PARIS — Pregnancy is a period of asthma instability; it entails an increased risk for exacerbations. While therapeutic de-escalation, if not the outright cessation of maintenance treatment, is common, experts used the 19th Francophone Congress of Allergology to emphasize the importance of well-controlled asthma for the mother, the fetus, and the pregnancy.

About 12% of women of childbearing age have asthma. It is the most common chronic condition in pregnant women. Pregnancy affects asthma, and vice versa. Due to mechanical, hormonal, and immunological changes, allergic conditions, including asthma, can worsen.

First, pregnancy exerts mechanical pressure on respiratory function because of the progressive increase in uterine volume, diaphragm elevation, and various anatomical changes leading to chest expansion. The latter changes include increased subcostal angle, anteroposterior and transverse diameters, and thoracic circumference. 

Respiratory function is affected, with a decrease in functional residual capacity and expiratory reserve volume but an increase in inspiratory capacity, maximal ventilation, and tidal volume. The resulting hyperventilation manifests clinically as dyspnea, which affects up to 70% of pregnant women and can be mistaken for exacerbation symptoms.

Besides mechanical impact, hormonal changes occur during pregnancy, including elevated estrogen and progesterone levels. Placental hormones increase during the third trimester. These steroid hormones weaken the respiratory mucosa through structural changes in the bronchial wall and the activity of inflammatory cells involved in asthma, while influencing bronchial muscle tone. Estrogens have a dual effect. They are immunostimulatory at low doses and immunosuppressive at high doses (as in late pregnancy). This phenomenon suggests a role in immune tolerance toward the fetus.
 

The Rule of Thirds

Asthma progression during pregnancy is unpredictable. According to older studies, about one third of cases remain stable, one third worsen, and one third improve. In 60% of cases, the course remains similar from one pregnancy to another. Pregnancy is considered a period of asthma instability, with a doubled risk for exacerbation compared with nonpregnant women. Several pregnancy-specific factors contribute, including gastroesophageal reflux, excessive weight gain, active or passive smoking, and usual risk factors like infections. However, the main risk factor for exacerbation and loss of asthma control is insufficient maintenance treatment.

“The control of asthma during pregnancy is influenced by pregnancy itself, but especially by the severity of the disease before pregnancy and the underuse of inhaled corticosteroids,” said Mohammed Tawfik el Fassy Fihry, MD, pulmonologist at Ibn Sina Souissi Hospital in Rabat, Morocco. “This treatment insufficiency is the main cause of poor asthma control and sometimes of severe exacerbations.”
 

Inhaled Corticosteroid Often Insufficient

A 2017 study conducted in France found that one third of women had their asthma treatment reduced in the first trimester of pregnancy. Another observation was the frequent replacement of fixed combinations (such as long- and short-acting bronchodilators and inhaled corticosteroids) with simple inhaled corticosteroid therapy.

“A significant proportion of pregnant women on maintenance therapy decide to stop it as soon as they discover their pregnancy,” said Chantal Raherison-Semjen, PhD, coordinator of the Women and Lung group of the French Society of Pulmonology (SPLF) and of the pulmonology department at the University Hospital of Pointe-à-Pitre in Guadeloupe, France. “Treating physicians also often opt for therapeutic de-escalation, which involves stopping long-acting bronchodilators in favor of only inhaled corticosteroid therapy, which is usually insufficient for optimal asthma control.”

In severe exacerbations, especially during the first trimester of pregnancy, poorly controlled asthma can lead to complications in fetal development, such as low birth weight, intrauterine growth retardation, prematurity, and congenital malformations.

It can also affect maternal health by increasing the risk for gestational diabetes and affecting the course of pregnancy itself, favoring the occurrence of preeclampsia, placenta previa, placental abruption, premature rupture of membranes, spontaneous miscarriage, cesarean section, and hemorrhagic complications before and after delivery.

“When a pregnant woman presents to the emergency room due to an asthma exacerbation, physicians are often reluctant to administer optimal treatment for fear of the effects of bronchodilators and systemic corticosteroids,” said Dr. Raherison-Semjen. “As a result, these women generally receive less effective treatment in such situations, compared with nonpregnant women. This is despite the risk that severe asthma exacerbations pose to the mother and her child.”
 

‘Pregnant Woman’ Pictogram

In France, manufacturers of teratogenic or fetotoxic drugs are required to display a pictogram on the label indicating the danger for pregnant women or the fetus. The guidelines for this labeling are left to the discretion of the laboratories, however, which sometimes leads to unjustified warnings on the packaging of inhaled corticosteroids or emergency treatments. French medical societies were not consulted on this matter, which complicates prescriptions for pregnant asthmatic women, said Dr. Raherison-Semjen. The SPLF condemns the harmful effects of this decision.

Corticosteroids and Omalizumab

“Given the low, if any, risks associated with the main asthma treatments for the mother and fetus, continuing treatments started before conception is highly recommended,” said Dr. Raherison-Semjen. Inhaled corticosteroids, the cornerstone of asthma treatment, are the primary therapy, and the dosage can be adjusted as strictly necessary. “When properly managed, treatment generally allows for asthma control and reduces the risk for complications during pregnancy to the same level observed in the general population.”

Depending on asthma control levels, long-acting beta-2 agonists (eg, formoterol, salmeterol, and indacaterol) can be added, and possibly leukotriene antagonists. Before pregnancy, prescribed medications should be continued, including biologics prescribed for severe asthma. The exception is omalizumab, which can be started during pregnancy without risk.

For its part, allergen immunotherapy should also be maintained but without dose increases. Oral corticosteroids are reserved for severe exacerbations.

As specified by the GINA report of 2023, the benefits of active asthma treatment during pregnancy far outweigh the risks of usual asthma medications (Level A). This view is supported by reassuring data from the Reference Center for Teratogenic Agents. “There is no scientific-medical evidence justifying that pregnant women with asthma should not be treated the same way as when they are not pregnant,” said Dr. Raherison-Semjen.
 

Useful Links

The Asthma Control Test is a quick questionnaire that allows practitioners to ensure their patient›s asthma control. A score below 20 of 25 indicates poor asthma control. It has been specifically validated for pregnancy.

Dr. Tawfik el Fassy Fihry reported having no relevant financial relationships. Dr. Raherison-Semjen reported receiving compensation from AstraZeneca, B. Ingelheim, ALK, Novartis, Banook, GSK, and Mundi Pharma.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

PARIS — Pregnancy is a period of asthma instability; it entails an increased risk for exacerbations. While therapeutic de-escalation, if not the outright cessation of maintenance treatment, is common, experts used the 19th Francophone Congress of Allergology to emphasize the importance of well-controlled asthma for the mother, the fetus, and the pregnancy.

About 12% of women of childbearing age have asthma. It is the most common chronic condition in pregnant women. Pregnancy affects asthma, and vice versa. Due to mechanical, hormonal, and immunological changes, allergic conditions, including asthma, can worsen.

First, pregnancy exerts mechanical pressure on respiratory function because of the progressive increase in uterine volume, diaphragm elevation, and various anatomical changes leading to chest expansion. The latter changes include increased subcostal angle, anteroposterior and transverse diameters, and thoracic circumference. 

Respiratory function is affected, with a decrease in functional residual capacity and expiratory reserve volume but an increase in inspiratory capacity, maximal ventilation, and tidal volume. The resulting hyperventilation manifests clinically as dyspnea, which affects up to 70% of pregnant women and can be mistaken for exacerbation symptoms.

Besides mechanical impact, hormonal changes occur during pregnancy, including elevated estrogen and progesterone levels. Placental hormones increase during the third trimester. These steroid hormones weaken the respiratory mucosa through structural changes in the bronchial wall and the activity of inflammatory cells involved in asthma, while influencing bronchial muscle tone. Estrogens have a dual effect. They are immunostimulatory at low doses and immunosuppressive at high doses (as in late pregnancy). This phenomenon suggests a role in immune tolerance toward the fetus.
 

The Rule of Thirds

Asthma progression during pregnancy is unpredictable. According to older studies, about one third of cases remain stable, one third worsen, and one third improve. In 60% of cases, the course remains similar from one pregnancy to another. Pregnancy is considered a period of asthma instability, with a doubled risk for exacerbation compared with nonpregnant women. Several pregnancy-specific factors contribute, including gastroesophageal reflux, excessive weight gain, active or passive smoking, and usual risk factors like infections. However, the main risk factor for exacerbation and loss of asthma control is insufficient maintenance treatment.

“The control of asthma during pregnancy is influenced by pregnancy itself, but especially by the severity of the disease before pregnancy and the underuse of inhaled corticosteroids,” said Mohammed Tawfik el Fassy Fihry, MD, pulmonologist at Ibn Sina Souissi Hospital in Rabat, Morocco. “This treatment insufficiency is the main cause of poor asthma control and sometimes of severe exacerbations.”
 

Inhaled Corticosteroid Often Insufficient

A 2017 study conducted in France found that one third of women had their asthma treatment reduced in the first trimester of pregnancy. Another observation was the frequent replacement of fixed combinations (such as long- and short-acting bronchodilators and inhaled corticosteroids) with simple inhaled corticosteroid therapy.

“A significant proportion of pregnant women on maintenance therapy decide to stop it as soon as they discover their pregnancy,” said Chantal Raherison-Semjen, PhD, coordinator of the Women and Lung group of the French Society of Pulmonology (SPLF) and of the pulmonology department at the University Hospital of Pointe-à-Pitre in Guadeloupe, France. “Treating physicians also often opt for therapeutic de-escalation, which involves stopping long-acting bronchodilators in favor of only inhaled corticosteroid therapy, which is usually insufficient for optimal asthma control.”

In severe exacerbations, especially during the first trimester of pregnancy, poorly controlled asthma can lead to complications in fetal development, such as low birth weight, intrauterine growth retardation, prematurity, and congenital malformations.

It can also affect maternal health by increasing the risk for gestational diabetes and affecting the course of pregnancy itself, favoring the occurrence of preeclampsia, placenta previa, placental abruption, premature rupture of membranes, spontaneous miscarriage, cesarean section, and hemorrhagic complications before and after delivery.

“When a pregnant woman presents to the emergency room due to an asthma exacerbation, physicians are often reluctant to administer optimal treatment for fear of the effects of bronchodilators and systemic corticosteroids,” said Dr. Raherison-Semjen. “As a result, these women generally receive less effective treatment in such situations, compared with nonpregnant women. This is despite the risk that severe asthma exacerbations pose to the mother and her child.”
 

‘Pregnant Woman’ Pictogram

In France, manufacturers of teratogenic or fetotoxic drugs are required to display a pictogram on the label indicating the danger for pregnant women or the fetus. The guidelines for this labeling are left to the discretion of the laboratories, however, which sometimes leads to unjustified warnings on the packaging of inhaled corticosteroids or emergency treatments. French medical societies were not consulted on this matter, which complicates prescriptions for pregnant asthmatic women, said Dr. Raherison-Semjen. The SPLF condemns the harmful effects of this decision.

Corticosteroids and Omalizumab

“Given the low, if any, risks associated with the main asthma treatments for the mother and fetus, continuing treatments started before conception is highly recommended,” said Dr. Raherison-Semjen. Inhaled corticosteroids, the cornerstone of asthma treatment, are the primary therapy, and the dosage can be adjusted as strictly necessary. “When properly managed, treatment generally allows for asthma control and reduces the risk for complications during pregnancy to the same level observed in the general population.”

Depending on asthma control levels, long-acting beta-2 agonists (eg, formoterol, salmeterol, and indacaterol) can be added, and possibly leukotriene antagonists. Before pregnancy, prescribed medications should be continued, including biologics prescribed for severe asthma. The exception is omalizumab, which can be started during pregnancy without risk.

For its part, allergen immunotherapy should also be maintained but without dose increases. Oral corticosteroids are reserved for severe exacerbations.

As specified by the GINA report of 2023, the benefits of active asthma treatment during pregnancy far outweigh the risks of usual asthma medications (Level A). This view is supported by reassuring data from the Reference Center for Teratogenic Agents. “There is no scientific-medical evidence justifying that pregnant women with asthma should not be treated the same way as when they are not pregnant,” said Dr. Raherison-Semjen.
 

Useful Links

The Asthma Control Test is a quick questionnaire that allows practitioners to ensure their patient›s asthma control. A score below 20 of 25 indicates poor asthma control. It has been specifically validated for pregnancy.

