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Combining Upper-Lower GI Screening Feasible, Effective
BERLIN — , including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.
“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.
While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.
The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”
Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.
Mixed Rates of GI Cancers Across Europe and the US
These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.
However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”
The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy.
A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.
Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.
Neoplasia and Preneoplasia Found
A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.
A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”
Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.
Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.
Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.
“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.
“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”
PROSPERO: Early Detection of Upper GI Conditions in a UK Population
Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”
“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.
“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”
Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”
TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.
Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.
A version of this article first appeared on Medscape.com.
BERLIN — , including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.
“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.
While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.
The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”
Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.
Mixed Rates of GI Cancers Across Europe and the US
These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.
However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”
The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy.
A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.
Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.
Neoplasia and Preneoplasia Found
A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.
A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”
Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.
Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.
Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.
“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.
“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”
PROSPERO: Early Detection of Upper GI Conditions in a UK Population
Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”
“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.
“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”
Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”
TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.
Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.
A version of this article first appeared on Medscape.com.
BERLIN — , including malignancies and lesions requiring ongoing surveillance, according to an interim analysis from the TOGAS study.
“There was an abundance of benign but clinically relevant findings,” said lead investigator Jan Bornschein, MD, gastroenterologist at Oxford University Hospitals NHS Foundation Trust, Oxford, England, who presented the interim resuts of the study at United European Gastroenterology (UEG) Week 2025.
While the study found upper GI neoplasia in only 1.4% of participants, 17.8% of individuals were marked for upper GI endoscopic surveillance.
The results may inform how Europe develops gastric cancer prevention programs alongside those for colorectal cancer, said Bornschein. “If we can combine the upper GI endoscopy with other modalities [colonoscopy], the more likelihood there is that you can have a one-stop test package,” he said. “A combination, particularly for bowel and stomach, is more feasible and also more cost-effective. So far, the findings show that it’s definitely a strategy that, in my opinion, is worth implementing.”
Bornschein and the TOGAS study group hope that the combined approach will prove workable across diverse European settings and will help identify a spectrum of upper GI pathology, from cancers and dysplasia to atrophy and intestinal metaplasia, that can meaningfully affect follow-up surveillance.
Mixed Rates of GI Cancers Across Europe and the US
These findings come amid data showing rising rates of early-onset (younger than 50 years) GI cancers in the US, including colorectal, gastric, pancreatic, and esophageal tumors. These trends, previously reported by this news organization, point to environmental and lifestyle drivers, strengthening the case for earlier detection and risk-tailored strategies for upper GI neoplasia and preneoplastic conditions detected during existing colorectal cancer screening pathways.
However, Bornschein noted that prevalence varies considerably across Europe. “There are areas, particularly in the Eastern regions, and in some parts of the West, for example, Portugal, that have a very high incidence of GI cancers. In the UK or in Germany, we have noticed a decline over the years, so the numbers are actually much better than they used to be.”
The study is the second in a series of three TOGAS pilot studies and was conducted across eight centers (France, Germany, Ireland, Latvia, Lithuania, the Netherlands, Portugal, and Spain) in adults aged 50-74 years attending screening or polyp-surveillance colonoscopy.
A European Society of Gastrointestinal Endoscopy-aligned protocol defining image documentation, biopsy sampling, and quality parameters was followed to ensure a standardized approach. “Marked preneoplastic change” was defined as gastric glandular atrophy or intestinal metaplasia at the Operative Link on Gastritis Assessment/Operative Link on Gastric Intestinal Metaplasia Assessment stage III-IV and/or Endoscopic Grading of Gastric Intestinal Metaplasia > 5, triggering a need for endoscopic surveillance.
Data were gathered on colonoscopy findings (including polyp surveillance and family history), EGD findings plus biopsies, serum pepsinogen, and Helicobacter pylori serology. Outcome measures included the prevalence of gastric cancer and preneoplastic conditions, the diagnostic accuracy of pepsinogen testing, comparisons between national settings, the relevance of upper endoscopy in fecal immunochemical test-positive cases, and overall H pylori prevalence.
Neoplasia and Preneoplasia Found
A total of 846 participants were analyzed. At baseline, the mean age was 62 years, 52.2% were men, and 84.2% were White, despite efforts to recruit a more diverse population. Around 390 participants drank alcohol, and 190 smoked tobacco.
A total of 37.8% of participants had undergone prior EGD, of which 94.7% were performed more than 3 years before the study start. The history of GI surgery was 13.7%, and the history of cancer was 14.5%. Around 11% took aspirin, and 14% took proton pump inhibitors (PPIs). “We were surprised at the low prevalence of PPI use,” remarked Bornschein. “It was also good news that around half were never smokers.”
Key results for upper GI neoplasia included six patients (0.7%) with gastric cancers, three (0.4%) with esophageal cancers, and five (0.6%) with duodenal tumors. H pylori positivity was found in 303 patients (35.8%), with an additional 81 (9.6%) reporting a history of eradication.
Colorectal findings included 15 patients (1.8%) with cancers and colon polyps in 503 (59.5%) participants.
Regarding preneoplastic conditions, endoscopy identified intestinal metaplasia in 174 patients (20.6%), of which 65 (7.7%) were multifocal. Atrophy was observed in 220 patients (26.0%), with 59 (7.0%) showing multifocal atrophic changes. Both intestinal metaplasia and atrophy were found together in 105 (12.4%) patients. Barrett’s esophagus was detected in 31 (3.7%) patients.
“I’d really like to highlight these further benign gastric findings,” said Bornschein. These included gastric ulcers in 28 (3.3%) patients, erosive gastritis in 245 (29.0%) patients, esophageal ulcers in three (0.4%) patients, Los Angeles Community College District classification esophagitis in 13 (1.5%) patients, and duodenal ulcers in 10 (1.2%) patients. “These were asymptomatic, but we were able to identify them,” he noted.
“We’ve had a very low rate of complications (0.01%),” he added.” I don’t want to jinx that now. These were basically related to sedation.”
PROSPERO: Early Detection of Upper GI Conditions in a UK Population
Massimiliano di Pietro, MD, consultant gastroenterologist at Addenbrooke’s Hospital, Cambridge, England, and the principal investigator of the PROSPERO study, which aimed to determine the prevalence of premalignant upper GI conditions in routine endoscopy in the UK, commented on the findings. The TOGAS study focuses on asymptomatic individuals referred for colonoscopy and examines the value of performing an upper GI endoscopy at the same time, he explained. “This approach might identify upper GI conditions that require monitoring, in particular early cancer.”
“On the other hand, the PROSPERO study focuses on patients referred for upper GI symptoms and diagnosis,” he said. Preliminary data from that study, presented during the same session as the TOGAS trial, showed a 13.6% prevalence of premalignant upper GI conditions in a symptomatic UK patient population referred for endoscopy.
“In some respects, the findings were similar, particularly the rate of upper GI cancer at 1.4%, although there were differences in the prevalence of premalignant conditions,” he noted. “This may be explained by the fact that TOGAS is a European study, while PROSPERO is UK-based, where the distribution of upper GI cancers differs, with more esophageal adenocarcinoma vs gastric adenocarcinoma.”
Reflecting on both of the studies, Di Pietro said they are “really important in fulfilling an unmet need in the quality of upper GI endoscopy. Currently, there are no diagnostic quality indicators in upper GI endoscopy, so it’s difficult to rate the performance of endoscopists in the same way as we can in lower GI. It’s really important to understand the population prevalence, both in symptomatic and asymptomatic individuals, of premalignant and malignant upper GI conditions.”
TOGAS 2 is recruiting until February 2026, with 1200 of a potential 1600 participants recruited to date. The data will be used for implementation modeling and to inform quality indicators for future screening programs. Final results and plans for a follow-up study are expected in 2026.
Bornschein declared receiving advisory and speaker fees from Flynn Pharma and Juvisé Pharmaceuticals. Di Pietro reported having no disclosures relevant to the studies discussed.
A version of this article first appeared on Medscape.com.
Real-World Pros & Cons of the New Liver Disease Nomenclature
VIENNA – Maria Effenberger, MD, Medical University of Innsbruck, Berlin, Germany, told attendees at United European Gastroenterology (UEG) Week 2025 in Vienna, Austria.
In her presentation, “Sense and Nonsense of the New Nomenclature,” Effenberger highlighted the clinical implications of the new liver-disease terminology and pointed to a few factors still needing to be sorted out.
Both NAFLD and MASLD are steatotic liver diseasesand, notably, there are few differences between the two in clinical studies, which makes the terminology shift easier, said Effenberger. She cited a recent study showing demographic and clinical profiles of individuals classified as NAFLD and MASLD in the US were “strikingly similar,” as were the accuracy of the noninvasive tests and all-cause and cause-specific mortality rates for both conditions.
However, “the important thing about MASLD is that the term is really connected to metabolic dysfunction,” said Effenberger. To be diagnosed with MASLD, patients with liver disease need to have at least one of five cardiometabolic abnormalities: a high BMI — over 25 in White people and over 23 in Asian people; type 2 diabetes (T2D) or prediabetes; arterial hypertension; high levels of triglycerides; or a low level of high-density lipoprotein cholesterol.
“MASLD is a systemic disease, and that term represents it much better than only looking at it as a hepatological disease,” Effenberger said. “Many factors, especially inflammatory ones, influence steatosis, inflammation, and fibrosis.” These include influences from adipose tissue, the gut microbiome, the brain, a hypocaloric diet, and from steatosis of the liver itself. Proinflammatory cytokines induced by the disease can lead to inflammation throughout the body, with clinical outcomes such as stroke, heart failure, arrhythmias, myocardial infarction, chronic kidney disease.
MASLD, MetALD, or ALD?
“What is important now,” said Effenberger, is that “every patient who has liver disease should be asked two questions.” The first question is whether the patient has any of the cardiometabolic criteria outlined above. Second, is the patient consuming alcohol?
If the patient has one of the cardiometabolic criteria but doesn’t consume alcohol, “we are straight at the diagnosis of MASLD,” she explained. If the patient does consume alcohol, it depends on how much.
Patients who have at least one cardiometabolic risk factor and consume 140-350 g for men and 210-420 g for women are considered to have Metabolic and Alcohol-Associated Liver Disease (MetALD). And those with steatotic liver disease who drink alcohol above the MetALD thresholds are considered to have ALD.
Effenberger pointed to two “cons” of the new nomenclature that need to be clarified. Although MetALD has poorer outcomes than MASLD, “it’s really hard to differentiate between ALD and MASLD,” she said. Yet the distinction is important because risks for cirrhosis, hepatocellular carcinoma (HCC), and overall mortality increase more for patients diagnosed with ALD vs MASLD.
“Do MASLD patients drink alcohol? Yes they do,” Effenberger said. “And if you have MASLD and another trigger factor like alcohol, the rates of mortality, morbidity and cancer go up.”
Moderator Laurent Castera, MD, PhD, Université Paris-Cité, Paris, France, noted that a “pro” of the new nomenclature is that it is “shedding light on the importance of alcohol because when we discuss steatotic liver disease or MASLD, alcohol is always the elephant in the room,” he said. “We need to increase the awareness that even in the absence of alcohol, you can still develop cirrhosis if you have severe metabolic risk factors.”
On the other hand, he said, “We desperately need more statistics on the true prevalence of alcohol consumption. While studies suggest the prevalence is low, at around 4% or 5%, that does not match the reality, in my opinion.”
Effenberger agreed. There’s a problem in trying to zero in on alcohol consumption because of the stigma attached to it, she said. She pointed to an Austrian study assessing patients who are diagnosed with MASLD. The researchers asked them, “Do you drink alcohol?” and all the participants said “no.” However, after completing a questionnaire designed to identify alcohol use disorders, and undergoing glucuronide tests in the urine and hair, it became clear that 25%-30% of these patients actually drank alcohol on a regular basis.
Cancer, Cirrhosis, CVD
MASLD is a trigger for cancer, especially HCC, Effenberger said. A recent review affirmed that MASLD is strongly associated with HCC, especially in Southeast Asia and India. The same study showed that many patients with MASLD are getting HCC without cirrhosis, and their cancer is often detected at a later stage, however, it’s not yet clear why they are getting HCC, and further study is needed.
