Are you interested in growing professionally and getting involved in work that you are excited about with colleagues across the country? You are in the driver’s seat as a hospitalist. You are in a position to lead, initiate quality improvement, impact patient outcomes, and advocate for your patients and your specialty in healthcare legislation.

SHM offers a wealth of volunteer experiences that will grow your strengths and interests, sharpen your professional acumen, and enhance your profile. New engagement opportunities are added regularly and represent unique ways to make a difference in hospital medicine. Check out some highlights:

These are just a few potential opportunities available from SHM. To learn more and find one that fits your interests, visit hospitalmedicine.org/professionalgrowth.

Are you interested in growing professionally and getting involved in work that you are excited about with colleagues across the country? You are in the driver’s seat as a hospitalist. You are in a position to lead, initiate quality improvement, impact patient outcomes, and advocate for your patients and your specialty in healthcare legislation.

SHM offers a wealth of volunteer experiences that will grow your strengths and interests, sharpen your professional acumen, and enhance your profile. New engagement opportunities are added regularly and represent unique ways to make a difference in hospital medicine. Check out some highlights:

These are just a few potential opportunities available from SHM. To learn more and find one that fits your interests, visit hospitalmedicine.org/professionalgrowth.

Are you interested in growing professionally and getting involved in work that you are excited about with colleagues across the country? You are in the driver’s seat as a hospitalist. You are in a position to lead, initiate quality improvement, impact patient outcomes, and advocate for your patients and your specialty in healthcare legislation.

SHM offers a wealth of volunteer experiences that will grow your strengths and interests, sharpen your professional acumen, and enhance your profile. New engagement opportunities are added regularly and represent unique ways to make a difference in hospital medicine. Check out some highlights:

These are just a few potential opportunities available from SHM. To learn more and find one that fits your interests, visit hospitalmedicine.org/professionalgrowth.

In November, Barbara Weisenbach took a new job as practice manager for the hospitalist group at Northwest Hospital in Seattle. She’s an experienced administrator but as for hospital medicine, not so much. And she is the group’s first full-fledged practice manager—as in, she’s not a physician taking on admin responsibilities and seeing a partial census.

She’s doing a lot of reshaping and a lot of learning, she said, standing outside Room 10 of the San Diego Convention Center, where a daylong pre-course on practice management was being held at SHM’s annual meeting.

“There have been a lot of business things that have been overlooked and not addressed ever before,” she said.

The pre-course, “The Highly Effective Hospital Medicine Group: Using SHM’s Key Characteristics to Drive Performance,” was led by John Nelson, MD, MHM, and Leslie Flores, MHA, SFHM, and offered one useful lesson after another, Weisenbach said.

“One of the most practical portions of the session this morning was about dashboards, which is something I’m currently working on and could definitely use some insight,” Weisenbach said, adding that a list of metrics a dashboard should include and general guidelines on effective dashboards were things she’ll find useful in her own implementation.

The pre-course expanded on the key principles and traits for effective groups, including effective leadership, engaged hospitalists, adequate resources, alignment with the hospital, and care coordination across settings.

HM16 also included two and a half days of practice management sessions. Plus, management themes were woven through workshops and sprinkled into other sessions.

In one session on handling change, presenters used a surfing analogy: Like a surfer’s intensity just before riding a wave, a laser focus is called for when the moment arrives to execute change.

“Get ready for the ride,” said Steve Behnke, MD, president of Columbus, Ohio–based MedOne Hospital Physicians.

He discussed details of introducing the electronic health record system Epic at their group. There was 18 months of planning involving the practice’s whole operational team, then a doubling of the staffing ratios when the system went live, followed by catered lunches to gather feedback and identify problems.

Presenters emphasized the idea of agility in responding to obstacles and realizing that change affects everyone. Successful change, they said, involves seeing the process from all perspectives and leaders should expect resistance.

“Court them. Listen to them. I can’t tell you how many times I’ve done that,” said Dea Robinson, MA, MedOne’s vice president of operations. “Just listening and giving a platform.”

