required root canals, dental surgery, and other procedures such as crowns and implants.
 

Recommendations

The FDA says health care providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their health care provider, as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.

Patients are also being advised to take extra steps to help lessen the risk of serious dental problems.

Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines.

Counsel them that after the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth, as the FDA advises. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

The FDA also advises that patients tell their provider about any history of tooth problems, including cavities, and schedule a dentist visit soon after starting the medicine.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

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

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Orally dissolving medications containing buprenorphine are linked to severe dental problems, including total tooth loss, the U.S. Food and Drug Administration warns in a safety communication.

The oral side effects of these medications, which are used to treat opioid use disorder (OUD) and pain, include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.



Multiple cases have been reported even in patients with no history of dental problems.

The FDA is adding a warning about the risk of dental problems to the prescribing information and the patient medication guide for all buprenorphine-containing medicines dissolved in the mouth.

The FDA emphasizes, however, that buprenorphine remains “an important treatment option for OUD and pain, and the benefits of these medicines clearly outweigh the risks.”
 

More than 300 reported cases

Buprenorphine was approved in 2002 as a sublingual tablet, and in 2015 as a film to be placed inside the cheek to treat pain. Both delivery methods have been associated with dental problems.

Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious.

There may be other cases, the FDA says, as this represents only cases reported to the FDA or published in the medical literature.

The average age of the patients who developed dental problems while taking buprenorphine is 42 years, but those as young as 18 years old were also affected.

Most cases occurred in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.

In 26 cases, patients had no prior history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

Among all 305 cases reported, 113 involved two or more teeth.

The most common treatment for the dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases required root canals, dental surgery, and other procedures such as crowns and implants.
 

Recommendations

The FDA says health care providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their health care provider, as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.

Patients are also being advised to take extra steps to help lessen the risk of serious dental problems.

Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines.

Counsel them that after the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth, as the FDA advises. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

The FDA also advises that patients tell their provider about any history of tooth problems, including cavities, and schedule a dentist visit soon after starting the medicine.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

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

Orally dissolving medications containing buprenorphine are linked to severe dental problems, including total tooth loss, the U.S. Food and Drug Administration warns in a safety communication.

The oral side effects of these medications, which are used to treat opioid use disorder (OUD) and pain, include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss.



Multiple cases have been reported even in patients with no history of dental problems.

The FDA is adding a warning about the risk of dental problems to the prescribing information and the patient medication guide for all buprenorphine-containing medicines dissolved in the mouth.

The FDA emphasizes, however, that buprenorphine remains “an important treatment option for OUD and pain, and the benefits of these medicines clearly outweigh the risks.”
 

More than 300 reported cases

Buprenorphine was approved in 2002 as a sublingual tablet, and in 2015 as a film to be placed inside the cheek to treat pain. Both delivery methods have been associated with dental problems.

Since buprenorphine was approved, the FDA has identified 305 cases of dental problems associated with orally dissolving buprenorphine, including 131 classified as serious.

There may be other cases, the FDA says, as this represents only cases reported to the FDA or published in the medical literature.

The average age of the patients who developed dental problems while taking buprenorphine is 42 years, but those as young as 18 years old were also affected.

Most cases occurred in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain.

In 26 cases, patients had no prior history of dental problems. Some dental problems developed as soon as 2 weeks after treatment began; the median time to diagnosis was about 2 years after starting treatment.

Among all 305 cases reported, 113 involved two or more teeth.

The most common treatment for the dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases required root canals, dental surgery, and other procedures such as crowns and implants.
 

Recommendations

The FDA says health care providers should counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of transmucosal buprenorphine-containing medicines and emphasize the importance of visiting their dentist to closely monitor their teeth.

Patients should be counseled to continue taking buprenorphine medications as prescribed and not stop suddenly without first talking to their health care provider, as this could lead to serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.

Patients are also being advised to take extra steps to help lessen the risk of serious dental problems.

Patients should also be educated on strategies to maintain or improve oral health while taking transmucosal buprenorphine medicines.

Counsel them that after the medicine is completely dissolved, the patient should take a large sip of water, swish it gently around the teeth and gums, swallow, and wait at least 1 hour before brushing their teeth, as the FDA advises. This will allow time for the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.

The FDA also advises that patients tell their provider about any history of tooth problems, including cavities, and schedule a dentist visit soon after starting the medicine.

Dental problems related to transmucosal buprenorphine-containing medicines should be reported to the FDA’s MedWatch program.

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

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More vitamin D not better for reducing cancer or CVD incidence

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Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D3 supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D3 supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D3, or 80 mcg (3,200 IU) of daily vitamin D3.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D3 was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D3 levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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

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Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D3 supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D3 supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D3, or 80 mcg (3,200 IU) of daily vitamin D3.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D3 was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D3 levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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

Vitamin D supplementation did not appear to influence the incidence of cancer or major cardiovascular disease (CVD) events in older adults who largely already had adequate vitamin D levels, according to a new randomized controlled study.

In the cohort of nearly 2,500 healthy individuals, the researchers found no differences in cancer or CVD incidence over 5 years between the groups randomly assigned to vitamin D supplementation and to placebo.

The findings, published online Jan. 4, 2022, in the American Journal of Clinical Nutrition, may be influenced by the fact that most participants had sufficient vitamin D levels at baseline, and thus received higher than recommended doses of vitamin D during the study.

“Vitamin D3 supplementation with 1600 or 3200 IU/day for 5 years did not reduce the incidence of major CVD events, any invasive cancer, or mortality among generally healthy and mostly vitamin D sufficient older adults in Finland,” write the authors, led by Jyrki Virtanen, RD, PhD, associate professor of nutrition and public health at University of Eastern Finland, Kuopio.

“The low number of subjects with low vitamin D concentrations was a bit of a surprise for us also, but it likely reflects the quite successful food fortification policy in Finland,” Dr. Virtanen told this news organization.

Prior research has found that vitamin D insufficiency is associated with a higher risk of nearly all diseases. Although the evidence on the benefits of vitamin D supplementation remains more limited, a meta-analysis reported a consistent and significant 13% reduction in cancer mortality in those who received vitamin D supplements.

In this study, Dr. Virtanen and colleagues investigated the effects of vitamin D3 supplementation on cancer and CVD incidence in a cohort of 2,495 healthy participants.

Men 60 years or older and women 65 years or older were randomly assigned to one of three groups: placebo, 40 mcg (1,600 IU) of daily vitamin D3, or 80 mcg (3,200 IU) of daily vitamin D3.

Data collected at baseline and throughout the trial included serum 25(OH)D concentrations, nutrition, sun exposure, medication use, mental health, and other factors that could affect the risk of disease.

The study’s primary endpoints were incident of major CVD and invasive cancer. Secondary endpoints included incidence of myocardial infarction, stroke, and CVD mortality as well as site-specific cancers and cancer death.

Follow-up occurred via annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person evaluations. In the sub-cohort, mean serum 25(OH)D concentration was 75 nmol/L (30 ng/mL) at baseline; 9.1% had concentrations less than 50 nmol/L (20 ng/mL) and 50.0% had concentrations of at least 75 nmol/L (30 ng/mL).

The authors identified no major differences between the three arms at baseline, but noted that, compared with the overall study population, those in the subcohort were younger, more likely to use their own vitamin D supplements, and more likely to rate their health as good or excellent.

Among 503 participants that had complete data from baseline, the mean increase in serum 25(OH)D in participants receiving 1,600 IU/day vitamin D3 was 23.4 nmol/L (9.4 ng/mL) and 43.6 nmol/L (17.4 ng/mL) in the arm receiving 3,200 IU/day between baseline and 6 months. The authors observed a small additional increase in levels between the 6-month and 12-month visits, but few changes in vitamin D3 levels in the placebo arm.

At the 5-year follow-up, major CVD events occurred in 4.9% of participants in the placebo arm, 5% in those in the 1,600 IU/d arm (hazard ratio, 0.97), and 4.3% of those in the 3,200 IU/d arm (HR, 0.84; P = .44). Invasive cancer at follow-up was diagnosed in 4.9% of placebo recipients, 5.8% of those on 1,600 IU/d supplementation (HR, 1.14; P = .55), and 4.8% in the 3,200 IU/d group (HR, 0.95; P = .81). No significant differences were observed in the secondary endpoints or in total mortality.