In addition, MASLD is also associated with higher rates of extrahepatic cancers, including cancers of the skin and androgenic cancers. This, too, requires further investigation.
Regarding cardiovascular disease (CVD) risk, Effenberger emphasized that cardiometabolic diseases are strongly linked to each other. “Therefore, if you have diabetes and MASLD, the rates of atherosclerosis and of heart insufficiency and arteriosclerotic events like stroke and heart attacks go up, leading to the question of whether a CVD risk assessment is necessary in patients with MASLD.”
One recent study suggests that yes, it is, she reported. “If a patient has MASLD and cardiometabolic risk factors, and a risk score that suggests the patient is at increased risk of CVD for 10 years, then a CT scan of the arteries of the heart is important. The increased risk could also lead to intensified medical therapy, including GLP-1s or SGLT2s.”
During the Q&A, one attendee asked whether all patients with noncirrhotic MASLD should be screened for HCC, given the increased risk. Effenberger agreed that would be the best way to identify those at high risk; however, she said, “I think science is not in a state where you can clearly define which patients will be at high risk, and so we don’t have any guidelines for that.”
Another attendee asked why HCC is more common in Indians and Asians. Effenberger said, “We don’t know, but it is likely that there is an HCC-driven genetic risk factor.”
Remaining Questions
And finally, there’s the question of “what do we do with burnt-out MASLD?” Effenberger asked. “We know the fat content of the liver decreases when liver severity goes up. Therefore, we have a lot of patients with cirrhosis whose disease is not defined as steatotic liver because the liver fat content is no longer more than 5%.”
The decrease in fat is an ongoing process, and therefore, these patients with MASLD and advanced hepatic disease need to be better represented in the nomenclature, she suggested.
No funding information was provided. Effenberger declared working with Ipsen as a potential conflict.
A version of this article first appeared on Medscape.com.
VIENNA – Maria Effenberger, MD, Medical University of Innsbruck, Berlin, Germany, told attendees at United European Gastroenterology (UEG) Week 2025 in Vienna, Austria.
In her presentation, “Sense and Nonsense of the New Nomenclature,” Effenberger highlighted the clinical implications of the new liver-disease terminology and pointed to a few factors still needing to be sorted out.
Both NAFLD and MASLD are steatotic liver diseasesand, notably, there are few differences between the two in clinical studies, which makes the terminology shift easier, said Effenberger. She cited a recent study showing demographic and clinical profiles of individuals classified as NAFLD and MASLD in the US were “strikingly similar,” as were the accuracy of the noninvasive tests and all-cause and cause-specific mortality rates for both conditions.
However, “the important thing about MASLD is that the term is really connected to metabolic dysfunction,” said Effenberger. To be diagnosed with MASLD, patients with liver disease need to have at least one of five cardiometabolic abnormalities: a high BMI — over 25 in White people and over 23 in Asian people; type 2 diabetes (T2D) or prediabetes; arterial hypertension; high levels of triglycerides; or a low level of high-density lipoprotein cholesterol.
“MASLD is a systemic disease, and that term represents it much better than only looking at it as a hepatological disease,” Effenberger said. “Many factors, especially inflammatory ones, influence steatosis, inflammation, and fibrosis.” These include influences from adipose tissue, the gut microbiome, the brain, a hypocaloric diet, and from steatosis of the liver itself. Proinflammatory cytokines induced by the disease can lead to inflammation throughout the body, with clinical outcomes such as stroke, heart failure, arrhythmias, myocardial infarction, chronic kidney disease.
MASLD, MetALD, or ALD?
“What is important now,” said Effenberger, is that “every patient who has liver disease should be asked two questions.” The first question is whether the patient has any of the cardiometabolic criteria outlined above. Second, is the patient consuming alcohol?
If the patient has one of the cardiometabolic criteria but doesn’t consume alcohol, “we are straight at the diagnosis of MASLD,” she explained. If the patient does consume alcohol, it depends on how much.
Patients who have at least one cardiometabolic risk factor and consume 140-350 g for men and 210-420 g for women are considered to have Metabolic and Alcohol-Associated Liver Disease (MetALD). And those with steatotic liver disease who drink alcohol above the MetALD thresholds are considered to have ALD.
Effenberger pointed to two “cons” of the new nomenclature that need to be clarified. Although MetALD has poorer outcomes than MASLD, “it’s really hard to differentiate between ALD and MASLD,” she said. Yet the distinction is important because risks for cirrhosis, hepatocellular carcinoma (HCC), and overall mortality increase more for patients diagnosed with ALD vs MASLD.
“Do MASLD patients drink alcohol? Yes they do,” Effenberger said. “And if you have MASLD and another trigger factor like alcohol, the rates of mortality, morbidity and cancer go up.”
Moderator Laurent Castera, MD, PhD, Université Paris-Cité, Paris, France, noted that a “pro” of the new nomenclature is that it is “shedding light on the importance of alcohol because when we discuss steatotic liver disease or MASLD, alcohol is always the elephant in the room,” he said. “We need to increase the awareness that even in the absence of alcohol, you can still develop cirrhosis if you have severe metabolic risk factors.”
On the other hand, he said, “We desperately need more statistics on the true prevalence of alcohol consumption. While studies suggest the prevalence is low, at around 4% or 5%, that does not match the reality, in my opinion.”
Effenberger agreed. There’s a problem in trying to zero in on alcohol consumption because of the stigma attached to it, she said. She pointed to an Austrian study assessing patients who are diagnosed with MASLD. The researchers asked them, “Do you drink alcohol?” and all the participants said “no.” However, after completing a questionnaire designed to identify alcohol use disorders, and undergoing glucuronide tests in the urine and hair, it became clear that 25%-30% of these patients actually drank alcohol on a regular basis.
Cancer, Cirrhosis, CVD
MASLD is a trigger for cancer, especially HCC, Effenberger said. A recent review affirmed that MASLD is strongly associated with HCC, especially in Southeast Asia and India. The same study showed that many patients with MASLD are getting HCC without cirrhosis, and their cancer is often detected at a later stage, however, it’s not yet clear why they are getting HCC, and further study is needed.
In addition, MASLD is also associated with higher rates of extrahepatic cancers, including cancers of the skin and androgenic cancers. This, too, requires further investigation.
Regarding cardiovascular disease (CVD) risk, Effenberger emphasized that cardiometabolic diseases are strongly linked to each other. “Therefore, if you have diabetes and MASLD, the rates of atherosclerosis and of heart insufficiency and arteriosclerotic events like stroke and heart attacks go up, leading to the question of whether a CVD risk assessment is necessary in patients with MASLD.”
One recent study suggests that yes, it is, she reported. “If a patient has MASLD and cardiometabolic risk factors, and a risk score that suggests the patient is at increased risk of CVD for 10 years, then a CT scan of the arteries of the heart is important. The increased risk could also lead to intensified medical therapy, including GLP-1s or SGLT2s.”
During the Q&A, one attendee asked whether all patients with noncirrhotic MASLD should be screened for HCC, given the increased risk. Effenberger agreed that would be the best way to identify those at high risk; however, she said, “I think science is not in a state where you can clearly define which patients will be at high risk, and so we don’t have any guidelines for that.”
Another attendee asked why HCC is more common in Indians and Asians. Effenberger said, “We don’t know, but it is likely that there is an HCC-driven genetic risk factor.”
Remaining Questions
And finally, there’s the question of “what do we do with burnt-out MASLD?” Effenberger asked. “We know the fat content of the liver decreases when liver severity goes up. Therefore, we have a lot of patients with cirrhosis whose disease is not defined as steatotic liver because the liver fat content is no longer more than 5%.”
The decrease in fat is an ongoing process, and therefore, these patients with MASLD and advanced hepatic disease need to be better represented in the nomenclature, she suggested.
No funding information was provided. Effenberger declared working with Ipsen as a potential conflict.
A version of this article first appeared on Medscape.com.
VIENNA – Maria Effenberger, MD, Medical University of Innsbruck, Berlin, Germany, told attendees at United European Gastroenterology (UEG) Week 2025 in Vienna, Austria.
In her presentation, “Sense and Nonsense of the New Nomenclature,” Effenberger highlighted the clinical implications of the new liver-disease terminology and pointed to a few factors still needing to be sorted out.
Both NAFLD and MASLD are steatotic liver diseasesand, notably, there are few differences between the two in clinical studies, which makes the terminology shift easier, said Effenberger. She cited a recent study showing demographic and clinical profiles of individuals classified as NAFLD and MASLD in the US were “strikingly similar,” as were the accuracy of the noninvasive tests and all-cause and cause-specific mortality rates for both conditions.
However, “the important thing about MASLD is that the term is really connected to metabolic dysfunction,” said Effenberger. To be diagnosed with MASLD, patients with liver disease need to have at least one of five cardiometabolic abnormalities: a high BMI — over 25 in White people and over 23 in Asian people; type 2 diabetes (T2D) or prediabetes; arterial hypertension; high levels of triglycerides; or a low level of high-density lipoprotein cholesterol.
“MASLD is a systemic disease, and that term represents it much better than only looking at it as a hepatological disease,” Effenberger said. “Many factors, especially inflammatory ones, influence steatosis, inflammation, and fibrosis.” These include influences from adipose tissue, the gut microbiome, the brain, a hypocaloric diet, and from steatosis of the liver itself. Proinflammatory cytokines induced by the disease can lead to inflammation throughout the body, with clinical outcomes such as stroke, heart failure, arrhythmias, myocardial infarction, chronic kidney disease.
MASLD, MetALD, or ALD?
“What is important now,” said Effenberger, is that “every patient who has liver disease should be asked two questions.” The first question is whether the patient has any of the cardiometabolic criteria outlined above. Second, is the patient consuming alcohol?
If the patient has one of the cardiometabolic criteria but doesn’t consume alcohol, “we are straight at the diagnosis of MASLD,” she explained. If the patient does consume alcohol, it depends on how much.
Patients who have at least one cardiometabolic risk factor and consume 140-350 g for men and 210-420 g for women are considered to have Metabolic and Alcohol-Associated Liver Disease (MetALD). And those with steatotic liver disease who drink alcohol above the MetALD thresholds are considered to have ALD.
Effenberger pointed to two “cons” of the new nomenclature that need to be clarified. Although MetALD has poorer outcomes than MASLD, “it’s really hard to differentiate between ALD and MASLD,” she said. Yet the distinction is important because risks for cirrhosis, hepatocellular carcinoma (HCC), and overall mortality increase more for patients diagnosed with ALD vs MASLD.
“Do MASLD patients drink alcohol? Yes they do,” Effenberger said. “And if you have MASLD and another trigger factor like alcohol, the rates of mortality, morbidity and cancer go up.”
Moderator Laurent Castera, MD, PhD, Université Paris-Cité, Paris, France, noted that a “pro” of the new nomenclature is that it is “shedding light on the importance of alcohol because when we discuss steatotic liver disease or MASLD, alcohol is always the elephant in the room,” he said. “We need to increase the awareness that even in the absence of alcohol, you can still develop cirrhosis if you have severe metabolic risk factors.”
On the other hand, he said, “We desperately need more statistics on the true prevalence of alcohol consumption. While studies suggest the prevalence is low, at around 4% or 5%, that does not match the reality, in my opinion.”
Effenberger agreed. There’s a problem in trying to zero in on alcohol consumption because of the stigma attached to it, she said. She pointed to an Austrian study assessing patients who are diagnosed with MASLD. The researchers asked them, “Do you drink alcohol?” and all the participants said “no.” However, after completing a questionnaire designed to identify alcohol use disorders, and undergoing glucuronide tests in the urine and hair, it became clear that 25%-30% of these patients actually drank alcohol on a regular basis.
Cancer, Cirrhosis, CVD
MASLD is a trigger for cancer, especially HCC, Effenberger said. A recent review affirmed that MASLD is strongly associated with HCC, especially in Southeast Asia and India. The same study showed that many patients with MASLD are getting HCC without cirrhosis, and their cancer is often detected at a later stage, however, it’s not yet clear why they are getting HCC, and further study is needed.
