Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States, according to a study of liver transplant registry data.

Researchers analyzed registry data for 2,408 adults who underwent urgent liver transplantation for acute hepatic necrosis between 2003 and 2015, 625 of whom were recorded as having drug-induced liver injury. Of these, 21 cases were reportedly due to herbal or dietary supplements, all of which occurred after 2007. Eight cases were attributed to Lipolyze, Hydroxycut, testosterone, and OxyElite Pro, a muscle-building and weight-loss dietary supplement containing a blend of plant-derived extracts. The remaining cases did not list a specific product (Transplantation Proc 2017;49[2]:322-5).

“The potential hepatotoxicity of these HDS [herbal/dietary supplement] agents can result in the need for liver transplantation for irreversible liver failure,” wrote Dr. Linda L. Wong of the University of Hawaii and coauthors, citing two cases in Hawaii where patients needed liver transplant after taking OxyElite Pro.

They also referred to other case reports and case series of liver transplantation occurring in individuals who had taken the supplements usnic acid, Herbalife, Hydroxycut, linoleic acid, black cohosh, Chinese herbs, kava kava, skullcap, ma huang, or bai fang herb. “The benefits of the current regulatory oversight of medications breaks down when patients misuse non-FDA [Food and Drug Administration] approved herbal/dietary supplements (HDS) or ‘natural remedies’ with their inherent unknown side effects, interactions, and complications,” they wrote.

The mean age of individuals for which an herbal/dietary supplement was thought to be the cause of the hepatotoxicity was 36.8 years, 14 of the 21 were female, and the mean waiting time for liver transplantation was 4.7 days. One of the 21 patients died.

Overall, the most common drug associated with drug-induced liver injury was acetaminophen (300 cases), followed by antituberculosis medications (30), and antibiotics (30).

The authors suggested the true figure for HDS-induced liver transplantation may be underestimated, pointing to the fact that in this study, a further 154 cases were recorded as drug-induced injury but no drug was listed.

“Transplant centers and physicians may have difficulty identifying the exact inciting agent because patients do not typically report HDS when queried about medication use,” the authors wrote.

Given this, they recommended that transplant professionals specifically ask potential transplant recipients about their use of HDS, and request a detailed list of these along with the time course of use. They noted that family members and friends may not be privy to this information, and the patients themselves may not be in a position to answer because of decompensation with encephalopathy.

“It is critical to obtain this information as early as possible in the evaluation of the potential liver transplant recipient with an unknown etiology of liver disease or who presents with acute hepatic decompensation,” they wrote.

They also called for transplant professionals to report any information about confirmed HDS use in their patients to the FDA.

“It is imperative that transplant professionals inform the FDA of these dangerous compounds, with the ultimate intent of enforcing regulatory oversight,” they wrote. “This adherence to strict reporting will in turn translate to a reduction in the need for liver transplantation from HDS use.”

No conflicts of interest were declared.

Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States, according to a study of liver transplant registry data.

Researchers analyzed registry data for 2,408 adults who underwent urgent liver transplantation for acute hepatic necrosis between 2003 and 2015, 625 of whom were recorded as having drug-induced liver injury. Of these, 21 cases were reportedly due to herbal or dietary supplements, all of which occurred after 2007. Eight cases were attributed to Lipolyze, Hydroxycut, testosterone, and OxyElite Pro, a muscle-building and weight-loss dietary supplement containing a blend of plant-derived extracts. The remaining cases did not list a specific product (Transplantation Proc 2017;49[2]:322-5).

“The potential hepatotoxicity of these HDS [herbal/dietary supplement] agents can result in the need for liver transplantation for irreversible liver failure,” wrote Dr. Linda L. Wong of the University of Hawaii and coauthors, citing two cases in Hawaii where patients needed liver transplant after taking OxyElite Pro.

They also referred to other case reports and case series of liver transplantation occurring in individuals who had taken the supplements usnic acid, Herbalife, Hydroxycut, linoleic acid, black cohosh, Chinese herbs, kava kava, skullcap, ma huang, or bai fang herb. “The benefits of the current regulatory oversight of medications breaks down when patients misuse non-FDA [Food and Drug Administration] approved herbal/dietary supplements (HDS) or ‘natural remedies’ with their inherent unknown side effects, interactions, and complications,” they wrote.

The mean age of individuals for which an herbal/dietary supplement was thought to be the cause of the hepatotoxicity was 36.8 years, 14 of the 21 were female, and the mean waiting time for liver transplantation was 4.7 days. One of the 21 patients died.

Overall, the most common drug associated with drug-induced liver injury was acetaminophen (300 cases), followed by antituberculosis medications (30), and antibiotics (30).

The authors suggested the true figure for HDS-induced liver transplantation may be underestimated, pointing to the fact that in this study, a further 154 cases were recorded as drug-induced injury but no drug was listed.

“Transplant centers and physicians may have difficulty identifying the exact inciting agent because patients do not typically report HDS when queried about medication use,” the authors wrote.

Given this, they recommended that transplant professionals specifically ask potential transplant recipients about their use of HDS, and request a detailed list of these along with the time course of use. They noted that family members and friends may not be privy to this information, and the patients themselves may not be in a position to answer because of decompensation with encephalopathy.

“It is critical to obtain this information as early as possible in the evaluation of the potential liver transplant recipient with an unknown etiology of liver disease or who presents with acute hepatic decompensation,” they wrote.

They also called for transplant professionals to report any information about confirmed HDS use in their patients to the FDA.

“It is imperative that transplant professionals inform the FDA of these dangerous compounds, with the ultimate intent of enforcing regulatory oversight,” they wrote. “This adherence to strict reporting will in turn translate to a reduction in the need for liver transplantation from HDS use.”

No conflicts of interest were declared.

Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States, according to a study of liver transplant registry data.

Researchers analyzed registry data for 2,408 adults who underwent urgent liver transplantation for acute hepatic necrosis between 2003 and 2015, 625 of whom were recorded as having drug-induced liver injury. Of these, 21 cases were reportedly due to herbal or dietary supplements, all of which occurred after 2007. Eight cases were attributed to Lipolyze, Hydroxycut, testosterone, and OxyElite Pro, a muscle-building and weight-loss dietary supplement containing a blend of plant-derived extracts. The remaining cases did not list a specific product (Transplantation Proc 2017;49[2]:322-5).

