News

TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

• The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
• Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

• Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
• During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
• After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
• As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
• Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
• Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
• Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
• Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

• The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
• Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

• Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
• During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
• After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
• As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
• Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
• Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
• Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
• Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

• The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
• Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

• Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
• During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
• After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
• As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
• Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
• Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
• Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
• Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

METHODOLOGY:

• Cefepime-taniborbactam is an antibiotic currently being explored as a treatment for antibiotic-resistant bacteria.
• The phase 3, double-blind, randomized trial included participants from 15 countries, including a safety group of 657 patients who were studied for adverse events and 436 in the micro intention-to-treat group who were studied for drug effectiveness.
• Each drug’s efficacy was measured as a combination of reduced bacteria levels and a resolution of symptoms and signs of infection.
• Patients in the study were over age 18; had a diagnosis of either complicated UTI or acute pyelonephritis; and had pyuria, at least one systemic sign, and at least one local sign or symptom. People were excluded if they had already received antibacterial drug therapy for more than 24 hours before randomization or had an infection with a meropenem-resistant pathogen.

TAKEAWAY:

• At days 19-23, 70.6% of patients in the cefepime-taniborbactam group showed a successful reduction in bacteria and symptoms compared with 58.0% in the meropenem group.
• Cefepime-taniborbactam was more effective than meropenem during follow-up, with 89.1% efficacy less than 24 hours after the last dose, compared to meropenem’s 86%. Cefepime-taniborbactam continued to have 63.8% efficacy up to 35 days after starting treatment, while meropenem was 51.7% during that timeframe.
• In the cefepime-taniborbactam group, 35.5% of patients experienced adverse effects that were mild to moderate, including headache, diarrhea, constipation, hypertension, and nausea, compared to 29% in the meropenem group.
• Overall, 3% of participants discontinued cefepime-taniborbactam and 1.8% discontinued meropenem, but reasons were heterogeneous.

IN PRACTICE:

“Cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a safety profile similar to that of meropenem,” the study authors wrote.

SOURCE:

Paul McGovern, MD, infectious disease specialist and senior vice president of Venatorx Pharmaceuticals, was the corresponding author of the study.

LIMITATIONS:

The authors reported no limitations.

DISCLOSURES:

The study was funded by Venatorx Pharmaceuticals, which received funding from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Global Antibiotic Research and Development Partnership, and Everest Medicines.

A version of this article appeared on Medscape.com.

TOPLINE:

Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

METHODOLOGY:

• Cefepime-taniborbactam is an antibiotic currently being explored as a treatment for antibiotic-resistant bacteria.
• The phase 3, double-blind, randomized trial included participants from 15 countries, including a safety group of 657 patients who were studied for adverse events and 436 in the micro intention-to-treat group who were studied for drug effectiveness.
• Each drug’s efficacy was measured as a combination of reduced bacteria levels and a resolution of symptoms and signs of infection.
• Patients in the study were over age 18; had a diagnosis of either complicated UTI or acute pyelonephritis; and had pyuria, at least one systemic sign, and at least one local sign or symptom. People were excluded if they had already received antibacterial drug therapy for more than 24 hours before randomization or had an infection with a meropenem-resistant pathogen.

TAKEAWAY:

• At days 19-23, 70.6% of patients in the cefepime-taniborbactam group showed a successful reduction in bacteria and symptoms compared with 58.0% in the meropenem group.
• Cefepime-taniborbactam was more effective than meropenem during follow-up, with 89.1% efficacy less than 24 hours after the last dose, compared to meropenem’s 86%. Cefepime-taniborbactam continued to have 63.8% efficacy up to 35 days after starting treatment, while meropenem was 51.7% during that timeframe.
• In the cefepime-taniborbactam group, 35.5% of patients experienced adverse effects that were mild to moderate, including headache, diarrhea, constipation, hypertension, and nausea, compared to 29% in the meropenem group.
• Overall, 3% of participants discontinued cefepime-taniborbactam and 1.8% discontinued meropenem, but reasons were heterogeneous.

IN PRACTICE:

“Cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a safety profile similar to that of meropenem,” the study authors wrote.

SOURCE:

Paul McGovern, MD, infectious disease specialist and senior vice president of Venatorx Pharmaceuticals, was the corresponding author of the study.

LIMITATIONS:

The authors reported no limitations.

DISCLOSURES:

The study was funded by Venatorx Pharmaceuticals, which received funding from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Global Antibiotic Research and Development Partnership, and Everest Medicines.

A version of this article appeared on Medscape.com.