Dr. Tawfik el Fassy Fihry reported having no relevant financial relationships. Dr. Raherison-Semjen reported receiving compensation from AstraZeneca, B. Ingelheim, ALK, Novartis, Banook, GSK, and Mundi Pharma.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

PARIS — Pregnancy is a period of asthma instability; it entails an increased risk for exacerbations. While therapeutic de-escalation, if not the outright cessation of maintenance treatment, is common, experts used the 19th Francophone Congress of Allergology to emphasize the importance of well-controlled asthma for the mother, the fetus, and the pregnancy.

About 12% of women of childbearing age have asthma. It is the most common chronic condition in pregnant women. Pregnancy affects asthma, and vice versa. Due to mechanical, hormonal, and immunological changes, allergic conditions, including asthma, can worsen.

First, pregnancy exerts mechanical pressure on respiratory function because of the progressive increase in uterine volume, diaphragm elevation, and various anatomical changes leading to chest expansion. The latter changes include increased subcostal angle, anteroposterior and transverse diameters, and thoracic circumference. 

Respiratory function is affected, with a decrease in functional residual capacity and expiratory reserve volume but an increase in inspiratory capacity, maximal ventilation, and tidal volume. The resulting hyperventilation manifests clinically as dyspnea, which affects up to 70% of pregnant women and can be mistaken for exacerbation symptoms.

Besides mechanical impact, hormonal changes occur during pregnancy, including elevated estrogen and progesterone levels. Placental hormones increase during the third trimester. These steroid hormones weaken the respiratory mucosa through structural changes in the bronchial wall and the activity of inflammatory cells involved in asthma, while influencing bronchial muscle tone. Estrogens have a dual effect. They are immunostimulatory at low doses and immunosuppressive at high doses (as in late pregnancy). This phenomenon suggests a role in immune tolerance toward the fetus.
 

The Rule of Thirds

Asthma progression during pregnancy is unpredictable. According to older studies, about one third of cases remain stable, one third worsen, and one third improve. In 60% of cases, the course remains similar from one pregnancy to another. Pregnancy is considered a period of asthma instability, with a doubled risk for exacerbation compared with nonpregnant women. Several pregnancy-specific factors contribute, including gastroesophageal reflux, excessive weight gain, active or passive smoking, and usual risk factors like infections. However, the main risk factor for exacerbation and loss of asthma control is insufficient maintenance treatment.

“The control of asthma during pregnancy is influenced by pregnancy itself, but especially by the severity of the disease before pregnancy and the underuse of inhaled corticosteroids,” said Mohammed Tawfik el Fassy Fihry, MD, pulmonologist at Ibn Sina Souissi Hospital in Rabat, Morocco. “This treatment insufficiency is the main cause of poor asthma control and sometimes of severe exacerbations.”
 

Inhaled Corticosteroid Often Insufficient

A 2017 study conducted in France found that one third of women had their asthma treatment reduced in the first trimester of pregnancy. Another observation was the frequent replacement of fixed combinations (such as long- and short-acting bronchodilators and inhaled corticosteroids) with simple inhaled corticosteroid therapy.

“A significant proportion of pregnant women on maintenance therapy decide to stop it as soon as they discover their pregnancy,” said Chantal Raherison-Semjen, PhD, coordinator of the Women and Lung group of the French Society of Pulmonology (SPLF) and of the pulmonology department at the University Hospital of Pointe-à-Pitre in Guadeloupe, France. “Treating physicians also often opt for therapeutic de-escalation, which involves stopping long-acting bronchodilators in favor of only inhaled corticosteroid therapy, which is usually insufficient for optimal asthma control.”

In severe exacerbations, especially during the first trimester of pregnancy, poorly controlled asthma can lead to complications in fetal development, such as low birth weight, intrauterine growth retardation, prematurity, and congenital malformations.

It can also affect maternal health by increasing the risk for gestational diabetes and affecting the course of pregnancy itself, favoring the occurrence of preeclampsia, placenta previa, placental abruption, premature rupture of membranes, spontaneous miscarriage, cesarean section, and hemorrhagic complications before and after delivery.

“When a pregnant woman presents to the emergency room due to an asthma exacerbation, physicians are often reluctant to administer optimal treatment for fear of the effects of bronchodilators and systemic corticosteroids,” said Dr. Raherison-Semjen. “As a result, these women generally receive less effective treatment in such situations, compared with nonpregnant women. This is despite the risk that severe asthma exacerbations pose to the mother and her child.”
 

‘Pregnant Woman’ Pictogram

In France, manufacturers of teratogenic or fetotoxic drugs are required to display a pictogram on the label indicating the danger for pregnant women or the fetus. The guidelines for this labeling are left to the discretion of the laboratories, however, which sometimes leads to unjustified warnings on the packaging of inhaled corticosteroids or emergency treatments. French medical societies were not consulted on this matter, which complicates prescriptions for pregnant asthmatic women, said Dr. Raherison-Semjen. The SPLF condemns the harmful effects of this decision.

Corticosteroids and Omalizumab

“Given the low, if any, risks associated with the main asthma treatments for the mother and fetus, continuing treatments started before conception is highly recommended,” said Dr. Raherison-Semjen. Inhaled corticosteroids, the cornerstone of asthma treatment, are the primary therapy, and the dosage can be adjusted as strictly necessary. “When properly managed, treatment generally allows for asthma control and reduces the risk for complications during pregnancy to the same level observed in the general population.”

Depending on asthma control levels, long-acting beta-2 agonists (eg, formoterol, salmeterol, and indacaterol) can be added, and possibly leukotriene antagonists. Before pregnancy, prescribed medications should be continued, including biologics prescribed for severe asthma. The exception is omalizumab, which can be started during pregnancy without risk.

For its part, allergen immunotherapy should also be maintained but without dose increases. Oral corticosteroids are reserved for severe exacerbations.

As specified by the GINA report of 2023, the benefits of active asthma treatment during pregnancy far outweigh the risks of usual asthma medications (Level A). This view is supported by reassuring data from the Reference Center for Teratogenic Agents. “There is no scientific-medical evidence justifying that pregnant women with asthma should not be treated the same way as when they are not pregnant,” said Dr. Raherison-Semjen.
 

Useful Links

The Asthma Control Test is a quick questionnaire that allows practitioners to ensure their patient›s asthma control. A score below 20 of 25 indicates poor asthma control. It has been specifically validated for pregnancy.

Dr. Tawfik el Fassy Fihry reported having no relevant financial relationships. Dr. Raherison-Semjen reported receiving compensation from AstraZeneca, B. Ingelheim, ALK, Novartis, Banook, GSK, and Mundi Pharma.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A meta-analysis showed that the use of oral tranexamic acid along with the standard triple combination cream (TCC) reduces melasma severity and recurrence in patients with melasma, without increasing toxicity.

METHODOLOGY:

• Current treatments for melasma focus on inducing remission and preventing relapse. Tranexamic acid, an antifibrinolytic drug, has shown promise in recent studies, but its optimal use, either alone or as an adjunct to TCC, remains unclear.
• Researchers conducted a meta-analysis of four randomized controlled trials patients that compared oral tranexamic acid plus TCC (hydroquinone, retinoic acid, and hydrocortisone) and TCC alone in 480 patients with melasma, divided almost evenly into the two treatment groups.
• The main outcome was the change in the Melasma Severity Area Index (MASI) score and recurrence rate from baseline.

TAKEAWAY:

• Patients treated with oral tranexamic acid plus TCC showed a greater reduction in MASI scores compared with those who received TCC alone (mean difference, −3.10; P = .03).
• The recurrence rate of melasma was significantly lower in the tranexamic acid plus TCC group (risk ratio [RR], 0.28; P < .001).
• There was no significant difference in the incidences of erythema (RR, 0.63; P = .147) and burning (RR, 0.59; P = .131).

IN PRACTICE:

“Evidence indicates that oral tranexamic acid confers clinical benefits, contributing to the enhancement of treatment outcomes in melasma when used in conjunction with TCC therapy,” and results are promising with regards to minimizing recurrence, the authors concluded.

SOURCE:

The study was led by Ocílio Ribeiro Gonçalves, MS, of the Federal University of Piauí, Teresina, Brazil, and was published online on June 8, 2024, in Clinical and Experimental Dermatology.

LIMITATIONS:

There was heterogeneity across studies, including different methods of administration, treatment protocols (including dosage), and timing of treatment.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A meta-analysis showed that the use of oral tranexamic acid along with the standard triple combination cream (TCC) reduces melasma severity and recurrence in patients with melasma, without increasing toxicity.

METHODOLOGY:

• Current treatments for melasma focus on inducing remission and preventing relapse. Tranexamic acid, an antifibrinolytic drug, has shown promise in recent studies, but its optimal use, either alone or as an adjunct to TCC, remains unclear.
• Researchers conducted a meta-analysis of four randomized controlled trials patients that compared oral tranexamic acid plus TCC (hydroquinone, retinoic acid, and hydrocortisone) and TCC alone in 480 patients with melasma, divided almost evenly into the two treatment groups.
• The main outcome was the change in the Melasma Severity Area Index (MASI) score and recurrence rate from baseline.

TAKEAWAY:

• Patients treated with oral tranexamic acid plus TCC showed a greater reduction in MASI scores compared with those who received TCC alone (mean difference, −3.10; P = .03).
• The recurrence rate of melasma was significantly lower in the tranexamic acid plus TCC group (risk ratio [RR], 0.28; P < .001).
• There was no significant difference in the incidences of erythema (RR, 0.63; P = .147) and burning (RR, 0.59; P = .131).

IN PRACTICE:

“Evidence indicates that oral tranexamic acid confers clinical benefits, contributing to the enhancement of treatment outcomes in melasma when used in conjunction with TCC therapy,” and results are promising with regards to minimizing recurrence, the authors concluded.

SOURCE:

The study was led by Ocílio Ribeiro Gonçalves, MS, of the Federal University of Piauí, Teresina, Brazil, and was published online on June 8, 2024, in Clinical and Experimental Dermatology.

LIMITATIONS:

There was heterogeneity across studies, including different methods of administration, treatment protocols (including dosage), and timing of treatment.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A meta-analysis showed that the use of oral tranexamic acid along with the standard triple combination cream (TCC) reduces melasma severity and recurrence in patients with melasma, without increasing toxicity.

METHODOLOGY:

• Current treatments for melasma focus on inducing remission and preventing relapse. Tranexamic acid, an antifibrinolytic drug, has shown promise in recent studies, but its optimal use, either alone or as an adjunct to TCC, remains unclear.
• Researchers conducted a meta-analysis of four randomized controlled trials patients that compared oral tranexamic acid plus TCC (hydroquinone, retinoic acid, and hydrocortisone) and TCC alone in 480 patients with melasma, divided almost evenly into the two treatment groups.
• The main outcome was the change in the Melasma Severity Area Index (MASI) score and recurrence rate from baseline.

TAKEAWAY:

• Patients treated with oral tranexamic acid plus TCC showed a greater reduction in MASI scores compared with those who received TCC alone (mean difference, −3.10; P = .03).
• The recurrence rate of melasma was significantly lower in the tranexamic acid plus TCC group (risk ratio [RR], 0.28; P < .001).
• There was no significant difference in the incidences of erythema (RR, 0.63; P = .147) and burning (RR, 0.59; P = .131).

IN PRACTICE:

“Evidence indicates that oral tranexamic acid confers clinical benefits, contributing to the enhancement of treatment outcomes in melasma when used in conjunction with TCC therapy,” and results are promising with regards to minimizing recurrence, the authors concluded.

SOURCE:

The study was led by Ocílio Ribeiro Gonçalves, MS, of the Federal University of Piauí, Teresina, Brazil, and was published online on June 8, 2024, in Clinical and Experimental Dermatology.

LIMITATIONS:

There was heterogeneity across studies, including different methods of administration, treatment protocols (including dosage), and timing of treatment.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Lung cancer screening was associated with earlier-stage diagnoses and improved survival in a retrospective analysis of a large cohort with low screening uptake. 

METHODOLOGY:

• Randomized trials have shown a mortality benefit with low-dose CT screening to detect lung cancer, but the benefits in clinical practice remain unclear, and lung cancer screening uptake has been slow.
• In this study, researchers assessed the impact of lung cancer screening among Veteran Health Administration patients diagnosed with lung cancer between 2011 and 2018.
• The team evaluated lung cancer stage at diagnosis, lung cancer–specific survival, and overall survival in patients with lung cancer who did vs did not receive screening before their diagnosis.
• Statistical analyses included Cox regression modeling and inverse propensity weighting with lead-time bias adjustment.

