Clinician Reviews

TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

• Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
• Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
• The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
• The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

• The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
• Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
• Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
• No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

• Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
• Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
• The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
• The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

• The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
• Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
• Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
• No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

• Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
• Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
• The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
• The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

• The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
• Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
• Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
• No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

TOPLINE:

Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.

METHODOLOGY:

• Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
• Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
• They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
• At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
• Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.

TAKEAWAY:

• Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
• Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
• This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
• Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
• When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.

IN PRACTICE:

“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.

SOURCE:

The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.

DISCLOSURES:

This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.

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

TOPLINE:

Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.

METHODOLOGY:

• Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
• Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
• They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
• At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
• Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.

TAKEAWAY:

• Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
• Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
• This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
• Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
• When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.

IN PRACTICE:

“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.

SOURCE:

The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.

DISCLOSURES:

This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.

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

TOPLINE:

Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.

METHODOLOGY:

• Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
• Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
• They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
• At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
• Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.

TAKEAWAY:

• Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
• Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
• This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
• Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
• When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.

IN PRACTICE:

“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.

SOURCE:

The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.

DISCLOSURES:

This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.

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

Fatigue, nausea, acid reflux, muscle loss, and the dreaded “Ozempic face” are side effects from using glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) such as semaglutide or the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA tirzepatide to control blood sugar and promote weight loss. 

But what I’ve learned from working with hundreds of patients on these medications, and others, is that most (if not all) of these side effects can be minimized by ensuring proper nutrition. 

Setting patients up for success requires dietary education and counseling, along with regular monitoring to determine any nutritional deficiencies. Although adequate intake of all the macro and micronutrients is obviously important, there are five nutrients in particular that clinicians should emphasize with their patients on GLP-1 RAs or GIP/GLP-1 RSs.
 

Protein

My patients are probably sick of hearing me talk about protein, but without the constant reinforcement, many of them wouldn’t consume enough of this macronutrient to maintain their baseline lean body mass. The recommended dietary allowance (RDA) for protein (0.8 g/kg bodyweight) doesn’t cut it, especially for older, obese patients, who need closer to 1.0-1.2 g/kg bodyweight to maintain their muscle mass. For example, for a 250-lb patient, I would recommend 114-136 g protein per day. This is equivalent to roughly 15 oz of cooked animal protein. It’s important to note, though, that individuals with kidney disease must limit their protein intake to 0.6-0.8 g/kg bodyweight per day, to avoid overtaxing their kidneys. In this situation, the benefit of increased protein intake does not outweigh the risk of harming the kidneys.

It’s often challenging for patients with suppressed appetites to even think about eating a large hunk of meat or fish, let alone consume it. Plus, eating more than 3-4 oz of protein in one meal can make some patients extremely uncomfortable, owing to the medication’s effect on gastric emptying. This means that daily protein intake must be spread out over multiple mini-meals. 

For patients who need more than 100 g of protein per day, protein powders and premade protein shakes can provide 20-30 g protein to fill in the gaps. Although I always try to promote food first, protein supplements have been game changers for my patients, especially those who find solid food less appealing on the medication, or those who avoid animal protein. 

Clinicians should have their patients monitor changes in their lean body mass using a dual-energy x-ray absorptiometry scan or a bioelectrical impedance scale; this can be a helpful tool in assessing whether protein intake is sufficient. 
 

Fiber

Even my most knowledgeable and compliant patients will experience some constipation. Generally speaking, when you eat less, you will have fewer bowel movements. Combine that with delayed gastric emptying and reduced fiber intake, and you have a perfect storm. Many patients are simply not able to get in the recommended 25-35 g fiber per day through food, because fibrous foods are filling. If they are prioritizing the protein in their meal, they will not have enough room for all the vegetables on their plate. 

To ensure that patients are getting sufficient fiber, clinicians should push consumption of certain vegetables and fruits, such as carrots, broccoli, Brussels sprouts, raspberries, blackberries, and apples, as well as beans and legumes. (Salads are great, but greens like spinach are not as fibrous as one might think.) If the fruit and veggie intake isn’t up to par, a fiber supplement such as psyllium husk can provide an effective boost.
 

Vitamin B12

Use of these medications is associated with a reduction in vitamin B12 levels, in part because delayed gastric emptying may affect B12 absorption. Low dietary intake of B12 while on the medications can also be to blame, though. The best food sources are animal proteins, so if possible, patients should prioritize having fish, lean meat, eggs, and dairy daily. 

Vegetarians and vegans, who are at an increased risk for deficiency, can incorporate nutritional yeast, an excellent source of vitamin B12, into their daily routine. It is beneficial for patients to get blood work periodically to check on B12 status, because insufficient B12 can contribute to the fatigue patients experience while on the medication.
 

Calcium

Individuals should have calcium on their radar, because weight loss is associated with a decrease in bone mineral density. Adequate intake of the mineral is crucial for optimal bone health, particularly among postmenopausal women and those who are at risk of developing osteoporosis. The RDA for calcium is 1000-1200 mg/d, which an estimated 50% of obese individuals do not take in. 

Although dairy products are well-known for being rich in calcium, there are other great sources. Dark green leafy vegetables, such as cooked collard greens and spinach, provide nearly 300 mg per cup. Tofu and sardines are also calcium powerhouses. Despite the plethora of calcium-rich foods, however, some patients may need a calcium supplement.
 

Vitamin D

Vitamin D deficiency or insufficiency is common among individuals with obesity, so even before these patients start the medications, supplementation may be warranted. The vitamin’s role in promoting calcium absorption, as well as in bone remodeling, make adequate intake essential for patients experiencing significant weight loss.

Clinicians should emphasize regular consumption of fatty fish, such as salmon, as well as eggs, mushrooms, and vitamin D–fortified milks. But unfortunately, that’s where the list of vitamin D–rich foods ends, so taking a vitamin D supplement will be necessary for many patients.

Regularly monitoring patients on GLP-1 RAs through blood work to check vitamin levels and body composition analysis can be helpful in assessing nutritional status while losing weight. Clinicians can also encourage their patients to work with a registered dietitian who is familiar with these medications, so they can develop optimal eating habits throughout their health journey.

Ms. Hanks, a registered dietitian in New York City, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Fatigue, nausea, acid reflux, muscle loss, and the dreaded “Ozempic face” are side effects from using glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) such as semaglutide or the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA tirzepatide to control blood sugar and promote weight loss. 

But what I’ve learned from working with hundreds of patients on these medications, and others, is that most (if not all) of these side effects can be minimized by ensuring proper nutrition. 

Setting patients up for success requires dietary education and counseling, along with regular monitoring to determine any nutritional deficiencies. Although adequate intake of all the macro and micronutrients is obviously important, there are five nutrients in particular that clinicians should emphasize with their patients on GLP-1 RAs or GIP/GLP-1 RSs.
 

Protein

My patients are probably sick of hearing me talk about protein, but without the constant reinforcement, many of them wouldn’t consume enough of this macronutrient to maintain their baseline lean body mass. The recommended dietary allowance (RDA) for protein (0.8 g/kg bodyweight) doesn’t cut it, especially for older, obese patients, who need closer to 1.0-1.2 g/kg bodyweight to maintain their muscle mass. For example, for a 250-lb patient, I would recommend 114-136 g protein per day. This is equivalent to roughly 15 oz of cooked animal protein. It’s important to note, though, that individuals with kidney disease must limit their protein intake to 0.6-0.8 g/kg bodyweight per day, to avoid overtaxing their kidneys. In this situation, the benefit of increased protein intake does not outweigh the risk of harming the kidneys.

It’s often challenging for patients with suppressed appetites to even think about eating a large hunk of meat or fish, let alone consume it. Plus, eating more than 3-4 oz of protein in one meal can make some patients extremely uncomfortable, owing to the medication’s effect on gastric emptying. This means that daily protein intake must be spread out over multiple mini-meals. 

For patients who need more than 100 g of protein per day, protein powders and premade protein shakes can provide 20-30 g protein to fill in the gaps. Although I always try to promote food first, protein supplements have been game changers for my patients, especially those who find solid food less appealing on the medication, or those who avoid animal protein. 

Clinicians should have their patients monitor changes in their lean body mass using a dual-energy x-ray absorptiometry scan or a bioelectrical impedance scale; this can be a helpful tool in assessing whether protein intake is sufficient. 
 

Fiber

Even my most knowledgeable and compliant patients will experience some constipation. Generally speaking, when you eat less, you will have fewer bowel movements. Combine that with delayed gastric emptying and reduced fiber intake, and you have a perfect storm. Many patients are simply not able to get in the recommended 25-35 g fiber per day through food, because fibrous foods are filling. If they are prioritizing the protein in their meal, they will not have enough room for all the vegetables on their plate. 

