SAN FRANCISCO – The lyrics found in hip-hop can help mental health professionals understand the triumphs and trauma experienced by African American boys and men, Sarah Y. Vinson, MD, said at the annual meeting of the American Psychiatric Association. This understanding can enable clinicians to recognize hopelessness and pain in those patients that they otherwise might have missed.

In this video, Dr. Vinson said her session at the APA meeting looked at the history of hip-hop and focused on the perspectives embedded in the work of several artists/groups, including N.W.A, Tupac Shakur, Childish Gambino (aka Donald Glover), J. Cole, and Kendrick Lamar.

One of the take-home points for clinicians, Dr. Vinson said, is that hip-hop, an art form that has spread across the world, came out of resilience. Another is that suicidality in black men might not look the same as it does in other patients. “It doesn’t necessarily look like cutting your own wrists or having thoughts of killing yourself – it may look like reckless behaviors that put you at risk of being killed by somebody else.”

Dr. Vinson, who is triple boarded in child and adolescent, adult, and forensic psychiatry, is in private practice in Atlanta. She had no financial disclosures.

ghenderson@mdedge.com

SAN FRANCISCO – The lyrics found in hip-hop can help mental health professionals understand the triumphs and trauma experienced by African American boys and men, Sarah Y. Vinson, MD, said at the annual meeting of the American Psychiatric Association. This understanding can enable clinicians to recognize hopelessness and pain in those patients that they otherwise might have missed.

In this video, Dr. Vinson said her session at the APA meeting looked at the history of hip-hop and focused on the perspectives embedded in the work of several artists/groups, including N.W.A, Tupac Shakur, Childish Gambino (aka Donald Glover), J. Cole, and Kendrick Lamar.

One of the take-home points for clinicians, Dr. Vinson said, is that hip-hop, an art form that has spread across the world, came out of resilience. Another is that suicidality in black men might not look the same as it does in other patients. “It doesn’t necessarily look like cutting your own wrists or having thoughts of killing yourself – it may look like reckless behaviors that put you at risk of being killed by somebody else.”

Dr. Vinson, who is triple boarded in child and adolescent, adult, and forensic psychiatry, is in private practice in Atlanta. She had no financial disclosures.

ghenderson@mdedge.com

SAN FRANCISCO – The lyrics found in hip-hop can help mental health professionals understand the triumphs and trauma experienced by African American boys and men, Sarah Y. Vinson, MD, said at the annual meeting of the American Psychiatric Association. This understanding can enable clinicians to recognize hopelessness and pain in those patients that they otherwise might have missed.

In this video, Dr. Vinson said her session at the APA meeting looked at the history of hip-hop and focused on the perspectives embedded in the work of several artists/groups, including N.W.A, Tupac Shakur, Childish Gambino (aka Donald Glover), J. Cole, and Kendrick Lamar.

One of the take-home points for clinicians, Dr. Vinson said, is that hip-hop, an art form that has spread across the world, came out of resilience. Another is that suicidality in black men might not look the same as it does in other patients. “It doesn’t necessarily look like cutting your own wrists or having thoughts of killing yourself – it may look like reckless behaviors that put you at risk of being killed by somebody else.”

Dr. Vinson, who is triple boarded in child and adolescent, adult, and forensic psychiatry, is in private practice in Atlanta. She had no financial disclosures.

ghenderson@mdedge.com

SAN DIEGO – Biliary duct dilation in the setting of an intact gallbladder and normal bilirubin levels was more common among those who used opioids, based on the results of a large, retrospective, single-center cohort study.

Patients were included in the study if they had a documented measurement for the diameter of the common bile duct, with no evidence of an obstructive lesion and a normal bilirubin level. The mean common bile duct diameter was significantly higher at 8.67 mm for 867 patients who used opioids, compared with 7.24 mm for 818 similar patients who did not use opioids (P less than .001). The association was strongest among opioid users with an intact gallbladder.

“Opiate use is associated with biliary dilation in the setting of normal bilirubin,” Monique Barakat, MD, a gastroenterologist at Stanford (Calif.) University, reported at the annual Digestive Disease Week. “Known opiate users with normal LFTs [liver function tests] may not require expensive and potentially risky endoscopic evaluation for biliary dilation.”

Dr. Barakat and senior author Subhas Banerjee, MD, professor of gastroenterology and hepatology at Stanford, decided to examine a possible association between biliary duct dilation and opioid use based on previous small clinical studies that found a possible association. Along with opioid status, Dr. Barakat and her coauthor also looked at patient age, cholecystectomy status, ethnicity, weight, and height for possible associations with bile duct diameter.

The researchers took a random 20% sample of adults seen for all causes in the ED at Stanford over a 5-year period. Using a health informatic platform based on the electronic medical record, they identified all patients who had received an abdominal CT or MRI. Patients were included in the study if they had a documented measurement for the diameter of the common bile duct, with no evidence of obstructive lesion and a normal bilirubin level.

Compared with 818 patients who did not use opioids, the 867 patients who used opioids had a significantly larger common bile duct diameter. Using 7 mm as the threshold for biliary duct enlargement, 84% of patients who used opioids had an enlarged common bile duct, compared with 27% of nonopioid users (P less than .001), said Dr. Barakat, recipient of an early investigator award for the study.

“We frequently get referrals for bile duct dilation with concern for more sinister causes of biliary duct dilation – stones, strictures, and malignancy,” said Dr. Barakat. Because of the increase in cross-sectional imaging via CT or MRI, bile duct dilation is being detected at increasingly higher rates.

Dr. Barakat said that about one-third of referrals to the therapeutic endoscopy clinic at Stanford are now for patients with biliary dilation and normal liver function tests. And similar increases are being “seen across all settings – so office, primary care clinic, inpatient, and most markedly, the emergency department. Coupled with this, the population is aging, and patients who present to each of these settings are more likely, if they are older, to undergo cross-sectional imaging.”

Other contributors to higher rates of bile duct dilation include increased rates of obesity and increased prevalence of nonalcoholic steatohepatitis (NASH). About 20% of individuals with NASH will also have abnormal LFTs, she said, and NASH can be the trigger for cross-sectional imaging.

For most of these patients with biliary duct dilation and normal LFTs, no obstructive process was found on endoscopic evaluation.

Although gastroenterology textbooks may say that bile duct diameter increases with age, Dr. Barakat and colleagues didn’t find this to be the case. Among nonopioid users in the study cohort, age did not predict of common bile duct diameter. Among the entire cohort, “Advancing age weakly predicts increased common bile duct diameter,” she said, suggesting that factors other than age along may drive increased bile duct diameter.

Limitations included the retrospective nature of the study, as well as the limitations of information from the electronic medical record. Also, interobserver variability may have come into play, as bile duct diameter measurements were made by multiple radiologists in the course of clinical care.

The study was funded by the National Institutes of Health. Dr. Barakat reported no relevant financial disclosures.

koakes@mdedge.com

SAN DIEGO – Biliary duct dilation in the setting of an intact gallbladder and normal bilirubin levels was more common among those who used opioids, based on the results of a large, retrospective, single-center cohort study.

Patients were included in the study if they had a documented measurement for the diameter of the common bile duct, with no evidence of an obstructive lesion and a normal bilirubin level. The mean common bile duct diameter was significantly higher at 8.67 mm for 867 patients who used opioids, compared with 7.24 mm for 818 similar patients who did not use opioids (P less than .001). The association was strongest among opioid users with an intact gallbladder.

“Opiate use is associated with biliary dilation in the setting of normal bilirubin,” Monique Barakat, MD, a gastroenterologist at Stanford (Calif.) University, reported at the annual Digestive Disease Week. “Known opiate users with normal LFTs [liver function tests] may not require expensive and potentially risky endoscopic evaluation for biliary dilation.”

Dr. Barakat and senior author Subhas Banerjee, MD, professor of gastroenterology and hepatology at Stanford, decided to examine a possible association between biliary duct dilation and opioid use based on previous small clinical studies that found a possible association. Along with opioid status, Dr. Barakat and her coauthor also looked at patient age, cholecystectomy status, ethnicity, weight, and height for possible associations with bile duct diameter.

The researchers took a random 20% sample of adults seen for all causes in the ED at Stanford over a 5-year period. Using a health informatic platform based on the electronic medical record, they identified all patients who had received an abdominal CT or MRI. Patients were included in the study if they had a documented measurement for the diameter of the common bile duct, with no evidence of obstructive lesion and a normal bilirubin level.

Compared with 818 patients who did not use opioids, the 867 patients who used opioids had a significantly larger common bile duct diameter. Using 7 mm as the threshold for biliary duct enlargement, 84% of patients who used opioids had an enlarged common bile duct, compared with 27% of nonopioid users (P less than .001), said Dr. Barakat, recipient of an early investigator award for the study.

“We frequently get referrals for bile duct dilation with concern for more sinister causes of biliary duct dilation – stones, strictures, and malignancy,” said Dr. Barakat. Because of the increase in cross-sectional imaging via CT or MRI, bile duct dilation is being detected at increasingly higher rates.

Dr. Barakat said that about one-third of referrals to the therapeutic endoscopy clinic at Stanford are now for patients with biliary dilation and normal liver function tests. And similar increases are being “seen across all settings – so office, primary care clinic, inpatient, and most markedly, the emergency department. Coupled with this, the population is aging, and patients who present to each of these settings are more likely, if they are older, to undergo cross-sectional imaging.”

Other contributors to higher rates of bile duct dilation include increased rates of obesity and increased prevalence of nonalcoholic steatohepatitis (NASH). About 20% of individuals with NASH will also have abnormal LFTs, she said, and NASH can be the trigger for cross-sectional imaging.

For most of these patients with biliary duct dilation and normal LFTs, no obstructive process was found on endoscopic evaluation.

Although gastroenterology textbooks may say that bile duct diameter increases with age, Dr. Barakat and colleagues didn’t find this to be the case. Among nonopioid users in the study cohort, age did not predict of common bile duct diameter. Among the entire cohort, “Advancing age weakly predicts increased common bile duct diameter,” she said, suggesting that factors other than age along may drive increased bile duct diameter.

Limitations included the retrospective nature of the study, as well as the limitations of information from the electronic medical record. Also, interobserver variability may have come into play, as bile duct diameter measurements were made by multiple radiologists in the course of clinical care.

The study was funded by the National Institutes of Health. Dr. Barakat reported no relevant financial disclosures.

koakes@mdedge.com

SAN DIEGO – Biliary duct dilation in the setting of an intact gallbladder and normal bilirubin levels was more common among those who used opioids, based on the results of a large, retrospective, single-center cohort study.

Patients were included in the study if they had a documented measurement for the diameter of the common bile duct, with no evidence of an obstructive lesion and a normal bilirubin level. The mean common bile duct diameter was significantly higher at 8.67 mm for 867 patients who used opioids, compared with 7.24 mm for 818 similar patients who did not use opioids (P less than .001). The association was strongest among opioid users with an intact gallbladder.

“Opiate use is associated with biliary dilation in the setting of normal bilirubin,” Monique Barakat, MD, a gastroenterologist at Stanford (Calif.) University, reported at the annual Digestive Disease Week. “Known opiate users with normal LFTs [liver function tests] may not require expensive and potentially risky endoscopic evaluation for biliary dilation.”

Dr. Barakat and senior author Subhas Banerjee, MD, professor of gastroenterology and hepatology at Stanford, decided to examine a possible association between biliary duct dilation and opioid use based on previous small clinical studies that found a possible association. Along with opioid status, Dr. Barakat and her coauthor also looked at patient age, cholecystectomy status, ethnicity, weight, and height for possible associations with bile duct diameter.

The researchers took a random 20% sample of adults seen for all causes in the ED at Stanford over a 5-year period. Using a health informatic platform based on the electronic medical record, they identified all patients who had received an abdominal CT or MRI. Patients were included in the study if they had a documented measurement for the diameter of the common bile duct, with no evidence of obstructive lesion and a normal bilirubin level.