The authors did not conduct a subanalysis in participants who had low 25(OH)D concentrations levels at baseline because “there were too few participants to do any meaningful analyses,” said Dr. Virtanen, who noted that blood samples were available for a representative subgroup of 550 subjects, and only 9% of them had low 25(OH)D concentrations at baseline.

Dr. Virtanen noted that future vitamin D supplementation trials should focus on recruiting participants with low vitamin D status.

The study was supported by funding from the Academy of Finland, University of Eastern Finland, Juho Vainio Foundation, Medicinska Understödsföreningen Liv och Hälsa, Finnish Foundation for Cardiovascular Research, Finnish Diabetes Research Foundation, and Finnish Cultural Foundation. Dr. Virtanen disclosed no relevant financial relationships.

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

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At-home cervical ripening linked with less time in L&D unit

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Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

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Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found.

The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to “create and adhere to evidence-based guidelines” for outpatient balloon use, according to the researchers.

“Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients and labor and delivery units,” the authors reported Jan. 6 in Obstetrics and Gynecology.

The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours.

The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the “most comprehensive” examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say.

The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity.

Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) versus the inpatient group (27%) (risk ratio, 0.76; 95% confidence interval, 0.59-0.98).

Corresponding author Vincenzo Berghella, MD, director of the Division of Maternal-Fetal Medicine at Jefferson University Hospitals, Philadelphia, called the data “very assuring.” He said, “We knew induction was good in the hospital for many indications. We now know that induction can be started at home and it’s safe.”

Dr. Berghella added that the lower rate of cesarean delivery in the outpatient group likely reflected less use of fetal heart-rate monitoring, which can produce false-positive predictions of fetal compromise.

Still, too few patients have been studied to completely rule out rare adverse events with use of the balloons in the outpatient setting, the researchers acknowledge.

Aaron B. Caughey, MD, PhD, of Oregon Health and Science University, Portland, who was not involved in the study, said current data do not put to rest all safety concerns with the balloons, and it will be vital for health systems to report outcomes as outpatient use of the devices increases.

“Outcomes such as chorioamnionitis and postpartum hemorrhage will be important to have more data on, though there do not appear to be trends from these data,” Dr. Caughey told this news organization. Rarer outcomes, such as cervical injury, placenta abruption, and fetal injury, he added, “will require much larger studies to examine these potential but unlikely risks.”

The authors and Dr. Caughey have disclosed no relevant financial relationships.

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

*Correction, 1/19/22: An earlier version of the headline of this article misstated a study finding. The study found that women who undergo balloon cervical ripening spend less time in the labor and delivery unit than those who have the induction procedure in a hospital.

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ACIP releases new dengue vaccine recommendations

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The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices has now recommended using Sanofi’s dengue vaccine, Dengvaxia, in the United States, with specific restrictions. The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.

Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.

The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.

The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.

Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.

In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.

Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
 

Antibody tests prevaccination

The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.

Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.

If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.

There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”

One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”

Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”

Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”

Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.

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

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The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices has now recommended using Sanofi’s dengue vaccine, Dengvaxia, in the United States, with specific restrictions. The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.

Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.

The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.

The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.

Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.

In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.

Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
 

Antibody tests prevaccination

The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.

Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.

If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.

There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”

One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”

Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”

Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”

Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.

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

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices has now recommended using Sanofi’s dengue vaccine, Dengvaxia, in the United States, with specific restrictions. The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.

Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.

The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.

The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.

Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.

In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.

Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
 

Antibody tests prevaccination

The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.

Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.

If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.

There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”

One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”

Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”

Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”

Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.

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

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Pregnancy diet linked to risk of obesity in child

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A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

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A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

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Clinician experience, life stressors drive HIV adherence, retention in new patients

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A novel twist on the concept of “meeting people where they are” may hold the key to retaining new HIV patients, and even bringing the elusive goal of ending the AIDS epidemic a bit closer. While the concept commonly refers to community outreach and engagement, understanding patient experiences and expectations and personal life stressors in the actual clinic setting may improve overall outcomes, according to new research.

In fact, accounting for both expectations and life stressors may help physicians predict which patients will be lost to follow-up (LTFU) in the first year of HIV care.

“Medical science is not necessarily [at the forefront] of where we want to focus our efforts right now,” Emmanuel Guajardo, MD, lead study author and instructor of infectious diseases at Baylor College of Medicine, Houston, told this news organization. 

Rather, “we need to focus on retention in care and adherence to medications. Doubling down on these efforts could really go a long way toward ending the HIV epidemic,” he said. 

Study findings were published online Jan. 5, 2022, in AIDS and Behavior.
 

First time’s a charm

A total of 450 patients attending an HIV clinic in Houston were asked to complete a postvisit survey detailing their experience with the HIV clinician, as well as personal life stressors in the preceding 6 months. Study participants were predominantly non-Hispanic Black (54.2%) or Hispanic (30.7%) and mostly men who have sex with men (MSM), populations that mimic the patients seen at Dr. Guajardo’s clinic. Patients were given the option of survey completion while awaiting discharge, within 2 weeks at the clinic, or (as a last resort) by phone.

Overall scores were based on a composite of validated scales: patient experience scores were defined dichotomously (best experience, most positive experience vs. not the best experience), and life stressor events (death, relationship, economic) were assigned weighted scores based on life change impact (for example, death of a spouse received a score of 100 while moved/changed living location was assigned a score of 25).

“We found that patients who reported better initial experiences with their provider at the first visit were less likely to be lost to follow-up at 6 and 12 months,” explained Dr. Guajardo. “Having fewer life stressors at the first visit [was] also [protective].”

At 6 months, mean overall patient experience scores were 8.60 for those LTFU versus and 8.98 for those not LTFU (P = .011); corresponding mean scores at 12 months were 8.43 and 8.98 respectively (P = .001).

For the dichotomized scoring, patients reporting the best experience with the health care professional were significantly less likely to be LTFU at 6 months (adjusted odd ratio, 0.866; P = .038) and 12 months (aOR, 1.263; P = .029) versus those not reporting the best experience.

Mean life change scores appeared to portend patient drop-off; patients reporting more stressful life events were likelier to be LTFU at 6 months (mean life change score, 129 vs. 100 for those retained in care) and at 12 months (126 vs. 101). 

Corresponding multivariate logistic regression models controlling for age, baseline CD4 cell count less than 200, and diagnosis of at least 3 months showed that patients with higher life stressor burdens were significantly more likely to be LTFU at both 6 months (aOR, 1.232, P = .037) and 12 months (aOR, 1.263, P = .029).
 

 

 

Approach matters

“The [study] really hits the nail on the head in terms of identifying a couple of these very salient issues that affect people’s care, especially concerning HIV,” Philip A. Chan, MD, infectious disease specialist and associate professor of medicine at Brown University, Providence, R.I, told this news organization.

“It highlights things that we see on the ground that can interfere with HIV care or [pre-exposure prophylaxis] care, just health care in general, certainly one’s relationship with the physician or provider, and also, you know, real-life stressors,” said Dr. Chan, who was not involved with the study.

Relationship building is especially important for historically underserved populations, a point that’s hardly lost on either Dr. Chan or Dr. Guajardo, who both pointed to higher levels of mistrust among certain patient populations because of their mistreatment by the health care system. The answer? Let the patient lead the initial discussion, allow them to feel comfortable and participate in their care in ways that are most beneficial to them. 

“There’s so much miscommunication, misunderstanding, and stigma related to HIV out in the community. So, it’s important to really open the floor for whatever they want to talk about first, before I push any agenda on a new patient.” Dr. Guajardo said. Thereafter, he relies on open-ended questions such as ‘tell me about your sexual partners?’ or ‘what sort of sexual practices do you engage in?’ 

“At the end of the day, you just need someone dedicated, who can be respectful and listening and caring, and dedicate time to patients to help keep them in care, to listen, and to navigate our incredibly, incredibly complex health care system,” Dr. Chan added.

This study was partly supported by use of the facilities and resources of the Houston Veterans Affairs Center for Innovations in Quality, Effectiveness, and Safety and Harris Health System. Support for the study was also provided by the National Institute of Mental Health and the University of Texas MD Anderson Foundation Chair at Baylor College of Medicine. Dr. Guajardo and Dr. Chan disclosed no relevant financial relationships.

