Jeff Craven

Patients with psoriasis and hypertension are at a higher risk of having to undergo cardiovascular procedures and surgery, compared with patients with hypertension alone.

“The results suggested that hypertensive patients with concurrent psoriasis experienced an earlier and more aggressive disease progression of hypertension, compared with general hypertensive patients,” Hsien-Yi Chiu, MD, PhD, from the department of dermatology at the National Taiwan University Hospital in Hsinchu, Taiwan, and his colleagues wrote in the Journal of Dermatology. “Thus, patients with hypertension and psoriasis should be considered for more aggressive strategies for prevention of primary [cardiovascular disease] and more intense assessments for cardiovascular interventions needed to improve [cardiovascular disease] outcome in these patients.”

They performed a nationwide cohort study of patients in the Taiwan National Health Insurance Research Database with new onset hypertension from 2005 to 2006. Those with psoriasis (4,039 patients) were matched by age and sex to patients in the database who were diagnosed with hypertension but not psoriasis; the mean follow-up was 5.62 years. Their mean age was 58 years and about 31% of the psoriasis cohort were female. They were divided into groups based on psoriasis severity (mild and severe psoriasis) and type (psoriasis with and without arthritis). Researchers noted patients with both psoriasis and hypertension also had higher rates of cerebrovascular disease, coronary heart disease, hyperlipidemia, and diabetes mellitus during the year prior to the study.

The outcome measured was having a cardiovascular procedure (percutaneous coronary intervention with/without stenting or percutaneous transluminal coronary angioplasty and transcatheter radiofrequency ablation for arrhythmia) and cardiovascular surgery (coronary artery bypass grafting and other surgery for heart valves, arrhythmia, cerebrovascular disease, peripheral vessels, and the aorta).

Patients with both psoriasis and hypertension were at an increased risk for having a cardiovascular procedure and surgery (adjusted hazard ratio, 1.28; 95% confidence interval, 1.07-1.53), compared with patients with only hypertension. The risk of this outcome was also increased among patients with severe psoriasis or psoriatic arthritis, compared with patients who had mild psoriasis (aHR, 1.22; 95% CI, 0.98-1.51) and with patients with psoriasis but not arthritis (aHR, 1.15; 95% CI, 0.84-1.58); however, the results did not reach statistical significance after adjustment, which the researchers attributed to the small subgroup size.


“Another possible explanation was that the observed increased requirement for cardiovascular procedure and surgery in patients with severe psoriasis was mediated by a complex interplay among inflammation, traditional risk factors for [cardiovascular disease], and antirheumatic drugs, which probably attenuate the effects conferred by psoriasis,” the authors wrote.

Limitations in the study included reliance on administrative claims data for psoriasis diagnosis, unavailability of some details of the cardiovascular procedures and surgery, lack of blood pressure data to identify hypertension severity, as well as unmeasured factors and confounders. Further, “comparative occurrence of a requirement for cardiovascular procedure and surgery in the two groups may be influenced by a competing risk for death,” the researchers noted.


This study was supported in part through grants by the National Taiwan University Hospital, Asia-Pacific La Roche–Posay Foundation 2014, and the Ministry of Science and Technology. Dr. Chiu is on the speaker’s bureau for AbbVie, Janssen Pharmaceuticals, Novartis, Eli Lilly and Pfizer. Another author has conducted clinical trials for or received fees for being a consultant or speaker for companies that include Abbvie, Boehringer Ingelheim, and Celgene. The remaining authors reported no relevant conflicts of interest.

SOURCE: Chiu H-Y et al. J Dermatol. 2018 Oct 16. doi: 10.1111/1346-8138.14654.

Patients with psoriasis and hypertension are at a higher risk of having to undergo cardiovascular procedures and surgery, compared with patients with hypertension alone.

“The results suggested that hypertensive patients with concurrent psoriasis experienced an earlier and more aggressive disease progression of hypertension, compared with general hypertensive patients,” Hsien-Yi Chiu, MD, PhD, from the department of dermatology at the National Taiwan University Hospital in Hsinchu, Taiwan, and his colleagues wrote in the Journal of Dermatology. “Thus, patients with hypertension and psoriasis should be considered for more aggressive strategies for prevention of primary [cardiovascular disease] and more intense assessments for cardiovascular interventions needed to improve [cardiovascular disease] outcome in these patients.”

They performed a nationwide cohort study of patients in the Taiwan National Health Insurance Research Database with new onset hypertension from 2005 to 2006. Those with psoriasis (4,039 patients) were matched by age and sex to patients in the database who were diagnosed with hypertension but not psoriasis; the mean follow-up was 5.62 years. Their mean age was 58 years and about 31% of the psoriasis cohort were female. They were divided into groups based on psoriasis severity (mild and severe psoriasis) and type (psoriasis with and without arthritis). Researchers noted patients with both psoriasis and hypertension also had higher rates of cerebrovascular disease, coronary heart disease, hyperlipidemia, and diabetes mellitus during the year prior to the study.

The outcome measured was having a cardiovascular procedure (percutaneous coronary intervention with/without stenting or percutaneous transluminal coronary angioplasty and transcatheter radiofrequency ablation for arrhythmia) and cardiovascular surgery (coronary artery bypass grafting and other surgery for heart valves, arrhythmia, cerebrovascular disease, peripheral vessels, and the aorta).

Patients with both psoriasis and hypertension were at an increased risk for having a cardiovascular procedure and surgery (adjusted hazard ratio, 1.28; 95% confidence interval, 1.07-1.53), compared with patients with only hypertension. The risk of this outcome was also increased among patients with severe psoriasis or psoriatic arthritis, compared with patients who had mild psoriasis (aHR, 1.22; 95% CI, 0.98-1.51) and with patients with psoriasis but not arthritis (aHR, 1.15; 95% CI, 0.84-1.58); however, the results did not reach statistical significance after adjustment, which the researchers attributed to the small subgroup size.


“Another possible explanation was that the observed increased requirement for cardiovascular procedure and surgery in patients with severe psoriasis was mediated by a complex interplay among inflammation, traditional risk factors for [cardiovascular disease], and antirheumatic drugs, which probably attenuate the effects conferred by psoriasis,” the authors wrote.

Limitations in the study included reliance on administrative claims data for psoriasis diagnosis, unavailability of some details of the cardiovascular procedures and surgery, lack of blood pressure data to identify hypertension severity, as well as unmeasured factors and confounders. Further, “comparative occurrence of a requirement for cardiovascular procedure and surgery in the two groups may be influenced by a competing risk for death,” the researchers noted.


This study was supported in part through grants by the National Taiwan University Hospital, Asia-Pacific La Roche–Posay Foundation 2014, and the Ministry of Science and Technology. Dr. Chiu is on the speaker’s bureau for AbbVie, Janssen Pharmaceuticals, Novartis, Eli Lilly and Pfizer. Another author has conducted clinical trials for or received fees for being a consultant or speaker for companies that include Abbvie, Boehringer Ingelheim, and Celgene. The remaining authors reported no relevant conflicts of interest.

SOURCE: Chiu H-Y et al. J Dermatol. 2018 Oct 16. doi: 10.1111/1346-8138.14654.

Patients with psoriasis and hypertension are at a higher risk of having to undergo cardiovascular procedures and surgery, compared with patients with hypertension alone.

“The results suggested that hypertensive patients with concurrent psoriasis experienced an earlier and more aggressive disease progression of hypertension, compared with general hypertensive patients,” Hsien-Yi Chiu, MD, PhD, from the department of dermatology at the National Taiwan University Hospital in Hsinchu, Taiwan, and his colleagues wrote in the Journal of Dermatology. “Thus, patients with hypertension and psoriasis should be considered for more aggressive strategies for prevention of primary [cardiovascular disease] and more intense assessments for cardiovascular interventions needed to improve [cardiovascular disease] outcome in these patients.”

They performed a nationwide cohort study of patients in the Taiwan National Health Insurance Research Database with new onset hypertension from 2005 to 2006. Those with psoriasis (4,039 patients) were matched by age and sex to patients in the database who were diagnosed with hypertension but not psoriasis; the mean follow-up was 5.62 years. Their mean age was 58 years and about 31% of the psoriasis cohort were female. They were divided into groups based on psoriasis severity (mild and severe psoriasis) and type (psoriasis with and without arthritis). Researchers noted patients with both psoriasis and hypertension also had higher rates of cerebrovascular disease, coronary heart disease, hyperlipidemia, and diabetes mellitus during the year prior to the study.

The outcome measured was having a cardiovascular procedure (percutaneous coronary intervention with/without stenting or percutaneous transluminal coronary angioplasty and transcatheter radiofrequency ablation for arrhythmia) and cardiovascular surgery (coronary artery bypass grafting and other surgery for heart valves, arrhythmia, cerebrovascular disease, peripheral vessels, and the aorta).

Patients with both psoriasis and hypertension were at an increased risk for having a cardiovascular procedure and surgery (adjusted hazard ratio, 1.28; 95% confidence interval, 1.07-1.53), compared with patients with only hypertension. The risk of this outcome was also increased among patients with severe psoriasis or psoriatic arthritis, compared with patients who had mild psoriasis (aHR, 1.22; 95% CI, 0.98-1.51) and with patients with psoriasis but not arthritis (aHR, 1.15; 95% CI, 0.84-1.58); however, the results did not reach statistical significance after adjustment, which the researchers attributed to the small subgroup size.


“Another possible explanation was that the observed increased requirement for cardiovascular procedure and surgery in patients with severe psoriasis was mediated by a complex interplay among inflammation, traditional risk factors for [cardiovascular disease], and antirheumatic drugs, which probably attenuate the effects conferred by psoriasis,” the authors wrote.

Limitations in the study included reliance on administrative claims data for psoriasis diagnosis, unavailability of some details of the cardiovascular procedures and surgery, lack of blood pressure data to identify hypertension severity, as well as unmeasured factors and confounders. Further, “comparative occurrence of a requirement for cardiovascular procedure and surgery in the two groups may be influenced by a competing risk for death,” the researchers noted.