In addition, MASLD is also associated with higher rates of extrahepatic cancers, including cancers of the skin and androgenic cancers. This, too, requires further investigation.
Regarding cardiovascular disease (CVD) risk, Effenberger emphasized that cardiometabolic diseases are strongly linked to each other. “Therefore, if you have diabetes and MASLD, the rates of atherosclerosis and of heart insufficiency and arteriosclerotic events like stroke and heart attacks go up, leading to the question of whether a CVD risk assessment is necessary in patients with MASLD.”
One recent study suggests that yes, it is, she reported. “If a patient has MASLD and cardiometabolic risk factors, and a risk score that suggests the patient is at increased risk of CVD for 10 years, then a CT scan of the arteries of the heart is important. The increased risk could also lead to intensified medical therapy, including GLP-1s or SGLT2s.”
During the Q&A, one attendee asked whether all patients with noncirrhotic MASLD should be screened for HCC, given the increased risk. Effenberger agreed that would be the best way to identify those at high risk; however, she said, “I think science is not in a state where you can clearly define which patients will be at high risk, and so we don’t have any guidelines for that.”
Another attendee asked why HCC is more common in Indians and Asians. Effenberger said, “We don’t know, but it is likely that there is an HCC-driven genetic risk factor.”
Remaining Questions
And finally, there’s the question of “what do we do with burnt-out MASLD?” Effenberger asked. “We know the fat content of the liver decreases when liver severity goes up. Therefore, we have a lot of patients with cirrhosis whose disease is not defined as steatotic liver because the liver fat content is no longer more than 5%.”
The decrease in fat is an ongoing process, and therefore, these patients with MASLD and advanced hepatic disease need to be better represented in the nomenclature, she suggested.
No funding information was provided. Effenberger declared working with Ipsen as a potential conflict.
A version of this article first appeared on Medscape.com.
Formula Type May Fuel NEC in Premature Infants
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
DENVER – , according to new data presented at the American Academy of Pediatrics (AAP) 2025 National Conference & Exhibition.
Necrotizing enterocolitis (NEC) can affect the intestinal wall of neonates, with potentially life-threatening results. The inflammatory condition is characterized by feeding intolerance, rectal bleeding, and bowel perforations, said presenting author Puja Kulkarni, medical student at California Northstate University College of Medicine, Elk Grove, California, and colleagues.
The etiology of NEC remains unclear, but previous research suggests that formula feeding may play a role, the researchers said. “NEC remains a leading cause of morbidity and mortality in premature infants, yet there is still no clear consensus on the optimal feeding strategy to reduce risk,” Kulkarni said in an interview with GI & Hepatology News.
Most hospital guidelines call for solely using SPFs in NICUs, especially in cases where maternal breast milk is not available, said Kulkarni. Therefore, “it was critical to investigate whether different types of formula, such as extensively hydrolyzed formula, could influence the incidence of NEC,” she said.
Kulkarni and colleagues conducted a literature search and identified three randomized, controlled trials that compared eHFs to SPFs in a study population of 1180 premature infants.
Overall, infants who received SPFs had a significantly greater risk for both NEC and feeding intolerance than those who received eHFs, with odds ratios of 2.54 and 2.87, respectively, and these associations remained after a sensitivity analysis.
Other research, such as the German Infant Nutritional Intervention (GINI) study, has shown similar results regarding the effect of formula type on childhood pathologies, Kulkarni noted. The GINI study showed that HFs can help prevent the development of allergic diseases in children with a family history of allergies, she said.
The results of the current analysis suggest a significantly increased risk for NEC, as well as feeding intolerance, which can be a precursor to NEC, in premature infants fed SPFs compared to those fed eHFs, said Kulkarni. “If validated by further research, this could lead to changes in NICU feeding protocols, especially in situations where donor breast milk is not available. Clinicians may want to consider the type of protein in formula as an important factor in NEC prevention,” she said. The current findings support the need for more research into the effects of formula throughout the infant and childhood years.
Additional studies are needed to validate the findings in larger, multicenter cohorts to ensure generalizability, especially in the US, where current guidelines favor SPFs based on limited data, said Kulkarni. Much of the research in the US has been conducted by the formula companies themselves, and she and her colleagues took this risk for bias into account in their meta-analysis.
Younger Babies at Greater Risk
Documented rates of NEC have remained stable or decreased slightly over the past 20 years, which supports the need for research on prevention and early identification, as well as effective medical treatment, said Catherine Haut, DNP, CPNP-AC/PC, in an interview.
“With improved neonatal intensive care, younger neonates are surviving, but these babies also have a higher risk of development of NEC,” said Haut, director of nursing research and evidence-based practice at Nemours Children’s Health, Delaware, New Jersey, who was not involved in the study.
“Historically, NEC has been related to feeding, among other variables, but the use of more specific or standardized feeding methods including increased use of human milk in very low-birth weight infants has resulted in better outcomes,” she said.
The finding from the current meta-analysis that the use of SPFs poses a higher risk for NEC than the use of eHFs was not unexpected, Haut told GI & Hepatology News. Some infants are allergic to cow’s milk, and replacing this type of formula with eHF is the recommended treatment as these formulas incorporate proteins which are more easily digested, she said.
Systematic reviews and meta-analyses are considered high levels of evidence, and the current study’s documentation of the benefits of eHF could help decrease the rate of NEC in premature infants, Haut said. “Despite a higher cost associated with eHF, in formula-fed preterm neonates, there would be benefit to using eHF vs risk of standard protein formulas,” she said.
However, the current study represents a very small population compared to the total number of infants born at less than 37 weeks’ gestation, which is reported to be 10% of all newborns in the US each year, Haut noted.
Additional large studies, including randomized control trials, are needed to further document the effects of using eHF in very young premature infants and potentially help reduce the incidence of NEC in this population, she said.
The study received no outside funding. The researchers and Haut had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Prevention and Risk-Based Surveillance Key to Curbing HCC
BERLIN — according to a joint statement from United European Gastroenterology (UEG) and the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS).
The statement calls on EU and national policymakers to embed a twofold approach into healthcare systems that combines surveillance and prevention, rather than relying on voluntary participation. It also encourages stronger prevention measures, such as improved food labeling and restrictions on marketing unhealthy foods to children. The statement — which was also endorsed by the European Association for the Study of the Liver (EASL) — was presented at UEG Week 2025 .
“Curing HCC in early stages rather than treating the disease in a palliative setting should be the goal for all liver doctors and carers, and this is certainly the goal for patients,” said Thomas Seufferlein, MD, professor of gastroenterology at Ulm University, Germany, and one of the members of the DGVS who initiated the statement.
“We have to take HCC screening seriously which means setting up a structured, nationwide, well-documented, and evaluated program for HCC screening in Germany,” he said in an interview.
HCC is mainly curable in the early stages by local ablation, resection, or liver transplantation, “so early diagnosis is of the utmost importance for improving survival,” added Patrick Michl, MD, gastroenterologist, University of Heidelberg, Germany, DGVS member and co-initiator of the statement.
Risk-Stratified HCC Surveillance
In the face of rising rates worldwide, the UEG/DGVS call on policymakers to recognize liver cancer as a preventable and growing public health priority and to implement structured surveillance programs guided by risk thresholds. In particular, they support the recent policy statement from EASL recommending risk-based screening.
EASL’s key recommendations include:
- Targeted surveillance for individuals with an annual HCC risk exceeding 1.5%, where it is both clinically beneficial and cost-effective
- Risk scoring tools such as the age-male-albumin-bilirubin-platelets score that incorporates age, sex, platelet count, albumin, and bilirubin, to stratify patients by HCC risk, including those without established cirrhosis
- Enhanced surveillance for very high-risk groups, where MRI-based surveillance may be warranted despite higher costs, given its superior sensitivity for early-stage disease
- A de-escalation in low-risk individuals
- Patients with an annual HCC risk < 0.5% may be safely spared surveillance, avoiding unnecessary interventions
Evidence from France, Italy, and the UK showed that structured surveillance in high-risk groups is both clinically beneficial and cost-effective. National models in France have demonstrated higher curative treatment rates and fewer costly late-stage cases with structured surveillance. In the UK, health technology assessments indicate targeted surveillance is an efficient use of National Health Services resources, particularly when uptake is optimized. Italian models show that earlier diagnosis in well-defined high-risk groups can offset downstream treatment costs.
Seufferlein noted that Germany needs a “structured program to be implemented and there is currently little public awareness regarding this surveillance strategy.” However, he added there is a structured hepatitis B vaccination program in Germany, which has been successful. “Studies show that the inclusion of hep B vaccination in infancy and childhood has led to good uptake among young age groups.”
Germany, however, has yet to conduct national studies. “Prospective data on HCC surveillance benefits in Germany are lacking,” said Michl, “but multi-country models incorporating Germany’s cost structures suggest similar benefits would accrue if there were greater adherence to guideline-based recommendations and if publicly funded screening programs were implemented.”
Current recommendations in Germany for surveillance are based on evidence-based guidelines of the DGVS with stronger (‘should’) or weaker (‘may’) evidence-based recommendations. For example, patients with chronic hepatitis B virus infection should be offered regular surveillance once their platelet age gender–hepatitis B risk score is ≥ 10. In patients with advanced fibrosis because of chronic hepatitis C virus infection, regular surveillance should also be offered.
Barriers to Screening Uptake
HCC remains one of the most lethal cancers in Europe, largely because it is often diagnosed too late. Underdiagnosis of chronic liver disease, limited access to imaging, and reimbursement gaps prevent timely intervention.
Maria Buti, MD, consultant hepatologist, Hospital Vall d’Hebron, Barcelona, Spain, who was not involved in drafting the statement, remarked that “Patients with liver cirrhosis, or with advanced fibrosis, and also some high-risk noncirrhotic patients such as those with hepatitis B, clearly benefit from surveillance. Surveillance can change life expectancy and also reduce morbidity.”
However, structural barriers continue to impede uptake. “It is not always easy to identify patients with liver cirrhosis because the majority are completely asymptomatic in the early stages,” she said.
Even when risk factors are identified, adherence to 6-monthly surveillance remains patchy. “Sometimes physicians forget to request ultrasounds, or patients don’t understand the importance of it because they feel well,” Buti told GI & Hepatology News.
Expanded Training and Public Health Measures
The joint statement also advocates for expanded physician training in nutrition and hepatology, equitable access to diagnostic tools including MRI, and EU-wide nutrition labeling systems such as Nutri-Score.
The authors also called for strengthened public health measures to tackle obesity, alcohol misuse, and hepatitis transmission, and fiscal and regulatory measures such as taxation of obesogenic foods, and reducing the cost burden of healthier foods.
“If we decrease the percentage of people with liver cirrhosis through prevention, fewer people will need surveillance,” Buti stated.
Seufferlein, Michl, and Buti all declared no relevant disclosures. All three experts are members of the UEG Public Affairs Group.
A version of this article appeared on Medscape.com.
BERLIN — according to a joint statement from United European Gastroenterology (UEG) and the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS).
The statement calls on EU and national policymakers to embed a twofold approach into healthcare systems that combines surveillance and prevention, rather than relying on voluntary participation. It also encourages stronger prevention measures, such as improved food labeling and restrictions on marketing unhealthy foods to children. The statement — which was also endorsed by the European Association for the Study of the Liver (EASL) — was presented at UEG Week 2025 .
“Curing HCC in early stages rather than treating the disease in a palliative setting should be the goal for all liver doctors and carers, and this is certainly the goal for patients,” said Thomas Seufferlein, MD, professor of gastroenterology at Ulm University, Germany, and one of the members of the DGVS who initiated the statement.
“We have to take HCC screening seriously which means setting up a structured, nationwide, well-documented, and evaluated program for HCC screening in Germany,” he said in an interview.
HCC is mainly curable in the early stages by local ablation, resection, or liver transplantation, “so early diagnosis is of the utmost importance for improving survival,” added Patrick Michl, MD, gastroenterologist, University of Heidelberg, Germany, DGVS member and co-initiator of the statement.