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

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A novel twist on the concept of “meeting people where they are” may hold the key to retaining new HIV patients, and even bringing the elusive goal of ending the AIDS epidemic a bit closer. While the concept commonly refers to community outreach and engagement, understanding patient experiences and expectations and personal life stressors in the actual clinic setting may improve overall outcomes, according to new research.

In fact, accounting for both expectations and life stressors may help physicians predict which patients will be lost to follow-up (LTFU) in the first year of HIV care.

“Medical science is not necessarily [at the forefront] of where we want to focus our efforts right now,” Emmanuel Guajardo, MD, lead study author and instructor of infectious diseases at Baylor College of Medicine, Houston, told this news organization. 

Rather, “we need to focus on retention in care and adherence to medications. Doubling down on these efforts could really go a long way toward ending the HIV epidemic,” he said. 

Study findings were published online Jan. 5, 2022, in AIDS and Behavior.
 

First time’s a charm

A total of 450 patients attending an HIV clinic in Houston were asked to complete a postvisit survey detailing their experience with the HIV clinician, as well as personal life stressors in the preceding 6 months. Study participants were predominantly non-Hispanic Black (54.2%) or Hispanic (30.7%) and mostly men who have sex with men (MSM), populations that mimic the patients seen at Dr. Guajardo’s clinic. Patients were given the option of survey completion while awaiting discharge, within 2 weeks at the clinic, or (as a last resort) by phone.

Overall scores were based on a composite of validated scales: patient experience scores were defined dichotomously (best experience, most positive experience vs. not the best experience), and life stressor events (death, relationship, economic) were assigned weighted scores based on life change impact (for example, death of a spouse received a score of 100 while moved/changed living location was assigned a score of 25).

“We found that patients who reported better initial experiences with their provider at the first visit were less likely to be lost to follow-up at 6 and 12 months,” explained Dr. Guajardo. “Having fewer life stressors at the first visit [was] also [protective].”

At 6 months, mean overall patient experience scores were 8.60 for those LTFU versus and 8.98 for those not LTFU (P = .011); corresponding mean scores at 12 months were 8.43 and 8.98 respectively (P = .001).

For the dichotomized scoring, patients reporting the best experience with the health care professional were significantly less likely to be LTFU at 6 months (adjusted odd ratio, 0.866; P = .038) and 12 months (aOR, 1.263; P = .029) versus those not reporting the best experience.

Mean life change scores appeared to portend patient drop-off; patients reporting more stressful life events were likelier to be LTFU at 6 months (mean life change score, 129 vs. 100 for those retained in care) and at 12 months (126 vs. 101). 

Corresponding multivariate logistic regression models controlling for age, baseline CD4 cell count less than 200, and diagnosis of at least 3 months showed that patients with higher life stressor burdens were significantly more likely to be LTFU at both 6 months (aOR, 1.232, P = .037) and 12 months (aOR, 1.263, P = .029).
 

 

 

Approach matters

“The [study] really hits the nail on the head in terms of identifying a couple of these very salient issues that affect people’s care, especially concerning HIV,” Philip A. Chan, MD, infectious disease specialist and associate professor of medicine at Brown University, Providence, R.I, told this news organization.

“It highlights things that we see on the ground that can interfere with HIV care or [pre-exposure prophylaxis] care, just health care in general, certainly one’s relationship with the physician or provider, and also, you know, real-life stressors,” said Dr. Chan, who was not involved with the study.

Relationship building is especially important for historically underserved populations, a point that’s hardly lost on either Dr. Chan or Dr. Guajardo, who both pointed to higher levels of mistrust among certain patient populations because of their mistreatment by the health care system. The answer? Let the patient lead the initial discussion, allow them to feel comfortable and participate in their care in ways that are most beneficial to them. 

“There’s so much miscommunication, misunderstanding, and stigma related to HIV out in the community. So, it’s important to really open the floor for whatever they want to talk about first, before I push any agenda on a new patient.” Dr. Guajardo said. Thereafter, he relies on open-ended questions such as ‘tell me about your sexual partners?’ or ‘what sort of sexual practices do you engage in?’ 

“At the end of the day, you just need someone dedicated, who can be respectful and listening and caring, and dedicate time to patients to help keep them in care, to listen, and to navigate our incredibly, incredibly complex health care system,” Dr. Chan added.

This study was partly supported by use of the facilities and resources of the Houston Veterans Affairs Center for Innovations in Quality, Effectiveness, and Safety and Harris Health System. Support for the study was also provided by the National Institute of Mental Health and the University of Texas MD Anderson Foundation Chair at Baylor College of Medicine. Dr. Guajardo and Dr. Chan disclosed no relevant financial relationships.

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

A novel twist on the concept of “meeting people where they are” may hold the key to retaining new HIV patients, and even bringing the elusive goal of ending the AIDS epidemic a bit closer. While the concept commonly refers to community outreach and engagement, understanding patient experiences and expectations and personal life stressors in the actual clinic setting may improve overall outcomes, according to new research.

In fact, accounting for both expectations and life stressors may help physicians predict which patients will be lost to follow-up (LTFU) in the first year of HIV care.

“Medical science is not necessarily [at the forefront] of where we want to focus our efforts right now,” Emmanuel Guajardo, MD, lead study author and instructor of infectious diseases at Baylor College of Medicine, Houston, told this news organization. 

Rather, “we need to focus on retention in care and adherence to medications. Doubling down on these efforts could really go a long way toward ending the HIV epidemic,” he said. 

Study findings were published online Jan. 5, 2022, in AIDS and Behavior.
 

First time’s a charm

A total of 450 patients attending an HIV clinic in Houston were asked to complete a postvisit survey detailing their experience with the HIV clinician, as well as personal life stressors in the preceding 6 months. Study participants were predominantly non-Hispanic Black (54.2%) or Hispanic (30.7%) and mostly men who have sex with men (MSM), populations that mimic the patients seen at Dr. Guajardo’s clinic. Patients were given the option of survey completion while awaiting discharge, within 2 weeks at the clinic, or (as a last resort) by phone.

Overall scores were based on a composite of validated scales: patient experience scores were defined dichotomously (best experience, most positive experience vs. not the best experience), and life stressor events (death, relationship, economic) were assigned weighted scores based on life change impact (for example, death of a spouse received a score of 100 while moved/changed living location was assigned a score of 25).

“We found that patients who reported better initial experiences with their provider at the first visit were less likely to be lost to follow-up at 6 and 12 months,” explained Dr. Guajardo. “Having fewer life stressors at the first visit [was] also [protective].”

At 6 months, mean overall patient experience scores were 8.60 for those LTFU versus and 8.98 for those not LTFU (P = .011); corresponding mean scores at 12 months were 8.43 and 8.98 respectively (P = .001).

For the dichotomized scoring, patients reporting the best experience with the health care professional were significantly less likely to be LTFU at 6 months (adjusted odd ratio, 0.866; P = .038) and 12 months (aOR, 1.263; P = .029) versus those not reporting the best experience.

Mean life change scores appeared to portend patient drop-off; patients reporting more stressful life events were likelier to be LTFU at 6 months (mean life change score, 129 vs. 100 for those retained in care) and at 12 months (126 vs. 101). 

Corresponding multivariate logistic regression models controlling for age, baseline CD4 cell count less than 200, and diagnosis of at least 3 months showed that patients with higher life stressor burdens were significantly more likely to be LTFU at both 6 months (aOR, 1.232, P = .037) and 12 months (aOR, 1.263, P = .029).
 

 

 

Approach matters

“The [study] really hits the nail on the head in terms of identifying a couple of these very salient issues that affect people’s care, especially concerning HIV,” Philip A. Chan, MD, infectious disease specialist and associate professor of medicine at Brown University, Providence, R.I, told this news organization.

“It highlights things that we see on the ground that can interfere with HIV care or [pre-exposure prophylaxis] care, just health care in general, certainly one’s relationship with the physician or provider, and also, you know, real-life stressors,” said Dr. Chan, who was not involved with the study.

Relationship building is especially important for historically underserved populations, a point that’s hardly lost on either Dr. Chan or Dr. Guajardo, who both pointed to higher levels of mistrust among certain patient populations because of their mistreatment by the health care system. The answer? Let the patient lead the initial discussion, allow them to feel comfortable and participate in their care in ways that are most beneficial to them. 