“The potential hepatotoxicity of these HDS [herbal/dietary supplement] agents can result in the need for liver transplantation for irreversible liver failure,” wrote Dr. Linda L. Wong of the University of Hawaii and coauthors, citing two cases in Hawaii where patients needed liver transplant after taking OxyElite Pro.

They also referred to other case reports and case series of liver transplantation occurring in individuals who had taken the supplements usnic acid, Herbalife, Hydroxycut, linoleic acid, black cohosh, Chinese herbs, kava kava, skullcap, ma huang, or bai fang herb. “The benefits of the current regulatory oversight of medications breaks down when patients misuse non-FDA [Food and Drug Administration] approved herbal/dietary supplements (HDS) or ‘natural remedies’ with their inherent unknown side effects, interactions, and complications,” they wrote.

The mean age of individuals for which an herbal/dietary supplement was thought to be the cause of the hepatotoxicity was 36.8 years, 14 of the 21 were female, and the mean waiting time for liver transplantation was 4.7 days. One of the 21 patients died.

Overall, the most common drug associated with drug-induced liver injury was acetaminophen (300 cases), followed by antituberculosis medications (30), and antibiotics (30).

The authors suggested the true figure for HDS-induced liver transplantation may be underestimated, pointing to the fact that in this study, a further 154 cases were recorded as drug-induced injury but no drug was listed.

“Transplant centers and physicians may have difficulty identifying the exact inciting agent because patients do not typically report HDS when queried about medication use,” the authors wrote.

Given this, they recommended that transplant professionals specifically ask potential transplant recipients about their use of HDS, and request a detailed list of these along with the time course of use. They noted that family members and friends may not be privy to this information, and the patients themselves may not be in a position to answer because of decompensation with encephalopathy.

“It is critical to obtain this information as early as possible in the evaluation of the potential liver transplant recipient with an unknown etiology of liver disease or who presents with acute hepatic decompensation,” they wrote.

They also called for transplant professionals to report any information about confirmed HDS use in their patients to the FDA.

“It is imperative that transplant professionals inform the FDA of these dangerous compounds, with the ultimate intent of enforcing regulatory oversight,” they wrote. “This adherence to strict reporting will in turn translate to a reduction in the need for liver transplantation from HDS use.”

No conflicts of interest were declared.

Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.

In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.

In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.

Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.

Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.

It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.

“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.

Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).

llaubach@frontlinemedcom.com

Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.

In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.

In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.

Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.

Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.

It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.

“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.

Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).

llaubach@frontlinemedcom.com

Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.

In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.

In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.

Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.

Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.

It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.

“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.

Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).

llaubach@frontlinemedcom.com

HOUSTON – A personalized lifestyle coaching program focused on healthy eating increased blood pressure control by 7%, compared with usual care, among black patients with persistent hypertension.

A year after the program was instituted, the rate of blood pressure control was 69% in the intervention group, compared with 62% in the group that had the usual care offered to hypertensive patients, Mai Nguyen-Huynh, MD, said at the International Stroke Conference sponsored by the American Heart Association.

• “Shake” the salt habit.

• “Rattle” the intensity of the existing blood pressure control protocol.

• “Roll” out the results and incorporate into clinical practice.

The study was organized into three arms. Usual care was Kaiser’s typical intensified hypertension management. Patients filled out health and diet questionnaires and could voluntarily undergo a 24-hour urine sodium test.

The enhanced monitoring arm consisted of usual care, plus an in-person session with a nurse to discuss resources and possible barriers to treatment; regular blood pressure checks; intensification of pharmacotherapy, focusing on thiazides; and the addition of spironolactone for patients who had persistent hypertension despite being on three or more medications.

The lifestyle intervention arm consisted of usual care plus personalized coaching, both on the phone and in person. Participants could have up to 16 phone sessions with a specially trained counselor, with the option of bimonthly in-person group sessions.

These were accompanied by a workbook that emphasized healthy eating, from meal planning to shopping and cooking. Restaurant dining was tackled as well, including fast food and carryout. The workbook covered eight sessions. Each session ended with goal-setting for the next meeting, and opened with a review of how the prior month’s goals were accomplished.

Individualization was an important part of the lifestyle intervention program, Dr. Nguyen-Huynh said. Counselors didn’t strive to make each participant fit into a cookie-cutter solution. Instead, they worked as a team to build interventions that would work for each person.

The study group comprised 1,660 subjects. About 70% were women. Diabetes was common (about 33%), and around 10% had a history of coronary artery disease. The mean body mass index was 34 kg/m².

The primary outcome was rate of blood pressure control in the usual care vs. enhanced monitoring groups, and the usual care vs. lifestyle modification groups after 1 year.

At the end of follow-up, there was no difference in the rate of control between the usual care group and the enhanced monitoring group (62% vs. 64%). However, there was a significant difference in the rate of control between the usual care and the lifestyle modification groups (62% vs. 69%).

Again, Dr. Nguyen-Huynh said, it was tough to pinpoint any particular reason for the improvement. There was no apparent increase in compliance with antihypertensive medication. The Morisky scale, an 8-point self-reported measure of medication compliance, was not different from baseline. Participants didn’t report any big changes in salt intake or salt use in food. This was borne out in the 24-hour urine sodium screens, which were also not different from baseline. There were no significant weight changes and no changes in the use of outpatient primary care.

“What we can say is that it apparently worked,” she said. “This culturally appropriate, telephone-based lifestyle intervention, that focuses on the DASH eating plan, may be something that can help African-Americans with uncontrolled hypertension manage their condition.”

She added that Kaiser will continue to drill down in the data to discover the source of its benefit and follow the participants for at least another year to assess the longevity of the its clinical effect.

Dr. Nguyen-Huynh had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

HOUSTON – A personalized lifestyle coaching program focused on healthy eating increased blood pressure control by 7%, compared with usual care, among black patients with persistent hypertension.

A year after the program was instituted, the rate of blood pressure control was 69% in the intervention group, compared with 62% in the group that had the usual care offered to hypertensive patients, Mai Nguyen-Huynh, MD, said at the International Stroke Conference sponsored by the American Heart Association.

