From the AGA Journals

When treating patients for ulcerative colitis (UC), clinicians should consider using vedolizumab, because the drug has been found to be both safe and highly effective in patients who have never received tumor necrosis factor (TNF)–antagonist treatment and those who have but did not benefit from it, according to a study published in the February issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.08.044).

“Approximately 50% of patients with UC do not respond to induction therapy with TNF antagonists or lose response over time such that after 1 year of treatment, clinical remission is observed in only 17%-34% of patients,” explained the authors of the report, led by Brian G. Feagan, MD, of the University of Western Ontario in London. “Furthermore, the risk of serious infection (with immunosuppressants in general, and TNF antagonists specifically) is an important concern [so] alternative approaches to treatment are needed.”

For this study, Dr. Feagan and his colleagues turned to the GEMINI 1 trial, which evaluated vedolizumab in patients with moderate and severe UC via a multicenter, phase III, randomized, placebo-controlled trial. This study produced data on 374 subjects who had been randomized into cohorts receiving either vedolizumab intravenously or a placebo. However, this number was deemed too low, so a further 521 patients were enrolled for an open-label study and randomized in the same 3:2 ratio as the previous study. The former study was called Cohort 1 and the latter called Cohort 2.

“Eligible patients had UC for [at least] 6 months before enrollment, MCS [Mayo Clinic scores for disease activity] from 6 to 12, and endoscopic subscores of [at least] 2 within 7 days before the first dose of study drug, and evidence of disease extending [at least] 15 cm proximal to the rectum,” the authors explained.

Vedolizumab was administered at baseline, with follow-up evaluations at 2, 4, and 6 weeks. Subjects who experienced a clinical response – defined as an MCS reduction of at least 3 points and 30%, along with at least a 1-point reduction in rectal bleeding and an absolute rectal bleeding subscore of either 0 or 1 – were re-randomized into cohorts that received the drug every 4 weeks or every 8 weeks, for a period of up to 46 weeks. The total length of the study was, therefore, 52 weeks; for patients that were re-randomized, follow-up evaluations took place every 4 weeks.

A total of 464 patients who were enrolled and completed the study were naive to TNF antagonists, while 367 had previously been treated with TNF antagonists unsuccessfully. At 6-week follow-up, 53.1% of naive subjects receiving vedolizumab had achieved clinical response, versus 26.3% of naive subjects on placebo (absolute difference, 26.4%; 95% confidence interval, 12.4-40.4). Similarly, those with previous TNF antagonist exposure who were given vedolizumab had a 39.0% clinical response rate, versus 20.6% of those on placebo (AD, 18.1%; 95% CI, 2.8-33.5).

At week 52, naive subjects on vedolizumab continued to have far higher rates of clinical response than did those on placebo, with 46.9% and 19.0%, respectively (AD, 28.0%; 95% CI, 14.9-41.1). For those with previous TNF antagonist exposure, the disparity between vedolizumab and placebo was similarly profound: 36.1% versus 5.3%, respectively (AD, 29.5%; 95% CI, 12.8-46.1).

Adverse event rates between naive and previously exposed patients were not significantly different, according to the findings. In naive patients, 74% of those on vedolizumab experienced an adverse event, and 9% experienced a serious adverse event. For those on placebo, those rates were 75% and 16%, respectively. For patients who had previously been on a TNF antagonist, subjects on vedolizumab had an 88% rate of adverse events and a 17% rate of serious adverse events, compared with 84% and 11%, respectively, for those on placebo.

“It is notable that, in maintenance, the absolute remission rates were substantially lower in the TNF failure population for both vedolizumab-treated and placebo-treated patients,” the investigators noted, positing that “The relatively low placebo response rate in the TNF-failure group could be attributed to the presence of a greater proportion of patients with more refractory disease and poor prognostic factors, such as pancolitis and long disease duration.”

The study was funded by Millennium Pharmaceuticals. Dr. Feagan disclosed serving as a consultant and receiving financial support for research from Millennium and other companies. No other coauthors reported relevant financial disclosures.
 

[email protected]

When treating patients for ulcerative colitis (UC), clinicians should consider using vedolizumab, because the drug has been found to be both safe and highly effective in patients who have never received tumor necrosis factor (TNF)–antagonist treatment and those who have but did not benefit from it, according to a study published in the February issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.08.044).

“Approximately 50% of patients with UC do not respond to induction therapy with TNF antagonists or lose response over time such that after 1 year of treatment, clinical remission is observed in only 17%-34% of patients,” explained the authors of the report, led by Brian G. Feagan, MD, of the University of Western Ontario in London. “Furthermore, the risk of serious infection (with immunosuppressants in general, and TNF antagonists specifically) is an important concern [so] alternative approaches to treatment are needed.”

For this study, Dr. Feagan and his colleagues turned to the GEMINI 1 trial, which evaluated vedolizumab in patients with moderate and severe UC via a multicenter, phase III, randomized, placebo-controlled trial. This study produced data on 374 subjects who had been randomized into cohorts receiving either vedolizumab intravenously or a placebo. However, this number was deemed too low, so a further 521 patients were enrolled for an open-label study and randomized in the same 3:2 ratio as the previous study. The former study was called Cohort 1 and the latter called Cohort 2.

“Eligible patients had UC for [at least] 6 months before enrollment, MCS [Mayo Clinic scores for disease activity] from 6 to 12, and endoscopic subscores of [at least] 2 within 7 days before the first dose of study drug, and evidence of disease extending [at least] 15 cm proximal to the rectum,” the authors explained.

Vedolizumab was administered at baseline, with follow-up evaluations at 2, 4, and 6 weeks. Subjects who experienced a clinical response – defined as an MCS reduction of at least 3 points and 30%, along with at least a 1-point reduction in rectal bleeding and an absolute rectal bleeding subscore of either 0 or 1 – were re-randomized into cohorts that received the drug every 4 weeks or every 8 weeks, for a period of up to 46 weeks. The total length of the study was, therefore, 52 weeks; for patients that were re-randomized, follow-up evaluations took place every 4 weeks.

A total of 464 patients who were enrolled and completed the study were naive to TNF antagonists, while 367 had previously been treated with TNF antagonists unsuccessfully. At 6-week follow-up, 53.1% of naive subjects receiving vedolizumab had achieved clinical response, versus 26.3% of naive subjects on placebo (absolute difference, 26.4%; 95% confidence interval, 12.4-40.4). Similarly, those with previous TNF antagonist exposure who were given vedolizumab had a 39.0% clinical response rate, versus 20.6% of those on placebo (AD, 18.1%; 95% CI, 2.8-33.5).

At week 52, naive subjects on vedolizumab continued to have far higher rates of clinical response than did those on placebo, with 46.9% and 19.0%, respectively (AD, 28.0%; 95% CI, 14.9-41.1). For those with previous TNF antagonist exposure, the disparity between vedolizumab and placebo was similarly profound: 36.1% versus 5.3%, respectively (AD, 29.5%; 95% CI, 12.8-46.1).

Adverse event rates between naive and previously exposed patients were not significantly different, according to the findings. In naive patients, 74% of those on vedolizumab experienced an adverse event, and 9% experienced a serious adverse event. For those on placebo, those rates were 75% and 16%, respectively. For patients who had previously been on a TNF antagonist, subjects on vedolizumab had an 88% rate of adverse events and a 17% rate of serious adverse events, compared with 84% and 11%, respectively, for those on placebo.

“It is notable that, in maintenance, the absolute remission rates were substantially lower in the TNF failure population for both vedolizumab-treated and placebo-treated patients,” the investigators noted, positing that “The relatively low placebo response rate in the TNF-failure group could be attributed to the presence of a greater proportion of patients with more refractory disease and poor prognostic factors, such as pancolitis and long disease duration.”

The study was funded by Millennium Pharmaceuticals. Dr. Feagan disclosed serving as a consultant and receiving financial support for research from Millennium and other companies. No other coauthors reported relevant financial disclosures.
 

[email protected]

When treating patients for ulcerative colitis (UC), clinicians should consider using vedolizumab, because the drug has been found to be both safe and highly effective in patients who have never received tumor necrosis factor (TNF)–antagonist treatment and those who have but did not benefit from it, according to a study published in the February issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.08.044).

“Approximately 50% of patients with UC do not respond to induction therapy with TNF antagonists or lose response over time such that after 1 year of treatment, clinical remission is observed in only 17%-34% of patients,” explained the authors of the report, led by Brian G. Feagan, MD, of the University of Western Ontario in London. “Furthermore, the risk of serious infection (with immunosuppressants in general, and TNF antagonists specifically) is an important concern [so] alternative approaches to treatment are needed.”

For this study, Dr. Feagan and his colleagues turned to the GEMINI 1 trial, which evaluated vedolizumab in patients with moderate and severe UC via a multicenter, phase III, randomized, placebo-controlled trial. This study produced data on 374 subjects who had been randomized into cohorts receiving either vedolizumab intravenously or a placebo. However, this number was deemed too low, so a further 521 patients were enrolled for an open-label study and randomized in the same 3:2 ratio as the previous study. The former study was called Cohort 1 and the latter called Cohort 2.

“Eligible patients had UC for [at least] 6 months before enrollment, MCS [Mayo Clinic scores for disease activity] from 6 to 12, and endoscopic subscores of [at least] 2 within 7 days before the first dose of study drug, and evidence of disease extending [at least] 15 cm proximal to the rectum,” the authors explained.

Vedolizumab was administered at baseline, with follow-up evaluations at 2, 4, and 6 weeks. Subjects who experienced a clinical response – defined as an MCS reduction of at least 3 points and 30%, along with at least a 1-point reduction in rectal bleeding and an absolute rectal bleeding subscore of either 0 or 1 – were re-randomized into cohorts that received the drug every 4 weeks or every 8 weeks, for a period of up to 46 weeks. The total length of the study was, therefore, 52 weeks; for patients that were re-randomized, follow-up evaluations took place every 4 weeks.