“There’s so much miscommunication, misunderstanding, and stigma related to HIV out in the community. So, it’s important to really open the floor for whatever they want to talk about first, before I push any agenda on a new patient.” Dr. Guajardo said. Thereafter, he relies on open-ended questions such as ‘tell me about your sexual partners?’ or ‘what sort of sexual practices do you engage in?’ 

“At the end of the day, you just need someone dedicated, who can be respectful and listening and caring, and dedicate time to patients to help keep them in care, to listen, and to navigate our incredibly, incredibly complex health care system,” Dr. Chan added.

This study was partly supported by use of the facilities and resources of the Houston Veterans Affairs Center for Innovations in Quality, Effectiveness, and Safety and Harris Health System. Support for the study was also provided by the National Institute of Mental Health and the University of Texas MD Anderson Foundation Chair at Baylor College of Medicine. Dr. Guajardo and Dr. Chan disclosed no relevant financial relationships.

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

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Lifestyle changes can lead to remission, but not a cure, in type 2 diabetes

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Whenever I get a new patient with type 2 diabetes, who is generally on metformin, one of the very first questions they ask me is, “Can I get off my medication?” Everybody, it seems, who gets diabetes wants to not have diabetes.

So, what does this really mean? What does this mean to me as a clinician? And what does this mean to my patients? The American Diabetes Association recently came out with a consensus statement that defines and interprets the definition of remission in people with type 2 diabetes. Basically, if the hemoglobin A1c is less than 6.5% without diabetes medications for at least 3 months, that’s considered remission.

There are other considerations, such as metabolic surgery, that can lead to remission. But again, such patients should be 3 months post surgery and at least 3 months off diabetes medication. As for a lifestyle intervention, the authors state that remission really happens within about 6 months.

Dr. Anne L. Peters

That leads me to wonder: What is remission? Remission really means temporary recovery, so it doesn’t mean a cure. Now, I’m not against curing diabetes. In fact, I’m all for it. But when somebody gets diabetes – and honestly, it doesn’t matter whether it’s type 1 or type 2 – the first thing I think of, and I think the first thing that my patients are taught, is how important it is to have a healthy lifestyle. This healthy lifestyle isn’t just for people with diabetes; it largely means the healthy lifestyle that all of us should follow, one where we eat fewer simple carbs, less processed food, more vegetables, more lean proteins and meats – all of the things that we know we should do. And all of the things that keep us healthy. To some degree, I don’t think you can ever get “remission” from diabetes, because if having diabetes points an individual toward having a healthier lifestyle, I think that’s great.

I think people should exercise more. When it comes to treating diabetes, exercise is key. When you think about obesity, we want to help people who are overweight or obese lose weight as part of their treatment for diabetes. And that doesn’t go away, either.

So, no, people who are diagnosed with diabetes don’t really go into remission if they keep their same old habits and don’t lose weight and don’t exercise. But many people with diabetes can get off medication if they do those things.

However, it’s not true for everybody, and I don’t want people to get unrealistic expectations because I think there are probably about a thousand different subtypes of type 2 diabetes. And I’ve definitely seen people who are lean with type 2 diabetes who don’t respond as well to a lifestyle intervention, or people who are more insulin deficient, who also need medication.

I think it’s really important to frame the expectation that, if remission means going back to the way it was before, when they didn’t have to think about what they ate or whether or not they exercised, that’s not going to happen. I think diabetes should really be a wake-up call that people need to be healthier in terms of their lifestyle habits.

The issue of medication is really an individual one, and I think we need to help patients look for what’s best for the individual, what their targets are, what their goals are. But we also have to think that diabetes isn’t just about glucose.

So remission in terms of the ADA’s definition looks at glucose, but I look at more than glucose. You have to look at lipids and blood pressure. And, as I mentioned earlier, you have to look at whether or not a person has preexisting cardiovascular disease or has the presence of microvascular complications that need to be screened for and treated.

I actually think that, in some ways, the diagnosis of diabetes is helpful simply because it helps put people on a better path to health. I don’t want people to think that remission means that they can go back to unhealthy habits. I really encourage all people to live a healthier lifestyle, and if it leads to improvements in glucose levels and getting off medication, I think that’s wonderful and a worthy goal. But remember, health and meeting one’s targets remain key in the treatment of type 2 diabetes.
 

Dr. Peters is a professor in the department of clinical medicine at the University of Southern California, Los Angeles. She reported serving on the advisory board or speakers’ bureau of Medscape and several pharmaceutical companies, and has received research support from Dexcom, MannKind, and AstraZeneca. This perspective and an accompanying video first appeared on Medscape.com.

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Whenever I get a new patient with type 2 diabetes, who is generally on metformin, one of the very first questions they ask me is, “Can I get off my medication?” Everybody, it seems, who gets diabetes wants to not have diabetes.

So, what does this really mean? What does this mean to me as a clinician? And what does this mean to my patients? The American Diabetes Association recently came out with a consensus statement that defines and interprets the definition of remission in people with type 2 diabetes. Basically, if the hemoglobin A1c is less than 6.5% without diabetes medications for at least 3 months, that’s considered remission.

There are other considerations, such as metabolic surgery, that can lead to remission. But again, such patients should be 3 months post surgery and at least 3 months off diabetes medication. As for a lifestyle intervention, the authors state that remission really happens within about 6 months.

Dr. Anne L. Peters

That leads me to wonder: What is remission? Remission really means temporary recovery, so it doesn’t mean a cure. Now, I’m not against curing diabetes. In fact, I’m all for it. But when somebody gets diabetes – and honestly, it doesn’t matter whether it’s type 1 or type 2 – the first thing I think of, and I think the first thing that my patients are taught, is how important it is to have a healthy lifestyle. This healthy lifestyle isn’t just for people with diabetes; it largely means the healthy lifestyle that all of us should follow, one where we eat fewer simple carbs, less processed food, more vegetables, more lean proteins and meats – all of the things that we know we should do. And all of the things that keep us healthy. To some degree, I don’t think you can ever get “remission” from diabetes, because if having diabetes points an individual toward having a healthier lifestyle, I think that’s great.

I think people should exercise more. When it comes to treating diabetes, exercise is key. When you think about obesity, we want to help people who are overweight or obese lose weight as part of their treatment for diabetes. And that doesn’t go away, either.

So, no, people who are diagnosed with diabetes don’t really go into remission if they keep their same old habits and don’t lose weight and don’t exercise. But many people with diabetes can get off medication if they do those things.

However, it’s not true for everybody, and I don’t want people to get unrealistic expectations because I think there are probably about a thousand different subtypes of type 2 diabetes. And I’ve definitely seen people who are lean with type 2 diabetes who don’t respond as well to a lifestyle intervention, or people who are more insulin deficient, who also need medication.

I think it’s really important to frame the expectation that, if remission means going back to the way it was before, when they didn’t have to think about what they ate or whether or not they exercised, that’s not going to happen. I think diabetes should really be a wake-up call that people need to be healthier in terms of their lifestyle habits.

The issue of medication is really an individual one, and I think we need to help patients look for what’s best for the individual, what their targets are, what their goals are. But we also have to think that diabetes isn’t just about glucose.

So remission in terms of the ADA’s definition looks at glucose, but I look at more than glucose. You have to look at lipids and blood pressure. And, as I mentioned earlier, you have to look at whether or not a person has preexisting cardiovascular disease or has the presence of microvascular complications that need to be screened for and treated.

I actually think that, in some ways, the diagnosis of diabetes is helpful simply because it helps put people on a better path to health. I don’t want people to think that remission means that they can go back to unhealthy habits. I really encourage all people to live a healthier lifestyle, and if it leads to improvements in glucose levels and getting off medication, I think that’s wonderful and a worthy goal. But remember, health and meeting one’s targets remain key in the treatment of type 2 diabetes.
 

Dr. Peters is a professor in the department of clinical medicine at the University of Southern California, Los Angeles. She reported serving on the advisory board or speakers’ bureau of Medscape and several pharmaceutical companies, and has received research support from Dexcom, MannKind, and AstraZeneca. This perspective and an accompanying video first appeared on Medscape.com.

Whenever I get a new patient with type 2 diabetes, who is generally on metformin, one of the very first questions they ask me is, “Can I get off my medication?” Everybody, it seems, who gets diabetes wants to not have diabetes.

So, what does this really mean? What does this mean to me as a clinician? And what does this mean to my patients? The American Diabetes Association recently came out with a consensus statement that defines and interprets the definition of remission in people with type 2 diabetes. Basically, if the hemoglobin A1c is less than 6.5% without diabetes medications for at least 3 months, that’s considered remission.