• “Shake” the salt habit.

• “Rattle” the intensity of the existing blood pressure control protocol.

• “Roll” out the results and incorporate into clinical practice.

The study was organized into three arms. Usual care was Kaiser’s typical intensified hypertension management. Patients filled out health and diet questionnaires and could voluntarily undergo a 24-hour urine sodium test.

The enhanced monitoring arm consisted of usual care, plus an in-person session with a nurse to discuss resources and possible barriers to treatment; regular blood pressure checks; intensification of pharmacotherapy, focusing on thiazides; and the addition of spironolactone for patients who had persistent hypertension despite being on three or more medications.

The lifestyle intervention arm consisted of usual care plus personalized coaching, both on the phone and in person. Participants could have up to 16 phone sessions with a specially trained counselor, with the option of bimonthly in-person group sessions.

These were accompanied by a workbook that emphasized healthy eating, from meal planning to shopping and cooking. Restaurant dining was tackled as well, including fast food and carryout. The workbook covered eight sessions. Each session ended with goal-setting for the next meeting, and opened with a review of how the prior month’s goals were accomplished.

Individualization was an important part of the lifestyle intervention program, Dr. Nguyen-Huynh said. Counselors didn’t strive to make each participant fit into a cookie-cutter solution. Instead, they worked as a team to build interventions that would work for each person.

The study group comprised 1,660 subjects. About 70% were women. Diabetes was common (about 33%), and around 10% had a history of coronary artery disease. The mean body mass index was 34 kg/m².

The primary outcome was rate of blood pressure control in the usual care vs. enhanced monitoring groups, and the usual care vs. lifestyle modification groups after 1 year.

At the end of follow-up, there was no difference in the rate of control between the usual care group and the enhanced monitoring group (62% vs. 64%). However, there was a significant difference in the rate of control between the usual care and the lifestyle modification groups (62% vs. 69%).

Again, Dr. Nguyen-Huynh said, it was tough to pinpoint any particular reason for the improvement. There was no apparent increase in compliance with antihypertensive medication. The Morisky scale, an 8-point self-reported measure of medication compliance, was not different from baseline. Participants didn’t report any big changes in salt intake or salt use in food. This was borne out in the 24-hour urine sodium screens, which were also not different from baseline. There were no significant weight changes and no changes in the use of outpatient primary care.

“What we can say is that it apparently worked,” she said. “This culturally appropriate, telephone-based lifestyle intervention, that focuses on the DASH eating plan, may be something that can help African-Americans with uncontrolled hypertension manage their condition.”

She added that Kaiser will continue to drill down in the data to discover the source of its benefit and follow the participants for at least another year to assess the longevity of the its clinical effect.

Dr. Nguyen-Huynh had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

HOUSTON – A personalized lifestyle coaching program focused on healthy eating increased blood pressure control by 7%, compared with usual care, among black patients with persistent hypertension.

A year after the program was instituted, the rate of blood pressure control was 69% in the intervention group, compared with 62% in the group that had the usual care offered to hypertensive patients, Mai Nguyen-Huynh, MD, said at the International Stroke Conference sponsored by the American Heart Association.

• “Shake” the salt habit.

• “Rattle” the intensity of the existing blood pressure control protocol.

• “Roll” out the results and incorporate into clinical practice.

The study was organized into three arms. Usual care was Kaiser’s typical intensified hypertension management. Patients filled out health and diet questionnaires and could voluntarily undergo a 24-hour urine sodium test.

The enhanced monitoring arm consisted of usual care, plus an in-person session with a nurse to discuss resources and possible barriers to treatment; regular blood pressure checks; intensification of pharmacotherapy, focusing on thiazides; and the addition of spironolactone for patients who had persistent hypertension despite being on three or more medications.

The lifestyle intervention arm consisted of usual care plus personalized coaching, both on the phone and in person. Participants could have up to 16 phone sessions with a specially trained counselor, with the option of bimonthly in-person group sessions.

These were accompanied by a workbook that emphasized healthy eating, from meal planning to shopping and cooking. Restaurant dining was tackled as well, including fast food and carryout. The workbook covered eight sessions. Each session ended with goal-setting for the next meeting, and opened with a review of how the prior month’s goals were accomplished.

Individualization was an important part of the lifestyle intervention program, Dr. Nguyen-Huynh said. Counselors didn’t strive to make each participant fit into a cookie-cutter solution. Instead, they worked as a team to build interventions that would work for each person.

The study group comprised 1,660 subjects. About 70% were women. Diabetes was common (about 33%), and around 10% had a history of coronary artery disease. The mean body mass index was 34 kg/m².

The primary outcome was rate of blood pressure control in the usual care vs. enhanced monitoring groups, and the usual care vs. lifestyle modification groups after 1 year.

At the end of follow-up, there was no difference in the rate of control between the usual care group and the enhanced monitoring group (62% vs. 64%). However, there was a significant difference in the rate of control between the usual care and the lifestyle modification groups (62% vs. 69%).

Again, Dr. Nguyen-Huynh said, it was tough to pinpoint any particular reason for the improvement. There was no apparent increase in compliance with antihypertensive medication. The Morisky scale, an 8-point self-reported measure of medication compliance, was not different from baseline. Participants didn’t report any big changes in salt intake or salt use in food. This was borne out in the 24-hour urine sodium screens, which were also not different from baseline. There were no significant weight changes and no changes in the use of outpatient primary care.

“What we can say is that it apparently worked,” she said. “This culturally appropriate, telephone-based lifestyle intervention, that focuses on the DASH eating plan, may be something that can help African-Americans with uncontrolled hypertension manage their condition.”

She added that Kaiser will continue to drill down in the data to discover the source of its benefit and follow the participants for at least another year to assess the longevity of the its clinical effect.

Dr. Nguyen-Huynh had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

SCOTTSDALE, ARIZ. – Most psychiatrists are familiar with many of the basic tenets of psychoanalysis, but they probably aren’t relying on its therapeutic powers in practice as much as they are pharmacotherapy, according to an expert.