TAKEAWAY:

• Among 57,919 individuals diagnosed with lung cancer during the study period, 2167 (3.9%) underwent screening with at least one low-dose CT before receiving their diagnosis. There were no significant differences in age, gender, or race among patients who had prior screening and those who did not.
• Screened patients had double the rate of stage I diagnoses compared with unscreened patients (52% vs 27%) and about one third the rate of stage IV diagnoses (11% vs 32%).
• Patients who received screening before their cancer diagnosis had better overall survival rates compared with unscreened patients. The overall survival rates were 81.2% vs 56.6% at 1 year, 69.9% vs 41.1% at 2 years, and 44.9% vs 22.3% at 5 years, respectively. Lung cancer–specific survival was also better: The survival rates were 82.5% vs 58.7% at 1 year, 74.3% vs 44.4% at 2 years, and 59.0% vs 29.7% at 5 years, respectively.
• A subset analysis of screening-eligible patients (defined as those between the ages of 50-88 who were smokers with a pack-year history of ≥ 20 years or former smokers who quit within 15 years) showed that among those who underwent National Comprehensive Cancer Network guideline-concordant treatment within 12 months of diagnosis, screening resulted in “substantial” reductions in all-cause mortality (adjusted hazard ratio [aHR], 0.79) and lung cancer–specific mortality (aHR, 0.61).

IN PRACTICE:

“These findings provide corroboration of the results of randomized [lung cancer screening] trials in clinical practice,” the authors wrote. “We hope that the striking association between [lung cancer screening], earlier stage diagnosis of lung cancer, and improved mortality spurs a more robust uptake of this life-saving intervention into clinical practice.”

SOURCE:

The study, led by Donna M. Edwards MD, PhD, of the University of Michigan School of Medicine, Ann Arbor, Michigan, was published online in Cancer.

LIMITATIONS:

The study was limited by its retrospective and correlative design, and the authors also were unable to assess whether lung cancer screening contributed to more subsequence procedures in screened vs unscreened patients.

DISCLOSURES:

The study was funded by the LUNGevity Foundation, US Department of Veterans Affairs, National Cancer Institute, and Lung Precision Oncology Program. One author declared being a consultant for industry. The other authors declared no conflicts of interest.

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

TOPLINE:

Lung cancer screening was associated with earlier-stage diagnoses and improved survival in a retrospective analysis of a large cohort with low screening uptake. 

METHODOLOGY:

• Randomized trials have shown a mortality benefit with low-dose CT screening to detect lung cancer, but the benefits in clinical practice remain unclear, and lung cancer screening uptake has been slow.
• In this study, researchers assessed the impact of lung cancer screening among Veteran Health Administration patients diagnosed with lung cancer between 2011 and 2018.
• The team evaluated lung cancer stage at diagnosis, lung cancer–specific survival, and overall survival in patients with lung cancer who did vs did not receive screening before their diagnosis.
• Statistical analyses included Cox regression modeling and inverse propensity weighting with lead-time bias adjustment.

TAKEAWAY:

• Among 57,919 individuals diagnosed with lung cancer during the study period, 2167 (3.9%) underwent screening with at least one low-dose CT before receiving their diagnosis. There were no significant differences in age, gender, or race among patients who had prior screening and those who did not.
• Screened patients had double the rate of stage I diagnoses compared with unscreened patients (52% vs 27%) and about one third the rate of stage IV diagnoses (11% vs 32%).
• Patients who received screening before their cancer diagnosis had better overall survival rates compared with unscreened patients. The overall survival rates were 81.2% vs 56.6% at 1 year, 69.9% vs 41.1% at 2 years, and 44.9% vs 22.3% at 5 years, respectively. Lung cancer–specific survival was also better: The survival rates were 82.5% vs 58.7% at 1 year, 74.3% vs 44.4% at 2 years, and 59.0% vs 29.7% at 5 years, respectively.
• A subset analysis of screening-eligible patients (defined as those between the ages of 50-88 who were smokers with a pack-year history of ≥ 20 years or former smokers who quit within 15 years) showed that among those who underwent National Comprehensive Cancer Network guideline-concordant treatment within 12 months of diagnosis, screening resulted in “substantial” reductions in all-cause mortality (adjusted hazard ratio [aHR], 0.79) and lung cancer–specific mortality (aHR, 0.61).

IN PRACTICE:

“These findings provide corroboration of the results of randomized [lung cancer screening] trials in clinical practice,” the authors wrote. “We hope that the striking association between [lung cancer screening], earlier stage diagnosis of lung cancer, and improved mortality spurs a more robust uptake of this life-saving intervention into clinical practice.”

SOURCE:

The study, led by Donna M. Edwards MD, PhD, of the University of Michigan School of Medicine, Ann Arbor, Michigan, was published online in Cancer.

LIMITATIONS:

The study was limited by its retrospective and correlative design, and the authors also were unable to assess whether lung cancer screening contributed to more subsequence procedures in screened vs unscreened patients.

DISCLOSURES:

The study was funded by the LUNGevity Foundation, US Department of Veterans Affairs, National Cancer Institute, and Lung Precision Oncology Program. One author declared being a consultant for industry. The other authors declared no conflicts of interest.

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

TOPLINE:

Lung cancer screening was associated with earlier-stage diagnoses and improved survival in a retrospective analysis of a large cohort with low screening uptake. 

METHODOLOGY:

• Randomized trials have shown a mortality benefit with low-dose CT screening to detect lung cancer, but the benefits in clinical practice remain unclear, and lung cancer screening uptake has been slow.
• In this study, researchers assessed the impact of lung cancer screening among Veteran Health Administration patients diagnosed with lung cancer between 2011 and 2018.
• The team evaluated lung cancer stage at diagnosis, lung cancer–specific survival, and overall survival in patients with lung cancer who did vs did not receive screening before their diagnosis.
• Statistical analyses included Cox regression modeling and inverse propensity weighting with lead-time bias adjustment.

TAKEAWAY:

• Among 57,919 individuals diagnosed with lung cancer during the study period, 2167 (3.9%) underwent screening with at least one low-dose CT before receiving their diagnosis. There were no significant differences in age, gender, or race among patients who had prior screening and those who did not.
• Screened patients had double the rate of stage I diagnoses compared with unscreened patients (52% vs 27%) and about one third the rate of stage IV diagnoses (11% vs 32%).
• Patients who received screening before their cancer diagnosis had better overall survival rates compared with unscreened patients. The overall survival rates were 81.2% vs 56.6% at 1 year, 69.9% vs 41.1% at 2 years, and 44.9% vs 22.3% at 5 years, respectively. Lung cancer–specific survival was also better: The survival rates were 82.5% vs 58.7% at 1 year, 74.3% vs 44.4% at 2 years, and 59.0% vs 29.7% at 5 years, respectively.
• A subset analysis of screening-eligible patients (defined as those between the ages of 50-88 who were smokers with a pack-year history of ≥ 20 years or former smokers who quit within 15 years) showed that among those who underwent National Comprehensive Cancer Network guideline-concordant treatment within 12 months of diagnosis, screening resulted in “substantial” reductions in all-cause mortality (adjusted hazard ratio [aHR], 0.79) and lung cancer–specific mortality (aHR, 0.61).

IN PRACTICE:

“These findings provide corroboration of the results of randomized [lung cancer screening] trials in clinical practice,” the authors wrote. “We hope that the striking association between [lung cancer screening], earlier stage diagnosis of lung cancer, and improved mortality spurs a more robust uptake of this life-saving intervention into clinical practice.”

SOURCE:

The study, led by Donna M. Edwards MD, PhD, of the University of Michigan School of Medicine, Ann Arbor, Michigan, was published online in Cancer.

LIMITATIONS:

The study was limited by its retrospective and correlative design, and the authors also were unable to assess whether lung cancer screening contributed to more subsequence procedures in screened vs unscreened patients.

DISCLOSURES:

The study was funded by the LUNGevity Foundation, US Department of Veterans Affairs, National Cancer Institute, and Lung Precision Oncology Program. One author declared being a consultant for industry. The other authors declared no conflicts of interest.

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

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

In the wake of a debilitating cyberattack against one of the nation’s largest health care systems, Marvin Ruckle, a nurse at an Ascension hospital in Wichita, Kansas, said he had a frightening experience: He nearly gave a baby “the wrong dose of narcotic” because of confusing paperwork.

Ruckle, who has worked in the neonatal intensive care unit at Ascension Via Christi St. Joseph for two decades, said it was “hard to decipher which was the correct dose” on the medication record. He’d “never seen that happen,” he said, “when we were on the computer system” before the cyberattack.

A May 8 ransomware attack against Ascension, a Catholic health system with 140 hospitals in at least 10 states, locked providers out of systems that track and coordinate nearly every aspect of patient care. They include its systems for electronic health records, some phones, and ones “utilized to order certain tests, procedures and medications,” the company said in a May 9 statement.

More than a dozen doctors and nurses who work for the sprawling health system told Michigan Public and KFF Health News that patient care at its hospitals across the nation was compromised in the fallout of the cyberattack over the past several weeks. Clinicians working for hospitals in three states described harrowing lapses, including delayed or lost lab results, medication errors, and an absence of routine safety checks via technology to prevent potentially fatal mistakes.

Despite a precipitous rise in cyberattacks against the health sector in recent years, a weeks-long disruption of this magnitude is beyond what most health systems are prepared for, said John S. Clark, an associate chief pharmacy officer at the University of Michigan health system.

“I don’t believe that anyone is fully prepared,” he said. Most emergency management plans “are designed around long-term downtimes that are into one, two, or three days.”

Ascension in a public statement May 9 said its care teams were “trained for these kinds of disruptions,” but did not respond to questions in early June about whether it had prepared for longer periods of downtime. Ascension said June 14 it had restored access to electronic health records across its network, but that patient “medical records and other information collected between May 8” and when the service was restored “may be temporarily inaccessible as we work to update the portal with information collected during the system downtime.”

Ruckle said he “had no training” for the cyberattack.
 

Back to Paper

Lisa Watson, an intensive care unit nurse at Ascension Via Christi St. Francis hospital in Wichita, described her own close call. She said she nearly administered the wrong medication to a critically ill patient because she couldn’t scan it as she normally would. “My patient probably would have passed away had I not caught it,” she said.

Watson is no stranger to using paper for patients’ medical charts, saying she did so “for probably half of my career,” before electronic health records became ubiquitous in hospitals. What happened after the cyberattack was “by no means the same.”

“When we paper-charted, we had systems in place to get those orders to other departments in a timely manner,” she said, “and those have all gone away.”

Melissa LaRue, an ICU nurse at Ascension Saint Agnes Hospital in Baltimore, described a close call with “administering the wrong dosage” of a patient’s blood pressure medication. “Luckily,” she said, it was “triple-checked and remedied before that could happen. But I think the potential for harm is there when you have so much information and paperwork that you have to go through.”

Clinicians say their hospitals have relied on slapdash workarounds, using handwritten notes, faxes, sticky notes, and basic computer spreadsheets — many devised on the fly by doctors and nurses — to care for patients.

More than a dozen other nurses and doctors, some of them without union protections, at Ascension hospitals in Michigan recounted situations in which they say patient care was compromised. Those clinicians spoke on the condition that they not be named for fear of retaliation by their employer.

An Ascension hospital emergency room doctor in Detroit said a man on the city’s east side was given a dangerous narcotic intended for another patient because of a paperwork mix-up. As a result, the patient’s breathing slowed to the point that he had to be put on a ventilator. “We intubated him and we sent him to the ICU because he got the wrong medication.”

A nurse in a Michigan Ascension hospital ER said a woman with low blood sugar and “altered mental status” went into cardiac arrest and died after staff said they waited four hours for lab results they needed to determine how to treat her, but never received. “If I started having crushing chest pain in the middle of work and thought I was having a big one, I would grab someone to drive me down the street to another hospital,” the same ER nurse said.

Similar concerns reportedly led a travel nurse at an Ascension hospital in Indiana to quit. “I just want to warn those patients that are coming to any of the Ascension facilities that there will be delays in care. There is potential for error and for harm,” Justin Neisser told CBS4 in Indianapolis in May.

Several nurses and doctors at Ascension hospitals said they feared the errors they’ve witnessed since the cyberattack began could threaten their professional licenses. “This is how a RaDonda Vaught happens,” one nurse said, referring to the Tennessee nurse who was convicted of criminally negligent homicide in 2022 for a fatal drug error.