There are other considerations, such as metabolic surgery, that can lead to remission. But again, such patients should be 3 months post surgery and at least 3 months off diabetes medication. As for a lifestyle intervention, the authors state that remission really happens within about 6 months.

Dr. Anne L. Peters

That leads me to wonder: What is remission? Remission really means temporary recovery, so it doesn’t mean a cure. Now, I’m not against curing diabetes. In fact, I’m all for it. But when somebody gets diabetes – and honestly, it doesn’t matter whether it’s type 1 or type 2 – the first thing I think of, and I think the first thing that my patients are taught, is how important it is to have a healthy lifestyle. This healthy lifestyle isn’t just for people with diabetes; it largely means the healthy lifestyle that all of us should follow, one where we eat fewer simple carbs, less processed food, more vegetables, more lean proteins and meats – all of the things that we know we should do. And all of the things that keep us healthy. To some degree, I don’t think you can ever get “remission” from diabetes, because if having diabetes points an individual toward having a healthier lifestyle, I think that’s great.

I think people should exercise more. When it comes to treating diabetes, exercise is key. When you think about obesity, we want to help people who are overweight or obese lose weight as part of their treatment for diabetes. And that doesn’t go away, either.

So, no, people who are diagnosed with diabetes don’t really go into remission if they keep their same old habits and don’t lose weight and don’t exercise. But many people with diabetes can get off medication if they do those things.

However, it’s not true for everybody, and I don’t want people to get unrealistic expectations because I think there are probably about a thousand different subtypes of type 2 diabetes. And I’ve definitely seen people who are lean with type 2 diabetes who don’t respond as well to a lifestyle intervention, or people who are more insulin deficient, who also need medication.

I think it’s really important to frame the expectation that, if remission means going back to the way it was before, when they didn’t have to think about what they ate or whether or not they exercised, that’s not going to happen. I think diabetes should really be a wake-up call that people need to be healthier in terms of their lifestyle habits.

The issue of medication is really an individual one, and I think we need to help patients look for what’s best for the individual, what their targets are, what their goals are. But we also have to think that diabetes isn’t just about glucose.

So remission in terms of the ADA’s definition looks at glucose, but I look at more than glucose. You have to look at lipids and blood pressure. And, as I mentioned earlier, you have to look at whether or not a person has preexisting cardiovascular disease or has the presence of microvascular complications that need to be screened for and treated.

I actually think that, in some ways, the diagnosis of diabetes is helpful simply because it helps put people on a better path to health. I don’t want people to think that remission means that they can go back to unhealthy habits. I really encourage all people to live a healthier lifestyle, and if it leads to improvements in glucose levels and getting off medication, I think that’s wonderful and a worthy goal. But remember, health and meeting one’s targets remain key in the treatment of type 2 diabetes.
 

Dr. Peters is a professor in the department of clinical medicine at the University of Southern California, Los Angeles. She reported serving on the advisory board or speakers’ bureau of Medscape and several pharmaceutical companies, and has received research support from Dexcom, MannKind, and AstraZeneca. This perspective and an accompanying video first appeared on Medscape.com.

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Docs react: Crowd crush survival guide, more dewormer, sizzling earwax

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New year, same old TikTok.

You would think after 2021’s often perilous online health trends that the people of the internet would learn a thing or two. Just kidding, who actually thought that? Luckily, physicians on TikTok are ready to offer advice and dispel stupidity as often as TikTok users are ready to dole it out.

Here’s to another year of “wow,” “ugh,” and “omg” moments. But let’s start with great advice from a doctor using TikTok to help save lives.
 

The good: Doctor explains how to survive crowd crush

J. Mack Slaughter, MD, (@drjmackslaughter_md) is an emergency physician who’s built his platform by engaging with and educating people on TikTok and Instagram. He recently reacted to the tragedy at the Travis Scott Astroworld music festival in Houston, where 10 people died due to a crowd surge. “This isn’t the first time this has happened, and it won’t be the last,” Dr. Slaughter captioned his post.

He used a video to spread awareness of how to best react to a crowd surge to his audience of over 368,000 followers, laying out four tips that people can use in case this ever happens to them.

Dr. Slaughter’s four tips are to (1) keep your arms up in front of you to give your chest as much room between someone in front of you as possible; (2) stay upright in order to avoid collapsing; (3) go with the flow of the crowd’s movement to conserve energy; (4) stay away from hard surfaces like walls or barriers “that can’t ebb and flow with the crowd.”

“When you get a densely packed area of people, not only can you lose control over your own movements, but you can have your chest compressed to the point where you can’t inhale,” Dr. Slaughter says. Hopefully, this crowd crush phenomenon is something that no one ever has to experience, but it’s better to have the knowledge on how to get through it.
 

The bad: Papaya seeds and parasites

TikTok user Jacqueline Rae posted about using papaya seeds as a detox method and dewormer in a video that has more than 32.5K likes and over a thousand comments – and she is just one of many TikTok users to promote this. “Papaya seeds on an empty stomach first thing in the morning is an antiparasitic,” Ms. Rae claims.

The papaya seed trend doesn’t come out of thin air, though. There was a study in 2007 where 60 Nigerian children who showed evidence of having intestinal parasites received papaya seeds as a treatment. For 71% of them, the treatment worked to clear their stool of the parasites. However, this is just one study with a pretty small sample size.

Unfortunately, TikTok’s algorithm can cater to hypochondriacs, and after scrolling through dewormer video after dewormer video, where people tout various products and cleanses, patients may really be convinced they have something they don’t.

Terry Simpson, MD, is a California-based physician and weight loss surgeon whose TikTok (@drterrysimpson) bio says: “Know your guts inside and out.” Dr. Simpson made his own video responding to the papaya seed craze, assuaging any anxiety or fears about contracting parasites.

In his video, Dr. Simpson says that most first-world countries like the United States have very few parasites, so patients shouldn’t be worried about them if they haven’t traveled to other countries recently. Additionally, he explains that what many people are seeing expelled after papaya seed cleanses is just fiber, and parasites aren’t visible to the naked eye.

“Papaya seeds are not a cure for parasites,” Dr. Simpson explains. “If you think you have parasites, see a doctor. One pill will get rid of all of the parasites that you can have, but the chances are you don’t have them.”

Symptoms that make people point toward parasites, such as low energy, frequent diarrhea, or other gut issues, can be symptoms of other issues unrelated to parasites, like irritable bowel syndrome or celiac disease. Because of this, it’s important to get a proper diagnosis amid signs of gut trouble.
 

 

 

The ugly: Hydrogen peroxide ear wax cleanse

TikTok user Ayisha Friedman-Negrin (@ayishafrita) got a whopping 2.7 million likes on her video where she puts hydrogen peroxide in her ear (yes, 2.7 million likes). This home remedy, she says, dissolves earwax that is stuck together. She lays her head on one side and waits for the hydrogen peroxide to “sizzle.” It bubbles like a hot spring before yellow-tinged liquid drips out. Yuck.

She isn’t totally wrong – hydrogen peroxide has been used for years to irrigate ears and help soften earwax. But there’s a lot of important information that people replicating this trend on TikTok tend to leave out of their videos. Thankfully, Sina Joorabchi, MD, is here to make sure TikTokers (and the rest of us) aren’t damaging their ears.

Dr. Joorabchi is a board-certified ear, nose, and throat doctor with his own TikTok account (@doctor.sina). He recommends in his video that if hydrogen peroxide is a patient’s go-to ear cleaner, it’s best to stick with one that’s of a 3% hydrogen peroxide concentration, as anything more can damage ears. Additionally, in the original video, Ms. Friedman-Negrin uses too much liquid, and 5 drops a day should work just fine for helping soften earwax.

“Definitely do not attempt [this] if you have an ear infection or history of ear perforation,” Dr. Joorabchi says. “And you don’t want to be using peroxide for an extended period of time. That can cause a lot of ear itching.”

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

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New year, same old TikTok.

You would think after 2021’s often perilous online health trends that the people of the internet would learn a thing or two. Just kidding, who actually thought that? Luckily, physicians on TikTok are ready to offer advice and dispel stupidity as often as TikTok users are ready to dole it out.

Here’s to another year of “wow,” “ugh,” and “omg” moments. But let’s start with great advice from a doctor using TikTok to help save lives.
 