To ensure that patients are getting sufficient fiber, clinicians should push consumption of certain vegetables and fruits, such as carrots, broccoli, Brussels sprouts, raspberries, blackberries, and apples, as well as beans and legumes. (Salads are great, but greens like spinach are not as fibrous as one might think.) If the fruit and veggie intake isn’t up to par, a fiber supplement such as psyllium husk can provide an effective boost.
 

Vitamin B12

Use of these medications is associated with a reduction in vitamin B12 levels, in part because delayed gastric emptying may affect B12 absorption. Low dietary intake of B12 while on the medications can also be to blame, though. The best food sources are animal proteins, so if possible, patients should prioritize having fish, lean meat, eggs, and dairy daily. 

Vegetarians and vegans, who are at an increased risk for deficiency, can incorporate nutritional yeast, an excellent source of vitamin B12, into their daily routine. It is beneficial for patients to get blood work periodically to check on B12 status, because insufficient B12 can contribute to the fatigue patients experience while on the medication.
 

Calcium

Individuals should have calcium on their radar, because weight loss is associated with a decrease in bone mineral density. Adequate intake of the mineral is crucial for optimal bone health, particularly among postmenopausal women and those who are at risk of developing osteoporosis. The RDA for calcium is 1000-1200 mg/d, which an estimated 50% of obese individuals do not take in. 

Although dairy products are well-known for being rich in calcium, there are other great sources. Dark green leafy vegetables, such as cooked collard greens and spinach, provide nearly 300 mg per cup. Tofu and sardines are also calcium powerhouses. Despite the plethora of calcium-rich foods, however, some patients may need a calcium supplement.
 

Vitamin D

Vitamin D deficiency or insufficiency is common among individuals with obesity, so even before these patients start the medications, supplementation may be warranted. The vitamin’s role in promoting calcium absorption, as well as in bone remodeling, make adequate intake essential for patients experiencing significant weight loss.

Clinicians should emphasize regular consumption of fatty fish, such as salmon, as well as eggs, mushrooms, and vitamin D–fortified milks. But unfortunately, that’s where the list of vitamin D–rich foods ends, so taking a vitamin D supplement will be necessary for many patients.

Regularly monitoring patients on GLP-1 RAs through blood work to check vitamin levels and body composition analysis can be helpful in assessing nutritional status while losing weight. Clinicians can also encourage their patients to work with a registered dietitian who is familiar with these medications, so they can develop optimal eating habits throughout their health journey.

Ms. Hanks, a registered dietitian in New York City, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Fatigue, nausea, acid reflux, muscle loss, and the dreaded “Ozempic face” are side effects from using glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) such as semaglutide or the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA tirzepatide to control blood sugar and promote weight loss. 

But what I’ve learned from working with hundreds of patients on these medications, and others, is that most (if not all) of these side effects can be minimized by ensuring proper nutrition. 

Setting patients up for success requires dietary education and counseling, along with regular monitoring to determine any nutritional deficiencies. Although adequate intake of all the macro and micronutrients is obviously important, there are five nutrients in particular that clinicians should emphasize with their patients on GLP-1 RAs or GIP/GLP-1 RSs.
 

Protein

My patients are probably sick of hearing me talk about protein, but without the constant reinforcement, many of them wouldn’t consume enough of this macronutrient to maintain their baseline lean body mass. The recommended dietary allowance (RDA) for protein (0.8 g/kg bodyweight) doesn’t cut it, especially for older, obese patients, who need closer to 1.0-1.2 g/kg bodyweight to maintain their muscle mass. For example, for a 250-lb patient, I would recommend 114-136 g protein per day. This is equivalent to roughly 15 oz of cooked animal protein. It’s important to note, though, that individuals with kidney disease must limit their protein intake to 0.6-0.8 g/kg bodyweight per day, to avoid overtaxing their kidneys. In this situation, the benefit of increased protein intake does not outweigh the risk of harming the kidneys.

It’s often challenging for patients with suppressed appetites to even think about eating a large hunk of meat or fish, let alone consume it. Plus, eating more than 3-4 oz of protein in one meal can make some patients extremely uncomfortable, owing to the medication’s effect on gastric emptying. This means that daily protein intake must be spread out over multiple mini-meals. 

For patients who need more than 100 g of protein per day, protein powders and premade protein shakes can provide 20-30 g protein to fill in the gaps. Although I always try to promote food first, protein supplements have been game changers for my patients, especially those who find solid food less appealing on the medication, or those who avoid animal protein. 

Clinicians should have their patients monitor changes in their lean body mass using a dual-energy x-ray absorptiometry scan or a bioelectrical impedance scale; this can be a helpful tool in assessing whether protein intake is sufficient. 
 

Fiber

Even my most knowledgeable and compliant patients will experience some constipation. Generally speaking, when you eat less, you will have fewer bowel movements. Combine that with delayed gastric emptying and reduced fiber intake, and you have a perfect storm. Many patients are simply not able to get in the recommended 25-35 g fiber per day through food, because fibrous foods are filling. If they are prioritizing the protein in their meal, they will not have enough room for all the vegetables on their plate. 

To ensure that patients are getting sufficient fiber, clinicians should push consumption of certain vegetables and fruits, such as carrots, broccoli, Brussels sprouts, raspberries, blackberries, and apples, as well as beans and legumes. (Salads are great, but greens like spinach are not as fibrous as one might think.) If the fruit and veggie intake isn’t up to par, a fiber supplement such as psyllium husk can provide an effective boost.
 

Vitamin B12

Use of these medications is associated with a reduction in vitamin B12 levels, in part because delayed gastric emptying may affect B12 absorption. Low dietary intake of B12 while on the medications can also be to blame, though. The best food sources are animal proteins, so if possible, patients should prioritize having fish, lean meat, eggs, and dairy daily. 

Vegetarians and vegans, who are at an increased risk for deficiency, can incorporate nutritional yeast, an excellent source of vitamin B12, into their daily routine. It is beneficial for patients to get blood work periodically to check on B12 status, because insufficient B12 can contribute to the fatigue patients experience while on the medication.
 

Calcium

Individuals should have calcium on their radar, because weight loss is associated with a decrease in bone mineral density. Adequate intake of the mineral is crucial for optimal bone health, particularly among postmenopausal women and those who are at risk of developing osteoporosis. The RDA for calcium is 1000-1200 mg/d, which an estimated 50% of obese individuals do not take in. 

Although dairy products are well-known for being rich in calcium, there are other great sources. Dark green leafy vegetables, such as cooked collard greens and spinach, provide nearly 300 mg per cup. Tofu and sardines are also calcium powerhouses. Despite the plethora of calcium-rich foods, however, some patients may need a calcium supplement.
 

Vitamin D

Vitamin D deficiency or insufficiency is common among individuals with obesity, so even before these patients start the medications, supplementation may be warranted. The vitamin’s role in promoting calcium absorption, as well as in bone remodeling, make adequate intake essential for patients experiencing significant weight loss.

Clinicians should emphasize regular consumption of fatty fish, such as salmon, as well as eggs, mushrooms, and vitamin D–fortified milks. But unfortunately, that’s where the list of vitamin D–rich foods ends, so taking a vitamin D supplement will be necessary for many patients.

Regularly monitoring patients on GLP-1 RAs through blood work to check vitamin levels and body composition analysis can be helpful in assessing nutritional status while losing weight. Clinicians can also encourage their patients to work with a registered dietitian who is familiar with these medications, so they can develop optimal eating habits throughout their health journey.

Ms. Hanks, a registered dietitian in New York City, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The origin of the COVID-19 pandemic has sparked much debate, and various hypotheses have been put forward.

“My colleagues and I have examined the issue with an open mind, taking into account all possible hypotheses. The laboratory origin hypothesis was legitimate and deserved to be investigated,” Florence Débarre, PhD, a research director at the French National Center for Scientific Research at the Institute of Ecology and Environmental Sciences in Paris, France, told this news organization. Nevertheless, research carried out as part of a large international collaboration points more toward an animal origin at the Wuhan market in China.

“We studied data from environmental samples taken at the Huanan market in Wuhan shortly after its closure in early 2020,” said Dr. Débarre. The data were shared by the Chinese Center for Disease Control and Prevention on open and public databases. They include the raw genetic sequences of more than 800 samples collected at the Huanan market, on cages and carts, on the floors and walls of the stalls, and in the pipes and sewers.

These data allowed researchers to highlight the co-presence at this location of genetic material from the SARS-CoV-2 virus and certain wild animals. Masked palm civets, which are wild canids similar to foxes, with a dark facial mask similar to that of raccoons, and civets, small carnivorous mammals close to mongooses, were at the site.

“These species were already involved in the emergence of the SARS epidemic in the early 2000s and considered to facilitate the transmission of the virus from animals to humans,” said Dr. Débarre.

These animals were identified based on their DNA and located in the southwest part of the market, which is also a hotspot where many samples tested positive for SARS-CoV-2.