Risk-Stratified HCC Surveillance
In the face of rising rates worldwide, the UEG/DGVS call on policymakers to recognize liver cancer as a preventable and growing public health priority and to implement structured surveillance programs guided by risk thresholds. In particular, they support the recent policy statement from EASL recommending risk-based screening.
EASL’s key recommendations include:
- Targeted surveillance for individuals with an annual HCC risk exceeding 1.5%, where it is both clinically beneficial and cost-effective
- Risk scoring tools such as the age-male-albumin-bilirubin-platelets score that incorporates age, sex, platelet count, albumin, and bilirubin, to stratify patients by HCC risk, including those without established cirrhosis
- Enhanced surveillance for very high-risk groups, where MRI-based surveillance may be warranted despite higher costs, given its superior sensitivity for early-stage disease
- A de-escalation in low-risk individuals
- Patients with an annual HCC risk < 0.5% may be safely spared surveillance, avoiding unnecessary interventions
Evidence from France, Italy, and the UK showed that structured surveillance in high-risk groups is both clinically beneficial and cost-effective. National models in France have demonstrated higher curative treatment rates and fewer costly late-stage cases with structured surveillance. In the UK, health technology assessments indicate targeted surveillance is an efficient use of National Health Services resources, particularly when uptake is optimized. Italian models show that earlier diagnosis in well-defined high-risk groups can offset downstream treatment costs.
Seufferlein noted that Germany needs a “structured program to be implemented and there is currently little public awareness regarding this surveillance strategy.” However, he added there is a structured hepatitis B vaccination program in Germany, which has been successful. “Studies show that the inclusion of hep B vaccination in infancy and childhood has led to good uptake among young age groups.”
Germany, however, has yet to conduct national studies. “Prospective data on HCC surveillance benefits in Germany are lacking,” said Michl, “but multi-country models incorporating Germany’s cost structures suggest similar benefits would accrue if there were greater adherence to guideline-based recommendations and if publicly funded screening programs were implemented.”
Current recommendations in Germany for surveillance are based on evidence-based guidelines of the DGVS with stronger (‘should’) or weaker (‘may’) evidence-based recommendations. For example, patients with chronic hepatitis B virus infection should be offered regular surveillance once their platelet age gender–hepatitis B risk score is ≥ 10. In patients with advanced fibrosis because of chronic hepatitis C virus infection, regular surveillance should also be offered.
Barriers to Screening Uptake
HCC remains one of the most lethal cancers in Europe, largely because it is often diagnosed too late. Underdiagnosis of chronic liver disease, limited access to imaging, and reimbursement gaps prevent timely intervention.
Maria Buti, MD, consultant hepatologist, Hospital Vall d’Hebron, Barcelona, Spain, who was not involved in drafting the statement, remarked that “Patients with liver cirrhosis, or with advanced fibrosis, and also some high-risk noncirrhotic patients such as those with hepatitis B, clearly benefit from surveillance. Surveillance can change life expectancy and also reduce morbidity.”
However, structural barriers continue to impede uptake. “It is not always easy to identify patients with liver cirrhosis because the majority are completely asymptomatic in the early stages,” she said.
Even when risk factors are identified, adherence to 6-monthly surveillance remains patchy. “Sometimes physicians forget to request ultrasounds, or patients don’t understand the importance of it because they feel well,” Buti told GI & Hepatology News.
Expanded Training and Public Health Measures
The joint statement also advocates for expanded physician training in nutrition and hepatology, equitable access to diagnostic tools including MRI, and EU-wide nutrition labeling systems such as Nutri-Score.
The authors also called for strengthened public health measures to tackle obesity, alcohol misuse, and hepatitis transmission, and fiscal and regulatory measures such as taxation of obesogenic foods, and reducing the cost burden of healthier foods.
“If we decrease the percentage of people with liver cirrhosis through prevention, fewer people will need surveillance,” Buti stated.
Seufferlein, Michl, and Buti all declared no relevant disclosures. All three experts are members of the UEG Public Affairs Group.
A version of this article appeared on Medscape.com.
BERLIN — according to a joint statement from United European Gastroenterology (UEG) and the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS).
The statement calls on EU and national policymakers to embed a twofold approach into healthcare systems that combines surveillance and prevention, rather than relying on voluntary participation. It also encourages stronger prevention measures, such as improved food labeling and restrictions on marketing unhealthy foods to children. The statement — which was also endorsed by the European Association for the Study of the Liver (EASL) — was presented at UEG Week 2025 .
“Curing HCC in early stages rather than treating the disease in a palliative setting should be the goal for all liver doctors and carers, and this is certainly the goal for patients,” said Thomas Seufferlein, MD, professor of gastroenterology at Ulm University, Germany, and one of the members of the DGVS who initiated the statement.
“We have to take HCC screening seriously which means setting up a structured, nationwide, well-documented, and evaluated program for HCC screening in Germany,” he said in an interview.
HCC is mainly curable in the early stages by local ablation, resection, or liver transplantation, “so early diagnosis is of the utmost importance for improving survival,” added Patrick Michl, MD, gastroenterologist, University of Heidelberg, Germany, DGVS member and co-initiator of the statement.
Risk-Stratified HCC Surveillance
In the face of rising rates worldwide, the UEG/DGVS call on policymakers to recognize liver cancer as a preventable and growing public health priority and to implement structured surveillance programs guided by risk thresholds. In particular, they support the recent policy statement from EASL recommending risk-based screening.
EASL’s key recommendations include:
- Targeted surveillance for individuals with an annual HCC risk exceeding 1.5%, where it is both clinically beneficial and cost-effective
- Risk scoring tools such as the age-male-albumin-bilirubin-platelets score that incorporates age, sex, platelet count, albumin, and bilirubin, to stratify patients by HCC risk, including those without established cirrhosis
- Enhanced surveillance for very high-risk groups, where MRI-based surveillance may be warranted despite higher costs, given its superior sensitivity for early-stage disease
- A de-escalation in low-risk individuals
- Patients with an annual HCC risk < 0.5% may be safely spared surveillance, avoiding unnecessary interventions
Evidence from France, Italy, and the UK showed that structured surveillance in high-risk groups is both clinically beneficial and cost-effective. National models in France have demonstrated higher curative treatment rates and fewer costly late-stage cases with structured surveillance. In the UK, health technology assessments indicate targeted surveillance is an efficient use of National Health Services resources, particularly when uptake is optimized. Italian models show that earlier diagnosis in well-defined high-risk groups can offset downstream treatment costs.
Seufferlein noted that Germany needs a “structured program to be implemented and there is currently little public awareness regarding this surveillance strategy.” However, he added there is a structured hepatitis B vaccination program in Germany, which has been successful. “Studies show that the inclusion of hep B vaccination in infancy and childhood has led to good uptake among young age groups.”
Germany, however, has yet to conduct national studies. “Prospective data on HCC surveillance benefits in Germany are lacking,” said Michl, “but multi-country models incorporating Germany’s cost structures suggest similar benefits would accrue if there were greater adherence to guideline-based recommendations and if publicly funded screening programs were implemented.”
Current recommendations in Germany for surveillance are based on evidence-based guidelines of the DGVS with stronger (‘should’) or weaker (‘may’) evidence-based recommendations. For example, patients with chronic hepatitis B virus infection should be offered regular surveillance once their platelet age gender–hepatitis B risk score is ≥ 10. In patients with advanced fibrosis because of chronic hepatitis C virus infection, regular surveillance should also be offered.
Barriers to Screening Uptake
HCC remains one of the most lethal cancers in Europe, largely because it is often diagnosed too late. Underdiagnosis of chronic liver disease, limited access to imaging, and reimbursement gaps prevent timely intervention.
Maria Buti, MD, consultant hepatologist, Hospital Vall d’Hebron, Barcelona, Spain, who was not involved in drafting the statement, remarked that “Patients with liver cirrhosis, or with advanced fibrosis, and also some high-risk noncirrhotic patients such as those with hepatitis B, clearly benefit from surveillance. Surveillance can change life expectancy and also reduce morbidity.”
However, structural barriers continue to impede uptake. “It is not always easy to identify patients with liver cirrhosis because the majority are completely asymptomatic in the early stages,” she said.
Even when risk factors are identified, adherence to 6-monthly surveillance remains patchy. “Sometimes physicians forget to request ultrasounds, or patients don’t understand the importance of it because they feel well,” Buti told GI & Hepatology News.
Expanded Training and Public Health Measures
The joint statement also advocates for expanded physician training in nutrition and hepatology, equitable access to diagnostic tools including MRI, and EU-wide nutrition labeling systems such as Nutri-Score.
The authors also called for strengthened public health measures to tackle obesity, alcohol misuse, and hepatitis transmission, and fiscal and regulatory measures such as taxation of obesogenic foods, and reducing the cost burden of healthier foods.
“If we decrease the percentage of people with liver cirrhosis through prevention, fewer people will need surveillance,” Buti stated.
Seufferlein, Michl, and Buti all declared no relevant disclosures. All three experts are members of the UEG Public Affairs Group.
A version of this article appeared on Medscape.com.
FROM UEG WEEK 2025
Linerixibat Reduces Itching in PBC
BERLIN — , according to phase 3 results from the GLISTEN trial.
The therapy also improved sleep interference associated with itching and was generally well-tolerated, offering hope for patients who do not respond to existing treatments.
“Linerixibat has the potential to be the first global therapy indicated for pruritus,” asserted Andreas E. Kremer, MD, Department of Gastroenterology and Hepatology, University Hospital Zürich, Switzerland, who presented the findings at United European Gastroenterology (UEG) Week 2025.
Cholestatic pruritus is one of the most distressing and disabling symptoms of PBC, often unrelieved by existing first-line therapies such as ursodeoxycholic acid.
Up to 70% of patients with PBC experience cholestatic pruritus which can seriously impair quality of life, comparable to that seen in severe Parkinson’s disease or heart failure, said Kremer. With the limitations of existing treatments, symptom control remains a major unmet clinical need.
The GLISTEN Trial
Linerixibat is a minimally absorbed oral IBAT inhibitor that inhibits bile acid reuptake and reduces key mediators of pruritus.
Participants in the double-blind, placebo-controlled trial were randomized to oral linerixibat 40 mg twice daily (n = 119) or to placebo (n = 119) for 24 weeks. Patients had PBC and moderate-to-severe pruritus (Worst Itch Numerical Rating Scale [WI-NRS] ≥ 4).
The primary endpoint was change from baseline in monthly worst-itch score over 24 weeks. Key secondary endpoints included change in itch at week 2, change in sleep interference over 24 weeks, responder rates (≥ 2-, ≥ 3-, and ≥ 4-point reduction), and patient-reported global impression of severity and change.
The majority of participants (95%) were women and had a mean WI-NRS of 7.3 at baseline. After 24 weeks of twice daily dosing of linerixibat or placebo, participants entered a blinded crossover period for 8 weeks.
24-Week Data
Linerixibat produced a significant improvement in pruritus vs placebo, with a least-squares mean change in WI-NRS of -2.86 compared with -2.15, respectively, resulting in an adjusted mean difference of -0.72 (P = .001). The benefit appeared rapid, with superiority already evident at 2 weeks (P < .001), noted Kremer, adding this is important for patients.
Pruritus-related sleep interference NRS also improved significantly (-2.77 vs -2.24; difference, -0.53; P = .024). By week 24, 56% of patients with linerixibat achieved a ≥ 3-point reduction compared with 43% of those treated with placebo (nominal P = .043).
“A three-point reduction for a patient with pruritus is a clearly meaningful benefit,” said Kremer.
In addition, a greater proportion of patients with linerixibat rated their itch as “absent” (21% vs 9%) on the patient global impression of severity scales. The ideal goal for these patients is complete relief, “and here we saw that every fifth patient on linerixibat achieved such relief,” he pointed out.