The good: Doctor explains how to survive crowd crush

J. Mack Slaughter, MD, (@drjmackslaughter_md) is an emergency physician who’s built his platform by engaging with and educating people on TikTok and Instagram. He recently reacted to the tragedy at the Travis Scott Astroworld music festival in Houston, where 10 people died due to a crowd surge. “This isn’t the first time this has happened, and it won’t be the last,” Dr. Slaughter captioned his post.

He used a video to spread awareness of how to best react to a crowd surge to his audience of over 368,000 followers, laying out four tips that people can use in case this ever happens to them.

Dr. Slaughter’s four tips are to (1) keep your arms up in front of you to give your chest as much room between someone in front of you as possible; (2) stay upright in order to avoid collapsing; (3) go with the flow of the crowd’s movement to conserve energy; (4) stay away from hard surfaces like walls or barriers “that can’t ebb and flow with the crowd.”

“When you get a densely packed area of people, not only can you lose control over your own movements, but you can have your chest compressed to the point where you can’t inhale,” Dr. Slaughter says. Hopefully, this crowd crush phenomenon is something that no one ever has to experience, but it’s better to have the knowledge on how to get through it.
 

The bad: Papaya seeds and parasites

TikTok user Jacqueline Rae posted about using papaya seeds as a detox method and dewormer in a video that has more than 32.5K likes and over a thousand comments – and she is just one of many TikTok users to promote this. “Papaya seeds on an empty stomach first thing in the morning is an antiparasitic,” Ms. Rae claims.

The papaya seed trend doesn’t come out of thin air, though. There was a study in 2007 where 60 Nigerian children who showed evidence of having intestinal parasites received papaya seeds as a treatment. For 71% of them, the treatment worked to clear their stool of the parasites. However, this is just one study with a pretty small sample size.

Unfortunately, TikTok’s algorithm can cater to hypochondriacs, and after scrolling through dewormer video after dewormer video, where people tout various products and cleanses, patients may really be convinced they have something they don’t.

Terry Simpson, MD, is a California-based physician and weight loss surgeon whose TikTok (@drterrysimpson) bio says: “Know your guts inside and out.” Dr. Simpson made his own video responding to the papaya seed craze, assuaging any anxiety or fears about contracting parasites.

In his video, Dr. Simpson says that most first-world countries like the United States have very few parasites, so patients shouldn’t be worried about them if they haven’t traveled to other countries recently. Additionally, he explains that what many people are seeing expelled after papaya seed cleanses is just fiber, and parasites aren’t visible to the naked eye.

“Papaya seeds are not a cure for parasites,” Dr. Simpson explains. “If you think you have parasites, see a doctor. One pill will get rid of all of the parasites that you can have, but the chances are you don’t have them.”

Symptoms that make people point toward parasites, such as low energy, frequent diarrhea, or other gut issues, can be symptoms of other issues unrelated to parasites, like irritable bowel syndrome or celiac disease. Because of this, it’s important to get a proper diagnosis amid signs of gut trouble.
 

 

 

The ugly: Hydrogen peroxide ear wax cleanse

TikTok user Ayisha Friedman-Negrin (@ayishafrita) got a whopping 2.7 million likes on her video where she puts hydrogen peroxide in her ear (yes, 2.7 million likes). This home remedy, she says, dissolves earwax that is stuck together. She lays her head on one side and waits for the hydrogen peroxide to “sizzle.” It bubbles like a hot spring before yellow-tinged liquid drips out. Yuck.

She isn’t totally wrong – hydrogen peroxide has been used for years to irrigate ears and help soften earwax. But there’s a lot of important information that people replicating this trend on TikTok tend to leave out of their videos. Thankfully, Sina Joorabchi, MD, is here to make sure TikTokers (and the rest of us) aren’t damaging their ears.

Dr. Joorabchi is a board-certified ear, nose, and throat doctor with his own TikTok account (@doctor.sina). He recommends in his video that if hydrogen peroxide is a patient’s go-to ear cleaner, it’s best to stick with one that’s of a 3% hydrogen peroxide concentration, as anything more can damage ears. Additionally, in the original video, Ms. Friedman-Negrin uses too much liquid, and 5 drops a day should work just fine for helping soften earwax.

“Definitely do not attempt [this] if you have an ear infection or history of ear perforation,” Dr. Joorabchi says. “And you don’t want to be using peroxide for an extended period of time. That can cause a lot of ear itching.”

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

New year, same old TikTok.

You would think after 2021’s often perilous online health trends that the people of the internet would learn a thing or two. Just kidding, who actually thought that? Luckily, physicians on TikTok are ready to offer advice and dispel stupidity as often as TikTok users are ready to dole it out.

Here’s to another year of “wow,” “ugh,” and “omg” moments. But let’s start with great advice from a doctor using TikTok to help save lives.
 

The good: Doctor explains how to survive crowd crush

J. Mack Slaughter, MD, (@drjmackslaughter_md) is an emergency physician who’s built his platform by engaging with and educating people on TikTok and Instagram. He recently reacted to the tragedy at the Travis Scott Astroworld music festival in Houston, where 10 people died due to a crowd surge. “This isn’t the first time this has happened, and it won’t be the last,” Dr. Slaughter captioned his post.

He used a video to spread awareness of how to best react to a crowd surge to his audience of over 368,000 followers, laying out four tips that people can use in case this ever happens to them.

Dr. Slaughter’s four tips are to (1) keep your arms up in front of you to give your chest as much room between someone in front of you as possible; (2) stay upright in order to avoid collapsing; (3) go with the flow of the crowd’s movement to conserve energy; (4) stay away from hard surfaces like walls or barriers “that can’t ebb and flow with the crowd.”

“When you get a densely packed area of people, not only can you lose control over your own movements, but you can have your chest compressed to the point where you can’t inhale,” Dr. Slaughter says. Hopefully, this crowd crush phenomenon is something that no one ever has to experience, but it’s better to have the knowledge on how to get through it.
 

The bad: Papaya seeds and parasites

TikTok user Jacqueline Rae posted about using papaya seeds as a detox method and dewormer in a video that has more than 32.5K likes and over a thousand comments – and she is just one of many TikTok users to promote this. “Papaya seeds on an empty stomach first thing in the morning is an antiparasitic,” Ms. Rae claims.

The papaya seed trend doesn’t come out of thin air, though. There was a study in 2007 where 60 Nigerian children who showed evidence of having intestinal parasites received papaya seeds as a treatment. For 71% of them, the treatment worked to clear their stool of the parasites. However, this is just one study with a pretty small sample size.

Unfortunately, TikTok’s algorithm can cater to hypochondriacs, and after scrolling through dewormer video after dewormer video, where people tout various products and cleanses, patients may really be convinced they have something they don’t.

Terry Simpson, MD, is a California-based physician and weight loss surgeon whose TikTok (@drterrysimpson) bio says: “Know your guts inside and out.” Dr. Simpson made his own video responding to the papaya seed craze, assuaging any anxiety or fears about contracting parasites.

In his video, Dr. Simpson says that most first-world countries like the United States have very few parasites, so patients shouldn’t be worried about them if they haven’t traveled to other countries recently. Additionally, he explains that what many people are seeing expelled after papaya seed cleanses is just fiber, and parasites aren’t visible to the naked eye.

“Papaya seeds are not a cure for parasites,” Dr. Simpson explains. “If you think you have parasites, see a doctor. One pill will get rid of all of the parasites that you can have, but the chances are you don’t have them.”

Symptoms that make people point toward parasites, such as low energy, frequent diarrhea, or other gut issues, can be symptoms of other issues unrelated to parasites, like irritable bowel syndrome or celiac disease. Because of this, it’s important to get a proper diagnosis amid signs of gut trouble.
 

 

 

The ugly: Hydrogen peroxide ear wax cleanse

TikTok user Ayisha Friedman-Negrin (@ayishafrita) got a whopping 2.7 million likes on her video where she puts hydrogen peroxide in her ear (yes, 2.7 million likes). This home remedy, she says, dissolves earwax that is stuck together. She lays her head on one side and waits for the hydrogen peroxide to “sizzle.” It bubbles like a hot spring before yellow-tinged liquid drips out. Yuck.