A total of 464 patients who were enrolled and completed the study were naive to TNF antagonists, while 367 had previously been treated with TNF antagonists unsuccessfully. At 6-week follow-up, 53.1% of naive subjects receiving vedolizumab had achieved clinical response, versus 26.3% of naive subjects on placebo (absolute difference, 26.4%; 95% confidence interval, 12.4-40.4). Similarly, those with previous TNF antagonist exposure who were given vedolizumab had a 39.0% clinical response rate, versus 20.6% of those on placebo (AD, 18.1%; 95% CI, 2.8-33.5).

At week 52, naive subjects on vedolizumab continued to have far higher rates of clinical response than did those on placebo, with 46.9% and 19.0%, respectively (AD, 28.0%; 95% CI, 14.9-41.1). For those with previous TNF antagonist exposure, the disparity between vedolizumab and placebo was similarly profound: 36.1% versus 5.3%, respectively (AD, 29.5%; 95% CI, 12.8-46.1).

Adverse event rates between naive and previously exposed patients were not significantly different, according to the findings. In naive patients, 74% of those on vedolizumab experienced an adverse event, and 9% experienced a serious adverse event. For those on placebo, those rates were 75% and 16%, respectively. For patients who had previously been on a TNF antagonist, subjects on vedolizumab had an 88% rate of adverse events and a 17% rate of serious adverse events, compared with 84% and 11%, respectively, for those on placebo.

“It is notable that, in maintenance, the absolute remission rates were substantially lower in the TNF failure population for both vedolizumab-treated and placebo-treated patients,” the investigators noted, positing that “The relatively low placebo response rate in the TNF-failure group could be attributed to the presence of a greater proportion of patients with more refractory disease and poor prognostic factors, such as pancolitis and long disease duration.”

The study was funded by Millennium Pharmaceuticals. Dr. Feagan disclosed serving as a consultant and receiving financial support for research from Millennium and other companies. No other coauthors reported relevant financial disclosures.
 

[email protected]

Women who undergo an endoscopy during pregnancy are increasing the chances that their baby will be born preterm, or be small for gestational age (SGA), according to research published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.016).

“Research in pregnancy outcome in women undergoing endoscopy during pregnancy is scarce,” wrote the authors, led by Jonas F. Ludvigsson, MD, of the Karolinska Institutet in Stockholm, adding that there are nine studies with original data on a total of 379 pregnant women undergoing endoscopy; two of these studies examined pregnancy outcome in upper endoscopy (n = 143), two examined pregnancy outcome in sigmoidoscopy or colonoscopy (n = 116), and four examined pregnancy outcome in endoscopic retrograde cholangiopancreatography (n = 120).

Additionally, the authors noted that, to their knowledge, there are no studies that offer data on the relative risk of endoscopy during pregnancy, and none that followed up subjects after birth. Of the few studies that do exist, a handful conclude that endoscopy during pregnancy is actually safe, but do not include data on stillbirths and neonatal deaths that did not occur immediately after patients underwent endoscopy, which could compromise that data.

To address the lack of reliable research on the effect of endoscopy on pregnancy, Dr. Ludvigsson and his coinvestigators launched a nationwide study of pregnancies in Sweden that occurred between 1992 and 2011, all of which were registered in the Swedish Medical Birth Registry and the Swedish Patient Registry. The databases revealed 2,025 upper endoscopies, 1,109 lower endoscopies, and 58 endoscopic retrograde cholangiopancreatographies, for a total of 3,052 pregnancies exposed to endoscopy over that time period.

The primary endpoint of the study was the frequency of preterm birth and stillbirth in this population. To measure this, the investigators used adjusted relative risk (ARR), calculated via Poisson regression by using data on 1,589,173 pregnancies that were not exposed to endoscopy as reference.

“Stillbirth is recorded from 22 completed gestational weeks since mid-2008, and before that from gestational week 28. Gestational age was determined using ultrasound, and when ultrasound data were missing, we used the first day of the last menstrual period for pregnancy start,” the authors wrote.

The results showed that mothers who had any kind of endoscopy during pregnancy were more likely to experience a preterm birth or give birth to a baby who was SGA, with the ARR being 1.54 (95% confidence interval, 1.36-1.75) and 1.30 (95% CI, 1.07-1.57), respectively. However, the risk of other adverse effects, such as stillbirth or congenital malformation, was not significant: Stillbirth ARR was 1.45 (95% CI, 0.87-2.40) and congenital malformation ARR was 1.00 (95% CI, 0.83-1.20).

Women who were exposed to endoscopy during pregnancy were more likely to have a preterm birth, compared with women who had endoscopy 1 year before or after pregnancy, but were not more highly predisposed to SGA, stillbirth, or congenital malformations. Additionally, when data on multiple pregnancies carried by the same mother were compared, no correlation was found between endoscopy and gestational age or birth weight, if the mother was exposed to endoscopy during only one of the pregnancies.

“Earlier recommendations suggest that endoscopy should only be performed during pregnancy if there are strong indications, and if so, not during the second trimester, [but] our study shows that endoscopy is unlikely to have a more than marginal influence on pregnancy outcome independently of trimester,” the authors concluded. “Neither does it seem that sigmoidoscopy is preferable to a full colonoscopy in the pregnant woman.”

Regarding the latter conclusion, the authors clarified that “it is possible that in women with particularly severe gastrointestinal disease where endoscopy is inevitable, the physician will prefer a sigmoidoscopy rather than a full colonoscopy, and under such circumstances the sigmoidoscopy will signal a more severe disease.”

The investigators also noted that their study had several limitations, including not knowing the length of time each endoscopy took, the sedatives and bowel preparations that were used, the patient’s position during the procedure, and the indication that prompted the endoscopy in the first place.

The study was funded by grants from the Swedish Society of Medicine and the Stockholm County Council, and the Swedish Research Council. Dr. Ludvigsson and his coauthors did not report any relevant financial disclosures.

[email protected]

Women who undergo an endoscopy during pregnancy are increasing the chances that their baby will be born preterm, or be small for gestational age (SGA), according to research published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.016).

“Research in pregnancy outcome in women undergoing endoscopy during pregnancy is scarce,” wrote the authors, led by Jonas F. Ludvigsson, MD, of the Karolinska Institutet in Stockholm, adding that there are nine studies with original data on a total of 379 pregnant women undergoing endoscopy; two of these studies examined pregnancy outcome in upper endoscopy (n = 143), two examined pregnancy outcome in sigmoidoscopy or colonoscopy (n = 116), and four examined pregnancy outcome in endoscopic retrograde cholangiopancreatography (n = 120).

Additionally, the authors noted that, to their knowledge, there are no studies that offer data on the relative risk of endoscopy during pregnancy, and none that followed up subjects after birth. Of the few studies that do exist, a handful conclude that endoscopy during pregnancy is actually safe, but do not include data on stillbirths and neonatal deaths that did not occur immediately after patients underwent endoscopy, which could compromise that data.

To address the lack of reliable research on the effect of endoscopy on pregnancy, Dr. Ludvigsson and his coinvestigators launched a nationwide study of pregnancies in Sweden that occurred between 1992 and 2011, all of which were registered in the Swedish Medical Birth Registry and the Swedish Patient Registry. The databases revealed 2,025 upper endoscopies, 1,109 lower endoscopies, and 58 endoscopic retrograde cholangiopancreatographies, for a total of 3,052 pregnancies exposed to endoscopy over that time period.

The primary endpoint of the study was the frequency of preterm birth and stillbirth in this population. To measure this, the investigators used adjusted relative risk (ARR), calculated via Poisson regression by using data on 1,589,173 pregnancies that were not exposed to endoscopy as reference.

“Stillbirth is recorded from 22 completed gestational weeks since mid-2008, and before that from gestational week 28. Gestational age was determined using ultrasound, and when ultrasound data were missing, we used the first day of the last menstrual period for pregnancy start,” the authors wrote.

The results showed that mothers who had any kind of endoscopy during pregnancy were more likely to experience a preterm birth or give birth to a baby who was SGA, with the ARR being 1.54 (95% confidence interval, 1.36-1.75) and 1.30 (95% CI, 1.07-1.57), respectively. However, the risk of other adverse effects, such as stillbirth or congenital malformation, was not significant: Stillbirth ARR was 1.45 (95% CI, 0.87-2.40) and congenital malformation ARR was 1.00 (95% CI, 0.83-1.20).

Women who were exposed to endoscopy during pregnancy were more likely to have a preterm birth, compared with women who had endoscopy 1 year before or after pregnancy, but were not more highly predisposed to SGA, stillbirth, or congenital malformations. Additionally, when data on multiple pregnancies carried by the same mother were compared, no correlation was found between endoscopy and gestational age or birth weight, if the mother was exposed to endoscopy during only one of the pregnancies.

“Earlier recommendations suggest that endoscopy should only be performed during pregnancy if there are strong indications, and if so, not during the second trimester, [but] our study shows that endoscopy is unlikely to have a more than marginal influence on pregnancy outcome independently of trimester,” the authors concluded. “Neither does it seem that sigmoidoscopy is preferable to a full colonoscopy in the pregnant woman.”

Regarding the latter conclusion, the authors clarified that “it is possible that in women with particularly severe gastrointestinal disease where endoscopy is inevitable, the physician will prefer a sigmoidoscopy rather than a full colonoscopy, and under such circumstances the sigmoidoscopy will signal a more severe disease.”

The investigators also noted that their study had several limitations, including not knowing the length of time each endoscopy took, the sedatives and bowel preparations that were used, the patient’s position during the procedure, and the indication that prompted the endoscopy in the first place.

The study was funded by grants from the Swedish Society of Medicine and the Stockholm County Council, and the Swedish Research Council. Dr. Ludvigsson and his coauthors did not report any relevant financial disclosures.

[email protected]

Women who undergo an endoscopy during pregnancy are increasing the chances that their baby will be born preterm, or be small for gestational age (SGA), according to research published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.016).

“Research in pregnancy outcome in women undergoing endoscopy during pregnancy is scarce,” wrote the authors, led by Jonas F. Ludvigsson, MD, of the Karolinska Institutet in Stockholm, adding that there are nine studies with original data on a total of 379 pregnant women undergoing endoscopy; two of these studies examined pregnancy outcome in upper endoscopy (n = 143), two examined pregnancy outcome in sigmoidoscopy or colonoscopy (n = 116), and four examined pregnancy outcome in endoscopic retrograde cholangiopancreatography (n = 120).