Reporters were not able to review records to verify clinicians’ claims because of privacy laws surrounding patients’ medical information that apply to health care professionals.

Ascension declined to answer questions about claims that care has been affected by the ransomware attack. “As we have made clear throughout this cyber attack which has impacted our system and our dedicated clinical providers, caring for our patients is our highest priority,” Sean Fitzpatrick, Ascension’s vice president of external communications, said via email on June 3. “We are confident that our care providers in our hospitals and facilities continue to provide quality medical care.”

The federal government requires hospitals to protect patients’ sensitive health data, according to cybersecurity experts. However, there are no federal requirements for hospitals to prevent or prepare for cyberattacks that could compromise their electronic systems.
 

Hospitals: ‘The No.1 Target of Ransomware’

“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” said Jeff Tully, a co-director of the Center for Healthcare Cybersecurity at the University of California-San Diego. “These types of cybersecurity incidents should be thought of as a matter of when, and not if.”

Josh Corman, a cybersecurity expert and advocate, said ransom crews regard hospitals as the perfect prey: “They have terrible security and they’ll pay. So almost immediately, hospitals went to the No. 1 target of ransomware.”

In 2023, the health sector experienced the largest share of ransomware attacks of 16 infrastructure sectors considered vital to national security or safety, according to an FBI report on internet crimes. In March, the federal Department of Health and Human Services said reported large breaches involving ransomware had jumped by 264% over the past five years.

A cyberattack this year on Change Healthcare, a unit of UnitedHealth Group’s Optum division that processes billions of health care transactions every year, crippled the business of providers, pharmacies, and hospitals.

In May, UnitedHealth Group CEO Andrew Witty told lawmakers the company paid a $22 million ransom as a result of the Change Healthcare attack — which occurred after hackers accessed a company portal that didn’t have multifactor authentication, a basic cybersecurity tool.

The Biden administration in recent months has pushed to bolster health care cybersecurity standards, but it’s not clear which new measures will be required.

In January, HHS nudged companies to improve email security, add multifactor authentication, and institute cybersecurity training and testing, among other voluntary measures. The Centers for Medicare & Medicaid Services is expected to release new requirements for hospitals, but the scope and timing are unclear. The same is true of an update HHS is expected to make to patient privacy regulations.

HHS said the voluntary measures “will inform the creation of new enforceable cybersecurity standards,” department spokesperson Jeff Nesbit said in a statement.

“The recent cyberattack at Ascension only underscores the need for everyone in the health care ecosystem to do their part to secure their systems and protect patients,” Nesbit said.

Meanwhile, lobbyists for the hospital industry contend cybersecurity mandates or penalties are misplaced and would curtail hospitals’ resources to fend off attacks.

“Hospitals and health systems are not the primary source of cyber risk exposure facing the health care sector,” the American Hospital Association, the largest lobbying group for U.S. hospitals, said in an April statement prepared for U.S. House lawmakers. Most large data breaches that hit hospitals in 2023 originated with third-party “business associates” or other health entities, including CMS itself, the AHA statement said.

Hospitals consolidating into large multistate health systems face increased risk of data breaches and ransomware attacks, according to one study. Ascension in 2022 was the third-largest hospital chain in the U.S. by number of beds, according to the most recent data from the federal Agency for Healthcare Research and Quality.

And while cybersecurity regulations can quickly become outdated, they can at least make it clear that if health systems fail to implement basic protections there “should be consequences for that,” Jim Bagian, a former director of the National Center for Patient Safety at the Veterans Health Administration, told Michigan Public’s Stateside.

Patients can pay the price when lapses occur. Those in hospital care face a greater likelihood of death during a cyberattack, according to researchers at the University of Minnesota School of Public Health.

Workers concerned about patient safety at Ascension hospitals in Michigan have called for the company to make changes.

“We implore Ascension to recognize the internal problems that continue to plague its hospitals, both publicly and transparently,” said Dina Carlisle, a nurse and the president of the OPEIU Local 40 union, which represents nurses at Ascension Providence Rochester. At least 125 staff members at that Ascension hospital have signed a petition asking administrators to temporarily reduce elective surgeries and nonemergency patient admissions, like under the protocols many hospitals adopted early in the covid-19 pandemic.

Watson, the Kansas ICU nurse, said in late May that nurses had urged management to bring in more nurses to help manage the workflow. “Everything that we say has fallen on deaf ears,” she said.

“It is very hard to be a nurse at Ascension right now,” Watson said in late May. “It is very hard to be a patient at Ascension right now.”

If you’re a patient or worker at an Ascension hospital and would like to tell KFF Health News about your experiences, click here to share your story with us.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

In the wake of a debilitating cyberattack against one of the nation’s largest health care systems, Marvin Ruckle, a nurse at an Ascension hospital in Wichita, Kansas, said he had a frightening experience: He nearly gave a baby “the wrong dose of narcotic” because of confusing paperwork.

Ruckle, who has worked in the neonatal intensive care unit at Ascension Via Christi St. Joseph for two decades, said it was “hard to decipher which was the correct dose” on the medication record. He’d “never seen that happen,” he said, “when we were on the computer system” before the cyberattack.

A May 8 ransomware attack against Ascension, a Catholic health system with 140 hospitals in at least 10 states, locked providers out of systems that track and coordinate nearly every aspect of patient care. They include its systems for electronic health records, some phones, and ones “utilized to order certain tests, procedures and medications,” the company said in a May 9 statement.

More than a dozen doctors and nurses who work for the sprawling health system told Michigan Public and KFF Health News that patient care at its hospitals across the nation was compromised in the fallout of the cyberattack over the past several weeks. Clinicians working for hospitals in three states described harrowing lapses, including delayed or lost lab results, medication errors, and an absence of routine safety checks via technology to prevent potentially fatal mistakes.

Despite a precipitous rise in cyberattacks against the health sector in recent years, a weeks-long disruption of this magnitude is beyond what most health systems are prepared for, said John S. Clark, an associate chief pharmacy officer at the University of Michigan health system.

“I don’t believe that anyone is fully prepared,” he said. Most emergency management plans “are designed around long-term downtimes that are into one, two, or three days.”

Ascension in a public statement May 9 said its care teams were “trained for these kinds of disruptions,” but did not respond to questions in early June about whether it had prepared for longer periods of downtime. Ascension said June 14 it had restored access to electronic health records across its network, but that patient “medical records and other information collected between May 8” and when the service was restored “may be temporarily inaccessible as we work to update the portal with information collected during the system downtime.”

Ruckle said he “had no training” for the cyberattack.
 

Back to Paper

Lisa Watson, an intensive care unit nurse at Ascension Via Christi St. Francis hospital in Wichita, described her own close call. She said she nearly administered the wrong medication to a critically ill patient because she couldn’t scan it as she normally would. “My patient probably would have passed away had I not caught it,” she said.

Watson is no stranger to using paper for patients’ medical charts, saying she did so “for probably half of my career,” before electronic health records became ubiquitous in hospitals. What happened after the cyberattack was “by no means the same.”

“When we paper-charted, we had systems in place to get those orders to other departments in a timely manner,” she said, “and those have all gone away.”

Melissa LaRue, an ICU nurse at Ascension Saint Agnes Hospital in Baltimore, described a close call with “administering the wrong dosage” of a patient’s blood pressure medication. “Luckily,” she said, it was “triple-checked and remedied before that could happen. But I think the potential for harm is there when you have so much information and paperwork that you have to go through.”

Clinicians say their hospitals have relied on slapdash workarounds, using handwritten notes, faxes, sticky notes, and basic computer spreadsheets — many devised on the fly by doctors and nurses — to care for patients.

More than a dozen other nurses and doctors, some of them without union protections, at Ascension hospitals in Michigan recounted situations in which they say patient care was compromised. Those clinicians spoke on the condition that they not be named for fear of retaliation by their employer.

An Ascension hospital emergency room doctor in Detroit said a man on the city’s east side was given a dangerous narcotic intended for another patient because of a paperwork mix-up. As a result, the patient’s breathing slowed to the point that he had to be put on a ventilator. “We intubated him and we sent him to the ICU because he got the wrong medication.”

A nurse in a Michigan Ascension hospital ER said a woman with low blood sugar and “altered mental status” went into cardiac arrest and died after staff said they waited four hours for lab results they needed to determine how to treat her, but never received. “If I started having crushing chest pain in the middle of work and thought I was having a big one, I would grab someone to drive me down the street to another hospital,” the same ER nurse said.

Similar concerns reportedly led a travel nurse at an Ascension hospital in Indiana to quit. “I just want to warn those patients that are coming to any of the Ascension facilities that there will be delays in care. There is potential for error and for harm,” Justin Neisser told CBS4 in Indianapolis in May.

Several nurses and doctors at Ascension hospitals said they feared the errors they’ve witnessed since the cyberattack began could threaten their professional licenses. “This is how a RaDonda Vaught happens,” one nurse said, referring to the Tennessee nurse who was convicted of criminally negligent homicide in 2022 for a fatal drug error.

Reporters were not able to review records to verify clinicians’ claims because of privacy laws surrounding patients’ medical information that apply to health care professionals.

Ascension declined to answer questions about claims that care has been affected by the ransomware attack. “As we have made clear throughout this cyber attack which has impacted our system and our dedicated clinical providers, caring for our patients is our highest priority,” Sean Fitzpatrick, Ascension’s vice president of external communications, said via email on June 3. “We are confident that our care providers in our hospitals and facilities continue to provide quality medical care.”

The federal government requires hospitals to protect patients’ sensitive health data, according to cybersecurity experts. However, there are no federal requirements for hospitals to prevent or prepare for cyberattacks that could compromise their electronic systems.
 

Hospitals: ‘The No.1 Target of Ransomware’

“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” said Jeff Tully, a co-director of the Center for Healthcare Cybersecurity at the University of California-San Diego. “These types of cybersecurity incidents should be thought of as a matter of when, and not if.”

Josh Corman, a cybersecurity expert and advocate, said ransom crews regard hospitals as the perfect prey: “They have terrible security and they’ll pay. So almost immediately, hospitals went to the No. 1 target of ransomware.”

In 2023, the health sector experienced the largest share of ransomware attacks of 16 infrastructure sectors considered vital to national security or safety, according to an FBI report on internet crimes. In March, the federal Department of Health and Human Services said reported large breaches involving ransomware had jumped by 264% over the past five years.

A cyberattack this year on Change Healthcare, a unit of UnitedHealth Group’s Optum division that processes billions of health care transactions every year, crippled the business of providers, pharmacies, and hospitals.

In May, UnitedHealth Group CEO Andrew Witty told lawmakers the company paid a $22 million ransom as a result of the Change Healthcare attack — which occurred after hackers accessed a company portal that didn’t have multifactor authentication, a basic cybersecurity tool.

The Biden administration in recent months has pushed to bolster health care cybersecurity standards, but it’s not clear which new measures will be required.

In January, HHS nudged companies to improve email security, add multifactor authentication, and institute cybersecurity training and testing, among other voluntary measures. The Centers for Medicare & Medicaid Services is expected to release new requirements for hospitals, but the scope and timing are unclear. The same is true of an update HHS is expected to make to patient privacy regulations.

HHS said the voluntary measures “will inform the creation of new enforceable cybersecurity standards,” department spokesperson Jeff Nesbit said in a statement.

“The recent cyberattack at Ascension only underscores the need for everyone in the health care ecosystem to do their part to secure their systems and protect patients,” Nesbit said.

Meanwhile, lobbyists for the hospital industry contend cybersecurity mandates or penalties are misplaced and would curtail hospitals’ resources to fend off attacks.

“Hospitals and health systems are not the primary source of cyber risk exposure facing the health care sector,” the American Hospital Association, the largest lobbying group for U.S. hospitals, said in an April statement prepared for U.S. House lawmakers. Most large data breaches that hit hospitals in 2023 originated with third-party “business associates” or other health entities, including CMS itself, the AHA statement said.

Hospitals consolidating into large multistate health systems face increased risk of data breaches and ransomware attacks, according to one study. Ascension in 2022 was the third-largest hospital chain in the U.S. by number of beds, according to the most recent data from the federal Agency for Healthcare Research and Quality.

And while cybersecurity regulations can quickly become outdated, they can at least make it clear that if health systems fail to implement basic protections there “should be consequences for that,” Jim Bagian, a former director of the National Center for Patient Safety at the Veterans Health Administration, told Michigan Public’s Stateside.