Compared with 818 patients who did not use opioids, the 867 patients who used opioids had a significantly larger common bile duct diameter. Using 7 mm as the threshold for biliary duct enlargement, 84% of patients who used opioids had an enlarged common bile duct, compared with 27% of nonopioid users (P less than .001), said Dr. Barakat, recipient of an early investigator award for the study.

“We frequently get referrals for bile duct dilation with concern for more sinister causes of biliary duct dilation – stones, strictures, and malignancy,” said Dr. Barakat. Because of the increase in cross-sectional imaging via CT or MRI, bile duct dilation is being detected at increasingly higher rates.

Dr. Barakat said that about one-third of referrals to the therapeutic endoscopy clinic at Stanford are now for patients with biliary dilation and normal liver function tests. And similar increases are being “seen across all settings – so office, primary care clinic, inpatient, and most markedly, the emergency department. Coupled with this, the population is aging, and patients who present to each of these settings are more likely, if they are older, to undergo cross-sectional imaging.”

Other contributors to higher rates of bile duct dilation include increased rates of obesity and increased prevalence of nonalcoholic steatohepatitis (NASH). About 20% of individuals with NASH will also have abnormal LFTs, she said, and NASH can be the trigger for cross-sectional imaging.

For most of these patients with biliary duct dilation and normal LFTs, no obstructive process was found on endoscopic evaluation.

Although gastroenterology textbooks may say that bile duct diameter increases with age, Dr. Barakat and colleagues didn’t find this to be the case. Among nonopioid users in the study cohort, age did not predict of common bile duct diameter. Among the entire cohort, “Advancing age weakly predicts increased common bile duct diameter,” she said, suggesting that factors other than age along may drive increased bile duct diameter.

Limitations included the retrospective nature of the study, as well as the limitations of information from the electronic medical record. Also, interobserver variability may have come into play, as bile duct diameter measurements were made by multiple radiologists in the course of clinical care.

The study was funded by the National Institutes of Health. Dr. Barakat reported no relevant financial disclosures.

koakes@mdedge.com

SAN DIEGO – Rapid proton pump inhibitor (PPI) metabolism was present in nearly one-third of patients who underwent bariatric surgery, results from a small, single-center study showed. Patients who were fast metabolizers also exhibited a higher, although not significant, incidence of early marginal ulceration following Roux-en-Y gastric bypass.

“Roux-en-Y gastric bypass [RYGB] is one of the most effective surgical approaches to mitigating obesity and its attendant comorbidities including diabetes, hypertension, hyperlipidemia, reflux, and sleep apnea,” lead study author Sabrena F. Noria, MD, PhD, said in an interview at the annual Digestive Disease Week. “However, as with all surgeries, there are associated risks, the more common of which is marginal ulceration, or ulcer formation at the gastrojejunostomy, which occurs at a rate of 1%-16%.”

Dr. Noria, surgical research director of the comprehensive weight management, metabolic/bariatric surgery program at the Ohio State University’s Wexner Medical Center, noted that marginal ulcers (MUs) are divided into early (within 90 days) and late (more than 90 days), based on their time of onset after surgery, and are usually diagnosed during upper endoscopy on postoperative patients who complain of epigastric pain, dysphagia, nausea/vomiting, and/or dehydration.

“Given that MUs are associated with multiple hospital readmissions for pain and dehydration, multiple diagnostic and therapeutic endoscopic procedures, and escalation in both antiulcer and analgesic medication, their clinical impact cannot be overstated, especially since RYGB is the second most commonly performed bariatric procedure in the U.S.,” she said. “Given that the majority of marginal ulcers occur early after surgery, bariatric surgery programs have adopted the prophylactic use of proton pump inhibitors for up to 90 days postoperatively. While studies have demonstrated up to a two-fold decrease in ulcer formation, sample heterogeneity, in terms of combining both early and late ulcers, make it difficult to determine the effect on early ulcer formation.”

In an effort to compare preoperative endoscopic findings and MU formation in patients with and without altered PPI metabolism, the researchers prospectively enrolled 94 bariatric patients to undergo genetic testing pertinent to drug metabolism for a comprehensive panel of medications using a commercially available pharmacogenetic testing kit for the activity of cytochrome P450 in drug metabolism. They grouped patients by whether they were fast or normal metabolizers, and compared preoperative endoscopic findings for patients on PPIs at baseline and rates of early (within 90 days) and late ulceration (between 90 and 180 days).

Dr. Noria reported that 28 patients (30%) in the entire cohort met criteria for being fast metabolizers. The researchers observed no differences in baseline body mass index, age, gender, or former smoking status between both groups. Among those treated with a PPI at baseline, fast metabolizers demonstrated a trend toward a higher incidence of gastritis on preoperative endoscopy, compared with controls (89% vs. 65%, respectively; P = .12), while detection of Helicobacter pylori and Barrett’s esophagus were nonsignificant between groups. Eight patients (17%) who underwent RYGB developed marginal ulcers within 6 months of the index operation, of which four (50%) were diagnosed within 90 days and categorized as early ulcers. Development of early ulceration was higher among fast metabolizers, compared with controls (13% vs. 6%), but this did not reach statistical significance (P = .60). All late ulcerations occurred within the control group.

“While none of our findings are statistically significant given the small sample size, there were two findings I found clinically compelling,” Dr. Noria said. “First, in the group of patients who were on PPIs preoperatively, we found a 24% increase in the presence of pathologically diagnosed gastritis in the rapid-metabolizer group, during screening endoscopy. This suggests that either these patients were undertreated or were not treated with the appropriate medication. The second interesting finding was an over doubling of early ulcer formation in the RYGB group who were rapid metabolizers. However, again I would caution against drawing any real conclusions as our sample size was not powered to detect any difference.”

She also acknowledged that the study was limited by the inability to determine the effect of confounders such as surgical approach and the lack of randomization.

Anahita D. Jalilvand, MD, a general surgery resident, postdoctoral research fellow, and PhD candidate, was instrumental to this study, Dr. Noria said.

The trial was sponsored by Pathnostics, a pharmacogenetic testing company, who covered the cost of the tests. The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SAN DIEGO – Rapid proton pump inhibitor (PPI) metabolism was present in nearly one-third of patients who underwent bariatric surgery, results from a small, single-center study showed. Patients who were fast metabolizers also exhibited a higher, although not significant, incidence of early marginal ulceration following Roux-en-Y gastric bypass.

“Roux-en-Y gastric bypass [RYGB] is one of the most effective surgical approaches to mitigating obesity and its attendant comorbidities including diabetes, hypertension, hyperlipidemia, reflux, and sleep apnea,” lead study author Sabrena F. Noria, MD, PhD, said in an interview at the annual Digestive Disease Week. “However, as with all surgeries, there are associated risks, the more common of which is marginal ulceration, or ulcer formation at the gastrojejunostomy, which occurs at a rate of 1%-16%.”

Dr. Noria, surgical research director of the comprehensive weight management, metabolic/bariatric surgery program at the Ohio State University’s Wexner Medical Center, noted that marginal ulcers (MUs) are divided into early (within 90 days) and late (more than 90 days), based on their time of onset after surgery, and are usually diagnosed during upper endoscopy on postoperative patients who complain of epigastric pain, dysphagia, nausea/vomiting, and/or dehydration.

“Given that MUs are associated with multiple hospital readmissions for pain and dehydration, multiple diagnostic and therapeutic endoscopic procedures, and escalation in both antiulcer and analgesic medication, their clinical impact cannot be overstated, especially since RYGB is the second most commonly performed bariatric procedure in the U.S.,” she said. “Given that the majority of marginal ulcers occur early after surgery, bariatric surgery programs have adopted the prophylactic use of proton pump inhibitors for up to 90 days postoperatively. While studies have demonstrated up to a two-fold decrease in ulcer formation, sample heterogeneity, in terms of combining both early and late ulcers, make it difficult to determine the effect on early ulcer formation.”

In an effort to compare preoperative endoscopic findings and MU formation in patients with and without altered PPI metabolism, the researchers prospectively enrolled 94 bariatric patients to undergo genetic testing pertinent to drug metabolism for a comprehensive panel of medications using a commercially available pharmacogenetic testing kit for the activity of cytochrome P450 in drug metabolism. They grouped patients by whether they were fast or normal metabolizers, and compared preoperative endoscopic findings for patients on PPIs at baseline and rates of early (within 90 days) and late ulceration (between 90 and 180 days).

Dr. Noria reported that 28 patients (30%) in the entire cohort met criteria for being fast metabolizers. The researchers observed no differences in baseline body mass index, age, gender, or former smoking status between both groups. Among those treated with a PPI at baseline, fast metabolizers demonstrated a trend toward a higher incidence of gastritis on preoperative endoscopy, compared with controls (89% vs. 65%, respectively; P = .12), while detection of Helicobacter pylori and Barrett’s esophagus were nonsignificant between groups. Eight patients (17%) who underwent RYGB developed marginal ulcers within 6 months of the index operation, of which four (50%) were diagnosed within 90 days and categorized as early ulcers. Development of early ulceration was higher among fast metabolizers, compared with controls (13% vs. 6%), but this did not reach statistical significance (P = .60). All late ulcerations occurred within the control group.

“While none of our findings are statistically significant given the small sample size, there were two findings I found clinically compelling,” Dr. Noria said. “First, in the group of patients who were on PPIs preoperatively, we found a 24% increase in the presence of pathologically diagnosed gastritis in the rapid-metabolizer group, during screening endoscopy. This suggests that either these patients were undertreated or were not treated with the appropriate medication. The second interesting finding was an over doubling of early ulcer formation in the RYGB group who were rapid metabolizers. However, again I would caution against drawing any real conclusions as our sample size was not powered to detect any difference.”

She also acknowledged that the study was limited by the inability to determine the effect of confounders such as surgical approach and the lack of randomization.

Anahita D. Jalilvand, MD, a general surgery resident, postdoctoral research fellow, and PhD candidate, was instrumental to this study, Dr. Noria said.

The trial was sponsored by Pathnostics, a pharmacogenetic testing company, who covered the cost of the tests. The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SAN DIEGO – Rapid proton pump inhibitor (PPI) metabolism was present in nearly one-third of patients who underwent bariatric surgery, results from a small, single-center study showed. Patients who were fast metabolizers also exhibited a higher, although not significant, incidence of early marginal ulceration following Roux-en-Y gastric bypass.

“Roux-en-Y gastric bypass [RYGB] is one of the most effective surgical approaches to mitigating obesity and its attendant comorbidities including diabetes, hypertension, hyperlipidemia, reflux, and sleep apnea,” lead study author Sabrena F. Noria, MD, PhD, said in an interview at the annual Digestive Disease Week. “However, as with all surgeries, there are associated risks, the more common of which is marginal ulceration, or ulcer formation at the gastrojejunostomy, which occurs at a rate of 1%-16%.”

Dr. Noria, surgical research director of the comprehensive weight management, metabolic/bariatric surgery program at the Ohio State University’s Wexner Medical Center, noted that marginal ulcers (MUs) are divided into early (within 90 days) and late (more than 90 days), based on their time of onset after surgery, and are usually diagnosed during upper endoscopy on postoperative patients who complain of epigastric pain, dysphagia, nausea/vomiting, and/or dehydration.

“Given that MUs are associated with multiple hospital readmissions for pain and dehydration, multiple diagnostic and therapeutic endoscopic procedures, and escalation in both antiulcer and analgesic medication, their clinical impact cannot be overstated, especially since RYGB is the second most commonly performed bariatric procedure in the U.S.,” she said. “Given that the majority of marginal ulcers occur early after surgery, bariatric surgery programs have adopted the prophylactic use of proton pump inhibitors for up to 90 days postoperatively. While studies have demonstrated up to a two-fold decrease in ulcer formation, sample heterogeneity, in terms of combining both early and late ulcers, make it difficult to determine the effect on early ulcer formation.”