Additionally, the authors noted that, to their knowledge, there are no studies that offer data on the relative risk of endoscopy during pregnancy, and none that followed up subjects after birth. Of the few studies that do exist, a handful conclude that endoscopy during pregnancy is actually safe, but do not include data on stillbirths and neonatal deaths that did not occur immediately after patients underwent endoscopy, which could compromise that data.

To address the lack of reliable research on the effect of endoscopy on pregnancy, Dr. Ludvigsson and his coinvestigators launched a nationwide study of pregnancies in Sweden that occurred between 1992 and 2011, all of which were registered in the Swedish Medical Birth Registry and the Swedish Patient Registry. The databases revealed 2,025 upper endoscopies, 1,109 lower endoscopies, and 58 endoscopic retrograde cholangiopancreatographies, for a total of 3,052 pregnancies exposed to endoscopy over that time period.

The primary endpoint of the study was the frequency of preterm birth and stillbirth in this population. To measure this, the investigators used adjusted relative risk (ARR), calculated via Poisson regression by using data on 1,589,173 pregnancies that were not exposed to endoscopy as reference.

“Stillbirth is recorded from 22 completed gestational weeks since mid-2008, and before that from gestational week 28. Gestational age was determined using ultrasound, and when ultrasound data were missing, we used the first day of the last menstrual period for pregnancy start,” the authors wrote.

The results showed that mothers who had any kind of endoscopy during pregnancy were more likely to experience a preterm birth or give birth to a baby who was SGA, with the ARR being 1.54 (95% confidence interval, 1.36-1.75) and 1.30 (95% CI, 1.07-1.57), respectively. However, the risk of other adverse effects, such as stillbirth or congenital malformation, was not significant: Stillbirth ARR was 1.45 (95% CI, 0.87-2.40) and congenital malformation ARR was 1.00 (95% CI, 0.83-1.20).

Women who were exposed to endoscopy during pregnancy were more likely to have a preterm birth, compared with women who had endoscopy 1 year before or after pregnancy, but were not more highly predisposed to SGA, stillbirth, or congenital malformations. Additionally, when data on multiple pregnancies carried by the same mother were compared, no correlation was found between endoscopy and gestational age or birth weight, if the mother was exposed to endoscopy during only one of the pregnancies.

“Earlier recommendations suggest that endoscopy should only be performed during pregnancy if there are strong indications, and if so, not during the second trimester, [but] our study shows that endoscopy is unlikely to have a more than marginal influence on pregnancy outcome independently of trimester,” the authors concluded. “Neither does it seem that sigmoidoscopy is preferable to a full colonoscopy in the pregnant woman.”

Regarding the latter conclusion, the authors clarified that “it is possible that in women with particularly severe gastrointestinal disease where endoscopy is inevitable, the physician will prefer a sigmoidoscopy rather than a full colonoscopy, and under such circumstances the sigmoidoscopy will signal a more severe disease.”

The investigators also noted that their study had several limitations, including not knowing the length of time each endoscopy took, the sedatives and bowel preparations that were used, the patient’s position during the procedure, and the indication that prompted the endoscopy in the first place.

The study was funded by grants from the Swedish Society of Medicine and the Stockholm County Council, and the Swedish Research Council. Dr. Ludvigsson and his coauthors did not report any relevant financial disclosures.

[email protected]

Patients with type 2 diabetes should be put on diets rich in either animal or plant protein to reduce not only liver fat, but insulin resistance and hepatic necroinflammation markers as well, according to a study published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.007).

“High-protein diets have shown variable and sometimes even favorable effects on glucose metabolism and insulin sensitivity in people with type 2 diabetes and it is unclear which metabolic pathways are involved,” wrote the authors of the study, led by Mariya Markova, MD, of the German Institute of Human Nutrition Potsdam-Rehbrücke in Nuthetal, Germany.

SOURCE: American Gastroenterological Association

Obesity and insulin resistance have long been linked to liver fat, with excessive amounts of the latter causing nonalcoholic fatty liver disease (NAFLD), with a significant risk of nonalcoholic steatohepatitis (NASH) developing as well. Compounding this issue, at least in the United States, are widespread dietary and nutritional habits that promote consumption of animal protein, carbohydrates, and saturated fats. This “hypercaloric Western style diet,” as the authors call it, exacerbates the accumulation of fat deposits in the liver and complicates the health of patients across the country, regardless of weight.

“Remarkably, diets restricted in methionine were shown to prevent the development of insulin resistance and of the metabolic syndrome in animal models [so] the type of protein may elicit different metabolic responses depending on the amino acid composition,” Dr. Markova and her coinvestigators noted. “It is therefore hypothesized that high-plant-protein diets exert favorable effects on hepatic fat content and metabolic responses as compared to high intake of animal protein rich in BCAA [branched-chain amino acids] and methionine,” both of which can be found in suitably low levels via plant protein.

Dr. Markova and her team devised a prospective, randomized, open-label clinical trial involving 44 patients with type 2 diabetes and NAFLD, all of whom were recruited at the department of clinical nutrition of the German Institute of Human Nutrition Potsdam-Rehbrücke between June 2013 and March 2015. Subjects were randomized into one of two cohorts, each of which were assigned a diet rich in either animal protein (AP) or plant protein (PP) for a period of 6 weeks. Median body mass index in the AP cohort was 31.0 ± 0.8, and was 29.4 ± 1.0 in the PP cohort.

The AP cohort diet consisted mainly of meat and dairy products, while legumes constituted the bulk of the PP cohort diet. Both diets were isocaloric and had the same macronutrient makeup: 30% protein, 40% carbohydrates, and 30% fat. Seven subjects dropped out prior to completion of the study; of the 37 that remained all the way through – 19 in the AP cohort, 18 in the PP cohort – the age range was 49-78 years. Subjects maintained the same physical exercise regimens throughout the study that they had beforehand, and were asked not to alter them. Hemoglobin A_1c levels ranged from 5.8% to 8.8% at baseline, and evaluations were carried out at fasting levels for each subject.

Patients in both cohorts saw significant decreases in intrahepatic fat content by the end of the trial period. Those in the AP cohort saw decreases of 48.0% (P = .0002), while those in the PP cohort saw a decrease of 35.7% (P = .001). Perhaps most importantly, the reductions in both cohorts were not correlated to body weight. In addition, levels of fibroblast growth factor 21 (FGF21), which has been shown to be a predictive marker of NAFLD, decreased by nearly 50% for both AP and PP cohorts (P less than .0002 for both).

“Despite the elevated intake and postprandial uptake of methionine and BCAA in the AP group, there was no indication of negative effects of these components,” the authors stated in the study. “The origin of protein – animal or plant – did not play a major role. Both high-protein diets unexpectedly induced strong reductions of FGF21, which was associated with metabolic improvements and the decrease of IHL.”

Despite these findings, however, the 6-week time span used here is not sufficient to determine just how viable this diet may be in the long term, according to the authors. Further studies will be needed, and will need to take place over longer periods of time, to “show the durability of the responses and eventual adverse effects of the diets.” Furthermore, different age groups must be examined to find out if the benefits observed by Dr. Markova and her coinvestigators were somehow related to the age of these subjects.

The study was funded by grants from German Federal Ministry of Food and Agriculture and German Center for Diabetes Research. Dr. Markova and her coauthors did not report any financial disclosures.

[email protected]

Patients with type 2 diabetes should be put on diets rich in either animal or plant protein to reduce not only liver fat, but insulin resistance and hepatic necroinflammation markers as well, according to a study published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.007).

“High-protein diets have shown variable and sometimes even favorable effects on glucose metabolism and insulin sensitivity in people with type 2 diabetes and it is unclear which metabolic pathways are involved,” wrote the authors of the study, led by Mariya Markova, MD, of the German Institute of Human Nutrition Potsdam-Rehbrücke in Nuthetal, Germany.

SOURCE: American Gastroenterological Association

Obesity and insulin resistance have long been linked to liver fat, with excessive amounts of the latter causing nonalcoholic fatty liver disease (NAFLD), with a significant risk of nonalcoholic steatohepatitis (NASH) developing as well. Compounding this issue, at least in the United States, are widespread dietary and nutritional habits that promote consumption of animal protein, carbohydrates, and saturated fats. This “hypercaloric Western style diet,” as the authors call it, exacerbates the accumulation of fat deposits in the liver and complicates the health of patients across the country, regardless of weight.

“Remarkably, diets restricted in methionine were shown to prevent the development of insulin resistance and of the metabolic syndrome in animal models [so] the type of protein may elicit different metabolic responses depending on the amino acid composition,” Dr. Markova and her coinvestigators noted. “It is therefore hypothesized that high-plant-protein diets exert favorable effects on hepatic fat content and metabolic responses as compared to high intake of animal protein rich in BCAA [branched-chain amino acids] and methionine,” both of which can be found in suitably low levels via plant protein.

Dr. Markova and her team devised a prospective, randomized, open-label clinical trial involving 44 patients with type 2 diabetes and NAFLD, all of whom were recruited at the department of clinical nutrition of the German Institute of Human Nutrition Potsdam-Rehbrücke between June 2013 and March 2015. Subjects were randomized into one of two cohorts, each of which were assigned a diet rich in either animal protein (AP) or plant protein (PP) for a period of 6 weeks. Median body mass index in the AP cohort was 31.0 ± 0.8, and was 29.4 ± 1.0 in the PP cohort.

The AP cohort diet consisted mainly of meat and dairy products, while legumes constituted the bulk of the PP cohort diet. Both diets were isocaloric and had the same macronutrient makeup: 30% protein, 40% carbohydrates, and 30% fat. Seven subjects dropped out prior to completion of the study; of the 37 that remained all the way through – 19 in the AP cohort, 18 in the PP cohort – the age range was 49-78 years. Subjects maintained the same physical exercise regimens throughout the study that they had beforehand, and were asked not to alter them. Hemoglobin A_1c levels ranged from 5.8% to 8.8% at baseline, and evaluations were carried out at fasting levels for each subject.