Linerixibat was generally well-tolerated, and the most frequent on-treatment adverse event was diarrhea, which occurred in 61% of patients compared with 18% of those on placebo. There were five (4%) discontinuations on linerixibat vs one (< 1%) on placebo. Abdominal pain was experienced by 18% on linerixibat and 3% on placebo. There was also a slight elevation of alanine aminotransferase in 11 (9%) vs three patients (3%).
“In summary, it is a safe drug from our perspective,” said Kremer.
Focusing on Symptoms, Not Biochemical Response
Commenting for GI & Hepatology News, Frank Tacke, MD, head of the Department of Hepatology and Gastroenterology at Charité Medical University Berlin, Germany, explained that so far drugs for the treatment of PBC focused on the biochemical response. These treatments have shown a reduction in liver enzymes and in disease activity, but less of a reduction in symptoms, he explained. “This is the first drug at phase 3 that focuses on itching, which is one of the major symptoms in people with PBC. As such, this is a major breakthrough.”
Sabine Weber, MD, gastroenterologist at the University Hospital of Munich, Germany, said that the data suggested particular potential for patients whose pruritus doesn’t respond to first-line treatment, even if the treatment is otherwise effective.
“This is so important for patients who — due to their extreme itching — experience serious lifestyle effects such as isolation because they can’t go out socially,” she said. “We desperately need drugs to help these patients, and here we have one drug that seems to do this.”
Weber noted that linerixibat works differently from other PBC treatments. It is licensed in pediatric medicine for a number of diseases, but “this is the first time we’ve seen it for use in adults,” she added.
Kremer disclosed receiving research support from Gilead, Intercept Pharmaceuticals, and Roche; consulting for AbbVie, Advanz, Alentis, Alphasigma, AstraZeneca, Avior, Bayer, CymaBay Therapeutics, Eisai, Escient, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor; and receiving payment or honoraria from AbbVie, Advanz, Alphasigma, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor. Tache declared that he previously gave lectures for GSK. Weber declared no relevant conflicts of interest.
The GLISTEN study was funded by GSK.
A version of this article appeared on Medscape.com.
BERLIN — , according to phase 3 results from the GLISTEN trial.
The therapy also improved sleep interference associated with itching and was generally well-tolerated, offering hope for patients who do not respond to existing treatments.
“Linerixibat has the potential to be the first global therapy indicated for pruritus,” asserted Andreas E. Kremer, MD, Department of Gastroenterology and Hepatology, University Hospital Zürich, Switzerland, who presented the findings at United European Gastroenterology (UEG) Week 2025.
Cholestatic pruritus is one of the most distressing and disabling symptoms of PBC, often unrelieved by existing first-line therapies such as ursodeoxycholic acid.
Up to 70% of patients with PBC experience cholestatic pruritus which can seriously impair quality of life, comparable to that seen in severe Parkinson’s disease or heart failure, said Kremer. With the limitations of existing treatments, symptom control remains a major unmet clinical need.
The GLISTEN Trial
Linerixibat is a minimally absorbed oral IBAT inhibitor that inhibits bile acid reuptake and reduces key mediators of pruritus.
Participants in the double-blind, placebo-controlled trial were randomized to oral linerixibat 40 mg twice daily (n = 119) or to placebo (n = 119) for 24 weeks. Patients had PBC and moderate-to-severe pruritus (Worst Itch Numerical Rating Scale [WI-NRS] ≥ 4).
The primary endpoint was change from baseline in monthly worst-itch score over 24 weeks. Key secondary endpoints included change in itch at week 2, change in sleep interference over 24 weeks, responder rates (≥ 2-, ≥ 3-, and ≥ 4-point reduction), and patient-reported global impression of severity and change.
The majority of participants (95%) were women and had a mean WI-NRS of 7.3 at baseline. After 24 weeks of twice daily dosing of linerixibat or placebo, participants entered a blinded crossover period for 8 weeks.
24-Week Data
Linerixibat produced a significant improvement in pruritus vs placebo, with a least-squares mean change in WI-NRS of -2.86 compared with -2.15, respectively, resulting in an adjusted mean difference of -0.72 (P = .001). The benefit appeared rapid, with superiority already evident at 2 weeks (P < .001), noted Kremer, adding this is important for patients.
Pruritus-related sleep interference NRS also improved significantly (-2.77 vs -2.24; difference, -0.53; P = .024). By week 24, 56% of patients with linerixibat achieved a ≥ 3-point reduction compared with 43% of those treated with placebo (nominal P = .043).
“A three-point reduction for a patient with pruritus is a clearly meaningful benefit,” said Kremer.
In addition, a greater proportion of patients with linerixibat rated their itch as “absent” (21% vs 9%) on the patient global impression of severity scales. The ideal goal for these patients is complete relief, “and here we saw that every fifth patient on linerixibat achieved such relief,” he pointed out.
Linerixibat was generally well-tolerated, and the most frequent on-treatment adverse event was diarrhea, which occurred in 61% of patients compared with 18% of those on placebo. There were five (4%) discontinuations on linerixibat vs one (< 1%) on placebo. Abdominal pain was experienced by 18% on linerixibat and 3% on placebo. There was also a slight elevation of alanine aminotransferase in 11 (9%) vs three patients (3%).
“In summary, it is a safe drug from our perspective,” said Kremer.
Focusing on Symptoms, Not Biochemical Response
Commenting for GI & Hepatology News, Frank Tacke, MD, head of the Department of Hepatology and Gastroenterology at Charité Medical University Berlin, Germany, explained that so far drugs for the treatment of PBC focused on the biochemical response. These treatments have shown a reduction in liver enzymes and in disease activity, but less of a reduction in symptoms, he explained. “This is the first drug at phase 3 that focuses on itching, which is one of the major symptoms in people with PBC. As such, this is a major breakthrough.”
Sabine Weber, MD, gastroenterologist at the University Hospital of Munich, Germany, said that the data suggested particular potential for patients whose pruritus doesn’t respond to first-line treatment, even if the treatment is otherwise effective.
“This is so important for patients who — due to their extreme itching — experience serious lifestyle effects such as isolation because they can’t go out socially,” she said. “We desperately need drugs to help these patients, and here we have one drug that seems to do this.”
Weber noted that linerixibat works differently from other PBC treatments. It is licensed in pediatric medicine for a number of diseases, but “this is the first time we’ve seen it for use in adults,” she added.
Kremer disclosed receiving research support from Gilead, Intercept Pharmaceuticals, and Roche; consulting for AbbVie, Advanz, Alentis, Alphasigma, AstraZeneca, Avior, Bayer, CymaBay Therapeutics, Eisai, Escient, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor; and receiving payment or honoraria from AbbVie, Advanz, Alphasigma, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor. Tache declared that he previously gave lectures for GSK. Weber declared no relevant conflicts of interest.
The GLISTEN study was funded by GSK.
A version of this article appeared on Medscape.com.
BERLIN — , according to phase 3 results from the GLISTEN trial.
The therapy also improved sleep interference associated with itching and was generally well-tolerated, offering hope for patients who do not respond to existing treatments.
“Linerixibat has the potential to be the first global therapy indicated for pruritus,” asserted Andreas E. Kremer, MD, Department of Gastroenterology and Hepatology, University Hospital Zürich, Switzerland, who presented the findings at United European Gastroenterology (UEG) Week 2025.
Cholestatic pruritus is one of the most distressing and disabling symptoms of PBC, often unrelieved by existing first-line therapies such as ursodeoxycholic acid.
Up to 70% of patients with PBC experience cholestatic pruritus which can seriously impair quality of life, comparable to that seen in severe Parkinson’s disease or heart failure, said Kremer. With the limitations of existing treatments, symptom control remains a major unmet clinical need.
The GLISTEN Trial
Linerixibat is a minimally absorbed oral IBAT inhibitor that inhibits bile acid reuptake and reduces key mediators of pruritus.
Participants in the double-blind, placebo-controlled trial were randomized to oral linerixibat 40 mg twice daily (n = 119) or to placebo (n = 119) for 24 weeks. Patients had PBC and moderate-to-severe pruritus (Worst Itch Numerical Rating Scale [WI-NRS] ≥ 4).
The primary endpoint was change from baseline in monthly worst-itch score over 24 weeks. Key secondary endpoints included change in itch at week 2, change in sleep interference over 24 weeks, responder rates (≥ 2-, ≥ 3-, and ≥ 4-point reduction), and patient-reported global impression of severity and change.
The majority of participants (95%) were women and had a mean WI-NRS of 7.3 at baseline. After 24 weeks of twice daily dosing of linerixibat or placebo, participants entered a blinded crossover period for 8 weeks.
24-Week Data
Linerixibat produced a significant improvement in pruritus vs placebo, with a least-squares mean change in WI-NRS of -2.86 compared with -2.15, respectively, resulting in an adjusted mean difference of -0.72 (P = .001). The benefit appeared rapid, with superiority already evident at 2 weeks (P < .001), noted Kremer, adding this is important for patients.
Pruritus-related sleep interference NRS also improved significantly (-2.77 vs -2.24; difference, -0.53; P = .024). By week 24, 56% of patients with linerixibat achieved a ≥ 3-point reduction compared with 43% of those treated with placebo (nominal P = .043).
“A three-point reduction for a patient with pruritus is a clearly meaningful benefit,” said Kremer.
In addition, a greater proportion of patients with linerixibat rated their itch as “absent” (21% vs 9%) on the patient global impression of severity scales. The ideal goal for these patients is complete relief, “and here we saw that every fifth patient on linerixibat achieved such relief,” he pointed out.
Linerixibat was generally well-tolerated, and the most frequent on-treatment adverse event was diarrhea, which occurred in 61% of patients compared with 18% of those on placebo. There were five (4%) discontinuations on linerixibat vs one (< 1%) on placebo. Abdominal pain was experienced by 18% on linerixibat and 3% on placebo. There was also a slight elevation of alanine aminotransferase in 11 (9%) vs three patients (3%).
“In summary, it is a safe drug from our perspective,” said Kremer.
Focusing on Symptoms, Not Biochemical Response
Commenting for GI & Hepatology News, Frank Tacke, MD, head of the Department of Hepatology and Gastroenterology at Charité Medical University Berlin, Germany, explained that so far drugs for the treatment of PBC focused on the biochemical response. These treatments have shown a reduction in liver enzymes and in disease activity, but less of a reduction in symptoms, he explained. “This is the first drug at phase 3 that focuses on itching, which is one of the major symptoms in people with PBC. As such, this is a major breakthrough.”
Sabine Weber, MD, gastroenterologist at the University Hospital of Munich, Germany, said that the data suggested particular potential for patients whose pruritus doesn’t respond to first-line treatment, even if the treatment is otherwise effective.
“This is so important for patients who — due to their extreme itching — experience serious lifestyle effects such as isolation because they can’t go out socially,” she said. “We desperately need drugs to help these patients, and here we have one drug that seems to do this.”
Weber noted that linerixibat works differently from other PBC treatments. It is licensed in pediatric medicine for a number of diseases, but “this is the first time we’ve seen it for use in adults,” she added.
Kremer disclosed receiving research support from Gilead, Intercept Pharmaceuticals, and Roche; consulting for AbbVie, Advanz, Alentis, Alphasigma, AstraZeneca, Avior, Bayer, CymaBay Therapeutics, Eisai, Escient, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor; and receiving payment or honoraria from AbbVie, Advanz, Alphasigma, Falk, Gilead, GSK, Intercept Pharmaceuticals, Ipsen, Mirum, MSD, Roche, Takeda, and Vifor. Tache declared that he previously gave lectures for GSK. Weber declared no relevant conflicts of interest.
The GLISTEN study was funded by GSK.
A version of this article appeared on Medscape.com.
Helicobacter pylori May Shift Gastric Cancer Earlier
Helicobacter pylori May Shift Gastric Cancer Earlier
ORLANDO, Fl — , new data suggested.
H pylori infection is a leading risk factor for gastric carcinoma, accounting for as many as 90% of cases. As the new data show, failure to screen routinely for the bacteria could be leading to younger people developing easily preventable forms of gastric cancer, experts said.