TOPLINE:

Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

METHODOLOGY:

• Cefepime-taniborbactam is an antibiotic currently being explored as a treatment for antibiotic-resistant bacteria.
• The phase 3, double-blind, randomized trial included participants from 15 countries, including a safety group of 657 patients who were studied for adverse events and 436 in the micro intention-to-treat group who were studied for drug effectiveness.
• Each drug’s efficacy was measured as a combination of reduced bacteria levels and a resolution of symptoms and signs of infection.
• Patients in the study were over age 18; had a diagnosis of either complicated UTI or acute pyelonephritis; and had pyuria, at least one systemic sign, and at least one local sign or symptom. People were excluded if they had already received antibacterial drug therapy for more than 24 hours before randomization or had an infection with a meropenem-resistant pathogen.

TAKEAWAY:

• At days 19-23, 70.6% of patients in the cefepime-taniborbactam group showed a successful reduction in bacteria and symptoms compared with 58.0% in the meropenem group.
• Cefepime-taniborbactam was more effective than meropenem during follow-up, with 89.1% efficacy less than 24 hours after the last dose, compared to meropenem’s 86%. Cefepime-taniborbactam continued to have 63.8% efficacy up to 35 days after starting treatment, while meropenem was 51.7% during that timeframe.
• In the cefepime-taniborbactam group, 35.5% of patients experienced adverse effects that were mild to moderate, including headache, diarrhea, constipation, hypertension, and nausea, compared to 29% in the meropenem group.
• Overall, 3% of participants discontinued cefepime-taniborbactam and 1.8% discontinued meropenem, but reasons were heterogeneous.

IN PRACTICE:

“Cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a safety profile similar to that of meropenem,” the study authors wrote.

SOURCE:

Paul McGovern, MD, infectious disease specialist and senior vice president of Venatorx Pharmaceuticals, was the corresponding author of the study.

LIMITATIONS:

The authors reported no limitations.

DISCLOSURES:

The study was funded by Venatorx Pharmaceuticals, which received funding from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Global Antibiotic Research and Development Partnership, and Everest Medicines.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting.

Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)–blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without an MEK inhibitor. 

The approval “offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” Samantha R. Guild, JD, president, AIM at Melanoma Foundation, stated in a press release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

The approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%)

Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA press release.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research stated in the FDA release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

“The melanoma community is so grateful to the patients, caregivers, and clinicians who have made the clinical trials of this therapy possible and got lifileucel to approval,” Allison Betof Warner, MD, PhD, director of Melanoma Medical Oncology at Stanford Medicine, wrote on X. “We are very excited to bring this life-saving therapy to patients ASAP! Available immediately at @StanfordCancer!!!”

For the C-144-01 trial, lifileucel was administered after a lymphodepletion regimen of 60 mg/kg/d of cyclophosphamide for 2 days followed by 25 mg/m2/d of fludarabine for 5 days. Between 3 and 34 hours after infusion, patients received 600,000 IU/Kg of the interleukin 2 aldesleukin every 8-12 hours for up to six doses to support cell expansion in vivo. 

The full prescribing information for lifileucel contains a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment. The most common adverse reactions, which occurred in at least 20% of patients, were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia, and dyspnea.

“Patients receiving this product should be closely monitored before and after infusion for signs and symptoms of adverse reactions. Treatment should be withheld or discontinued in the presence of these symptoms, as indicated,” according to the FDA statement.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting.

Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)–blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without an MEK inhibitor. 

The approval “offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” Samantha R. Guild, JD, president, AIM at Melanoma Foundation, stated in a press release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

The approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%)

Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA press release.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research stated in the FDA release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

“The melanoma community is so grateful to the patients, caregivers, and clinicians who have made the clinical trials of this therapy possible and got lifileucel to approval,” Allison Betof Warner, MD, PhD, director of Melanoma Medical Oncology at Stanford Medicine, wrote on X. “We are very excited to bring this life-saving therapy to patients ASAP! Available immediately at @StanfordCancer!!!”

For the C-144-01 trial, lifileucel was administered after a lymphodepletion regimen of 60 mg/kg/d of cyclophosphamide for 2 days followed by 25 mg/m2/d of fludarabine for 5 days. Between 3 and 34 hours after infusion, patients received 600,000 IU/Kg of the interleukin 2 aldesleukin every 8-12 hours for up to six doses to support cell expansion in vivo. 

The full prescribing information for lifileucel contains a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment. The most common adverse reactions, which occurred in at least 20% of patients, were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia, and dyspnea.

“Patients receiving this product should be closely monitored before and after infusion for signs and symptoms of adverse reactions. Treatment should be withheld or discontinued in the presence of these symptoms, as indicated,” according to the FDA statement.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumor setting.

Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)–blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without an MEK inhibitor. 

The approval “offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” Samantha R. Guild, JD, president, AIM at Melanoma Foundation, stated in a press release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”

The approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%)

Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA press release.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research stated in the FDA release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

“The melanoma community is so grateful to the patients, caregivers, and clinicians who have made the clinical trials of this therapy possible and got lifileucel to approval,” Allison Betof Warner, MD, PhD, director of Melanoma Medical Oncology at Stanford Medicine, wrote on X. “We are very excited to bring this life-saving therapy to patients ASAP! Available immediately at @StanfordCancer!!!”

For the C-144-01 trial, lifileucel was administered after a lymphodepletion regimen of 60 mg/kg/d of cyclophosphamide for 2 days followed by 25 mg/m2/d of fludarabine for 5 days. Between 3 and 34 hours after infusion, patients received 600,000 IU/Kg of the interleukin 2 aldesleukin every 8-12 hours for up to six doses to support cell expansion in vivo. 

The full prescribing information for lifileucel contains a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment. The most common adverse reactions, which occurred in at least 20% of patients, were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia, and dyspnea.

“Patients receiving this product should be closely monitored before and after infusion for signs and symptoms of adverse reactions. Treatment should be withheld or discontinued in the presence of these symptoms, as indicated,” according to the FDA statement.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

Cognitive impairment in some US veterans may be due to treatable hepatic encephalopathy (HE) rather than dementia, new research suggested.

From 5%-10% of veterans diagnosed with dementia had possible undiagnosed cirrhosis, implicating HE as a contributor to cognitive impairment, found the study by Jasmohan S. Bajaj, MD, of Virginia Commonwealth University and Richmond VA Medical Center, Virginia, and colleagues.

The research was prompted, in part, by an earlier case study by Dr. Bajaj and colleagues that showed that two older men diagnosed with dementia and Parkinson’s disease actually had HE, meaning their symptoms were due to advanced but treatable liver disease.

“Once they were properly diagnosed, whatever had been considered dementia was gone,” Dr. Bajaj said. “The spouse of one man said, ‘My husband is a different person now.’ It’s not that clinicians don’t know how to treat HE; the problem was that they did not suspect it.”

Among veterans with cirrhosis, concomitant dementia is common and is difficult to distinguish from HE, but the extent to which patients with dementia also have undiagnosed cirrhosis and HE is unknown, the authors of the current study wrote. “Undiagnosed cirrhosis among veterans with dementia could raise the possibility that part of their cognitive impairment may be due to reversible HE,” they added.

To investigate, the researchers examined the prevalence and risk factors of undiagnosed cirrhosis — and therefore, possible HE — among US veterans.

The study was published online in JAMA Network Open.
 

Dementia or Cirrhosis?

Using the VHA Corporate Data Warehouse, researchers analyzed medical records of 177,422 US veterans diagnosed with dementia but not cirrhosis between 2009 and 2019 and with sufficient laboratory test results to calculate their Fibrosis-4 (FIB-4) scores. The mean age was 78.35 years, 97.1% were men, and 80.7% were White individuals.

The FIB-4 score for each patient was calculated using the most recent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or values and platelet values that were closest to the index date during the two years after the index dementia date.

Age is in the numerator of the FIB-4 score calculation; hence, higher age could lead to an erroneously high FIB-4 score, the authors noted. Therefore, for patients older than 65 years, the researchers entered 65 years as an input variable, rather than the actual age.

A FIB-4 score > 2.67 was suggestive of advanced fibrosis, whereas a score > 3.25 was suggestive of cirrhosis. 

A total of 18,390 (10.3%) veterans had a FIB-4 score > 2.67, and 9373 (5.3%) had a FIB-4 score > 3.25.

In multivariable logistic regression models, a FIB-4 score > 3.25 was associated with older age (odds ratio [OR], 1.07), male sex (OR, 1.43), congestive heart failure (OR, 1.48), viral hepatitis (OR, 1.79), an Alcohol Use Disorders Identification Test score showing problem drinking (OR, 1.56), and chronic kidney disease (OR, 1.11).

In contrast, a FIB-4 score > 3.25 was inversely associated with the White race (OR, 0.79), diabetes (OR, 0.78), hyperlipidemia (OR, 0.84), stroke (OR, 0.85), tobacco use disorder (OR, 0.78), and rural residence (OR, 0.92).

Similar findings were associated with the FIB-4 greater than 2.67 threshold.