“There’s a great deal of discussion about whether psychoanalysis has an adequate evidence base. That’s a popular concept. It’s not so much about whether practitioners want to use it, but whether or not they can defend using it in their dialogs with insurance companies, government agencies, and other sources of support,” Robert Michels, MD, a Walsh McDermott University Professor of Medicine, and professor of psychiatry, at Cornell University, New York, said at the annual meeting of the American College of Psychiatrists. “My summary is that it has less adequate data supporting it [than pharmacologic interventions]. … There is, however, convincing evidence that all of these treatments, ranging from cognitive-behavioral therapy to [dialectical behavior therapy], to dynamic psychoanalysis, to mentalization-based treatment, do have an effect.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – Most psychiatrists are familiar with many of the basic tenets of psychoanalysis, but they probably aren’t relying on its therapeutic powers in practice as much as they are pharmacotherapy, according to an expert.

“There’s a great deal of discussion about whether psychoanalysis has an adequate evidence base. That’s a popular concept. It’s not so much about whether practitioners want to use it, but whether or not they can defend using it in their dialogs with insurance companies, government agencies, and other sources of support,” Robert Michels, MD, a Walsh McDermott University Professor of Medicine, and professor of psychiatry, at Cornell University, New York, said at the annual meeting of the American College of Psychiatrists. “My summary is that it has less adequate data supporting it [than pharmacologic interventions]. … There is, however, convincing evidence that all of these treatments, ranging from cognitive-behavioral therapy to [dialectical behavior therapy], to dynamic psychoanalysis, to mentalization-based treatment, do have an effect.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – Most psychiatrists are familiar with many of the basic tenets of psychoanalysis, but they probably aren’t relying on its therapeutic powers in practice as much as they are pharmacotherapy, according to an expert.

“There’s a great deal of discussion about whether psychoanalysis has an adequate evidence base. That’s a popular concept. It’s not so much about whether practitioners want to use it, but whether or not they can defend using it in their dialogs with insurance companies, government agencies, and other sources of support,” Robert Michels, MD, a Walsh McDermott University Professor of Medicine, and professor of psychiatry, at Cornell University, New York, said at the annual meeting of the American College of Psychiatrists. “My summary is that it has less adequate data supporting it [than pharmacologic interventions]. … There is, however, convincing evidence that all of these treatments, ranging from cognitive-behavioral therapy to [dialectical behavior therapy], to dynamic psychoanalysis, to mentalization-based treatment, do have an effect.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

ORLANDO – Ibrutinib was associated with clinically meaningful and durable responses in patients with chronic graft-versus-host disease that did not respond to frontline systemic therapy, based on the final results of a phase II study.

Preliminary findings from that study led in 2016 to a Food and Drug Administration Breakthrough Therapy Designation for ibrutinib for chronic graft-versus-host disease (cGVHD) after the failure of one or more lines of systemic therapy, and the responses seen in this pretreated, high-risk population support the study of ibrutinib for frontline treatment of cGVHD, said David Miklos, MD, of Stanford (Calif.) University.

Sharon Worcester/Frontline Medical news

ORLANDO – Ibrutinib was associated with clinically meaningful and durable responses in patients with chronic graft-versus-host disease that did not respond to frontline systemic therapy, based on the final results of a phase II study.

Preliminary findings from that study led in 2016 to a Food and Drug Administration Breakthrough Therapy Designation for ibrutinib for chronic graft-versus-host disease (cGVHD) after the failure of one or more lines of systemic therapy, and the responses seen in this pretreated, high-risk population support the study of ibrutinib for frontline treatment of cGVHD, said David Miklos, MD, of Stanford (Calif.) University.

Sharon Worcester/Frontline Medical news

ORLANDO – Ibrutinib was associated with clinically meaningful and durable responses in patients with chronic graft-versus-host disease that did not respond to frontline systemic therapy, based on the final results of a phase II study.

Preliminary findings from that study led in 2016 to a Food and Drug Administration Breakthrough Therapy Designation for ibrutinib for chronic graft-versus-host disease (cGVHD) after the failure of one or more lines of systemic therapy, and the responses seen in this pretreated, high-risk population support the study of ibrutinib for frontline treatment of cGVHD, said David Miklos, MD, of Stanford (Calif.) University.

Sharon Worcester/Frontline Medical news

Patients with beta thalassemia major who were chelated only with oral deferasirox experienced significant improvements in liver stiffness, both from baseline and compared with patients who interrupted deferasirox therapy because of pregnancy, according to a small prospective 5-year study.

Transient elastography showed that continuous therapy with deferasirox (median dose, 35 mg per kg) yielded an 0.85 kPa average improvement in liver stiffness compared with baseline (P = .02), reported Nikolaos Sousos of Aristotle University of Thessaloniki, Greece, and his associates (Br J Haematol. 2017 Jan 20. doi: 10.1111/bjh.14509).

In contrast, interrupting therapy for a median of 16 months because of successful pregnancy led to an average increase in liver stiffness of 1.84 kPa – a significant difference between groups (P = .005) even after the researchers controlled for gender, age, ferritin levels, and T2-weighted magnetic resonance imaging (MRI) measurements of iron deposition in the liver and heart.

Patients with beta thalassemia major often develop liver fibrosis because of excessive intestinal iron absorption, iron overload from transfusions, or hepatitis C virus infection, the investigators noted. The median age of the patients in this study was 32 years (range, 20-47 years), they were HCV negative, and they received regular transfusions to maintain hemoglobin levels above 95 g/L. The seven female participants who temporarily stopped deferasirox because of pregnancy all restarted therapy at least 8 months before their follow-up transient elastography liver stiffness measurement, the investigators reported.

T2-weighted MRI measurements of liver iron concentration also had improved at follow-up, reflecting “better control of iron overload,” although the difference from baseline was not statistically significant, the investigators noted. This result reinforces previous findings (Gastroenterology. 2011;141[4]:1202-11) that long-term deferasirox therapy can significantly improve liver fibrosis in patients with beta thalassemia, regardless of liver iron concentration, the researchers added. Together, those findings suggest that “improvement in liver fibrosis, rather than liver iron concentration should be the primary effect of chelation therapy,” they suggested.

The Research Committee of Aristotle University of Thessaloniki, Novartis Hellas (Novartis AG, Basel, Switzerland), and the Greek Thalassaemia Association funded the study. The authors declared having no competing interests.