“The most concerning and the most interesting finding for us was we found higher prevalence” of gastric cancer linked to H pylori in the younger group, Neel Patel, MD, MPH, with the Department of Pathology at Staten Island University Hospital in Staten Island, New York, told GI & Hepatology News.
“This does not mean most patients are young. Rather, it means H pylori increases the likelihood of gastric cancer appearing earlier in life compared with non-H pylori cases.”
For the study, Patel and his colleagues, who presented their findings at the annual meeting of the College of American Pathologists (CAP) 2025, used 2016-2020 data from the Nationwide Inpatient Sample, which included records for adults with primary diagnoses of gastric cancer. They looked at outcomes of those whose cancer was associated with H pylori compared with the non-H pylori group.
Among 91,670 adult hospitalizations, 1830 (2%) had gastric cancer linked to H pylori (2016-2020). Patel said the low percentage resulted from focusing solely on diagnostic codes for primary diagnoses of gastric cancer and excluding secondary diagnoses.
These cancers were twice as prevalent in patients aged 18-49 years (3.97%) as in those older than 65 years (1.65%).
Septicemia Odds Higher in H pylori Group
Patients in the H pylori group also had a higher burden of comorbidities such as anemia, chronic blood loss, and metastatic cancer, according to the data. The researcher found these patients also had significantly higher odds of septicemia (odds ratio, 1.62; 95% CI, 1.17-2.24; P = .003) and spent an average of 8 days in the hospital — two more than those with cancers not associated with the infection.
Dipti M. Karamchandani, MD, a professor of pathology at the University of Texas Southwestern Medical Center in Dallas, who was not part of the study, said the longer hospital stays and greater risk for septicemia may be related to increased comorbidities among people who get H pylori infection in general. The infection often is caused by unsanitary conditions, and the groups infected may also be more likely to experience malnutrition, anemia, or lower body reserves, for example, she said.
“Also, H pylori often causes gastric ulcers, even before causing cancer, and those patients may be prone to chronic blood loss,” Karamchandani said. “These are all reasons that these patients may be more prone to longer hospital stay.”
US Guidelines Lacking
H pylori infection is a strong predictor of gastric cancer, but it often goes undetected. “Sometimes we ignore the symptoms,” Patel said.
“There are no standard guidelines for screening for H pylori,” he added. “We need to stop the transition from H pylori to gastric cancer.”
“This abstract highlights an important issue: Gastric cancer is rising among younger adults in the US, particularly in noncardia gastric cancer, which is most often associated with Helicobacter pylori infection,” said Chul S. Hyun, MD, PhD, MPH, director of the Gastric Cancer Prevention and Screening Program at Yale School of Medicine in New Haven, Connecticut.
Hyun said the 2% of patients in the study diagnosed with gastric cancer associated with H pylori likely reflected undercoding and “incomplete capture” in the database and noted that subgroup comparisons “become difficult to interpret reliably.” By extension, the findings also underscore, “We are not adequately capturing H pylori in routine US coding and claims.”
“What we do know is that H pylori is the central, modifiable driver of risk, and that prevention efforts should focus on high prevalence populations — including Asian, Hispanic, and immigrant communities — where systematic H pylori screening remains a major unmet need,” said Hyun, who was not involved in the new research.
Currently no US society guideline recommends systematic screening, Hyun said. “Other high-incidence countries, such as Japan and Korea, already incorporate H pylori and gastroscopy screening into national policy,” he said. “For these reasons, guidelines urgently need to evolve to recommend targeted H pylori screening in high prevalence groups.”
Patel, Karamchandani, and Hyun reported having no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
ORLANDO, Fl — , new data suggested.
H pylori infection is a leading risk factor for gastric carcinoma, accounting for as many as 90% of cases. As the new data show, failure to screen routinely for the bacteria could be leading to younger people developing easily preventable forms of gastric cancer, experts said.
“The most concerning and the most interesting finding for us was we found higher prevalence” of gastric cancer linked to H pylori in the younger group, Neel Patel, MD, MPH, with the Department of Pathology at Staten Island University Hospital in Staten Island, New York, told GI & Hepatology News.
“This does not mean most patients are young. Rather, it means H pylori increases the likelihood of gastric cancer appearing earlier in life compared with non-H pylori cases.”
For the study, Patel and his colleagues, who presented their findings at the annual meeting of the College of American Pathologists (CAP) 2025, used 2016-2020 data from the Nationwide Inpatient Sample, which included records for adults with primary diagnoses of gastric cancer. They looked at outcomes of those whose cancer was associated with H pylori compared with the non-H pylori group.
Among 91,670 adult hospitalizations, 1830 (2%) had gastric cancer linked to H pylori (2016-2020). Patel said the low percentage resulted from focusing solely on diagnostic codes for primary diagnoses of gastric cancer and excluding secondary diagnoses.
These cancers were twice as prevalent in patients aged 18-49 years (3.97%) as in those older than 65 years (1.65%).
Septicemia Odds Higher in H pylori Group
Patients in the H pylori group also had a higher burden of comorbidities such as anemia, chronic blood loss, and metastatic cancer, according to the data. The researcher found these patients also had significantly higher odds of septicemia (odds ratio, 1.62; 95% CI, 1.17-2.24; P = .003) and spent an average of 8 days in the hospital — two more than those with cancers not associated with the infection.
Dipti M. Karamchandani, MD, a professor of pathology at the University of Texas Southwestern Medical Center in Dallas, who was not part of the study, said the longer hospital stays and greater risk for septicemia may be related to increased comorbidities among people who get H pylori infection in general. The infection often is caused by unsanitary conditions, and the groups infected may also be more likely to experience malnutrition, anemia, or lower body reserves, for example, she said.
“Also, H pylori often causes gastric ulcers, even before causing cancer, and those patients may be prone to chronic blood loss,” Karamchandani said. “These are all reasons that these patients may be more prone to longer hospital stay.”
US Guidelines Lacking
H pylori infection is a strong predictor of gastric cancer, but it often goes undetected. “Sometimes we ignore the symptoms,” Patel said.
“There are no standard guidelines for screening for H pylori,” he added. “We need to stop the transition from H pylori to gastric cancer.”
“This abstract highlights an important issue: Gastric cancer is rising among younger adults in the US, particularly in noncardia gastric cancer, which is most often associated with Helicobacter pylori infection,” said Chul S. Hyun, MD, PhD, MPH, director of the Gastric Cancer Prevention and Screening Program at Yale School of Medicine in New Haven, Connecticut.
Hyun said the 2% of patients in the study diagnosed with gastric cancer associated with H pylori likely reflected undercoding and “incomplete capture” in the database and noted that subgroup comparisons “become difficult to interpret reliably.” By extension, the findings also underscore, “We are not adequately capturing H pylori in routine US coding and claims.”
“What we do know is that H pylori is the central, modifiable driver of risk, and that prevention efforts should focus on high prevalence populations — including Asian, Hispanic, and immigrant communities — where systematic H pylori screening remains a major unmet need,” said Hyun, who was not involved in the new research.
Currently no US society guideline recommends systematic screening, Hyun said. “Other high-incidence countries, such as Japan and Korea, already incorporate H pylori and gastroscopy screening into national policy,” he said. “For these reasons, guidelines urgently need to evolve to recommend targeted H pylori screening in high prevalence groups.”
Patel, Karamchandani, and Hyun reported having no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
ORLANDO, Fl — , new data suggested.
H pylori infection is a leading risk factor for gastric carcinoma, accounting for as many as 90% of cases. As the new data show, failure to screen routinely for the bacteria could be leading to younger people developing easily preventable forms of gastric cancer, experts said.
“The most concerning and the most interesting finding for us was we found higher prevalence” of gastric cancer linked to H pylori in the younger group, Neel Patel, MD, MPH, with the Department of Pathology at Staten Island University Hospital in Staten Island, New York, told GI & Hepatology News.
“This does not mean most patients are young. Rather, it means H pylori increases the likelihood of gastric cancer appearing earlier in life compared with non-H pylori cases.”
For the study, Patel and his colleagues, who presented their findings at the annual meeting of the College of American Pathologists (CAP) 2025, used 2016-2020 data from the Nationwide Inpatient Sample, which included records for adults with primary diagnoses of gastric cancer. They looked at outcomes of those whose cancer was associated with H pylori compared with the non-H pylori group.
Among 91,670 adult hospitalizations, 1830 (2%) had gastric cancer linked to H pylori (2016-2020). Patel said the low percentage resulted from focusing solely on diagnostic codes for primary diagnoses of gastric cancer and excluding secondary diagnoses.
These cancers were twice as prevalent in patients aged 18-49 years (3.97%) as in those older than 65 years (1.65%).
Septicemia Odds Higher in H pylori Group
Patients in the H pylori group also had a higher burden of comorbidities such as anemia, chronic blood loss, and metastatic cancer, according to the data. The researcher found these patients also had significantly higher odds of septicemia (odds ratio, 1.62; 95% CI, 1.17-2.24; P = .003) and spent an average of 8 days in the hospital — two more than those with cancers not associated with the infection.
Dipti M. Karamchandani, MD, a professor of pathology at the University of Texas Southwestern Medical Center in Dallas, who was not part of the study, said the longer hospital stays and greater risk for septicemia may be related to increased comorbidities among people who get H pylori infection in general. The infection often is caused by unsanitary conditions, and the groups infected may also be more likely to experience malnutrition, anemia, or lower body reserves, for example, she said.
“Also, H pylori often causes gastric ulcers, even before causing cancer, and those patients may be prone to chronic blood loss,” Karamchandani said. “These are all reasons that these patients may be more prone to longer hospital stay.”
US Guidelines Lacking
H pylori infection is a strong predictor of gastric cancer, but it often goes undetected. “Sometimes we ignore the symptoms,” Patel said.
“There are no standard guidelines for screening for H pylori,” he added. “We need to stop the transition from H pylori to gastric cancer.”
“This abstract highlights an important issue: Gastric cancer is rising among younger adults in the US, particularly in noncardia gastric cancer, which is most often associated with Helicobacter pylori infection,” said Chul S. Hyun, MD, PhD, MPH, director of the Gastric Cancer Prevention and Screening Program at Yale School of Medicine in New Haven, Connecticut.
Hyun said the 2% of patients in the study diagnosed with gastric cancer associated with H pylori likely reflected undercoding and “incomplete capture” in the database and noted that subgroup comparisons “become difficult to interpret reliably.” By extension, the findings also underscore, “We are not adequately capturing H pylori in routine US coding and claims.”
“What we do know is that H pylori is the central, modifiable driver of risk, and that prevention efforts should focus on high prevalence populations — including Asian, Hispanic, and immigrant communities — where systematic H pylori screening remains a major unmet need,” said Hyun, who was not involved in the new research.
Currently no US society guideline recommends systematic screening, Hyun said. “Other high-incidence countries, such as Japan and Korea, already incorporate H pylori and gastroscopy screening into national policy,” he said. “For these reasons, guidelines urgently need to evolve to recommend targeted H pylori screening in high prevalence groups.”
Patel, Karamchandani, and Hyun reported having no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Helicobacter pylori May Shift Gastric Cancer Earlier
Helicobacter pylori May Shift Gastric Cancer Earlier
Screening for H. pylori May Reduce Bleeding in Some Patients With MI
Screening for H. pylori May Reduce Bleeding in Some Patients With MI
, according to the HELP-MI SWEDEHEART trial published in JAMA and presented at the European Society of Cardiology (ESC) Congress 2025.
Bleeding in the upper gastrointestinal tract is a common complication after MI. It increases morbidity and mortality itself but can also reduce the effectiveness of antithrombotic treatments and lead to new cardiovascular events. It is often related to infection with H. pylori, the bacterium that can cause stomach inflammation, ulcers, and cancer, said Robin Hofmann, MD, PhD, a cardiologist at the Karolinska Institute in Stockholm, Sweden, who presented the trial results.Hofmann and his colleagues wondered whether screening for the bacterium using a simple urea breath test would help reduce the risk for bleeds. Using Sweden’s national SWEDEHEART registry, researchers performed a cluster-randomized crossover trial of more than 18,000 patients with MI at 35 Swedish hospitals. They found that screening for H. pylori reduced the risk for upper gastrointestinal bleeding by 10%, but the results were not statistically significant.