This study was supported in part through grants by the National Taiwan University Hospital, Asia-Pacific La Roche–Posay Foundation 2014, and the Ministry of Science and Technology. Dr. Chiu is on the speaker’s bureau for AbbVie, Janssen Pharmaceuticals, Novartis, Eli Lilly and Pfizer. Another author has conducted clinical trials for or received fees for being a consultant or speaker for companies that include Abbvie, Boehringer Ingelheim, and Celgene. The remaining authors reported no relevant conflicts of interest.

SOURCE: Chiu H-Y et al. J Dermatol. 2018 Oct 16. doi: 10.1111/1346-8138.14654.

Short interpregnancy intervals carry an increased risk of adverse pregnancy outcomes for women of all ages and increased adverse fetal and infant outcome risks for women between 20 and 34 years old, according to research published in JAMA Internal Medicine.

“This finding may be reassuring particularly for older women who must weigh the competing risks of increasing maternal age with longer interpregnancy intervals (including infertility and chromosomal anomalies) against the risks of short interpregnancy intervals,” wrote Laura Schummers, SD, of the department of epidemiology at Harvard T. H. Chan School of Public Health, Boston, and her colleagues.

The researchers examined 148,544 pregnancies of women in British Columbia who were younger than 20 years old at the index (5%), 20-34 years at the index birth (83%), and 35 years or older (12%). The women had two or more consecutive singleton pregnancies that resulted in a live birth between 2004 and 2014 and were recorded in the British Columbia Perinatal Data Registry. There was a lower number of short interpregnancy intervals, defined as less than 6 months between the index and second pregnancy, among women in the 35-years-or-older group, compared with the 20- to 34-year-old group (4.4% vs. 5.5%); the 35-years-or-older group instead had a higher number of interpregnancy intervals between 6 and 11 months and between 12 and 17 months, compared with the 20- to 34-year-old group (17.7% vs. 16.6%, and 25.2% vs. 22.5%, respectively).

The risk for maternal mortality or severe morbidity was higher in women who were a minimum 35 years old with 6 months between pregnancies (0.62%), compared with women who had 18 months (0.26%) between pregnancies (adjusted relative risk [aRR], 2.39). There was no significant increase in those aged between 20 and 34 years at 6 months, compared with 18 months (0.23% vs. 0.25%; aRR, 0.92). However, the 20- to 34-year-old group did have an increased risk of fetal and infant adverse outcomes at 6 months, compared with 18 months (2.0% vs. 1.4%; aRR, 1.42) and compared with women in the 35-years-or-older group at 6 months and 18 months (2.1% vs. 1.8%; aRR, 1.15).

There was a 5.3% increased risk at 6 months and a 3.2% increased risk at 18 months of spontaneous preterm delivery in the 20- to 34-year-old group (aRR, 1.65), compared with a 5.0% risk at 6 months and 3.6% at 18 months in the 35-years-or-older group (aRR, 1.40). The researchers noted “modest increases” in newborns who were born small for their gestational age and indicated preterm delivery at short intervals that did not differ by age group.

The authors reported no conflicts of interest. Dr Schummers was supported a National Research Service Award from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and received a grant from the Canadian Institutes for Health Research and the Public Health Agency of Canada Family Planning Public Health Chair Seed Grant. Two of her coauthors were supported by various other awards.

SOURCE: Schummers L et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4696.

Short interpregnancy intervals carry an increased risk of adverse pregnancy outcomes for women of all ages and increased adverse fetal and infant outcome risks for women between 20 and 34 years old, according to research published in JAMA Internal Medicine.

“This finding may be reassuring particularly for older women who must weigh the competing risks of increasing maternal age with longer interpregnancy intervals (including infertility and chromosomal anomalies) against the risks of short interpregnancy intervals,” wrote Laura Schummers, SD, of the department of epidemiology at Harvard T. H. Chan School of Public Health, Boston, and her colleagues.

The researchers examined 148,544 pregnancies of women in British Columbia who were younger than 20 years old at the index (5%), 20-34 years at the index birth (83%), and 35 years or older (12%). The women had two or more consecutive singleton pregnancies that resulted in a live birth between 2004 and 2014 and were recorded in the British Columbia Perinatal Data Registry. There was a lower number of short interpregnancy intervals, defined as less than 6 months between the index and second pregnancy, among women in the 35-years-or-older group, compared with the 20- to 34-year-old group (4.4% vs. 5.5%); the 35-years-or-older group instead had a higher number of interpregnancy intervals between 6 and 11 months and between 12 and 17 months, compared with the 20- to 34-year-old group (17.7% vs. 16.6%, and 25.2% vs. 22.5%, respectively).

The risk for maternal mortality or severe morbidity was higher in women who were a minimum 35 years old with 6 months between pregnancies (0.62%), compared with women who had 18 months (0.26%) between pregnancies (adjusted relative risk [aRR], 2.39). There was no significant increase in those aged between 20 and 34 years at 6 months, compared with 18 months (0.23% vs. 0.25%; aRR, 0.92). However, the 20- to 34-year-old group did have an increased risk of fetal and infant adverse outcomes at 6 months, compared with 18 months (2.0% vs. 1.4%; aRR, 1.42) and compared with women in the 35-years-or-older group at 6 months and 18 months (2.1% vs. 1.8%; aRR, 1.15).

There was a 5.3% increased risk at 6 months and a 3.2% increased risk at 18 months of spontaneous preterm delivery in the 20- to 34-year-old group (aRR, 1.65), compared with a 5.0% risk at 6 months and 3.6% at 18 months in the 35-years-or-older group (aRR, 1.40). The researchers noted “modest increases” in newborns who were born small for their gestational age and indicated preterm delivery at short intervals that did not differ by age group.

The authors reported no conflicts of interest. Dr Schummers was supported a National Research Service Award from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and received a grant from the Canadian Institutes for Health Research and the Public Health Agency of Canada Family Planning Public Health Chair Seed Grant. Two of her coauthors were supported by various other awards.

SOURCE: Schummers L et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4696.

Short interpregnancy intervals carry an increased risk of adverse pregnancy outcomes for women of all ages and increased adverse fetal and infant outcome risks for women between 20 and 34 years old, according to research published in JAMA Internal Medicine.

“This finding may be reassuring particularly for older women who must weigh the competing risks of increasing maternal age with longer interpregnancy intervals (including infertility and chromosomal anomalies) against the risks of short interpregnancy intervals,” wrote Laura Schummers, SD, of the department of epidemiology at Harvard T. H. Chan School of Public Health, Boston, and her colleagues.

The researchers examined 148,544 pregnancies of women in British Columbia who were younger than 20 years old at the index (5%), 20-34 years at the index birth (83%), and 35 years or older (12%). The women had two or more consecutive singleton pregnancies that resulted in a live birth between 2004 and 2014 and were recorded in the British Columbia Perinatal Data Registry. There was a lower number of short interpregnancy intervals, defined as less than 6 months between the index and second pregnancy, among women in the 35-years-or-older group, compared with the 20- to 34-year-old group (4.4% vs. 5.5%); the 35-years-or-older group instead had a higher number of interpregnancy intervals between 6 and 11 months and between 12 and 17 months, compared with the 20- to 34-year-old group (17.7% vs. 16.6%, and 25.2% vs. 22.5%, respectively).

The risk for maternal mortality or severe morbidity was higher in women who were a minimum 35 years old with 6 months between pregnancies (0.62%), compared with women who had 18 months (0.26%) between pregnancies (adjusted relative risk [aRR], 2.39). There was no significant increase in those aged between 20 and 34 years at 6 months, compared with 18 months (0.23% vs. 0.25%; aRR, 0.92). However, the 20- to 34-year-old group did have an increased risk of fetal and infant adverse outcomes at 6 months, compared with 18 months (2.0% vs. 1.4%; aRR, 1.42) and compared with women in the 35-years-or-older group at 6 months and 18 months (2.1% vs. 1.8%; aRR, 1.15).

There was a 5.3% increased risk at 6 months and a 3.2% increased risk at 18 months of spontaneous preterm delivery in the 20- to 34-year-old group (aRR, 1.65), compared with a 5.0% risk at 6 months and 3.6% at 18 months in the 35-years-or-older group (aRR, 1.40). The researchers noted “modest increases” in newborns who were born small for their gestational age and indicated preterm delivery at short intervals that did not differ by age group.

The authors reported no conflicts of interest. Dr Schummers was supported a National Research Service Award from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and received a grant from the Canadian Institutes for Health Research and the Public Health Agency of Canada Family Planning Public Health Chair Seed Grant. Two of her coauthors were supported by various other awards.

SOURCE: Schummers L et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4696.

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

PHILADELPHIA – Patients with cirrhosis have a higher risk of hospital readmission if their length of stay is less than 4 days, if they have cirrhosis-related complications, and if they are discharged to an extended-care facility or to home health care, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

“The presence of cirrhosis-related complications is very strongly associated with readmissions,” Chandraprakash Umapathy, MD, MS, from the University of California, San Francisco, Fresno, said during his presentation. “Quality improvement efforts should focus on optimizing the management of complications of cirrhosis in the outpatient setting to reduce readmissions.”

In a retrospective cohort study, Dr. Umapathy and colleagues identified 230,036 patients from the Healthcare Cost and Utilization Project National Readmission Database for 2014 who had been discharged with a diagnosis of cirrhosis; of these patients, there were 185,737 index cases after excluding readmissions. Included patients had a mean age of 60.2 years and mean length of stay of 6.4 days, with 46% of patients having a length of stay longer than 4 days and mean total charges of $56,519. With regard to cirrhosis, 55% of patients displayed cirrhosis complications and 6.7% had more than three cirrhosis-related complications; the most common complication was ascites, in 32% of patients.

Overall, 11.09% of patients were readmitted at 30 days and 18.74% of patients were readmitted at 90 days, Dr. Umapathy said. Patients were more likely to be readmitted at 30 days if they were originally admitted on a weekend (adjusted prevalence ratio, 1.06; P = .001); into a medium (1.09; P = .009) or large (1.11; P less than .001) hospital; were admitted at a metropolitan teaching hospital (1.07; P less than .001); were insured by Medicaid (1.07; P less than .001); or were transferred to an extended care (1.51; P less than .001) facility or discharged to home health care (1.43; P less than .001).