In a follow-up validation study among 89 veterans diagnosed with dementia at a single center, the researchers found similar results: 4.4%-11.2% of participants had high FIB-4 scores, suggestive of HE.

After investigating further, they concluded that 5% of patients in that cohort had reasons other than cirrhosis for their high FIB-4 scores. The remaining patients (95%) had evidence of cirrhosis, had risk factors, and/or had no other explanation for their high FIB-4 scores.

“The combination of high FIB-4 scores and other risk factors for liver disease in patients with dementia raises the possibility that reversible HE could be a factor associated with cognitive impairment,” the authors wrote. “These findings highlight the potential to enhance cognitive function and quality of life by increasing awareness of risk factors and diagnostic indicators of advanced liver disease that may be associated with HE as a factor or as a differential diagnosis of dementia among clinicians other than liver specialists.”
 

FIB-4 Screening Advised

“An elderly patient with cirrhosis used to be an oxymoron, because we never used to have people who lived this long or were diagnosed this late with cirrhosis,” Dr. Bajaj told this news organization. “It’s a good problem to have because people are now living longer, but it also means that we need to have every single person who is taking care of patients with what is deemed to be dementia know that the patient could also have an element of encephalopathy.”

Increased awareness is important because, unlike dementia, encephalopathy is very easily treated, Dr. Bajaj said. “The biggest, easiest, correctable cause is to figure out if they have severe liver disease, and if that’s the case, your friendly neighborhood gastroenterologist is waiting for you,” he added.

The finding that cirrhosis was present in 95% of patients in the validation cohort is “very impressive, as they had excluded from the consideration all those with obvious cirrhosis before the FIB-4 was done,” said William Carey, MD, acting hepatology section head in the Department of Gastroenterology, Hepatology and Nutrition at Cleveland Clinic’s Digestive Disease Institute in Ohio. “This validates FIB-4 as a powerful tool for cirrhosis case-finding.” 

Ordering a FIB-4 “is within the skill set of every healthcare provider,” Dr. Carey, who was not involved in the study, told this news organization. “Patients with altered mental status, including suspected or proven dementia, should be screened for possible cirrhosis, as future management will change. Those with elevated FIB-4 results should also be tested for possible HE and treated if it is present.”

The study was partly funded by VA Merit Review grants to Dr. Bajaj. Dr. Bajaj reported receiving grants from Bausch, Grifols, Sequana, and Mallinckrodt outside the submitted work. Dr. Carey reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Cognitive impairment in some US veterans may be due to treatable hepatic encephalopathy (HE) rather than dementia, new research suggested.

From 5%-10% of veterans diagnosed with dementia had possible undiagnosed cirrhosis, implicating HE as a contributor to cognitive impairment, found the study by Jasmohan S. Bajaj, MD, of Virginia Commonwealth University and Richmond VA Medical Center, Virginia, and colleagues.

The research was prompted, in part, by an earlier case study by Dr. Bajaj and colleagues that showed that two older men diagnosed with dementia and Parkinson’s disease actually had HE, meaning their symptoms were due to advanced but treatable liver disease.

“Once they were properly diagnosed, whatever had been considered dementia was gone,” Dr. Bajaj said. “The spouse of one man said, ‘My husband is a different person now.’ It’s not that clinicians don’t know how to treat HE; the problem was that they did not suspect it.”

Among veterans with cirrhosis, concomitant dementia is common and is difficult to distinguish from HE, but the extent to which patients with dementia also have undiagnosed cirrhosis and HE is unknown, the authors of the current study wrote. “Undiagnosed cirrhosis among veterans with dementia could raise the possibility that part of their cognitive impairment may be due to reversible HE,” they added.

To investigate, the researchers examined the prevalence and risk factors of undiagnosed cirrhosis — and therefore, possible HE — among US veterans.

The study was published online in JAMA Network Open.
 

Dementia or Cirrhosis?

Using the VHA Corporate Data Warehouse, researchers analyzed medical records of 177,422 US veterans diagnosed with dementia but not cirrhosis between 2009 and 2019 and with sufficient laboratory test results to calculate their Fibrosis-4 (FIB-4) scores. The mean age was 78.35 years, 97.1% were men, and 80.7% were White individuals.

The FIB-4 score for each patient was calculated using the most recent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or values and platelet values that were closest to the index date during the two years after the index dementia date.

Age is in the numerator of the FIB-4 score calculation; hence, higher age could lead to an erroneously high FIB-4 score, the authors noted. Therefore, for patients older than 65 years, the researchers entered 65 years as an input variable, rather than the actual age.

A FIB-4 score > 2.67 was suggestive of advanced fibrosis, whereas a score > 3.25 was suggestive of cirrhosis. 

