New COVID-19 cases and hospital admissions in children continue to decline, while the slow pace of vaccinations has not deterred manufacturers from seeking new emergency authorizations.

There were just over 55,000 new cases reported during the week of Sept. 16-22, marking three consecutive weeks of declines through the end of summer. Since reaching a post-Omicron peak of 112,000 in late May, the number of weekly cases has fluctuated, with no stretch of increases or decreases lasting more than 4 weeks or the weekly count rising above 97,000 or falling lower than the current 55,000, according to state-level data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

New admissions with confirmed COVID for children aged 0-17 years, which did not follow that pattern and instead continued to rise through the spring and early summer, have been largely decreasing in recent weeks and had fallen to 0.27 per 100,000 population as of Sept. 21 after peaking at 0.46 per 100,000 in late July, the Centers for Disease Control and Prevention reported. A similar decline has been seen for emergency department visits since late August.

The biggest vaccination news of the week came from Moderna and Pfizer and BioNTech, which are each seeking emergency authorization from the Food and Drug Administration for bivalent vaccine boosters that target both the original COVID strain and the BA.4 and BA.5 strains of Omicron.

“Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series [and] Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series,” WebMD said.

Although almost 61% of children aged 12-17 years are already fully vaccinated, that is not the case among those aged 5-11, of whom only 31.4% have completed the initial vaccine regimen. Since becoming eligible in June, just 1.9% of children under 5 years of age have been fully vaccinated and 6.3% have received at least one dose, the CDC said on its COVID Data Tracker. The latest data put the already boosted child populations at 28.8% for 12- to 17-year-olds and 14.8% in those aged 5-11.

About 51,000 children under age 5 years received their initial COVID vaccination during the week of Sept. 15-21, and the trend for that measure is one of gradual decline since July. Among the older children that same week, there were 28,000 initial vaccinations in the 5- to 11-year-olds and 18,000 for those aged 12-17, and activity in both age groups has largely stagnated since the spring, according to a separate AAP report based on CDC data.

New COVID-19 cases and hospital admissions in children continue to decline, while the slow pace of vaccinations has not deterred manufacturers from seeking new emergency authorizations.

There were just over 55,000 new cases reported during the week of Sept. 16-22, marking three consecutive weeks of declines through the end of summer. Since reaching a post-Omicron peak of 112,000 in late May, the number of weekly cases has fluctuated, with no stretch of increases or decreases lasting more than 4 weeks or the weekly count rising above 97,000 or falling lower than the current 55,000, according to state-level data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

New admissions with confirmed COVID for children aged 0-17 years, which did not follow that pattern and instead continued to rise through the spring and early summer, have been largely decreasing in recent weeks and had fallen to 0.27 per 100,000 population as of Sept. 21 after peaking at 0.46 per 100,000 in late July, the Centers for Disease Control and Prevention reported. A similar decline has been seen for emergency department visits since late August.

The biggest vaccination news of the week came from Moderna and Pfizer and BioNTech, which are each seeking emergency authorization from the Food and Drug Administration for bivalent vaccine boosters that target both the original COVID strain and the BA.4 and BA.5 strains of Omicron.

“Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series [and] Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series,” WebMD said.

Although almost 61% of children aged 12-17 years are already fully vaccinated, that is not the case among those aged 5-11, of whom only 31.4% have completed the initial vaccine regimen. Since becoming eligible in June, just 1.9% of children under 5 years of age have been fully vaccinated and 6.3% have received at least one dose, the CDC said on its COVID Data Tracker. The latest data put the already boosted child populations at 28.8% for 12- to 17-year-olds and 14.8% in those aged 5-11.

About 51,000 children under age 5 years received their initial COVID vaccination during the week of Sept. 15-21, and the trend for that measure is one of gradual decline since July. Among the older children that same week, there were 28,000 initial vaccinations in the 5- to 11-year-olds and 18,000 for those aged 12-17, and activity in both age groups has largely stagnated since the spring, according to a separate AAP report based on CDC data.

New COVID-19 cases and hospital admissions in children continue to decline, while the slow pace of vaccinations has not deterred manufacturers from seeking new emergency authorizations.

There were just over 55,000 new cases reported during the week of Sept. 16-22, marking three consecutive weeks of declines through the end of summer. Since reaching a post-Omicron peak of 112,000 in late May, the number of weekly cases has fluctuated, with no stretch of increases or decreases lasting more than 4 weeks or the weekly count rising above 97,000 or falling lower than the current 55,000, according to state-level data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

New admissions with confirmed COVID for children aged 0-17 years, which did not follow that pattern and instead continued to rise through the spring and early summer, have been largely decreasing in recent weeks and had fallen to 0.27 per 100,000 population as of Sept. 21 after peaking at 0.46 per 100,000 in late July, the Centers for Disease Control and Prevention reported. A similar decline has been seen for emergency department visits since late August.

The biggest vaccination news of the week came from Moderna and Pfizer and BioNTech, which are each seeking emergency authorization from the Food and Drug Administration for bivalent vaccine boosters that target both the original COVID strain and the BA.4 and BA.5 strains of Omicron.

“Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series [and] Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series,” WebMD said.

Although almost 61% of children aged 12-17 years are already fully vaccinated, that is not the case among those aged 5-11, of whom only 31.4% have completed the initial vaccine regimen. Since becoming eligible in June, just 1.9% of children under 5 years of age have been fully vaccinated and 6.3% have received at least one dose, the CDC said on its COVID Data Tracker. The latest data put the already boosted child populations at 28.8% for 12- to 17-year-olds and 14.8% in those aged 5-11.

About 51,000 children under age 5 years received their initial COVID vaccination during the week of Sept. 15-21, and the trend for that measure is one of gradual decline since July. Among the older children that same week, there were 28,000 initial vaccinations in the 5- to 11-year-olds and 18,000 for those aged 12-17, and activity in both age groups has largely stagnated since the spring, according to a separate AAP report based on CDC data.

All atopic diseases, as well as environmental and parental factors, appear to be linked with hand eczema (HE), a longitudinal study from Finland has shown.

“In this population-based study, all atopic diseases, not only atopic dermatitis, were found as individual risk factors for HE. In addition, female gender, obesity and mold exposure increased the risk of HE,” wrote Marjut Koskelo, MD, and her colleagues at the University of Oulu in Finland. Their report was published in Contact Dermatitis.

“Parental allergy was also a risk factor of offspring’s HE. Moderate or high physical activity as well as owning a dog appeared as protective factors of HE. No association was found between other lifestyle factors and HE,” they added.

Hand eczema is one of the most common skin disorders and is the most common occupational skin disease, the authors wrote. Many risk factors, including atopic dermatitis, are known to be linked with HE, but whether various other factors might also be linked has not been well studied.

The research team investigated the link between HE and atopic diseases, parental factors, environmental factors (exposure to mold, keeping animals), and lifestyle factors (physical activity, obesity, tobacco and alcohol use).

They analyzed data of people who took part in the Northern Finland Birth Cohort 1966 Study. The data, collected since 1965, includes details about 12,055 mothers in northern Finland who were expected to deliver babies in 1966, and their 12,058 live-born children. The children have been followed over the years with questionnaires and clinical examinations, and their parents have been followed by national registers and medical reports.

For the 46-year follow-up, 6,830 respondents aged 45-46 years, roughly half of them women, completed a 132-question form covering physical health, lifestyle, environmental factors, socioeconomic status, and history of hand eczema and other atopic diseases.

In the statistical analysis, the researchers adjusted for atopic dermatitis, asthma, allergic rhinoconjunctivitis, education level, body mass index, maternal BMI, parental allergy, physical activity, living on a farm, and mold exposure and symptoms.

Of the 900 respondents who reported having had HE, 592 (65.8%) were women and 308 (34.2%) were men (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.49-2.0).
 

Various factors linked with hand eczema risk

The authors found the following:

• Atopic diseases and HE were linked: atopic dermatitis (adjusted odds ratio [aOR], 9.66; 95% CI, 8.03-11.66), asthma (aOR, 1.38; 95% CI, 1.12-1.71), and allergic rhinoconjunctivitis (aOR, 1.28; 95% CI, 1.04-1.56). Sex did not affect the link between atopic diseases and HE.
• Respondents who reported visible mold or mold odor in their apartments had higher risk for HE than did those without a history of mold exposure (OR, 1.32; 95% CI, 1.07-1.61).
• Obesity was linked with HE (OR, 3.44; 95% CI, 1.05-22.8), but smoking status, alcohol intake, and education level were not statistically significant risk factors for HE.
• Participants who reported moderate or high physical activity had lower risk for HE (OR, 0.78; 95% CI, 0.64-0.94; and OR, 0.56; 95% CI, 0.33-0.91, respectively) than those who were less active.
• Parental allergy increased risk for HE (OR, 1.98; 95% CI, 1.70-2.30); as maternal age, BMI, and menarche age increased, so did the risk for the child’s HE, but the increases were not statistically significant; and no significant links were found between maternal tobacco smoking, parental asthma, birth weight, parity, gestational age, and HE.
• Dog owners had less risk for HE than did people without a dog (OR, 0.83; 95% CI, 0.71-0.97); links between cat or farm animal owners and HE were not significant.

“There is a strong association between hand eczema and atopic diseases,” Maya Jonas, MD, clinical assistant professor of dermatology at The Ohio State University Wexner Medical Center in Columbus, told this news organization.

“When evaluating patients with hand eczema, it is important to ask if they have a history of atopic dermatitis, asthma, or allergic rhinitis,” said Dr. Jonas, who was not involved in the study.

Elma Baron, MD, professor and director, Skin Study Center, department of dermatology, Case Western Reserve University, Cleveland, was surprised by the inverse link between physical activity and HE. 

“What struck me as interesting is the inverse association between hand eczema and physical activity, that greater physical activity will decrease the risk for hand eczema,” she said in an interview. “It’s an interesting finding that’s worth exploring.

“Dermatologists have also speculated about the association with the female gender, because women are more likely to be in situations that involve frequent hand washing or in occupations, such as hairdressing, that involve known irritants and allergens,” added Dr. Baron, who was not involved in the study.

The main weakness, she noted, is the reliance on self-reported diagnosis. “Hand eczema is a common condition, but the etiologies of reported hand eczema may vary.

“Being cognizant of these associations can help us prescribe appropriate medications and advise patients about how they can avoid exposures that will aggravate their condition,” Dr. Baron advised.

The authors recommend further related studies.

The authors, Dr. Jonas, and Dr. Baron report no relevant financial relationships. The study was not funded.

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

All atopic diseases, as well as environmental and parental factors, appear to be linked with hand eczema (HE), a longitudinal study from Finland has shown.