Compared with patients who were not readmitted at 30 days, patients with 30-day readmission had a higher rate of alcoholic liver disease (43% vs. 46%; P less than .001), hepatitis C (28% vs. 32%; P less than .001), ascites (31% vs. 43%; P less than .001), hepatic encephalopathy (15% vs. 22%; P less than .001), hepatorenal syndrome (2.3% vs. 4.9%; P less than .001), hepatocellular cancer (5.1% vs. 5.7%; P = .001), presence of any cirrhosis complications (54% vs. 65%; P less than .001), and presence of more than three cirrhosis-related complications (6.3% vs. 10%; P less than .001). When adjusted in a multivariate analysis, association with readmission at 30 days for patients with cirrhosis-related complications such as ascites (1.42; P less than .001), hepatic encephalopathy (1.44; P less than .001), and hepatorenal syndrome (1.34; P less than .001) remained, Dr. Umapathy noted.

Length of stay longer than 4 days (0.84; P less than .001) and variceal hemorrhage (0.74; P = .002) were associated with reduced risk of readmissions at 30 days. “Focus on length of stay may result in patients being discharged prematurely, leading to higher early readmission,” Dr. Umapathy said.

Dr. Umapathy reports no relevant conflicts of interest.

SOURCE: Umapathy C et al. ACG 2018, Presentation 60

PHILADELPHIA – Patients with cirrhosis have a higher risk of hospital readmission if their length of stay is less than 4 days, if they have cirrhosis-related complications, and if they are discharged to an extended-care facility or to home health care, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

“The presence of cirrhosis-related complications is very strongly associated with readmissions,” Chandraprakash Umapathy, MD, MS, from the University of California, San Francisco, Fresno, said during his presentation. “Quality improvement efforts should focus on optimizing the management of complications of cirrhosis in the outpatient setting to reduce readmissions.”

In a retrospective cohort study, Dr. Umapathy and colleagues identified 230,036 patients from the Healthcare Cost and Utilization Project National Readmission Database for 2014 who had been discharged with a diagnosis of cirrhosis; of these patients, there were 185,737 index cases after excluding readmissions. Included patients had a mean age of 60.2 years and mean length of stay of 6.4 days, with 46% of patients having a length of stay longer than 4 days and mean total charges of $56,519. With regard to cirrhosis, 55% of patients displayed cirrhosis complications and 6.7% had more than three cirrhosis-related complications; the most common complication was ascites, in 32% of patients.

Overall, 11.09% of patients were readmitted at 30 days and 18.74% of patients were readmitted at 90 days, Dr. Umapathy said. Patients were more likely to be readmitted at 30 days if they were originally admitted on a weekend (adjusted prevalence ratio, 1.06; P = .001); into a medium (1.09; P = .009) or large (1.11; P less than .001) hospital; were admitted at a metropolitan teaching hospital (1.07; P less than .001); were insured by Medicaid (1.07; P less than .001); or were transferred to an extended care (1.51; P less than .001) facility or discharged to home health care (1.43; P less than .001).

Compared with patients who were not readmitted at 30 days, patients with 30-day readmission had a higher rate of alcoholic liver disease (43% vs. 46%; P less than .001), hepatitis C (28% vs. 32%; P less than .001), ascites (31% vs. 43%; P less than .001), hepatic encephalopathy (15% vs. 22%; P less than .001), hepatorenal syndrome (2.3% vs. 4.9%; P less than .001), hepatocellular cancer (5.1% vs. 5.7%; P = .001), presence of any cirrhosis complications (54% vs. 65%; P less than .001), and presence of more than three cirrhosis-related complications (6.3% vs. 10%; P less than .001). When adjusted in a multivariate analysis, association with readmission at 30 days for patients with cirrhosis-related complications such as ascites (1.42; P less than .001), hepatic encephalopathy (1.44; P less than .001), and hepatorenal syndrome (1.34; P less than .001) remained, Dr. Umapathy noted.

Length of stay longer than 4 days (0.84; P less than .001) and variceal hemorrhage (0.74; P = .002) were associated with reduced risk of readmissions at 30 days. “Focus on length of stay may result in patients being discharged prematurely, leading to higher early readmission,” Dr. Umapathy said.

Dr. Umapathy reports no relevant conflicts of interest.

SOURCE: Umapathy C et al. ACG 2018, Presentation 60

PHILADELPHIA – Patients with cirrhosis have a higher risk of hospital readmission if their length of stay is less than 4 days, if they have cirrhosis-related complications, and if they are discharged to an extended-care facility or to home health care, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

“The presence of cirrhosis-related complications is very strongly associated with readmissions,” Chandraprakash Umapathy, MD, MS, from the University of California, San Francisco, Fresno, said during his presentation. “Quality improvement efforts should focus on optimizing the management of complications of cirrhosis in the outpatient setting to reduce readmissions.”

In a retrospective cohort study, Dr. Umapathy and colleagues identified 230,036 patients from the Healthcare Cost and Utilization Project National Readmission Database for 2014 who had been discharged with a diagnosis of cirrhosis; of these patients, there were 185,737 index cases after excluding readmissions. Included patients had a mean age of 60.2 years and mean length of stay of 6.4 days, with 46% of patients having a length of stay longer than 4 days and mean total charges of $56,519. With regard to cirrhosis, 55% of patients displayed cirrhosis complications and 6.7% had more than three cirrhosis-related complications; the most common complication was ascites, in 32% of patients.

Overall, 11.09% of patients were readmitted at 30 days and 18.74% of patients were readmitted at 90 days, Dr. Umapathy said. Patients were more likely to be readmitted at 30 days if they were originally admitted on a weekend (adjusted prevalence ratio, 1.06; P = .001); into a medium (1.09; P = .009) or large (1.11; P less than .001) hospital; were admitted at a metropolitan teaching hospital (1.07; P less than .001); were insured by Medicaid (1.07; P less than .001); or were transferred to an extended care (1.51; P less than .001) facility or discharged to home health care (1.43; P less than .001).

Compared with patients who were not readmitted at 30 days, patients with 30-day readmission had a higher rate of alcoholic liver disease (43% vs. 46%; P less than .001), hepatitis C (28% vs. 32%; P less than .001), ascites (31% vs. 43%; P less than .001), hepatic encephalopathy (15% vs. 22%; P less than .001), hepatorenal syndrome (2.3% vs. 4.9%; P less than .001), hepatocellular cancer (5.1% vs. 5.7%; P = .001), presence of any cirrhosis complications (54% vs. 65%; P less than .001), and presence of more than three cirrhosis-related complications (6.3% vs. 10%; P less than .001). When adjusted in a multivariate analysis, association with readmission at 30 days for patients with cirrhosis-related complications such as ascites (1.42; P less than .001), hepatic encephalopathy (1.44; P less than .001), and hepatorenal syndrome (1.34; P less than .001) remained, Dr. Umapathy noted.

Length of stay longer than 4 days (0.84; P less than .001) and variceal hemorrhage (0.74; P = .002) were associated with reduced risk of readmissions at 30 days. “Focus on length of stay may result in patients being discharged prematurely, leading to higher early readmission,” Dr. Umapathy said.

Dr. Umapathy reports no relevant conflicts of interest.

SOURCE: Umapathy C et al. ACG 2018, Presentation 60

PHILADELPHIA – Although overt hepatic encephalopathy was reduced in patients taking rifaximin with baseline Child-Pugh class A, B, or C, there was no significant difference in the reduction based on the level of hepatic impairment, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Steven L. Flamm, MD, from Northwestern University, Chicago, and his colleagues examined results from a previous randomized, double-blinded trial of 140 patients receiving twice-daily rifaximin at 550 mg for 6 months in which the results showed rifaximin successfully maintained remission of hepatic encephalopathy (HE), compared with 159 patients receiving placebo.

“This pivotal study was published in March of 2010, but one of the post hoc assessments that was not performed was looking at various different phases of hepatic impairment as dictated by [Child-Pugh] class and each of those responses to this product,” Dr. Flamm said in his presentation.

Patients in the study were included if they had a Model For End-Stage Liver Disease score of 25 or less and two or more overt HE within 6 months (Conn score 1 or less) but were currently in remission. The researchers allowed the use of concomitant lactulose during the study period, which was used in 94.1% of rifaximin and 91.2% of placebo patients.

In the post hoc analysis, Dr. Flamm and his colleagues divided rifaximin and placebo patients into Child-Pugh class A (46 patients vs. 56 patients), class B (65 patients vs. 72 patients), and class C (17 patients vs. 14 patients) groups. For rifaximin and placebo patients, the mean age was 57.3 years and 57.2 years in the class A group, 54.4 years and 57.0 years in the class B group, and 56.1 years and 57.6 years in the class C group, respectively.

Overall, 8 of 46 rifaximin patients (17.4%) in the Child-Pugh class A and 15 of 65 rifaximin patients (23.1%) in the class B groups experienced an overt HE event during the 6-month study period, compared with 26 of 56 patients in the class A (46.4%) and 32 of 72 patients (44.4%) in the class B placebo groups; 5 of 17 rifaximin patients (29.4%) in the Child-Pugh class C group experienced their first overt HE event, compared with 9 of 14 (64.3%) patients in the placebo group.

With regard to first HE-related hospitalization, 5 of 46 patients (10.9%) in the rifaximin Child-Pugh class A group, 8 of 65 rifaximin patients (12.3%) in the class B group, and 4 of 17 rifaximin patients (23.5%) in the class C group experienced hospitalization because of HE, compared with 15 of 56 patients (23.2%) in the Child-Pugh class A group, 15 of 72 patients (20.8%) in the class B group, and 5 of 14 patients (35.7%) in the class C placebo group. The researchers noted lactulose use in the majority of patient cases in the study “provided further benefit” in reducing overt HE events.