She isn’t totally wrong – hydrogen peroxide has been used for years to irrigate ears and help soften earwax. But there’s a lot of important information that people replicating this trend on TikTok tend to leave out of their videos. Thankfully, Sina Joorabchi, MD, is here to make sure TikTokers (and the rest of us) aren’t damaging their ears.

Dr. Joorabchi is a board-certified ear, nose, and throat doctor with his own TikTok account (@doctor.sina). He recommends in his video that if hydrogen peroxide is a patient’s go-to ear cleaner, it’s best to stick with one that’s of a 3% hydrogen peroxide concentration, as anything more can damage ears. Additionally, in the original video, Ms. Friedman-Negrin uses too much liquid, and 5 drops a day should work just fine for helping soften earwax.

“Definitely do not attempt [this] if you have an ear infection or history of ear perforation,” Dr. Joorabchi says. “And you don’t want to be using peroxide for an extended period of time. That can cause a lot of ear itching.”

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

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U.S. cancer deaths continue to fall, especially lung cancer

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In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

 

 

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

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

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In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

 

 

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

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

In the United States, the risk of death from cancer overall has been continuously dropping since 1991, the American Cancer Society (ACS) noted in its latest report.

There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.

“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.

The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.

In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.

For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.

Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.

Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.

However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.

This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.

Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.

Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.


 

Patterns are changing

With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”

 

 

The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.

As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.

The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.

Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.

Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.

On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
 

Survival at 5 years

For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.

In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.

Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.

Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.

Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.

“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.

That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.

“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.

As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.

All the authors are employed by the ACS.

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

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FROM CA: A CANCER JOURNAL FOR CLINICIANS

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Swallowable intragastric balloon shows significant weight loss

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The Allurion intragastric balloon (formerly the Elipse, Allurion Technologies), a novel balloon that is swallowed, requiring no surgery or endoscopic placement, shows high efficacy in achieving weight loss and an improved metabolic profile, with fewer adverse events than reported with other available gastric balloons, results from a meta-analysis show.

“We believe this analysis to be the most comprehensive review [of the Allurion balloon],” reported first author Daryl Ramai, MD, of the division of gastroenterology and hepatology, University of Utah, Salt Lake City, and colleagues in the research, published in the November/December 2021 issue of the Journal of Clinical Gastroenterology.

“Our study showed that the Allurion balloon reduces waist circumference and triglyceride levels and [is] associated with less adverse events when compared with other intragastric balloons,” the authors concluded.

Unlike other balloons, the Allurion gastric balloon is compressed into a small capsule that is connected to a thin catheter and, once swallowed, it is then inflated with 550 mL of liquid through the catheter to create a feeling of fullness and help control hunger.

The procedure can be performed on an outpatient basis in approximately 20 minutes, potentially avoiding the burden and extra costs of surgery or endoscopic placement and removal. After approximately 4 months, the balloon is designed to empty through a valve that spontaneously opens, and the balloon is then passed in the stool.

Though currently used around the world, the balloon does not yet have approval from the Food and Drug Administration.
 

Meta-analysis shows 12.2% average weight loss across studies

To assess the balloon’s performance, the authors identified 7 out of 273 published studies that met the analysis criteria. The studies included 2,152 patients, ranging in age from 18 to 65 years, with a mean baseline body mass index of 32.1-38.6 kg/m2.

All of the studies were prospective, with reported outcomes at 3-4 months, when the Allurion balloon typically deflates. Three of the studies were multicenter, while four were single center.

In terms of improvements in BMI, the results showed the pooled mean difference from baseline through to the end of the studies was 0.88 (P = .001), and the weighted average percentage of total body weight loss during treatment across the studies was 12.2%.

The mean excess body weight loss across the Allurion studies was 49.1%.

The analysis was not designed to directly compare outcomes with other balloons, but the authors note, for instance, that the ReShape Duo intragastric balloon (an FDA-approved dual-balloon system) has been reported in a previous study to be associated with a percentage of total body weight loss of 7.6% at 6 months, compared with 3.6% observed among those with lifestyle modifications.

However, a separate meta-analysis showed the pooled percentage of total body weight loss with the FDA-approved Orbera balloon to be about the same as the current Allurion analysis, at 12.3% at 3 months after implantation (followed by 13.2% at 6 months and 11.3% at 12 months). The analysis further showed excess body weight loss with the Orbera balloon at 12 months to be 25.4%.

In other outcomes, the current meta-analysis also showed significant improvements with the Allurion balloon in waist circumference of 0.89 (P = .001) and in triglyceride levels of 0.66 (P = .004) versus baseline.

Previous research involving the FDA-approved Obalon intragastric balloon, which is inflated with gas rather than liquid, showed a significant reduction in waist circumference from 109 cm (±12.3) to 99 cm (±10.5) (P < .05), and another study showed that 37.5% of patients receiving the Orbera balloon had normalized triglyceride levels after 4 months, without concomitant medical therapy.
 

 

 

Adverse events appear lower vs. other balloons

Potential risks associated with the Allurion balloon include the potential for early deflation; however, the pooled rate of early balloon deflation observed in the meta-analysis was relatively low at 1.8%.

Other adverse events reported with the Allurion balloon were abdominal pain (37.5%), vomiting (29.6%), diarrhea (15.4%), and small bowel obstruction (0.5%).

The corresponding rates of abdominal pain with the ReShape Duo and Orbera balloons have been reported at 54.5% and 57.5%, respectively, with the effects possibly caused by overinflation, the authors noted.

And rates of vomiting with the ReShape Duo and Orbera balloons have been reported as much higher, at 86.7% and 86.8%, respectively.

Of note, there were no deaths or cases of acute pancreatitis reported in the meta-analysis studies of Allurion.

As reported by this news organization, such concerns have been raised in previous FDA alerts regarding the Orbera and ReShape Duo liquid-filled intragastric balloons.

In the most recent update, issued in April 2020, the FDA described receiving reports of 18 deaths that had occurred worldwide since the approvals of the Orbera and ReShape balloons, including eight in the United States.

Dr. Ramai noted that the concern about the issues is warranted.

“These concerns are valid,” he told this news organization. “Theoretically, since the Allurion balloon is placed for a shorter time span, it is conceivable that there may be less adverse events. However, comparative trials are needed to confirm this.”

Although the balloons show efficacy in patients struggling with weight loss, metabolic syndrome, and fatty liver disease, “the type and duration of intragastric balloons should be tailored to the patient,” Dr. Ramai said.

“Clinicians should thoroughly discuss with their patients the benefits and risks of using an intragastric balloon,” he added. “Furthermore, placement of intragastric balloons should only be attempted by clinicians with expertise in bariatric endoscopy.”

The study received no financial support. Dr. Ramai reported no relevant financial relationships.

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

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The Allurion intragastric balloon (formerly the Elipse, Allurion Technologies), a novel balloon that is swallowed, requiring no surgery or endoscopic placement, shows high efficacy in achieving weight loss and an improved metabolic profile, with fewer adverse events than reported with other available gastric balloons, results from a meta-analysis show.

“We believe this analysis to be the most comprehensive review [of the Allurion balloon],” reported first author Daryl Ramai, MD, of the division of gastroenterology and hepatology, University of Utah, Salt Lake City, and colleagues in the research, published in the November/December 2021 issue of the Journal of Clinical Gastroenterology.

“Our study showed that the Allurion balloon reduces waist circumference and triglyceride levels and [is] associated with less adverse events when compared with other intragastric balloons,” the authors concluded.

Unlike other balloons, the Allurion gastric balloon is compressed into a small capsule that is connected to a thin catheter and, once swallowed, it is then inflated with 550 mL of liquid through the catheter to create a feeling of fullness and help control hunger.

The procedure can be performed on an outpatient basis in approximately 20 minutes, potentially avoiding the burden and extra costs of surgery or endoscopic placement and removal. After approximately 4 months, the balloon is designed to empty through a valve that spontaneously opens, and the balloon is then passed in the stool.

Though currently used around the world, the balloon does not yet have approval from the Food and Drug Administration.
 

Meta-analysis shows 12.2% average weight loss across studies

To assess the balloon’s performance, the authors identified 7 out of 273 published studies that met the analysis criteria. The studies included 2,152 patients, ranging in age from 18 to 65 years, with a mean baseline body mass index of 32.1-38.6 kg/m2.

All of the studies were prospective, with reported outcomes at 3-4 months, when the Allurion balloon typically deflates. Three of the studies were multicenter, while four were single center.