Several factors may have contributed to the neutral result, noted Hofmann. Just 70% of the people in the screening population were actually screened — though he said that is a fairly good number for a diagnostic test. A relatively small number, around 23%, were positive for H. pylori, a much lower rate than in many other parts of the world, and about 25% of participants in both arms of the trial were already taking proton pump inhibitors to reduce the risk for bleeding.
Signals of Benefit in High-Risk Patients
But in some high-risk subgroups, there was a clearer signal of benefit. Patients with anemia or kidney failure, for example, who are at higher risk for bleeding, saw a relative risk reduction of around 50% in the screening group — though the numbers were too small for formal statistical analysis.
“In unselected patients with myocardial infarction we could not show a significant reduction in bleeding,” said Hofmann. “But it’s very likely that there is a clinical effect, at least in those individuals at increased risk of bleeding.”
Discussant Paul Ridker, MD, a cardiologist at Harvard Medical School, Boston, said he agreed that the trial was technically neutral but clinically positive. He noted that in every subgroup, the trend was in the direction of benefit, with only the top end of the cardiac indices crossing over into no benefit. And the benefit appeared larger among high-risk patients with anemia or kidney failure.
“These are the very patients I’m most concerned about and don’t want to bleed,” he said.Because the urea breath test and eradication therapy are simple, safe, and inexpensive, Hofmann said he thinks there is “good evidence to recommend H. pylori screening in patients at higher risk of bleeding.”
“I’m very sure from a clinical perspective that we will be able to identify the groups that are low-hanging fruit,” he said. “But the guideline committees will have to decide if this evidence is enough.”
Hofmann and Ridker reported having no financial conflicts of interest.
A version of this article appeared on Medscape.com.
, according to the HELP-MI SWEDEHEART trial published in JAMA and presented at the European Society of Cardiology (ESC) Congress 2025.
Bleeding in the upper gastrointestinal tract is a common complication after MI. It increases morbidity and mortality itself but can also reduce the effectiveness of antithrombotic treatments and lead to new cardiovascular events. It is often related to infection with H. pylori, the bacterium that can cause stomach inflammation, ulcers, and cancer, said Robin Hofmann, MD, PhD, a cardiologist at the Karolinska Institute in Stockholm, Sweden, who presented the trial results.Hofmann and his colleagues wondered whether screening for the bacterium using a simple urea breath test would help reduce the risk for bleeds. Using Sweden’s national SWEDEHEART registry, researchers performed a cluster-randomized crossover trial of more than 18,000 patients with MI at 35 Swedish hospitals. They found that screening for H. pylori reduced the risk for upper gastrointestinal bleeding by 10%, but the results were not statistically significant.
Several factors may have contributed to the neutral result, noted Hofmann. Just 70% of the people in the screening population were actually screened — though he said that is a fairly good number for a diagnostic test. A relatively small number, around 23%, were positive for H. pylori, a much lower rate than in many other parts of the world, and about 25% of participants in both arms of the trial were already taking proton pump inhibitors to reduce the risk for bleeding.
Signals of Benefit in High-Risk Patients
But in some high-risk subgroups, there was a clearer signal of benefit. Patients with anemia or kidney failure, for example, who are at higher risk for bleeding, saw a relative risk reduction of around 50% in the screening group — though the numbers were too small for formal statistical analysis.
“In unselected patients with myocardial infarction we could not show a significant reduction in bleeding,” said Hofmann. “But it’s very likely that there is a clinical effect, at least in those individuals at increased risk of bleeding.”
Discussant Paul Ridker, MD, a cardiologist at Harvard Medical School, Boston, said he agreed that the trial was technically neutral but clinically positive. He noted that in every subgroup, the trend was in the direction of benefit, with only the top end of the cardiac indices crossing over into no benefit. And the benefit appeared larger among high-risk patients with anemia or kidney failure.
“These are the very patients I’m most concerned about and don’t want to bleed,” he said.Because the urea breath test and eradication therapy are simple, safe, and inexpensive, Hofmann said he thinks there is “good evidence to recommend H. pylori screening in patients at higher risk of bleeding.”
“I’m very sure from a clinical perspective that we will be able to identify the groups that are low-hanging fruit,” he said. “But the guideline committees will have to decide if this evidence is enough.”
Hofmann and Ridker reported having no financial conflicts of interest.
A version of this article appeared on Medscape.com.
, according to the HELP-MI SWEDEHEART trial published in JAMA and presented at the European Society of Cardiology (ESC) Congress 2025.
Bleeding in the upper gastrointestinal tract is a common complication after MI. It increases morbidity and mortality itself but can also reduce the effectiveness of antithrombotic treatments and lead to new cardiovascular events. It is often related to infection with H. pylori, the bacterium that can cause stomach inflammation, ulcers, and cancer, said Robin Hofmann, MD, PhD, a cardiologist at the Karolinska Institute in Stockholm, Sweden, who presented the trial results.Hofmann and his colleagues wondered whether screening for the bacterium using a simple urea breath test would help reduce the risk for bleeds. Using Sweden’s national SWEDEHEART registry, researchers performed a cluster-randomized crossover trial of more than 18,000 patients with MI at 35 Swedish hospitals. They found that screening for H. pylori reduced the risk for upper gastrointestinal bleeding by 10%, but the results were not statistically significant.
Several factors may have contributed to the neutral result, noted Hofmann. Just 70% of the people in the screening population were actually screened — though he said that is a fairly good number for a diagnostic test. A relatively small number, around 23%, were positive for H. pylori, a much lower rate than in many other parts of the world, and about 25% of participants in both arms of the trial were already taking proton pump inhibitors to reduce the risk for bleeding.
Signals of Benefit in High-Risk Patients
But in some high-risk subgroups, there was a clearer signal of benefit. Patients with anemia or kidney failure, for example, who are at higher risk for bleeding, saw a relative risk reduction of around 50% in the screening group — though the numbers were too small for formal statistical analysis.
“In unselected patients with myocardial infarction we could not show a significant reduction in bleeding,” said Hofmann. “But it’s very likely that there is a clinical effect, at least in those individuals at increased risk of bleeding.”
Discussant Paul Ridker, MD, a cardiologist at Harvard Medical School, Boston, said he agreed that the trial was technically neutral but clinically positive. He noted that in every subgroup, the trend was in the direction of benefit, with only the top end of the cardiac indices crossing over into no benefit. And the benefit appeared larger among high-risk patients with anemia or kidney failure.
“These are the very patients I’m most concerned about and don’t want to bleed,” he said.Because the urea breath test and eradication therapy are simple, safe, and inexpensive, Hofmann said he thinks there is “good evidence to recommend H. pylori screening in patients at higher risk of bleeding.”
“I’m very sure from a clinical perspective that we will be able to identify the groups that are low-hanging fruit,” he said. “But the guideline committees will have to decide if this evidence is enough.”
Hofmann and Ridker reported having no financial conflicts of interest.
A version of this article appeared on Medscape.com.
Screening for H. pylori May Reduce Bleeding in Some Patients With MI
Screening for H. pylori May Reduce Bleeding in Some Patients With MI
Clinical Characteristics and Outcomes of Tall Cell Carcinoma with Reversed Polarity
Background
Tall cell carcinoma with reversed polarity (TCCRP) is a rare and distinct subtype of invasive breast carcinoma, defined by tall columnar cells with eosinophilic cytoplasm and reversed nuclear polarity. TCCRP remains poorly characterized in the literature, with limited population-level evidence to guide management and prognostication. This study uses the National Cancer Database (NCDB) to examine the epidemiology, clinical features, and outcomes of this neoplasm.
Methods
A retrospective cohort analysis included 951 patients diagnosed with TCCRP (ICD-O-3 code 8509) from 2018–2020 using the NCDB. Demographic and treatment variables were analyzed using descriptive statistics. Incidence trends were assessed using linear regression, and overall survival was evaluated using Kaplan-Meier methods.
Results
Most patients were female (98.1%) with a mean age of 69.1 years. The majority were White (82.0%), followed by Black (9.0%) and Hispanic (8.7%). Primary tumor sites included overlapping breast lesions (28.5%) and the upper-inner quadrant (27.0%). Incidence remained stable (R2 = 0.0). Most patients were diagnosed at Stage I (58.4%) and had a Charlson-Deyo score of 0 (76.2%). Socioeconomically, 41.8% lived in the highest income quartile (≥$74,063), and most had Medicare (64.7%). The most common treatment settings were comprehensive community cancer programs (40.3%). Surgery was performed in 95.6% of cases, with negative margins in 91.1%. Radiation therapy (46.6%) and hormone therapy (44.3%) were frequently used. Mortality was 1.1% at 30 days and 1.7% at 90 days. Survival was 98.9% at 2 years, 97.3% at 5 years, and 94.5% at 10 years, with a mean survival of 46.4 months.
Conclusions
This is the first NCDB-based study of TCCRP, highlighting favorable outcomes and distinct clinicodemographic features. Patients were predominantly older, White, and Medicare-insured, often receiving care at community cancer programs. These findings suggest that socioeconomic factors may influence access and treatment. Results may inform strategies to promote equitable care delivery across health systems and guide further research on clinical management and survivorship in TCCRP, particularly for rare cancers within community-based settings such as the VHA.
Background
Tall cell carcinoma with reversed polarity (TCCRP) is a rare and distinct subtype of invasive breast carcinoma, defined by tall columnar cells with eosinophilic cytoplasm and reversed nuclear polarity. TCCRP remains poorly characterized in the literature, with limited population-level evidence to guide management and prognostication. This study uses the National Cancer Database (NCDB) to examine the epidemiology, clinical features, and outcomes of this neoplasm.
Methods
A retrospective cohort analysis included 951 patients diagnosed with TCCRP (ICD-O-3 code 8509) from 2018–2020 using the NCDB. Demographic and treatment variables were analyzed using descriptive statistics. Incidence trends were assessed using linear regression, and overall survival was evaluated using Kaplan-Meier methods.
Results
Most patients were female (98.1%) with a mean age of 69.1 years. The majority were White (82.0%), followed by Black (9.0%) and Hispanic (8.7%). Primary tumor sites included overlapping breast lesions (28.5%) and the upper-inner quadrant (27.0%). Incidence remained stable (R2 = 0.0). Most patients were diagnosed at Stage I (58.4%) and had a Charlson-Deyo score of 0 (76.2%). Socioeconomically, 41.8% lived in the highest income quartile (≥$74,063), and most had Medicare (64.7%). The most common treatment settings were comprehensive community cancer programs (40.3%). Surgery was performed in 95.6% of cases, with negative margins in 91.1%. Radiation therapy (46.6%) and hormone therapy (44.3%) were frequently used. Mortality was 1.1% at 30 days and 1.7% at 90 days. Survival was 98.9% at 2 years, 97.3% at 5 years, and 94.5% at 10 years, with a mean survival of 46.4 months.
Conclusions
This is the first NCDB-based study of TCCRP, highlighting favorable outcomes and distinct clinicodemographic features. Patients were predominantly older, White, and Medicare-insured, often receiving care at community cancer programs. These findings suggest that socioeconomic factors may influence access and treatment. Results may inform strategies to promote equitable care delivery across health systems and guide further research on clinical management and survivorship in TCCRP, particularly for rare cancers within community-based settings such as the VHA.
Background
Tall cell carcinoma with reversed polarity (TCCRP) is a rare and distinct subtype of invasive breast carcinoma, defined by tall columnar cells with eosinophilic cytoplasm and reversed nuclear polarity. TCCRP remains poorly characterized in the literature, with limited population-level evidence to guide management and prognostication. This study uses the National Cancer Database (NCDB) to examine the epidemiology, clinical features, and outcomes of this neoplasm.
Methods
A retrospective cohort analysis included 951 patients diagnosed with TCCRP (ICD-O-3 code 8509) from 2018–2020 using the NCDB. Demographic and treatment variables were analyzed using descriptive statistics. Incidence trends were assessed using linear regression, and overall survival was evaluated using Kaplan-Meier methods.