In an effort to compare preoperative endoscopic findings and MU formation in patients with and without altered PPI metabolism, the researchers prospectively enrolled 94 bariatric patients to undergo genetic testing pertinent to drug metabolism for a comprehensive panel of medications using a commercially available pharmacogenetic testing kit for the activity of cytochrome P450 in drug metabolism. They grouped patients by whether they were fast or normal metabolizers, and compared preoperative endoscopic findings for patients on PPIs at baseline and rates of early (within 90 days) and late ulceration (between 90 and 180 days).

Dr. Noria reported that 28 patients (30%) in the entire cohort met criteria for being fast metabolizers. The researchers observed no differences in baseline body mass index, age, gender, or former smoking status between both groups. Among those treated with a PPI at baseline, fast metabolizers demonstrated a trend toward a higher incidence of gastritis on preoperative endoscopy, compared with controls (89% vs. 65%, respectively; P = .12), while detection of Helicobacter pylori and Barrett’s esophagus were nonsignificant between groups. Eight patients (17%) who underwent RYGB developed marginal ulcers within 6 months of the index operation, of which four (50%) were diagnosed within 90 days and categorized as early ulcers. Development of early ulceration was higher among fast metabolizers, compared with controls (13% vs. 6%), but this did not reach statistical significance (P = .60). All late ulcerations occurred within the control group.

“While none of our findings are statistically significant given the small sample size, there were two findings I found clinically compelling,” Dr. Noria said. “First, in the group of patients who were on PPIs preoperatively, we found a 24% increase in the presence of pathologically diagnosed gastritis in the rapid-metabolizer group, during screening endoscopy. This suggests that either these patients were undertreated or were not treated with the appropriate medication. The second interesting finding was an over doubling of early ulcer formation in the RYGB group who were rapid metabolizers. However, again I would caution against drawing any real conclusions as our sample size was not powered to detect any difference.”

She also acknowledged that the study was limited by the inability to determine the effect of confounders such as surgical approach and the lack of randomization.

Anahita D. Jalilvand, MD, a general surgery resident, postdoctoral research fellow, and PhD candidate, was instrumental to this study, Dr. Noria said.

The trial was sponsored by Pathnostics, a pharmacogenetic testing company, who covered the cost of the tests. The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SAN FRANCISCO – Patients taking antidepressants for anxiety disorders face a therapeutic dilemma when their anxiety goes into remission. Relapse is more likely in the absence of medication and, if they resume their antidepressant after relapse, some patients experience adverse events or drug resistance.

Jim Kling/MDedge News

“It’s important that we realize that anxiety disorders can be treated effectively in the short term, but it’s very difficult to treat them for the long term. We know that within a year, it’s better to continue the medication. There’s a lack of data to give evidence-based advice after 1 year,” Neeltje Batelaan, MD, PhD, a psychiatrist and senior researcher at VU University Medical Center, Amsterdam, said in an interview.

Dr. Batelaan moderated a session at the annual meeting of the American Psychiatric Association on discontinuation of antidepressant medications in these patients.

Anxiety disorders can often be successfully treated with antidepressants, but their adverse effects can become less tolerable over time, especially after patients go into remission. When patients begin treatment, they are willing to endure side effects in the service of resolving their symptoms. But when they go into remission, “they want to get on with their lives, so their sexual side effects or their weight gain rates a lot worse,” Dr. Batelaan said.

A meta-analysis of 28 studies, with follow-up periods ranging from 8 to 52 weeks, found that the anxiety relapse risk after discontinuation of antidepressants was 36.4%, compared with 16.4% in those who stayed on medication. Even continuing antidepressants isn’t completely protective, she noted. The study found a number needed to treat of five to prevent one relapse.

Researchers at the VU University Medical Center developed a cognitive-behavioral therapy (CBT) regimen aimed at reducing anxiety relapses. In their study, 87 patients with a remitted anxiety disorder who wanted to stop their antidepressants were randomized to do so either with or without CBT intervention.

Unfortunately, the study had to be stopped when an interim analysis showed a lack of efficacy. In fact, patients who received CBT actually had higher relapse rates. Surprisingly, just 37% of patients succeeded in completely discontinuing medication, which hints at the inherent challenges of the transition.

“Unfortunately, building a CBT relapse prevention did not come true, but we learned some valuable lessons that will guide further studies,” Willemijn Scholten, PhD, a postdoc researcher at VU University Medical Center, said during one of the presentations.

In his presentation, Anton (Ton) Van Balkom, MD, PhD, professor of psychiatry at VU University Medical Center, recounted the case of a woman who had been functioning well with an antidepressant but grew tired of the sexual side effects. She carefully discontinued her medication under his guidance, but in 2 months she experienced her first panic attack in 30 years. Reintroducing the medication failed to resolve the issue, and it took years of effort before cognitive behavioral therapy resulted in a remission.

Further, a meta-analysis of nine studies showed that 17% of patients with remitted anxiety who went off and then restarted their antidepressants experienced tachycardia.

To help reduce tachycardia, Dr. Van Balkom suggested alternative options to antidepressants in less-complicated patients with anxiety, and to anticipate long-term use of antidepressants once those medications are employed.

Dr. Batelaan agreed with that assessment, drawing an analogy with type 2 diabetes. “You first start with a diet, and advise the patient to lose weight, and then if that’s not successful you go to [medication] and you realize it’s lifelong. Maybe we have to differentiate antidepressant therapies and [not start them until necessary]. But if you have to start them, realize that there’s a difficult decision waiting ahead.”

SAN FRANCISCO – Patients taking antidepressants for anxiety disorders face a therapeutic dilemma when their anxiety goes into remission. Relapse is more likely in the absence of medication and, if they resume their antidepressant after relapse, some patients experience adverse events or drug resistance.

Jim Kling/MDedge News

“It’s important that we realize that anxiety disorders can be treated effectively in the short term, but it’s very difficult to treat them for the long term. We know that within a year, it’s better to continue the medication. There’s a lack of data to give evidence-based advice after 1 year,” Neeltje Batelaan, MD, PhD, a psychiatrist and senior researcher at VU University Medical Center, Amsterdam, said in an interview.

Dr. Batelaan moderated a session at the annual meeting of the American Psychiatric Association on discontinuation of antidepressant medications in these patients.

Anxiety disorders can often be successfully treated with antidepressants, but their adverse effects can become less tolerable over time, especially after patients go into remission. When patients begin treatment, they are willing to endure side effects in the service of resolving their symptoms. But when they go into remission, “they want to get on with their lives, so their sexual side effects or their weight gain rates a lot worse,” Dr. Batelaan said.

A meta-analysis of 28 studies, with follow-up periods ranging from 8 to 52 weeks, found that the anxiety relapse risk after discontinuation of antidepressants was 36.4%, compared with 16.4% in those who stayed on medication. Even continuing antidepressants isn’t completely protective, she noted. The study found a number needed to treat of five to prevent one relapse.

Researchers at the VU University Medical Center developed a cognitive-behavioral therapy (CBT) regimen aimed at reducing anxiety relapses. In their study, 87 patients with a remitted anxiety disorder who wanted to stop their antidepressants were randomized to do so either with or without CBT intervention.

Unfortunately, the study had to be stopped when an interim analysis showed a lack of efficacy. In fact, patients who received CBT actually had higher relapse rates. Surprisingly, just 37% of patients succeeded in completely discontinuing medication, which hints at the inherent challenges of the transition.

“Unfortunately, building a CBT relapse prevention did not come true, but we learned some valuable lessons that will guide further studies,” Willemijn Scholten, PhD, a postdoc researcher at VU University Medical Center, said during one of the presentations.

In his presentation, Anton (Ton) Van Balkom, MD, PhD, professor of psychiatry at VU University Medical Center, recounted the case of a woman who had been functioning well with an antidepressant but grew tired of the sexual side effects. She carefully discontinued her medication under his guidance, but in 2 months she experienced her first panic attack in 30 years. Reintroducing the medication failed to resolve the issue, and it took years of effort before cognitive behavioral therapy resulted in a remission.

Further, a meta-analysis of nine studies showed that 17% of patients with remitted anxiety who went off and then restarted their antidepressants experienced tachycardia.

To help reduce tachycardia, Dr. Van Balkom suggested alternative options to antidepressants in less-complicated patients with anxiety, and to anticipate long-term use of antidepressants once those medications are employed.

Dr. Batelaan agreed with that assessment, drawing an analogy with type 2 diabetes. “You first start with a diet, and advise the patient to lose weight, and then if that’s not successful you go to [medication] and you realize it’s lifelong. Maybe we have to differentiate antidepressant therapies and [not start them until necessary]. But if you have to start them, realize that there’s a difficult decision waiting ahead.”

SAN FRANCISCO – Patients taking antidepressants for anxiety disorders face a therapeutic dilemma when their anxiety goes into remission. Relapse is more likely in the absence of medication and, if they resume their antidepressant after relapse, some patients experience adverse events or drug resistance.

Jim Kling/MDedge News

“It’s important that we realize that anxiety disorders can be treated effectively in the short term, but it’s very difficult to treat them for the long term. We know that within a year, it’s better to continue the medication. There’s a lack of data to give evidence-based advice after 1 year,” Neeltje Batelaan, MD, PhD, a psychiatrist and senior researcher at VU University Medical Center, Amsterdam, said in an interview.

Dr. Batelaan moderated a session at the annual meeting of the American Psychiatric Association on discontinuation of antidepressant medications in these patients.

Anxiety disorders can often be successfully treated with antidepressants, but their adverse effects can become less tolerable over time, especially after patients go into remission. When patients begin treatment, they are willing to endure side effects in the service of resolving their symptoms. But when they go into remission, “they want to get on with their lives, so their sexual side effects or their weight gain rates a lot worse,” Dr. Batelaan said.

A meta-analysis of 28 studies, with follow-up periods ranging from 8 to 52 weeks, found that the anxiety relapse risk after discontinuation of antidepressants was 36.4%, compared with 16.4% in those who stayed on medication. Even continuing antidepressants isn’t completely protective, she noted. The study found a number needed to treat of five to prevent one relapse.

Researchers at the VU University Medical Center developed a cognitive-behavioral therapy (CBT) regimen aimed at reducing anxiety relapses. In their study, 87 patients with a remitted anxiety disorder who wanted to stop their antidepressants were randomized to do so either with or without CBT intervention.

Unfortunately, the study had to be stopped when an interim analysis showed a lack of efficacy. In fact, patients who received CBT actually had higher relapse rates. Surprisingly, just 37% of patients succeeded in completely discontinuing medication, which hints at the inherent challenges of the transition.

“Unfortunately, building a CBT relapse prevention did not come true, but we learned some valuable lessons that will guide further studies,” Willemijn Scholten, PhD, a postdoc researcher at VU University Medical Center, said during one of the presentations.

In his presentation, Anton (Ton) Van Balkom, MD, PhD, professor of psychiatry at VU University Medical Center, recounted the case of a woman who had been functioning well with an antidepressant but grew tired of the sexual side effects. She carefully discontinued her medication under his guidance, but in 2 months she experienced her first panic attack in 30 years. Reintroducing the medication failed to resolve the issue, and it took years of effort before cognitive behavioral therapy resulted in a remission.

Further, a meta-analysis of nine studies showed that 17% of patients with remitted anxiety who went off and then restarted their antidepressants experienced tachycardia.

To help reduce tachycardia, Dr. Van Balkom suggested alternative options to antidepressants in less-complicated patients with anxiety, and to anticipate long-term use of antidepressants once those medications are employed.

Dr. Batelaan agreed with that assessment, drawing an analogy with type 2 diabetes. “You first start with a diet, and advise the patient to lose weight, and then if that’s not successful you go to [medication] and you realize it’s lifelong. Maybe we have to differentiate antidepressant therapies and [not start them until necessary]. But if you have to start them, realize that there’s a difficult decision waiting ahead.”