“In this population-based study, all atopic diseases, not only atopic dermatitis, were found as individual risk factors for HE. In addition, female gender, obesity and mold exposure increased the risk of HE,” wrote Marjut Koskelo, MD, and her colleagues at the University of Oulu in Finland. Their report was published in Contact Dermatitis.

“Parental allergy was also a risk factor of offspring’s HE. Moderate or high physical activity as well as owning a dog appeared as protective factors of HE. No association was found between other lifestyle factors and HE,” they added.

Hand eczema is one of the most common skin disorders and is the most common occupational skin disease, the authors wrote. Many risk factors, including atopic dermatitis, are known to be linked with HE, but whether various other factors might also be linked has not been well studied.

The research team investigated the link between HE and atopic diseases, parental factors, environmental factors (exposure to mold, keeping animals), and lifestyle factors (physical activity, obesity, tobacco and alcohol use).

They analyzed data of people who took part in the Northern Finland Birth Cohort 1966 Study. The data, collected since 1965, includes details about 12,055 mothers in northern Finland who were expected to deliver babies in 1966, and their 12,058 live-born children. The children have been followed over the years with questionnaires and clinical examinations, and their parents have been followed by national registers and medical reports.

For the 46-year follow-up, 6,830 respondents aged 45-46 years, roughly half of them women, completed a 132-question form covering physical health, lifestyle, environmental factors, socioeconomic status, and history of hand eczema and other atopic diseases.

In the statistical analysis, the researchers adjusted for atopic dermatitis, asthma, allergic rhinoconjunctivitis, education level, body mass index, maternal BMI, parental allergy, physical activity, living on a farm, and mold exposure and symptoms.

Of the 900 respondents who reported having had HE, 592 (65.8%) were women and 308 (34.2%) were men (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.49-2.0).
 

Various factors linked with hand eczema risk

The authors found the following:

• Atopic diseases and HE were linked: atopic dermatitis (adjusted odds ratio [aOR], 9.66; 95% CI, 8.03-11.66), asthma (aOR, 1.38; 95% CI, 1.12-1.71), and allergic rhinoconjunctivitis (aOR, 1.28; 95% CI, 1.04-1.56). Sex did not affect the link between atopic diseases and HE.
• Respondents who reported visible mold or mold odor in their apartments had higher risk for HE than did those without a history of mold exposure (OR, 1.32; 95% CI, 1.07-1.61).
• Obesity was linked with HE (OR, 3.44; 95% CI, 1.05-22.8), but smoking status, alcohol intake, and education level were not statistically significant risk factors for HE.
• Participants who reported moderate or high physical activity had lower risk for HE (OR, 0.78; 95% CI, 0.64-0.94; and OR, 0.56; 95% CI, 0.33-0.91, respectively) than those who were less active.
• Parental allergy increased risk for HE (OR, 1.98; 95% CI, 1.70-2.30); as maternal age, BMI, and menarche age increased, so did the risk for the child’s HE, but the increases were not statistically significant; and no significant links were found between maternal tobacco smoking, parental asthma, birth weight, parity, gestational age, and HE.
• Dog owners had less risk for HE than did people without a dog (OR, 0.83; 95% CI, 0.71-0.97); links between cat or farm animal owners and HE were not significant.

“There is a strong association between hand eczema and atopic diseases,” Maya Jonas, MD, clinical assistant professor of dermatology at The Ohio State University Wexner Medical Center in Columbus, told this news organization.

“When evaluating patients with hand eczema, it is important to ask if they have a history of atopic dermatitis, asthma, or allergic rhinitis,” said Dr. Jonas, who was not involved in the study.

Elma Baron, MD, professor and director, Skin Study Center, department of dermatology, Case Western Reserve University, Cleveland, was surprised by the inverse link between physical activity and HE. 

“What struck me as interesting is the inverse association between hand eczema and physical activity, that greater physical activity will decrease the risk for hand eczema,” she said in an interview. “It’s an interesting finding that’s worth exploring.

“Dermatologists have also speculated about the association with the female gender, because women are more likely to be in situations that involve frequent hand washing or in occupations, such as hairdressing, that involve known irritants and allergens,” added Dr. Baron, who was not involved in the study.

The main weakness, she noted, is the reliance on self-reported diagnosis. “Hand eczema is a common condition, but the etiologies of reported hand eczema may vary.

“Being cognizant of these associations can help us prescribe appropriate medications and advise patients about how they can avoid exposures that will aggravate their condition,” Dr. Baron advised.

The authors recommend further related studies.

The authors, Dr. Jonas, and Dr. Baron report no relevant financial relationships. The study was not funded.

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

All atopic diseases, as well as environmental and parental factors, appear to be linked with hand eczema (HE), a longitudinal study from Finland has shown.

“In this population-based study, all atopic diseases, not only atopic dermatitis, were found as individual risk factors for HE. In addition, female gender, obesity and mold exposure increased the risk of HE,” wrote Marjut Koskelo, MD, and her colleagues at the University of Oulu in Finland. Their report was published in Contact Dermatitis.

“Parental allergy was also a risk factor of offspring’s HE. Moderate or high physical activity as well as owning a dog appeared as protective factors of HE. No association was found between other lifestyle factors and HE,” they added.

Hand eczema is one of the most common skin disorders and is the most common occupational skin disease, the authors wrote. Many risk factors, including atopic dermatitis, are known to be linked with HE, but whether various other factors might also be linked has not been well studied.

The research team investigated the link between HE and atopic diseases, parental factors, environmental factors (exposure to mold, keeping animals), and lifestyle factors (physical activity, obesity, tobacco and alcohol use).

They analyzed data of people who took part in the Northern Finland Birth Cohort 1966 Study. The data, collected since 1965, includes details about 12,055 mothers in northern Finland who were expected to deliver babies in 1966, and their 12,058 live-born children. The children have been followed over the years with questionnaires and clinical examinations, and their parents have been followed by national registers and medical reports.

For the 46-year follow-up, 6,830 respondents aged 45-46 years, roughly half of them women, completed a 132-question form covering physical health, lifestyle, environmental factors, socioeconomic status, and history of hand eczema and other atopic diseases.

In the statistical analysis, the researchers adjusted for atopic dermatitis, asthma, allergic rhinoconjunctivitis, education level, body mass index, maternal BMI, parental allergy, physical activity, living on a farm, and mold exposure and symptoms.

Of the 900 respondents who reported having had HE, 592 (65.8%) were women and 308 (34.2%) were men (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.49-2.0).
 

Various factors linked with hand eczema risk

The authors found the following:

• Atopic diseases and HE were linked: atopic dermatitis (adjusted odds ratio [aOR], 9.66; 95% CI, 8.03-11.66), asthma (aOR, 1.38; 95% CI, 1.12-1.71), and allergic rhinoconjunctivitis (aOR, 1.28; 95% CI, 1.04-1.56). Sex did not affect the link between atopic diseases and HE.
• Respondents who reported visible mold or mold odor in their apartments had higher risk for HE than did those without a history of mold exposure (OR, 1.32; 95% CI, 1.07-1.61).
• Obesity was linked with HE (OR, 3.44; 95% CI, 1.05-22.8), but smoking status, alcohol intake, and education level were not statistically significant risk factors for HE.
• Participants who reported moderate or high physical activity had lower risk for HE (OR, 0.78; 95% CI, 0.64-0.94; and OR, 0.56; 95% CI, 0.33-0.91, respectively) than those who were less active.
• Parental allergy increased risk for HE (OR, 1.98; 95% CI, 1.70-2.30); as maternal age, BMI, and menarche age increased, so did the risk for the child’s HE, but the increases were not statistically significant; and no significant links were found between maternal tobacco smoking, parental asthma, birth weight, parity, gestational age, and HE.
• Dog owners had less risk for HE than did people without a dog (OR, 0.83; 95% CI, 0.71-0.97); links between cat or farm animal owners and HE were not significant.

“There is a strong association between hand eczema and atopic diseases,” Maya Jonas, MD, clinical assistant professor of dermatology at The Ohio State University Wexner Medical Center in Columbus, told this news organization.

“When evaluating patients with hand eczema, it is important to ask if they have a history of atopic dermatitis, asthma, or allergic rhinitis,” said Dr. Jonas, who was not involved in the study.

Elma Baron, MD, professor and director, Skin Study Center, department of dermatology, Case Western Reserve University, Cleveland, was surprised by the inverse link between physical activity and HE. 

“What struck me as interesting is the inverse association between hand eczema and physical activity, that greater physical activity will decrease the risk for hand eczema,” she said in an interview. “It’s an interesting finding that’s worth exploring.

“Dermatologists have also speculated about the association with the female gender, because women are more likely to be in situations that involve frequent hand washing or in occupations, such as hairdressing, that involve known irritants and allergens,” added Dr. Baron, who was not involved in the study.

The main weakness, she noted, is the reliance on self-reported diagnosis. “Hand eczema is a common condition, but the etiologies of reported hand eczema may vary.

“Being cognizant of these associations can help us prescribe appropriate medications and advise patients about how they can avoid exposures that will aggravate their condition,” Dr. Baron advised.

The authors recommend further related studies.

The authors, Dr. Jonas, and Dr. Baron report no relevant financial relationships. The study was not funded.

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

Despite a higher symptom burden, patients with major depressive disorder (MDD) and a history of childhood trauma (CT) can achieve significant recovery following treatment with a combination of pharmacotherapy and psychotherapy, new research suggests.
 

Results from a meta-analysis of 29 studies from 1966 to 2019, which included almost 7,000 adults with MDD, showed that more than 60% reported a history of CT. But despite having more severe depression at baseline, those with CT benefited from active treatment. Effect sizes were comparable, and dropout rates were similar to those of their counterparts without CT.

“Evidence-based psychotherapy and pharmacotherapy should be offered to depressed patients, regardless of their childhood trauma status,” lead author Erika Kuzminskaite, MSc, a PhD candidate at Amsterdam UMC department of psychiatry, the Netherlands, told this news organization.

“Screening for childhood trauma is important to identify individuals at risk for more severe course of the disorder and post-treatment residual symptoms,” she added.

The study was published online in the Lancet Psychiatry.
 

Common and potent risk factor

The researchers note that CT is common and is a potent risk factor for depression. Previous studies have “consistently indicated significantly higher severity and persistence of depressive symptoms in adult patients with depression and a history of childhood trauma.”

Previous individual and meta-analytic studies “indicated poorer response to first-line depression treatments in patients with childhood trauma, compared to those without trauma, suggesting the need for new personalized treatments for depressed patients with childhood trauma history,” Ms. Kuzminskaite said.

“However, the evidence on poorer treatment outcomes has not been definitive, and a comprehensive meta-analysis of available findings has been lacking,” she added.