Patients can pay the price when lapses occur. Those in hospital care face a greater likelihood of death during a cyberattack, according to researchers at the University of Minnesota School of Public Health.

Workers concerned about patient safety at Ascension hospitals in Michigan have called for the company to make changes.

“We implore Ascension to recognize the internal problems that continue to plague its hospitals, both publicly and transparently,” said Dina Carlisle, a nurse and the president of the OPEIU Local 40 union, which represents nurses at Ascension Providence Rochester. At least 125 staff members at that Ascension hospital have signed a petition asking administrators to temporarily reduce elective surgeries and nonemergency patient admissions, like under the protocols many hospitals adopted early in the covid-19 pandemic.

Watson, the Kansas ICU nurse, said in late May that nurses had urged management to bring in more nurses to help manage the workflow. “Everything that we say has fallen on deaf ears,” she said.

“It is very hard to be a nurse at Ascension right now,” Watson said in late May. “It is very hard to be a patient at Ascension right now.”

If you’re a patient or worker at an Ascension hospital and would like to tell KFF Health News about your experiences, click here to share your story with us.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

In the wake of a debilitating cyberattack against one of the nation’s largest health care systems, Marvin Ruckle, a nurse at an Ascension hospital in Wichita, Kansas, said he had a frightening experience: He nearly gave a baby “the wrong dose of narcotic” because of confusing paperwork.

Ruckle, who has worked in the neonatal intensive care unit at Ascension Via Christi St. Joseph for two decades, said it was “hard to decipher which was the correct dose” on the medication record. He’d “never seen that happen,” he said, “when we were on the computer system” before the cyberattack.

A May 8 ransomware attack against Ascension, a Catholic health system with 140 hospitals in at least 10 states, locked providers out of systems that track and coordinate nearly every aspect of patient care. They include its systems for electronic health records, some phones, and ones “utilized to order certain tests, procedures and medications,” the company said in a May 9 statement.

More than a dozen doctors and nurses who work for the sprawling health system told Michigan Public and KFF Health News that patient care at its hospitals across the nation was compromised in the fallout of the cyberattack over the past several weeks. Clinicians working for hospitals in three states described harrowing lapses, including delayed or lost lab results, medication errors, and an absence of routine safety checks via technology to prevent potentially fatal mistakes.

Despite a precipitous rise in cyberattacks against the health sector in recent years, a weeks-long disruption of this magnitude is beyond what most health systems are prepared for, said John S. Clark, an associate chief pharmacy officer at the University of Michigan health system.

“I don’t believe that anyone is fully prepared,” he said. Most emergency management plans “are designed around long-term downtimes that are into one, two, or three days.”

Ascension in a public statement May 9 said its care teams were “trained for these kinds of disruptions,” but did not respond to questions in early June about whether it had prepared for longer periods of downtime. Ascension said June 14 it had restored access to electronic health records across its network, but that patient “medical records and other information collected between May 8” and when the service was restored “may be temporarily inaccessible as we work to update the portal with information collected during the system downtime.”

Ruckle said he “had no training” for the cyberattack.
 

Back to Paper

Lisa Watson, an intensive care unit nurse at Ascension Via Christi St. Francis hospital in Wichita, described her own close call. She said she nearly administered the wrong medication to a critically ill patient because she couldn’t scan it as she normally would. “My patient probably would have passed away had I not caught it,” she said.

Watson is no stranger to using paper for patients’ medical charts, saying she did so “for probably half of my career,” before electronic health records became ubiquitous in hospitals. What happened after the cyberattack was “by no means the same.”

“When we paper-charted, we had systems in place to get those orders to other departments in a timely manner,” she said, “and those have all gone away.”

Melissa LaRue, an ICU nurse at Ascension Saint Agnes Hospital in Baltimore, described a close call with “administering the wrong dosage” of a patient’s blood pressure medication. “Luckily,” she said, it was “triple-checked and remedied before that could happen. But I think the potential for harm is there when you have so much information and paperwork that you have to go through.”

Clinicians say their hospitals have relied on slapdash workarounds, using handwritten notes, faxes, sticky notes, and basic computer spreadsheets — many devised on the fly by doctors and nurses — to care for patients.

More than a dozen other nurses and doctors, some of them without union protections, at Ascension hospitals in Michigan recounted situations in which they say patient care was compromised. Those clinicians spoke on the condition that they not be named for fear of retaliation by their employer.

An Ascension hospital emergency room doctor in Detroit said a man on the city’s east side was given a dangerous narcotic intended for another patient because of a paperwork mix-up. As a result, the patient’s breathing slowed to the point that he had to be put on a ventilator. “We intubated him and we sent him to the ICU because he got the wrong medication.”

A nurse in a Michigan Ascension hospital ER said a woman with low blood sugar and “altered mental status” went into cardiac arrest and died after staff said they waited four hours for lab results they needed to determine how to treat her, but never received. “If I started having crushing chest pain in the middle of work and thought I was having a big one, I would grab someone to drive me down the street to another hospital,” the same ER nurse said.

Similar concerns reportedly led a travel nurse at an Ascension hospital in Indiana to quit. “I just want to warn those patients that are coming to any of the Ascension facilities that there will be delays in care. There is potential for error and for harm,” Justin Neisser told CBS4 in Indianapolis in May.

Several nurses and doctors at Ascension hospitals said they feared the errors they’ve witnessed since the cyberattack began could threaten their professional licenses. “This is how a RaDonda Vaught happens,” one nurse said, referring to the Tennessee nurse who was convicted of criminally negligent homicide in 2022 for a fatal drug error.

Reporters were not able to review records to verify clinicians’ claims because of privacy laws surrounding patients’ medical information that apply to health care professionals.

Ascension declined to answer questions about claims that care has been affected by the ransomware attack. “As we have made clear throughout this cyber attack which has impacted our system and our dedicated clinical providers, caring for our patients is our highest priority,” Sean Fitzpatrick, Ascension’s vice president of external communications, said via email on June 3. “We are confident that our care providers in our hospitals and facilities continue to provide quality medical care.”

The federal government requires hospitals to protect patients’ sensitive health data, according to cybersecurity experts. However, there are no federal requirements for hospitals to prevent or prepare for cyberattacks that could compromise their electronic systems.
 

Hospitals: ‘The No.1 Target of Ransomware’

“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” said Jeff Tully, a co-director of the Center for Healthcare Cybersecurity at the University of California-San Diego. “These types of cybersecurity incidents should be thought of as a matter of when, and not if.”

Josh Corman, a cybersecurity expert and advocate, said ransom crews regard hospitals as the perfect prey: “They have terrible security and they’ll pay. So almost immediately, hospitals went to the No. 1 target of ransomware.”

In 2023, the health sector experienced the largest share of ransomware attacks of 16 infrastructure sectors considered vital to national security or safety, according to an FBI report on internet crimes. In March, the federal Department of Health and Human Services said reported large breaches involving ransomware had jumped by 264% over the past five years.

A cyberattack this year on Change Healthcare, a unit of UnitedHealth Group’s Optum division that processes billions of health care transactions every year, crippled the business of providers, pharmacies, and hospitals.

In May, UnitedHealth Group CEO Andrew Witty told lawmakers the company paid a $22 million ransom as a result of the Change Healthcare attack — which occurred after hackers accessed a company portal that didn’t have multifactor authentication, a basic cybersecurity tool.

The Biden administration in recent months has pushed to bolster health care cybersecurity standards, but it’s not clear which new measures will be required.

In January, HHS nudged companies to improve email security, add multifactor authentication, and institute cybersecurity training and testing, among other voluntary measures. The Centers for Medicare & Medicaid Services is expected to release new requirements for hospitals, but the scope and timing are unclear. The same is true of an update HHS is expected to make to patient privacy regulations.

HHS said the voluntary measures “will inform the creation of new enforceable cybersecurity standards,” department spokesperson Jeff Nesbit said in a statement.

“The recent cyberattack at Ascension only underscores the need for everyone in the health care ecosystem to do their part to secure their systems and protect patients,” Nesbit said.

Meanwhile, lobbyists for the hospital industry contend cybersecurity mandates or penalties are misplaced and would curtail hospitals’ resources to fend off attacks.

“Hospitals and health systems are not the primary source of cyber risk exposure facing the health care sector,” the American Hospital Association, the largest lobbying group for U.S. hospitals, said in an April statement prepared for U.S. House lawmakers. Most large data breaches that hit hospitals in 2023 originated with third-party “business associates” or other health entities, including CMS itself, the AHA statement said.

Hospitals consolidating into large multistate health systems face increased risk of data breaches and ransomware attacks, according to one study. Ascension in 2022 was the third-largest hospital chain in the U.S. by number of beds, according to the most recent data from the federal Agency for Healthcare Research and Quality.

And while cybersecurity regulations can quickly become outdated, they can at least make it clear that if health systems fail to implement basic protections there “should be consequences for that,” Jim Bagian, a former director of the National Center for Patient Safety at the Veterans Health Administration, told Michigan Public’s Stateside.

Patients can pay the price when lapses occur. Those in hospital care face a greater likelihood of death during a cyberattack, according to researchers at the University of Minnesota School of Public Health.

Workers concerned about patient safety at Ascension hospitals in Michigan have called for the company to make changes.

“We implore Ascension to recognize the internal problems that continue to plague its hospitals, both publicly and transparently,” said Dina Carlisle, a nurse and the president of the OPEIU Local 40 union, which represents nurses at Ascension Providence Rochester. At least 125 staff members at that Ascension hospital have signed a petition asking administrators to temporarily reduce elective surgeries and nonemergency patient admissions, like under the protocols many hospitals adopted early in the covid-19 pandemic.

Watson, the Kansas ICU nurse, said in late May that nurses had urged management to bring in more nurses to help manage the workflow. “Everything that we say has fallen on deaf ears,” she said.

“It is very hard to be a nurse at Ascension right now,” Watson said in late May. “It is very hard to be a patient at Ascension right now.”

If you’re a patient or worker at an Ascension hospital and would like to tell KFF Health News about your experiences, click here to share your story with us.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

TOPLINE:

Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.

METHODOLOGY:

• Researchers compared the effects on gastrointestinal symptoms, the gut microbiome, and circulating cytokines and metabolites of two low-calorie, 8-week dietary interventions: A Mediterranean-style continuous CR diet based on US dietary recommendations and an IF-P diet. The interventions were matched for energy intake.
• Participants included men and women with overweight/obesity who were randomly assigned to one of the two groups: CR diet (n = 20) and IF-P diet (n = 21).
• Researchers used samples and data from an ongoing randomized controlled trial (https://clinicaltrials.gov/study/NCT04327141) comparing the effects of the CR diet vs the IF-P diet on anthropometric and cardiometabolic outcomes.
• In a subanalysis for the current study, researchers compared outcomes in “high” and “low” responders to the IF-P regimen, based on relative weight loss.

TAKEAWAY:

• The IF-P diet resulted in more substantial reductions in patient-reported symptoms of gastrointestinal problems and more pronounced increases in gut microbiota diversity and in the abundance of microbial families and genera associated with favorable metabolic profiles, such as Christensenellaceae, Rikenellaceae, and Marvinbryantia, than the CR diet.
• The IF-P diet significantly increased cytokines linked to lipolysis, weight loss, inflammation, and the immune response.
• With the CR diet, metabolites associated with a longevity-related metabolic pathway increased.
• The subgroup analysis of high and low responders to the IF-P diet showed an increased abundance of certain bacteria associated with metabolic benefits and anti-inflammatory effects among high responders, whereas low responders showed an increased abundance of butyrate-producing and nutritionally adaptive species such as Eubacterium ventriosum and Roseburia inulinivorans.
• A fecal metabolome analysis revealed that high responders showed enrichment of fecal metabolites involved in lipid metabolism, whereas more prominent pathways in low responders were related to the metabolism of amino acids and peptides, as well as tyrosine metabolism and arginine biosynthesis.

IN PRACTICE:

“These findings shed light on the differential effects of IF regimens, including IF-P, as a promising dietary intervention for obesity management and microbiotic and metabolic health.”

SOURCE:

The study, with corresponding author Paul J. Arciero, PhD, of the Human Nutrition and Metabolism Laboratory at Skidmore College, Saratoga Springs, New York, was published online in Nature Communications.

LIMITATIONS:

The reliance on fecal samples to represent the gut microbiome may have overlooked potential microbial populations in the upper gastrointestinal tract. Other limitations include the short, 8-week duration of the trial and small number of patients.