A total of 18,390 (10.3%) veterans had a FIB-4 score > 2.67, and 9373 (5.3%) had a FIB-4 score > 3.25.

In multivariable logistic regression models, a FIB-4 score > 3.25 was associated with older age (odds ratio [OR], 1.07), male sex (OR, 1.43), congestive heart failure (OR, 1.48), viral hepatitis (OR, 1.79), an Alcohol Use Disorders Identification Test score showing problem drinking (OR, 1.56), and chronic kidney disease (OR, 1.11).

In contrast, a FIB-4 score > 3.25 was inversely associated with the White race (OR, 0.79), diabetes (OR, 0.78), hyperlipidemia (OR, 0.84), stroke (OR, 0.85), tobacco use disorder (OR, 0.78), and rural residence (OR, 0.92).

Similar findings were associated with the FIB-4 greater than 2.67 threshold.

In a follow-up validation study among 89 veterans diagnosed with dementia at a single center, the researchers found similar results: 4.4%-11.2% of participants had high FIB-4 scores, suggestive of HE.

After investigating further, they concluded that 5% of patients in that cohort had reasons other than cirrhosis for their high FIB-4 scores. The remaining patients (95%) had evidence of cirrhosis, had risk factors, and/or had no other explanation for their high FIB-4 scores.

“The combination of high FIB-4 scores and other risk factors for liver disease in patients with dementia raises the possibility that reversible HE could be a factor associated with cognitive impairment,” the authors wrote. “These findings highlight the potential to enhance cognitive function and quality of life by increasing awareness of risk factors and diagnostic indicators of advanced liver disease that may be associated with HE as a factor or as a differential diagnosis of dementia among clinicians other than liver specialists.”
 

FIB-4 Screening Advised

“An elderly patient with cirrhosis used to be an oxymoron, because we never used to have people who lived this long or were diagnosed this late with cirrhosis,” Dr. Bajaj told this news organization. “It’s a good problem to have because people are now living longer, but it also means that we need to have every single person who is taking care of patients with what is deemed to be dementia know that the patient could also have an element of encephalopathy.”

Increased awareness is important because, unlike dementia, encephalopathy is very easily treated, Dr. Bajaj said. “The biggest, easiest, correctable cause is to figure out if they have severe liver disease, and if that’s the case, your friendly neighborhood gastroenterologist is waiting for you,” he added.

The finding that cirrhosis was present in 95% of patients in the validation cohort is “very impressive, as they had excluded from the consideration all those with obvious cirrhosis before the FIB-4 was done,” said William Carey, MD, acting hepatology section head in the Department of Gastroenterology, Hepatology and Nutrition at Cleveland Clinic’s Digestive Disease Institute in Ohio. “This validates FIB-4 as a powerful tool for cirrhosis case-finding.” 

Ordering a FIB-4 “is within the skill set of every healthcare provider,” Dr. Carey, who was not involved in the study, told this news organization. “Patients with altered mental status, including suspected or proven dementia, should be screened for possible cirrhosis, as future management will change. Those with elevated FIB-4 results should also be tested for possible HE and treated if it is present.”

The study was partly funded by VA Merit Review grants to Dr. Bajaj. Dr. Bajaj reported receiving grants from Bausch, Grifols, Sequana, and Mallinckrodt outside the submitted work. Dr. Carey reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Cognitive impairment in some US veterans may be due to treatable hepatic encephalopathy (HE) rather than dementia, new research suggested.

From 5%-10% of veterans diagnosed with dementia had possible undiagnosed cirrhosis, implicating HE as a contributor to cognitive impairment, found the study by Jasmohan S. Bajaj, MD, of Virginia Commonwealth University and Richmond VA Medical Center, Virginia, and colleagues.

The research was prompted, in part, by an earlier case study by Dr. Bajaj and colleagues that showed that two older men diagnosed with dementia and Parkinson’s disease actually had HE, meaning their symptoms were due to advanced but treatable liver disease.

“Once they were properly diagnosed, whatever had been considered dementia was gone,” Dr. Bajaj said. “The spouse of one man said, ‘My husband is a different person now.’ It’s not that clinicians don’t know how to treat HE; the problem was that they did not suspect it.”

Among veterans with cirrhosis, concomitant dementia is common and is difficult to distinguish from HE, but the extent to which patients with dementia also have undiagnosed cirrhosis and HE is unknown, the authors of the current study wrote. “Undiagnosed cirrhosis among veterans with dementia could raise the possibility that part of their cognitive impairment may be due to reversible HE,” they added.