The previous meta-analyses showed high between-study heterogeneity, and some primary studies reported similar or even superior improvement for patients with CT, compared with those without such history, following treatment with evidence-based psychotherapy or pharmacotherapy.

Previous studies also did not investigate the “relative contribution of different childhood trauma types.”

To address this gap, investigators in the Childhood Trauma Meta-Analysis Study Group conducted the “largest and most comprehensive study of available evidence examining the effects of childhood trauma on the efficacy and effectiveness of first-line treatments for adults with MDD.”

To be included, a study had to focus on adults over 18 years old who had received a primary diagnosis of depression. The study had to have included an available assessment of childhood trauma, and patients were required to have undergone psychotherapy and/or pharmacotherapy for depression alone or in combination with other guideline-recommended treatments. Studies were also required to have a comparator group, when applicable, and to have reported depression severity before and after the acute treatment phase.

Of 10,505 publications, 54 trials met inclusion criteria; of these, 29 (20 randomized controlled trials and 9 open trials), encompassing 6,830 participants aged 18-85 years, included data that had been made available by authors of the various studies and were included in the current analysis.

Most studies focused on MDD; 11 trials focused on patients with chronic or treatment-resistant depression.

The primary outcome was “depression severity change from baseline to the end of the acute treatment phase” (expressed as standardized effect size – Hedges’ g).
 

Greater treatment motivation?

Of the included patients, 62% reported a history of CT. They were found to have more severe depression at baseline, compared with those without CT (g = .202; 95% confidence interval, 0.145-0.258; I² = 0%).

The benefits from active treatment obtained by these patients with CT were similar to the benefits obtained by their counterparts without CT (between-group treatment effect difference: g = .016; 95% CI, –0.094-0.125; I² = 44.3%).

No significant difference in active treatment effects (in comparison with control condition) was found between individuals with and those without CT (g = .605; 95% CI, 0.294-0.916; I² = 58.0%; and g = .178; 95% CI, –0.195-0.552; I² = 67.5%, respectively; between-group difference P = .051).

Dropout rates were similar for the participants with and those without CT (risk ratio, 1.063; 95% CI, 0.945-1.195; I² = 0%).

“Findings did not significantly differ by childhood trauma type, study design, depression diagnosis, assessment method of childhood trauma, study quality, year, or treatment type or length,” the authors report.

The findings did, however, differ by country, with North American studies showing larger treatment effects for patients with CT, compared with studies conducted in Asian-Pacific countries (g = 0.150; 95% CI, 0.030-0.269; vs. g = 0.255; 95% CI, –0.508- –0.002, respectively; corrected false discovery rate, 0.0080). “However, because of limited power, these findings should be interpreted with caution,” the authors warn.

“It could be a chance finding and is certainly not causal,” Ms. Kuzminskaite suggested.

Most studies (21 of the 29) had a “moderate to high risk of bias.” But when the researchers conducted a sensitivity analysis in the low-bias studies, they found that results were similar to those of the primary analysis that included all the studies.

“Treatments were similarly effective for patients with and without childhood trauma, with slightly larger active treatment (vs. control condition – placebo, wait list, care-as-usual) effects for patients with childhood trauma history,” Ms. Kuzminskaite said.

“Some evidence suggests that patients with childhood trauma are characterized by greater treatment motivation,” she noted. Moreover, “they are also more severely depressed prior to treatment [and] thus have more room for improvement.”
 

‘Hopeful message’

Commenting for this news organization, Yvette Sheline, MD, McLure professor of psychiatry, radiology, and neurology and director of the center for neuromodulation in depression and Stress, University of Pennsylvania, Philadelphia, called it a “well-executed” and “straightforward” study “with clear-cut findings.”

Dr. Sheline, the director of the section on mood, anxiety, and trauma, who was not involved with the study, agrees with the authors’ conclusions – “to use evidence-based treatments for depression in all patients,” with or without a history of CT.

In an accompanying editorial, Antoine Yrondi, MD, PhD, of Université de Toulouse (France), called the findings “important and encouraging” but cautioned that CT could be associated with conditions other than depression, which could make MDD “more difficult to treat.”

Nevertheless, the meta-analysis “delivers a hopeful message to patients with childhood trauma that evidence-based psychotherapy and pharmacotherapy could improve depressive symptoms,” Dr. Yrondi said.

Dr. Yrondi encouraged physicians not to neglect CT in patients with MDD. “For this, it is important that physicians are trained to evaluate childhood trauma and to take it into account in their daily practice.”

No source of funding for the study was listed. The authors and Dr. Sheline have disclosed no relevant financial relationships. Dr. Yrondi has received speaker’s honoraria from AstraZeneca, Janssen, Lundbeck, Otsuka, and Jazz and has carried out clinical studies in relation to the development of a medicine for Janssen and Lundbeck that are unrelated to this work.

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

Despite a higher symptom burden, patients with major depressive disorder (MDD) and a history of childhood trauma (CT) can achieve significant recovery following treatment with a combination of pharmacotherapy and psychotherapy, new research suggests.
 

Results from a meta-analysis of 29 studies from 1966 to 2019, which included almost 7,000 adults with MDD, showed that more than 60% reported a history of CT. But despite having more severe depression at baseline, those with CT benefited from active treatment. Effect sizes were comparable, and dropout rates were similar to those of their counterparts without CT.

“Evidence-based psychotherapy and pharmacotherapy should be offered to depressed patients, regardless of their childhood trauma status,” lead author Erika Kuzminskaite, MSc, a PhD candidate at Amsterdam UMC department of psychiatry, the Netherlands, told this news organization.

“Screening for childhood trauma is important to identify individuals at risk for more severe course of the disorder and post-treatment residual symptoms,” she added.

The study was published online in the Lancet Psychiatry.
 

Common and potent risk factor

The researchers note that CT is common and is a potent risk factor for depression. Previous studies have “consistently indicated significantly higher severity and persistence of depressive symptoms in adult patients with depression and a history of childhood trauma.”

Previous individual and meta-analytic studies “indicated poorer response to first-line depression treatments in patients with childhood trauma, compared to those without trauma, suggesting the need for new personalized treatments for depressed patients with childhood trauma history,” Ms. Kuzminskaite said.

“However, the evidence on poorer treatment outcomes has not been definitive, and a comprehensive meta-analysis of available findings has been lacking,” she added.

The previous meta-analyses showed high between-study heterogeneity, and some primary studies reported similar or even superior improvement for patients with CT, compared with those without such history, following treatment with evidence-based psychotherapy or pharmacotherapy.

Previous studies also did not investigate the “relative contribution of different childhood trauma types.”

To address this gap, investigators in the Childhood Trauma Meta-Analysis Study Group conducted the “largest and most comprehensive study of available evidence examining the effects of childhood trauma on the efficacy and effectiveness of first-line treatments for adults with MDD.”

To be included, a study had to focus on adults over 18 years old who had received a primary diagnosis of depression. The study had to have included an available assessment of childhood trauma, and patients were required to have undergone psychotherapy and/or pharmacotherapy for depression alone or in combination with other guideline-recommended treatments. Studies were also required to have a comparator group, when applicable, and to have reported depression severity before and after the acute treatment phase.

Of 10,505 publications, 54 trials met inclusion criteria; of these, 29 (20 randomized controlled trials and 9 open trials), encompassing 6,830 participants aged 18-85 years, included data that had been made available by authors of the various studies and were included in the current analysis.

Most studies focused on MDD; 11 trials focused on patients with chronic or treatment-resistant depression.

The primary outcome was “depression severity change from baseline to the end of the acute treatment phase” (expressed as standardized effect size – Hedges’ g).
 

Greater treatment motivation?

Of the included patients, 62% reported a history of CT. They were found to have more severe depression at baseline, compared with those without CT (g = .202; 95% confidence interval, 0.145-0.258; I² = 0%).

The benefits from active treatment obtained by these patients with CT were similar to the benefits obtained by their counterparts without CT (between-group treatment effect difference: g = .016; 95% CI, –0.094-0.125; I² = 44.3%).

No significant difference in active treatment effects (in comparison with control condition) was found between individuals with and those without CT (g = .605; 95% CI, 0.294-0.916; I² = 58.0%; and g = .178; 95% CI, –0.195-0.552; I² = 67.5%, respectively; between-group difference P = .051).

Dropout rates were similar for the participants with and those without CT (risk ratio, 1.063; 95% CI, 0.945-1.195; I² = 0%).

“Findings did not significantly differ by childhood trauma type, study design, depression diagnosis, assessment method of childhood trauma, study quality, year, or treatment type or length,” the authors report.

The findings did, however, differ by country, with North American studies showing larger treatment effects for patients with CT, compared with studies conducted in Asian-Pacific countries (g = 0.150; 95% CI, 0.030-0.269; vs. g = 0.255; 95% CI, –0.508- –0.002, respectively; corrected false discovery rate, 0.0080). “However, because of limited power, these findings should be interpreted with caution,” the authors warn.

“It could be a chance finding and is certainly not causal,” Ms. Kuzminskaite suggested.

Most studies (21 of the 29) had a “moderate to high risk of bias.” But when the researchers conducted a sensitivity analysis in the low-bias studies, they found that results were similar to those of the primary analysis that included all the studies.

“Treatments were similarly effective for patients with and without childhood trauma, with slightly larger active treatment (vs. control condition – placebo, wait list, care-as-usual) effects for patients with childhood trauma history,” Ms. Kuzminskaite said.

“Some evidence suggests that patients with childhood trauma are characterized by greater treatment motivation,” she noted. Moreover, “they are also more severely depressed prior to treatment [and] thus have more room for improvement.”
 

‘Hopeful message’

Commenting for this news organization, Yvette Sheline, MD, McLure professor of psychiatry, radiology, and neurology and director of the center for neuromodulation in depression and Stress, University of Pennsylvania, Philadelphia, called it a “well-executed” and “straightforward” study “with clear-cut findings.”

Dr. Sheline, the director of the section on mood, anxiety, and trauma, who was not involved with the study, agrees with the authors’ conclusions – “to use evidence-based treatments for depression in all patients,” with or without a history of CT.

In an accompanying editorial, Antoine Yrondi, MD, PhD, of Université de Toulouse (France), called the findings “important and encouraging” but cautioned that CT could be associated with conditions other than depression, which could make MDD “more difficult to treat.”

Nevertheless, the meta-analysis “delivers a hopeful message to patients with childhood trauma that evidence-based psychotherapy and pharmacotherapy could improve depressive symptoms,” Dr. Yrondi said.

Dr. Yrondi encouraged physicians not to neglect CT in patients with MDD. “For this, it is important that physicians are trained to evaluate childhood trauma and to take it into account in their daily practice.”