Patients in both cohorts saw significant decreases in intrahepatic fat content by the end of the trial period. Those in the AP cohort saw decreases of 48.0% (P = .0002), while those in the PP cohort saw a decrease of 35.7% (P = .001). Perhaps most importantly, the reductions in both cohorts were not correlated to body weight. In addition, levels of fibroblast growth factor 21 (FGF21), which has been shown to be a predictive marker of NAFLD, decreased by nearly 50% for both AP and PP cohorts (P less than .0002 for both).

“Despite the elevated intake and postprandial uptake of methionine and BCAA in the AP group, there was no indication of negative effects of these components,” the authors stated in the study. “The origin of protein – animal or plant – did not play a major role. Both high-protein diets unexpectedly induced strong reductions of FGF21, which was associated with metabolic improvements and the decrease of IHL.”

Despite these findings, however, the 6-week time span used here is not sufficient to determine just how viable this diet may be in the long term, according to the authors. Further studies will be needed, and will need to take place over longer periods of time, to “show the durability of the responses and eventual adverse effects of the diets.” Furthermore, different age groups must be examined to find out if the benefits observed by Dr. Markova and her coinvestigators were somehow related to the age of these subjects.

The study was funded by grants from German Federal Ministry of Food and Agriculture and German Center for Diabetes Research. Dr. Markova and her coauthors did not report any financial disclosures.

[email protected]

Patients with type 2 diabetes should be put on diets rich in either animal or plant protein to reduce not only liver fat, but insulin resistance and hepatic necroinflammation markers as well, according to a study published in the February issue of Gastroenterology (doi: 10.1053/j.gastro.2016.10.007).

“High-protein diets have shown variable and sometimes even favorable effects on glucose metabolism and insulin sensitivity in people with type 2 diabetes and it is unclear which metabolic pathways are involved,” wrote the authors of the study, led by Mariya Markova, MD, of the German Institute of Human Nutrition Potsdam-Rehbrücke in Nuthetal, Germany.

SOURCE: American Gastroenterological Association

Obesity and insulin resistance have long been linked to liver fat, with excessive amounts of the latter causing nonalcoholic fatty liver disease (NAFLD), with a significant risk of nonalcoholic steatohepatitis (NASH) developing as well. Compounding this issue, at least in the United States, are widespread dietary and nutritional habits that promote consumption of animal protein, carbohydrates, and saturated fats. This “hypercaloric Western style diet,” as the authors call it, exacerbates the accumulation of fat deposits in the liver and complicates the health of patients across the country, regardless of weight.

“Remarkably, diets restricted in methionine were shown to prevent the development of insulin resistance and of the metabolic syndrome in animal models [so] the type of protein may elicit different metabolic responses depending on the amino acid composition,” Dr. Markova and her coinvestigators noted. “It is therefore hypothesized that high-plant-protein diets exert favorable effects on hepatic fat content and metabolic responses as compared to high intake of animal protein rich in BCAA [branched-chain amino acids] and methionine,” both of which can be found in suitably low levels via plant protein.

Dr. Markova and her team devised a prospective, randomized, open-label clinical trial involving 44 patients with type 2 diabetes and NAFLD, all of whom were recruited at the department of clinical nutrition of the German Institute of Human Nutrition Potsdam-Rehbrücke between June 2013 and March 2015. Subjects were randomized into one of two cohorts, each of which were assigned a diet rich in either animal protein (AP) or plant protein (PP) for a period of 6 weeks. Median body mass index in the AP cohort was 31.0 ± 0.8, and was 29.4 ± 1.0 in the PP cohort.

The AP cohort diet consisted mainly of meat and dairy products, while legumes constituted the bulk of the PP cohort diet. Both diets were isocaloric and had the same macronutrient makeup: 30% protein, 40% carbohydrates, and 30% fat. Seven subjects dropped out prior to completion of the study; of the 37 that remained all the way through – 19 in the AP cohort, 18 in the PP cohort – the age range was 49-78 years. Subjects maintained the same physical exercise regimens throughout the study that they had beforehand, and were asked not to alter them. Hemoglobin A_1c levels ranged from 5.8% to 8.8% at baseline, and evaluations were carried out at fasting levels for each subject.

Patients in both cohorts saw significant decreases in intrahepatic fat content by the end of the trial period. Those in the AP cohort saw decreases of 48.0% (P = .0002), while those in the PP cohort saw a decrease of 35.7% (P = .001). Perhaps most importantly, the reductions in both cohorts were not correlated to body weight. In addition, levels of fibroblast growth factor 21 (FGF21), which has been shown to be a predictive marker of NAFLD, decreased by nearly 50% for both AP and PP cohorts (P less than .0002 for both).

“Despite the elevated intake and postprandial uptake of methionine and BCAA in the AP group, there was no indication of negative effects of these components,” the authors stated in the study. “The origin of protein – animal or plant – did not play a major role. Both high-protein diets unexpectedly induced strong reductions of FGF21, which was associated with metabolic improvements and the decrease of IHL.”

Despite these findings, however, the 6-week time span used here is not sufficient to determine just how viable this diet may be in the long term, according to the authors. Further studies will be needed, and will need to take place over longer periods of time, to “show the durability of the responses and eventual adverse effects of the diets.” Furthermore, different age groups must be examined to find out if the benefits observed by Dr. Markova and her coinvestigators were somehow related to the age of these subjects.

The study was funded by grants from German Federal Ministry of Food and Agriculture and German Center for Diabetes Research. Dr. Markova and her coauthors did not report any financial disclosures.

[email protected]

Acute alcoholic hepatitis carries a high risk of mortality, yet only a minority of patients admitted to the hospital with the condition receive appropriate treatment, said the authors of an expert review.

Writing in the January 2017 issue of Clinical Gastroenterology and Hepatology, Mack C. Mitchell Jr., MD, of the University of Texas Southwestern Medical Center, Dallas, and Craig J. McClain, MD, of the University of Louisville (Ky.), described the challenges associated with treating acute alcoholic hepatitis and its consequences.

Acute alcohol hepatitis develops in heavy drinkers and presents with rapid onset of malaise, anorexia, tender hepatomegaly, and features of the systemic inflammatory response syndrome. Patients with alcoholic hepatitis also are at high risk of nutritional deficiency, infection, acute kidney injury, and multiorgan failure.
 

The two most widely used therapies are glucocorticoids – generally considered the standard of care for severe alcoholic hepatitis – and the phosphodiesterase inhibitor pentoxifylline (Clin Gastroenterol Hepatol. 2017. doi: 10.1016/j.cgh.2016.08.047).

“Although in its most severe form AH has a high short-term mortality rate if untreated, in 2011, only 28% of more than 1,600 patients admitted to U.S. hospitals were treated with glucocorticoids and 17% with pentoxifylline (PTX), suggesting a lack of widespread confidence in the two most frequently used therapies for AH,” the authors wrote.

Both drugs work by addressing the underlying inflammation that plays a key role in liver injury, but the evidence for both is mixed: A 2008 Cochrane systematic review of 15 trials concluded there was no benefit from glucocorticoids, largely because of substantial variability in bias across the trials, while two meta-analyses of pentoxifylline trials concluded that there were no differences in short-term mortality between those who received it and those who did not.

Some patients are unsuitable for glucocorticoids and others may develop resistance. There is also the possibility that, while glucocorticoids may improve short-term survival, the associated increase in infection risk removes that advantage at 90 days and 1 year after diagnosis. These infections, in turn, often precede the development of acute kidney injury and multiorgan failure.

The authors, however, did suggest that the approach of very high, short-term bursts of glucocorticoids to induce “immune paralysis” – an approach taken for lupus nephritis – might be considered.

They stressed that abstinence was the cornerstone of treatment for acute alcoholic hepatitis, with studies showing that patients with alcoholic hepatitis who resume heavy drinking have significantly worse outcomes than those who don’t.

“Although abstinence is important at all stages, it is particularly important to emphasize abstinence beyond 90 days when many patients are regaining normal functioning,” Dr. Mitchell and Dr. McClain wrote.

Infection, kidney injury, and malnutrition are all significant concerns in patients with acute alcoholic hepatitis.

With respect to infection, the authors said considerable suspicion is required to pick up bacterial and fungal infections, as patients may not always have a fever and an elevated white blood cell count is an unreliable indicator. Infection also can lead to acute kidney injury.

Malnutrition is not only common in patients with alcohol hepatitis, but it has a significant negative impact on recovery. All patients should be encouraged to meet nutritional goals as early as possible, but just how to achieve this is controversial, the authors stressed.

For example, one study suggested that enteral nutrition was as good as glucocorticoids in reducing 28-day mortality, while another found enteral nutrition via nasogastric tube – in addition to glucocorticoids – was no better than glucocorticoids alone. “Whether [nasogastric] tubes should be used to provide enteral nutrition is a subject of controversy,” the authors wrote. “Normal- to high-protein diets are safe and do not increase the risk of encephalopathy in patients with AH.”

No conflicts of interest were declared.

Acute alcoholic hepatitis carries a high risk of mortality, yet only a minority of patients admitted to the hospital with the condition receive appropriate treatment, said the authors of an expert review.

Writing in the January 2017 issue of Clinical Gastroenterology and Hepatology, Mack C. Mitchell Jr., MD, of the University of Texas Southwestern Medical Center, Dallas, and Craig J. McClain, MD, of the University of Louisville (Ky.), described the challenges associated with treating acute alcoholic hepatitis and its consequences.

Acute alcohol hepatitis develops in heavy drinkers and presents with rapid onset of malaise, anorexia, tender hepatomegaly, and features of the systemic inflammatory response syndrome. Patients with alcoholic hepatitis also are at high risk of nutritional deficiency, infection, acute kidney injury, and multiorgan failure.
 

The two most widely used therapies are glucocorticoids – generally considered the standard of care for severe alcoholic hepatitis – and the phosphodiesterase inhibitor pentoxifylline (Clin Gastroenterol Hepatol. 2017. doi: 10.1016/j.cgh.2016.08.047).

“Although in its most severe form AH has a high short-term mortality rate if untreated, in 2011, only 28% of more than 1,600 patients admitted to U.S. hospitals were treated with glucocorticoids and 17% with pentoxifylline (PTX), suggesting a lack of widespread confidence in the two most frequently used therapies for AH,” the authors wrote.