In terms of improvements in BMI, the results showed the pooled mean difference from baseline through to the end of the studies was 0.88 (P = .001), and the weighted average percentage of total body weight loss during treatment across the studies was 12.2%.

The mean excess body weight loss across the Allurion studies was 49.1%.

The analysis was not designed to directly compare outcomes with other balloons, but the authors note, for instance, that the ReShape Duo intragastric balloon (an FDA-approved dual-balloon system) has been reported in a previous study to be associated with a percentage of total body weight loss of 7.6% at 6 months, compared with 3.6% observed among those with lifestyle modifications.

However, a separate meta-analysis showed the pooled percentage of total body weight loss with the FDA-approved Orbera balloon to be about the same as the current Allurion analysis, at 12.3% at 3 months after implantation (followed by 13.2% at 6 months and 11.3% at 12 months). The analysis further showed excess body weight loss with the Orbera balloon at 12 months to be 25.4%.

In other outcomes, the current meta-analysis also showed significant improvements with the Allurion balloon in waist circumference of 0.89 (P = .001) and in triglyceride levels of 0.66 (P = .004) versus baseline.

Previous research involving the FDA-approved Obalon intragastric balloon, which is inflated with gas rather than liquid, showed a significant reduction in waist circumference from 109 cm (±12.3) to 99 cm (±10.5) (P < .05), and another study showed that 37.5% of patients receiving the Orbera balloon had normalized triglyceride levels after 4 months, without concomitant medical therapy.
 

 

 

Adverse events appear lower vs. other balloons

Potential risks associated with the Allurion balloon include the potential for early deflation; however, the pooled rate of early balloon deflation observed in the meta-analysis was relatively low at 1.8%.

Other adverse events reported with the Allurion balloon were abdominal pain (37.5%), vomiting (29.6%), diarrhea (15.4%), and small bowel obstruction (0.5%).

The corresponding rates of abdominal pain with the ReShape Duo and Orbera balloons have been reported at 54.5% and 57.5%, respectively, with the effects possibly caused by overinflation, the authors noted.

And rates of vomiting with the ReShape Duo and Orbera balloons have been reported as much higher, at 86.7% and 86.8%, respectively.

Of note, there were no deaths or cases of acute pancreatitis reported in the meta-analysis studies of Allurion.

As reported by this news organization, such concerns have been raised in previous FDA alerts regarding the Orbera and ReShape Duo liquid-filled intragastric balloons.

In the most recent update, issued in April 2020, the FDA described receiving reports of 18 deaths that had occurred worldwide since the approvals of the Orbera and ReShape balloons, including eight in the United States.

Dr. Ramai noted that the concern about the issues is warranted.

“These concerns are valid,” he told this news organization. “Theoretically, since the Allurion balloon is placed for a shorter time span, it is conceivable that there may be less adverse events. However, comparative trials are needed to confirm this.”

Although the balloons show efficacy in patients struggling with weight loss, metabolic syndrome, and fatty liver disease, “the type and duration of intragastric balloons should be tailored to the patient,” Dr. Ramai said.

“Clinicians should thoroughly discuss with their patients the benefits and risks of using an intragastric balloon,” he added. “Furthermore, placement of intragastric balloons should only be attempted by clinicians with expertise in bariatric endoscopy.”

The study received no financial support. Dr. Ramai reported no relevant financial relationships.

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

The Allurion intragastric balloon (formerly the Elipse, Allurion Technologies), a novel balloon that is swallowed, requiring no surgery or endoscopic placement, shows high efficacy in achieving weight loss and an improved metabolic profile, with fewer adverse events than reported with other available gastric balloons, results from a meta-analysis show.

“We believe this analysis to be the most comprehensive review [of the Allurion balloon],” reported first author Daryl Ramai, MD, of the division of gastroenterology and hepatology, University of Utah, Salt Lake City, and colleagues in the research, published in the November/December 2021 issue of the Journal of Clinical Gastroenterology.

“Our study showed that the Allurion balloon reduces waist circumference and triglyceride levels and [is] associated with less adverse events when compared with other intragastric balloons,” the authors concluded.

Unlike other balloons, the Allurion gastric balloon is compressed into a small capsule that is connected to a thin catheter and, once swallowed, it is then inflated with 550 mL of liquid through the catheter to create a feeling of fullness and help control hunger.

The procedure can be performed on an outpatient basis in approximately 20 minutes, potentially avoiding the burden and extra costs of surgery or endoscopic placement and removal. After approximately 4 months, the balloon is designed to empty through a valve that spontaneously opens, and the balloon is then passed in the stool.

Though currently used around the world, the balloon does not yet have approval from the Food and Drug Administration.
 

Meta-analysis shows 12.2% average weight loss across studies

To assess the balloon’s performance, the authors identified 7 out of 273 published studies that met the analysis criteria. The studies included 2,152 patients, ranging in age from 18 to 65 years, with a mean baseline body mass index of 32.1-38.6 kg/m2.

All of the studies were prospective, with reported outcomes at 3-4 months, when the Allurion balloon typically deflates. Three of the studies were multicenter, while four were single center.

In terms of improvements in BMI, the results showed the pooled mean difference from baseline through to the end of the studies was 0.88 (P = .001), and the weighted average percentage of total body weight loss during treatment across the studies was 12.2%.

The mean excess body weight loss across the Allurion studies was 49.1%.

The analysis was not designed to directly compare outcomes with other balloons, but the authors note, for instance, that the ReShape Duo intragastric balloon (an FDA-approved dual-balloon system) has been reported in a previous study to be associated with a percentage of total body weight loss of 7.6% at 6 months, compared with 3.6% observed among those with lifestyle modifications.

However, a separate meta-analysis showed the pooled percentage of total body weight loss with the FDA-approved Orbera balloon to be about the same as the current Allurion analysis, at 12.3% at 3 months after implantation (followed by 13.2% at 6 months and 11.3% at 12 months). The analysis further showed excess body weight loss with the Orbera balloon at 12 months to be 25.4%.

In other outcomes, the current meta-analysis also showed significant improvements with the Allurion balloon in waist circumference of 0.89 (P = .001) and in triglyceride levels of 0.66 (P = .004) versus baseline.

Previous research involving the FDA-approved Obalon intragastric balloon, which is inflated with gas rather than liquid, showed a significant reduction in waist circumference from 109 cm (±12.3) to 99 cm (±10.5) (P < .05), and another study showed that 37.5% of patients receiving the Orbera balloon had normalized triglyceride levels after 4 months, without concomitant medical therapy.
 

 

 

Adverse events appear lower vs. other balloons

Potential risks associated with the Allurion balloon include the potential for early deflation; however, the pooled rate of early balloon deflation observed in the meta-analysis was relatively low at 1.8%.

Other adverse events reported with the Allurion balloon were abdominal pain (37.5%), vomiting (29.6%), diarrhea (15.4%), and small bowel obstruction (0.5%).

The corresponding rates of abdominal pain with the ReShape Duo and Orbera balloons have been reported at 54.5% and 57.5%, respectively, with the effects possibly caused by overinflation, the authors noted.

And rates of vomiting with the ReShape Duo and Orbera balloons have been reported as much higher, at 86.7% and 86.8%, respectively.

Of note, there were no deaths or cases of acute pancreatitis reported in the meta-analysis studies of Allurion.

As reported by this news organization, such concerns have been raised in previous FDA alerts regarding the Orbera and ReShape Duo liquid-filled intragastric balloons.

In the most recent update, issued in April 2020, the FDA described receiving reports of 18 deaths that had occurred worldwide since the approvals of the Orbera and ReShape balloons, including eight in the United States.

Dr. Ramai noted that the concern about the issues is warranted.

“These concerns are valid,” he told this news organization. “Theoretically, since the Allurion balloon is placed for a shorter time span, it is conceivable that there may be less adverse events. However, comparative trials are needed to confirm this.”

Although the balloons show efficacy in patients struggling with weight loss, metabolic syndrome, and fatty liver disease, “the type and duration of intragastric balloons should be tailored to the patient,” Dr. Ramai said.

“Clinicians should thoroughly discuss with their patients the benefits and risks of using an intragastric balloon,” he added. “Furthermore, placement of intragastric balloons should only be attempted by clinicians with expertise in bariatric endoscopy.”

The study received no financial support. Dr. Ramai reported no relevant financial relationships.

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

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FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY

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