BIRMINGHAM, ENGLAND – Being diagnosed with rheumatoid arthritis at age 75 years or older made it less likely that patients would receive intensive therapy than their younger counterparts, but that did not mean that they were treated any less favorably overall, according to findings derived from the Early RA Network cohort.

“The claim that the elderly are treated less aggressively isn’t completely true throughout the whole treat-to-target strategy,” said Simone Howard of King’s College London at the British Society for Rheumatology annual conference. While older patients were less likely to receive intensive treatment up to 2 years after their diagnosis, there was a shorter delay between the onset of symptoms and the first outpatient visit to a rheumatology clinic.

When compared against patients who were younger than 65 years, those aged 65-74 years and 75 years and older were 11% (P = .02) and 15% (P = .02) more likely to have their first outpatient visit within 10 months.

Furthermore, no significant differences were seen between any age groups in the time to first initiation of a conventional synthetic disease-modifying antirheumatic drug (csDMARD), which averaged nearly 3 months after symptoms appeared.

Ms. Howard, who has previously worked at the European Medicines Agency, noted that, during her time at the EMA, “there was a real push to incorporate the elderly into the regulatory framework more. In parallel, there were also reports of the elderly being treated less aggressively. So the question was, where was that coming from?”

Similar therapeutic approaches are advocated for older and younger RA patients, and to look for any disparities, Ms. Howard and associates turned to the Early RA Network (ERAN) to “investigate potential treatment bias against the elderly.”

ERAN is a hospital-based inception cohort of 1,236 patients with early RA who were recruited across 23 centers in the United Kingdom and Ireland between 2002 and 2014.

Of 1,131 patients used in the analyses, 9.7% (n = 110) were 75 years or older, 21.5% (n = 243) were aged 65-74 years, and 68.8% (n = 778) were 65 years or younger. The majority (67.7%) of patients were female.

Patients aged 75 years and older were more likely to present with comorbidities than the youngest group, and they had higher health assessment questionnaire scores at baseline. However, they were no more likely to have high disease activity at the first visit, which was defined as a disease activity score in 28 joints of more than 5, and the older patients were 27% less likely to be seropositive (P = .004).

“It’s when we come to pharmacological aspects of care that we are seeing treatment biases,” Ms. Howard noted. Patients over 75 years were significantly more likely than the youngest age group to be treated with glucocorticoids or csDMARD monotherapy at 1 year, and 23% more likely to be on less aggressive therapy (P equal to or less than .0001). Aggressive therapy was defined as the use of a combination of csDMARDs or the use of biologic drugs.

At 2 years, the oldest patients were 46% more likely than those under 65 years to be on less-intensive therapies (P equal to or less than .0001), with those aged 65-74 years 19% more likely to be on glucocorticoid or csDMARD therapy (P = .005).

Factors such as patient choice and tolerance were not considered in the analyses and could be important, Ms. Howard conceded in response to a question after her presentation.

Another point raised was that perhaps the prescribing of aggressive therapy would rationally be different in someone diagnosed with RA at age 85 versus 65 because the duration of time that would be likely to be lived with accumulating joint damage would be shorter at the older age and that would be balanced against the other effects of the therapy. So, there may be important reasons in shared decision making that influenced the treatment choices other than the age of patients.

Ms. Howard agreed, noting that this demonstrated the need to be careful around the language used for defining what constituted aggressive or intensive therapy.

She and her coauthors reported no conflicts of interest.

SOURCE: Howard S et al. Rheumatology. 2019;58(suppl 3), Abstract 011.

BIRMINGHAM, ENGLAND – Being diagnosed with rheumatoid arthritis at age 75 years or older made it less likely that patients would receive intensive therapy than their younger counterparts, but that did not mean that they were treated any less favorably overall, according to findings derived from the Early RA Network cohort.

“The claim that the elderly are treated less aggressively isn’t completely true throughout the whole treat-to-target strategy,” said Simone Howard of King’s College London at the British Society for Rheumatology annual conference. While older patients were less likely to receive intensive treatment up to 2 years after their diagnosis, there was a shorter delay between the onset of symptoms and the first outpatient visit to a rheumatology clinic.

When compared against patients who were younger than 65 years, those aged 65-74 years and 75 years and older were 11% (P = .02) and 15% (P = .02) more likely to have their first outpatient visit within 10 months.

Furthermore, no significant differences were seen between any age groups in the time to first initiation of a conventional synthetic disease-modifying antirheumatic drug (csDMARD), which averaged nearly 3 months after symptoms appeared.

Ms. Howard, who has previously worked at the European Medicines Agency, noted that, during her time at the EMA, “there was a real push to incorporate the elderly into the regulatory framework more. In parallel, there were also reports of the elderly being treated less aggressively. So the question was, where was that coming from?”

Similar therapeutic approaches are advocated for older and younger RA patients, and to look for any disparities, Ms. Howard and associates turned to the Early RA Network (ERAN) to “investigate potential treatment bias against the elderly.”

ERAN is a hospital-based inception cohort of 1,236 patients with early RA who were recruited across 23 centers in the United Kingdom and Ireland between 2002 and 2014.

Of 1,131 patients used in the analyses, 9.7% (n = 110) were 75 years or older, 21.5% (n = 243) were aged 65-74 years, and 68.8% (n = 778) were 65 years or younger. The majority (67.7%) of patients were female.

Patients aged 75 years and older were more likely to present with comorbidities than the youngest group, and they had higher health assessment questionnaire scores at baseline. However, they were no more likely to have high disease activity at the first visit, which was defined as a disease activity score in 28 joints of more than 5, and the older patients were 27% less likely to be seropositive (P = .004).

“It’s when we come to pharmacological aspects of care that we are seeing treatment biases,” Ms. Howard noted. Patients over 75 years were significantly more likely than the youngest age group to be treated with glucocorticoids or csDMARD monotherapy at 1 year, and 23% more likely to be on less aggressive therapy (P equal to or less than .0001). Aggressive therapy was defined as the use of a combination of csDMARDs or the use of biologic drugs.

At 2 years, the oldest patients were 46% more likely than those under 65 years to be on less-intensive therapies (P equal to or less than .0001), with those aged 65-74 years 19% more likely to be on glucocorticoid or csDMARD therapy (P = .005).

Factors such as patient choice and tolerance were not considered in the analyses and could be important, Ms. Howard conceded in response to a question after her presentation.

Another point raised was that perhaps the prescribing of aggressive therapy would rationally be different in someone diagnosed with RA at age 85 versus 65 because the duration of time that would be likely to be lived with accumulating joint damage would be shorter at the older age and that would be balanced against the other effects of the therapy. So, there may be important reasons in shared decision making that influenced the treatment choices other than the age of patients.

Ms. Howard agreed, noting that this demonstrated the need to be careful around the language used for defining what constituted aggressive or intensive therapy.

She and her coauthors reported no conflicts of interest.

SOURCE: Howard S et al. Rheumatology. 2019;58(suppl 3), Abstract 011.

BIRMINGHAM, ENGLAND – Being diagnosed with rheumatoid arthritis at age 75 years or older made it less likely that patients would receive intensive therapy than their younger counterparts, but that did not mean that they were treated any less favorably overall, according to findings derived from the Early RA Network cohort.

“The claim that the elderly are treated less aggressively isn’t completely true throughout the whole treat-to-target strategy,” said Simone Howard of King’s College London at the British Society for Rheumatology annual conference. While older patients were less likely to receive intensive treatment up to 2 years after their diagnosis, there was a shorter delay between the onset of symptoms and the first outpatient visit to a rheumatology clinic.

When compared against patients who were younger than 65 years, those aged 65-74 years and 75 years and older were 11% (P = .02) and 15% (P = .02) more likely to have their first outpatient visit within 10 months.

Furthermore, no significant differences were seen between any age groups in the time to first initiation of a conventional synthetic disease-modifying antirheumatic drug (csDMARD), which averaged nearly 3 months after symptoms appeared.

Ms. Howard, who has previously worked at the European Medicines Agency, noted that, during her time at the EMA, “there was a real push to incorporate the elderly into the regulatory framework more. In parallel, there were also reports of the elderly being treated less aggressively. So the question was, where was that coming from?”

Similar therapeutic approaches are advocated for older and younger RA patients, and to look for any disparities, Ms. Howard and associates turned to the Early RA Network (ERAN) to “investigate potential treatment bias against the elderly.”

ERAN is a hospital-based inception cohort of 1,236 patients with early RA who were recruited across 23 centers in the United Kingdom and Ireland between 2002 and 2014.

Of 1,131 patients used in the analyses, 9.7% (n = 110) were 75 years or older, 21.5% (n = 243) were aged 65-74 years, and 68.8% (n = 778) were 65 years or younger. The majority (67.7%) of patients were female.

Patients aged 75 years and older were more likely to present with comorbidities than the youngest group, and they had higher health assessment questionnaire scores at baseline. However, they were no more likely to have high disease activity at the first visit, which was defined as a disease activity score in 28 joints of more than 5, and the older patients were 27% less likely to be seropositive (P = .004).

“It’s when we come to pharmacological aspects of care that we are seeing treatment biases,” Ms. Howard noted. Patients over 75 years were significantly more likely than the youngest age group to be treated with glucocorticoids or csDMARD monotherapy at 1 year, and 23% more likely to be on less aggressive therapy (P equal to or less than .0001). Aggressive therapy was defined as the use of a combination of csDMARDs or the use of biologic drugs.

At 2 years, the oldest patients were 46% more likely than those under 65 years to be on less-intensive therapies (P equal to or less than .0001), with those aged 65-74 years 19% more likely to be on glucocorticoid or csDMARD therapy (P = .005).

Factors such as patient choice and tolerance were not considered in the analyses and could be important, Ms. Howard conceded in response to a question after her presentation.

Another point raised was that perhaps the prescribing of aggressive therapy would rationally be different in someone diagnosed with RA at age 85 versus 65 because the duration of time that would be likely to be lived with accumulating joint damage would be shorter at the older age and that would be balanced against the other effects of the therapy. So, there may be important reasons in shared decision making that influenced the treatment choices other than the age of patients.

Ms. Howard agreed, noting that this demonstrated the need to be careful around the language used for defining what constituted aggressive or intensive therapy.

She and her coauthors reported no conflicts of interest.

SOURCE: Howard S et al. Rheumatology. 2019;58(suppl 3), Abstract 011.

Patients with mild asthma who rely solely on short-acting beta2-agonists (SABAs) to control their asthma symptoms remain at increased risk of exacerbations, according to investigators.

Two recent studies presented at the American Thoracic Society’s international conference demonstrated the benefits of glucocorticoid therapy among patients with mild persistent or intermittent asthma while highlighting differential responses to steroids among patients with high versus low levels of eosinophils in sputum. Both studies were simultaneously published in the New England Journal of Medicine.

The first study, SIENA, led by Stephen C. Lazarus, MD of the University of California, San Francisco, and colleagues, involved 295 patients with mild, persistent asthma. Patients were classified as having either a high or low level of eosinophils in sputum, with a low level defined by two sputum samples consisting of less than 2% eosinophils. After a single-blind placebo run-in period of 6 weeks, patients were randomized to receive either mometasone (an inhaled glucocorticoid), tiotropium (a long-acting muscarinic antagonist [LAMA]), or placebo for 12 weeks each, with subsequent crossover through the two remaining treatments. The primary outcome was the response to each active agent, compared with placebo among low-eosinophil patients who had a differential response to a trial agent.

Out of 295 patients, 221 (75%) had low eosinophils and 74 (25%) had high eosinophils. In the low-eosinophil subgroup, 59% of patients had a differential response to a trial agent; among these, 57% responded better to mometasone, compared with 43% who responded better to placebo, and 60% responded better to tiotropium, compared with 40% who responded better to placebo.