“There is a particular stall where the virus and the animals were found,” she said.

Since the data used are based on environmental samples, it is not possible to formally demonstrate that the animals were infected, but the discovery of virus samples located in the same place as the genetic material of these animals suggests that they were.

“There were samples taken from some animals at the market, but not from others, as they had already been evacuated when the sampling services arrived,” said Dr. Débarre. These results add to a large body of evidence that all points in the same direction: an animal origin at the Wuhan market.

The team also found other zoonotic viruses, such as avian flu. “This study confirms that live animal markets pose a high health risk, especially when they are at the heart of urban centers,” said Dr. Débarre. “It can provide avenues for prevention, particularly by limiting interactions between humans and wild fauna.”

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 appeared on Medscape.com.

The origin of the COVID-19 pandemic has sparked much debate, and various hypotheses have been put forward.

“My colleagues and I have examined the issue with an open mind, taking into account all possible hypotheses. The laboratory origin hypothesis was legitimate and deserved to be investigated,” Florence Débarre, PhD, a research director at the French National Center for Scientific Research at the Institute of Ecology and Environmental Sciences in Paris, France, told this news organization. Nevertheless, research carried out as part of a large international collaboration points more toward an animal origin at the Wuhan market in China.

“We studied data from environmental samples taken at the Huanan market in Wuhan shortly after its closure in early 2020,” said Dr. Débarre. The data were shared by the Chinese Center for Disease Control and Prevention on open and public databases. They include the raw genetic sequences of more than 800 samples collected at the Huanan market, on cages and carts, on the floors and walls of the stalls, and in the pipes and sewers.

These data allowed researchers to highlight the co-presence at this location of genetic material from the SARS-CoV-2 virus and certain wild animals. Masked palm civets, which are wild canids similar to foxes, with a dark facial mask similar to that of raccoons, and civets, small carnivorous mammals close to mongooses, were at the site.

“These species were already involved in the emergence of the SARS epidemic in the early 2000s and considered to facilitate the transmission of the virus from animals to humans,” said Dr. Débarre.

These animals were identified based on their DNA and located in the southwest part of the market, which is also a hotspot where many samples tested positive for SARS-CoV-2.

“There is a particular stall where the virus and the animals were found,” she said.

Since the data used are based on environmental samples, it is not possible to formally demonstrate that the animals were infected, but the discovery of virus samples located in the same place as the genetic material of these animals suggests that they were.

“There were samples taken from some animals at the market, but not from others, as they had already been evacuated when the sampling services arrived,” said Dr. Débarre. These results add to a large body of evidence that all points in the same direction: an animal origin at the Wuhan market.

The team also found other zoonotic viruses, such as avian flu. “This study confirms that live animal markets pose a high health risk, especially when they are at the heart of urban centers,” said Dr. Débarre. “It can provide avenues for prevention, particularly by limiting interactions between humans and wild fauna.”

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 appeared on Medscape.com.

The origin of the COVID-19 pandemic has sparked much debate, and various hypotheses have been put forward.

“My colleagues and I have examined the issue with an open mind, taking into account all possible hypotheses. The laboratory origin hypothesis was legitimate and deserved to be investigated,” Florence Débarre, PhD, a research director at the French National Center for Scientific Research at the Institute of Ecology and Environmental Sciences in Paris, France, told this news organization. Nevertheless, research carried out as part of a large international collaboration points more toward an animal origin at the Wuhan market in China.

“We studied data from environmental samples taken at the Huanan market in Wuhan shortly after its closure in early 2020,” said Dr. Débarre. The data were shared by the Chinese Center for Disease Control and Prevention on open and public databases. They include the raw genetic sequences of more than 800 samples collected at the Huanan market, on cages and carts, on the floors and walls of the stalls, and in the pipes and sewers.

These data allowed researchers to highlight the co-presence at this location of genetic material from the SARS-CoV-2 virus and certain wild animals. Masked palm civets, which are wild canids similar to foxes, with a dark facial mask similar to that of raccoons, and civets, small carnivorous mammals close to mongooses, were at the site.

“These species were already involved in the emergence of the SARS epidemic in the early 2000s and considered to facilitate the transmission of the virus from animals to humans,” said Dr. Débarre.

These animals were identified based on their DNA and located in the southwest part of the market, which is also a hotspot where many samples tested positive for SARS-CoV-2.

“There is a particular stall where the virus and the animals were found,” she said.

Since the data used are based on environmental samples, it is not possible to formally demonstrate that the animals were infected, but the discovery of virus samples located in the same place as the genetic material of these animals suggests that they were.

“There were samples taken from some animals at the market, but not from others, as they had already been evacuated when the sampling services arrived,” said Dr. Débarre. These results add to a large body of evidence that all points in the same direction: an animal origin at the Wuhan market.

The team also found other zoonotic viruses, such as avian flu. “This study confirms that live animal markets pose a high health risk, especially when they are at the heart of urban centers,” said Dr. Débarre. “It can provide avenues for prevention, particularly by limiting interactions between humans and wild fauna.”

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 appeared on Medscape.com.

TOPLINE:

Diabetes and prediabetes are associated with accelerated brain aging with brain age gaps of 2.29 and 0.50 years, respectively. This association is more pronounced in men and those with poor cardiometabolic health but may be mitigated by a healthy lifestyle.

METHODOLOGY:

• Diabetes is a known risk factor for cognitive impairment, dementia, and global brain atrophy but conflicting results have been reported for prediabetes, and it’s unknown whether a healthy lifestyle can counteract the negative impact of prediabetes.
• Researchers examined the cross-sectional and longitudinal relationship between hyperglycemia and brain aging, as well as the potential mitigating effect of a healthy lifestyle in 31,229 dementia-free adults (mean age, 54.8 years; 53% women) from the UK Biobank, including 13,518 participants with prediabetes and 1149 with diabetes.
• The glycemic status of the participants was determined by their medical history, medication use, and A1c levels.
• The brain age gap was calculated as a difference between chronologic age and brain age estimated from MRI data from six modalities vs several hundred brain MRI phenotypes that were modeled from a subset of healthy individuals.
• The role of sex, cardiometabolic risk factors, and a healthy lifestyle and their association with brain age was also explored, with a healthy lifestyle defined as never smoking, no or light or moderate alcohol consumption, and high physical activity.

TAKEAWAY:

• Prediabetes and diabetes were associated with a higher brain age gap than normoglycemia (beta-coefficient, 0.22 and 2.01; 95% CI, 0.10-0.34 and 1.70-2.32, respectively), and diabetes was more pronounced in men vs women and those with a higher vs lower burden of cardiometabolic risk factors.
• The brain ages of those with prediabetes and diabetes were 0.50 years and 2.29 years older on average than their respective chronologic ages.
• In an exploratory longitudinal analysis of the 2414 participants with two brain MRI scans, diabetes was linked to a 0.27-year annual increase in the brain age gap, and higher A1c, but not prediabetes, was associated with a significant increase in brain age gap.
• A healthy lifestyle attenuated the association between diabetes and a higher brain age gap (P = .003), reducing it by 1.68 years, also with a significant interaction between glycemic status and lifestyle.

IN PRACTICE:

“Our findings highlight diabetes and prediabetes as ideal targets for lifestyle-based interventions to promote brain health,” the authors wrote.

SOURCE:

This study, led by Abigail Dove, Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden, was published online in Diabetes Care.

LIMITATIONS:

The generalizability of the findings was limited due to a healthy volunteer bias in the UK Biobank. A high proportion of missing data prevented the inclusion of diet in the healthy lifestyle construct. Reverse causality may be possible as an older brain may contribute to the development of prediabetes by making it more difficult to manage medical conditions and adhere to a healthy lifestyle. A1c levels were measured only at baseline, preventing the assessment of changes in glycemic control over time.

DISCLOSURES:

The authors reported receiving funding from the Swedish Research Council; Swedish Research Council for Health, Working Life and Welfare; Karolinska Institutet Board of Research; Riksbankens Jubileumsfond; Marianne and Marcus Wallenberg Foundation; Alzheimerfonden; and Demensfonden. They declared no relevant conflicts of interest.

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

TOPLINE:

Diabetes and prediabetes are associated with accelerated brain aging with brain age gaps of 2.29 and 0.50 years, respectively. This association is more pronounced in men and those with poor cardiometabolic health but may be mitigated by a healthy lifestyle.