No source of funding for the study was listed. The authors and Dr. Sheline have disclosed no relevant financial relationships. Dr. Yrondi has received speaker’s honoraria from AstraZeneca, Janssen, Lundbeck, Otsuka, and Jazz and has carried out clinical studies in relation to the development of a medicine for Janssen and Lundbeck that are unrelated to this work.

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

Despite a higher symptom burden, patients with major depressive disorder (MDD) and a history of childhood trauma (CT) can achieve significant recovery following treatment with a combination of pharmacotherapy and psychotherapy, new research suggests.
 

Results from a meta-analysis of 29 studies from 1966 to 2019, which included almost 7,000 adults with MDD, showed that more than 60% reported a history of CT. But despite having more severe depression at baseline, those with CT benefited from active treatment. Effect sizes were comparable, and dropout rates were similar to those of their counterparts without CT.

“Evidence-based psychotherapy and pharmacotherapy should be offered to depressed patients, regardless of their childhood trauma status,” lead author Erika Kuzminskaite, MSc, a PhD candidate at Amsterdam UMC department of psychiatry, the Netherlands, told this news organization.

“Screening for childhood trauma is important to identify individuals at risk for more severe course of the disorder and post-treatment residual symptoms,” she added.

The study was published online in the Lancet Psychiatry.
 

Common and potent risk factor

The researchers note that CT is common and is a potent risk factor for depression. Previous studies have “consistently indicated significantly higher severity and persistence of depressive symptoms in adult patients with depression and a history of childhood trauma.”

Previous individual and meta-analytic studies “indicated poorer response to first-line depression treatments in patients with childhood trauma, compared to those without trauma, suggesting the need for new personalized treatments for depressed patients with childhood trauma history,” Ms. Kuzminskaite said.

“However, the evidence on poorer treatment outcomes has not been definitive, and a comprehensive meta-analysis of available findings has been lacking,” she added.

The previous meta-analyses showed high between-study heterogeneity, and some primary studies reported similar or even superior improvement for patients with CT, compared with those without such history, following treatment with evidence-based psychotherapy or pharmacotherapy.

Previous studies also did not investigate the “relative contribution of different childhood trauma types.”

To address this gap, investigators in the Childhood Trauma Meta-Analysis Study Group conducted the “largest and most comprehensive study of available evidence examining the effects of childhood trauma on the efficacy and effectiveness of first-line treatments for adults with MDD.”

To be included, a study had to focus on adults over 18 years old who had received a primary diagnosis of depression. The study had to have included an available assessment of childhood trauma, and patients were required to have undergone psychotherapy and/or pharmacotherapy for depression alone or in combination with other guideline-recommended treatments. Studies were also required to have a comparator group, when applicable, and to have reported depression severity before and after the acute treatment phase.

Of 10,505 publications, 54 trials met inclusion criteria; of these, 29 (20 randomized controlled trials and 9 open trials), encompassing 6,830 participants aged 18-85 years, included data that had been made available by authors of the various studies and were included in the current analysis.

Most studies focused on MDD; 11 trials focused on patients with chronic or treatment-resistant depression.

The primary outcome was “depression severity change from baseline to the end of the acute treatment phase” (expressed as standardized effect size – Hedges’ g).
 

Greater treatment motivation?

Of the included patients, 62% reported a history of CT. They were found to have more severe depression at baseline, compared with those without CT (g = .202; 95% confidence interval, 0.145-0.258; I² = 0%).

The benefits from active treatment obtained by these patients with CT were similar to the benefits obtained by their counterparts without CT (between-group treatment effect difference: g = .016; 95% CI, –0.094-0.125; I² = 44.3%).

No significant difference in active treatment effects (in comparison with control condition) was found between individuals with and those without CT (g = .605; 95% CI, 0.294-0.916; I² = 58.0%; and g = .178; 95% CI, –0.195-0.552; I² = 67.5%, respectively; between-group difference P = .051).

Dropout rates were similar for the participants with and those without CT (risk ratio, 1.063; 95% CI, 0.945-1.195; I² = 0%).

“Findings did not significantly differ by childhood trauma type, study design, depression diagnosis, assessment method of childhood trauma, study quality, year, or treatment type or length,” the authors report.

The findings did, however, differ by country, with North American studies showing larger treatment effects for patients with CT, compared with studies conducted in Asian-Pacific countries (g = 0.150; 95% CI, 0.030-0.269; vs. g = 0.255; 95% CI, –0.508- –0.002, respectively; corrected false discovery rate, 0.0080). “However, because of limited power, these findings should be interpreted with caution,” the authors warn.

“It could be a chance finding and is certainly not causal,” Ms. Kuzminskaite suggested.

Most studies (21 of the 29) had a “moderate to high risk of bias.” But when the researchers conducted a sensitivity analysis in the low-bias studies, they found that results were similar to those of the primary analysis that included all the studies.

“Treatments were similarly effective for patients with and without childhood trauma, with slightly larger active treatment (vs. control condition – placebo, wait list, care-as-usual) effects for patients with childhood trauma history,” Ms. Kuzminskaite said.

“Some evidence suggests that patients with childhood trauma are characterized by greater treatment motivation,” she noted. Moreover, “they are also more severely depressed prior to treatment [and] thus have more room for improvement.”
 

‘Hopeful message’

Commenting for this news organization, Yvette Sheline, MD, McLure professor of psychiatry, radiology, and neurology and director of the center for neuromodulation in depression and Stress, University of Pennsylvania, Philadelphia, called it a “well-executed” and “straightforward” study “with clear-cut findings.”

Dr. Sheline, the director of the section on mood, anxiety, and trauma, who was not involved with the study, agrees with the authors’ conclusions – “to use evidence-based treatments for depression in all patients,” with or without a history of CT.

In an accompanying editorial, Antoine Yrondi, MD, PhD, of Université de Toulouse (France), called the findings “important and encouraging” but cautioned that CT could be associated with conditions other than depression, which could make MDD “more difficult to treat.”

Nevertheless, the meta-analysis “delivers a hopeful message to patients with childhood trauma that evidence-based psychotherapy and pharmacotherapy could improve depressive symptoms,” Dr. Yrondi said.

Dr. Yrondi encouraged physicians not to neglect CT in patients with MDD. “For this, it is important that physicians are trained to evaluate childhood trauma and to take it into account in their daily practice.”

No source of funding for the study was listed. The authors and Dr. Sheline have disclosed no relevant financial relationships. Dr. Yrondi has received speaker’s honoraria from AstraZeneca, Janssen, Lundbeck, Otsuka, and Jazz and has carried out clinical studies in relation to the development of a medicine for Janssen and Lundbeck that are unrelated to this work.

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

Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.

The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.

It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.

Fat reductions maintained at 1-year mark

The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.

Courtesy Dr. Joel M. Gelfand

As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.

“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”

Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.

Courtesy NYU Langone

Seventy patients enrolled

In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.

Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m². Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).

There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.

“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”

This study highlights the importance of screening, Dr. Garshick said.

He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.

Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.

Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.

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

Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.

The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.

It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.

Fat reductions maintained at 1-year mark

The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.

Courtesy Dr. Joel M. Gelfand

As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.

“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”

Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.

Courtesy NYU Langone

Seventy patients enrolled

In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.

Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m². Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).

There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.

“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”

This study highlights the importance of screening, Dr. Garshick said.

He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.

Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.

Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.

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

Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.

The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.

It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.

Fat reductions maintained at 1-year mark

The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.

Courtesy Dr. Joel M. Gelfand

As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.

“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”

Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.

Courtesy NYU Langone

Seventy patients enrolled

In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.

Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m². Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).

There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.

“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”

This study highlights the importance of screening, Dr. Garshick said.

He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.

Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.

Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.

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

Recent study findings published in Allergy (2022 Aug 23. doi: 10.1111/all.15491) suggest that twice-daily application of emollients within the first 8 weeks of life significantly reduces the cumulative incidence of atopic dermatitis (AD) among infants at high risk for the condition, at least within the first year of life.

The single-center STOP-AD clinical trial recruited term infants within 4 days of birth who were at high risk for AD, as determined on the basis of a parent-reported history of the disease or asthma or allergic rhinitis. Infants were randomly assigned to undergo either a standard skin care routine (control group; n = 160) or twice-daily emollient application for the first 8 weeks of life (intervention group; n = 161).

In the intervention group, infants received an emollient that was specifically formulated for AD-prone skin. The control group received standard skin care advice, which did not include specific advice on bathing frequency or regular emollient use.

The mean age of the infants at randomization was 1.9 days. A total of 41 infants in the intervention group and 20 infants in the control group were withdrawn from the study. Most withdrawals (80%) occurred prior to the 2-week visit.

At 12 months, the cumulative incidence of AD was 32.8% in the intervention group and 46.4% in the control group (P = .036). The investigators note that daily emollient use was associated with a 29% lower risk of cumulative AD at 1 year in comparison with the control intervention.

No significant difference was observed between the groups regarding the incidence of parent-reported skin infections during the treatment period (5.0% vs. 5.7%; P > .05).

Study investigator Jonathan O’Brien Hourihane, MBBS, of the Royal College of Surgeons in Dublin, said in an interview that previously published findings from the BASELINE study supported the rationale for the early use of emollients in infancy to prevent AD.

The investigators of the BASELINE study found that skin barrier function, as measured by transepidermal water loss, increased from birth to 8 weeks but then became stable at 6 months. These observations suggest that the period during early infancy “could be a critical window in which to protect the skin barrier” of infants at risk for AD, Dr. Hourihane added.

Dr. Hourihane, who serves as the head of department of pediatrics at the Royal College of Surgeons, explained that the long-term clinical burden of AD is often more significant if the condition begins earlier in life, underscoring the importance of early prevention and control.

“The casual role [of AD] in other allergic conditions remains suspected but not proven, but its association is clear,” he said. He noted that infants with eczema “also have poorer sleep, and the condition causes increased family disruption,” highlighting the far-reaching burden of AD.

Commenting on the study, Adelaide Hebert, MD, professor of pediatric dermatology at the University of Texas, Houston, said in an interview that the barrier defect observed in AD is one of the prime areas to address as a means of controlling the chronic, relapsing disorder. She noted that the use of emollients can repair this defective barrier.

“Early initiation of emollients has the potential to reduce dryness, itching, transgression of allergens, and infectious agents,” explained Dr. Hebert, who wasn’t involved in the study. “Emollient application also allows the parent to inspect the skin surface and address any challenges in a timely manner.”

In the STOP-AD trial, Dr. Hourihane and colleagues also found that, among patients with loss-of-function (LoF) mutations in the filaggrin gene (FLG), the prevalence of AD at 6 and 12 months seemed to be a higher than among patients with the wild-type gene, but the difference did not reach statistical significance.