Turning to secondary analyses, among patients with high eosinophil levels who had a differential response, 74% responded better to mometasone, compared with 26% who responded better to placebo, and 57% responded better to tiotropium, compared with 43% who responded better to placebo.

In an additional exploratory analysis, adults with low eosinophil levels had better responses to tiotropium than placebo (62% vs 38%).

The researchers stated that a key finding of the study is that three-quarters of the mild, persistent asthma population had low eosinophil levels, far fewer than expected and that the difference in their response to mometasone compared to tiotropium was not significant.

“Our results raise the question of whether treatment guidelines should be reevaluated for patients with mild, persistent asthma for whom evidence of type 2 inflammation is lacking,” the investigators wrote. “The need for a change in treatment strategy is further highlighted by a growing body of literature suggesting that mild, persistent asthma can be managed safely without the daily use of inhaled glucocorticoids and by data showing that patients with a low eosinophil level may not have a favorable response to inhaled glucocorticoids” (New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1814917).

The second study, Novel START, conducted by lead author Richard Beasley, DSc, of the Medical Research Institute of New Zealand, Wellington, and colleagues, compared the efficacy of two inhaled glucocorticoid regimens and albuterol alone for patients with mild persistent or intermittent asthma, measured by annualized exacerbation rate.

Initial randomization involved 675 patients, of whom 668 were included in the final analysis. Patients were randomized into three groups: albuterol as needed (100 mcg, two inhalations as needed for asthma symptoms), budesonide maintenance (200 mcg, one inhalation twice daily with as-needed albuterol), or budesonide/formoterol (budesonide 200 mcg and formoterol 6 mcg, one inhalation as needed). Along with annualized exacerbation rate, several secondary outcomes assessed symptoms, respiratory function, and number of severe exacerbations.

Data analysis showed that patients in the budesonide groups had similar rates of annualized exacerbation, both of which were significantly better than the exacerbation rate in the albuterol-only group; the absolute rate of exacerbations per patient per year was 0.175, 0.195, and 0.400 for budesonide maintenance, budesonide/formoterol, and albuterol only, respectively. Similarly, the median fraction of exhaled nitric oxide (FENO) was lower in the budesonide groups than in the albuterol-only group. Patients in the budesonide/formoterol group had a 56% lower relative risk of severe pulmonary exacerbation than patients in the budesonide maintenance group and a 60% lower relative risk than the albuterol group. However, maintenance budesonide provided better symptom relief than budesonide/formoterol, “which suggests that for the patient for whom asthma symptoms rather than exacerbations are the most bothersome, maintenance treatment has value,” the investigators wrote (New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1901963).

“The findings of our trial are consistent with evidence regarding the treatment of moderate and severe asthma – that maintenance and reliever therapy” with inhaled glucocorticoid/formoterol “results in a lower risk of severe exacerbations than maintenance therapy with an inhaled glucocorticoid–[long-acting beta agonist] and as-needed SABA,” the investigators concluded.

SIENA was funded by National Heart, Lung, and Blood Institute, with medications provided by Boehringer Ingelheim, Merck, and Teva; the investigators reported relationships with Sanofi, Vectura, Circassia, DBV Technologies, and others. Novel START was funded by AstraZeneca and the Health Research Council of New Zealand; the investigators reported relationships with GlaxoSmithKline, Genentech, Theravance Biopharma, and others.

SOURCES: Beasley et al. New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1901963; Lazarus et al. New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1814917.

Patients with mild asthma who rely solely on short-acting beta2-agonists (SABAs) to control their asthma symptoms remain at increased risk of exacerbations, according to investigators.

Two recent studies presented at the American Thoracic Society’s international conference demonstrated the benefits of glucocorticoid therapy among patients with mild persistent or intermittent asthma while highlighting differential responses to steroids among patients with high versus low levels of eosinophils in sputum. Both studies were simultaneously published in the New England Journal of Medicine.

The first study, SIENA, led by Stephen C. Lazarus, MD of the University of California, San Francisco, and colleagues, involved 295 patients with mild, persistent asthma. Patients were classified as having either a high or low level of eosinophils in sputum, with a low level defined by two sputum samples consisting of less than 2% eosinophils. After a single-blind placebo run-in period of 6 weeks, patients were randomized to receive either mometasone (an inhaled glucocorticoid), tiotropium (a long-acting muscarinic antagonist [LAMA]), or placebo for 12 weeks each, with subsequent crossover through the two remaining treatments. The primary outcome was the response to each active agent, compared with placebo among low-eosinophil patients who had a differential response to a trial agent.

Out of 295 patients, 221 (75%) had low eosinophils and 74 (25%) had high eosinophils. In the low-eosinophil subgroup, 59% of patients had a differential response to a trial agent; among these, 57% responded better to mometasone, compared with 43% who responded better to placebo, and 60% responded better to tiotropium, compared with 40% who responded better to placebo.

Turning to secondary analyses, among patients with high eosinophil levels who had a differential response, 74% responded better to mometasone, compared with 26% who responded better to placebo, and 57% responded better to tiotropium, compared with 43% who responded better to placebo.

In an additional exploratory analysis, adults with low eosinophil levels had better responses to tiotropium than placebo (62% vs 38%).

The researchers stated that a key finding of the study is that three-quarters of the mild, persistent asthma population had low eosinophil levels, far fewer than expected and that the difference in their response to mometasone compared to tiotropium was not significant.

“Our results raise the question of whether treatment guidelines should be reevaluated for patients with mild, persistent asthma for whom evidence of type 2 inflammation is lacking,” the investigators wrote. “The need for a change in treatment strategy is further highlighted by a growing body of literature suggesting that mild, persistent asthma can be managed safely without the daily use of inhaled glucocorticoids and by data showing that patients with a low eosinophil level may not have a favorable response to inhaled glucocorticoids” (New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1814917).

The second study, Novel START, conducted by lead author Richard Beasley, DSc, of the Medical Research Institute of New Zealand, Wellington, and colleagues, compared the efficacy of two inhaled glucocorticoid regimens and albuterol alone for patients with mild persistent or intermittent asthma, measured by annualized exacerbation rate.

Initial randomization involved 675 patients, of whom 668 were included in the final analysis. Patients were randomized into three groups: albuterol as needed (100 mcg, two inhalations as needed for asthma symptoms), budesonide maintenance (200 mcg, one inhalation twice daily with as-needed albuterol), or budesonide/formoterol (budesonide 200 mcg and formoterol 6 mcg, one inhalation as needed). Along with annualized exacerbation rate, several secondary outcomes assessed symptoms, respiratory function, and number of severe exacerbations.

Data analysis showed that patients in the budesonide groups had similar rates of annualized exacerbation, both of which were significantly better than the exacerbation rate in the albuterol-only group; the absolute rate of exacerbations per patient per year was 0.175, 0.195, and 0.400 for budesonide maintenance, budesonide/formoterol, and albuterol only, respectively. Similarly, the median fraction of exhaled nitric oxide (FENO) was lower in the budesonide groups than in the albuterol-only group. Patients in the budesonide/formoterol group had a 56% lower relative risk of severe pulmonary exacerbation than patients in the budesonide maintenance group and a 60% lower relative risk than the albuterol group. However, maintenance budesonide provided better symptom relief than budesonide/formoterol, “which suggests that for the patient for whom asthma symptoms rather than exacerbations are the most bothersome, maintenance treatment has value,” the investigators wrote (New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1901963).

“The findings of our trial are consistent with evidence regarding the treatment of moderate and severe asthma – that maintenance and reliever therapy” with inhaled glucocorticoid/formoterol “results in a lower risk of severe exacerbations than maintenance therapy with an inhaled glucocorticoid–[long-acting beta agonist] and as-needed SABA,” the investigators concluded.

SIENA was funded by National Heart, Lung, and Blood Institute, with medications provided by Boehringer Ingelheim, Merck, and Teva; the investigators reported relationships with Sanofi, Vectura, Circassia, DBV Technologies, and others. Novel START was funded by AstraZeneca and the Health Research Council of New Zealand; the investigators reported relationships with GlaxoSmithKline, Genentech, Theravance Biopharma, and others.

SOURCES: Beasley et al. New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1901963; Lazarus et al. New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1814917.

Patients with mild asthma who rely solely on short-acting beta2-agonists (SABAs) to control their asthma symptoms remain at increased risk of exacerbations, according to investigators.

Two recent studies presented at the American Thoracic Society’s international conference demonstrated the benefits of glucocorticoid therapy among patients with mild persistent or intermittent asthma while highlighting differential responses to steroids among patients with high versus low levels of eosinophils in sputum. Both studies were simultaneously published in the New England Journal of Medicine.

The first study, SIENA, led by Stephen C. Lazarus, MD of the University of California, San Francisco, and colleagues, involved 295 patients with mild, persistent asthma. Patients were classified as having either a high or low level of eosinophils in sputum, with a low level defined by two sputum samples consisting of less than 2% eosinophils. After a single-blind placebo run-in period of 6 weeks, patients were randomized to receive either mometasone (an inhaled glucocorticoid), tiotropium (a long-acting muscarinic antagonist [LAMA]), or placebo for 12 weeks each, with subsequent crossover through the two remaining treatments. The primary outcome was the response to each active agent, compared with placebo among low-eosinophil patients who had a differential response to a trial agent.

Out of 295 patients, 221 (75%) had low eosinophils and 74 (25%) had high eosinophils. In the low-eosinophil subgroup, 59% of patients had a differential response to a trial agent; among these, 57% responded better to mometasone, compared with 43% who responded better to placebo, and 60% responded better to tiotropium, compared with 40% who responded better to placebo.

Turning to secondary analyses, among patients with high eosinophil levels who had a differential response, 74% responded better to mometasone, compared with 26% who responded better to placebo, and 57% responded better to tiotropium, compared with 43% who responded better to placebo.

In an additional exploratory analysis, adults with low eosinophil levels had better responses to tiotropium than placebo (62% vs 38%).

The researchers stated that a key finding of the study is that three-quarters of the mild, persistent asthma population had low eosinophil levels, far fewer than expected and that the difference in their response to mometasone compared to tiotropium was not significant.

“Our results raise the question of whether treatment guidelines should be reevaluated for patients with mild, persistent asthma for whom evidence of type 2 inflammation is lacking,” the investigators wrote. “The need for a change in treatment strategy is further highlighted by a growing body of literature suggesting that mild, persistent asthma can be managed safely without the daily use of inhaled glucocorticoids and by data showing that patients with a low eosinophil level may not have a favorable response to inhaled glucocorticoids” (New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1814917).

The second study, Novel START, conducted by lead author Richard Beasley, DSc, of the Medical Research Institute of New Zealand, Wellington, and colleagues, compared the efficacy of two inhaled glucocorticoid regimens and albuterol alone for patients with mild persistent or intermittent asthma, measured by annualized exacerbation rate.

Initial randomization involved 675 patients, of whom 668 were included in the final analysis. Patients were randomized into three groups: albuterol as needed (100 mcg, two inhalations as needed for asthma symptoms), budesonide maintenance (200 mcg, one inhalation twice daily with as-needed albuterol), or budesonide/formoterol (budesonide 200 mcg and formoterol 6 mcg, one inhalation as needed). Along with annualized exacerbation rate, several secondary outcomes assessed symptoms, respiratory function, and number of severe exacerbations.

Data analysis showed that patients in the budesonide groups had similar rates of annualized exacerbation, both of which were significantly better than the exacerbation rate in the albuterol-only group; the absolute rate of exacerbations per patient per year was 0.175, 0.195, and 0.400 for budesonide maintenance, budesonide/formoterol, and albuterol only, respectively. Similarly, the median fraction of exhaled nitric oxide (FENO) was lower in the budesonide groups than in the albuterol-only group. Patients in the budesonide/formoterol group had a 56% lower relative risk of severe pulmonary exacerbation than patients in the budesonide maintenance group and a 60% lower relative risk than the albuterol group. However, maintenance budesonide provided better symptom relief than budesonide/formoterol, “which suggests that for the patient for whom asthma symptoms rather than exacerbations are the most bothersome, maintenance treatment has value,” the investigators wrote (New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1901963).