“Although numeric differences were observed favoring rifaximin for the incidence of HE-related hospitalizations, a risk reduction versus placebo could not be firmly established, and presumably this was largely due to a lack of adequate power because of small sample size,” Dr. Flamm said.

This study and its analysis were supported by Salix Pharmaceuticals. Dr. Flamm and other coauthors report advisory committee membership, board membership, employment, or consultancy with AbbVie, Bristol-Myers Squibb, Gilead Sciences, Intercept Pharmaceuticals, Merck and Salix Pharmaceuticals. One coauthor reported no relevant conflicts of interest.

SOURCE: Flamm SL et al ACG 2018, Presentation 58.

PHILADELPHIA – Although overt hepatic encephalopathy was reduced in patients taking rifaximin with baseline Child-Pugh class A, B, or C, there was no significant difference in the reduction based on the level of hepatic impairment, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Steven L. Flamm, MD, from Northwestern University, Chicago, and his colleagues examined results from a previous randomized, double-blinded trial of 140 patients receiving twice-daily rifaximin at 550 mg for 6 months in which the results showed rifaximin successfully maintained remission of hepatic encephalopathy (HE), compared with 159 patients receiving placebo.

“This pivotal study was published in March of 2010, but one of the post hoc assessments that was not performed was looking at various different phases of hepatic impairment as dictated by [Child-Pugh] class and each of those responses to this product,” Dr. Flamm said in his presentation.

Patients in the study were included if they had a Model For End-Stage Liver Disease score of 25 or less and two or more overt HE within 6 months (Conn score 1 or less) but were currently in remission. The researchers allowed the use of concomitant lactulose during the study period, which was used in 94.1% of rifaximin and 91.2% of placebo patients.

In the post hoc analysis, Dr. Flamm and his colleagues divided rifaximin and placebo patients into Child-Pugh class A (46 patients vs. 56 patients), class B (65 patients vs. 72 patients), and class C (17 patients vs. 14 patients) groups. For rifaximin and placebo patients, the mean age was 57.3 years and 57.2 years in the class A group, 54.4 years and 57.0 years in the class B group, and 56.1 years and 57.6 years in the class C group, respectively.

Overall, 8 of 46 rifaximin patients (17.4%) in the Child-Pugh class A and 15 of 65 rifaximin patients (23.1%) in the class B groups experienced an overt HE event during the 6-month study period, compared with 26 of 56 patients in the class A (46.4%) and 32 of 72 patients (44.4%) in the class B placebo groups; 5 of 17 rifaximin patients (29.4%) in the Child-Pugh class C group experienced their first overt HE event, compared with 9 of 14 (64.3%) patients in the placebo group.

With regard to first HE-related hospitalization, 5 of 46 patients (10.9%) in the rifaximin Child-Pugh class A group, 8 of 65 rifaximin patients (12.3%) in the class B group, and 4 of 17 rifaximin patients (23.5%) in the class C group experienced hospitalization because of HE, compared with 15 of 56 patients (23.2%) in the Child-Pugh class A group, 15 of 72 patients (20.8%) in the class B group, and 5 of 14 patients (35.7%) in the class C placebo group. The researchers noted lactulose use in the majority of patient cases in the study “provided further benefit” in reducing overt HE events.

“Although numeric differences were observed favoring rifaximin for the incidence of HE-related hospitalizations, a risk reduction versus placebo could not be firmly established, and presumably this was largely due to a lack of adequate power because of small sample size,” Dr. Flamm said.

This study and its analysis were supported by Salix Pharmaceuticals. Dr. Flamm and other coauthors report advisory committee membership, board membership, employment, or consultancy with AbbVie, Bristol-Myers Squibb, Gilead Sciences, Intercept Pharmaceuticals, Merck and Salix Pharmaceuticals. One coauthor reported no relevant conflicts of interest.

SOURCE: Flamm SL et al ACG 2018, Presentation 58.

PHILADELPHIA – Although overt hepatic encephalopathy was reduced in patients taking rifaximin with baseline Child-Pugh class A, B, or C, there was no significant difference in the reduction based on the level of hepatic impairment, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Steven L. Flamm, MD, from Northwestern University, Chicago, and his colleagues examined results from a previous randomized, double-blinded trial of 140 patients receiving twice-daily rifaximin at 550 mg for 6 months in which the results showed rifaximin successfully maintained remission of hepatic encephalopathy (HE), compared with 159 patients receiving placebo.

“This pivotal study was published in March of 2010, but one of the post hoc assessments that was not performed was looking at various different phases of hepatic impairment as dictated by [Child-Pugh] class and each of those responses to this product,” Dr. Flamm said in his presentation.

Patients in the study were included if they had a Model For End-Stage Liver Disease score of 25 or less and two or more overt HE within 6 months (Conn score 1 or less) but were currently in remission. The researchers allowed the use of concomitant lactulose during the study period, which was used in 94.1% of rifaximin and 91.2% of placebo patients.

In the post hoc analysis, Dr. Flamm and his colleagues divided rifaximin and placebo patients into Child-Pugh class A (46 patients vs. 56 patients), class B (65 patients vs. 72 patients), and class C (17 patients vs. 14 patients) groups. For rifaximin and placebo patients, the mean age was 57.3 years and 57.2 years in the class A group, 54.4 years and 57.0 years in the class B group, and 56.1 years and 57.6 years in the class C group, respectively.

Overall, 8 of 46 rifaximin patients (17.4%) in the Child-Pugh class A and 15 of 65 rifaximin patients (23.1%) in the class B groups experienced an overt HE event during the 6-month study period, compared with 26 of 56 patients in the class A (46.4%) and 32 of 72 patients (44.4%) in the class B placebo groups; 5 of 17 rifaximin patients (29.4%) in the Child-Pugh class C group experienced their first overt HE event, compared with 9 of 14 (64.3%) patients in the placebo group.

With regard to first HE-related hospitalization, 5 of 46 patients (10.9%) in the rifaximin Child-Pugh class A group, 8 of 65 rifaximin patients (12.3%) in the class B group, and 4 of 17 rifaximin patients (23.5%) in the class C group experienced hospitalization because of HE, compared with 15 of 56 patients (23.2%) in the Child-Pugh class A group, 15 of 72 patients (20.8%) in the class B group, and 5 of 14 patients (35.7%) in the class C placebo group. The researchers noted lactulose use in the majority of patient cases in the study “provided further benefit” in reducing overt HE events.

“Although numeric differences were observed favoring rifaximin for the incidence of HE-related hospitalizations, a risk reduction versus placebo could not be firmly established, and presumably this was largely due to a lack of adequate power because of small sample size,” Dr. Flamm said.

This study and its analysis were supported by Salix Pharmaceuticals. Dr. Flamm and other coauthors report advisory committee membership, board membership, employment, or consultancy with AbbVie, Bristol-Myers Squibb, Gilead Sciences, Intercept Pharmaceuticals, Merck and Salix Pharmaceuticals. One coauthor reported no relevant conflicts of interest.

SOURCE: Flamm SL et al ACG 2018, Presentation 58.

PHILADELPHIA – Use of a device on the distal end of a colonoscope to expand the view of the colon lowered the mean inspection time during colonoscopy without significantly reducing adenoma or sessile serrated polyp detection rate, according to a presentation at the annual meeting of the American College of Gastroenterology.

“The finger projections on the tip of the Endocuff can engage the colonic folds, and that allows us to see the proximal sides of these folds,” Seth A. Gross, MD, chief of gastroenterology at NYU Langone Health Tisch Hospital in New York, said in his presentation. “It also changes topography and temporarily stretches different segments of the colon depending on where you are to help expose more surface area and ultimately identify more polyps.”

Dr. Gross and his colleagues analyzed the withdrawal time of colonoscopy with the Endocuff Vision (Olympus, Center Valley, Penn.) in 101 patients, compared with withdrawal time during a standard colonoscopy in 99 patients as measured by stopwatch. Other endpoints in the study included insertion time, adenoma detection rate (ADR), sessile serrated polyp detection (SSPD), and number of adenomas and sessile serrated polyps per colonoscopy. Patients were included if they were at least 40 years old with a screening, surveillance, or diagnostic indication for colonoscopy; they were excluded if they had inflammatory bowel disease, polyposis syndrome, prior colon resection, prior colorectal polyp or cancer, previous incomplete colonoscopy or severe diverticular disease.

Inspection time in the Endocuff group was 6.3 minutes, compared with 8.2 minutes in the standard colonoscopy group (P less than .001), and insertion time was 9.9 minutes in the Endocuff group, compared with 11.3 minutes in the standard colonoscopy group. A multivariate analysis showed the shorter inspection times in the Endocuff group remained significant (P less than .0001).

In the Endocuff group, ADR was 61.4% with 1.43 adenomas per colonoscopy, while the standard colonoscopy group had an ADR of 52.5% with an adenoma detection rate of 1.07 per colonoscopy. SSPD was 19.8% in the Endocuff group and 11.1% in the standard group with a SSPD per colonoscopy of 0.27 and 0.21, respectively.

The study was unblinded and there were two endoscopists performing the procedures, which raises the question of whether the results could be generalized to other gastroenterologists, Dr. Gross noted.

“We recommend that future studies that are meant to be powered for adenoma detection rate and sessile serrated lesions be done to sort of validate this, and probably have more endoscopists involved in a study like this,” Dr. Gross said. “But this is the start of an interesting conversation where one could be more efficient without sacrificing our detection rate for both adenomas and sessile serrated lesions.”

Dr. Gross reports a consultancy with Olympus.

SOURCE: Gross SA et al. ACG 2018, Presentation 37.

PHILADELPHIA – Use of a device on the distal end of a colonoscope to expand the view of the colon lowered the mean inspection time during colonoscopy without significantly reducing adenoma or sessile serrated polyp detection rate, according to a presentation at the annual meeting of the American College of Gastroenterology.

“The finger projections on the tip of the Endocuff can engage the colonic folds, and that allows us to see the proximal sides of these folds,” Seth A. Gross, MD, chief of gastroenterology at NYU Langone Health Tisch Hospital in New York, said in his presentation. “It also changes topography and temporarily stretches different segments of the colon depending on where you are to help expose more surface area and ultimately identify more polyps.”