Back at the pre-course, Dr. Nelson, a hospital medicine consultant, talked about the importance of effective leadership.

“An effective group leader is a really key element of a successful group,” said The Hospitalist’s resident practice management columnist. “I’ve worked on-site with many hundreds of hospitalist groups around the country. There’s pretty good correlation between the effectiveness of the leader and the success of the group overall. But a good leader alone is not enough.”

He added that there are too “few leaders to go around.”

A good leader is an active one, he said, adding with funny-because-it’s-true humor that a lot of leaders say their main job is to make the schedule. Good leaders, he said, need to be focused on making the group high-functioning, should be available for administrative work even when not on a clinical shift, and must be able to delegate.

Another critical ingredient for a successful group, he said, is having engaged frontline hospitalists. Reviews need to be meaningful, and meetings should be held regularly with attendance essentially mandatory. Meetings, he said, might need a “tune-up,” with actual voting, written agendas, minutes taken, and group problem-solving above one-way information.

Win Whitcomb, MD, MHM, on care coordination, said the relationship with primary care physicians is crucial though difficult.

“I think we have to go out of our way to build relationships,” he said. “And we don’t have occasion to see them, so we need to figure out a way to get to know our community.”

He suggested:

• Having dedicated transcriptionists for hospitalists,
• Tracking the rate at which discharge summaries are generated within 24 hours,
• Making sure PCPs know how to reach hospitalists, and
• Scheduling events—perhaps an annual event—for meeting PCPs and skill-nursing facility healthcare professionals.

It was clear that, in a field whose dimensions seem to be changing all the time, practice management remained a top interest at HM16. Robert Clothier, RN, a practice manager for the hospitalist group at ThedaCare in Wisconsin, recently switched from managing a cardiology clinic. He said there were huge differences in hospital medicine.

“The profession is growing so fast, and really nobody knows where the end is,” he said. “I can’t even think of anything where you could say, ‘Well, no, they’ll never do that.’ It’s endless. That’s going to be hardest thing. People are going to be pulling on us, and leadership from the hospital is going to be saying, ‘You guys need to do this.’

“So how can I control what we pick, and how can I make sure that we have the resources to do it?” TH

In November, Barbara Weisenbach took a new job as practice manager for the hospitalist group at Northwest Hospital in Seattle. She’s an experienced administrator but as for hospital medicine, not so much. And she is the group’s first full-fledged practice manager—as in, she’s not a physician taking on admin responsibilities and seeing a partial census.

She’s doing a lot of reshaping and a lot of learning, she said, standing outside Room 10 of the San Diego Convention Center, where a daylong pre-course on practice management was being held at SHM’s annual meeting.

“There have been a lot of business things that have been overlooked and not addressed ever before,” she said.

The pre-course, “The Highly Effective Hospital Medicine Group: Using SHM’s Key Characteristics to Drive Performance,” was led by John Nelson, MD, MHM, and Leslie Flores, MHA, SFHM, and offered one useful lesson after another, Weisenbach said.

“One of the most practical portions of the session this morning was about dashboards, which is something I’m currently working on and could definitely use some insight,” Weisenbach said, adding that a list of metrics a dashboard should include and general guidelines on effective dashboards were things she’ll find useful in her own implementation.

The pre-course expanded on the key principles and traits for effective groups, including effective leadership, engaged hospitalists, adequate resources, alignment with the hospital, and care coordination across settings.

HM16 also included two and a half days of practice management sessions. Plus, management themes were woven through workshops and sprinkled into other sessions.

In one session on handling change, presenters used a surfing analogy: Like a surfer’s intensity just before riding a wave, a laser focus is called for when the moment arrives to execute change.

“Get ready for the ride,” said Steve Behnke, MD, president of Columbus, Ohio–based MedOne Hospital Physicians.