DISCLOSURES:

The study was primarily funded by an unrestricted grant from Isagenix International LLC to Arciero, with secondary funding provided to a coauthor. Dr. Arciero is a consultant for Isagenix International LLC, is an advisory board member of the International Protein Board, and received financial compensation for books and keynote presentations on protein pacing. One coauthor is employed by the funder.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.

METHODOLOGY:

• Researchers compared the effects on gastrointestinal symptoms, the gut microbiome, and circulating cytokines and metabolites of two low-calorie, 8-week dietary interventions: A Mediterranean-style continuous CR diet based on US dietary recommendations and an IF-P diet. The interventions were matched for energy intake.
• Participants included men and women with overweight/obesity who were randomly assigned to one of the two groups: CR diet (n = 20) and IF-P diet (n = 21).
• Researchers used samples and data from an ongoing randomized controlled trial (https://clinicaltrials.gov/study/NCT04327141) comparing the effects of the CR diet vs the IF-P diet on anthropometric and cardiometabolic outcomes.
• In a subanalysis for the current study, researchers compared outcomes in “high” and “low” responders to the IF-P regimen, based on relative weight loss.

TAKEAWAY:

• The IF-P diet resulted in more substantial reductions in patient-reported symptoms of gastrointestinal problems and more pronounced increases in gut microbiota diversity and in the abundance of microbial families and genera associated with favorable metabolic profiles, such as Christensenellaceae, Rikenellaceae, and Marvinbryantia, than the CR diet.
• The IF-P diet significantly increased cytokines linked to lipolysis, weight loss, inflammation, and the immune response.
• With the CR diet, metabolites associated with a longevity-related metabolic pathway increased.
• The subgroup analysis of high and low responders to the IF-P diet showed an increased abundance of certain bacteria associated with metabolic benefits and anti-inflammatory effects among high responders, whereas low responders showed an increased abundance of butyrate-producing and nutritionally adaptive species such as Eubacterium ventriosum and Roseburia inulinivorans.
• A fecal metabolome analysis revealed that high responders showed enrichment of fecal metabolites involved in lipid metabolism, whereas more prominent pathways in low responders were related to the metabolism of amino acids and peptides, as well as tyrosine metabolism and arginine biosynthesis.

IN PRACTICE:

“These findings shed light on the differential effects of IF regimens, including IF-P, as a promising dietary intervention for obesity management and microbiotic and metabolic health.”

SOURCE:

The study, with corresponding author Paul J. Arciero, PhD, of the Human Nutrition and Metabolism Laboratory at Skidmore College, Saratoga Springs, New York, was published online in Nature Communications.

LIMITATIONS:

The reliance on fecal samples to represent the gut microbiome may have overlooked potential microbial populations in the upper gastrointestinal tract. Other limitations include the short, 8-week duration of the trial and small number of patients.

DISCLOSURES:

The study was primarily funded by an unrestricted grant from Isagenix International LLC to Arciero, with secondary funding provided to a coauthor. Dr. Arciero is a consultant for Isagenix International LLC, is an advisory board member of the International Protein Board, and received financial compensation for books and keynote presentations on protein pacing. One coauthor is employed by the funder.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.

METHODOLOGY:

• Researchers compared the effects on gastrointestinal symptoms, the gut microbiome, and circulating cytokines and metabolites of two low-calorie, 8-week dietary interventions: A Mediterranean-style continuous CR diet based on US dietary recommendations and an IF-P diet. The interventions were matched for energy intake.
• Participants included men and women with overweight/obesity who were randomly assigned to one of the two groups: CR diet (n = 20) and IF-P diet (n = 21).
• Researchers used samples and data from an ongoing randomized controlled trial (https://clinicaltrials.gov/study/NCT04327141) comparing the effects of the CR diet vs the IF-P diet on anthropometric and cardiometabolic outcomes.
• In a subanalysis for the current study, researchers compared outcomes in “high” and “low” responders to the IF-P regimen, based on relative weight loss.

TAKEAWAY:

• The IF-P diet resulted in more substantial reductions in patient-reported symptoms of gastrointestinal problems and more pronounced increases in gut microbiota diversity and in the abundance of microbial families and genera associated with favorable metabolic profiles, such as Christensenellaceae, Rikenellaceae, and Marvinbryantia, than the CR diet.
• The IF-P diet significantly increased cytokines linked to lipolysis, weight loss, inflammation, and the immune response.
• With the CR diet, metabolites associated with a longevity-related metabolic pathway increased.
• The subgroup analysis of high and low responders to the IF-P diet showed an increased abundance of certain bacteria associated with metabolic benefits and anti-inflammatory effects among high responders, whereas low responders showed an increased abundance of butyrate-producing and nutritionally adaptive species such as Eubacterium ventriosum and Roseburia inulinivorans.
• A fecal metabolome analysis revealed that high responders showed enrichment of fecal metabolites involved in lipid metabolism, whereas more prominent pathways in low responders were related to the metabolism of amino acids and peptides, as well as tyrosine metabolism and arginine biosynthesis.

IN PRACTICE:

“These findings shed light on the differential effects of IF regimens, including IF-P, as a promising dietary intervention for obesity management and microbiotic and metabolic health.”

SOURCE:

The study, with corresponding author Paul J. Arciero, PhD, of the Human Nutrition and Metabolism Laboratory at Skidmore College, Saratoga Springs, New York, was published online in Nature Communications.

LIMITATIONS:

The reliance on fecal samples to represent the gut microbiome may have overlooked potential microbial populations in the upper gastrointestinal tract. Other limitations include the short, 8-week duration of the trial and small number of patients.

DISCLOSURES:

The study was primarily funded by an unrestricted grant from Isagenix International LLC to Arciero, with secondary funding provided to a coauthor. Dr. Arciero is a consultant for Isagenix International LLC, is an advisory board member of the International Protein Board, and received financial compensation for books and keynote presentations on protein pacing. One coauthor is employed by the funder.
 

A version of this article appeared on Medscape.com.

SAN DIEGO — A new analysis of patients with new daily persistent headache (NDPH) lends insight into the condition and provides some hints as to some of the more effective treatments, including some calcitonin gene-related peptide (CGRP) inhibitors.

“There’s just not a lot [of information] about these patients,” Mark Burish, MD, PhD, associate professor of neurology at UT Houston, said in an interview. He presented the results of the survey at the annual meeting of the American Headache Society.

There have been some retrospective analyses of patient data, but that has a lot of potential for bias. “It’s only the patients who can afford to be there, and who needed those treatments, and so we want to do more of a general survey,” said Dr. Burish.

The results weren’t particularly surprising, and tended to reaffirm what was known anecdotally, including symptoms similar to those of migraine, but it gave some insight into treatments. “Some of the CGRP inhibitors and the onabotulinum toxin seem to be some of the more effective treatments, according to our survey, so those are probably worth looking into for these patients if you can get them approved by insurance, and if you can get patients to accept the idea they might have to give themselves an injection of some sort,” said Dr. Burish.

Despite having some promise, there was variation among CGRP inhibitors. Eptinezumab, rimegepant, and atogepant were commonly reported as effective, but others, such as erenumab and galcanezumab, were less often reported. “None of them were incredibly effective. These were just the best things we have at this time,” said Dr. Burish.
 

Additional Information on a Rare, Hard-to-Treat Condition

Jason Sico, MD, who moderated the session, was asked for comment. “I’m so appreciative that the team has looked at a new daily persistent headache. It’s a rare type of headache disorder. It’s also one that is notoriously difficult to treat and something that we that we really need to know more about. It is difficult to really get good, robust in-depth information on these patients, and the team did a really nice job with that,” said Dr. Sico, associate professor of neurology and internal medicine at Yale School of Medicine and national director of the Headache Centers of Excellence Program within the Veterans Health Administration.

He noted that the researchers found that opioids were the most commonly used acute treatment. That’s not surprising, but “it would be interesting to see what was tried before someone had gotten to opioids,” he said.

The findings also gave some unexpected insight into the condition. “I really found it striking that an overwhelming majority of patients reported brain fog. Given the context that it is daily persistent headache, one could surmise that they have brain fog a lot of the time,” said Dr. Sico.
 

‘A Good Data Set’

The researchers analyzed data from 337 international patients who responded to a survey. They also randomly selected 34 patients for an interview, and 32 of those were deemed likely to have NDPH. “So we really spent some effort making sure this was a good data set,” said Dr. Burish. The participant population was 72% female, 83.7% White, and 70.7% were based in the United States, though other countries included Canada, the United Kingdom, Australia, Ireland, Germany, Sweden, and Switzerland. The mean age was 41.2 years. The peak ages of onset were between 11 and 40 years, though there were a few cases in the 0-5 age range and over 70. Possible triggers that occurred in the 3 months before onset included psychological stressors (34%), infection or inflammation (32%, COVID infection (5%), injury or surgery (8%), or a change in medications (4%). No clear trigger was identified by 22% of respondents.

The survey included information on associated features, and frequently reported issues included brain fog (approximate 75%), sound sensitivity (about 62%), light sensitivity (57%), nausea (39%), smell sensitivity (32%), visual disturbances (28%), vomiting (13%), and chills (9%).
 

Insights Into Treatment Efficacy

Dr. Burish showed a slide of responses to questions about acute treatments that respondents had tried at least once and viewed as ‘completely effective,’ ‘mostly effective,’ or ‘somewhat effective.’

“No medicine was completely effective, which I think a lot of people know from NDPH. It is notoriously difficult to treat. The things on the top of the list are mostly opioids. There’s one (non-opioid), the DHE (dihydroergotamine) injection. All the way on the other side, you have diphenhydramine. The NSAIDs and triptans are mostly in the middle. We did ask about some of the wearable devices, and we had extra questions about, are you using it appropriately? Those are kind of in the middle or towards the bottom [in frequency],” said Dr. Burish.

There was a similar question regarding effective preventive medications that had been tried for at least 2 months or 3 months in the cause of onabotulinum toxin or CGRP medications. “This one had a little bit more of a pattern to it: A lot of the CGRP medications are up toward the top. It’s not perfect. Erenumab and galcanezumab are closer to the bottom, but it was interesting that a lot of the CGRP medicines were toward the top. Onabotulinum toxin was also somewhat toward the top. We looked at a few different anti-inflammatories. Methylprednisolone is kind of toward the upper half at least, whereas prednisone and montelukast are at the absolute bottom. And the prednisone is a pretty good dose, 50 milligrams or higher. There are some people thinking that this is an inflammation or infectious etiology, (but) it wasn’t that all of the anti-inflammatories were necessarily toward the top of the list,” said Dr. Burish.

Dr. Burish has received funding from Lundbeck. Dr. Sico has no relevant financial disclosures.

SAN DIEGO — A new analysis of patients with new daily persistent headache (NDPH) lends insight into the condition and provides some hints as to some of the more effective treatments, including some calcitonin gene-related peptide (CGRP) inhibitors.

“There’s just not a lot [of information] about these patients,” Mark Burish, MD, PhD, associate professor of neurology at UT Houston, said in an interview. He presented the results of the survey at the annual meeting of the American Headache Society.

There have been some retrospective analyses of patient data, but that has a lot of potential for bias. “It’s only the patients who can afford to be there, and who needed those treatments, and so we want to do more of a general survey,” said Dr. Burish.

The results weren’t particularly surprising, and tended to reaffirm what was known anecdotally, including symptoms similar to those of migraine, but it gave some insight into treatments. “Some of the CGRP inhibitors and the onabotulinum toxin seem to be some of the more effective treatments, according to our survey, so those are probably worth looking into for these patients if you can get them approved by insurance, and if you can get patients to accept the idea they might have to give themselves an injection of some sort,” said Dr. Burish.

Despite having some promise, there was variation among CGRP inhibitors. Eptinezumab, rimegepant, and atogepant were commonly reported as effective, but others, such as erenumab and galcanezumab, were less often reported. “None of them were incredibly effective. These were just the best things we have at this time,” said Dr. Burish.
 

Additional Information on a Rare, Hard-to-Treat Condition

Jason Sico, MD, who moderated the session, was asked for comment. “I’m so appreciative that the team has looked at a new daily persistent headache. It’s a rare type of headache disorder. It’s also one that is notoriously difficult to treat and something that we that we really need to know more about. It is difficult to really get good, robust in-depth information on these patients, and the team did a really nice job with that,” said Dr. Sico, associate professor of neurology and internal medicine at Yale School of Medicine and national director of the Headache Centers of Excellence Program within the Veterans Health Administration.