“The findings of our trial are consistent with evidence regarding the treatment of moderate and severe asthma – that maintenance and reliever therapy” with inhaled glucocorticoid/formoterol “results in a lower risk of severe exacerbations than maintenance therapy with an inhaled glucocorticoid–[long-acting beta agonist] and as-needed SABA,” the investigators concluded.

SIENA was funded by National Heart, Lung, and Blood Institute, with medications provided by Boehringer Ingelheim, Merck, and Teva; the investigators reported relationships with Sanofi, Vectura, Circassia, DBV Technologies, and others. Novel START was funded by AstraZeneca and the Health Research Council of New Zealand; the investigators reported relationships with GlaxoSmithKline, Genentech, Theravance Biopharma, and others.

SOURCES: Beasley et al. New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1901963; Lazarus et al. New Engl J Med. 2019 May 19. doi: 10.1056/NEJMoa1814917.

Routine use of the Oncotype DX recurrence score to personalize treatment of early breast cancer could reduce the first-year costs of care, according to results of a population-based cohort study.

“Practice changes based on evidence from the TAILORx trial on using tumor genomic profiles to personalize care could result in small decreases in U.S. national cancer care costs in the initial 12 months post breast cancer diagnosis,” Angela Mariotto, PhD, and colleagues concluded in a study published in JNCI: Journal of the National Cancer Institute. “Longer-term studies will be needed to evaluate the true long-term economic impact and nonmonetary benefits of personalized breast cancer care.”

Findings of the landmark TAILORx trial showed that, with use of the 21-gene score, the majority of women who have node-negative, hormone receptor–positive, HER2-negative breast cancers could safely skip adjuvant chemotherapy (N Engl J Med. 2018;379:111-21). But cost impact of its uptake into routine practice is unclear.

Dr. Mariotto, of the National Cancer Institute and her colleagues used data from the Surveillance, Epidemiology and End Results (SEER), SEER-Medicare, and SEER–Genomic Health datasets to assess how expected changes in practice after the trial might affect costs. They estimated Oncotype DX testing and chemotherapy rates and mean initial costs in 2018 dollars in the pre-TAILORx period (2010-2015) and post-TAILORx period (2018), assuming all women in the latter period received the test and score-suggested therapy.

Going from the pretrial period to the posttrial period, Oncotype DX testing costs were projected to increase from $115 million to $231 million, but chemotherapy use was projected to decrease from 25% to 17%. Mean total initial costs of care fell from $2.816 billion in the pretrial period to $2.766 billion in the posttrial period, for a net savings of $49 million (a 1.8% decrease).

Findings were similar in a variety of sensitivity scenarios entailing alternative compliance with testing, score-suggested treatment, and estimation methods. The only exception was the scenario in which all women aged 50 years or younger having a recurrence score of 16-25 opted to receive chemotherapy, wherein initial care costs could increase by $105 million (a 4% increase).

The investigators reported that they had no relevant conflicts of interest. The study was supported by the National Cancer Institute and its Coordinating Center For Clinical Trials; a Lombardi Comprehensive Cancer Center American Cancer Society Young Investigator Award; and the Cancer Prevention Research Fellowship, sponsored by the American Society of Preventive Oncology and Breast Cancer Research Foundation.

SOURCE: Mariotto A et al. J Natl Cancer Inst. 2019 Apr 24. doi: 10.1093/jnci/djz068.

Routine use of the Oncotype DX recurrence score to personalize treatment of early breast cancer could reduce the first-year costs of care, according to results of a population-based cohort study.

“Practice changes based on evidence from the TAILORx trial on using tumor genomic profiles to personalize care could result in small decreases in U.S. national cancer care costs in the initial 12 months post breast cancer diagnosis,” Angela Mariotto, PhD, and colleagues concluded in a study published in JNCI: Journal of the National Cancer Institute. “Longer-term studies will be needed to evaluate the true long-term economic impact and nonmonetary benefits of personalized breast cancer care.”

Findings of the landmark TAILORx trial showed that, with use of the 21-gene score, the majority of women who have node-negative, hormone receptor–positive, HER2-negative breast cancers could safely skip adjuvant chemotherapy (N Engl J Med. 2018;379:111-21). But cost impact of its uptake into routine practice is unclear.

Dr. Mariotto, of the National Cancer Institute and her colleagues used data from the Surveillance, Epidemiology and End Results (SEER), SEER-Medicare, and SEER–Genomic Health datasets to assess how expected changes in practice after the trial might affect costs. They estimated Oncotype DX testing and chemotherapy rates and mean initial costs in 2018 dollars in the pre-TAILORx period (2010-2015) and post-TAILORx period (2018), assuming all women in the latter period received the test and score-suggested therapy.

Going from the pretrial period to the posttrial period, Oncotype DX testing costs were projected to increase from $115 million to $231 million, but chemotherapy use was projected to decrease from 25% to 17%. Mean total initial costs of care fell from $2.816 billion in the pretrial period to $2.766 billion in the posttrial period, for a net savings of $49 million (a 1.8% decrease).

Findings were similar in a variety of sensitivity scenarios entailing alternative compliance with testing, score-suggested treatment, and estimation methods. The only exception was the scenario in which all women aged 50 years or younger having a recurrence score of 16-25 opted to receive chemotherapy, wherein initial care costs could increase by $105 million (a 4% increase).

The investigators reported that they had no relevant conflicts of interest. The study was supported by the National Cancer Institute and its Coordinating Center For Clinical Trials; a Lombardi Comprehensive Cancer Center American Cancer Society Young Investigator Award; and the Cancer Prevention Research Fellowship, sponsored by the American Society of Preventive Oncology and Breast Cancer Research Foundation.

SOURCE: Mariotto A et al. J Natl Cancer Inst. 2019 Apr 24. doi: 10.1093/jnci/djz068.

Routine use of the Oncotype DX recurrence score to personalize treatment of early breast cancer could reduce the first-year costs of care, according to results of a population-based cohort study.

“Practice changes based on evidence from the TAILORx trial on using tumor genomic profiles to personalize care could result in small decreases in U.S. national cancer care costs in the initial 12 months post breast cancer diagnosis,” Angela Mariotto, PhD, and colleagues concluded in a study published in JNCI: Journal of the National Cancer Institute. “Longer-term studies will be needed to evaluate the true long-term economic impact and nonmonetary benefits of personalized breast cancer care.”

Findings of the landmark TAILORx trial showed that, with use of the 21-gene score, the majority of women who have node-negative, hormone receptor–positive, HER2-negative breast cancers could safely skip adjuvant chemotherapy (N Engl J Med. 2018;379:111-21). But cost impact of its uptake into routine practice is unclear.

Dr. Mariotto, of the National Cancer Institute and her colleagues used data from the Surveillance, Epidemiology and End Results (SEER), SEER-Medicare, and SEER–Genomic Health datasets to assess how expected changes in practice after the trial might affect costs. They estimated Oncotype DX testing and chemotherapy rates and mean initial costs in 2018 dollars in the pre-TAILORx period (2010-2015) and post-TAILORx period (2018), assuming all women in the latter period received the test and score-suggested therapy.

Going from the pretrial period to the posttrial period, Oncotype DX testing costs were projected to increase from $115 million to $231 million, but chemotherapy use was projected to decrease from 25% to 17%. Mean total initial costs of care fell from $2.816 billion in the pretrial period to $2.766 billion in the posttrial period, for a net savings of $49 million (a 1.8% decrease).

Findings were similar in a variety of sensitivity scenarios entailing alternative compliance with testing, score-suggested treatment, and estimation methods. The only exception was the scenario in which all women aged 50 years or younger having a recurrence score of 16-25 opted to receive chemotherapy, wherein initial care costs could increase by $105 million (a 4% increase).

The investigators reported that they had no relevant conflicts of interest. The study was supported by the National Cancer Institute and its Coordinating Center For Clinical Trials; a Lombardi Comprehensive Cancer Center American Cancer Society Young Investigator Award; and the Cancer Prevention Research Fellowship, sponsored by the American Society of Preventive Oncology and Breast Cancer Research Foundation.

SOURCE: Mariotto A et al. J Natl Cancer Inst. 2019 Apr 24. doi: 10.1093/jnci/djz068.

Elderly patients with a history of localized melanoma recognized the importance of skin self-examination (SSE), but expressed low confidence in their abilities to do it correctly, based on results of a small study. While many were willing to use teledermoscopy to assist them in self-exams, patients still preferred to rely on regularly scheduled exams by physicians.

“Low confidence in SSE is a key barrier to patient-led surveillance and to the use of digital technologies for SSE,” wrote Mbathio Dieng, PhD, of the University of Sydney and her coauthors in a study published in JAMA Dermatology.

The Australian researchers conducted semistructured interviews with 37 patients from Sydney. Patients’ median age was 67 years; 26 of 37 (70%) were men.

Barriers to SSE included a perceived lack of competence in self-exams; the patients said they doubted they would catch anything that needed to be caught.

As for digitally supported SSE, many patients expressed a willingness to consider tools that would assist in the self-assessment process. Several said they valued the additional reassurance between clinical visits and the ability to create their own action plan.

The authors acknowledged that they only recruited from a single tertiary center so the results are limited. However, in terms of steps forward, they noted that their study was one of the first “to assess the perceptions of patients with melanoma of the use of new digital technologies in surveillance for recurrent or new primary melanomas.”

The study was supported by a grant from the Australian National Health and Medical Research Council (NHMRC). One author reported receiving salary support from an Australian NHMRC fellowship; another received fellowships from the NHMRC and Cancer Institute New South Wales. Another author received scholarships and awards from the University of Sydney and the Sydney Catalyst Translational Cancer Research Centre.

SOURCE: Dieng M et al. JAMA Dermatol. 2019 May 15. doi: 10.1001/jamadermatol.2019.0434.

Elderly patients with a history of localized melanoma recognized the importance of skin self-examination (SSE), but expressed low confidence in their abilities to do it correctly, based on results of a small study. While many were willing to use teledermoscopy to assist them in self-exams, patients still preferred to rely on regularly scheduled exams by physicians.

“Low confidence in SSE is a key barrier to patient-led surveillance and to the use of digital technologies for SSE,” wrote Mbathio Dieng, PhD, of the University of Sydney and her coauthors in a study published in JAMA Dermatology.

The Australian researchers conducted semistructured interviews with 37 patients from Sydney. Patients’ median age was 67 years; 26 of 37 (70%) were men.

Barriers to SSE included a perceived lack of competence in self-exams; the patients said they doubted they would catch anything that needed to be caught.

As for digitally supported SSE, many patients expressed a willingness to consider tools that would assist in the self-assessment process. Several said they valued the additional reassurance between clinical visits and the ability to create their own action plan.

The authors acknowledged that they only recruited from a single tertiary center so the results are limited. However, in terms of steps forward, they noted that their study was one of the first “to assess the perceptions of patients with melanoma of the use of new digital technologies in surveillance for recurrent or new primary melanomas.”

The study was supported by a grant from the Australian National Health and Medical Research Council (NHMRC). One author reported receiving salary support from an Australian NHMRC fellowship; another received fellowships from the NHMRC and Cancer Institute New South Wales. Another author received scholarships and awards from the University of Sydney and the Sydney Catalyst Translational Cancer Research Centre.

SOURCE: Dieng M et al. JAMA Dermatol. 2019 May 15. doi: 10.1001/jamadermatol.2019.0434.

Elderly patients with a history of localized melanoma recognized the importance of skin self-examination (SSE), but expressed low confidence in their abilities to do it correctly, based on results of a small study. While many were willing to use teledermoscopy to assist them in self-exams, patients still preferred to rely on regularly scheduled exams by physicians.