METHODOLOGY:

• Diabetes is a known risk factor for cognitive impairment, dementia, and global brain atrophy but conflicting results have been reported for prediabetes, and it’s unknown whether a healthy lifestyle can counteract the negative impact of prediabetes.
• Researchers examined the cross-sectional and longitudinal relationship between hyperglycemia and brain aging, as well as the potential mitigating effect of a healthy lifestyle in 31,229 dementia-free adults (mean age, 54.8 years; 53% women) from the UK Biobank, including 13,518 participants with prediabetes and 1149 with diabetes.
• The glycemic status of the participants was determined by their medical history, medication use, and A1c levels.
• The brain age gap was calculated as a difference between chronologic age and brain age estimated from MRI data from six modalities vs several hundred brain MRI phenotypes that were modeled from a subset of healthy individuals.
• The role of sex, cardiometabolic risk factors, and a healthy lifestyle and their association with brain age was also explored, with a healthy lifestyle defined as never smoking, no or light or moderate alcohol consumption, and high physical activity.

TAKEAWAY:

• Prediabetes and diabetes were associated with a higher brain age gap than normoglycemia (beta-coefficient, 0.22 and 2.01; 95% CI, 0.10-0.34 and 1.70-2.32, respectively), and diabetes was more pronounced in men vs women and those with a higher vs lower burden of cardiometabolic risk factors.
• The brain ages of those with prediabetes and diabetes were 0.50 years and 2.29 years older on average than their respective chronologic ages.
• In an exploratory longitudinal analysis of the 2414 participants with two brain MRI scans, diabetes was linked to a 0.27-year annual increase in the brain age gap, and higher A1c, but not prediabetes, was associated with a significant increase in brain age gap.
• A healthy lifestyle attenuated the association between diabetes and a higher brain age gap (P = .003), reducing it by 1.68 years, also with a significant interaction between glycemic status and lifestyle.

IN PRACTICE:

“Our findings highlight diabetes and prediabetes as ideal targets for lifestyle-based interventions to promote brain health,” the authors wrote.

SOURCE:

This study, led by Abigail Dove, Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden, was published online in Diabetes Care.

LIMITATIONS:

The generalizability of the findings was limited due to a healthy volunteer bias in the UK Biobank. A high proportion of missing data prevented the inclusion of diet in the healthy lifestyle construct. Reverse causality may be possible as an older brain may contribute to the development of prediabetes by making it more difficult to manage medical conditions and adhere to a healthy lifestyle. A1c levels were measured only at baseline, preventing the assessment of changes in glycemic control over time.

DISCLOSURES:

The authors reported receiving funding from the Swedish Research Council; Swedish Research Council for Health, Working Life and Welfare; Karolinska Institutet Board of Research; Riksbankens Jubileumsfond; Marianne and Marcus Wallenberg Foundation; Alzheimerfonden; and Demensfonden. They declared no relevant conflicts of interest.

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

TOPLINE:

Diabetes and prediabetes are associated with accelerated brain aging with brain age gaps of 2.29 and 0.50 years, respectively. This association is more pronounced in men and those with poor cardiometabolic health but may be mitigated by a healthy lifestyle.

METHODOLOGY:

• Diabetes is a known risk factor for cognitive impairment, dementia, and global brain atrophy but conflicting results have been reported for prediabetes, and it’s unknown whether a healthy lifestyle can counteract the negative impact of prediabetes.
• Researchers examined the cross-sectional and longitudinal relationship between hyperglycemia and brain aging, as well as the potential mitigating effect of a healthy lifestyle in 31,229 dementia-free adults (mean age, 54.8 years; 53% women) from the UK Biobank, including 13,518 participants with prediabetes and 1149 with diabetes.
• The glycemic status of the participants was determined by their medical history, medication use, and A1c levels.
• The brain age gap was calculated as a difference between chronologic age and brain age estimated from MRI data from six modalities vs several hundred brain MRI phenotypes that were modeled from a subset of healthy individuals.
• The role of sex, cardiometabolic risk factors, and a healthy lifestyle and their association with brain age was also explored, with a healthy lifestyle defined as never smoking, no or light or moderate alcohol consumption, and high physical activity.

TAKEAWAY:

• Prediabetes and diabetes were associated with a higher brain age gap than normoglycemia (beta-coefficient, 0.22 and 2.01; 95% CI, 0.10-0.34 and 1.70-2.32, respectively), and diabetes was more pronounced in men vs women and those with a higher vs lower burden of cardiometabolic risk factors.
• The brain ages of those with prediabetes and diabetes were 0.50 years and 2.29 years older on average than their respective chronologic ages.
• In an exploratory longitudinal analysis of the 2414 participants with two brain MRI scans, diabetes was linked to a 0.27-year annual increase in the brain age gap, and higher A1c, but not prediabetes, was associated with a significant increase in brain age gap.
• A healthy lifestyle attenuated the association between diabetes and a higher brain age gap (P = .003), reducing it by 1.68 years, also with a significant interaction between glycemic status and lifestyle.

IN PRACTICE:

“Our findings highlight diabetes and prediabetes as ideal targets for lifestyle-based interventions to promote brain health,” the authors wrote.

SOURCE:

This study, led by Abigail Dove, Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden, was published online in Diabetes Care.

LIMITATIONS:

The generalizability of the findings was limited due to a healthy volunteer bias in the UK Biobank. A high proportion of missing data prevented the inclusion of diet in the healthy lifestyle construct. Reverse causality may be possible as an older brain may contribute to the development of prediabetes by making it more difficult to manage medical conditions and adhere to a healthy lifestyle. A1c levels were measured only at baseline, preventing the assessment of changes in glycemic control over time.

DISCLOSURES:

The authors reported receiving funding from the Swedish Research Council; Swedish Research Council for Health, Working Life and Welfare; Karolinska Institutet Board of Research; Riksbankens Jubileumsfond; Marianne and Marcus Wallenberg Foundation; Alzheimerfonden; and Demensfonden. They declared no relevant conflicts of interest.

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

Pertussis cases in the United States have increased fourfold compared with the same time period last year, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.

The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.

Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.

Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.

Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.

Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
 

Beyond Easing Pandemic Precautions

Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.

“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.

The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
 

Not Just the Young Ones

A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.

Clinical Clues

The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.

The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.

In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said. 

Dr. Cennimo had no financial conflicts to disclose.

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

Pertussis cases in the United States have increased fourfold compared with the same time period last year, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.

The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.

Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.

Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.

Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.

Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
 

Beyond Easing Pandemic Precautions

Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.

“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.

The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
 

Not Just the Young Ones

A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.

Clinical Clues

The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.

The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.

In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said. 

Dr. Cennimo had no financial conflicts to disclose.

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

Pertussis cases in the United States have increased fourfold compared with the same time period last year, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.

The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.

Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.

Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.

Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.

Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
 

Beyond Easing Pandemic Precautions

Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.

“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.

The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
 

Not Just the Young Ones

A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.

Clinical Clues

The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.

The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.

In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said. 

Dr. Cennimo had no financial conflicts to disclose.

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

Case: A 38-year-old presents for acute onset runny nose, cough, and fever for the last 3 days. Her children at home have a similar presentation. She believes that she has been managing her symptoms well with Tylenol and rest. The patient is up to date on her COVID and flu shots and was wondering if there was anything else she could have done to prevent her symptoms. She saw a commercial about vitamin C supplements boosting the immune system and was wondering about their efficacy. How would you respond?

Studies of Vitamin C

Linus Pauling, FRS, did a summary of four relatively small published studies of vitamin C and concluded that vitamin C supplementation helped prevent and lessen colds.¹ He mentioned a placebo-controlled study of vitamin C with viral inoculation which did not show any effect. His overall conclusion of efficacy for vitamin C led to the widespread belief that vitamin C was a proven effective therapy to prevent and treat the common cold. Since then, multiple trials and studies have examined the effect of vitamin C on the prevention and treatment of colds.

The Cochrane Review conducted a meta-analysis comparing 29 placebo-controlled trials involving 11,306 participants.² Criteria included vitamin C supplementation of 0.2 g-1 g/day to study its efficacy in preventing the common cold. The analysis showed that supplemental vitamin C did not significantly reduce the incidence of colds. However, there was a statistically significant 8% reduction in adults and 14% in children in the duration of colds. In terms of treatment, there was no evidence of vitamin C’s efficacy.

A 2001 study conducted a small double-blind, randomized control trial to evaluate large doses of vitamin C as treatment for the common cold.³ Volunteers were divided and instructed to take varying doses ranging from 1 to 3 g of vitamin C vs a placebo at the onset of cold-like symptoms. Subjects were expected to assess the duration and severity of their cold. The data showed no significant difference in the severity or duration of cold symptoms between small or large vitamin C doses or placebo.

Summary

While vitamin C is safe, there is no evidence for its ability to prevent the common cold. Although the Cochrane review and more a recent meta-analysis by Hemilä and Chalker demonstrated statistical significance in shortening the duration of symptoms, it was a minimal reduction with little clinical significance. Educating patients that supplemental vitamin C does not prevent colds can help them save money and avoid costs for unnecessary supplements.

Ms. Ibabao is a fourth year medical student at the University of Washington School of Medicine; Dr. Paauw is Professor of Medicine, Rathmann Family Foundation Endowed Chair Patient-centered Clinical Education, at the University of Washington School of Medicine, Seattle. They have no conflicts of interest.
 