Dr. Gross and his colleagues analyzed the withdrawal time of colonoscopy with the Endocuff Vision (Olympus, Center Valley, Penn.) in 101 patients, compared with withdrawal time during a standard colonoscopy in 99 patients as measured by stopwatch. Other endpoints in the study included insertion time, adenoma detection rate (ADR), sessile serrated polyp detection (SSPD), and number of adenomas and sessile serrated polyps per colonoscopy. Patients were included if they were at least 40 years old with a screening, surveillance, or diagnostic indication for colonoscopy; they were excluded if they had inflammatory bowel disease, polyposis syndrome, prior colon resection, prior colorectal polyp or cancer, previous incomplete colonoscopy or severe diverticular disease.

Inspection time in the Endocuff group was 6.3 minutes, compared with 8.2 minutes in the standard colonoscopy group (P less than .001), and insertion time was 9.9 minutes in the Endocuff group, compared with 11.3 minutes in the standard colonoscopy group. A multivariate analysis showed the shorter inspection times in the Endocuff group remained significant (P less than .0001).

In the Endocuff group, ADR was 61.4% with 1.43 adenomas per colonoscopy, while the standard colonoscopy group had an ADR of 52.5% with an adenoma detection rate of 1.07 per colonoscopy. SSPD was 19.8% in the Endocuff group and 11.1% in the standard group with a SSPD per colonoscopy of 0.27 and 0.21, respectively.

The study was unblinded and there were two endoscopists performing the procedures, which raises the question of whether the results could be generalized to other gastroenterologists, Dr. Gross noted.

“We recommend that future studies that are meant to be powered for adenoma detection rate and sessile serrated lesions be done to sort of validate this, and probably have more endoscopists involved in a study like this,” Dr. Gross said. “But this is the start of an interesting conversation where one could be more efficient without sacrificing our detection rate for both adenomas and sessile serrated lesions.”

Dr. Gross reports a consultancy with Olympus.

SOURCE: Gross SA et al. ACG 2018, Presentation 37.

PHILADELPHIA – Use of a device on the distal end of a colonoscope to expand the view of the colon lowered the mean inspection time during colonoscopy without significantly reducing adenoma or sessile serrated polyp detection rate, according to a presentation at the annual meeting of the American College of Gastroenterology.

“The finger projections on the tip of the Endocuff can engage the colonic folds, and that allows us to see the proximal sides of these folds,” Seth A. Gross, MD, chief of gastroenterology at NYU Langone Health Tisch Hospital in New York, said in his presentation. “It also changes topography and temporarily stretches different segments of the colon depending on where you are to help expose more surface area and ultimately identify more polyps.”

Dr. Gross and his colleagues analyzed the withdrawal time of colonoscopy with the Endocuff Vision (Olympus, Center Valley, Penn.) in 101 patients, compared with withdrawal time during a standard colonoscopy in 99 patients as measured by stopwatch. Other endpoints in the study included insertion time, adenoma detection rate (ADR), sessile serrated polyp detection (SSPD), and number of adenomas and sessile serrated polyps per colonoscopy. Patients were included if they were at least 40 years old with a screening, surveillance, or diagnostic indication for colonoscopy; they were excluded if they had inflammatory bowel disease, polyposis syndrome, prior colon resection, prior colorectal polyp or cancer, previous incomplete colonoscopy or severe diverticular disease.

Inspection time in the Endocuff group was 6.3 minutes, compared with 8.2 minutes in the standard colonoscopy group (P less than .001), and insertion time was 9.9 minutes in the Endocuff group, compared with 11.3 minutes in the standard colonoscopy group. A multivariate analysis showed the shorter inspection times in the Endocuff group remained significant (P less than .0001).

In the Endocuff group, ADR was 61.4% with 1.43 adenomas per colonoscopy, while the standard colonoscopy group had an ADR of 52.5% with an adenoma detection rate of 1.07 per colonoscopy. SSPD was 19.8% in the Endocuff group and 11.1% in the standard group with a SSPD per colonoscopy of 0.27 and 0.21, respectively.

The study was unblinded and there were two endoscopists performing the procedures, which raises the question of whether the results could be generalized to other gastroenterologists, Dr. Gross noted.

“We recommend that future studies that are meant to be powered for adenoma detection rate and sessile serrated lesions be done to sort of validate this, and probably have more endoscopists involved in a study like this,” Dr. Gross said. “But this is the start of an interesting conversation where one could be more efficient without sacrificing our detection rate for both adenomas and sessile serrated lesions.”

Dr. Gross reports a consultancy with Olympus.

SOURCE: Gross SA et al. ACG 2018, Presentation 37.

PHILADELPHIA – There was a significantly higher adenoma detection rate when the withdrawal rate in the right colon was more than 3 minutes in patients undergoing colonoscopy, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Although adenomas precede colon cancer in approximately 70% of cases, and detection of adenomas is associated with 5% risk of dying from colorectal cancer, miss rates of adenomas are high in both sides of the colon and ideal withdrawal times are not known, Fahad F. Mir, MD, MSc, from the University of Missouri-Kansas City, said.

“Miss rates are high, especially in the right side of the colon. A colonoscopy offers protection in up to 80% of the left side of the patients but only up to 40%-60% in the right side of patients,” Dr. Mir stated in his presentation. “The quality standard now [for withdrawal time] is 6 minutes, so we hypothesized that adenoma detection rate is not the same if the right colon withdrawal time is equal to or more than 3 minutes, compared to less than 3 minutes.”

The abstract received an ACG Governor’s Award for Excellence in Clinical Research.

Dr. Mir and his colleagues performed a prospective, randomized, case-controlled study of 226 patients undergoing colonoscopy at three endoscopy centers in St. Luke’s Health System, Kansas City, who were aged at least 50 years and had not undergone colonic resections, emergent procedures, or were unable to consent because of mental status or language barrier. Patients were randomized to a control group (113 patients) in whom right colon withdrawal time was under 3 minutes and an intervention group (113 patients) in whom withdrawal time was 3 minutes or more.

There was a 33% adenoma detection rate in the 3 minute or more group, compared with 14% in the less than 3 minutes group (odds ratio, 3.0; 95% confidence interval, 1.62-5.64; P less than .001). Polyp detection rates were 49% in the 3 minutes or more group and 14% in the less than 3 minutes group (OR 5.1; 95% CI, 2.84-9.32; P less than .001). The optimal cut-off point was 3 minutes and 1 second with optimal sensitivity and specificity with an area under the curve of 0.73 (95% CI, 0.65-0.81; P less than .001) for optimal cut-off time for withdrawal from the right colon.

“There was a difference in fellow involvement, where fellows were more likely to be involved when the withdrawal time was more than 3 minutes as opposed to less than 3 minutes; the ADR [adenoma detection rate] was not different based upon fellow involvement,” Dr. Mir said.

The researchers noted similar rates of retroflexion between both groups and said there were no adverse events related to the study in either group. Limitations of the study included its unblinded design, data collection from multiple centers, and a higher rate of previous polyps in patients in the withdrawal in more than 3 minutes group.

Dr. Mir report no relevant conflicts of interest.
 

SOURCE: Mir FF et al. ACG 2018, Presentation 5.

PHILADELPHIA – There was a significantly higher adenoma detection rate when the withdrawal rate in the right colon was more than 3 minutes in patients undergoing colonoscopy, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Although adenomas precede colon cancer in approximately 70% of cases, and detection of adenomas is associated with 5% risk of dying from colorectal cancer, miss rates of adenomas are high in both sides of the colon and ideal withdrawal times are not known, Fahad F. Mir, MD, MSc, from the University of Missouri-Kansas City, said.

“Miss rates are high, especially in the right side of the colon. A colonoscopy offers protection in up to 80% of the left side of the patients but only up to 40%-60% in the right side of patients,” Dr. Mir stated in his presentation. “The quality standard now [for withdrawal time] is 6 minutes, so we hypothesized that adenoma detection rate is not the same if the right colon withdrawal time is equal to or more than 3 minutes, compared to less than 3 minutes.”

The abstract received an ACG Governor’s Award for Excellence in Clinical Research.

Dr. Mir and his colleagues performed a prospective, randomized, case-controlled study of 226 patients undergoing colonoscopy at three endoscopy centers in St. Luke’s Health System, Kansas City, who were aged at least 50 years and had not undergone colonic resections, emergent procedures, or were unable to consent because of mental status or language barrier. Patients were randomized to a control group (113 patients) in whom right colon withdrawal time was under 3 minutes and an intervention group (113 patients) in whom withdrawal time was 3 minutes or more.

There was a 33% adenoma detection rate in the 3 minute or more group, compared with 14% in the less than 3 minutes group (odds ratio, 3.0; 95% confidence interval, 1.62-5.64; P less than .001). Polyp detection rates were 49% in the 3 minutes or more group and 14% in the less than 3 minutes group (OR 5.1; 95% CI, 2.84-9.32; P less than .001). The optimal cut-off point was 3 minutes and 1 second with optimal sensitivity and specificity with an area under the curve of 0.73 (95% CI, 0.65-0.81; P less than .001) for optimal cut-off time for withdrawal from the right colon.

“There was a difference in fellow involvement, where fellows were more likely to be involved when the withdrawal time was more than 3 minutes as opposed to less than 3 minutes; the ADR [adenoma detection rate] was not different based upon fellow involvement,” Dr. Mir said.

The researchers noted similar rates of retroflexion between both groups and said there were no adverse events related to the study in either group. Limitations of the study included its unblinded design, data collection from multiple centers, and a higher rate of previous polyps in patients in the withdrawal in more than 3 minutes group.

Dr. Mir report no relevant conflicts of interest.
 

SOURCE: Mir FF et al. ACG 2018, Presentation 5.