Both drugs work by addressing the underlying inflammation that plays a key role in liver injury, but the evidence for both is mixed: A 2008 Cochrane systematic review of 15 trials concluded there was no benefit from glucocorticoids, largely because of substantial variability in bias across the trials, while two meta-analyses of pentoxifylline trials concluded that there were no differences in short-term mortality between those who received it and those who did not.

Some patients are unsuitable for glucocorticoids and others may develop resistance. There is also the possibility that, while glucocorticoids may improve short-term survival, the associated increase in infection risk removes that advantage at 90 days and 1 year after diagnosis. These infections, in turn, often precede the development of acute kidney injury and multiorgan failure.

The authors, however, did suggest that the approach of very high, short-term bursts of glucocorticoids to induce “immune paralysis” – an approach taken for lupus nephritis – might be considered.

They stressed that abstinence was the cornerstone of treatment for acute alcoholic hepatitis, with studies showing that patients with alcoholic hepatitis who resume heavy drinking have significantly worse outcomes than those who don’t.

“Although abstinence is important at all stages, it is particularly important to emphasize abstinence beyond 90 days when many patients are regaining normal functioning,” Dr. Mitchell and Dr. McClain wrote.

Infection, kidney injury, and malnutrition are all significant concerns in patients with acute alcoholic hepatitis.

With respect to infection, the authors said considerable suspicion is required to pick up bacterial and fungal infections, as patients may not always have a fever and an elevated white blood cell count is an unreliable indicator. Infection also can lead to acute kidney injury.

Malnutrition is not only common in patients with alcohol hepatitis, but it has a significant negative impact on recovery. All patients should be encouraged to meet nutritional goals as early as possible, but just how to achieve this is controversial, the authors stressed.

For example, one study suggested that enteral nutrition was as good as glucocorticoids in reducing 28-day mortality, while another found enteral nutrition via nasogastric tube – in addition to glucocorticoids – was no better than glucocorticoids alone. “Whether [nasogastric] tubes should be used to provide enteral nutrition is a subject of controversy,” the authors wrote. “Normal- to high-protein diets are safe and do not increase the risk of encephalopathy in patients with AH.”

No conflicts of interest were declared.

Acute alcoholic hepatitis carries a high risk of mortality, yet only a minority of patients admitted to the hospital with the condition receive appropriate treatment, said the authors of an expert review.

Writing in the January 2017 issue of Clinical Gastroenterology and Hepatology, Mack C. Mitchell Jr., MD, of the University of Texas Southwestern Medical Center, Dallas, and Craig J. McClain, MD, of the University of Louisville (Ky.), described the challenges associated with treating acute alcoholic hepatitis and its consequences.

Acute alcohol hepatitis develops in heavy drinkers and presents with rapid onset of malaise, anorexia, tender hepatomegaly, and features of the systemic inflammatory response syndrome. Patients with alcoholic hepatitis also are at high risk of nutritional deficiency, infection, acute kidney injury, and multiorgan failure.
 

The two most widely used therapies are glucocorticoids – generally considered the standard of care for severe alcoholic hepatitis – and the phosphodiesterase inhibitor pentoxifylline (Clin Gastroenterol Hepatol. 2017. doi: 10.1016/j.cgh.2016.08.047).

“Although in its most severe form AH has a high short-term mortality rate if untreated, in 2011, only 28% of more than 1,600 patients admitted to U.S. hospitals were treated with glucocorticoids and 17% with pentoxifylline (PTX), suggesting a lack of widespread confidence in the two most frequently used therapies for AH,” the authors wrote.

Both drugs work by addressing the underlying inflammation that plays a key role in liver injury, but the evidence for both is mixed: A 2008 Cochrane systematic review of 15 trials concluded there was no benefit from glucocorticoids, largely because of substantial variability in bias across the trials, while two meta-analyses of pentoxifylline trials concluded that there were no differences in short-term mortality between those who received it and those who did not.

Some patients are unsuitable for glucocorticoids and others may develop resistance. There is also the possibility that, while glucocorticoids may improve short-term survival, the associated increase in infection risk removes that advantage at 90 days and 1 year after diagnosis. These infections, in turn, often precede the development of acute kidney injury and multiorgan failure.

The authors, however, did suggest that the approach of very high, short-term bursts of glucocorticoids to induce “immune paralysis” – an approach taken for lupus nephritis – might be considered.

They stressed that abstinence was the cornerstone of treatment for acute alcoholic hepatitis, with studies showing that patients with alcoholic hepatitis who resume heavy drinking have significantly worse outcomes than those who don’t.

“Although abstinence is important at all stages, it is particularly important to emphasize abstinence beyond 90 days when many patients are regaining normal functioning,” Dr. Mitchell and Dr. McClain wrote.

Infection, kidney injury, and malnutrition are all significant concerns in patients with acute alcoholic hepatitis.

With respect to infection, the authors said considerable suspicion is required to pick up bacterial and fungal infections, as patients may not always have a fever and an elevated white blood cell count is an unreliable indicator. Infection also can lead to acute kidney injury.

Malnutrition is not only common in patients with alcohol hepatitis, but it has a significant negative impact on recovery. All patients should be encouraged to meet nutritional goals as early as possible, but just how to achieve this is controversial, the authors stressed.

For example, one study suggested that enteral nutrition was as good as glucocorticoids in reducing 28-day mortality, while another found enteral nutrition via nasogastric tube – in addition to glucocorticoids – was no better than glucocorticoids alone. “Whether [nasogastric] tubes should be used to provide enteral nutrition is a subject of controversy,” the authors wrote. “Normal- to high-protein diets are safe and do not increase the risk of encephalopathy in patients with AH.”

No conflicts of interest were declared.

One-year survival without liver transplant was far more likely when transjugular intrahepatic portosystemic shunts (TIPS) with covered stents were used to treat cirrhosis with recurrent ascites, instead of ongoing large-volume paracenteses with albumin, in a 62-patient randomized trial from France.

“TIPS with covered stents ... should therefore be preferred to LVP [large-volume paracenteses] with volume expansion... These findings support TIPS as the first-line intervention,” said investigators led by gastroenterologist Christophe Bureau, MD, of Toulouse (France) University in the January issue of Gastroenterology (doi: 10.1053/j.gastro.2016.09.016).

All 62 patients had at least two LVPs prior to the study; 29 were then randomized to covered transjugular intrahepatic portosystemic shunt (TIPS), and 33 to LVP and albumin as needed. All the patients were on a low-salt diet.

Twenty-seven TIPS patients (93%) were alive without a liver transplant at 1 year, versus 17 (52%) in the LVP group (P = .003). TIPS patients had a total of 32 paracenteses in the first year, versus 320 in the LVP group. Six paracentesis patients (18%) had portal hypertension–related bleeding, and six had hernia-related complications; none of the TIPS patients had either. LVP patients spent a mean of 35 days in the hospital, versus 17 days for the TIPS group (P = .04). The probability of remaining free of encephalopathy at 1 year was the same in both groups, at 65%.

It has been shown before that TIPS has the edge on LVP for reducing recurrence of tense ascites. However, early studies used uncovered stents and, due to their almost 80% risk of dysfunction, they did not show a significant benefit for survival. As a result, repeated paracenteses have been recommended as first-line treatment, with TIPS held in reserve for patients who need very frequent LVP.

Polytetrafluoroethylene-covered stents appear to have changed the equation, “owing to a substantial decrease in the rate of shunt dysfunction,” the investigators said.

The French results are a bit better than previous reports of covered TIPS. “This could be related to greater experience with the TIPS procedure;” there were no technical failures. The study also mostly included patients younger than 65 years with Child-Pugh class B disease and no prior encephalopathy – favorable factors that also may have contributed to the results. However, “we believe that the use of covered stents was the main determinant of the observed improvement in outcomes... TIPS with uncovered stent[s] should not be considered effective or recommended any longer for the long-term treatment of” portal hypertension, they said.

Cirrhosis in the trial was due almost entirely to alcohol abuse. About three-quarters of both groups reported abstinence while enrolled. The mean age was 56 years, and the majority of subjects were men.

The work was funded by the French Ministry of Health and supported by Gore, maker of the covered stent used in the study. Dr. Bureau and another author are Gore consultants.

[email protected]

One-year survival without liver transplant was far more likely when transjugular intrahepatic portosystemic shunts (TIPS) with covered stents were used to treat cirrhosis with recurrent ascites, instead of ongoing large-volume paracenteses with albumin, in a 62-patient randomized trial from France.

“TIPS with covered stents ... should therefore be preferred to LVP [large-volume paracenteses] with volume expansion... These findings support TIPS as the first-line intervention,” said investigators led by gastroenterologist Christophe Bureau, MD, of Toulouse (France) University in the January issue of Gastroenterology (doi: 10.1053/j.gastro.2016.09.016).

All 62 patients had at least two LVPs prior to the study; 29 were then randomized to covered transjugular intrahepatic portosystemic shunt (TIPS), and 33 to LVP and albumin as needed. All the patients were on a low-salt diet.

Twenty-seven TIPS patients (93%) were alive without a liver transplant at 1 year, versus 17 (52%) in the LVP group (P = .003). TIPS patients had a total of 32 paracenteses in the first year, versus 320 in the LVP group. Six paracentesis patients (18%) had portal hypertension–related bleeding, and six had hernia-related complications; none of the TIPS patients had either. LVP patients spent a mean of 35 days in the hospital, versus 17 days for the TIPS group (P = .04). The probability of remaining free of encephalopathy at 1 year was the same in both groups, at 65%.

It has been shown before that TIPS has the edge on LVP for reducing recurrence of tense ascites. However, early studies used uncovered stents and, due to their almost 80% risk of dysfunction, they did not show a significant benefit for survival. As a result, repeated paracenteses have been recommended as first-line treatment, with TIPS held in reserve for patients who need very frequent LVP.

Polytetrafluoroethylene-covered stents appear to have changed the equation, “owing to a substantial decrease in the rate of shunt dysfunction,” the investigators said.