References

1. Pauling L. The significance of the evidence about ascorbic acid and the common cold. Proc Natl Acad Sci USA. 1971;68:2678-2671.

2. Hemilä H, Chalker E. Vitamin C for preventing and treating the common cold. Cochrane Database of Systematic Reviews. 2013;1(1).

3. Audera C et al. Mega‐dose vitamin C in treatment of the common cold: a randomised controlled trial. Med J Australia. 2001;175(7):359-362.

4. Hemilä H, Chalker E. Vitamin C reduces the severity of common colds: a meta-analysis. BMC Public Health. 2023;23:2468.

Case: A 38-year-old presents for acute onset runny nose, cough, and fever for the last 3 days. Her children at home have a similar presentation. She believes that she has been managing her symptoms well with Tylenol and rest. The patient is up to date on her COVID and flu shots and was wondering if there was anything else she could have done to prevent her symptoms. She saw a commercial about vitamin C supplements boosting the immune system and was wondering about their efficacy. How would you respond?

Studies of Vitamin C

Linus Pauling, FRS, did a summary of four relatively small published studies of vitamin C and concluded that vitamin C supplementation helped prevent and lessen colds.¹ He mentioned a placebo-controlled study of vitamin C with viral inoculation which did not show any effect. His overall conclusion of efficacy for vitamin C led to the widespread belief that vitamin C was a proven effective therapy to prevent and treat the common cold. Since then, multiple trials and studies have examined the effect of vitamin C on the prevention and treatment of colds.

The Cochrane Review conducted a meta-analysis comparing 29 placebo-controlled trials involving 11,306 participants.² Criteria included vitamin C supplementation of 0.2 g-1 g/day to study its efficacy in preventing the common cold. The analysis showed that supplemental vitamin C did not significantly reduce the incidence of colds. However, there was a statistically significant 8% reduction in adults and 14% in children in the duration of colds. In terms of treatment, there was no evidence of vitamin C’s efficacy.

A 2001 study conducted a small double-blind, randomized control trial to evaluate large doses of vitamin C as treatment for the common cold.³ Volunteers were divided and instructed to take varying doses ranging from 1 to 3 g of vitamin C vs a placebo at the onset of cold-like symptoms. Subjects were expected to assess the duration and severity of their cold. The data showed no significant difference in the severity or duration of cold symptoms between small or large vitamin C doses or placebo.

Summary

While vitamin C is safe, there is no evidence for its ability to prevent the common cold. Although the Cochrane review and more a recent meta-analysis by Hemilä and Chalker demonstrated statistical significance in shortening the duration of symptoms, it was a minimal reduction with little clinical significance. Educating patients that supplemental vitamin C does not prevent colds can help them save money and avoid costs for unnecessary supplements.

Ms. Ibabao is a fourth year medical student at the University of Washington School of Medicine; Dr. Paauw is Professor of Medicine, Rathmann Family Foundation Endowed Chair Patient-centered Clinical Education, at the University of Washington School of Medicine, Seattle. They have no conflicts of interest.
 

References

1. Pauling L. The significance of the evidence about ascorbic acid and the common cold. Proc Natl Acad Sci USA. 1971;68:2678-2671.

2. Hemilä H, Chalker E. Vitamin C for preventing and treating the common cold. Cochrane Database of Systematic Reviews. 2013;1(1).

3. Audera C et al. Mega‐dose vitamin C in treatment of the common cold: a randomised controlled trial. Med J Australia. 2001;175(7):359-362.

4. Hemilä H, Chalker E. Vitamin C reduces the severity of common colds: a meta-analysis. BMC Public Health. 2023;23:2468.

Case: A 38-year-old presents for acute onset runny nose, cough, and fever for the last 3 days. Her children at home have a similar presentation. She believes that she has been managing her symptoms well with Tylenol and rest. The patient is up to date on her COVID and flu shots and was wondering if there was anything else she could have done to prevent her symptoms. She saw a commercial about vitamin C supplements boosting the immune system and was wondering about their efficacy. How would you respond?

Studies of Vitamin C

Linus Pauling, FRS, did a summary of four relatively small published studies of vitamin C and concluded that vitamin C supplementation helped prevent and lessen colds.¹ He mentioned a placebo-controlled study of vitamin C with viral inoculation which did not show any effect. His overall conclusion of efficacy for vitamin C led to the widespread belief that vitamin C was a proven effective therapy to prevent and treat the common cold. Since then, multiple trials and studies have examined the effect of vitamin C on the prevention and treatment of colds.

The Cochrane Review conducted a meta-analysis comparing 29 placebo-controlled trials involving 11,306 participants.² Criteria included vitamin C supplementation of 0.2 g-1 g/day to study its efficacy in preventing the common cold. The analysis showed that supplemental vitamin C did not significantly reduce the incidence of colds. However, there was a statistically significant 8% reduction in adults and 14% in children in the duration of colds. In terms of treatment, there was no evidence of vitamin C’s efficacy.

A 2001 study conducted a small double-blind, randomized control trial to evaluate large doses of vitamin C as treatment for the common cold.³ Volunteers were divided and instructed to take varying doses ranging from 1 to 3 g of vitamin C vs a placebo at the onset of cold-like symptoms. Subjects were expected to assess the duration and severity of their cold. The data showed no significant difference in the severity or duration of cold symptoms between small or large vitamin C doses or placebo.

Summary

While vitamin C is safe, there is no evidence for its ability to prevent the common cold. Although the Cochrane review and more a recent meta-analysis by Hemilä and Chalker demonstrated statistical significance in shortening the duration of symptoms, it was a minimal reduction with little clinical significance. Educating patients that supplemental vitamin C does not prevent colds can help them save money and avoid costs for unnecessary supplements.

Ms. Ibabao is a fourth year medical student at the University of Washington School of Medicine; Dr. Paauw is Professor of Medicine, Rathmann Family Foundation Endowed Chair Patient-centered Clinical Education, at the University of Washington School of Medicine, Seattle. They have no conflicts of interest.
 

References

1. Pauling L. The significance of the evidence about ascorbic acid and the common cold. Proc Natl Acad Sci USA. 1971;68:2678-2671.

2. Hemilä H, Chalker E. Vitamin C for preventing and treating the common cold. Cochrane Database of Systematic Reviews. 2013;1(1).

3. Audera C et al. Mega‐dose vitamin C in treatment of the common cold: a randomised controlled trial. Med J Australia. 2001;175(7):359-362.

4. Hemilä H, Chalker E. Vitamin C reduces the severity of common colds: a meta-analysis. BMC Public Health. 2023;23:2468.

BARCELONA, SPAIN — Patients with high-risk stage III resectable melanoma treated with neoadjuvant combination immunotherapy achieved higher event- and recurrence-free survival than patients who received monotherapy with immunotherapy or a targeted agent or targeted therapy plus immunotherapy, according to a large-scale pooled analysis from the International Neoadjuvant Melanoma Consortium.

Importantly, the analysis — presented at the annual meeting of the European Society for Medical Oncology — showed that achieving a major pathological response to neoadjuvant therapy is a key indicator of survival outcomes.

After 3 years of follow-up, the results showed that neoadjuvant therapy is not delaying melanoma recurrence, “it’s actually preventing it,” coinvestigator Hussein A. Tawbi, MD, PhD, Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, said in an interview. That’s “a big deal.”

Since 2010, the introduction of novel adjuvant and neoadjuvant therapies for high-risk stage III resectable melanoma has led to incremental gains for patients, said Georgina V. Long, MD, PhD, BSc, chair of Melanoma Medical Oncology and Translational Research at the University of Sydney in Australia, who presented the results.

The first pooled analysis of neoadjuvant therapy in 189 patients, published in 2021, indicated that those who achieved a major pathological response — defined as either a pathological complete response (with no remaining vital tumor) or a near-complete pathological response (with vital tumor ≤ 10%) — had the best recurrence-free survival rates.

In the current study, the researchers expanded their cohort to include 818 patients from 18 centers. Patients received at least one dose of neoadjuvant therapy — either combination immunotherapy, combination of targeted and immunotherapy agents, or monotherapy with either an immune checkpoint inhibitor or a targeted agent.

The median age was 59 years, and 38% of patients were women. The median follow-up so far is 38.8 months.

Overall, the 3-year event-free survival was 74% in patients who received any immunotherapy, 72% in those who received immunotherapy plus a targeted BRAF/MEK therapy, and just 37% in those who received targeted therapy alone. Similarly, 3-year recurrence-free survival rates were highest in patients who received immunotherapy at 77% vs 73% in those who received immunotherapy plus a targeted BRAF/MEK therapy and just 37% in those who received targeted therapy alone.