Patients with beta thalassemia major who were chelated only with oral deferasirox experienced significant improvements in liver stiffness, both from baseline and compared with patients who interrupted deferasirox therapy because of pregnancy, according to a small prospective 5-year study.

Transient elastography showed that continuous therapy with deferasirox (median dose, 35 mg per kg) yielded an 0.85 kPa average improvement in liver stiffness compared with baseline (P = .02), reported Nikolaos Sousos of Aristotle University of Thessaloniki, Greece, and his associates (Br J Haematol. 2017 Jan 20. doi: 10.1111/bjh.14509).

In contrast, interrupting therapy for a median of 16 months because of successful pregnancy led to an average increase in liver stiffness of 1.84 kPa – a significant difference between groups (P = .005) even after the researchers controlled for gender, age, ferritin levels, and T2-weighted magnetic resonance imaging (MRI) measurements of iron deposition in the liver and heart.

Patients with beta thalassemia major often develop liver fibrosis because of excessive intestinal iron absorption, iron overload from transfusions, or hepatitis C virus infection, the investigators noted. The median age of the patients in this study was 32 years (range, 20-47 years), they were HCV negative, and they received regular transfusions to maintain hemoglobin levels above 95 g/L. The seven female participants who temporarily stopped deferasirox because of pregnancy all restarted therapy at least 8 months before their follow-up transient elastography liver stiffness measurement, the investigators reported.

T2-weighted MRI measurements of liver iron concentration also had improved at follow-up, reflecting “better control of iron overload,” although the difference from baseline was not statistically significant, the investigators noted. This result reinforces previous findings (Gastroenterology. 2011;141[4]:1202-11) that long-term deferasirox therapy can significantly improve liver fibrosis in patients with beta thalassemia, regardless of liver iron concentration, the researchers added. Together, those findings suggest that “improvement in liver fibrosis, rather than liver iron concentration should be the primary effect of chelation therapy,” they suggested.

The Research Committee of Aristotle University of Thessaloniki, Novartis Hellas (Novartis AG, Basel, Switzerland), and the Greek Thalassaemia Association funded the study. The authors declared having no competing interests.

Patients with beta thalassemia major who were chelated only with oral deferasirox experienced significant improvements in liver stiffness, both from baseline and compared with patients who interrupted deferasirox therapy because of pregnancy, according to a small prospective 5-year study.

Transient elastography showed that continuous therapy with deferasirox (median dose, 35 mg per kg) yielded an 0.85 kPa average improvement in liver stiffness compared with baseline (P = .02), reported Nikolaos Sousos of Aristotle University of Thessaloniki, Greece, and his associates (Br J Haematol. 2017 Jan 20. doi: 10.1111/bjh.14509).

In contrast, interrupting therapy for a median of 16 months because of successful pregnancy led to an average increase in liver stiffness of 1.84 kPa – a significant difference between groups (P = .005) even after the researchers controlled for gender, age, ferritin levels, and T2-weighted magnetic resonance imaging (MRI) measurements of iron deposition in the liver and heart.

Patients with beta thalassemia major often develop liver fibrosis because of excessive intestinal iron absorption, iron overload from transfusions, or hepatitis C virus infection, the investigators noted. The median age of the patients in this study was 32 years (range, 20-47 years), they were HCV negative, and they received regular transfusions to maintain hemoglobin levels above 95 g/L. The seven female participants who temporarily stopped deferasirox because of pregnancy all restarted therapy at least 8 months before their follow-up transient elastography liver stiffness measurement, the investigators reported.

T2-weighted MRI measurements of liver iron concentration also had improved at follow-up, reflecting “better control of iron overload,” although the difference from baseline was not statistically significant, the investigators noted. This result reinforces previous findings (Gastroenterology. 2011;141[4]:1202-11) that long-term deferasirox therapy can significantly improve liver fibrosis in patients with beta thalassemia, regardless of liver iron concentration, the researchers added. Together, those findings suggest that “improvement in liver fibrosis, rather than liver iron concentration should be the primary effect of chelation therapy,” they suggested.

The Research Committee of Aristotle University of Thessaloniki, Novartis Hellas (Novartis AG, Basel, Switzerland), and the Greek Thalassaemia Association funded the study. The authors declared having no competing interests.

Mitoxantrone plus prednisone (MP) added to androgen deprivation therapy (ADT) does not improve outcomes in patients with clinically localized prostate cancer, according to the results of a large long-term multicenter clinical trial.

At a follow-up time of almost 11 years, outcomes were nearly the same whether patients had received chemotherapy and ADT or just ADT.

Overall survival was 87% in the cohort that received ADT only and 86% in the study arm that received ADT plus MP (HR 1.05 (CI 0.78, 1.42), P = .74). Recurrence-free survival was 84% in both groups (HR 0.98 (CI 0.78, 1.23), P = .83).

Disease free survival was 72% in both arms, and there was no statistical difference. Similarly, death without recurrence were also similar in both arms.

“Survival was greater than anticipated in both arms,” lead author L. Michael Glode, MD, of the University of Colorado, Denver, said in a press briefing held at the 2017 genitourinary cancers symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. “There is no evidence that MP improves prostate cancer specific survival when added to 2 years of adjuvant ADT.”

There were 85 deaths in the ADT arm compared to 91 in the chemotherapy arm. Prostate cancer accounted for 18% of deaths among the patients receiving ADT only and 22% in the chemotherapy arm, but the incidence of other cancers was twice as common in the chemotherapy arm as in the ADT only arm.

“The predominant cancers were GI and lung,” said Dr. Glode, “And noncancer deaths were variable.”

Of note, MP increased the incidence of leukemia (one case in the ADT group vs. five in the chemotherapy group).

“This trial demonstrates the feasibility of doing adjuvant trials in prostate cancer post radical prostatectomy,” said Dr. Glode. “Survival was greater than anticipated in both arms.”

The assumptions of this trial were that 2 years of adjuvant ADT would improve overall survival and progression-free survival although definitive data were unavailable.