“Low confidence in SSE is a key barrier to patient-led surveillance and to the use of digital technologies for SSE,” wrote Mbathio Dieng, PhD, of the University of Sydney and her coauthors in a study published in JAMA Dermatology.

The Australian researchers conducted semistructured interviews with 37 patients from Sydney. Patients’ median age was 67 years; 26 of 37 (70%) were men.

Barriers to SSE included a perceived lack of competence in self-exams; the patients said they doubted they would catch anything that needed to be caught.

As for digitally supported SSE, many patients expressed a willingness to consider tools that would assist in the self-assessment process. Several said they valued the additional reassurance between clinical visits and the ability to create their own action plan.

The authors acknowledged that they only recruited from a single tertiary center so the results are limited. However, in terms of steps forward, they noted that their study was one of the first “to assess the perceptions of patients with melanoma of the use of new digital technologies in surveillance for recurrent or new primary melanomas.”

The study was supported by a grant from the Australian National Health and Medical Research Council (NHMRC). One author reported receiving salary support from an Australian NHMRC fellowship; another received fellowships from the NHMRC and Cancer Institute New South Wales. Another author received scholarships and awards from the University of Sydney and the Sydney Catalyst Translational Cancer Research Centre.

SOURCE: Dieng M et al. JAMA Dermatol. 2019 May 15. doi: 10.1001/jamadermatol.2019.0434.

SAN FRANCISCO – Lupus patients have about 10 times as many low-attenuation, noncalcified coronary artery plaques – a highly dangerous kind of plaque – as healthy people, and those plaques do not regress over time, according to an investigation from Johns Hopkins University, Baltimore.

M. Alexander Otto/MDedge News

All of the 102 lupus patients in the coronary artery CT angiography study also had positive plaque remodeling, meaning that at least one low-attenuation plaque was growing into the lumen wall, not the lumen itself, which makes them difficult to detect on standard imaging. Low-attenuation plaques were defined in the study as a plaque larger than 1 mm² with a radiodensity below 30 Hounsfield units.

Low-attenuation plaques are inherently unstable; they’re fatty, necrotic, and have a high risk of rupturing; their presence in the lumen wall is especially worrisome. In the general population, they sometimes regress, scarring down over time and no longer posing a threat. That didn’t happen in the 30 lupus patients who had follow-up CT angiographies, some 9 years after their first.

The team conducted the study to help understand why cardiovascular disease is so common in lupus, and the leading cause of death. Hopkins investigators have shown previously that statins have no effect on the risk or plaque occurrence and progression, and the cardiovascular risk doesn’t always seem to correlate with disease control. For those and other reasons, the current thinking at Hopkins is that cardiovascular disease in lupus is somehow different than in the general population, said George Stojan, MD, an assistant professor of rheumatology at the school and codirector of the Hopkins Lupus Center.

The goal is “to figure out exactly what to look for when we assess the risk; I don’t think we understand that at this point. We assume patients with lupus behave exactly like patients who don’t have lupus, but they obviously don’t. They do not respond to statins. They have a higher risk no matter what you do for them, even when their disease activity is low, and how much plaque they have over time doesn’t really correlate with disease activity,” he said at an international conference on systemic lupus erythematosus.

“Once we understand” the mechanism, “then we can try to [alter] it. Maybe we can look at new drugs, like the PCSK9 inhibitors which have shown a lot of promise in the general population.” At this point, however, “we don’t really know how to intervene,” Dr. Stojan said.

In the meantime, positive remodeling and low-attenuation, noncalcified plaques (LANCPs) might be something to look for when assessing systemic lupus erythematosus cardiovascular risk. “A simple coronary calcium score, something that all doctors do,” is not enough in lupus, nor is simply checking for lumen obstruction. Also, it’s important not to be misled by an overall reduction in noncalcified plaques. “Low-attenuation, noncalcified plaques don’t [regress] over time in lupus, and they are the ones that lead to cardiovascular events,” he said.

The CT angiography findings were compared with findings in 100 healthy controls who had two CT angiograms in a University of California, Los Angeles, cohort. Overall, there was a mean of 458 LANCPs among lupus patients, versus 42 among controls, a more than 900% difference (P less than .001).

Women with lupus aged under 44 years had a mean of 63 LANCPs; none were detected in healthy women under 44 years. Among women aged 45-59 years, there was a mean of 451 LANCPs in the lupus group versus 53 in the control arm. The findings were highly statistically significant, and almost statistically significant for women 60 years or older, 695 lesions among lupus patients versus 22 (P = .0576).

There were only nine men with lupus in the study, but the findings were similar versus male controls.

While mean LANCP volume regressed over time in the control group (mean, –6.90 mm³; P = .0002), a mean regression of –13.56 mm³ in the lupus group was not statistically significant (P = .4570).

Both controls and lupus patients had a positive remodeling index. It progressed in the lupus group over time, and regressed in controls, but the findings were not statistically significant.

“Statins did nothing for the lupus patients. They didn’t affect progress of coronary plaques at all. We still treat patients because theoretically we don’t have anything better, but we know that they don’t really work in this population,” Dr. Stojan said

The work is funded by the National Institutes of Health. Dr. Stojan didn’t report any relevant disclosures.

aotto@mdedge.com

SOURCE: Stojan G et al. Lupus Sci Med. 2019;6[suppl 1]:A200, Abstract 274.

SAN FRANCISCO – Lupus patients have about 10 times as many low-attenuation, noncalcified coronary artery plaques – a highly dangerous kind of plaque – as healthy people, and those plaques do not regress over time, according to an investigation from Johns Hopkins University, Baltimore.

M. Alexander Otto/MDedge News

All of the 102 lupus patients in the coronary artery CT angiography study also had positive plaque remodeling, meaning that at least one low-attenuation plaque was growing into the lumen wall, not the lumen itself, which makes them difficult to detect on standard imaging. Low-attenuation plaques were defined in the study as a plaque larger than 1 mm² with a radiodensity below 30 Hounsfield units.

Low-attenuation plaques are inherently unstable; they’re fatty, necrotic, and have a high risk of rupturing; their presence in the lumen wall is especially worrisome. In the general population, they sometimes regress, scarring down over time and no longer posing a threat. That didn’t happen in the 30 lupus patients who had follow-up CT angiographies, some 9 years after their first.

The team conducted the study to help understand why cardiovascular disease is so common in lupus, and the leading cause of death. Hopkins investigators have shown previously that statins have no effect on the risk or plaque occurrence and progression, and the cardiovascular risk doesn’t always seem to correlate with disease control. For those and other reasons, the current thinking at Hopkins is that cardiovascular disease in lupus is somehow different than in the general population, said George Stojan, MD, an assistant professor of rheumatology at the school and codirector of the Hopkins Lupus Center.

The goal is “to figure out exactly what to look for when we assess the risk; I don’t think we understand that at this point. We assume patients with lupus behave exactly like patients who don’t have lupus, but they obviously don’t. They do not respond to statins. They have a higher risk no matter what you do for them, even when their disease activity is low, and how much plaque they have over time doesn’t really correlate with disease activity,” he said at an international conference on systemic lupus erythematosus.

“Once we understand” the mechanism, “then we can try to [alter] it. Maybe we can look at new drugs, like the PCSK9 inhibitors which have shown a lot of promise in the general population.” At this point, however, “we don’t really know how to intervene,” Dr. Stojan said.

In the meantime, positive remodeling and low-attenuation, noncalcified plaques (LANCPs) might be something to look for when assessing systemic lupus erythematosus cardiovascular risk. “A simple coronary calcium score, something that all doctors do,” is not enough in lupus, nor is simply checking for lumen obstruction. Also, it’s important not to be misled by an overall reduction in noncalcified plaques. “Low-attenuation, noncalcified plaques don’t [regress] over time in lupus, and they are the ones that lead to cardiovascular events,” he said.

The CT angiography findings were compared with findings in 100 healthy controls who had two CT angiograms in a University of California, Los Angeles, cohort. Overall, there was a mean of 458 LANCPs among lupus patients, versus 42 among controls, a more than 900% difference (P less than .001).

Women with lupus aged under 44 years had a mean of 63 LANCPs; none were detected in healthy women under 44 years. Among women aged 45-59 years, there was a mean of 451 LANCPs in the lupus group versus 53 in the control arm. The findings were highly statistically significant, and almost statistically significant for women 60 years or older, 695 lesions among lupus patients versus 22 (P = .0576).

There were only nine men with lupus in the study, but the findings were similar versus male controls.

While mean LANCP volume regressed over time in the control group (mean, –6.90 mm³; P = .0002), a mean regression of –13.56 mm³ in the lupus group was not statistically significant (P = .4570).

Both controls and lupus patients had a positive remodeling index. It progressed in the lupus group over time, and regressed in controls, but the findings were not statistically significant.

“Statins did nothing for the lupus patients. They didn’t affect progress of coronary plaques at all. We still treat patients because theoretically we don’t have anything better, but we know that they don’t really work in this population,” Dr. Stojan said

The work is funded by the National Institutes of Health. Dr. Stojan didn’t report any relevant disclosures.

aotto@mdedge.com

SOURCE: Stojan G et al. Lupus Sci Med. 2019;6[suppl 1]:A200, Abstract 274.

SAN FRANCISCO – Lupus patients have about 10 times as many low-attenuation, noncalcified coronary artery plaques – a highly dangerous kind of plaque – as healthy people, and those plaques do not regress over time, according to an investigation from Johns Hopkins University, Baltimore.

M. Alexander Otto/MDedge News

All of the 102 lupus patients in the coronary artery CT angiography study also had positive plaque remodeling, meaning that at least one low-attenuation plaque was growing into the lumen wall, not the lumen itself, which makes them difficult to detect on standard imaging. Low-attenuation plaques were defined in the study as a plaque larger than 1 mm² with a radiodensity below 30 Hounsfield units.

Low-attenuation plaques are inherently unstable; they’re fatty, necrotic, and have a high risk of rupturing; their presence in the lumen wall is especially worrisome. In the general population, they sometimes regress, scarring down over time and no longer posing a threat. That didn’t happen in the 30 lupus patients who had follow-up CT angiographies, some 9 years after their first.

The team conducted the study to help understand why cardiovascular disease is so common in lupus, and the leading cause of death. Hopkins investigators have shown previously that statins have no effect on the risk or plaque occurrence and progression, and the cardiovascular risk doesn’t always seem to correlate with disease control. For those and other reasons, the current thinking at Hopkins is that cardiovascular disease in lupus is somehow different than in the general population, said George Stojan, MD, an assistant professor of rheumatology at the school and codirector of the Hopkins Lupus Center.

The goal is “to figure out exactly what to look for when we assess the risk; I don’t think we understand that at this point. We assume patients with lupus behave exactly like patients who don’t have lupus, but they obviously don’t. They do not respond to statins. They have a higher risk no matter what you do for them, even when their disease activity is low, and how much plaque they have over time doesn’t really correlate with disease activity,” he said at an international conference on systemic lupus erythematosus.

“Once we understand” the mechanism, “then we can try to [alter] it. Maybe we can look at new drugs, like the PCSK9 inhibitors which have shown a lot of promise in the general population.” At this point, however, “we don’t really know how to intervene,” Dr. Stojan said.

In the meantime, positive remodeling and low-attenuation, noncalcified plaques (LANCPs) might be something to look for when assessing systemic lupus erythematosus cardiovascular risk. “A simple coronary calcium score, something that all doctors do,” is not enough in lupus, nor is simply checking for lumen obstruction. Also, it’s important not to be misled by an overall reduction in noncalcified plaques. “Low-attenuation, noncalcified plaques don’t [regress] over time in lupus, and they are the ones that lead to cardiovascular events,” he said.