Looking specifically at progressive death 1 (PD-1)–based immunotherapy regimens, combination therapy led to a 3-year event-free survival rate between 77% and 95%, depending on the specific combinations, vs 64% with PD-1 monotherapy and 37% with combination targeted therapy.

Overall, patients who had a major pathological response were more likely to be recurrence free at 3 years. The 3-year recurrence-free survival was 88% in patients with a complete response, 68% in those with a partial pathological response, and 40% in those without a response.

Patients who received immunotherapy were more likely to have major pathological response. The 3-year recurrence-free survival was about 94% in patients who received combination or monotherapy with immune checkpoint inhibition, and about 87% in those who received immunotherapy plus targeted therapy. The recurrence-free survival rate was much lower in patients given only BRAF/MEK inhibitors.

The current overall survival data, which are still immature, suggested a few differences when stratifying the patients by treatment. Almost all patients with a major pathological response were alive at 3 years, compared with 86% of those with a partial pathological response and 70% of those without a pathological response.

Overall, the results showed that immunotherapy — as either combination or monotherapy — is “quite a bit” better than targeted therapy with BRAF/MEK agents, which offers no substantial benefit, said Dr. Twabi.

“When you see the same pattern happening in study after study, in a very clear, robust way, it actually becomes very powerful,” he explained.

Rebecca A. Dent, MD, MSc, chair of the ESMO Scientific Committee who was not involved in the study, told a press conference that the introduction of immunotherapy and combination immunotherapy has dramatically changed outcomes in melanoma.

Commenting on the current study results, Dr. Dent said that “combination immunotherapy is clearly showing exceptional stability in terms of long-term benefits.”

The question now is what are the toxicities and costs that come with combination immunotherapy, said Dr. Dent, from National Cancer Centre Singapore and Duke-NUS Medical School, Singapore.

No funding source was declared. Dr. Long declared relationships with a variety of companies, including AstraZeneca UK Limited, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, and Regeneron. Dr. Twabi declared relationships with Bristol-Myers Squibb, Novartis, Merck, Genentech, GlaxoSmithKline, Eisai, and others. Dr. Dent declared relationships with AstraZeneca, Roche, Eisai, Gilead Sciences, Eli Lilly, Merck, and Pfizer.

A version of this article appeared on Medscape.com.

BARCELONA, SPAIN — Patients with high-risk stage III resectable melanoma treated with neoadjuvant combination immunotherapy achieved higher event- and recurrence-free survival than patients who received monotherapy with immunotherapy or a targeted agent or targeted therapy plus immunotherapy, according to a large-scale pooled analysis from the International Neoadjuvant Melanoma Consortium.

Importantly, the analysis — presented at the annual meeting of the European Society for Medical Oncology — showed that achieving a major pathological response to neoadjuvant therapy is a key indicator of survival outcomes.

After 3 years of follow-up, the results showed that neoadjuvant therapy is not delaying melanoma recurrence, “it’s actually preventing it,” coinvestigator Hussein A. Tawbi, MD, PhD, Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, said in an interview. That’s “a big deal.”

Since 2010, the introduction of novel adjuvant and neoadjuvant therapies for high-risk stage III resectable melanoma has led to incremental gains for patients, said Georgina V. Long, MD, PhD, BSc, chair of Melanoma Medical Oncology and Translational Research at the University of Sydney in Australia, who presented the results.

The first pooled analysis of neoadjuvant therapy in 189 patients, published in 2021, indicated that those who achieved a major pathological response — defined as either a pathological complete response (with no remaining vital tumor) or a near-complete pathological response (with vital tumor ≤ 10%) — had the best recurrence-free survival rates.

In the current study, the researchers expanded their cohort to include 818 patients from 18 centers. Patients received at least one dose of neoadjuvant therapy — either combination immunotherapy, combination of targeted and immunotherapy agents, or monotherapy with either an immune checkpoint inhibitor or a targeted agent.

The median age was 59 years, and 38% of patients were women. The median follow-up so far is 38.8 months.

Overall, the 3-year event-free survival was 74% in patients who received any immunotherapy, 72% in those who received immunotherapy plus a targeted BRAF/MEK therapy, and just 37% in those who received targeted therapy alone. Similarly, 3-year recurrence-free survival rates were highest in patients who received immunotherapy at 77% vs 73% in those who received immunotherapy plus a targeted BRAF/MEK therapy and just 37% in those who received targeted therapy alone.

Looking specifically at progressive death 1 (PD-1)–based immunotherapy regimens, combination therapy led to a 3-year event-free survival rate between 77% and 95%, depending on the specific combinations, vs 64% with PD-1 monotherapy and 37% with combination targeted therapy.

Overall, patients who had a major pathological response were more likely to be recurrence free at 3 years. The 3-year recurrence-free survival was 88% in patients with a complete response, 68% in those with a partial pathological response, and 40% in those without a response.

Patients who received immunotherapy were more likely to have major pathological response. The 3-year recurrence-free survival was about 94% in patients who received combination or monotherapy with immune checkpoint inhibition, and about 87% in those who received immunotherapy plus targeted therapy. The recurrence-free survival rate was much lower in patients given only BRAF/MEK inhibitors.

The current overall survival data, which are still immature, suggested a few differences when stratifying the patients by treatment. Almost all patients with a major pathological response were alive at 3 years, compared with 86% of those with a partial pathological response and 70% of those without a pathological response.

Overall, the results showed that immunotherapy — as either combination or monotherapy — is “quite a bit” better than targeted therapy with BRAF/MEK agents, which offers no substantial benefit, said Dr. Twabi.

“When you see the same pattern happening in study after study, in a very clear, robust way, it actually becomes very powerful,” he explained.

Rebecca A. Dent, MD, MSc, chair of the ESMO Scientific Committee who was not involved in the study, told a press conference that the introduction of immunotherapy and combination immunotherapy has dramatically changed outcomes in melanoma.

Commenting on the current study results, Dr. Dent said that “combination immunotherapy is clearly showing exceptional stability in terms of long-term benefits.”

The question now is what are the toxicities and costs that come with combination immunotherapy, said Dr. Dent, from National Cancer Centre Singapore and Duke-NUS Medical School, Singapore.

No funding source was declared. Dr. Long declared relationships with a variety of companies, including AstraZeneca UK Limited, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, and Regeneron. Dr. Twabi declared relationships with Bristol-Myers Squibb, Novartis, Merck, Genentech, GlaxoSmithKline, Eisai, and others. Dr. Dent declared relationships with AstraZeneca, Roche, Eisai, Gilead Sciences, Eli Lilly, Merck, and Pfizer.

A version of this article appeared on Medscape.com.

BARCELONA, SPAIN — Patients with high-risk stage III resectable melanoma treated with neoadjuvant combination immunotherapy achieved higher event- and recurrence-free survival than patients who received monotherapy with immunotherapy or a targeted agent or targeted therapy plus immunotherapy, according to a large-scale pooled analysis from the International Neoadjuvant Melanoma Consortium.

Importantly, the analysis — presented at the annual meeting of the European Society for Medical Oncology — showed that achieving a major pathological response to neoadjuvant therapy is a key indicator of survival outcomes.

After 3 years of follow-up, the results showed that neoadjuvant therapy is not delaying melanoma recurrence, “it’s actually preventing it,” coinvestigator Hussein A. Tawbi, MD, PhD, Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, said in an interview. That’s “a big deal.”

Since 2010, the introduction of novel adjuvant and neoadjuvant therapies for high-risk stage III resectable melanoma has led to incremental gains for patients, said Georgina V. Long, MD, PhD, BSc, chair of Melanoma Medical Oncology and Translational Research at the University of Sydney in Australia, who presented the results.

The first pooled analysis of neoadjuvant therapy in 189 patients, published in 2021, indicated that those who achieved a major pathological response — defined as either a pathological complete response (with no remaining vital tumor) or a near-complete pathological response (with vital tumor ≤ 10%) — had the best recurrence-free survival rates.

In the current study, the researchers expanded their cohort to include 818 patients from 18 centers. Patients received at least one dose of neoadjuvant therapy — either combination immunotherapy, combination of targeted and immunotherapy agents, or monotherapy with either an immune checkpoint inhibitor or a targeted agent.

The median age was 59 years, and 38% of patients were women. The median follow-up so far is 38.8 months.

Overall, the 3-year event-free survival was 74% in patients who received any immunotherapy, 72% in those who received immunotherapy plus a targeted BRAF/MEK therapy, and just 37% in those who received targeted therapy alone. Similarly, 3-year recurrence-free survival rates were highest in patients who received immunotherapy at 77% vs 73% in those who received immunotherapy plus a targeted BRAF/MEK therapy and just 37% in those who received targeted therapy alone.

Looking specifically at progressive death 1 (PD-1)–based immunotherapy regimens, combination therapy led to a 3-year event-free survival rate between 77% and 95%, depending on the specific combinations, vs 64% with PD-1 monotherapy and 37% with combination targeted therapy.