To investigate, the researchers examined the prevalence and risk factors of undiagnosed cirrhosis — and therefore, possible HE — among US veterans.

The study was published online in JAMA Network Open.
 

Dementia or Cirrhosis?

Using the VHA Corporate Data Warehouse, researchers analyzed medical records of 177,422 US veterans diagnosed with dementia but not cirrhosis between 2009 and 2019 and with sufficient laboratory test results to calculate their Fibrosis-4 (FIB-4) scores. The mean age was 78.35 years, 97.1% were men, and 80.7% were White individuals.

The FIB-4 score for each patient was calculated using the most recent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or values and platelet values that were closest to the index date during the two years after the index dementia date.

Age is in the numerator of the FIB-4 score calculation; hence, higher age could lead to an erroneously high FIB-4 score, the authors noted. Therefore, for patients older than 65 years, the researchers entered 65 years as an input variable, rather than the actual age.

A FIB-4 score > 2.67 was suggestive of advanced fibrosis, whereas a score > 3.25 was suggestive of cirrhosis. 

A total of 18,390 (10.3%) veterans had a FIB-4 score > 2.67, and 9373 (5.3%) had a FIB-4 score > 3.25.

In multivariable logistic regression models, a FIB-4 score > 3.25 was associated with older age (odds ratio [OR], 1.07), male sex (OR, 1.43), congestive heart failure (OR, 1.48), viral hepatitis (OR, 1.79), an Alcohol Use Disorders Identification Test score showing problem drinking (OR, 1.56), and chronic kidney disease (OR, 1.11).

In contrast, a FIB-4 score > 3.25 was inversely associated with the White race (OR, 0.79), diabetes (OR, 0.78), hyperlipidemia (OR, 0.84), stroke (OR, 0.85), tobacco use disorder (OR, 0.78), and rural residence (OR, 0.92).

Similar findings were associated with the FIB-4 greater than 2.67 threshold.

In a follow-up validation study among 89 veterans diagnosed with dementia at a single center, the researchers found similar results: 4.4%-11.2% of participants had high FIB-4 scores, suggestive of HE.

After investigating further, they concluded that 5% of patients in that cohort had reasons other than cirrhosis for their high FIB-4 scores. The remaining patients (95%) had evidence of cirrhosis, had risk factors, and/or had no other explanation for their high FIB-4 scores.

“The combination of high FIB-4 scores and other risk factors for liver disease in patients with dementia raises the possibility that reversible HE could be a factor associated with cognitive impairment,” the authors wrote. “These findings highlight the potential to enhance cognitive function and quality of life by increasing awareness of risk factors and diagnostic indicators of advanced liver disease that may be associated with HE as a factor or as a differential diagnosis of dementia among clinicians other than liver specialists.”
 

FIB-4 Screening Advised

“An elderly patient with cirrhosis used to be an oxymoron, because we never used to have people who lived this long or were diagnosed this late with cirrhosis,” Dr. Bajaj told this news organization. “It’s a good problem to have because people are now living longer, but it also means that we need to have every single person who is taking care of patients with what is deemed to be dementia know that the patient could also have an element of encephalopathy.”

Increased awareness is important because, unlike dementia, encephalopathy is very easily treated, Dr. Bajaj said. “The biggest, easiest, correctable cause is to figure out if they have severe liver disease, and if that’s the case, your friendly neighborhood gastroenterologist is waiting for you,” he added.

The finding that cirrhosis was present in 95% of patients in the validation cohort is “very impressive, as they had excluded from the consideration all those with obvious cirrhosis before the FIB-4 was done,” said William Carey, MD, acting hepatology section head in the Department of Gastroenterology, Hepatology and Nutrition at Cleveland Clinic’s Digestive Disease Institute in Ohio. “This validates FIB-4 as a powerful tool for cirrhosis case-finding.” 

Ordering a FIB-4 “is within the skill set of every healthcare provider,” Dr. Carey, who was not involved in the study, told this news organization. “Patients with altered mental status, including suspected or proven dementia, should be screened for possible cirrhosis, as future management will change. Those with elevated FIB-4 results should also be tested for possible HE and treated if it is present.”

The study was partly funded by VA Merit Review grants to Dr. Bajaj. Dr. Bajaj reported receiving grants from Bausch, Grifols, Sequana, and Mallinckrodt outside the submitted work. Dr. Carey reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

A Pennsylvania urologist is suing his former employer for the alleged illegal enforcement of a noncompete agreement that limits his ability to practice locally for the next 2 years. 

The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice. 

According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania. 

Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure. 

Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN. 

Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation. 

After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said. 

Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said. 

Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs. 

For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1. 

“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland. 

Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said. 

Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”

That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses. 

Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants. 

Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.” 

As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord. 
 

A version of this article appeared on Medscape.com .

A Pennsylvania urologist is suing his former employer for the alleged illegal enforcement of a noncompete agreement that limits his ability to practice locally for the next 2 years. 

The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice. 

According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania. 

Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure. 

Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN. 

Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation. 

After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said. 

Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said. 

Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs. 

For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1. 

“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland. 

Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said. 

Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”

That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses. 

Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants. 

Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.” 

As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord. 
 

A version of this article appeared on Medscape.com .

A Pennsylvania urologist is suing his former employer for the alleged illegal enforcement of a noncompete agreement that limits his ability to practice locally for the next 2 years. 

The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice. 

According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania. 

Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure. 

Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN. 

Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation. 

After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said. 

Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said. 

Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs. 

For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1. 

“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland. 

Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said. 

Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”

That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses. 

Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants. 

Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.” 

As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord. 
 

A version of this article appeared on Medscape.com .

A Nepali medical graduate has filed a federal lawsuit against the National Board of Medical Examiners (NBME), which invalidated her test results earlier this year in response to a widespread cheating scandal. 

Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act. 

Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action. 

The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal. 

The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.

A spokesman for the NBME said the board does not comment on pending litigation. 

Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit. 

“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
 

Doctor Says She Didn’t Cheat

Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam. 

A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.

Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years. 

If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit. 

“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
 

Lawsuit: Board Did Not Follow Published Practices

Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid. 

Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint. 

About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit. 

Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted. 

“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”

Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents. 

Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.

A version of this article appeared on Medscape.com.

A Nepali medical graduate has filed a federal lawsuit against the National Board of Medical Examiners (NBME), which invalidated her test results earlier this year in response to a widespread cheating scandal. 

Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act. 

Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action. 

The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal. 

The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.

A spokesman for the NBME said the board does not comment on pending litigation. 

Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit. 

“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
 

Doctor Says She Didn’t Cheat

Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam. 

A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.

Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years. 

If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit. 

“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
 

Lawsuit: Board Did Not Follow Published Practices

Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid. 

Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint. 

About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit. 

Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted. 

“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”

Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents. 

Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.

A version of this article appeared on Medscape.com.

A Nepali medical graduate has filed a federal lawsuit against the National Board of Medical Examiners (NBME), which invalidated her test results earlier this year in response to a widespread cheating scandal. 

Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act. 

Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action. 

The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal. 

The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.

A spokesman for the NBME said the board does not comment on pending litigation. 

Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit. 

“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
 

Doctor Says She Didn’t Cheat

Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam. 

A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.

Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years. 

If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit. 

“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
 

Lawsuit: Board Did Not Follow Published Practices

Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid. 

Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint. 

About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit. 

Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted. 

“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”

Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents. 

Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.

A version of this article appeared on Medscape.com.

Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.

Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.

What Is Hyperbaric Oxygen Therapy?

Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
 

What Is the Current State of Play?

In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.

Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.

Despite the FDA clearance, there is limited evidence to suggest hyperbaric oxygen therapy reduces the late toxic effects of breast irradiation, and the research to date has largely come from small and non-randomized studies.

While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
 

Does the Latest Study Clarify Whether This Therapy Works?

The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.

Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.

The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.

Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
 

What Are the Limitations of the Current Study?

The investigators and editorialists highlighted a handful of limitations.

For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.

Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.

Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
 

Will the Latest Evidence Usher This Therapy Into More Standard Use?

Probably not, the editorialists concluded.

The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”

Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”

HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
 

A version of this article appeared on Medscape.com.

Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.

Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.

What Is Hyperbaric Oxygen Therapy?

Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
 

What Is the Current State of Play?

In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.

Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.

Despite the FDA clearance, there is limited evidence to suggest hyperbaric oxygen therapy reduces the late toxic effects of breast irradiation, and the research to date has largely come from small and non-randomized studies.

While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
 

Does the Latest Study Clarify Whether This Therapy Works?

The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.

Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.

The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.

Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
 

What Are the Limitations of the Current Study?

The investigators and editorialists highlighted a handful of limitations.

For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.

Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.

Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
 

Will the Latest Evidence Usher This Therapy Into More Standard Use?

Probably not, the editorialists concluded.

The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”

Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”

HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
 

A version of this article appeared on Medscape.com.

Although a new study of hyperbaric oxygen therapy in JAMA Oncology has been “ anxiously awaited” by breast radiation oncologists, the trial does not provide the smoking gun evidence that would justify its routine use, according to experts.