The French results are a bit better than previous reports of covered TIPS. “This could be related to greater experience with the TIPS procedure;” there were no technical failures. The study also mostly included patients younger than 65 years with Child-Pugh class B disease and no prior encephalopathy – favorable factors that also may have contributed to the results. However, “we believe that the use of covered stents was the main determinant of the observed improvement in outcomes... TIPS with uncovered stent[s] should not be considered effective or recommended any longer for the long-term treatment of” portal hypertension, they said.

Cirrhosis in the trial was due almost entirely to alcohol abuse. About three-quarters of both groups reported abstinence while enrolled. The mean age was 56 years, and the majority of subjects were men.

The work was funded by the French Ministry of Health and supported by Gore, maker of the covered stent used in the study. Dr. Bureau and another author are Gore consultants.

[email protected]

One-year survival without liver transplant was far more likely when transjugular intrahepatic portosystemic shunts (TIPS) with covered stents were used to treat cirrhosis with recurrent ascites, instead of ongoing large-volume paracenteses with albumin, in a 62-patient randomized trial from France.

“TIPS with covered stents ... should therefore be preferred to LVP [large-volume paracenteses] with volume expansion... These findings support TIPS as the first-line intervention,” said investigators led by gastroenterologist Christophe Bureau, MD, of Toulouse (France) University in the January issue of Gastroenterology (doi: 10.1053/j.gastro.2016.09.016).

All 62 patients had at least two LVPs prior to the study; 29 were then randomized to covered transjugular intrahepatic portosystemic shunt (TIPS), and 33 to LVP and albumin as needed. All the patients were on a low-salt diet.

Twenty-seven TIPS patients (93%) were alive without a liver transplant at 1 year, versus 17 (52%) in the LVP group (P = .003). TIPS patients had a total of 32 paracenteses in the first year, versus 320 in the LVP group. Six paracentesis patients (18%) had portal hypertension–related bleeding, and six had hernia-related complications; none of the TIPS patients had either. LVP patients spent a mean of 35 days in the hospital, versus 17 days for the TIPS group (P = .04). The probability of remaining free of encephalopathy at 1 year was the same in both groups, at 65%.

It has been shown before that TIPS has the edge on LVP for reducing recurrence of tense ascites. However, early studies used uncovered stents and, due to their almost 80% risk of dysfunction, they did not show a significant benefit for survival. As a result, repeated paracenteses have been recommended as first-line treatment, with TIPS held in reserve for patients who need very frequent LVP.

Polytetrafluoroethylene-covered stents appear to have changed the equation, “owing to a substantial decrease in the rate of shunt dysfunction,” the investigators said.

The French results are a bit better than previous reports of covered TIPS. “This could be related to greater experience with the TIPS procedure;” there were no technical failures. The study also mostly included patients younger than 65 years with Child-Pugh class B disease and no prior encephalopathy – favorable factors that also may have contributed to the results. However, “we believe that the use of covered stents was the main determinant of the observed improvement in outcomes... TIPS with uncovered stent[s] should not be considered effective or recommended any longer for the long-term treatment of” portal hypertension, they said.

Cirrhosis in the trial was due almost entirely to alcohol abuse. About three-quarters of both groups reported abstinence while enrolled. The mean age was 56 years, and the majority of subjects were men.

The work was funded by the French Ministry of Health and supported by Gore, maker of the covered stent used in the study. Dr. Bureau and another author are Gore consultants.

[email protected]

Stool calprotectin correlates with severity of small-bowel Crohn’s disease, as measured against balloon-assisted enteroscopy and computed tomography enterography, according to a review reported in the January issue of Clinical Gastroenterology and Hepatology of 89 patients at Toho University in Chiba, Japan.

Although the correlation was moderate, the findings suggest that fecal calprotectin (FC), with additional work, might turn out to be a good biomarker for tracking small-bowel Crohn’s disease (CD) and its response to tumor necrosis factor blockers. “Currently, it is not widely accepted that FC relates to disease activity in patients with small-intestinal CD,” said investigators led by Tsunetaka Arai of Toho University’s division of gastroenterology and hepatology (Clin Gastroenterol Hepatol. 2016 Aug 23. doi: 10.1016/j.cgh.2016.08.015).

Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

[email protected]

Stool calprotectin correlates with severity of small-bowel Crohn’s disease, as measured against balloon-assisted enteroscopy and computed tomography enterography, according to a review reported in the January issue of Clinical Gastroenterology and Hepatology of 89 patients at Toho University in Chiba, Japan.

Although the correlation was moderate, the findings suggest that fecal calprotectin (FC), with additional work, might turn out to be a good biomarker for tracking small-bowel Crohn’s disease (CD) and its response to tumor necrosis factor blockers. “Currently, it is not widely accepted that FC relates to disease activity in patients with small-intestinal CD,” said investigators led by Tsunetaka Arai of Toho University’s division of gastroenterology and hepatology (Clin Gastroenterol Hepatol. 2016 Aug 23. doi: 10.1016/j.cgh.2016.08.015).

Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

[email protected]

Stool calprotectin correlates with severity of small-bowel Crohn’s disease, as measured against balloon-assisted enteroscopy and computed tomography enterography, according to a review reported in the January issue of Clinical Gastroenterology and Hepatology of 89 patients at Toho University in Chiba, Japan.

Although the correlation was moderate, the findings suggest that fecal calprotectin (FC), with additional work, might turn out to be a good biomarker for tracking small-bowel Crohn’s disease (CD) and its response to tumor necrosis factor blockers. “Currently, it is not widely accepted that FC relates to disease activity in patients with small-intestinal CD,” said investigators led by Tsunetaka Arai of Toho University’s division of gastroenterology and hepatology (Clin Gastroenterol Hepatol. 2016 Aug 23. doi: 10.1016/j.cgh.2016.08.015).

Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

[email protected]

Mobile health indexes for remotely monitoring Crohn’s disease and ulcerative colitis accurately identified clinically active disease and changed significantly as disease activity did, researchers reported in the December issue of Clinical Gastroenterology and Hepatology.

The mobile health index for Crohn’s disease predicted clinical disease activity with an area under the receiver operating characteristic curve (AUC) of 0.90, Welmoed K. van Deen, MD, of the University of California, Los Angeles, and her associates wrote in Clinical Gastroenterology and Hepatology. The AUC for the ulcerative colitis index for ulcerative colitis was very similar, at 0.91. “The [mobile health indexes] are specifically designed for implementation on a mobile application, and are currently available to patients with IBD [inflammatory bowel disease] treated at the UCLA Center for IBD,” the researchers said. “Prospective, randomized studies need to assess the effect of remote monitoring on disease control, quality of life, patient satisfaction, and health care costs.”

Inspired by the lack of smartphone applications for remotely managing inflammatory bowel disease, the researchers administered comprehensive disease-specific questionnaires to 110 patients with Crohn’s disease and 109 patients with ulcerative colitis who visited the UCLA IBD center in 2013 and 2014. They compared patient-reported outcomes across 10 domains of disease activity with scores on a number of existing disease activity indexes, and used logistic regression to identify which self-reported outcomes best predicted disease activity in both Crohn’s disease and ulcerative colitis (Clin Gastroenterol Hepatol. 2015 Nov 18. doi: 10.1016/j.cgh.2015.10.035).

The resulting Crohn’s disease mobile health index asked how many liquid or “very soft” stools patients had per day, if they had abdominal pain, and how they would rate their well-being and level of disease control on scales ranging between 0 and 10. The ulcerative colitis mobile health index asked about number of stools the day before and had patients score abdominal pain, frequency of rectal bleeding, and level of disease control between 0 and 10. The researchers also validated each mobile health index in multicenter cohorts of 301 patients with Crohn’s disease and 265 patients with ulcerative colitis.

Each mobile health index detected clinical disease activity with about 90% accuracy, compared with standard measures, including the Crohn’s disease activity index and the Harvey Bradshaw index for Crohn’s disease, the partial Mayo score, the simple clinical colitis activity index, and the modified Truelove and Witts index for ulcerative colitis. But the mobile indexes detected endoscopic disease activity less accurately, with AUCs of 0.82 for ulcerative colitis and only 0.63 for Crohn’s disease. “As previously shown, ulcerative colitis clinical disease activity highly correlates with endoscopic disease activity, whereas correlation between Crohn’s disease symptoms and endoscopic findings is poor,” the researchers noted. However, both mobile indexes reliably detected changes in disease activity, varying significantly depending on whether patients were clinically improved, stable, or worse, regardless of whether they had Crohn’s disease (P = .003) or ulcerative colitis (P = .0025).

To explore intrapatient reliability, the researchers also compared initial and follow-up mobile health index results for subgroups of 40 Crohn’s disease patients tested a median of 21 hours apart, and 37 ulcerative colitis patients tested a median of 23 hours apart. In both cases, the intraclass correlation coefficient reached 0.94 (95% confidence interval, 0.89-0.97). “Cloud-based health technologies are predicted to revolutionize care delivery and patient engagement,” the investigators commented. “Patients can participate in their care by signaling meaningful health outcomes during year-round monitoring. Barriers for more widespread implementation of mobile health in inflammatory bowel disease care include policies affecting reimbursement and regulatory requirements, and privacy and security concerns.”

Genova Diagnostics provided stool collection kits and fecal calprotectin testing. The investigators had no disclosures.

Mobile health indexes for remotely monitoring Crohn’s disease and ulcerative colitis accurately identified clinically active disease and changed significantly as disease activity did, researchers reported in the December issue of Clinical Gastroenterology and Hepatology.

The mobile health index for Crohn’s disease predicted clinical disease activity with an area under the receiver operating characteristic curve (AUC) of 0.90, Welmoed K. van Deen, MD, of the University of California, Los Angeles, and her associates wrote in Clinical Gastroenterology and Hepatology. The AUC for the ulcerative colitis index for ulcerative colitis was very similar, at 0.91. “The [mobile health indexes] are specifically designed for implementation on a mobile application, and are currently available to patients with IBD [inflammatory bowel disease] treated at the UCLA Center for IBD,” the researchers said. “Prospective, randomized studies need to assess the effect of remote monitoring on disease control, quality of life, patient satisfaction, and health care costs.”