The rationale for doing a study using adjuvant therapy was based on published literature, in which findings had showed that while short-term neoadjuvant ADT prior to prostatectomy reduced positive margins, it had no effect on disease-free survival. In addition, research had shown that longer-term ADT improved outcomes for patients undergoing curative radiation therapy.

For chemotherapy, Dr. Glode pointed to data showing that adjuvant chemotherapy improved progression-free survival in patients who had undergone both prostatectomy and radiation therapy.

“We hypothesized that the addition of modestly active chemotherapy earlier in disease might improve overall survival and progression-free survival,” he said.

The primary objective was overall survival and the secondary endpoint was disease-free survival.

The S9921 trial enrolled 983 patients from October 1999 to January 2007 with clinically localized prostate cancer, before enrollment ceased because of the increased incidence of leukemia in the ADT plus MP arm.

Of this group, 22 patients were ineligible, and the remaining patients were assigned to goserelin acetate 10.8 mg plus bicalutamide 50 mg (n = 481) or the same ADT plus MP (n = 480).

The patients were stratified by stage (≤pT2, ≥pT3, N0 or N+), Gleason score, and intent to receive adjuvant radiation, and the presurgical PSA was 7.6 ng/mL. Radiation therapy was allowed in both arms at physician discretion, and 26% intended to receive radiation therapy.

In the ADT only arm, 402 completed the treatment, and 390 completed treatment in the ADT plus chemotherapy arm.

Grade 3 or higher adverse events were more common in the chemotherapy group (56%/30%, P less than .0001). “As for toxicities, the main difference was the presence of leukopenia in the chemotherapy arm,” said Dr. Glode.

The study was funded by Southwest Oncology Group’s Urologic Cancer Outreach Program, Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, Clinical Trials Support Unit, and National Cancer Institute. None of the authors had disclosures.

Mitoxantrone plus prednisone (MP) added to androgen deprivation therapy (ADT) does not improve outcomes in patients with clinically localized prostate cancer, according to the results of a large long-term multicenter clinical trial.

At a follow-up time of almost 11 years, outcomes were nearly the same whether patients had received chemotherapy and ADT or just ADT.

Overall survival was 87% in the cohort that received ADT only and 86% in the study arm that received ADT plus MP (HR 1.05 (CI 0.78, 1.42), P = .74). Recurrence-free survival was 84% in both groups (HR 0.98 (CI 0.78, 1.23), P = .83).

Disease free survival was 72% in both arms, and there was no statistical difference. Similarly, death without recurrence were also similar in both arms.

“Survival was greater than anticipated in both arms,” lead author L. Michael Glode, MD, of the University of Colorado, Denver, said in a press briefing held at the 2017 genitourinary cancers symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. “There is no evidence that MP improves prostate cancer specific survival when added to 2 years of adjuvant ADT.”

There were 85 deaths in the ADT arm compared to 91 in the chemotherapy arm. Prostate cancer accounted for 18% of deaths among the patients receiving ADT only and 22% in the chemotherapy arm, but the incidence of other cancers was twice as common in the chemotherapy arm as in the ADT only arm.

“The predominant cancers were GI and lung,” said Dr. Glode, “And noncancer deaths were variable.”

Of note, MP increased the incidence of leukemia (one case in the ADT group vs. five in the chemotherapy group).

“This trial demonstrates the feasibility of doing adjuvant trials in prostate cancer post radical prostatectomy,” said Dr. Glode. “Survival was greater than anticipated in both arms.”

The assumptions of this trial were that 2 years of adjuvant ADT would improve overall survival and progression-free survival although definitive data were unavailable.

The rationale for doing a study using adjuvant therapy was based on published literature, in which findings had showed that while short-term neoadjuvant ADT prior to prostatectomy reduced positive margins, it had no effect on disease-free survival. In addition, research had shown that longer-term ADT improved outcomes for patients undergoing curative radiation therapy.

For chemotherapy, Dr. Glode pointed to data showing that adjuvant chemotherapy improved progression-free survival in patients who had undergone both prostatectomy and radiation therapy.

“We hypothesized that the addition of modestly active chemotherapy earlier in disease might improve overall survival and progression-free survival,” he said.

The primary objective was overall survival and the secondary endpoint was disease-free survival.

The S9921 trial enrolled 983 patients from October 1999 to January 2007 with clinically localized prostate cancer, before enrollment ceased because of the increased incidence of leukemia in the ADT plus MP arm.

Of this group, 22 patients were ineligible, and the remaining patients were assigned to goserelin acetate 10.8 mg plus bicalutamide 50 mg (n = 481) or the same ADT plus MP (n = 480).

The patients were stratified by stage (≤pT2, ≥pT3, N0 or N+), Gleason score, and intent to receive adjuvant radiation, and the presurgical PSA was 7.6 ng/mL. Radiation therapy was allowed in both arms at physician discretion, and 26% intended to receive radiation therapy.

In the ADT only arm, 402 completed the treatment, and 390 completed treatment in the ADT plus chemotherapy arm.

Grade 3 or higher adverse events were more common in the chemotherapy group (56%/30%, P less than .0001). “As for toxicities, the main difference was the presence of leukopenia in the chemotherapy arm,” said Dr. Glode.

The study was funded by Southwest Oncology Group’s Urologic Cancer Outreach Program, Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, Clinical Trials Support Unit, and National Cancer Institute. None of the authors had disclosures.

Mitoxantrone plus prednisone (MP) added to androgen deprivation therapy (ADT) does not improve outcomes in patients with clinically localized prostate cancer, according to the results of a large long-term multicenter clinical trial.

At a follow-up time of almost 11 years, outcomes were nearly the same whether patients had received chemotherapy and ADT or just ADT.

Overall survival was 87% in the cohort that received ADT only and 86% in the study arm that received ADT plus MP (HR 1.05 (CI 0.78, 1.42), P = .74). Recurrence-free survival was 84% in both groups (HR 0.98 (CI 0.78, 1.23), P = .83).

Disease free survival was 72% in both arms, and there was no statistical difference. Similarly, death without recurrence were also similar in both arms.

“Survival was greater than anticipated in both arms,” lead author L. Michael Glode, MD, of the University of Colorado, Denver, said in a press briefing held at the 2017 genitourinary cancers symposium sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology. “There is no evidence that MP improves prostate cancer specific survival when added to 2 years of adjuvant ADT.”