Here’s a snapshot of the current state of affairs regarding hyperbaric oxygen therapy in breast radiation oncology.

What Is Hyperbaric Oxygen Therapy?

Hyperbaric oxygen therapy is a medical procedure aimed at reducing the late toxic effects of breast irradiation, including pain, fibrosis, and edema. Patients breathe pure oxygen at greater than atmospheric pressure in a specialized chamber or room. The process leads to increased partial pressures of oxygen in blood and tissues, which can help form new blood vessels and repair damaged irradiated tissue.
 

What Is the Current State of Play?

In 2021, the US Food and Drug Administration (FDA) cleared the therapy for a variety of disorders, including radiation injuries. Some health insurers may cover the procedure as well.

Still, the FDA has cautioned clinicians “to be wary of unproven claims of effect,” University of Toronto radiation oncologist Ezra Hahn, MD, and colleagues Aron Popovtzer, MD, and Benjamin W. Corn, MD, said in a JAMA Oncology editorial.

Despite the FDA clearance, there is limited evidence to suggest hyperbaric oxygen therapy reduces the late toxic effects of breast irradiation, and the research to date has largely come from small and non-randomized studies.

While the procedure is “seldom used by many in practice,” there is growing industry for the procedure. More than 1000 facilities in the United States offer hyperbaric oxygen therapy, but only about 15% are accredited by the Undersea and Hyperbaric Medical Society, which may signal misuse of the procedure.
 

Does the Latest Study Clarify Whether This Therapy Works?

The most recent evidence on hyperbaric oxygen therapy comes from a single-institution, randomized trial from the Netherlands, dubbed HONEY. In the trial, 189 women who experienced late toxic effects following adjuvant breast radiation were randomized 2:1 to hyperbaric oxygen therapy or a control arm. Of the 125 women offered hyperbaric oxygen therapy, only 25% (31 patients) accepted and completed treatment; those who declined received usual follow-up care.

Among women who completed hyperbaric oxygen therapy, 32% (10 of 31) reported moderate or severe pain at follow-up vs 75% of controls — a 66% reduction. Similarly, 17% of women who completed hyperbaric oxygen therapy reported moderate or severe fibrosis at follow-up vs 86% among the hypothetical treatment-completing controls — an 86% reduction. However, the authors did not observe a significant effect of hyperbaric oxygen therapy on breast edema, movement restriction, or overall quality of life.

The authors also included an intention-to-treat analysis, which included patients who declined hyperbaric oxygen therapy as part of the intervention group. This analysis estimated clinical outcomes among patients who had the intervention available to them, with some taking advantage and others not.

Overall, hyperbaric oxygen therapy “seems effective for reducing pain and fibrosis in women with late local toxic effects after breast irradiation,” concluded investigators led by Dieuwke R. Mink van der Molen, PhD, a researcher at the University Medical Centre Utrecht, the Netherlands. However, most patients offered the therapy declined the invitation, largely because of the “high treatment intensity” burden.
 

What Are the Limitations of the Current Study?

The investigators and editorialists highlighted a handful of limitations.

For one, the trial had no sham hyperbaric oxygen therapy procedure in the control group. In fact, control patients were selected from a larger cohort of ongoing studies in the Netherlands who were not aware the trial was being conducted.

Because radiation toxicity fluctuates over time and can improve on its own, “a high-quality control arm” would be needed in such a trial, especially to account for subjective and patient-reported outcomes, the editorialists said.

Another key issue: Only a quarter of women offered hyperbaric oxygen therapy agreed to and completed treatment. The treatment burden was the most common reason for declining the procedure. Study participants underwent 30-40 2-hour sessions over 6-8 weeks.
 

Will the Latest Evidence Usher This Therapy Into More Standard Use?

Probably not, the editorialists concluded.

The HONEY trial “reminds us that convenience has become a factor weighted heavily by patients during the process of decision-making,” Dr. Hahn and colleagues wrote. “Despite experiencing relatively severe symptoms, many declined hyperbaric therapy after being counseled by HONEY investigators about the time commitment.”

Despite its limitations, the trial does offer “modest evidence to justify the use of [hyperbaric oxygen therapy] in treating the chronic morbidities associated with breast irradiation,” the editorialists said. But an “adequately powered randomized, sham-controlled, double-blind trials will be necessary to truly determine the benefit.”

HONEY was partially funded by The Da Vinci Clinic, the Netherlands. The investigators didn’t have any disclosures. One of Dr. Hahn’s coauthors reported personal fees from Lutris Pharma as Chief Medical Officer.
 

A version of this article appeared on Medscape.com.