Inspired by the lack of smartphone applications for remotely managing inflammatory bowel disease, the researchers administered comprehensive disease-specific questionnaires to 110 patients with Crohn’s disease and 109 patients with ulcerative colitis who visited the UCLA IBD center in 2013 and 2014. They compared patient-reported outcomes across 10 domains of disease activity with scores on a number of existing disease activity indexes, and used logistic regression to identify which self-reported outcomes best predicted disease activity in both Crohn’s disease and ulcerative colitis (Clin Gastroenterol Hepatol. 2015 Nov 18. doi: 10.1016/j.cgh.2015.10.035).

The resulting Crohn’s disease mobile health index asked how many liquid or “very soft” stools patients had per day, if they had abdominal pain, and how they would rate their well-being and level of disease control on scales ranging between 0 and 10. The ulcerative colitis mobile health index asked about number of stools the day before and had patients score abdominal pain, frequency of rectal bleeding, and level of disease control between 0 and 10. The researchers also validated each mobile health index in multicenter cohorts of 301 patients with Crohn’s disease and 265 patients with ulcerative colitis.

Each mobile health index detected clinical disease activity with about 90% accuracy, compared with standard measures, including the Crohn’s disease activity index and the Harvey Bradshaw index for Crohn’s disease, the partial Mayo score, the simple clinical colitis activity index, and the modified Truelove and Witts index for ulcerative colitis. But the mobile indexes detected endoscopic disease activity less accurately, with AUCs of 0.82 for ulcerative colitis and only 0.63 for Crohn’s disease. “As previously shown, ulcerative colitis clinical disease activity highly correlates with endoscopic disease activity, whereas correlation between Crohn’s disease symptoms and endoscopic findings is poor,” the researchers noted. However, both mobile indexes reliably detected changes in disease activity, varying significantly depending on whether patients were clinically improved, stable, or worse, regardless of whether they had Crohn’s disease (P = .003) or ulcerative colitis (P = .0025).

To explore intrapatient reliability, the researchers also compared initial and follow-up mobile health index results for subgroups of 40 Crohn’s disease patients tested a median of 21 hours apart, and 37 ulcerative colitis patients tested a median of 23 hours apart. In both cases, the intraclass correlation coefficient reached 0.94 (95% confidence interval, 0.89-0.97). “Cloud-based health technologies are predicted to revolutionize care delivery and patient engagement,” the investigators commented. “Patients can participate in their care by signaling meaningful health outcomes during year-round monitoring. Barriers for more widespread implementation of mobile health in inflammatory bowel disease care include policies affecting reimbursement and regulatory requirements, and privacy and security concerns.”

Genova Diagnostics provided stool collection kits and fecal calprotectin testing. The investigators had no disclosures.

Mobile health indexes for remotely monitoring Crohn’s disease and ulcerative colitis accurately identified clinically active disease and changed significantly as disease activity did, researchers reported in the December issue of Clinical Gastroenterology and Hepatology.

The mobile health index for Crohn’s disease predicted clinical disease activity with an area under the receiver operating characteristic curve (AUC) of 0.90, Welmoed K. van Deen, MD, of the University of California, Los Angeles, and her associates wrote in Clinical Gastroenterology and Hepatology. The AUC for the ulcerative colitis index for ulcerative colitis was very similar, at 0.91. “The [mobile health indexes] are specifically designed for implementation on a mobile application, and are currently available to patients with IBD [inflammatory bowel disease] treated at the UCLA Center for IBD,” the researchers said. “Prospective, randomized studies need to assess the effect of remote monitoring on disease control, quality of life, patient satisfaction, and health care costs.”

Inspired by the lack of smartphone applications for remotely managing inflammatory bowel disease, the researchers administered comprehensive disease-specific questionnaires to 110 patients with Crohn’s disease and 109 patients with ulcerative colitis who visited the UCLA IBD center in 2013 and 2014. They compared patient-reported outcomes across 10 domains of disease activity with scores on a number of existing disease activity indexes, and used logistic regression to identify which self-reported outcomes best predicted disease activity in both Crohn’s disease and ulcerative colitis (Clin Gastroenterol Hepatol. 2015 Nov 18. doi: 10.1016/j.cgh.2015.10.035).

The resulting Crohn’s disease mobile health index asked how many liquid or “very soft” stools patients had per day, if they had abdominal pain, and how they would rate their well-being and level of disease control on scales ranging between 0 and 10. The ulcerative colitis mobile health index asked about number of stools the day before and had patients score abdominal pain, frequency of rectal bleeding, and level of disease control between 0 and 10. The researchers also validated each mobile health index in multicenter cohorts of 301 patients with Crohn’s disease and 265 patients with ulcerative colitis.

Each mobile health index detected clinical disease activity with about 90% accuracy, compared with standard measures, including the Crohn’s disease activity index and the Harvey Bradshaw index for Crohn’s disease, the partial Mayo score, the simple clinical colitis activity index, and the modified Truelove and Witts index for ulcerative colitis. But the mobile indexes detected endoscopic disease activity less accurately, with AUCs of 0.82 for ulcerative colitis and only 0.63 for Crohn’s disease. “As previously shown, ulcerative colitis clinical disease activity highly correlates with endoscopic disease activity, whereas correlation between Crohn’s disease symptoms and endoscopic findings is poor,” the researchers noted. However, both mobile indexes reliably detected changes in disease activity, varying significantly depending on whether patients were clinically improved, stable, or worse, regardless of whether they had Crohn’s disease (P = .003) or ulcerative colitis (P = .0025).

To explore intrapatient reliability, the researchers also compared initial and follow-up mobile health index results for subgroups of 40 Crohn’s disease patients tested a median of 21 hours apart, and 37 ulcerative colitis patients tested a median of 23 hours apart. In both cases, the intraclass correlation coefficient reached 0.94 (95% confidence interval, 0.89-0.97). “Cloud-based health technologies are predicted to revolutionize care delivery and patient engagement,” the investigators commented. “Patients can participate in their care by signaling meaningful health outcomes during year-round monitoring. Barriers for more widespread implementation of mobile health in inflammatory bowel disease care include policies affecting reimbursement and regulatory requirements, and privacy and security concerns.”

Genova Diagnostics provided stool collection kits and fecal calprotectin testing. The investigators had no disclosures.

Patients with diarrhea-predominant irritable bowel syndrome (IBS-D) who responded to rifaximin but relapsed after completing treatment were significantly more likely to respond to a second course of the antibiotic than to placebo, according to a report in the December issue of Gastroenterology (2016 Aug 5. doi: 10.1053/j.gastro.2016.08.003).

A total of 38% of patients who received a second course of rifaximin met the primary endpoint in the randomized double-blinded trial, compared with 31.5% of the placebo group (P = .03), Dr. Anthony Lembo of Beth Israel Deaconess Medical Center, Boston, and his associates wrote in Gastroenterology. “Although this study had a positive outcome, questions remain regarding the role of nonsystemic antibiotics in the long term, particularly when patients with IBS-D may require years of symptom management,” they added. “Further research is needed to better understand the treatment algorithm in patients who may lose responsiveness to rifaximin.”

Patients with diarrhea-predominant irritable bowel syndrome (IBS-D) who responded to rifaximin but relapsed after completing treatment were significantly more likely to respond to a second course of the antibiotic than to placebo, according to a report in the December issue of Gastroenterology (2016 Aug 5. doi: 10.1053/j.gastro.2016.08.003).

A total of 38% of patients who received a second course of rifaximin met the primary endpoint in the randomized double-blinded trial, compared with 31.5% of the placebo group (P = .03), Dr. Anthony Lembo of Beth Israel Deaconess Medical Center, Boston, and his associates wrote in Gastroenterology. “Although this study had a positive outcome, questions remain regarding the role of nonsystemic antibiotics in the long term, particularly when patients with IBS-D may require years of symptom management,” they added. “Further research is needed to better understand the treatment algorithm in patients who may lose responsiveness to rifaximin.”

Patients with diarrhea-predominant irritable bowel syndrome (IBS-D) who responded to rifaximin but relapsed after completing treatment were significantly more likely to respond to a second course of the antibiotic than to placebo, according to a report in the December issue of Gastroenterology (2016 Aug 5. doi: 10.1053/j.gastro.2016.08.003).

A total of 38% of patients who received a second course of rifaximin met the primary endpoint in the randomized double-blinded trial, compared with 31.5% of the placebo group (P = .03), Dr. Anthony Lembo of Beth Israel Deaconess Medical Center, Boston, and his associates wrote in Gastroenterology. “Although this study had a positive outcome, questions remain regarding the role of nonsystemic antibiotics in the long term, particularly when patients with IBS-D may require years of symptom management,” they added. “Further research is needed to better understand the treatment algorithm in patients who may lose responsiveness to rifaximin.”

Yoga may be a feasible and safe add-on therapy for patients with irritable bowel syndrome, based on a systematic review of six randomized controlled trials of 273 patients published in the December issue of Clinical Gastroenterology and Hepatology.

Yoga significantly outperformed no treatment and resembled pharmacologic therapies for IBS on measures of bowel symptoms, anxiety, and quality of life, said Dania Schumann of the University of Duisburg-Essen, Essen, Germany.

“Yoga also seems to be equally effective as a walking program in improving patient-reported outcomes,” she and her coinvestigators wrote. But “wide methodological heterogeneity” and a “mostly unclear risk of bias,” precluded a direct recommendation for yoga in IBS, they said. Nonetheless, “its practice need not be discouraged in this patient population, especially when [patients] believe that it benefits their health, quality of life, or IBS-related comorbidities.”

iStock

Yoga may be a feasible and safe add-on therapy for patients with irritable bowel syndrome, based on a systematic review of six randomized controlled trials of 273 patients published in the December issue of Clinical Gastroenterology and Hepatology.

Yoga significantly outperformed no treatment and resembled pharmacologic therapies for IBS on measures of bowel symptoms, anxiety, and quality of life, said Dania Schumann of the University of Duisburg-Essen, Essen, Germany.