There were 85 deaths in the ADT arm compared to 91 in the chemotherapy arm. Prostate cancer accounted for 18% of deaths among the patients receiving ADT only and 22% in the chemotherapy arm, but the incidence of other cancers was twice as common in the chemotherapy arm as in the ADT only arm.

“The predominant cancers were GI and lung,” said Dr. Glode, “And noncancer deaths were variable.”

Of note, MP increased the incidence of leukemia (one case in the ADT group vs. five in the chemotherapy group).

“This trial demonstrates the feasibility of doing adjuvant trials in prostate cancer post radical prostatectomy,” said Dr. Glode. “Survival was greater than anticipated in both arms.”

The assumptions of this trial were that 2 years of adjuvant ADT would improve overall survival and progression-free survival although definitive data were unavailable.

The rationale for doing a study using adjuvant therapy was based on published literature, in which findings had showed that while short-term neoadjuvant ADT prior to prostatectomy reduced positive margins, it had no effect on disease-free survival. In addition, research had shown that longer-term ADT improved outcomes for patients undergoing curative radiation therapy.

For chemotherapy, Dr. Glode pointed to data showing that adjuvant chemotherapy improved progression-free survival in patients who had undergone both prostatectomy and radiation therapy.

“We hypothesized that the addition of modestly active chemotherapy earlier in disease might improve overall survival and progression-free survival,” he said.

The primary objective was overall survival and the secondary endpoint was disease-free survival.

The S9921 trial enrolled 983 patients from October 1999 to January 2007 with clinically localized prostate cancer, before enrollment ceased because of the increased incidence of leukemia in the ADT plus MP arm.

Of this group, 22 patients were ineligible, and the remaining patients were assigned to goserelin acetate 10.8 mg plus bicalutamide 50 mg (n = 481) or the same ADT plus MP (n = 480).

The patients were stratified by stage (≤pT2, ≥pT3, N0 or N+), Gleason score, and intent to receive adjuvant radiation, and the presurgical PSA was 7.6 ng/mL. Radiation therapy was allowed in both arms at physician discretion, and 26% intended to receive radiation therapy.

In the ADT only arm, 402 completed the treatment, and 390 completed treatment in the ADT plus chemotherapy arm.

Grade 3 or higher adverse events were more common in the chemotherapy group (56%/30%, P less than .0001). “As for toxicities, the main difference was the presence of leukopenia in the chemotherapy arm,” said Dr. Glode.

The study was funded by Southwest Oncology Group’s Urologic Cancer Outreach Program, Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, Clinical Trials Support Unit, and National Cancer Institute. None of the authors had disclosures.

A rapid point-of-care assay for acetaminophen-related liver toxicity had a sensitivity of 100% and a specificity of 86%, compared with etiologic diagnosis, based on the results of a multicenter study published in the April issue of Clinical Gastroenterology and Hepatology.

The test might help guide treatment decisions for these patients in the emergency department and intensive care unit, said Dean W. Roberts, PhD, of the University of Arkansas, Little Rock, and his associates.

About 45% of acute liver failure cases in the United States stem from acetaminophen toxicity, but the diagnosis can be hard to confirm because the drug has a short half-life and patients often cannot or will not report an overdose, which also may consist of multiple exposures, limiting the interpretability of the Rumack nonogram. High-pressure liquid chromatography with electrochemical detection (HPLC-EC) accurately detects acetaminophen-protein adducts (3-[cysteine-S-yl] acetaminophen) released by lysed hepatocytes into the peripheral circulation, but this test requires specialized equipment and skilled personnel, the researchers noted (Clin Gastroenterol Hepatol. 2016 Sep 15. doi: 10.1016/j.cgh.2016.09.007).

ironstealth/Thinkstock

Source: American Gastroenterological Association

A rapid point-of-care assay for acetaminophen-related liver toxicity had a sensitivity of 100% and a specificity of 86%, compared with etiologic diagnosis, based on the results of a multicenter study published in the April issue of Clinical Gastroenterology and Hepatology.

The test might help guide treatment decisions for these patients in the emergency department and intensive care unit, said Dean W. Roberts, PhD, of the University of Arkansas, Little Rock, and his associates.

About 45% of acute liver failure cases in the United States stem from acetaminophen toxicity, but the diagnosis can be hard to confirm because the drug has a short half-life and patients often cannot or will not report an overdose, which also may consist of multiple exposures, limiting the interpretability of the Rumack nonogram. High-pressure liquid chromatography with electrochemical detection (HPLC-EC) accurately detects acetaminophen-protein adducts (3-[cysteine-S-yl] acetaminophen) released by lysed hepatocytes into the peripheral circulation, but this test requires specialized equipment and skilled personnel, the researchers noted (Clin Gastroenterol Hepatol. 2016 Sep 15. doi: 10.1016/j.cgh.2016.09.007).

ironstealth/Thinkstock

Source: American Gastroenterological Association

A rapid point-of-care assay for acetaminophen-related liver toxicity had a sensitivity of 100% and a specificity of 86%, compared with etiologic diagnosis, based on the results of a multicenter study published in the April issue of Clinical Gastroenterology and Hepatology.

The test might help guide treatment decisions for these patients in the emergency department and intensive care unit, said Dean W. Roberts, PhD, of the University of Arkansas, Little Rock, and his associates.

About 45% of acute liver failure cases in the United States stem from acetaminophen toxicity, but the diagnosis can be hard to confirm because the drug has a short half-life and patients often cannot or will not report an overdose, which also may consist of multiple exposures, limiting the interpretability of the Rumack nonogram. High-pressure liquid chromatography with electrochemical detection (HPLC-EC) accurately detects acetaminophen-protein adducts (3-[cysteine-S-yl] acetaminophen) released by lysed hepatocytes into the peripheral circulation, but this test requires specialized equipment and skilled personnel, the researchers noted (Clin Gastroenterol Hepatol. 2016 Sep 15. doi: 10.1016/j.cgh.2016.09.007).

ironstealth/Thinkstock

Source: American Gastroenterological Association

In his first address to a joint session of Congress, President Donald Trump promised “heroic veterans will get the care they so desperately need,” that he would eliminate the defense sequester, and called for “one of the largest increases in national defense spending in American history.”