Overall, patients who had a major pathological response were more likely to be recurrence free at 3 years. The 3-year recurrence-free survival was 88% in patients with a complete response, 68% in those with a partial pathological response, and 40% in those without a response.

Patients who received immunotherapy were more likely to have major pathological response. The 3-year recurrence-free survival was about 94% in patients who received combination or monotherapy with immune checkpoint inhibition, and about 87% in those who received immunotherapy plus targeted therapy. The recurrence-free survival rate was much lower in patients given only BRAF/MEK inhibitors.

The current overall survival data, which are still immature, suggested a few differences when stratifying the patients by treatment. Almost all patients with a major pathological response were alive at 3 years, compared with 86% of those with a partial pathological response and 70% of those without a pathological response.

Overall, the results showed that immunotherapy — as either combination or monotherapy — is “quite a bit” better than targeted therapy with BRAF/MEK agents, which offers no substantial benefit, said Dr. Twabi.

“When you see the same pattern happening in study after study, in a very clear, robust way, it actually becomes very powerful,” he explained.

Rebecca A. Dent, MD, MSc, chair of the ESMO Scientific Committee who was not involved in the study, told a press conference that the introduction of immunotherapy and combination immunotherapy has dramatically changed outcomes in melanoma.

Commenting on the current study results, Dr. Dent said that “combination immunotherapy is clearly showing exceptional stability in terms of long-term benefits.”

The question now is what are the toxicities and costs that come with combination immunotherapy, said Dr. Dent, from National Cancer Centre Singapore and Duke-NUS Medical School, Singapore.

No funding source was declared. Dr. Long declared relationships with a variety of companies, including AstraZeneca UK Limited, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, and Regeneron. Dr. Twabi declared relationships with Bristol-Myers Squibb, Novartis, Merck, Genentech, GlaxoSmithKline, Eisai, and others. Dr. Dent declared relationships with AstraZeneca, Roche, Eisai, Gilead Sciences, Eli Lilly, Merck, and Pfizer.

A version of this article appeared on Medscape.com.

TOPLINE:

Optimal management of blood pressure, A1c levels, low-density lipoprotein cholesterol (LDL-C), albuminuria, smoking, and physical activity may reduce the excess risk for chronic kidney disease (CKD) typically linked to obesity. The protective effect is more pronounced in men, in those with lower healthy food scores, and in users of diabetes medication.

METHODOLOGY:

• Obesity is a significant risk factor for CKD, but it is unknown if managing multiple other obesity-related CKD risk factors can mitigate the excess CKD risk.
• Researchers assessed CKD risk factor control in 97,538 participants with obesity from the UK Biobank and compared them with an equal number of age- and sex-matched control participants with normal body weight and no CKD at baseline.
• Participants with obesity were assessed for six modifiable risk factors: Blood pressure, A1c levels, LDL-C, albuminuria, smoking, and physical activity.
• Overall, 2487, 12,720, 32,388, 36,988, and 15,381 participants with obesity had at most two, three, four, five, and six risk factors under combined control, respectively, with the two or fewer group serving as the reference.
• The primary outcome was incident CKD and the degree of combined risk factor control in persons. The CKD risk and risk factor control in participants with obesity were also compared with CKD incidence in matched normal weight participants.

TAKEAWAY:

• During a median follow-up period of 10.8 years, 3954 cases of incident CKD were reported in participants with obesity and 1498 cases in matched persons of normal body mass index (BMI).
• In a stepwise pattern, optimal control of each additional risk factor was associated with 11% (adjusted hazard ratio [aHR], 0.89; 95% CI, 0.86-0.91) reduction in the incidence of CKD events, down to a 49% reduction in CKD incidence (aHR, 0.51; 95% CI, 0.43-0.61) for combined control of all six risk factors in participants with obesity.
• The protective effect of combined control of risk factors was more pronounced in men vs women, in those with lower vs higher healthy diet scores, and in users vs nonusers of diabetes medication.
• A similar stepwise pattern emerged between the number of risk factors controlled and CKD risk in participants with obesity compared with matched individuals of normal BMI, with the excess CKD risk eliminated in participants with obesity with six risk factors under control.

IN PRACTICE:

“Comprehensive control of risk factors might effectively neutralize the excessive CKD risk associated with obesity, emphasizing the potential of a joint management approach in the prevention of CKD in this population,” the authors wrote.

SOURCE:

The study was led by Rui Tang, MS, Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana. It was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The evaluated risk factors for CKD were arbitrarily selected, which may not represent the ideal group. The study did not consider the time-varying effect of joint risk factor control owing to the lack of some variables such as A1c. The generalizability of the findings was limited because over 90% of the UK Biobank cohort is composed of White people and individuals with healthier behaviors compared with the overall UK population.

DISCLOSURES:

The study was supported by grants from the US National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

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

TOPLINE:

Optimal management of blood pressure, A1c levels, low-density lipoprotein cholesterol (LDL-C), albuminuria, smoking, and physical activity may reduce the excess risk for chronic kidney disease (CKD) typically linked to obesity. The protective effect is more pronounced in men, in those with lower healthy food scores, and in users of diabetes medication.

METHODOLOGY:

• Obesity is a significant risk factor for CKD, but it is unknown if managing multiple other obesity-related CKD risk factors can mitigate the excess CKD risk.
• Researchers assessed CKD risk factor control in 97,538 participants with obesity from the UK Biobank and compared them with an equal number of age- and sex-matched control participants with normal body weight and no CKD at baseline.
• Participants with obesity were assessed for six modifiable risk factors: Blood pressure, A1c levels, LDL-C, albuminuria, smoking, and physical activity.
• Overall, 2487, 12,720, 32,388, 36,988, and 15,381 participants with obesity had at most two, three, four, five, and six risk factors under combined control, respectively, with the two or fewer group serving as the reference.
• The primary outcome was incident CKD and the degree of combined risk factor control in persons. The CKD risk and risk factor control in participants with obesity were also compared with CKD incidence in matched normal weight participants.

TAKEAWAY:

• During a median follow-up period of 10.8 years, 3954 cases of incident CKD were reported in participants with obesity and 1498 cases in matched persons of normal body mass index (BMI).
• In a stepwise pattern, optimal control of each additional risk factor was associated with 11% (adjusted hazard ratio [aHR], 0.89; 95% CI, 0.86-0.91) reduction in the incidence of CKD events, down to a 49% reduction in CKD incidence (aHR, 0.51; 95% CI, 0.43-0.61) for combined control of all six risk factors in participants with obesity.
• The protective effect of combined control of risk factors was more pronounced in men vs women, in those with lower vs higher healthy diet scores, and in users vs nonusers of diabetes medication.
• A similar stepwise pattern emerged between the number of risk factors controlled and CKD risk in participants with obesity compared with matched individuals of normal BMI, with the excess CKD risk eliminated in participants with obesity with six risk factors under control.

IN PRACTICE:

“Comprehensive control of risk factors might effectively neutralize the excessive CKD risk associated with obesity, emphasizing the potential of a joint management approach in the prevention of CKD in this population,” the authors wrote.

SOURCE:

The study was led by Rui Tang, MS, Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana. It was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The evaluated risk factors for CKD were arbitrarily selected, which may not represent the ideal group. The study did not consider the time-varying effect of joint risk factor control owing to the lack of some variables such as A1c. The generalizability of the findings was limited because over 90% of the UK Biobank cohort is composed of White people and individuals with healthier behaviors compared with the overall UK population.

DISCLOSURES:

The study was supported by grants from the US National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

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

TOPLINE:

Optimal management of blood pressure, A1c levels, low-density lipoprotein cholesterol (LDL-C), albuminuria, smoking, and physical activity may reduce the excess risk for chronic kidney disease (CKD) typically linked to obesity. The protective effect is more pronounced in men, in those with lower healthy food scores, and in users of diabetes medication.

METHODOLOGY:

• Obesity is a significant risk factor for CKD, but it is unknown if managing multiple other obesity-related CKD risk factors can mitigate the excess CKD risk.
• Researchers assessed CKD risk factor control in 97,538 participants with obesity from the UK Biobank and compared them with an equal number of age- and sex-matched control participants with normal body weight and no CKD at baseline.
• Participants with obesity were assessed for six modifiable risk factors: Blood pressure, A1c levels, LDL-C, albuminuria, smoking, and physical activity.
• Overall, 2487, 12,720, 32,388, 36,988, and 15,381 participants with obesity had at most two, three, four, five, and six risk factors under combined control, respectively, with the two or fewer group serving as the reference.
• The primary outcome was incident CKD and the degree of combined risk factor control in persons. The CKD risk and risk factor control in participants with obesity were also compared with CKD incidence in matched normal weight participants.