The CT angiography findings were compared with findings in 100 healthy controls who had two CT angiograms in a University of California, Los Angeles, cohort. Overall, there was a mean of 458 LANCPs among lupus patients, versus 42 among controls, a more than 900% difference (P less than .001).

Women with lupus aged under 44 years had a mean of 63 LANCPs; none were detected in healthy women under 44 years. Among women aged 45-59 years, there was a mean of 451 LANCPs in the lupus group versus 53 in the control arm. The findings were highly statistically significant, and almost statistically significant for women 60 years or older, 695 lesions among lupus patients versus 22 (P = .0576).

There were only nine men with lupus in the study, but the findings were similar versus male controls.

While mean LANCP volume regressed over time in the control group (mean, –6.90 mm³; P = .0002), a mean regression of –13.56 mm³ in the lupus group was not statistically significant (P = .4570).

Both controls and lupus patients had a positive remodeling index. It progressed in the lupus group over time, and regressed in controls, but the findings were not statistically significant.

“Statins did nothing for the lupus patients. They didn’t affect progress of coronary plaques at all. We still treat patients because theoretically we don’t have anything better, but we know that they don’t really work in this population,” Dr. Stojan said

The work is funded by the National Institutes of Health. Dr. Stojan didn’t report any relevant disclosures.

aotto@mdedge.com

SOURCE: Stojan G et al. Lupus Sci Med. 2019;6[suppl 1]:A200, Abstract 274.

SAN DIEGO – Patients on systemic anticoagulation had decreased odds of acute pancreatitis occurrence, reduced mortality, and improved outcomes, compared with patients who were not on systemic anticoagulation, results from a large retrospective analysis showed.

“Acute pancreatitis is a very common disease,” lead study author Yan Bi, MD, PhD, a senior associate consultant and assistant professor in the department of gastroenterology and hepatology at Mayo Clinic, Jacksonville, Fla., said in an interview in advance of the annual Digestive Disease Week. “It’s the number one GI cause for hospitalization. Unfortunately, even after decades of basic science and clinical research, there’s still no cure; there’s nothing to prevent it from happening. The only treatment we can offer is supportive care, which includes fluid hydration, pain control, and nutrition support.”

The pathogenesis of acute pancreatitis (AP) is complex, she continued, and represents a sequence of distinct and interconnected pathologic events. “Both animal data and human studies have shown that acute pancreatitis is a hypercoagulable state,” she said. “We hypothesize that coagulation plays important roles in the development of pancreatitis.”

To test their hypothesis, Dr. Bi and associates performed a retrospective study. They drew from the 2014 National Inpatient Sample to evaluate the effect of systemic anticoagulation prior to AP onset on outcomes of the condition. They used ICD-9 codes to identify patients with a primary diagnosis of AP as well as those who were taking systemic anticoagulation. The primary outcome was the odds of AP in patients taking systemic anticoagulation, compared with those who were not. Secondary outcomes were mortality, morbidity, length of hospital stay, and total hospitalization charges and costs. The researchers used propensity score matching to create a 1:1 matching population for sex, age, and Charlson Comorbidity Index, and multivariate regression to adjust for patient ZIP code, income, hospital region, location, size, and teaching status.


Dr. Bi presented results from 442,535 patients with AP. Of these, 12,735 were on systemic anticoagulation prior to AP. Their mean age was 66 and 47% were female. After adjustment for confounders, patients on systemic anticoagulation prior to AP onset displayed a decreased odds of AP occurrence, compared with those who were not on anticoagulation (OR 0.56; P less than .01). In addition, patients on anticoagulation displayed improved outcomes in a number of variables, compared with their counterparts who were not on anticoagulation: mortality (OR 0.65), shock (OR 0.68), acute kidney injury (OR 0.83), ICU admission (OR 0.57), multiorgan failure (OR 0.85), and hospital charges (a mean reduction of $9,275), as well as AP induced by alcohol use (OR 0.26; P less than .01 for all associations). “These data suggest that the majority of AP associated with alcohol was prevented by anticoagulation medication,” Dr. Bi said. “This is very striking. Anticoagulation may hold promise in both the prevention and treatment of AP.”

To further prove their points, Dr. Bi teamed with Baoan Ji, MD, PhD, a basic research scientist at Mayo Clinic, and developed a humanized AP animal model. With this model, they showed that Pradaxa, a Food and Drug Administration–approved anticoagulant, is effective in experimental AP prevention and treatment. “We are currently enrolling patients into a prospective clinical trial to further prove this in humans,” Dr. Bi said. The experimental therapeutic study will be reported at DDW on May 20.

She cautioned against using systemic anticoagulants in this patient population before results of the trial currently underway at Mayo Clinic’s Florida campus are known. “That should be sometime in mid-2020,” she said. “And the bleeding risk should be carefully monitored when using anticoagulants.”

The researchers were supported by funding from the Mayo Clinic and the Department of Defense.

dbrunk@mdedge.com

SOURCE: Bi Y et al. DDW 2019, Abstract Sa1381.

SAN DIEGO – Patients on systemic anticoagulation had decreased odds of acute pancreatitis occurrence, reduced mortality, and improved outcomes, compared with patients who were not on systemic anticoagulation, results from a large retrospective analysis showed.

“Acute pancreatitis is a very common disease,” lead study author Yan Bi, MD, PhD, a senior associate consultant and assistant professor in the department of gastroenterology and hepatology at Mayo Clinic, Jacksonville, Fla., said in an interview in advance of the annual Digestive Disease Week. “It’s the number one GI cause for hospitalization. Unfortunately, even after decades of basic science and clinical research, there’s still no cure; there’s nothing to prevent it from happening. The only treatment we can offer is supportive care, which includes fluid hydration, pain control, and nutrition support.”

The pathogenesis of acute pancreatitis (AP) is complex, she continued, and represents a sequence of distinct and interconnected pathologic events. “Both animal data and human studies have shown that acute pancreatitis is a hypercoagulable state,” she said. “We hypothesize that coagulation plays important roles in the development of pancreatitis.”

To test their hypothesis, Dr. Bi and associates performed a retrospective study. They drew from the 2014 National Inpatient Sample to evaluate the effect of systemic anticoagulation prior to AP onset on outcomes of the condition. They used ICD-9 codes to identify patients with a primary diagnosis of AP as well as those who were taking systemic anticoagulation. The primary outcome was the odds of AP in patients taking systemic anticoagulation, compared with those who were not. Secondary outcomes were mortality, morbidity, length of hospital stay, and total hospitalization charges and costs. The researchers used propensity score matching to create a 1:1 matching population for sex, age, and Charlson Comorbidity Index, and multivariate regression to adjust for patient ZIP code, income, hospital region, location, size, and teaching status.


Dr. Bi presented results from 442,535 patients with AP. Of these, 12,735 were on systemic anticoagulation prior to AP. Their mean age was 66 and 47% were female. After adjustment for confounders, patients on systemic anticoagulation prior to AP onset displayed a decreased odds of AP occurrence, compared with those who were not on anticoagulation (OR 0.56; P less than .01). In addition, patients on anticoagulation displayed improved outcomes in a number of variables, compared with their counterparts who were not on anticoagulation: mortality (OR 0.65), shock (OR 0.68), acute kidney injury (OR 0.83), ICU admission (OR 0.57), multiorgan failure (OR 0.85), and hospital charges (a mean reduction of $9,275), as well as AP induced by alcohol use (OR 0.26; P less than .01 for all associations). “These data suggest that the majority of AP associated with alcohol was prevented by anticoagulation medication,” Dr. Bi said. “This is very striking. Anticoagulation may hold promise in both the prevention and treatment of AP.”

To further prove their points, Dr. Bi teamed with Baoan Ji, MD, PhD, a basic research scientist at Mayo Clinic, and developed a humanized AP animal model. With this model, they showed that Pradaxa, a Food and Drug Administration–approved anticoagulant, is effective in experimental AP prevention and treatment. “We are currently enrolling patients into a prospective clinical trial to further prove this in humans,” Dr. Bi said. The experimental therapeutic study will be reported at DDW on May 20.

She cautioned against using systemic anticoagulants in this patient population before results of the trial currently underway at Mayo Clinic’s Florida campus are known. “That should be sometime in mid-2020,” she said. “And the bleeding risk should be carefully monitored when using anticoagulants.”

The researchers were supported by funding from the Mayo Clinic and the Department of Defense.

dbrunk@mdedge.com

SOURCE: Bi Y et al. DDW 2019, Abstract Sa1381.

SAN DIEGO – Patients on systemic anticoagulation had decreased odds of acute pancreatitis occurrence, reduced mortality, and improved outcomes, compared with patients who were not on systemic anticoagulation, results from a large retrospective analysis showed.

“Acute pancreatitis is a very common disease,” lead study author Yan Bi, MD, PhD, a senior associate consultant and assistant professor in the department of gastroenterology and hepatology at Mayo Clinic, Jacksonville, Fla., said in an interview in advance of the annual Digestive Disease Week. “It’s the number one GI cause for hospitalization. Unfortunately, even after decades of basic science and clinical research, there’s still no cure; there’s nothing to prevent it from happening. The only treatment we can offer is supportive care, which includes fluid hydration, pain control, and nutrition support.”

The pathogenesis of acute pancreatitis (AP) is complex, she continued, and represents a sequence of distinct and interconnected pathologic events. “Both animal data and human studies have shown that acute pancreatitis is a hypercoagulable state,” she said. “We hypothesize that coagulation plays important roles in the development of pancreatitis.”

To test their hypothesis, Dr. Bi and associates performed a retrospective study. They drew from the 2014 National Inpatient Sample to evaluate the effect of systemic anticoagulation prior to AP onset on outcomes of the condition. They used ICD-9 codes to identify patients with a primary diagnosis of AP as well as those who were taking systemic anticoagulation. The primary outcome was the odds of AP in patients taking systemic anticoagulation, compared with those who were not. Secondary outcomes were mortality, morbidity, length of hospital stay, and total hospitalization charges and costs. The researchers used propensity score matching to create a 1:1 matching population for sex, age, and Charlson Comorbidity Index, and multivariate regression to adjust for patient ZIP code, income, hospital region, location, size, and teaching status.


Dr. Bi presented results from 442,535 patients with AP. Of these, 12,735 were on systemic anticoagulation prior to AP. Their mean age was 66 and 47% were female. After adjustment for confounders, patients on systemic anticoagulation prior to AP onset displayed a decreased odds of AP occurrence, compared with those who were not on anticoagulation (OR 0.56; P less than .01). In addition, patients on anticoagulation displayed improved outcomes in a number of variables, compared with their counterparts who were not on anticoagulation: mortality (OR 0.65), shock (OR 0.68), acute kidney injury (OR 0.83), ICU admission (OR 0.57), multiorgan failure (OR 0.85), and hospital charges (a mean reduction of $9,275), as well as AP induced by alcohol use (OR 0.26; P less than .01 for all associations). “These data suggest that the majority of AP associated with alcohol was prevented by anticoagulation medication,” Dr. Bi said. “This is very striking. Anticoagulation may hold promise in both the prevention and treatment of AP.”

To further prove their points, Dr. Bi teamed with Baoan Ji, MD, PhD, a basic research scientist at Mayo Clinic, and developed a humanized AP animal model. With this model, they showed that Pradaxa, a Food and Drug Administration–approved anticoagulant, is effective in experimental AP prevention and treatment. “We are currently enrolling patients into a prospective clinical trial to further prove this in humans,” Dr. Bi said. The experimental therapeutic study will be reported at DDW on May 20.

She cautioned against using systemic anticoagulants in this patient population before results of the trial currently underway at Mayo Clinic’s Florida campus are known. “That should be sometime in mid-2020,” she said. “And the bleeding risk should be carefully monitored when using anticoagulants.”

The researchers were supported by funding from the Mayo Clinic and the Department of Defense.

dbrunk@mdedge.com

SOURCE: Bi Y et al. DDW 2019, Abstract Sa1381.