Commenting on this finding, Dr. Hebert noted that LoF FLG mutation carriers may benefit especially from emollient use, given that LoF mutations in FLG is associated with reduced production of natural moisturizing factors in the skin.

Regarding future research directions, Dr. Hourihane stated that there is a need for replication and validation of the findings in studies that include infants from different ethnic backgrounds as well as those from various social settings. These studies should also include variable treatment windows to determine both short- and longer-term effects of emollient use in this population, Dr. Hourihane explained.

Dr. Hourihane added that he and the investigators do not yet understand which aspect of the study’s program was key for reducing the incidence of AD in the first year of life. “The timing of emollient initiation, the duration of treatment, the products, or maybe just a combination of these” could be possible explanations.

The study was independently supported. Dr. Hourihand reported receiving grant funding from Aimmune Therapeutics and DBV Technologies. Dr. Hebert reported no relevant financial relationships.

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

Recent study findings published in Allergy (2022 Aug 23. doi: 10.1111/all.15491) suggest that twice-daily application of emollients within the first 8 weeks of life significantly reduces the cumulative incidence of atopic dermatitis (AD) among infants at high risk for the condition, at least within the first year of life.

The single-center STOP-AD clinical trial recruited term infants within 4 days of birth who were at high risk for AD, as determined on the basis of a parent-reported history of the disease or asthma or allergic rhinitis. Infants were randomly assigned to undergo either a standard skin care routine (control group; n = 160) or twice-daily emollient application for the first 8 weeks of life (intervention group; n = 161).

In the intervention group, infants received an emollient that was specifically formulated for AD-prone skin. The control group received standard skin care advice, which did not include specific advice on bathing frequency or regular emollient use.

The mean age of the infants at randomization was 1.9 days. A total of 41 infants in the intervention group and 20 infants in the control group were withdrawn from the study. Most withdrawals (80%) occurred prior to the 2-week visit.

At 12 months, the cumulative incidence of AD was 32.8% in the intervention group and 46.4% in the control group (P = .036). The investigators note that daily emollient use was associated with a 29% lower risk of cumulative AD at 1 year in comparison with the control intervention.

No significant difference was observed between the groups regarding the incidence of parent-reported skin infections during the treatment period (5.0% vs. 5.7%; P > .05).

Study investigator Jonathan O’Brien Hourihane, MBBS, of the Royal College of Surgeons in Dublin, said in an interview that previously published findings from the BASELINE study supported the rationale for the early use of emollients in infancy to prevent AD.

The investigators of the BASELINE study found that skin barrier function, as measured by transepidermal water loss, increased from birth to 8 weeks but then became stable at 6 months. These observations suggest that the period during early infancy “could be a critical window in which to protect the skin barrier” of infants at risk for AD, Dr. Hourihane added.

Dr. Hourihane, who serves as the head of department of pediatrics at the Royal College of Surgeons, explained that the long-term clinical burden of AD is often more significant if the condition begins earlier in life, underscoring the importance of early prevention and control.

“The casual role [of AD] in other allergic conditions remains suspected but not proven, but its association is clear,” he said. He noted that infants with eczema “also have poorer sleep, and the condition causes increased family disruption,” highlighting the far-reaching burden of AD.

Commenting on the study, Adelaide Hebert, MD, professor of pediatric dermatology at the University of Texas, Houston, said in an interview that the barrier defect observed in AD is one of the prime areas to address as a means of controlling the chronic, relapsing disorder. She noted that the use of emollients can repair this defective barrier.

“Early initiation of emollients has the potential to reduce dryness, itching, transgression of allergens, and infectious agents,” explained Dr. Hebert, who wasn’t involved in the study. “Emollient application also allows the parent to inspect the skin surface and address any challenges in a timely manner.”

In the STOP-AD trial, Dr. Hourihane and colleagues also found that, among patients with loss-of-function (LoF) mutations in the filaggrin gene (FLG), the prevalence of AD at 6 and 12 months seemed to be a higher than among patients with the wild-type gene, but the difference did not reach statistical significance.

Commenting on this finding, Dr. Hebert noted that LoF FLG mutation carriers may benefit especially from emollient use, given that LoF mutations in FLG is associated with reduced production of natural moisturizing factors in the skin.

Regarding future research directions, Dr. Hourihane stated that there is a need for replication and validation of the findings in studies that include infants from different ethnic backgrounds as well as those from various social settings. These studies should also include variable treatment windows to determine both short- and longer-term effects of emollient use in this population, Dr. Hourihane explained.

Dr. Hourihane added that he and the investigators do not yet understand which aspect of the study’s program was key for reducing the incidence of AD in the first year of life. “The timing of emollient initiation, the duration of treatment, the products, or maybe just a combination of these” could be possible explanations.

The study was independently supported. Dr. Hourihand reported receiving grant funding from Aimmune Therapeutics and DBV Technologies. Dr. Hebert reported no relevant financial relationships.

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

Recent study findings published in Allergy (2022 Aug 23. doi: 10.1111/all.15491) suggest that twice-daily application of emollients within the first 8 weeks of life significantly reduces the cumulative incidence of atopic dermatitis (AD) among infants at high risk for the condition, at least within the first year of life.

The single-center STOP-AD clinical trial recruited term infants within 4 days of birth who were at high risk for AD, as determined on the basis of a parent-reported history of the disease or asthma or allergic rhinitis. Infants were randomly assigned to undergo either a standard skin care routine (control group; n = 160) or twice-daily emollient application for the first 8 weeks of life (intervention group; n = 161).

In the intervention group, infants received an emollient that was specifically formulated for AD-prone skin. The control group received standard skin care advice, which did not include specific advice on bathing frequency or regular emollient use.

The mean age of the infants at randomization was 1.9 days. A total of 41 infants in the intervention group and 20 infants in the control group were withdrawn from the study. Most withdrawals (80%) occurred prior to the 2-week visit.

At 12 months, the cumulative incidence of AD was 32.8% in the intervention group and 46.4% in the control group (P = .036). The investigators note that daily emollient use was associated with a 29% lower risk of cumulative AD at 1 year in comparison with the control intervention.

No significant difference was observed between the groups regarding the incidence of parent-reported skin infections during the treatment period (5.0% vs. 5.7%; P > .05).

Study investigator Jonathan O’Brien Hourihane, MBBS, of the Royal College of Surgeons in Dublin, said in an interview that previously published findings from the BASELINE study supported the rationale for the early use of emollients in infancy to prevent AD.

The investigators of the BASELINE study found that skin barrier function, as measured by transepidermal water loss, increased from birth to 8 weeks but then became stable at 6 months. These observations suggest that the period during early infancy “could be a critical window in which to protect the skin barrier” of infants at risk for AD, Dr. Hourihane added.

Dr. Hourihane, who serves as the head of department of pediatrics at the Royal College of Surgeons, explained that the long-term clinical burden of AD is often more significant if the condition begins earlier in life, underscoring the importance of early prevention and control.

“The casual role [of AD] in other allergic conditions remains suspected but not proven, but its association is clear,” he said. He noted that infants with eczema “also have poorer sleep, and the condition causes increased family disruption,” highlighting the far-reaching burden of AD.

Commenting on the study, Adelaide Hebert, MD, professor of pediatric dermatology at the University of Texas, Houston, said in an interview that the barrier defect observed in AD is one of the prime areas to address as a means of controlling the chronic, relapsing disorder. She noted that the use of emollients can repair this defective barrier.

“Early initiation of emollients has the potential to reduce dryness, itching, transgression of allergens, and infectious agents,” explained Dr. Hebert, who wasn’t involved in the study. “Emollient application also allows the parent to inspect the skin surface and address any challenges in a timely manner.”

In the STOP-AD trial, Dr. Hourihane and colleagues also found that, among patients with loss-of-function (LoF) mutations in the filaggrin gene (FLG), the prevalence of AD at 6 and 12 months seemed to be a higher than among patients with the wild-type gene, but the difference did not reach statistical significance.

Commenting on this finding, Dr. Hebert noted that LoF FLG mutation carriers may benefit especially from emollient use, given that LoF mutations in FLG is associated with reduced production of natural moisturizing factors in the skin.

Regarding future research directions, Dr. Hourihane stated that there is a need for replication and validation of the findings in studies that include infants from different ethnic backgrounds as well as those from various social settings. These studies should also include variable treatment windows to determine both short- and longer-term effects of emollient use in this population, Dr. Hourihane explained.

Dr. Hourihane added that he and the investigators do not yet understand which aspect of the study’s program was key for reducing the incidence of AD in the first year of life. “The timing of emollient initiation, the duration of treatment, the products, or maybe just a combination of these” could be possible explanations.

The study was independently supported. Dr. Hourihand reported receiving grant funding from Aimmune Therapeutics and DBV Technologies. Dr. Hebert reported no relevant financial relationships.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

BOSTON – Despite a promising start, extended follow-up from the SUGAR trial found that the Cre8 EVO drug-eluting stent could not maintain superiority over the Resolute Onyx DES at 2 years in patients with diabetes undergoing revascularization for coronary artery disease.

The Cre8 EVO stent (Alvimedica) is not available in the United States but, as previously reported, caused a stir last year after demonstrating a 35% relative risk reduction in the primary endpoint of target lesion failure (TLF) at 1 year in a prespecified superiority analysis.

At 2 years, however, the TLF rate was 10.4% with the polymer-free Cre8 EVO amphilimus-eluting stent and 12.1% with the durable polymer Resolute Onyx (Medtronic) zotarolimus-eluting stent, which did not achieve superiority (hazard ratio, 0.84; 95% confidence interval, 0.60-1.19).

Rates were numerically lower with the Cre8 EVO stent for the endpoint’s individual components of cardiac death (3.1% vs. 3.4%), target vessel MI (6.6% vs. 7.6%), and target lesion revascularization (4.3% vs. 4.6%).

Results were also similar between the Cre8 EVO and Resolute Onyx stents for all-cause mortality (7.1% vs. 6.8%), any MI (9.0% vs. 9.2%), target vessel revascularization (5.5% vs. 5.1%), all new revascularizations (7.6% vs. 9.4%), definite stent thrombosis (1.0% vs. 1.2%), and major adverse cardiac events (18.3% vs. 20.8%), Pablo Salinas, MD, PhD, of Hospital Clinico San Carlos, Madrid, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

He noted that all-cause mortality was 7% in just 2 years in the diabetic cohort, or twice the number of cardiac deaths. “In other words, these patients had the same chance of dying from cardiac causes and noncardiac causes, so we need a more comprehensive approach to the disease. Also, if you look at all new revascularizations, roughly 50% were off target, so there is disease progression at 2 years in this population.”