TAKEAWAY:

• During a median follow-up period of 10.8 years, 3954 cases of incident CKD were reported in participants with obesity and 1498 cases in matched persons of normal body mass index (BMI).
• In a stepwise pattern, optimal control of each additional risk factor was associated with 11% (adjusted hazard ratio [aHR], 0.89; 95% CI, 0.86-0.91) reduction in the incidence of CKD events, down to a 49% reduction in CKD incidence (aHR, 0.51; 95% CI, 0.43-0.61) for combined control of all six risk factors in participants with obesity.
• The protective effect of combined control of risk factors was more pronounced in men vs women, in those with lower vs higher healthy diet scores, and in users vs nonusers of diabetes medication.
• A similar stepwise pattern emerged between the number of risk factors controlled and CKD risk in participants with obesity compared with matched individuals of normal BMI, with the excess CKD risk eliminated in participants with obesity with six risk factors under control.

IN PRACTICE:

“Comprehensive control of risk factors might effectively neutralize the excessive CKD risk associated with obesity, emphasizing the potential of a joint management approach in the prevention of CKD in this population,” the authors wrote.

SOURCE:

The study was led by Rui Tang, MS, Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana. It was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The evaluated risk factors for CKD were arbitrarily selected, which may not represent the ideal group. The study did not consider the time-varying effect of joint risk factor control owing to the lack of some variables such as A1c. The generalizability of the findings was limited because over 90% of the UK Biobank cohort is composed of White people and individuals with healthier behaviors compared with the overall UK population.

DISCLOSURES:

The study was supported by grants from the US National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

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

People who received systemic glucocorticoids during short hospital stays were more than twice as likely to develop new onset diabetes than those who didn’t, reported the authors of a large study that analyzed more than a decade’s worth of patient records.

Rajna Golubic, MD, PhD, of the diabetes trials unit at the University of Oxford, United Kingdom, and colleagues did an observational cohort study, using data from electronic healthcare records of more than patients admitted between January 1, 2013, and October 1, 2023.

They looked for patients who didn’t have a diabetes diagnosis at the time of admission and who were not taking a steroid. Their research was presented this month at the 2024 annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain.

About 1.8%, of 316, of the 17,258 patients who received systemic glucocorticoids (tablets, injections, or infusions) during their hospital stay developed new-onset diabetes, while this happened to only 0.8%, or 3450, of the 434,348 who did not get these drugs, according to an abstract of the EASD presentation.

The median length of stay was 3 days (2-8) for the group of patients who took steroids, compared with 1 day (1-3) in those who did not. Further analysis showed that, when age and sex were factored in, patients receiving systemic glucocorticoids were more than twice as likely (2.6 times) to develop diabetes as those not receiving the treatment, Dr. Golubic said.

This research builds on previous studies that looked at smaller groups of patients and the diabetes risk in patients with specific conditions, including rheumatoid arthritis, Dr. Golubic said. It may prove helpful for clinicians considering when to employ steroids, which are useful medications for managing inflammation associated with many conditions.

“This gives them a very good estimate of how much more likely people treated with systemic glucocorticoids are to develop new-onset diabetes,” Dr. Golubic said.

Glucocorticoids have for decades been used for managing acute and chronic inflammatory diseases. The link to diabetes has been previously reported in smaller studies and in ones linked to specific conditions such as respiratory disease and rheumatoid arthritis.

Carolyn Cummins, PhD, an associate professor at the University of Toronto, Canada, who was not part of this study, told this news organization she was pleased to see a study of diabetes and steroids done with the scope that Dr. Golubic and colleagues undertook. Dr. Cummins in 2022 published an article titled “Fresh insights into glucocorticoid-induced diabetes mellitus and new therapeutic directions” in Nature Reviews Endocrinology. 

“We know that this is an issue, but we didn’t necessarily know numerically how significant it was,” Dr. Cummins said. “I would say it wasn’t a surprising finding, but it’s nice to actually have the numbers from a large study.”

Dr. Golubic and Dr. Cummins reported no relevant financial relationships.
 

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

People who received systemic glucocorticoids during short hospital stays were more than twice as likely to develop new onset diabetes than those who didn’t, reported the authors of a large study that analyzed more than a decade’s worth of patient records.

Rajna Golubic, MD, PhD, of the diabetes trials unit at the University of Oxford, United Kingdom, and colleagues did an observational cohort study, using data from electronic healthcare records of more than patients admitted between January 1, 2013, and October 1, 2023.

They looked for patients who didn’t have a diabetes diagnosis at the time of admission and who were not taking a steroid. Their research was presented this month at the 2024 annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain.

About 1.8%, of 316, of the 17,258 patients who received systemic glucocorticoids (tablets, injections, or infusions) during their hospital stay developed new-onset diabetes, while this happened to only 0.8%, or 3450, of the 434,348 who did not get these drugs, according to an abstract of the EASD presentation.

The median length of stay was 3 days (2-8) for the group of patients who took steroids, compared with 1 day (1-3) in those who did not. Further analysis showed that, when age and sex were factored in, patients receiving systemic glucocorticoids were more than twice as likely (2.6 times) to develop diabetes as those not receiving the treatment, Dr. Golubic said.

This research builds on previous studies that looked at smaller groups of patients and the diabetes risk in patients with specific conditions, including rheumatoid arthritis, Dr. Golubic said. It may prove helpful for clinicians considering when to employ steroids, which are useful medications for managing inflammation associated with many conditions.

“This gives them a very good estimate of how much more likely people treated with systemic glucocorticoids are to develop new-onset diabetes,” Dr. Golubic said.

Glucocorticoids have for decades been used for managing acute and chronic inflammatory diseases. The link to diabetes has been previously reported in smaller studies and in ones linked to specific conditions such as respiratory disease and rheumatoid arthritis.

Carolyn Cummins, PhD, an associate professor at the University of Toronto, Canada, who was not part of this study, told this news organization she was pleased to see a study of diabetes and steroids done with the scope that Dr. Golubic and colleagues undertook. Dr. Cummins in 2022 published an article titled “Fresh insights into glucocorticoid-induced diabetes mellitus and new therapeutic directions” in Nature Reviews Endocrinology. 

“We know that this is an issue, but we didn’t necessarily know numerically how significant it was,” Dr. Cummins said. “I would say it wasn’t a surprising finding, but it’s nice to actually have the numbers from a large study.”

Dr. Golubic and Dr. Cummins reported no relevant financial relationships.
 

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

People who received systemic glucocorticoids during short hospital stays were more than twice as likely to develop new onset diabetes than those who didn’t, reported the authors of a large study that analyzed more than a decade’s worth of patient records.

Rajna Golubic, MD, PhD, of the diabetes trials unit at the University of Oxford, United Kingdom, and colleagues did an observational cohort study, using data from electronic healthcare records of more than patients admitted between January 1, 2013, and October 1, 2023.

They looked for patients who didn’t have a diabetes diagnosis at the time of admission and who were not taking a steroid. Their research was presented this month at the 2024 annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain.

About 1.8%, of 316, of the 17,258 patients who received systemic glucocorticoids (tablets, injections, or infusions) during their hospital stay developed new-onset diabetes, while this happened to only 0.8%, or 3450, of the 434,348 who did not get these drugs, according to an abstract of the EASD presentation.

The median length of stay was 3 days (2-8) for the group of patients who took steroids, compared with 1 day (1-3) in those who did not. Further analysis showed that, when age and sex were factored in, patients receiving systemic glucocorticoids were more than twice as likely (2.6 times) to develop diabetes as those not receiving the treatment, Dr. Golubic said.

This research builds on previous studies that looked at smaller groups of patients and the diabetes risk in patients with specific conditions, including rheumatoid arthritis, Dr. Golubic said. It may prove helpful for clinicians considering when to employ steroids, which are useful medications for managing inflammation associated with many conditions.

“This gives them a very good estimate of how much more likely people treated with systemic glucocorticoids are to develop new-onset diabetes,” Dr. Golubic said.

Glucocorticoids have for decades been used for managing acute and chronic inflammatory diseases. The link to diabetes has been previously reported in smaller studies and in ones linked to specific conditions such as respiratory disease and rheumatoid arthritis.

Carolyn Cummins, PhD, an associate professor at the University of Toronto, Canada, who was not part of this study, told this news organization she was pleased to see a study of diabetes and steroids done with the scope that Dr. Golubic and colleagues undertook. Dr. Cummins in 2022 published an article titled “Fresh insights into glucocorticoid-induced diabetes mellitus and new therapeutic directions” in Nature Reviews Endocrinology. 

“We know that this is an issue, but we didn’t necessarily know numerically how significant it was,” Dr. Cummins said. “I would say it wasn’t a surprising finding, but it’s nice to actually have the numbers from a large study.”

Dr. Golubic and Dr. Cummins reported no relevant financial relationships.
 

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