PHILADELPHIA – There was a significantly higher adenoma detection rate when the withdrawal rate in the right colon was more than 3 minutes in patients undergoing colonoscopy, according to a recent presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Although adenomas precede colon cancer in approximately 70% of cases, and detection of adenomas is associated with 5% risk of dying from colorectal cancer, miss rates of adenomas are high in both sides of the colon and ideal withdrawal times are not known, Fahad F. Mir, MD, MSc, from the University of Missouri-Kansas City, said.

“Miss rates are high, especially in the right side of the colon. A colonoscopy offers protection in up to 80% of the left side of the patients but only up to 40%-60% in the right side of patients,” Dr. Mir stated in his presentation. “The quality standard now [for withdrawal time] is 6 minutes, so we hypothesized that adenoma detection rate is not the same if the right colon withdrawal time is equal to or more than 3 minutes, compared to less than 3 minutes.”

The abstract received an ACG Governor’s Award for Excellence in Clinical Research.

Dr. Mir and his colleagues performed a prospective, randomized, case-controlled study of 226 patients undergoing colonoscopy at three endoscopy centers in St. Luke’s Health System, Kansas City, who were aged at least 50 years and had not undergone colonic resections, emergent procedures, or were unable to consent because of mental status or language barrier. Patients were randomized to a control group (113 patients) in whom right colon withdrawal time was under 3 minutes and an intervention group (113 patients) in whom withdrawal time was 3 minutes or more.

There was a 33% adenoma detection rate in the 3 minute or more group, compared with 14% in the less than 3 minutes group (odds ratio, 3.0; 95% confidence interval, 1.62-5.64; P less than .001). Polyp detection rates were 49% in the 3 minutes or more group and 14% in the less than 3 minutes group (OR 5.1; 95% CI, 2.84-9.32; P less than .001). The optimal cut-off point was 3 minutes and 1 second with optimal sensitivity and specificity with an area under the curve of 0.73 (95% CI, 0.65-0.81; P less than .001) for optimal cut-off time for withdrawal from the right colon.

“There was a difference in fellow involvement, where fellows were more likely to be involved when the withdrawal time was more than 3 minutes as opposed to less than 3 minutes; the ADR [adenoma detection rate] was not different based upon fellow involvement,” Dr. Mir said.

The researchers noted similar rates of retroflexion between both groups and said there were no adverse events related to the study in either group. Limitations of the study included its unblinded design, data collection from multiple centers, and a higher rate of previous polyps in patients in the withdrawal in more than 3 minutes group.

Dr. Mir report no relevant conflicts of interest.
 

SOURCE: Mir FF et al. ACG 2018, Presentation 5.

PHILADELPHIA – Use of etrasimod was associated with improved clinical and endoscopic results, and was generally safe and well tolerated compared with placebo in patients with moderate to severe ulcerative colitis, according to a recent award-winning presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

“Patients with moderate to severe ulcerative colitis receiving etrasimod 2 mg per day achieved statistically significant and clinically meaningful differences in all of the primary and secondary endpoints, and most exploratory endpoints were also significantly proved,” William J. Sandborn, MD, AGAF, FACG, professor of clinical medicine at the University of California, San Diego, stated in his presentation at the meeting. “A dose-response relationship was observed in virtually all of the measures of treatment efficacy.”

The abstract received the ACG Auxiliary Award (Member), which is given to ACG members each year with outstanding abstract submissions.

Dr. Sandborn and his colleagues enrolled 156 patients with ulcerative colitis (UC) into the OASIS study, a randomized, double-blind, parallel-group, phase 2 study of etrasimod, an oral sphingosine 1-phosphate (S1P) receptor modulator, compared with placebo. Patients were aged 18-80 years, with moderate to severe UC as defined by a three-component Mayo Clinic Score (MCS) comprising rectal bleeding, frequency of stool, and endoscopy.

Those patients who achieved an MCS score between 4 and 9 points with an endoscopic subscore of at least 2 and rectal bleeding (RB) subscore of at least 1 were included. Patients were divided into once-daily etrasimod 1 mg (52 patients), once-daily etrasimod 2 mg (50 patients) and placebo (54 patients) groups and treated over a 12-week period.

At 12 weeks, the least-squares mean difference for change in baseline in three-component MCS was 1.94 in the 1-mg etrasimod group and 2.49 in the 2-mg etrasimod group compared with placebo (1.50). Endoscopic improvement was greater in the 1-mg etrasimod (22.5%) and 2-mg (41.8%) groups compared with placebo (17.8%); endoscopic remission rates also improved in the 1-mg etrasimod (13.7%) and 2-mg (15.3%) groups compared with placebo (5.3%). Lymphocyte count circulation significantly decreased in the 1-mg etrasimod (37.2%) and 2-mg (57.3%) groups compared with the placebo group. With regard to rectal bleeding, the rectal bleeding subscore also decreased in the 1-mg etrasimod and 2-mg groups compared with placebo at 12 weeks from baseline.

The researchers noted no significant differences in adverse events among groups, with the placebo group showing a higher rate of major adverse events (11.1%) compared with the 1-mg etrasimod (5.8%) and 2-mg etrasimod (0%) groups.

“The OASIS trial results for etrasimod would support proceeding to a phase 3 program for this drug in patients with moderate to severe ulcerative colitis,” Dr. Sandborn concluded.

Dr. Sandborn reports consultancies, speaker bureau memberships, and research support from AbbVie, Biogen, Celgene, Ferring, Genentech, Gilead Sciences, Immune Pharmaceuticals, Janssen, Lilly, MedImmune, Novartis, Pfizer, Regeneron, Ritter Pharmaceuticals, Salix, Theradiag, UCB Pharma, and Vascular Biogenics, among others.

SOURCE: Sandborn WJ et al. ACG 2018. Presentation 11.

PHILADELPHIA – Use of etrasimod was associated with improved clinical and endoscopic results, and was generally safe and well tolerated compared with placebo in patients with moderate to severe ulcerative colitis, according to a recent award-winning presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

“Patients with moderate to severe ulcerative colitis receiving etrasimod 2 mg per day achieved statistically significant and clinically meaningful differences in all of the primary and secondary endpoints, and most exploratory endpoints were also significantly proved,” William J. Sandborn, MD, AGAF, FACG, professor of clinical medicine at the University of California, San Diego, stated in his presentation at the meeting. “A dose-response relationship was observed in virtually all of the measures of treatment efficacy.”

The abstract received the ACG Auxiliary Award (Member), which is given to ACG members each year with outstanding abstract submissions.

Dr. Sandborn and his colleagues enrolled 156 patients with ulcerative colitis (UC) into the OASIS study, a randomized, double-blind, parallel-group, phase 2 study of etrasimod, an oral sphingosine 1-phosphate (S1P) receptor modulator, compared with placebo. Patients were aged 18-80 years, with moderate to severe UC as defined by a three-component Mayo Clinic Score (MCS) comprising rectal bleeding, frequency of stool, and endoscopy.

Those patients who achieved an MCS score between 4 and 9 points with an endoscopic subscore of at least 2 and rectal bleeding (RB) subscore of at least 1 were included. Patients were divided into once-daily etrasimod 1 mg (52 patients), once-daily etrasimod 2 mg (50 patients) and placebo (54 patients) groups and treated over a 12-week period.

At 12 weeks, the least-squares mean difference for change in baseline in three-component MCS was 1.94 in the 1-mg etrasimod group and 2.49 in the 2-mg etrasimod group compared with placebo (1.50). Endoscopic improvement was greater in the 1-mg etrasimod (22.5%) and 2-mg (41.8%) groups compared with placebo (17.8%); endoscopic remission rates also improved in the 1-mg etrasimod (13.7%) and 2-mg (15.3%) groups compared with placebo (5.3%). Lymphocyte count circulation significantly decreased in the 1-mg etrasimod (37.2%) and 2-mg (57.3%) groups compared with the placebo group. With regard to rectal bleeding, the rectal bleeding subscore also decreased in the 1-mg etrasimod and 2-mg groups compared with placebo at 12 weeks from baseline.

The researchers noted no significant differences in adverse events among groups, with the placebo group showing a higher rate of major adverse events (11.1%) compared with the 1-mg etrasimod (5.8%) and 2-mg etrasimod (0%) groups.

“The OASIS trial results for etrasimod would support proceeding to a phase 3 program for this drug in patients with moderate to severe ulcerative colitis,” Dr. Sandborn concluded.

Dr. Sandborn reports consultancies, speaker bureau memberships, and research support from AbbVie, Biogen, Celgene, Ferring, Genentech, Gilead Sciences, Immune Pharmaceuticals, Janssen, Lilly, MedImmune, Novartis, Pfizer, Regeneron, Ritter Pharmaceuticals, Salix, Theradiag, UCB Pharma, and Vascular Biogenics, among others.

SOURCE: Sandborn WJ et al. ACG 2018. Presentation 11.

PHILADELPHIA – Use of etrasimod was associated with improved clinical and endoscopic results, and was generally safe and well tolerated compared with placebo in patients with moderate to severe ulcerative colitis, according to a recent award-winning presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

“Patients with moderate to severe ulcerative colitis receiving etrasimod 2 mg per day achieved statistically significant and clinically meaningful differences in all of the primary and secondary endpoints, and most exploratory endpoints were also significantly proved,” William J. Sandborn, MD, AGAF, FACG, professor of clinical medicine at the University of California, San Diego, stated in his presentation at the meeting. “A dose-response relationship was observed in virtually all of the measures of treatment efficacy.”

The abstract received the ACG Auxiliary Award (Member), which is given to ACG members each year with outstanding abstract submissions.

Dr. Sandborn and his colleagues enrolled 156 patients with ulcerative colitis (UC) into the OASIS study, a randomized, double-blind, parallel-group, phase 2 study of etrasimod, an oral sphingosine 1-phosphate (S1P) receptor modulator, compared with placebo. Patients were aged 18-80 years, with moderate to severe UC as defined by a three-component Mayo Clinic Score (MCS) comprising rectal bleeding, frequency of stool, and endoscopy.