Among the 586 Cre8 EVO and 589 Resolute Onyx patients who underwent percutaneous coronary intervention (PCI), roughly half had multivessel coronary artery disease, 83% had hypertension, 81% had dyslipidemia, and 21% were current smokers. Nearly all patients had diabetes type 2 for an average of 10.6 years for Cre8 EVO and 11.4 years for Resolute Onyx, with hemoglobin A1c levels of 7.4% and 7.5%, respectively.

Although there is “insufficient evidence” the Cre8 EVO stent is superior to the Resolute Onyx stent with regard to TLF, Dr. Salinas concluded extended follow-up until 5 years is warranted.

During a discussion of the results, Dr. Salinas said he expects the 5-year results will “probably go parallel” but that it’s worth following this very valuable cohort. “There are not so many trials with 1,000 diabetic patients. We always speak about how complex they are, the results are bad, but we don’t use the diabetic population in trials,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

Asked during a TCT press conference what could have caused the catch-up in TLF at 2 years, Dr. Salinas said there were only 25 primary events from years 1 to 2, driven primarily by periprocedural MI, but that the timing of restenosis was different. Events accrued “drop by drop” with the Cre8 EVO, whereas with the Resolute Onyx there was a “bump in restenosis” after 6 months “but then it is very nice to see it is flat, which means that durable polymers are also safe because we have not seen late events.”

Press conference discussant Carlo Di Mario, MD, from Careggi University Hospital, Florence, Italy, who was not involved in the study, said the reversal of superiority for the Cre8 EVO might be a “bitter note” for the investigators but “maybe it is not bitter for us because overall, the percentage of figures are so low that it’s very difficult to find a difference” between the two stents.

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

BOSTON – Despite a promising start, extended follow-up from the SUGAR trial found that the Cre8 EVO drug-eluting stent could not maintain superiority over the Resolute Onyx DES at 2 years in patients with diabetes undergoing revascularization for coronary artery disease.

The Cre8 EVO stent (Alvimedica) is not available in the United States but, as previously reported, caused a stir last year after demonstrating a 35% relative risk reduction in the primary endpoint of target lesion failure (TLF) at 1 year in a prespecified superiority analysis.

At 2 years, however, the TLF rate was 10.4% with the polymer-free Cre8 EVO amphilimus-eluting stent and 12.1% with the durable polymer Resolute Onyx (Medtronic) zotarolimus-eluting stent, which did not achieve superiority (hazard ratio, 0.84; 95% confidence interval, 0.60-1.19).

Rates were numerically lower with the Cre8 EVO stent for the endpoint’s individual components of cardiac death (3.1% vs. 3.4%), target vessel MI (6.6% vs. 7.6%), and target lesion revascularization (4.3% vs. 4.6%).

Results were also similar between the Cre8 EVO and Resolute Onyx stents for all-cause mortality (7.1% vs. 6.8%), any MI (9.0% vs. 9.2%), target vessel revascularization (5.5% vs. 5.1%), all new revascularizations (7.6% vs. 9.4%), definite stent thrombosis (1.0% vs. 1.2%), and major adverse cardiac events (18.3% vs. 20.8%), Pablo Salinas, MD, PhD, of Hospital Clinico San Carlos, Madrid, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

He noted that all-cause mortality was 7% in just 2 years in the diabetic cohort, or twice the number of cardiac deaths. “In other words, these patients had the same chance of dying from cardiac causes and noncardiac causes, so we need a more comprehensive approach to the disease. Also, if you look at all new revascularizations, roughly 50% were off target, so there is disease progression at 2 years in this population.”

Among the 586 Cre8 EVO and 589 Resolute Onyx patients who underwent percutaneous coronary intervention (PCI), roughly half had multivessel coronary artery disease, 83% had hypertension, 81% had dyslipidemia, and 21% were current smokers. Nearly all patients had diabetes type 2 for an average of 10.6 years for Cre8 EVO and 11.4 years for Resolute Onyx, with hemoglobin A1c levels of 7.4% and 7.5%, respectively.

Although there is “insufficient evidence” the Cre8 EVO stent is superior to the Resolute Onyx stent with regard to TLF, Dr. Salinas concluded extended follow-up until 5 years is warranted.

During a discussion of the results, Dr. Salinas said he expects the 5-year results will “probably go parallel” but that it’s worth following this very valuable cohort. “There are not so many trials with 1,000 diabetic patients. We always speak about how complex they are, the results are bad, but we don’t use the diabetic population in trials,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

Asked during a TCT press conference what could have caused the catch-up in TLF at 2 years, Dr. Salinas said there were only 25 primary events from years 1 to 2, driven primarily by periprocedural MI, but that the timing of restenosis was different. Events accrued “drop by drop” with the Cre8 EVO, whereas with the Resolute Onyx there was a “bump in restenosis” after 6 months “but then it is very nice to see it is flat, which means that durable polymers are also safe because we have not seen late events.”

Press conference discussant Carlo Di Mario, MD, from Careggi University Hospital, Florence, Italy, who was not involved in the study, said the reversal of superiority for the Cre8 EVO might be a “bitter note” for the investigators but “maybe it is not bitter for us because overall, the percentage of figures are so low that it’s very difficult to find a difference” between the two stents.

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

BOSTON – Despite a promising start, extended follow-up from the SUGAR trial found that the Cre8 EVO drug-eluting stent could not maintain superiority over the Resolute Onyx DES at 2 years in patients with diabetes undergoing revascularization for coronary artery disease.

The Cre8 EVO stent (Alvimedica) is not available in the United States but, as previously reported, caused a stir last year after demonstrating a 35% relative risk reduction in the primary endpoint of target lesion failure (TLF) at 1 year in a prespecified superiority analysis.

At 2 years, however, the TLF rate was 10.4% with the polymer-free Cre8 EVO amphilimus-eluting stent and 12.1% with the durable polymer Resolute Onyx (Medtronic) zotarolimus-eluting stent, which did not achieve superiority (hazard ratio, 0.84; 95% confidence interval, 0.60-1.19).

Rates were numerically lower with the Cre8 EVO stent for the endpoint’s individual components of cardiac death (3.1% vs. 3.4%), target vessel MI (6.6% vs. 7.6%), and target lesion revascularization (4.3% vs. 4.6%).

Results were also similar between the Cre8 EVO and Resolute Onyx stents for all-cause mortality (7.1% vs. 6.8%), any MI (9.0% vs. 9.2%), target vessel revascularization (5.5% vs. 5.1%), all new revascularizations (7.6% vs. 9.4%), definite stent thrombosis (1.0% vs. 1.2%), and major adverse cardiac events (18.3% vs. 20.8%), Pablo Salinas, MD, PhD, of Hospital Clinico San Carlos, Madrid, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

He noted that all-cause mortality was 7% in just 2 years in the diabetic cohort, or twice the number of cardiac deaths. “In other words, these patients had the same chance of dying from cardiac causes and noncardiac causes, so we need a more comprehensive approach to the disease. Also, if you look at all new revascularizations, roughly 50% were off target, so there is disease progression at 2 years in this population.”

Among the 586 Cre8 EVO and 589 Resolute Onyx patients who underwent percutaneous coronary intervention (PCI), roughly half had multivessel coronary artery disease, 83% had hypertension, 81% had dyslipidemia, and 21% were current smokers. Nearly all patients had diabetes type 2 for an average of 10.6 years for Cre8 EVO and 11.4 years for Resolute Onyx, with hemoglobin A1c levels of 7.4% and 7.5%, respectively.

Although there is “insufficient evidence” the Cre8 EVO stent is superior to the Resolute Onyx stent with regard to TLF, Dr. Salinas concluded extended follow-up until 5 years is warranted.

During a discussion of the results, Dr. Salinas said he expects the 5-year results will “probably go parallel” but that it’s worth following this very valuable cohort. “There are not so many trials with 1,000 diabetic patients. We always speak about how complex they are, the results are bad, but we don’t use the diabetic population in trials,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

Asked during a TCT press conference what could have caused the catch-up in TLF at 2 years, Dr. Salinas said there were only 25 primary events from years 1 to 2, driven primarily by periprocedural MI, but that the timing of restenosis was different. Events accrued “drop by drop” with the Cre8 EVO, whereas with the Resolute Onyx there was a “bump in restenosis” after 6 months “but then it is very nice to see it is flat, which means that durable polymers are also safe because we have not seen late events.”

Press conference discussant Carlo Di Mario, MD, from Careggi University Hospital, Florence, Italy, who was not involved in the study, said the reversal of superiority for the Cre8 EVO might be a “bitter note” for the investigators but “maybe it is not bitter for us because overall, the percentage of figures are so low that it’s very difficult to find a difference” between the two stents.

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

I recently presented a clinical scenario about a patient of mine named Brenda. This 35-year-old woman came to me with symptoms that had been going on for a year already. I asked for readers’ comments about my management of Brenda.

I appreciate the comments I received regarding this case. The most common suggestion was to encourage Brenda to exercise, and a systematic review of randomized clinical trials published in 2019 supports this recommendation. This review included nine studies with a total of 680 participants, and the overall effect of exercise was a twofold improvement in symptoms associated with constipation. Walking was the most common exercise intervention, and along with qigong (which combines body position, breathing, and meditation), these two modes of exercise were effective in improving constipation. However, the one study evaluating resistance training failed to demonstrate a significant effect. Importantly, the reviewers considered the collective research to be at a high risk of bias.

Exercise will probably help Brenda, although some brainstorming might be necessary to help her fit exercise into her busy schedule. Another suggestion focused on her risk for colorectal cancer, and Dr. Cooke and Dr. Boboc both astutely noted that colorectal cancer is increasingly common among adults at early middle age. This stands in contrast to a steady decline in the prevalence of colorectal cancer among U.S. adults at age 65 years or older. Whereas colorectal cancer declined by 3.3% annually among U.S. older adults from 2011 to 2016, there was a reversal of this favorable trend among individuals between 50 and 64 years of age, with rates increasing by 1% annually.

The increase in the incidence of colorectal cancer among adults 50-64 years of age has been outpaced by the increase among adults younger than 50 years, who have experienced a 2.2% increase in the incidence of colorectal cancer annually between 2012 and 2016. Previously, the increase in colorectal cancer among early middle-aged adults was driven by higher rates of rectal cancer, but more recently this trend has included higher rates of proximal and distal colon tumors. In 2020, 12% of new cases of colorectal cancer were expected to be among individuals younger than 50 years.

So how do we act on this context in the case of Brenda? Her history suggests no overt warning signs for cancer. The history did not address a family history of gastrointestinal symptoms or colorectal cancer, which is an important omission.