He discussed details of introducing the electronic health record system Epic at their group. There was 18 months of planning involving the practice’s whole operational team, then a doubling of the staffing ratios when the system went live, followed by catered lunches to gather feedback and identify problems.

Presenters emphasized the idea of agility in responding to obstacles and realizing that change affects everyone. Successful change, they said, involves seeing the process from all perspectives and leaders should expect resistance.

“Court them. Listen to them. I can’t tell you how many times I’ve done that,” said Dea Robinson, MA, MedOne’s vice president of operations. “Just listening and giving a platform.”

Back at the pre-course, Dr. Nelson, a hospital medicine consultant, talked about the importance of effective leadership.

“An effective group leader is a really key element of a successful group,” said The Hospitalist’s resident practice management columnist. “I’ve worked on-site with many hundreds of hospitalist groups around the country. There’s pretty good correlation between the effectiveness of the leader and the success of the group overall. But a good leader alone is not enough.”

He added that there are too “few leaders to go around.”

A good leader is an active one, he said, adding with funny-because-it’s-true humor that a lot of leaders say their main job is to make the schedule. Good leaders, he said, need to be focused on making the group high-functioning, should be available for administrative work even when not on a clinical shift, and must be able to delegate.

Another critical ingredient for a successful group, he said, is having engaged frontline hospitalists. Reviews need to be meaningful, and meetings should be held regularly with attendance essentially mandatory. Meetings, he said, might need a “tune-up,” with actual voting, written agendas, minutes taken, and group problem-solving above one-way information.

Win Whitcomb, MD, MHM, on care coordination, said the relationship with primary care physicians is crucial though difficult.

“I think we have to go out of our way to build relationships,” he said. “And we don’t have occasion to see them, so we need to figure out a way to get to know our community.”

He suggested:

• Having dedicated transcriptionists for hospitalists,
• Tracking the rate at which discharge summaries are generated within 24 hours,
• Making sure PCPs know how to reach hospitalists, and
• Scheduling events—perhaps an annual event—for meeting PCPs and skill-nursing facility healthcare professionals.

It was clear that, in a field whose dimensions seem to be changing all the time, practice management remained a top interest at HM16. Robert Clothier, RN, a practice manager for the hospitalist group at ThedaCare in Wisconsin, recently switched from managing a cardiology clinic. He said there were huge differences in hospital medicine.

“The profession is growing so fast, and really nobody knows where the end is,” he said. “I can’t even think of anything where you could say, ‘Well, no, they’ll never do that.’ It’s endless. That’s going to be hardest thing. People are going to be pulling on us, and leadership from the hospital is going to be saying, ‘You guys need to do this.’

“So how can I control what we pick, and how can I make sure that we have the resources to do it?” TH

In November, Barbara Weisenbach took a new job as practice manager for the hospitalist group at Northwest Hospital in Seattle. She’s an experienced administrator but as for hospital medicine, not so much. And she is the group’s first full-fledged practice manager—as in, she’s not a physician taking on admin responsibilities and seeing a partial census.

She’s doing a lot of reshaping and a lot of learning, she said, standing outside Room 10 of the San Diego Convention Center, where a daylong pre-course on practice management was being held at SHM’s annual meeting.

“There have been a lot of business things that have been overlooked and not addressed ever before,” she said.

The pre-course, “The Highly Effective Hospital Medicine Group: Using SHM’s Key Characteristics to Drive Performance,” was led by John Nelson, MD, MHM, and Leslie Flores, MHA, SFHM, and offered one useful lesson after another, Weisenbach said.

“One of the most practical portions of the session this morning was about dashboards, which is something I’m currently working on and could definitely use some insight,” Weisenbach said, adding that a list of metrics a dashboard should include and general guidelines on effective dashboards were things she’ll find useful in her own implementation.

The pre-course expanded on the key principles and traits for effective groups, including effective leadership, engaged hospitalists, adequate resources, alignment with the hospital, and care coordination across settings.

HM16 also included two and a half days of practice management sessions. Plus, management themes were woven through workshops and sprinkled into other sessions.