He noted that the researchers found that opioids were the most commonly used acute treatment. That’s not surprising, but “it would be interesting to see what was tried before someone had gotten to opioids,” he said.

The findings also gave some unexpected insight into the condition. “I really found it striking that an overwhelming majority of patients reported brain fog. Given the context that it is daily persistent headache, one could surmise that they have brain fog a lot of the time,” said Dr. Sico.
 

‘A Good Data Set’

The researchers analyzed data from 337 international patients who responded to a survey. They also randomly selected 34 patients for an interview, and 32 of those were deemed likely to have NDPH. “So we really spent some effort making sure this was a good data set,” said Dr. Burish. The participant population was 72% female, 83.7% White, and 70.7% were based in the United States, though other countries included Canada, the United Kingdom, Australia, Ireland, Germany, Sweden, and Switzerland. The mean age was 41.2 years. The peak ages of onset were between 11 and 40 years, though there were a few cases in the 0-5 age range and over 70. Possible triggers that occurred in the 3 months before onset included psychological stressors (34%), infection or inflammation (32%, COVID infection (5%), injury or surgery (8%), or a change in medications (4%). No clear trigger was identified by 22% of respondents.

The survey included information on associated features, and frequently reported issues included brain fog (approximate 75%), sound sensitivity (about 62%), light sensitivity (57%), nausea (39%), smell sensitivity (32%), visual disturbances (28%), vomiting (13%), and chills (9%).
 

Insights Into Treatment Efficacy

Dr. Burish showed a slide of responses to questions about acute treatments that respondents had tried at least once and viewed as ‘completely effective,’ ‘mostly effective,’ or ‘somewhat effective.’

“No medicine was completely effective, which I think a lot of people know from NDPH. It is notoriously difficult to treat. The things on the top of the list are mostly opioids. There’s one (non-opioid), the DHE (dihydroergotamine) injection. All the way on the other side, you have diphenhydramine. The NSAIDs and triptans are mostly in the middle. We did ask about some of the wearable devices, and we had extra questions about, are you using it appropriately? Those are kind of in the middle or towards the bottom [in frequency],” said Dr. Burish.

There was a similar question regarding effective preventive medications that had been tried for at least 2 months or 3 months in the cause of onabotulinum toxin or CGRP medications. “This one had a little bit more of a pattern to it: A lot of the CGRP medications are up toward the top. It’s not perfect. Erenumab and galcanezumab are closer to the bottom, but it was interesting that a lot of the CGRP medicines were toward the top. Onabotulinum toxin was also somewhat toward the top. We looked at a few different anti-inflammatories. Methylprednisolone is kind of toward the upper half at least, whereas prednisone and montelukast are at the absolute bottom. And the prednisone is a pretty good dose, 50 milligrams or higher. There are some people thinking that this is an inflammation or infectious etiology, (but) it wasn’t that all of the anti-inflammatories were necessarily toward the top of the list,” said Dr. Burish.

Dr. Burish has received funding from Lundbeck. Dr. Sico has no relevant financial disclosures.

SAN DIEGO — A new analysis of patients with new daily persistent headache (NDPH) lends insight into the condition and provides some hints as to some of the more effective treatments, including some calcitonin gene-related peptide (CGRP) inhibitors.

“There’s just not a lot [of information] about these patients,” Mark Burish, MD, PhD, associate professor of neurology at UT Houston, said in an interview. He presented the results of the survey at the annual meeting of the American Headache Society.

There have been some retrospective analyses of patient data, but that has a lot of potential for bias. “It’s only the patients who can afford to be there, and who needed those treatments, and so we want to do more of a general survey,” said Dr. Burish.

The results weren’t particularly surprising, and tended to reaffirm what was known anecdotally, including symptoms similar to those of migraine, but it gave some insight into treatments. “Some of the CGRP inhibitors and the onabotulinum toxin seem to be some of the more effective treatments, according to our survey, so those are probably worth looking into for these patients if you can get them approved by insurance, and if you can get patients to accept the idea they might have to give themselves an injection of some sort,” said Dr. Burish.

Despite having some promise, there was variation among CGRP inhibitors. Eptinezumab, rimegepant, and atogepant were commonly reported as effective, but others, such as erenumab and galcanezumab, were less often reported. “None of them were incredibly effective. These were just the best things we have at this time,” said Dr. Burish.
 

Additional Information on a Rare, Hard-to-Treat Condition

Jason Sico, MD, who moderated the session, was asked for comment. “I’m so appreciative that the team has looked at a new daily persistent headache. It’s a rare type of headache disorder. It’s also one that is notoriously difficult to treat and something that we that we really need to know more about. It is difficult to really get good, robust in-depth information on these patients, and the team did a really nice job with that,” said Dr. Sico, associate professor of neurology and internal medicine at Yale School of Medicine and national director of the Headache Centers of Excellence Program within the Veterans Health Administration.

He noted that the researchers found that opioids were the most commonly used acute treatment. That’s not surprising, but “it would be interesting to see what was tried before someone had gotten to opioids,” he said.

The findings also gave some unexpected insight into the condition. “I really found it striking that an overwhelming majority of patients reported brain fog. Given the context that it is daily persistent headache, one could surmise that they have brain fog a lot of the time,” said Dr. Sico.
 

‘A Good Data Set’

The researchers analyzed data from 337 international patients who responded to a survey. They also randomly selected 34 patients for an interview, and 32 of those were deemed likely to have NDPH. “So we really spent some effort making sure this was a good data set,” said Dr. Burish. The participant population was 72% female, 83.7% White, and 70.7% were based in the United States, though other countries included Canada, the United Kingdom, Australia, Ireland, Germany, Sweden, and Switzerland. The mean age was 41.2 years. The peak ages of onset were between 11 and 40 years, though there were a few cases in the 0-5 age range and over 70. Possible triggers that occurred in the 3 months before onset included psychological stressors (34%), infection or inflammation (32%, COVID infection (5%), injury or surgery (8%), or a change in medications (4%). No clear trigger was identified by 22% of respondents.

The survey included information on associated features, and frequently reported issues included brain fog (approximate 75%), sound sensitivity (about 62%), light sensitivity (57%), nausea (39%), smell sensitivity (32%), visual disturbances (28%), vomiting (13%), and chills (9%).
 

Insights Into Treatment Efficacy

Dr. Burish showed a slide of responses to questions about acute treatments that respondents had tried at least once and viewed as ‘completely effective,’ ‘mostly effective,’ or ‘somewhat effective.’

“No medicine was completely effective, which I think a lot of people know from NDPH. It is notoriously difficult to treat. The things on the top of the list are mostly opioids. There’s one (non-opioid), the DHE (dihydroergotamine) injection. All the way on the other side, you have diphenhydramine. The NSAIDs and triptans are mostly in the middle. We did ask about some of the wearable devices, and we had extra questions about, are you using it appropriately? Those are kind of in the middle or towards the bottom [in frequency],” said Dr. Burish.

There was a similar question regarding effective preventive medications that had been tried for at least 2 months or 3 months in the cause of onabotulinum toxin or CGRP medications. “This one had a little bit more of a pattern to it: A lot of the CGRP medications are up toward the top. It’s not perfect. Erenumab and galcanezumab are closer to the bottom, but it was interesting that a lot of the CGRP medicines were toward the top. Onabotulinum toxin was also somewhat toward the top. We looked at a few different anti-inflammatories. Methylprednisolone is kind of toward the upper half at least, whereas prednisone and montelukast are at the absolute bottom. And the prednisone is a pretty good dose, 50 milligrams or higher. There are some people thinking that this is an inflammation or infectious etiology, (but) it wasn’t that all of the anti-inflammatories were necessarily toward the top of the list,” said Dr. Burish.

Dr. Burish has received funding from Lundbeck. Dr. Sico has no relevant financial disclosures.

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.

Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.

The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,

In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.

Metformin in Fathers

Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.

The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.

“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”

TOPLINE:

Whether they have normal weight, overweight, or obesity, individuals with metabolically healthy (MH) phenotypes show a lower frequency of impaired glucose metabolism than their unhealthy counterparts across all weight categories.

METHODOLOGY:

• The concepts of MH overweight and MH obesity refer to a subset of people who exhibit an absence of cardiometabolic risk factors despite excess body fat, but the prevalence of prediabetes has not been investigated by metabolic phenotype and body mass index (BMI).
• This study first validated the use of estimated glucose disposal rate (eGDR), an index of insulin sensitivity calculated from clinical variables, in 350 individuals without diabetes (mean age, 37 years; 219 women; mean BMI, 30.3) from the EUGENE2 project who had varying glucose tolerance values originally assessed by insulin-stimulated glucose disposal.
• Researchers then stratified 2201 participants without diabetes (mean age, 46 years; White; 1290 women; mean BMI, 31.2) from the CATAMERI study according to BMI into three groups — individuals with normal weight (BMI, 18-24.9), overweight (BMI, 25-29.9), and obesity (BMI, ≥ 30).
• The men and women in each BMI group were separated into quartiles of insulin sensitivity based on eGDR index:
• In the normal weight group, men and women were defined as MH in the top three eGDR quartiles and metabolically unhealthy (MU) in the lowest quartile.
• In the overweight and obesity groups, people were defined as MH in the top eGDR quartile and MU in the lower three quartiles.
• Impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and combined IFG+IGT conditions (from an oral glucose tolerance test) were compared in individuals without diabetes based on MH or unhealthy phenotypes across normal weight, overweight, and obese categories.

TAKEAWAY:

• eGDR demonstrated good accuracy in detecting individuals with higher insulin sensitivity in the EUGENE2 cohort.
• The MH overweight and MH obesity groups showed comparable glycemic parameters as the MH normal weight group, whereas the MU overweight and MU obesity groups exhibited higher A1c levels and fasting and 2-hour post-load glucose than the MH normal weight group.
• The frequencies of IFG, IGT, and IFG+IGT conditions were similar among the MH normal weight, MH overweight, and MH obesity groups but were higher in the MU overweight and MU obesity groups than in the MU normal weight group.
• Furthermore, compared with those in the MH normal weight group, the odds of prediabetes were at least two times higher in the MU obesity (odds ratio [OR], 2.54; P < .001) and MU overweight (OR, 2.06; P < .001) groups but not significantly different in the MU normal weight, MH obesity, and MH overweight groups.

IN PRACTICE:

The authors wrote, “Overall, the results of this cross-sectional study support the notion that metabolically healthy individuals with overweight or obesity have a more favorable metabolic risk profile in comparison to metabolically unhealthy subjects with overweight or obesity.”

SOURCE:

The study was conducted by Chiara M.A. Cefalo, MD, department of clinical and molecular medicine, Sapienza University of Rome, Rome, Italy, and was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was no consensus on the parameters and cutoff values for defining metabolic health status, allowing for potential variations in results. The study design suggested an association with prevalent IFG and IGT conditions but not with incident IFG and IGT conditions. All participants in this study were White, limiting the generalizability of its findings.

DISCLOSURES:

The study was supported by Sapienza University of Rome and the Italian Ministry of University. The authors declared no conflicts of interest.

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

TOPLINE:

Whether they have normal weight, overweight, or obesity, individuals with metabolically healthy (MH) phenotypes show a lower frequency of impaired glucose metabolism than their unhealthy counterparts across all weight categories.

METHODOLOGY:

• The concepts of MH overweight and MH obesity refer to a subset of people who exhibit an absence of cardiometabolic risk factors despite excess body fat, but the prevalence of prediabetes has not been investigated by metabolic phenotype and body mass index (BMI).
• This study first validated the use of estimated glucose disposal rate (eGDR), an index of insulin sensitivity calculated from clinical variables, in 350 individuals without diabetes (mean age, 37 years; 219 women; mean BMI, 30.3) from the EUGENE2 project who had varying glucose tolerance values originally assessed by insulin-stimulated glucose disposal.
• Researchers then stratified 2201 participants without diabetes (mean age, 46 years; White; 1290 women; mean BMI, 31.2) from the CATAMERI study according to BMI into three groups — individuals with normal weight (BMI, 18-24.9), overweight (BMI, 25-29.9), and obesity (BMI, ≥ 30).
• The men and women in each BMI group were separated into quartiles of insulin sensitivity based on eGDR index:
• In the normal weight group, men and women were defined as MH in the top three eGDR quartiles and metabolically unhealthy (MU) in the lowest quartile.
• In the overweight and obesity groups, people were defined as MH in the top eGDR quartile and MU in the lower three quartiles.
• Impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and combined IFG+IGT conditions (from an oral glucose tolerance test) were compared in individuals without diabetes based on MH or unhealthy phenotypes across normal weight, overweight, and obese categories.