Although the number of cases of cancer among persons younger than 50 years may be rising, the overall prevalence of colorectal cancer among younger adults is well under 1%. At 35 years of age, it is not necessary to evaluate Brenda for colorectal cancer. However, persistent or worsening symptoms could prompt a referral for colonoscopy at a later time.

Finally, let’s address how to practically manage Brenda’s case, because many options are available. I would begin with recommendations regarding her lifestyle, including regular exercise, adequate sleep, and whatever she can achieve in the FODMAP diet. I would also recommend psyllium as a soluble fiber and expect that these changes would help her constipation. But they might be less effective for abdominal cramping, so I would also recommend peppermint oil at this time.

If Brenda commits to these recommendations, she will very likely improve. If she does not, I will be more concerned regarding anxiety and depression complicating her illness. Treating those disorders can make a big difference.

In addition, if there is an inadequate response to initial therapy, I will initiate linaclotide or lubiprostone. Plecanatide is another reasonable option. At this point, I will also consider referral to a gastroenterologist for a recalcitrant case and will certainly refer if one of these specific treatments fails in Brenda. Conditions such as pelvic floor dysfunction can mimic irritable bowel syndrome with constipation and merit consideration.

However, I really believe that Brenda will feel better. Thanks for all of the insightful and interesting comments. It is easy to see how we are all invested in improving patients’ lives.
 

Dr. Vega is a clinical professor of family medicine at the University of California, Irvine. He reported disclosures with McNeil Pharmaceuticals. A version of this article first appeared on Medscape.com.

I recently presented a clinical scenario about a patient of mine named Brenda. This 35-year-old woman came to me with symptoms that had been going on for a year already. I asked for readers’ comments about my management of Brenda.

I appreciate the comments I received regarding this case. The most common suggestion was to encourage Brenda to exercise, and a systematic review of randomized clinical trials published in 2019 supports this recommendation. This review included nine studies with a total of 680 participants, and the overall effect of exercise was a twofold improvement in symptoms associated with constipation. Walking was the most common exercise intervention, and along with qigong (which combines body position, breathing, and meditation), these two modes of exercise were effective in improving constipation. However, the one study evaluating resistance training failed to demonstrate a significant effect. Importantly, the reviewers considered the collective research to be at a high risk of bias.

Exercise will probably help Brenda, although some brainstorming might be necessary to help her fit exercise into her busy schedule. Another suggestion focused on her risk for colorectal cancer, and Dr. Cooke and Dr. Boboc both astutely noted that colorectal cancer is increasingly common among adults at early middle age. This stands in contrast to a steady decline in the prevalence of colorectal cancer among U.S. adults at age 65 years or older. Whereas colorectal cancer declined by 3.3% annually among U.S. older adults from 2011 to 2016, there was a reversal of this favorable trend among individuals between 50 and 64 years of age, with rates increasing by 1% annually.

The increase in the incidence of colorectal cancer among adults 50-64 years of age has been outpaced by the increase among adults younger than 50 years, who have experienced a 2.2% increase in the incidence of colorectal cancer annually between 2012 and 2016. Previously, the increase in colorectal cancer among early middle-aged adults was driven by higher rates of rectal cancer, but more recently this trend has included higher rates of proximal and distal colon tumors. In 2020, 12% of new cases of colorectal cancer were expected to be among individuals younger than 50 years.

So how do we act on this context in the case of Brenda? Her history suggests no overt warning signs for cancer. The history did not address a family history of gastrointestinal symptoms or colorectal cancer, which is an important omission.

Although the number of cases of cancer among persons younger than 50 years may be rising, the overall prevalence of colorectal cancer among younger adults is well under 1%. At 35 years of age, it is not necessary to evaluate Brenda for colorectal cancer. However, persistent or worsening symptoms could prompt a referral for colonoscopy at a later time.

Finally, let’s address how to practically manage Brenda’s case, because many options are available. I would begin with recommendations regarding her lifestyle, including regular exercise, adequate sleep, and whatever she can achieve in the FODMAP diet. I would also recommend psyllium as a soluble fiber and expect that these changes would help her constipation. But they might be less effective for abdominal cramping, so I would also recommend peppermint oil at this time.

If Brenda commits to these recommendations, she will very likely improve. If she does not, I will be more concerned regarding anxiety and depression complicating her illness. Treating those disorders can make a big difference.

In addition, if there is an inadequate response to initial therapy, I will initiate linaclotide or lubiprostone. Plecanatide is another reasonable option. At this point, I will also consider referral to a gastroenterologist for a recalcitrant case and will certainly refer if one of these specific treatments fails in Brenda. Conditions such as pelvic floor dysfunction can mimic irritable bowel syndrome with constipation and merit consideration.

However, I really believe that Brenda will feel better. Thanks for all of the insightful and interesting comments. It is easy to see how we are all invested in improving patients’ lives.
 

Dr. Vega is a clinical professor of family medicine at the University of California, Irvine. He reported disclosures with McNeil Pharmaceuticals. A version of this article first appeared on Medscape.com.

I recently presented a clinical scenario about a patient of mine named Brenda. This 35-year-old woman came to me with symptoms that had been going on for a year already. I asked for readers’ comments about my management of Brenda.

I appreciate the comments I received regarding this case. The most common suggestion was to encourage Brenda to exercise, and a systematic review of randomized clinical trials published in 2019 supports this recommendation. This review included nine studies with a total of 680 participants, and the overall effect of exercise was a twofold improvement in symptoms associated with constipation. Walking was the most common exercise intervention, and along with qigong (which combines body position, breathing, and meditation), these two modes of exercise were effective in improving constipation. However, the one study evaluating resistance training failed to demonstrate a significant effect. Importantly, the reviewers considered the collective research to be at a high risk of bias.

Exercise will probably help Brenda, although some brainstorming might be necessary to help her fit exercise into her busy schedule. Another suggestion focused on her risk for colorectal cancer, and Dr. Cooke and Dr. Boboc both astutely noted that colorectal cancer is increasingly common among adults at early middle age. This stands in contrast to a steady decline in the prevalence of colorectal cancer among U.S. adults at age 65 years or older. Whereas colorectal cancer declined by 3.3% annually among U.S. older adults from 2011 to 2016, there was a reversal of this favorable trend among individuals between 50 and 64 years of age, with rates increasing by 1% annually.

The increase in the incidence of colorectal cancer among adults 50-64 years of age has been outpaced by the increase among adults younger than 50 years, who have experienced a 2.2% increase in the incidence of colorectal cancer annually between 2012 and 2016. Previously, the increase in colorectal cancer among early middle-aged adults was driven by higher rates of rectal cancer, but more recently this trend has included higher rates of proximal and distal colon tumors. In 2020, 12% of new cases of colorectal cancer were expected to be among individuals younger than 50 years.

So how do we act on this context in the case of Brenda? Her history suggests no overt warning signs for cancer. The history did not address a family history of gastrointestinal symptoms or colorectal cancer, which is an important omission.

Although the number of cases of cancer among persons younger than 50 years may be rising, the overall prevalence of colorectal cancer among younger adults is well under 1%. At 35 years of age, it is not necessary to evaluate Brenda for colorectal cancer. However, persistent or worsening symptoms could prompt a referral for colonoscopy at a later time.

Finally, let’s address how to practically manage Brenda’s case, because many options are available. I would begin with recommendations regarding her lifestyle, including regular exercise, adequate sleep, and whatever she can achieve in the FODMAP diet. I would also recommend psyllium as a soluble fiber and expect that these changes would help her constipation. But they might be less effective for abdominal cramping, so I would also recommend peppermint oil at this time.

If Brenda commits to these recommendations, she will very likely improve. If she does not, I will be more concerned regarding anxiety and depression complicating her illness. Treating those disorders can make a big difference.

In addition, if there is an inadequate response to initial therapy, I will initiate linaclotide or lubiprostone. Plecanatide is another reasonable option. At this point, I will also consider referral to a gastroenterologist for a recalcitrant case and will certainly refer if one of these specific treatments fails in Brenda. Conditions such as pelvic floor dysfunction can mimic irritable bowel syndrome with constipation and merit consideration.

However, I really believe that Brenda will feel better. Thanks for all of the insightful and interesting comments. It is easy to see how we are all invested in improving patients’ lives.
 

Dr. Vega is a clinical professor of family medicine at the University of California, Irvine. He reported disclosures with McNeil Pharmaceuticals. A version of this article first appeared on Medscape.com.

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

The phase 3 NALA trial² demonstrated superior outcomes with the combination of neratinib plus capecitabine vs lapatinib plus capecitabine among patients with previously treated HER2+ metastatic breast cancer (hazard ratio 0.76; 1-year PFS 29% vs 15%). Findings from a single-center retrospective study including 72 patients with HER2+ advanced breast cancer who received either neratinib plus capecitabine or neratinib alone support efficacy and tolerability in the real-world setting (Cunningham et al). Among all patients, the median PFS was 5.9 months and median OS was 15.0 months; for those with brain metastases (n = 38), median PFS and median OS were 5.7 and 12.5 months, respectively. The gastrointestinal toxicity of neratinib can affect its clinical use, and a total of 64% of patients in this study reported diarrhea (10% reported grade 3) despite using antidiarrheal prophylaxis.

The treatment algorithm for HER2+ metastatic breast cancer has been evolving at a rapid pace, specifically for second-line and beyond. Neratinib remains a relevant therapy choice for these patients. The central nervous system activity of neratinib and other tyrosine kinase inhibitors, such as tucatinib, often make these the preferred treatment options for patients with brain metastases and stimulate the idea of prevention of brain metastases at an earlier time point.

Young women with breast cancer encounter unique challenges related to the stage of life during which they are diagnosed. It is essential to consider the effect of cancer treatment on fertility, including direct effects of chemotherapy and the duration of endocrine therapy (5-10 years) that can delay attempts at conceiving. Potential concerns surrounding fertility preservation (FP) include the theoretical risk of increased estradiol levels and treatment delay to allow these procedures to occur; however, various studies have supported the safety of FP.³

A prospective cohort study including 1257 women of reproductive age who were diagnosed with breast cancer and underwent FP treatment demonstrated similar disease-specific mortality in women who underwent hormonal FP (adjusted hazard ratio [aHR] 0.59; 95% CI 0.32-1.09), those who underwent nonhormonal FP (aHR 0.51, 95% CI 0.20-1.29), and women who did not pursue FP (Marklund et al). Furthermore, among 723 women with detailed information on relapse there was no significant difference in rate of relapse or death among those who underwent hormonal FP (aHR 0.81; 95% CI 0.49-1.37) vs those who underwent nonhormonal FP (aHR 0.75; 95% CI 0.35-1.62).