In one session on handling change, presenters used a surfing analogy: Like a surfer’s intensity just before riding a wave, a laser focus is called for when the moment arrives to execute change.

“Get ready for the ride,” said Steve Behnke, MD, president of Columbus, Ohio–based MedOne Hospital Physicians.

He discussed details of introducing the electronic health record system Epic at their group. There was 18 months of planning involving the practice’s whole operational team, then a doubling of the staffing ratios when the system went live, followed by catered lunches to gather feedback and identify problems.

Presenters emphasized the idea of agility in responding to obstacles and realizing that change affects everyone. Successful change, they said, involves seeing the process from all perspectives and leaders should expect resistance.

“Court them. Listen to them. I can’t tell you how many times I’ve done that,” said Dea Robinson, MA, MedOne’s vice president of operations. “Just listening and giving a platform.”

Back at the pre-course, Dr. Nelson, a hospital medicine consultant, talked about the importance of effective leadership.

“An effective group leader is a really key element of a successful group,” said The Hospitalist’s resident practice management columnist. “I’ve worked on-site with many hundreds of hospitalist groups around the country. There’s pretty good correlation between the effectiveness of the leader and the success of the group overall. But a good leader alone is not enough.”

He added that there are too “few leaders to go around.”

A good leader is an active one, he said, adding with funny-because-it’s-true humor that a lot of leaders say their main job is to make the schedule. Good leaders, he said, need to be focused on making the group high-functioning, should be available for administrative work even when not on a clinical shift, and must be able to delegate.

Another critical ingredient for a successful group, he said, is having engaged frontline hospitalists. Reviews need to be meaningful, and meetings should be held regularly with attendance essentially mandatory. Meetings, he said, might need a “tune-up,” with actual voting, written agendas, minutes taken, and group problem-solving above one-way information.

Win Whitcomb, MD, MHM, on care coordination, said the relationship with primary care physicians is crucial though difficult.

“I think we have to go out of our way to build relationships,” he said. “And we don’t have occasion to see them, so we need to figure out a way to get to know our community.”

He suggested:

• Having dedicated transcriptionists for hospitalists,
• Tracking the rate at which discharge summaries are generated within 24 hours,
• Making sure PCPs know how to reach hospitalists, and
• Scheduling events—perhaps an annual event—for meeting PCPs and skill-nursing facility healthcare professionals.

It was clear that, in a field whose dimensions seem to be changing all the time, practice management remained a top interest at HM16. Robert Clothier, RN, a practice manager for the hospitalist group at ThedaCare in Wisconsin, recently switched from managing a cardiology clinic. He said there were huge differences in hospital medicine.

“The profession is growing so fast, and really nobody knows where the end is,” he said. “I can’t even think of anything where you could say, ‘Well, no, they’ll never do that.’ It’s endless. That’s going to be hardest thing. People are going to be pulling on us, and leadership from the hospital is going to be saying, ‘You guys need to do this.’

“So how can I control what we pick, and how can I make sure that we have the resources to do it?” TH

NEW YORK (Reuters Health) - The prevalence of antibiotic resistance in pediatric urinary tract infection (UTI) has reached such high levels in many countries that existing empiric therapies may no longer be effective, researchers from UK report."

Prevalence of resistance to commonly prescribed antibiotics in primary care in children with urinary tract infections caused by E. coli is high, and there was remarkable variability in E. coli resistance among countries in the study, particularly in countries outside the OECD (Organization for Economic Cooperation and Development), where one possible explanation is the availability of antibiotics over the counter," Ashley Bryce from the University of Bristol in the U.K. and Dr. Céire E. Costelloe from Imperial College London told Reuters Health in a joint email.

"This could render some antibiotics ineffective as first-line treatments for urinary tract infection," they said.

E. coli is responsible for more than 80% of all UTIs and is also the most common cause of bacteremia and foodborne infections and one cause of meningitis in neonates.