Results
Most patients were female (98.1%) with a mean age of 69.1 years. The majority were White (82.0%), followed by Black (9.0%) and Hispanic (8.7%). Primary tumor sites included overlapping breast lesions (28.5%) and the upper-inner quadrant (27.0%). Incidence remained stable (R2 = 0.0). Most patients were diagnosed at Stage I (58.4%) and had a Charlson-Deyo score of 0 (76.2%). Socioeconomically, 41.8% lived in the highest income quartile (≥$74,063), and most had Medicare (64.7%). The most common treatment settings were comprehensive community cancer programs (40.3%). Surgery was performed in 95.6% of cases, with negative margins in 91.1%. Radiation therapy (46.6%) and hormone therapy (44.3%) were frequently used. Mortality was 1.1% at 30 days and 1.7% at 90 days. Survival was 98.9% at 2 years, 97.3% at 5 years, and 94.5% at 10 years, with a mean survival of 46.4 months.
Conclusions
This is the first NCDB-based study of TCCRP, highlighting favorable outcomes and distinct clinicodemographic features. Patients were predominantly older, White, and Medicare-insured, often receiving care at community cancer programs. These findings suggest that socioeconomic factors may influence access and treatment. Results may inform strategies to promote equitable care delivery across health systems and guide further research on clinical management and survivorship in TCCRP, particularly for rare cancers within community-based settings such as the VHA.
ERCC2, KDM6A, and TERT as Key Prognostic Factors in Bladder Cancer: Insights from the AACR Project GENIE Database
Background
Urothelial carcinoma (UC) is among the top 10 frequently diagnosed cancers in the world. Mutations in FGFR3, ARID1A, and TP53 are well documented as being some of the most frequent mutations found in UC. Despite advances in treatment, survival outcomes remain poor, especially in advanced stages. To promote future pharmacotherapeutic development, the molecular understanding of UC needs to be continually updated using more recently available databases.
Methods
This study utilizes the AACR Project GENIE database from the American Association for Cancer Research to explore the mutational profiles of patients with UC. Gene mutation frequencies were calculated, and two Kaplan-Meier curves were drawn for each gene, showing one curve for patients with the mutation and one for those without. Log-Rank tests were calculated with subsequent FDR (Benjamini–Hochberg) correction applied to account for multiple hypothesis testing. Data was analyzed using R 4.4.2 and statistical significance was set at α = 0.05.
Results
In this study, 4525 patients had histology consistent with UC. The 5 most common mutations were TERT (n = 1714, 37.9%), TP53 (n = 1689, 37.3%), KDM6A (n = 1091, 24.1%), ARID1A (n = 872, 19.3%), and FGFR3 (n = 762, 16.8%). Mutations associated with differential survival outcomes included ERCC2 (mutated n = 387, wild type n = 3751, p < 0.0001), KDM6A (mutated n = 1091, wild type n = 3047, p < 0.0001), TERT (mutated n = 1714, wild type n = 2424), and TP53 (mutated n = 1689, wild type n = 2449, p < 0.0001).
Conclusions
Interestingly, while mutations in TP53 and ERCC2 were associated with shorter median survival, mutations in KDM6A and TERT were associated with longer median survival.
Background
Urothelial carcinoma (UC) is among the top 10 frequently diagnosed cancers in the world. Mutations in FGFR3, ARID1A, and TP53 are well documented as being some of the most frequent mutations found in UC. Despite advances in treatment, survival outcomes remain poor, especially in advanced stages. To promote future pharmacotherapeutic development, the molecular understanding of UC needs to be continually updated using more recently available databases.
Methods
This study utilizes the AACR Project GENIE database from the American Association for Cancer Research to explore the mutational profiles of patients with UC. Gene mutation frequencies were calculated, and two Kaplan-Meier curves were drawn for each gene, showing one curve for patients with the mutation and one for those without. Log-Rank tests were calculated with subsequent FDR (Benjamini–Hochberg) correction applied to account for multiple hypothesis testing. Data was analyzed using R 4.4.2 and statistical significance was set at α = 0.05.
Results
In this study, 4525 patients had histology consistent with UC. The 5 most common mutations were TERT (n = 1714, 37.9%), TP53 (n = 1689, 37.3%), KDM6A (n = 1091, 24.1%), ARID1A (n = 872, 19.3%), and FGFR3 (n = 762, 16.8%). Mutations associated with differential survival outcomes included ERCC2 (mutated n = 387, wild type n = 3751, p < 0.0001), KDM6A (mutated n = 1091, wild type n = 3047, p < 0.0001), TERT (mutated n = 1714, wild type n = 2424), and TP53 (mutated n = 1689, wild type n = 2449, p < 0.0001).
Conclusions
Interestingly, while mutations in TP53 and ERCC2 were associated with shorter median survival, mutations in KDM6A and TERT were associated with longer median survival.
Background
Urothelial carcinoma (UC) is among the top 10 frequently diagnosed cancers in the world. Mutations in FGFR3, ARID1A, and TP53 are well documented as being some of the most frequent mutations found in UC. Despite advances in treatment, survival outcomes remain poor, especially in advanced stages. To promote future pharmacotherapeutic development, the molecular understanding of UC needs to be continually updated using more recently available databases.
Methods
This study utilizes the AACR Project GENIE database from the American Association for Cancer Research to explore the mutational profiles of patients with UC. Gene mutation frequencies were calculated, and two Kaplan-Meier curves were drawn for each gene, showing one curve for patients with the mutation and one for those without. Log-Rank tests were calculated with subsequent FDR (Benjamini–Hochberg) correction applied to account for multiple hypothesis testing. Data was analyzed using R 4.4.2 and statistical significance was set at α = 0.05.
Results
In this study, 4525 patients had histology consistent with UC. The 5 most common mutations were TERT (n = 1714, 37.9%), TP53 (n = 1689, 37.3%), KDM6A (n = 1091, 24.1%), ARID1A (n = 872, 19.3%), and FGFR3 (n = 762, 16.8%). Mutations associated with differential survival outcomes included ERCC2 (mutated n = 387, wild type n = 3751, p < 0.0001), KDM6A (mutated n = 1091, wild type n = 3047, p < 0.0001), TERT (mutated n = 1714, wild type n = 2424), and TP53 (mutated n = 1689, wild type n = 2449, p < 0.0001).
Conclusions
Interestingly, while mutations in TP53 and ERCC2 were associated with shorter median survival, mutations in KDM6A and TERT were associated with longer median survival.
Communication Modality (CM) Among Veterans Using National TeleOncology (NTO) Services
Background
We examined characteristics of Veterans receiving care through NTO and their CM (e.g., telephone only [T], video only [V], or both [TV]). Relevant background: In-person VA cancer care can be challenging for many Veterans due to rurality, transportation, finances, and distance to subspecialists. Such factors may impact care modality preferences.
Methods
We linked a list of all Veterans who received NTO care with Corporate Data Warehouse data to confirm an ICD-10 diagnostic code for malignancy, and to define the number of NTO interactions, latency of days between diagnosis and first NTO interaction, and demographics. The Office of Rural Health categories for rurality and NIH categories for race were used.
Data analysis
We report descriptive statistics for CM. To compare differences between Veterans by CM, we report chi-squared tests for categorical variables and ANOVAs for continuous variables.
Results
Among 13,902 NTO Veterans with CM data, most were V (9,998, 72%), few were T 2% (n= 295), and some were TV 26% (n= 3,609). There were statistically significant differences between CM in number of interactions, latency between diagnosis and first NTO interaction, age at first NTO interaction, sex, race, rurality, and cancer type. Veterans diagnosed with lung cancer were more likely to exclusively use T. Veterans with breast cancer were more likely to exclusively use V. Specifically, T were oldest (mean age = 74.3), followed by TV (69.0) and V (61.6; p < .001). Women were most represented in V (28.3%) and Rural or highly rural residence was most common among T users (54.6%), compared to V (36.8%) and TV (43.0%; p < .001). Urban users were more prevalent in the TV group (61.9%) than in the T only group (45.4%).
Implications
We identified differences in communication modality based on Veteran characteristics. This could suggest differences in Veteran or provider preference, feasibility, or acceptability, based on CM.
Significance
While V communications appear to be achievable for many Veterans, more work is needed to determine preference, feasibility, and acceptability among Veterans and their care teams regarding V and T only cancer care.
Background
We examined characteristics of Veterans receiving care through NTO and their CM (e.g., telephone only [T], video only [V], or both [TV]). Relevant background: In-person VA cancer care can be challenging for many Veterans due to rurality, transportation, finances, and distance to subspecialists. Such factors may impact care modality preferences.
Methods
We linked a list of all Veterans who received NTO care with Corporate Data Warehouse data to confirm an ICD-10 diagnostic code for malignancy, and to define the number of NTO interactions, latency of days between diagnosis and first NTO interaction, and demographics. The Office of Rural Health categories for rurality and NIH categories for race were used.
Data analysis
We report descriptive statistics for CM. To compare differences between Veterans by CM, we report chi-squared tests for categorical variables and ANOVAs for continuous variables.
Results
Among 13,902 NTO Veterans with CM data, most were V (9,998, 72%), few were T 2% (n= 295), and some were TV 26% (n= 3,609). There were statistically significant differences between CM in number of interactions, latency between diagnosis and first NTO interaction, age at first NTO interaction, sex, race, rurality, and cancer type. Veterans diagnosed with lung cancer were more likely to exclusively use T. Veterans with breast cancer were more likely to exclusively use V. Specifically, T were oldest (mean age = 74.3), followed by TV (69.0) and V (61.6; p < .001). Women were most represented in V (28.3%) and Rural or highly rural residence was most common among T users (54.6%), compared to V (36.8%) and TV (43.0%; p < .001). Urban users were more prevalent in the TV group (61.9%) than in the T only group (45.4%).
Implications
We identified differences in communication modality based on Veteran characteristics. This could suggest differences in Veteran or provider preference, feasibility, or acceptability, based on CM.
Significance
While V communications appear to be achievable for many Veterans, more work is needed to determine preference, feasibility, and acceptability among Veterans and their care teams regarding V and T only cancer care.
Background
We examined characteristics of Veterans receiving care through NTO and their CM (e.g., telephone only [T], video only [V], or both [TV]). Relevant background: In-person VA cancer care can be challenging for many Veterans due to rurality, transportation, finances, and distance to subspecialists. Such factors may impact care modality preferences.
Methods
We linked a list of all Veterans who received NTO care with Corporate Data Warehouse data to confirm an ICD-10 diagnostic code for malignancy, and to define the number of NTO interactions, latency of days between diagnosis and first NTO interaction, and demographics. The Office of Rural Health categories for rurality and NIH categories for race were used.
Data analysis
We report descriptive statistics for CM. To compare differences between Veterans by CM, we report chi-squared tests for categorical variables and ANOVAs for continuous variables.
Results
Among 13,902 NTO Veterans with CM data, most were V (9,998, 72%), few were T 2% (n= 295), and some were TV 26% (n= 3,609). There were statistically significant differences between CM in number of interactions, latency between diagnosis and first NTO interaction, age at first NTO interaction, sex, race, rurality, and cancer type. Veterans diagnosed with lung cancer were more likely to exclusively use T. Veterans with breast cancer were more likely to exclusively use V. Specifically, T were oldest (mean age = 74.3), followed by TV (69.0) and V (61.6; p < .001). Women were most represented in V (28.3%) and Rural or highly rural residence was most common among T users (54.6%), compared to V (36.8%) and TV (43.0%; p < .001). Urban users were more prevalent in the TV group (61.9%) than in the T only group (45.4%).
Implications
We identified differences in communication modality based on Veteran characteristics. This could suggest differences in Veteran or provider preference, feasibility, or acceptability, based on CM.
Significance
While V communications appear to be achievable for many Veterans, more work is needed to determine preference, feasibility, and acceptability among Veterans and their care teams regarding V and T only cancer care.