“Yoga also seems to be equally effective as a walking program in improving patient-reported outcomes,” she and her coinvestigators wrote. But “wide methodological heterogeneity” and a “mostly unclear risk of bias,” precluded a direct recommendation for yoga in IBS, they said. Nonetheless, “its practice need not be discouraged in this patient population, especially when [patients] believe that it benefits their health, quality of life, or IBS-related comorbidities.”

iStock

Yoga may be a feasible and safe add-on therapy for patients with irritable bowel syndrome, based on a systematic review of six randomized controlled trials of 273 patients published in the December issue of Clinical Gastroenterology and Hepatology.

Yoga significantly outperformed no treatment and resembled pharmacologic therapies for IBS on measures of bowel symptoms, anxiety, and quality of life, said Dania Schumann of the University of Duisburg-Essen, Essen, Germany.

“Yoga also seems to be equally effective as a walking program in improving patient-reported outcomes,” she and her coinvestigators wrote. But “wide methodological heterogeneity” and a “mostly unclear risk of bias,” precluded a direct recommendation for yoga in IBS, they said. Nonetheless, “its practice need not be discouraged in this patient population, especially when [patients] believe that it benefits their health, quality of life, or IBS-related comorbidities.”

iStock

Among patients on low-dose aspirin at risk for recurrent GI bleeding, there were slightly fewer GI bleeds or ulcers when patients were on the proton pump inhibitor rabeprazole (Aciphex) instead of the histamine₂-receptor antagonist famotidine (Pepcid), but the difference was not statistically significant according to a study reported in the January issue of Gastroenterology.

SOURCE: American Gastroenterological Association

In a 270-subject, double-blind, randomized trial in Hong Kong and Japan led by Francis Chan, MD, of the Chinese University of Hong Kong, investigators found, “Among high-risk aspirin users, the incidence of recurrent bleeding is comparable with either use of PPI [proton pump inhibitor] or H₂RA [H₂-receptor antagonist].” However, “since a small difference in efficacy cannot be excluded, PPI probably remains the preferred treatment for long-term protection against upper GI bleeding in high-risk aspirin users” (Gastroenterology. 2016 Sep 15. doi: 10.1053/j.gastro.2016.09.006).

Even so, “our findings suggest that famotidine may be a reasonable alternative option for aspirin users who disfavor long-term PPI therapy,” they said.

Because of concerns about the long-term safety of PPIs, including the association between PPIs and increased risk of serious cardiovascular events in patients on clopidogrel (Plavix), clinicians have been looking for alternatives. The findings reassure that H₂RAs are a reasonable choice; many clinicians have already turned to them.

All 270 subjects had previously had endoscopically confirmed ulcer bleeding while on low-dose aspirin (325 mg or less per day). “Considering clinicians will be most concerned with the adequacy of gastroprotective treatment effect in aspirin users with the highest risk, we exclusively enrolled patients with endoscopy-proven upper GI bleeding,” Dr. Chan and his colleagues said.

After the ulcers healed, the subjects resumed aspirin (80 mg) daily and were randomized to either famotidine 40 mg once daily (n = 132) or rabeprazole 20 mg daily (n = 138) for up to 12 months. Helicobacter pylori was eradicated prior to randomization in patients who tested positive. Subjects were evaluated every 2 months, with repeat endoscopy for symptoms of upper GI bleeding or significant drops in hemoglobin, as well as at the end of the study.

During the 12-month study period, upper GI bleeding recurred in one patient receiving rabeprazole (0.7%) and four receiving famotidine (3.1%; P = .16). The composite endpoint of recurrent bleeding or endoscopic ulcers at month 12 was reached by nine patients in the rabeprazole group (7.9%) and 13 receiving famotidine (12.4%; P = .26).

“Our findings indicate that both treatments are comparable in preventing recurrent upper GI bleeding in high-risk aspirin users, although a small difference in efficacy cannot be excluded,” the investigators said.

Over two-thirds of the subjects were men, and the mean age was 73 years. About a quarter in the PPI group and almost 40% in the H₂RA group had H. pylori cleared before randomization.

The Research Grant Council of Hong Kong funded the work. Dr. Chan has served as a consultant to Pfizer, Eisai, Takeda, and Otsuka, and has received research grants from Pfizer and lecture fees from Pfizer, AstraZeneca, and Takeda. Several other authors reported similar industry disclosures.

[email protected]

Among patients on low-dose aspirin at risk for recurrent GI bleeding, there were slightly fewer GI bleeds or ulcers when patients were on the proton pump inhibitor rabeprazole (Aciphex) instead of the histamine₂-receptor antagonist famotidine (Pepcid), but the difference was not statistically significant according to a study reported in the January issue of Gastroenterology.

SOURCE: American Gastroenterological Association

In a 270-subject, double-blind, randomized trial in Hong Kong and Japan led by Francis Chan, MD, of the Chinese University of Hong Kong, investigators found, “Among high-risk aspirin users, the incidence of recurrent bleeding is comparable with either use of PPI [proton pump inhibitor] or H₂RA [H₂-receptor antagonist].” However, “since a small difference in efficacy cannot be excluded, PPI probably remains the preferred treatment for long-term protection against upper GI bleeding in high-risk aspirin users” (Gastroenterology. 2016 Sep 15. doi: 10.1053/j.gastro.2016.09.006).

Even so, “our findings suggest that famotidine may be a reasonable alternative option for aspirin users who disfavor long-term PPI therapy,” they said.

Because of concerns about the long-term safety of PPIs, including the association between PPIs and increased risk of serious cardiovascular events in patients on clopidogrel (Plavix), clinicians have been looking for alternatives. The findings reassure that H₂RAs are a reasonable choice; many clinicians have already turned to them.

All 270 subjects had previously had endoscopically confirmed ulcer bleeding while on low-dose aspirin (325 mg or less per day). “Considering clinicians will be most concerned with the adequacy of gastroprotective treatment effect in aspirin users with the highest risk, we exclusively enrolled patients with endoscopy-proven upper GI bleeding,” Dr. Chan and his colleagues said.

After the ulcers healed, the subjects resumed aspirin (80 mg) daily and were randomized to either famotidine 40 mg once daily (n = 132) or rabeprazole 20 mg daily (n = 138) for up to 12 months. Helicobacter pylori was eradicated prior to randomization in patients who tested positive. Subjects were evaluated every 2 months, with repeat endoscopy for symptoms of upper GI bleeding or significant drops in hemoglobin, as well as at the end of the study.

During the 12-month study period, upper GI bleeding recurred in one patient receiving rabeprazole (0.7%) and four receiving famotidine (3.1%; P = .16). The composite endpoint of recurrent bleeding or endoscopic ulcers at month 12 was reached by nine patients in the rabeprazole group (7.9%) and 13 receiving famotidine (12.4%; P = .26).

“Our findings indicate that both treatments are comparable in preventing recurrent upper GI bleeding in high-risk aspirin users, although a small difference in efficacy cannot be excluded,” the investigators said.

Over two-thirds of the subjects were men, and the mean age was 73 years. About a quarter in the PPI group and almost 40% in the H₂RA group had H. pylori cleared before randomization.

The Research Grant Council of Hong Kong funded the work. Dr. Chan has served as a consultant to Pfizer, Eisai, Takeda, and Otsuka, and has received research grants from Pfizer and lecture fees from Pfizer, AstraZeneca, and Takeda. Several other authors reported similar industry disclosures.

[email protected]

Among patients on low-dose aspirin at risk for recurrent GI bleeding, there were slightly fewer GI bleeds or ulcers when patients were on the proton pump inhibitor rabeprazole (Aciphex) instead of the histamine₂-receptor antagonist famotidine (Pepcid), but the difference was not statistically significant according to a study reported in the January issue of Gastroenterology.

SOURCE: American Gastroenterological Association

In a 270-subject, double-blind, randomized trial in Hong Kong and Japan led by Francis Chan, MD, of the Chinese University of Hong Kong, investigators found, “Among high-risk aspirin users, the incidence of recurrent bleeding is comparable with either use of PPI [proton pump inhibitor] or H₂RA [H₂-receptor antagonist].” However, “since a small difference in efficacy cannot be excluded, PPI probably remains the preferred treatment for long-term protection against upper GI bleeding in high-risk aspirin users” (Gastroenterology. 2016 Sep 15. doi: 10.1053/j.gastro.2016.09.006).

Even so, “our findings suggest that famotidine may be a reasonable alternative option for aspirin users who disfavor long-term PPI therapy,” they said.

Because of concerns about the long-term safety of PPIs, including the association between PPIs and increased risk of serious cardiovascular events in patients on clopidogrel (Plavix), clinicians have been looking for alternatives. The findings reassure that H₂RAs are a reasonable choice; many clinicians have already turned to them.

All 270 subjects had previously had endoscopically confirmed ulcer bleeding while on low-dose aspirin (325 mg or less per day). “Considering clinicians will be most concerned with the adequacy of gastroprotective treatment effect in aspirin users with the highest risk, we exclusively enrolled patients with endoscopy-proven upper GI bleeding,” Dr. Chan and his colleagues said.

After the ulcers healed, the subjects resumed aspirin (80 mg) daily and were randomized to either famotidine 40 mg once daily (n = 132) or rabeprazole 20 mg daily (n = 138) for up to 12 months. Helicobacter pylori was eradicated prior to randomization in patients who tested positive. Subjects were evaluated every 2 months, with repeat endoscopy for symptoms of upper GI bleeding or significant drops in hemoglobin, as well as at the end of the study.

During the 12-month study period, upper GI bleeding recurred in one patient receiving rabeprazole (0.7%) and four receiving famotidine (3.1%; P = .16). The composite endpoint of recurrent bleeding or endoscopic ulcers at month 12 was reached by nine patients in the rabeprazole group (7.9%) and 13 receiving famotidine (12.4%; P = .26).

“Our findings indicate that both treatments are comparable in preventing recurrent upper GI bleeding in high-risk aspirin users, although a small difference in efficacy cannot be excluded,” the investigators said.

Over two-thirds of the subjects were men, and the mean age was 73 years. About a quarter in the PPI group and almost 40% in the H₂RA group had H. pylori cleared before randomization.

The Research Grant Council of Hong Kong funded the work. Dr. Chan has served as a consultant to Pfizer, Eisai, Takeda, and Otsuka, and has received research grants from Pfizer and lecture fees from Pfizer, AstraZeneca, and Takeda. Several other authors reported similar industry disclosures.

[email protected]