Bryce, Dr. Costelloe, and colleagues investigated the prevalence of resistance in community-acquired E. coli UTI to the most commonly prescribed antibiotics given to children in primary care in their systematic review of 58 published reports.

For all antibiotics tested, the prevalence of antibiotic resistance was higher in non-OECD countries than in OECD countries, the team reports in an article online March 15 in The BMJ.

The prevalence of resistance was highest for ampicillin, ranging from 41% in Switzerland to 100% in Ghana and Nigeria.

Resistance to co-trimoxazole and trimethoprim was 30% in OECD countries and 67% in Saudi Arabia, the only non-OECD country for which rates were available.

Pooled prevalences of resistance to ciprofloxacin and ceftazidime were around 2% in OECD countries but over 26% in non-OECD countries.

For all time periods analyzed, the odds of resistance were greater in children exposed to antibiotics than in those who were unexposed.

"The Infectious Diseases Society of America (IDSA) in collaboration with the European Society for Microbiology and Infectious Diseases (ESCMID) recommend that an antibiotic should be selected for first line empirical treatment of urinary tract infection only if the local prevalence of resistance is less than 20%," the researchers note.

"According to these guidelines, our review suggests ampicillin, co-trimoxazole, and trimethoprim are no longer suitable first line treatment options for urinary tract infection in many OECD countries and that as a result many guidelines, such as those published by the National Institute for Health and Care Excellence (NICE), might need updating," they write. "In non-OECD countries, resistance to all first line antibiotics specified for urinary tract infections was in excess of 20%, suggesting that choices of first line treatment might need to be re-evaluated in less well developed countries."

"We are not able to advise clinicians on which antibiotic is best to prescribe as this often depends on the individual case," Bryce and Dr. Costelloe said. "Clinicians should, however, adhere to local or national guidelines wherever possible, which is why it is of great importance that such guidelines are kept up to date and reflect current resistance rates."

"Clinicians may also wish to consider the antibiotic history of the child when they present to primary care with symptoms of an infection, especially in light of the suggestion of our results that previous treatment with an antibiotic is associated with resistance to that same antibiotic, and that this association may be present up to 6 months post treatment," they added.

Dr. Grant Russell from Monash University in Melbourne, Australia, wrote an editorial accompanying the report. He told Reuters Health by email, "I found the extent of the resistance (and the fact that it covered all of the regularly used empiric antibiotics) both concerning and surprising. The fact that choices are diminishing is disturbing, and the fact that the situation is dire in the developing world is deeply troubling."

"We need to do what we can do to prevent bacterial infections, and when treating them to consider that effective antibiotics are a finite resource," he said. "We all have a responsibility in attempting to conserve that resource."

"No new classes of antibiotics have been developed in the last 30 years - this and the dire situation in both the developed and the developing world suggests that the 'global problem' of antibiotic resistance is going to become more and more of an issue in years and decades to come," Dr. Russell concluded.

NEW YORK (Reuters Health) - The prevalence of antibiotic resistance in pediatric urinary tract infection (UTI) has reached such high levels in many countries that existing empiric therapies may no longer be effective, researchers from UK report."

Prevalence of resistance to commonly prescribed antibiotics in primary care in children with urinary tract infections caused by E. coli is high, and there was remarkable variability in E. coli resistance among countries in the study, particularly in countries outside the OECD (Organization for Economic Cooperation and Development), where one possible explanation is the availability of antibiotics over the counter," Ashley Bryce from the University of Bristol in the U.K. and Dr. Céire E. Costelloe from Imperial College London told Reuters Health in a joint email.

"This could render some antibiotics ineffective as first-line treatments for urinary tract infection," they said.

E. coli is responsible for more than 80% of all UTIs and is also the most common cause of bacteremia and foodborne infections and one cause of meningitis in neonates.

Bryce, Dr. Costelloe, and colleagues investigated the prevalence of resistance in community-acquired E. coli UTI to the most commonly prescribed antibiotics given to children in primary care in their systematic review of 58 published reports.