“This looks like an increase in resources for us,” VA Secretary David Shulkin, MD, is reported to have told reporters early in the day at an American Legion meeting. “I'm confident this budget is going to reflect the President’s commitment to his ability to deliver on his promises to make veterans care better and stronger.” According to reports, the White House already has approved 37,000 exemptions from the federal hiring ban to help fill the VA’s  45,000 current job vacancies.

Reports also suggest that the military will receive an additional $54 billion in funding, a 10% increase. Details of where that extra money will go have not been released. The President’s military budget is less than the $640 billion budget proposed by Senator John McCain (R- AZ) and represents a 3% increase over the budget that had been projected by President Obama.

The overall impact on federal health care remains unclear. While President Trump held to his promise to repeal and replace the Affordable Care Act, to “invest in women’s health,” and to “give our state governors the resources and flexibility they need with Medicaid to make sure no one is left out,” there were few details of how those promises would be implemented and where the funding will come from.

In the address, the President outlined 4 necessary elements of an Affordable Care Act replacement:

1.  Americans with pre-existing conditions would have access to coverage, and a stable transition for health care exchanges enrollees;
2. The use of tax credits and savings accounts for purchasing private insurance;
3. Flexibility for states to expand Medicaid coverage; and
4. Legal reforms that “protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately.”

The FDA also drew the President’s attention. Calling the approval process “slow and burdensome,” the President charged that the FDA “keeps too many advances… from reaching those in need.” The agency is still waiting on a nomination for its commissioner position, and it is unclear how it can speed up approval while under the federal hiring freeze.

Recognizing the devastation of opioid addiction, the President also promised to “stop the drugs from pouring into our country and poisoning our youth, and we will expand treatment for those who have become so badly addicted.” The President did not specify whether treatment resources would be exempt from the hiring freeze, incorporated into the Affordable Care Act, or handled in a different manner.

In his first address to a joint session of Congress, President Donald Trump promised “heroic veterans will get the care they so desperately need,” that he would eliminate the defense sequester, and called for “one of the largest increases in national defense spending in American history.”

“This looks like an increase in resources for us,” VA Secretary David Shulkin, MD, is reported to have told reporters early in the day at an American Legion meeting. “I'm confident this budget is going to reflect the President’s commitment to his ability to deliver on his promises to make veterans care better and stronger.” According to reports, the White House already has approved 37,000 exemptions from the federal hiring ban to help fill the VA’s  45,000 current job vacancies.

Reports also suggest that the military will receive an additional $54 billion in funding, a 10% increase. Details of where that extra money will go have not been released. The President’s military budget is less than the $640 billion budget proposed by Senator John McCain (R- AZ) and represents a 3% increase over the budget that had been projected by President Obama.

The overall impact on federal health care remains unclear. While President Trump held to his promise to repeal and replace the Affordable Care Act, to “invest in women’s health,” and to “give our state governors the resources and flexibility they need with Medicaid to make sure no one is left out,” there were few details of how those promises would be implemented and where the funding will come from.

In the address, the President outlined 4 necessary elements of an Affordable Care Act replacement:

1.  Americans with pre-existing conditions would have access to coverage, and a stable transition for health care exchanges enrollees;
2. The use of tax credits and savings accounts for purchasing private insurance;
3. Flexibility for states to expand Medicaid coverage; and
4. Legal reforms that “protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately.”

The FDA also drew the President’s attention. Calling the approval process “slow and burdensome,” the President charged that the FDA “keeps too many advances… from reaching those in need.” The agency is still waiting on a nomination for its commissioner position, and it is unclear how it can speed up approval while under the federal hiring freeze.

Recognizing the devastation of opioid addiction, the President also promised to “stop the drugs from pouring into our country and poisoning our youth, and we will expand treatment for those who have become so badly addicted.” The President did not specify whether treatment resources would be exempt from the hiring freeze, incorporated into the Affordable Care Act, or handled in a different manner.

In his first address to a joint session of Congress, President Donald Trump promised “heroic veterans will get the care they so desperately need,” that he would eliminate the defense sequester, and called for “one of the largest increases in national defense spending in American history.”

“This looks like an increase in resources for us,” VA Secretary David Shulkin, MD, is reported to have told reporters early in the day at an American Legion meeting. “I'm confident this budget is going to reflect the President’s commitment to his ability to deliver on his promises to make veterans care better and stronger.” According to reports, the White House already has approved 37,000 exemptions from the federal hiring ban to help fill the VA’s  45,000 current job vacancies.

Reports also suggest that the military will receive an additional $54 billion in funding, a 10% increase. Details of where that extra money will go have not been released. The President’s military budget is less than the $640 billion budget proposed by Senator John McCain (R- AZ) and represents a 3% increase over the budget that had been projected by President Obama.

The overall impact on federal health care remains unclear. While President Trump held to his promise to repeal and replace the Affordable Care Act, to “invest in women’s health,” and to “give our state governors the resources and flexibility they need with Medicaid to make sure no one is left out,” there were few details of how those promises would be implemented and where the funding will come from.

In the address, the President outlined 4 necessary elements of an Affordable Care Act replacement:

1.  Americans with pre-existing conditions would have access to coverage, and a stable transition for health care exchanges enrollees;
2. The use of tax credits and savings accounts for purchasing private insurance;
3. Flexibility for states to expand Medicaid coverage; and
4. Legal reforms that “protect patients and doctors from unnecessary costs that drive up the price of insurance and work to bring down the artificially high price of drugs and bring them down immediately.”

The FDA also drew the President’s attention. Calling the approval process “slow and burdensome,” the President charged that the FDA “keeps too many advances… from reaching those in need.” The agency is still waiting on a nomination for its commissioner position, and it is unclear how it can speed up approval while under the federal hiring freeze.

Recognizing the devastation of opioid addiction, the President also promised to “stop the drugs from pouring into our country and poisoning our youth, and we will expand treatment for those who have become so badly addicted.” The President did not specify whether treatment resources would be exempt from the hiring freeze, incorporated into the Affordable Care Act, or handled in a different manner.