Those patients who achieved an MCS score between 4 and 9 points with an endoscopic subscore of at least 2 and rectal bleeding (RB) subscore of at least 1 were included. Patients were divided into once-daily etrasimod 1 mg (52 patients), once-daily etrasimod 2 mg (50 patients) and placebo (54 patients) groups and treated over a 12-week period.

At 12 weeks, the least-squares mean difference for change in baseline in three-component MCS was 1.94 in the 1-mg etrasimod group and 2.49 in the 2-mg etrasimod group compared with placebo (1.50). Endoscopic improvement was greater in the 1-mg etrasimod (22.5%) and 2-mg (41.8%) groups compared with placebo (17.8%); endoscopic remission rates also improved in the 1-mg etrasimod (13.7%) and 2-mg (15.3%) groups compared with placebo (5.3%). Lymphocyte count circulation significantly decreased in the 1-mg etrasimod (37.2%) and 2-mg (57.3%) groups compared with the placebo group. With regard to rectal bleeding, the rectal bleeding subscore also decreased in the 1-mg etrasimod and 2-mg groups compared with placebo at 12 weeks from baseline.

The researchers noted no significant differences in adverse events among groups, with the placebo group showing a higher rate of major adverse events (11.1%) compared with the 1-mg etrasimod (5.8%) and 2-mg etrasimod (0%) groups.

“The OASIS trial results for etrasimod would support proceeding to a phase 3 program for this drug in patients with moderate to severe ulcerative colitis,” Dr. Sandborn concluded.

Dr. Sandborn reports consultancies, speaker bureau memberships, and research support from AbbVie, Biogen, Celgene, Ferring, Genentech, Gilead Sciences, Immune Pharmaceuticals, Janssen, Lilly, MedImmune, Novartis, Pfizer, Regeneron, Ritter Pharmaceuticals, Salix, Theradiag, UCB Pharma, and Vascular Biogenics, among others.

SOURCE: Sandborn WJ et al. ACG 2018. Presentation 11.

PHILADELPHIA – A novel score accurately predicted the size and presence of esophageal varices in a noninvasive manner, which may help clinicians avoid unnecessary esophagogastroduodenoscopy in patients with cirrhosis, according to a recent award-winning presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Although there are two validated scores for predicting esophageal varices (EV), platelet count to spleen diameter ratio and Baveno VI criteria, they have drawbacks, Tien Dong, MD, from the University of California, Los Angeles said.

“The limitations to these existing scores and criteria are both of them require imaging to do, so because of that, they oftentimes are limited in national clinical use,” Dr. Dong said in his presentation of his team’s abstract, which won the ACG Governors Award for Excellence in Clinical Research. “The other thing is that, even though it’s recommended, sometimes spleen diameter on a normal ultrasound is not reported. Furthermore, elastography – even though it’s becoming more and more common – is still not yet readily available across the country.”

Dr. Dong and his colleagues sought to identify noninvasive clinical predictors of EV to create a predictive score to identify EV to overcome these drawbacks. They gathered endoscopy data from the Olive View–UCLA and West Los Angeles Veterans Affairs Hospital to create a discovery cohort (165 patients) and tested the score on patients from Ronald Reagan UCLA Medical Center in a validation cohort (73 patients).

They used a random forest classifier machine learning algorithm “to create a forest of decision trees so that it can tell us which variables it believes to be the most predictive of our outcomes of interest,” Dr. Dong said.

The algorithm identified several variables that appeared to be predictive of EV presence, such as international normalized ratio, aminotransferase, platelet mean, hemoglobin, albumin and blood urea nitrogen less than or equal to 3, which the researchers used to create an EV-endoscopy (EV-Endo) score.

In the discovery cohort, area under the curve (AUC) for the presence of EV was 0.81, compared with an AUC of 0.82 in the validation cohort, while there was an AUC of 0.77 in the discovery cohort and an AUC of 0.79 for small/absent vs. medium/large EV. Patients with Child-Pugh class A cirrhosis had an AUC of 0.81 for EV presence and an AUC of 0.77 for EV size. The researchers then created a cutoff score of 3.48 or less and 7.70 or more for EV presence, which had a sensitivity and specificity of 93.9% and 97.5%, respectively. EV-Endo score EV size cutoff scores were also 3.48 or less and 7.70 or more, with a sensitivity of 95.8% and specificity of 95.0%.

Dr. Dong reports no conflicts of interest.

SOURCE: Hauer M et al. ACG 2018. Presentation 31.

PHILADELPHIA – A novel score accurately predicted the size and presence of esophageal varices in a noninvasive manner, which may help clinicians avoid unnecessary esophagogastroduodenoscopy in patients with cirrhosis, according to a recent award-winning presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Although there are two validated scores for predicting esophageal varices (EV), platelet count to spleen diameter ratio and Baveno VI criteria, they have drawbacks, Tien Dong, MD, from the University of California, Los Angeles said.

“The limitations to these existing scores and criteria are both of them require imaging to do, so because of that, they oftentimes are limited in national clinical use,” Dr. Dong said in his presentation of his team’s abstract, which won the ACG Governors Award for Excellence in Clinical Research. “The other thing is that, even though it’s recommended, sometimes spleen diameter on a normal ultrasound is not reported. Furthermore, elastography – even though it’s becoming more and more common – is still not yet readily available across the country.”

Dr. Dong and his colleagues sought to identify noninvasive clinical predictors of EV to create a predictive score to identify EV to overcome these drawbacks. They gathered endoscopy data from the Olive View–UCLA and West Los Angeles Veterans Affairs Hospital to create a discovery cohort (165 patients) and tested the score on patients from Ronald Reagan UCLA Medical Center in a validation cohort (73 patients).

They used a random forest classifier machine learning algorithm “to create a forest of decision trees so that it can tell us which variables it believes to be the most predictive of our outcomes of interest,” Dr. Dong said.

The algorithm identified several variables that appeared to be predictive of EV presence, such as international normalized ratio, aminotransferase, platelet mean, hemoglobin, albumin and blood urea nitrogen less than or equal to 3, which the researchers used to create an EV-endoscopy (EV-Endo) score.

In the discovery cohort, area under the curve (AUC) for the presence of EV was 0.81, compared with an AUC of 0.82 in the validation cohort, while there was an AUC of 0.77 in the discovery cohort and an AUC of 0.79 for small/absent vs. medium/large EV. Patients with Child-Pugh class A cirrhosis had an AUC of 0.81 for EV presence and an AUC of 0.77 for EV size. The researchers then created a cutoff score of 3.48 or less and 7.70 or more for EV presence, which had a sensitivity and specificity of 93.9% and 97.5%, respectively. EV-Endo score EV size cutoff scores were also 3.48 or less and 7.70 or more, with a sensitivity of 95.8% and specificity of 95.0%.

Dr. Dong reports no conflicts of interest.

SOURCE: Hauer M et al. ACG 2018. Presentation 31.

PHILADELPHIA – A novel score accurately predicted the size and presence of esophageal varices in a noninvasive manner, which may help clinicians avoid unnecessary esophagogastroduodenoscopy in patients with cirrhosis, according to a recent award-winning presentation at the annual meeting of the American College of Gastroenterology.

Jeff Craven/MDedge News

Although there are two validated scores for predicting esophageal varices (EV), platelet count to spleen diameter ratio and Baveno VI criteria, they have drawbacks, Tien Dong, MD, from the University of California, Los Angeles said.

“The limitations to these existing scores and criteria are both of them require imaging to do, so because of that, they oftentimes are limited in national clinical use,” Dr. Dong said in his presentation of his team’s abstract, which won the ACG Governors Award for Excellence in Clinical Research. “The other thing is that, even though it’s recommended, sometimes spleen diameter on a normal ultrasound is not reported. Furthermore, elastography – even though it’s becoming more and more common – is still not yet readily available across the country.”

Dr. Dong and his colleagues sought to identify noninvasive clinical predictors of EV to create a predictive score to identify EV to overcome these drawbacks. They gathered endoscopy data from the Olive View–UCLA and West Los Angeles Veterans Affairs Hospital to create a discovery cohort (165 patients) and tested the score on patients from Ronald Reagan UCLA Medical Center in a validation cohort (73 patients).

They used a random forest classifier machine learning algorithm “to create a forest of decision trees so that it can tell us which variables it believes to be the most predictive of our outcomes of interest,” Dr. Dong said.

The algorithm identified several variables that appeared to be predictive of EV presence, such as international normalized ratio, aminotransferase, platelet mean, hemoglobin, albumin and blood urea nitrogen less than or equal to 3, which the researchers used to create an EV-endoscopy (EV-Endo) score.

In the discovery cohort, area under the curve (AUC) for the presence of EV was 0.81, compared with an AUC of 0.82 in the validation cohort, while there was an AUC of 0.77 in the discovery cohort and an AUC of 0.79 for small/absent vs. medium/large EV. Patients with Child-Pugh class A cirrhosis had an AUC of 0.81 for EV presence and an AUC of 0.77 for EV size. The researchers then created a cutoff score of 3.48 or less and 7.70 or more for EV presence, which had a sensitivity and specificity of 93.9% and 97.5%, respectively. EV-Endo score EV size cutoff scores were also 3.48 or less and 7.70 or more, with a sensitivity of 95.8% and specificity of 95.0%.

Dr. Dong reports no conflicts of interest.

SOURCE: Hauer M et al. ACG 2018. Presentation 31.

Unplanned pregnancy among women with epilepsy was associated with twice the risk of spontaneous fetal loss when compared against women with epilepsy who planned their pregnancy, according to recent results from a retrospective study published in JAMA Neurology.

“This analysis adds the finding that unplanned pregnancy may increase the risk of [spontaneous fetal loss] in women with epilepsy and identifies pregnancy planning, maternal age, and interpregnancy interval as significant modifiable variables,” Andrew G. Herzog, MD, of the Harvard Neuroendocrine Unit at Beth Israel Deaconess Medical Center in Wellesley, Mass., and colleagues wrote in their study.