The growing body of evidence in this field highlights the importance of oncofertility awareness for both patients and providers. Young women diagnosed with breast cancer should be offered referrals to fertility specialists when interested and educated on the safety of these approaches as it relates to breast cancer outcomes.

A multicenter retrospective study compared the efficacy and safety of controlled ovarian hyperstimulation with letrozole (LetCOH) or without letrozole (cCOH) among 97 young women (≤ 40 years) diagnosed with early-stage breast cancer (Goldrat et al). The LetCOH group had lower peak estradiol levels (343 pg/mL vs 1009 pg/mL; P < .001) and higher oocyte maturation rates compared with the cCOH group, but a similar number of mature oocytes collected (P = .281). Disease recurrence occurred more frequently in the LetCOH group than in the cCOH group (17% vs 7.2%), and five patients in total had a distant recurrence (four undergoing LetCOH vs one undergoing cCOH).

The LetCOH group did have larger tumors and a higher number of HER2+ cancers. These findings suggest that a COH protocol using letrozole can yield FP outcomes similar to those of the conventional protocol while minimizing exposure to high levels of estradiol. Extended follow-up and future prospective studies will be essential to gain survival data and further define the roles of various FP procedures.

Additional References

1. Bardia A, Tolaney SM, Loirat D, et al. Sacituzumab govitecan (SG) versus treatment of physician's choice (TPC) in patients (pts) with previously treated, metastatic triple-negative breast cancer (mTNBC): final results from the phase 3 ASCENT study. J Clin Oncol. 2022;40(16 Suppl):107 Doi: 10.1200/JCO.2022.40.16_suppl.1071
2. Saura C, Oliveira M, Feng YH, et al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: phase III NALA trial. J Clin Oncol. 2020;38:3138-3149. Doi: 10.1200/JCO.20.00147
3. Moravek MB, Confino R, Lawson AK, et al. Predictors and outcomes in breast cancer patients who did or did not pursue fertility preservation. Breast Cancer Res Treat. 2021;186:429-437. Doi: 10.1007/s10549-020-06031-4

The phase 3 NALA trial² demonstrated superior outcomes with the combination of neratinib plus capecitabine vs lapatinib plus capecitabine among patients with previously treated HER2+ metastatic breast cancer (hazard ratio 0.76; 1-year PFS 29% vs 15%). Findings from a single-center retrospective study including 72 patients with HER2+ advanced breast cancer who received either neratinib plus capecitabine or neratinib alone support efficacy and tolerability in the real-world setting (Cunningham et al). Among all patients, the median PFS was 5.9 months and median OS was 15.0 months; for those with brain metastases (n = 38), median PFS and median OS were 5.7 and 12.5 months, respectively. The gastrointestinal toxicity of neratinib can affect its clinical use, and a total of 64% of patients in this study reported diarrhea (10% reported grade 3) despite using antidiarrheal prophylaxis.

The treatment algorithm for HER2+ metastatic breast cancer has been evolving at a rapid pace, specifically for second-line and beyond. Neratinib remains a relevant therapy choice for these patients. The central nervous system activity of neratinib and other tyrosine kinase inhibitors, such as tucatinib, often make these the preferred treatment options for patients with brain metastases and stimulate the idea of prevention of brain metastases at an earlier time point.

Young women with breast cancer encounter unique challenges related to the stage of life during which they are diagnosed. It is essential to consider the effect of cancer treatment on fertility, including direct effects of chemotherapy and the duration of endocrine therapy (5-10 years) that can delay attempts at conceiving. Potential concerns surrounding fertility preservation (FP) include the theoretical risk of increased estradiol levels and treatment delay to allow these procedures to occur; however, various studies have supported the safety of FP.³

A prospective cohort study including 1257 women of reproductive age who were diagnosed with breast cancer and underwent FP treatment demonstrated similar disease-specific mortality in women who underwent hormonal FP (adjusted hazard ratio [aHR] 0.59; 95% CI 0.32-1.09), those who underwent nonhormonal FP (aHR 0.51, 95% CI 0.20-1.29), and women who did not pursue FP (Marklund et al). Furthermore, among 723 women with detailed information on relapse there was no significant difference in rate of relapse or death among those who underwent hormonal FP (aHR 0.81; 95% CI 0.49-1.37) vs those who underwent nonhormonal FP (aHR 0.75; 95% CI 0.35-1.62).

The growing body of evidence in this field highlights the importance of oncofertility awareness for both patients and providers. Young women diagnosed with breast cancer should be offered referrals to fertility specialists when interested and educated on the safety of these approaches as it relates to breast cancer outcomes.

A multicenter retrospective study compared the efficacy and safety of controlled ovarian hyperstimulation with letrozole (LetCOH) or without letrozole (cCOH) among 97 young women (≤ 40 years) diagnosed with early-stage breast cancer (Goldrat et al). The LetCOH group had lower peak estradiol levels (343 pg/mL vs 1009 pg/mL; P < .001) and higher oocyte maturation rates compared with the cCOH group, but a similar number of mature oocytes collected (P = .281). Disease recurrence occurred more frequently in the LetCOH group than in the cCOH group (17% vs 7.2%), and five patients in total had a distant recurrence (four undergoing LetCOH vs one undergoing cCOH).

The LetCOH group did have larger tumors and a higher number of HER2+ cancers. These findings suggest that a COH protocol using letrozole can yield FP outcomes similar to those of the conventional protocol while minimizing exposure to high levels of estradiol. Extended follow-up and future prospective studies will be essential to gain survival data and further define the roles of various FP procedures.

Additional References

1. Bardia A, Tolaney SM, Loirat D, et al. Sacituzumab govitecan (SG) versus treatment of physician's choice (TPC) in patients (pts) with previously treated, metastatic triple-negative breast cancer (mTNBC): final results from the phase 3 ASCENT study. J Clin Oncol. 2022;40(16 Suppl):107 Doi: 10.1200/JCO.2022.40.16_suppl.1071
2. Saura C, Oliveira M, Feng YH, et al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: phase III NALA trial. J Clin Oncol. 2020;38:3138-3149. Doi: 10.1200/JCO.20.00147
3. Moravek MB, Confino R, Lawson AK, et al. Predictors and outcomes in breast cancer patients who did or did not pursue fertility preservation. Breast Cancer Res Treat. 2021;186:429-437. Doi: 10.1007/s10549-020-06031-4

The phase 3 NALA trial² demonstrated superior outcomes with the combination of neratinib plus capecitabine vs lapatinib plus capecitabine among patients with previously treated HER2+ metastatic breast cancer (hazard ratio 0.76; 1-year PFS 29% vs 15%). Findings from a single-center retrospective study including 72 patients with HER2+ advanced breast cancer who received either neratinib plus capecitabine or neratinib alone support efficacy and tolerability in the real-world setting (Cunningham et al). Among all patients, the median PFS was 5.9 months and median OS was 15.0 months; for those with brain metastases (n = 38), median PFS and median OS were 5.7 and 12.5 months, respectively. The gastrointestinal toxicity of neratinib can affect its clinical use, and a total of 64% of patients in this study reported diarrhea (10% reported grade 3) despite using antidiarrheal prophylaxis.

The treatment algorithm for HER2+ metastatic breast cancer has been evolving at a rapid pace, specifically for second-line and beyond. Neratinib remains a relevant therapy choice for these patients. The central nervous system activity of neratinib and other tyrosine kinase inhibitors, such as tucatinib, often make these the preferred treatment options for patients with brain metastases and stimulate the idea of prevention of brain metastases at an earlier time point.

Young women with breast cancer encounter unique challenges related to the stage of life during which they are diagnosed. It is essential to consider the effect of cancer treatment on fertility, including direct effects of chemotherapy and the duration of endocrine therapy (5-10 years) that can delay attempts at conceiving. Potential concerns surrounding fertility preservation (FP) include the theoretical risk of increased estradiol levels and treatment delay to allow these procedures to occur; however, various studies have supported the safety of FP.³

A prospective cohort study including 1257 women of reproductive age who were diagnosed with breast cancer and underwent FP treatment demonstrated similar disease-specific mortality in women who underwent hormonal FP (adjusted hazard ratio [aHR] 0.59; 95% CI 0.32-1.09), those who underwent nonhormonal FP (aHR 0.51, 95% CI 0.20-1.29), and women who did not pursue FP (Marklund et al). Furthermore, among 723 women with detailed information on relapse there was no significant difference in rate of relapse or death among those who underwent hormonal FP (aHR 0.81; 95% CI 0.49-1.37) vs those who underwent nonhormonal FP (aHR 0.75; 95% CI 0.35-1.62).

The growing body of evidence in this field highlights the importance of oncofertility awareness for both patients and providers. Young women diagnosed with breast cancer should be offered referrals to fertility specialists when interested and educated on the safety of these approaches as it relates to breast cancer outcomes.

A multicenter retrospective study compared the efficacy and safety of controlled ovarian hyperstimulation with letrozole (LetCOH) or without letrozole (cCOH) among 97 young women (≤ 40 years) diagnosed with early-stage breast cancer (Goldrat et al). The LetCOH group had lower peak estradiol levels (343 pg/mL vs 1009 pg/mL; P < .001) and higher oocyte maturation rates compared with the cCOH group, but a similar number of mature oocytes collected (P = .281). Disease recurrence occurred more frequently in the LetCOH group than in the cCOH group (17% vs 7.2%), and five patients in total had a distant recurrence (four undergoing LetCOH vs one undergoing cCOH).

The LetCOH group did have larger tumors and a higher number of HER2+ cancers. These findings suggest that a COH protocol using letrozole can yield FP outcomes similar to those of the conventional protocol while minimizing exposure to high levels of estradiol. Extended follow-up and future prospective studies will be essential to gain survival data and further define the roles of various FP procedures.

Additional References

1. Bardia A, Tolaney SM, Loirat D, et al. Sacituzumab govitecan (SG) versus treatment of physician's choice (TPC) in patients (pts) with previously treated, metastatic triple-negative breast cancer (mTNBC): final results from the phase 3 ASCENT study. J Clin Oncol. 2022;40(16 Suppl):107 Doi: 10.1200/JCO.2022.40.16_suppl.1071
2. Saura C, Oliveira M, Feng YH, et al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: phase III NALA trial. J Clin Oncol. 2020;38:3138-3149. Doi: 10.1200/JCO.20.00147
3. Moravek MB, Confino R, Lawson AK, et al. Predictors and outcomes in breast cancer patients who did or did not pursue fertility preservation. Breast Cancer Res Treat. 2021;186:429-437. Doi: 10.1007/s10549-020-06031-4