TAKEAWAY:

• eGDR demonstrated good accuracy in detecting individuals with higher insulin sensitivity in the EUGENE2 cohort.
• The MH overweight and MH obesity groups showed comparable glycemic parameters as the MH normal weight group, whereas the MU overweight and MU obesity groups exhibited higher A1c levels and fasting and 2-hour post-load glucose than the MH normal weight group.
• The frequencies of IFG, IGT, and IFG+IGT conditions were similar among the MH normal weight, MH overweight, and MH obesity groups but were higher in the MU overweight and MU obesity groups than in the MU normal weight group.
• Furthermore, compared with those in the MH normal weight group, the odds of prediabetes were at least two times higher in the MU obesity (odds ratio [OR], 2.54; P < .001) and MU overweight (OR, 2.06; P < .001) groups but not significantly different in the MU normal weight, MH obesity, and MH overweight groups.

IN PRACTICE:

The authors wrote, “Overall, the results of this cross-sectional study support the notion that metabolically healthy individuals with overweight or obesity have a more favorable metabolic risk profile in comparison to metabolically unhealthy subjects with overweight or obesity.”

SOURCE:

The study was conducted by Chiara M.A. Cefalo, MD, department of clinical and molecular medicine, Sapienza University of Rome, Rome, Italy, and was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was no consensus on the parameters and cutoff values for defining metabolic health status, allowing for potential variations in results. The study design suggested an association with prevalent IFG and IGT conditions but not with incident IFG and IGT conditions. All participants in this study were White, limiting the generalizability of its findings.

DISCLOSURES:

The study was supported by Sapienza University of Rome and the Italian Ministry of University. The authors declared no conflicts of interest.

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

TOPLINE:

Whether they have normal weight, overweight, or obesity, individuals with metabolically healthy (MH) phenotypes show a lower frequency of impaired glucose metabolism than their unhealthy counterparts across all weight categories.

METHODOLOGY:

• The concepts of MH overweight and MH obesity refer to a subset of people who exhibit an absence of cardiometabolic risk factors despite excess body fat, but the prevalence of prediabetes has not been investigated by metabolic phenotype and body mass index (BMI).
• This study first validated the use of estimated glucose disposal rate (eGDR), an index of insulin sensitivity calculated from clinical variables, in 350 individuals without diabetes (mean age, 37 years; 219 women; mean BMI, 30.3) from the EUGENE2 project who had varying glucose tolerance values originally assessed by insulin-stimulated glucose disposal.
• Researchers then stratified 2201 participants without diabetes (mean age, 46 years; White; 1290 women; mean BMI, 31.2) from the CATAMERI study according to BMI into three groups — individuals with normal weight (BMI, 18-24.9), overweight (BMI, 25-29.9), and obesity (BMI, ≥ 30).
• The men and women in each BMI group were separated into quartiles of insulin sensitivity based on eGDR index:
• In the normal weight group, men and women were defined as MH in the top three eGDR quartiles and metabolically unhealthy (MU) in the lowest quartile.
• In the overweight and obesity groups, people were defined as MH in the top eGDR quartile and MU in the lower three quartiles.
• Impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and combined IFG+IGT conditions (from an oral glucose tolerance test) were compared in individuals without diabetes based on MH or unhealthy phenotypes across normal weight, overweight, and obese categories.

TAKEAWAY:

• eGDR demonstrated good accuracy in detecting individuals with higher insulin sensitivity in the EUGENE2 cohort.
• The MH overweight and MH obesity groups showed comparable glycemic parameters as the MH normal weight group, whereas the MU overweight and MU obesity groups exhibited higher A1c levels and fasting and 2-hour post-load glucose than the MH normal weight group.
• The frequencies of IFG, IGT, and IFG+IGT conditions were similar among the MH normal weight, MH overweight, and MH obesity groups but were higher in the MU overweight and MU obesity groups than in the MU normal weight group.
• Furthermore, compared with those in the MH normal weight group, the odds of prediabetes were at least two times higher in the MU obesity (odds ratio [OR], 2.54; P < .001) and MU overweight (OR, 2.06; P < .001) groups but not significantly different in the MU normal weight, MH obesity, and MH overweight groups.

IN PRACTICE:

The authors wrote, “Overall, the results of this cross-sectional study support the notion that metabolically healthy individuals with overweight or obesity have a more favorable metabolic risk profile in comparison to metabolically unhealthy subjects with overweight or obesity.”

SOURCE:

The study was conducted by Chiara M.A. Cefalo, MD, department of clinical and molecular medicine, Sapienza University of Rome, Rome, Italy, and was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was no consensus on the parameters and cutoff values for defining metabolic health status, allowing for potential variations in results. The study design suggested an association with prevalent IFG and IGT conditions but not with incident IFG and IGT conditions. All participants in this study were White, limiting the generalizability of its findings.

DISCLOSURES:

The study was supported by Sapienza University of Rome and the Italian Ministry of University. The authors declared no conflicts of interest.

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

TOPLINE:

Mortality and disability-adjusted life years (DALYs) among people with type 1 diabetes (T1D) aged ≥ 65 years dropped significantly from 1990 to 2019. Both were lower among women and those living in higher sociodemographic areas.

METHODOLOGY:

• A population-based study of adults aged ≥ 65 years from 21 regions and 204 countries and territories, 1990-2019, was conducted.

TAKEAWAY:

• Globally, the prevalence of T1D among people aged ≥ 65 years increased by 180% between 1990 and 2019, from 1.3 million to 3.7 million.
• The proportion of older people with T1D has consistently trended upward, from 12% of all people with T1D in 1990 to 17% in 2019.
• Age-standardized mortality from T1D among this age group significantly decreased by 25%, from 4.7/100,000 population in 1990 to 3.5/100,000 in 2019.
• Age-standardized increases in T1D prevalence have occurred in both men and women worldwide, while the increase was more rapid among men (average annual percent change, 1.00% vs 0.74%).
• Globally, T1D prevalence at least tripled in every age subgroup of those aged ≥ 65 years, and even fivefold to sixfold for those ≥ 90-95 years (0.02-0.11 million for ages 90-94 years; 0.005-0.03 million for ages ≥ 95 years).
• No decreases occurred in T1D prevalence among those aged ≥ 65 years in any of the 21 global regions.
• Three primary risk factors associated with DALYs for T1D among people aged ≥ 65 years were high fasting plasma glucose levels, low temperature, and high temperature, accounting for 103 DALYs per 100,000 people, 3/100,000 people, and 1/100,000 people, respectively, in 2019.

IN PRACTICE:

“The results suggest that T1DM is no longer a contributory factor in decreased life expectancy owing to improvements in medical care over the three decades,” the authors wrote. “Management of high fasting plasma glucose levels remains a major challenge for older people with T1D, and targeted clinical guidelines are needed.”

SOURCE:

The study was conducted by Kaijie Yang, the Department of Endocrinology and Metabolism, the Institute of Endocrinology, NHC Key Laboratory of Diagnosis and Treatment of Thyroid Diseases, First Hospital of China Medical University, Shenyang, China, and colleagues. The study was published online in the BMJ.

LIMITATIONS:

Data were extrapolated from countries that have epidemiologic data. Health information systems and reporting mechanisms vary across countries and regions. Disease burden data include a time lag. Diagnosing T1D in older people can be challenging.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and the China Postdoctoral Science Foundation. The authors reported no additional financial relationships.

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

TOPLINE:

Mortality and disability-adjusted life years (DALYs) among people with type 1 diabetes (T1D) aged ≥ 65 years dropped significantly from 1990 to 2019. Both were lower among women and those living in higher sociodemographic areas.

METHODOLOGY:

• A population-based study of adults aged ≥ 65 years from 21 regions and 204 countries and territories, 1990-2019, was conducted.

TAKEAWAY:

• Globally, the prevalence of T1D among people aged ≥ 65 years increased by 180% between 1990 and 2019, from 1.3 million to 3.7 million.
• The proportion of older people with T1D has consistently trended upward, from 12% of all people with T1D in 1990 to 17% in 2019.
• Age-standardized mortality from T1D among this age group significantly decreased by 25%, from 4.7/100,000 population in 1990 to 3.5/100,000 in 2019.
• Age-standardized increases in T1D prevalence have occurred in both men and women worldwide, while the increase was more rapid among men (average annual percent change, 1.00% vs 0.74%).
• Globally, T1D prevalence at least tripled in every age subgroup of those aged ≥ 65 years, and even fivefold to sixfold for those ≥ 90-95 years (0.02-0.11 million for ages 90-94 years; 0.005-0.03 million for ages ≥ 95 years).
• No decreases occurred in T1D prevalence among those aged ≥ 65 years in any of the 21 global regions.
• Three primary risk factors associated with DALYs for T1D among people aged ≥ 65 years were high fasting plasma glucose levels, low temperature, and high temperature, accounting for 103 DALYs per 100,000 people, 3/100,000 people, and 1/100,000 people, respectively, in 2019.

IN PRACTICE:

“The results suggest that T1DM is no longer a contributory factor in decreased life expectancy owing to improvements in medical care over the three decades,” the authors wrote. “Management of high fasting plasma glucose levels remains a major challenge for older people with T1D, and targeted clinical guidelines are needed.”

SOURCE:

The study was conducted by Kaijie Yang, the Department of Endocrinology and Metabolism, the Institute of Endocrinology, NHC Key Laboratory of Diagnosis and Treatment of Thyroid Diseases, First Hospital of China Medical University, Shenyang, China, and colleagues. The study was published online in the BMJ.

LIMITATIONS:

Data were extrapolated from countries that have epidemiologic data. Health information systems and reporting mechanisms vary across countries and regions. Disease burden data include a time lag. Diagnosing T1D in older people can be challenging.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and the China Postdoctoral Science Foundation. The authors reported no additional financial relationships.

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

TOPLINE:

Mortality and disability-adjusted life years (DALYs) among people with type 1 diabetes (T1D) aged ≥ 65 years dropped significantly from 1990 to 2019. Both were lower among women and those living in higher sociodemographic areas.

METHODOLOGY:

• A population-based study of adults aged ≥ 65 years from 21 regions and 204 countries and territories, 1990-2019, was conducted.

TAKEAWAY:

• Globally, the prevalence of T1D among people aged ≥ 65 years increased by 180% between 1990 and 2019, from 1.3 million to 3.7 million.
• The proportion of older people with T1D has consistently trended upward, from 12% of all people with T1D in 1990 to 17% in 2019.
• Age-standardized mortality from T1D among this age group significantly decreased by 25%, from 4.7/100,000 population in 1990 to 3.5/100,000 in 2019.
• Age-standardized increases in T1D prevalence have occurred in both men and women worldwide, while the increase was more rapid among men (average annual percent change, 1.00% vs 0.74%).
• Globally, T1D prevalence at least tripled in every age subgroup of those aged ≥ 65 years, and even fivefold to sixfold for those ≥ 90-95 years (0.02-0.11 million for ages 90-94 years; 0.005-0.03 million for ages ≥ 95 years).
• No decreases occurred in T1D prevalence among those aged ≥ 65 years in any of the 21 global regions.
• Three primary risk factors associated with DALYs for T1D among people aged ≥ 65 years were high fasting plasma glucose levels, low temperature, and high temperature, accounting for 103 DALYs per 100,000 people, 3/100,000 people, and 1/100,000 people, respectively, in 2019.

IN PRACTICE:

“The results suggest that T1DM is no longer a contributory factor in decreased life expectancy owing to improvements in medical care over the three decades,” the authors wrote. “Management of high fasting plasma glucose levels remains a major challenge for older people with T1D, and targeted clinical guidelines are needed.”

SOURCE:

The study was conducted by Kaijie Yang, the Department of Endocrinology and Metabolism, the Institute of Endocrinology, NHC Key Laboratory of Diagnosis and Treatment of Thyroid Diseases, First Hospital of China Medical University, Shenyang, China, and colleagues. The study was published online in the BMJ.

LIMITATIONS:

Data were extrapolated from countries that have epidemiologic data. Health information systems and reporting mechanisms vary across countries and regions. Disease burden data include a time lag. Diagnosing T1D in older people can be challenging.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and the China Postdoctoral Science Foundation. The authors reported no additional financial relationships.

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