The researchers examined results from a web-based survey completed by 1,144 women in the Epilepsy Birth Control Registry (EBCR) between 2010 and 2014 with data on contraception use, pregnancy history, and antiepileptic drug (AED) treatment. Patients were aged 18-47 years (mean 28.5 years) with 8.7% of the cohort consisting of minority women and 39.8% having household incomes of $25,000 or less.

Pregnancy history data included number of pregnancies, number of planned or unplanned pregnancies, AED type used during pregnancies, pregnancy outcomes such as live birth, induced abortion, and spontaneous fetal loss (SFL), while AED data included categorizing patients into no therapy, monotherapy, and polytherapy groups. AED use was further subdivided into no AED, enzyme-inducing AED, non–enzyme-inducing AED, enzyme-inhibiting AED, glucuronidated AED, and mixed category groups.

Of 794 pregnancies, 530 pregnancies (66.8%) were unplanned and 264 (33.2%) were planned, with 473 live births (59.6%), 141 induced abortions (17.8%), and 180 SFL (22.7%). Among patients who did not have an induced abortion, SFL risk was higher if the pregnancy was unplanned (137 patients, 35.0%), compared with those who planned (43 patients, 16.4%) their pregnancy (risk ratio = 2.14; 95% confidence interval, 1.59-2.90; P less than .001). According to a regression analysis, SFL risk was higher for patients where “planning was entered alone” in unplanned pregnancies (odds ratio = 2.75; 95% CI, 1.87-4.05; P less than .001) as well as when adjusted for AED category, maternal age, and interpregnancy interval (OR = 3.57; 95% CI, 1.54-8.78; P = .003).

There was an association between maternal age (OR = 0.957; 95% CI, 0.928-0.986; P = .02) and risk of SFL, with lower risk seen in the 18- to 27-year-old group (118 patients, 29.5%; RR = 0.57; 95% CI, 0.39-0.84; P less than .004) and 28- to 37-year-old group (44 patients, 20.8%; RR = 0.40; 95% CI, 0.26-0.62; P less than .001), compared with the under-18 group (15 patients, 51.7%). There was also a higher risk of SFL with regard to interpregnancy interval (OR = 2.878; 95% CI, 1.8094-4.5801; P = .008), with a greater risk seen if the interpregnancy interval was under 1 year (56 patients, 45.9%), compared with 1 year (56 patients, 22.8%) or higher (RR = 2.02; 95% CI, 1.49-2.72; P less than .001).

“In view of the finding of increased risk for SFL in unplanned pregnancies in women with epilepsy, and because a history of SFL in women with epilepsy may increase the risk that subsequent live-born offspring will develop epilepsy, the finding warrants prospective investigation with medical record verification of pregnancy outcomes,” Dr. Herzog and his colleagues wrote.

The Epilepsy Foundation and Lundbeck funded the study. Dr. Herzog reports support by grants, and two coauthors received salary support from grants, from the two organizations.

SOURCE: Herzog AG et al. JAMA Neurol. 2018 Oct 15. doi: 10.1001/jamaneurol.2018.3089.

Unplanned pregnancy among women with epilepsy was associated with twice the risk of spontaneous fetal loss when compared against women with epilepsy who planned their pregnancy, according to recent results from a retrospective study published in JAMA Neurology.

“This analysis adds the finding that unplanned pregnancy may increase the risk of [spontaneous fetal loss] in women with epilepsy and identifies pregnancy planning, maternal age, and interpregnancy interval as significant modifiable variables,” Andrew G. Herzog, MD, of the Harvard Neuroendocrine Unit at Beth Israel Deaconess Medical Center in Wellesley, Mass., and colleagues wrote in their study.

The researchers examined results from a web-based survey completed by 1,144 women in the Epilepsy Birth Control Registry (EBCR) between 2010 and 2014 with data on contraception use, pregnancy history, and antiepileptic drug (AED) treatment. Patients were aged 18-47 years (mean 28.5 years) with 8.7% of the cohort consisting of minority women and 39.8% having household incomes of $25,000 or less.

Pregnancy history data included number of pregnancies, number of planned or unplanned pregnancies, AED type used during pregnancies, pregnancy outcomes such as live birth, induced abortion, and spontaneous fetal loss (SFL), while AED data included categorizing patients into no therapy, monotherapy, and polytherapy groups. AED use was further subdivided into no AED, enzyme-inducing AED, non–enzyme-inducing AED, enzyme-inhibiting AED, glucuronidated AED, and mixed category groups.

Of 794 pregnancies, 530 pregnancies (66.8%) were unplanned and 264 (33.2%) were planned, with 473 live births (59.6%), 141 induced abortions (17.8%), and 180 SFL (22.7%). Among patients who did not have an induced abortion, SFL risk was higher if the pregnancy was unplanned (137 patients, 35.0%), compared with those who planned (43 patients, 16.4%) their pregnancy (risk ratio = 2.14; 95% confidence interval, 1.59-2.90; P less than .001). According to a regression analysis, SFL risk was higher for patients where “planning was entered alone” in unplanned pregnancies (odds ratio = 2.75; 95% CI, 1.87-4.05; P less than .001) as well as when adjusted for AED category, maternal age, and interpregnancy interval (OR = 3.57; 95% CI, 1.54-8.78; P = .003).

There was an association between maternal age (OR = 0.957; 95% CI, 0.928-0.986; P = .02) and risk of SFL, with lower risk seen in the 18- to 27-year-old group (118 patients, 29.5%; RR = 0.57; 95% CI, 0.39-0.84; P less than .004) and 28- to 37-year-old group (44 patients, 20.8%; RR = 0.40; 95% CI, 0.26-0.62; P less than .001), compared with the under-18 group (15 patients, 51.7%). There was also a higher risk of SFL with regard to interpregnancy interval (OR = 2.878; 95% CI, 1.8094-4.5801; P = .008), with a greater risk seen if the interpregnancy interval was under 1 year (56 patients, 45.9%), compared with 1 year (56 patients, 22.8%) or higher (RR = 2.02; 95% CI, 1.49-2.72; P less than .001).

“In view of the finding of increased risk for SFL in unplanned pregnancies in women with epilepsy, and because a history of SFL in women with epilepsy may increase the risk that subsequent live-born offspring will develop epilepsy, the finding warrants prospective investigation with medical record verification of pregnancy outcomes,” Dr. Herzog and his colleagues wrote.

The Epilepsy Foundation and Lundbeck funded the study. Dr. Herzog reports support by grants, and two coauthors received salary support from grants, from the two organizations.

SOURCE: Herzog AG et al. JAMA Neurol. 2018 Oct 15. doi: 10.1001/jamaneurol.2018.3089.

Unplanned pregnancy among women with epilepsy was associated with twice the risk of spontaneous fetal loss when compared against women with epilepsy who planned their pregnancy, according to recent results from a retrospective study published in JAMA Neurology.

“This analysis adds the finding that unplanned pregnancy may increase the risk of [spontaneous fetal loss] in women with epilepsy and identifies pregnancy planning, maternal age, and interpregnancy interval as significant modifiable variables,” Andrew G. Herzog, MD, of the Harvard Neuroendocrine Unit at Beth Israel Deaconess Medical Center in Wellesley, Mass., and colleagues wrote in their study.

The researchers examined results from a web-based survey completed by 1,144 women in the Epilepsy Birth Control Registry (EBCR) between 2010 and 2014 with data on contraception use, pregnancy history, and antiepileptic drug (AED) treatment. Patients were aged 18-47 years (mean 28.5 years) with 8.7% of the cohort consisting of minority women and 39.8% having household incomes of $25,000 or less.

Pregnancy history data included number of pregnancies, number of planned or unplanned pregnancies, AED type used during pregnancies, pregnancy outcomes such as live birth, induced abortion, and spontaneous fetal loss (SFL), while AED data included categorizing patients into no therapy, monotherapy, and polytherapy groups. AED use was further subdivided into no AED, enzyme-inducing AED, non–enzyme-inducing AED, enzyme-inhibiting AED, glucuronidated AED, and mixed category groups.

Of 794 pregnancies, 530 pregnancies (66.8%) were unplanned and 264 (33.2%) were planned, with 473 live births (59.6%), 141 induced abortions (17.8%), and 180 SFL (22.7%). Among patients who did not have an induced abortion, SFL risk was higher if the pregnancy was unplanned (137 patients, 35.0%), compared with those who planned (43 patients, 16.4%) their pregnancy (risk ratio = 2.14; 95% confidence interval, 1.59-2.90; P less than .001). According to a regression analysis, SFL risk was higher for patients where “planning was entered alone” in unplanned pregnancies (odds ratio = 2.75; 95% CI, 1.87-4.05; P less than .001) as well as when adjusted for AED category, maternal age, and interpregnancy interval (OR = 3.57; 95% CI, 1.54-8.78; P = .003).

There was an association between maternal age (OR = 0.957; 95% CI, 0.928-0.986; P = .02) and risk of SFL, with lower risk seen in the 18- to 27-year-old group (118 patients, 29.5%; RR = 0.57; 95% CI, 0.39-0.84; P less than .004) and 28- to 37-year-old group (44 patients, 20.8%; RR = 0.40; 95% CI, 0.26-0.62; P less than .001), compared with the under-18 group (15 patients, 51.7%). There was also a higher risk of SFL with regard to interpregnancy interval (OR = 2.878; 95% CI, 1.8094-4.5801; P = .008), with a greater risk seen if the interpregnancy interval was under 1 year (56 patients, 45.9%), compared with 1 year (56 patients, 22.8%) or higher (RR = 2.02; 95% CI, 1.49-2.72; P less than .001).

“In view of the finding of increased risk for SFL in unplanned pregnancies in women with epilepsy, and because a history of SFL in women with epilepsy may increase the risk that subsequent live-born offspring will develop epilepsy, the finding warrants prospective investigation with medical record verification of pregnancy outcomes,” Dr. Herzog and his colleagues wrote.

The Epilepsy Foundation and Lundbeck funded the study. Dr. Herzog reports support by grants, and two coauthors received salary support from grants, from the two organizations.

SOURCE: Herzog AG et al. JAMA Neurol. 2018 Oct 15. doi: 10.1001/jamaneurol.2018.3089.