For all antibiotics tested, the prevalence of antibiotic resistance was higher in non-OECD countries than in OECD countries, the team reports in an article online March 15 in The BMJ.

The prevalence of resistance was highest for ampicillin, ranging from 41% in Switzerland to 100% in Ghana and Nigeria.

Resistance to co-trimoxazole and trimethoprim was 30% in OECD countries and 67% in Saudi Arabia, the only non-OECD country for which rates were available.

Pooled prevalences of resistance to ciprofloxacin and ceftazidime were around 2% in OECD countries but over 26% in non-OECD countries.

For all time periods analyzed, the odds of resistance were greater in children exposed to antibiotics than in those who were unexposed.

"The Infectious Diseases Society of America (IDSA) in collaboration with the European Society for Microbiology and Infectious Diseases (ESCMID) recommend that an antibiotic should be selected for first line empirical treatment of urinary tract infection only if the local prevalence of resistance is less than 20%," the researchers note.

"According to these guidelines, our review suggests ampicillin, co-trimoxazole, and trimethoprim are no longer suitable first line treatment options for urinary tract infection in many OECD countries and that as a result many guidelines, such as those published by the National Institute for Health and Care Excellence (NICE), might need updating," they write. "In non-OECD countries, resistance to all first line antibiotics specified for urinary tract infections was in excess of 20%, suggesting that choices of first line treatment might need to be re-evaluated in less well developed countries."

"We are not able to advise clinicians on which antibiotic is best to prescribe as this often depends on the individual case," Bryce and Dr. Costelloe said. "Clinicians should, however, adhere to local or national guidelines wherever possible, which is why it is of great importance that such guidelines are kept up to date and reflect current resistance rates."

"Clinicians may also wish to consider the antibiotic history of the child when they present to primary care with symptoms of an infection, especially in light of the suggestion of our results that previous treatment with an antibiotic is associated with resistance to that same antibiotic, and that this association may be present up to 6 months post treatment," they added.

Dr. Grant Russell from Monash University in Melbourne, Australia, wrote an editorial accompanying the report. He told Reuters Health by email, "I found the extent of the resistance (and the fact that it covered all of the regularly used empiric antibiotics) both concerning and surprising. The fact that choices are diminishing is disturbing, and the fact that the situation is dire in the developing world is deeply troubling."

"We need to do what we can do to prevent bacterial infections, and when treating them to consider that effective antibiotics are a finite resource," he said. "We all have a responsibility in attempting to conserve that resource."

"No new classes of antibiotics have been developed in the last 30 years - this and the dire situation in both the developed and the developing world suggests that the 'global problem' of antibiotic resistance is going to become more and more of an issue in years and decades to come," Dr. Russell concluded.

NEW YORK (Reuters Health) - The prevalence of antibiotic resistance in pediatric urinary tract infection (UTI) has reached such high levels in many countries that existing empiric therapies may no longer be effective, researchers from UK report."

Prevalence of resistance to commonly prescribed antibiotics in primary care in children with urinary tract infections caused by E. coli is high, and there was remarkable variability in E. coli resistance among countries in the study, particularly in countries outside the OECD (Organization for Economic Cooperation and Development), where one possible explanation is the availability of antibiotics over the counter," Ashley Bryce from the University of Bristol in the U.K. and Dr. Céire E. Costelloe from Imperial College London told Reuters Health in a joint email.

"This could render some antibiotics ineffective as first-line treatments for urinary tract infection," they said.

E. coli is responsible for more than 80% of all UTIs and is also the most common cause of bacteremia and foodborne infections and one cause of meningitis in neonates.

Bryce, Dr. Costelloe, and colleagues investigated the prevalence of resistance in community-acquired E. coli UTI to the most commonly prescribed antibiotics given to children in primary care in their systematic review of 58 published reports.

For all antibiotics tested, the prevalence of antibiotic resistance was higher in non-OECD countries than in OECD countries, the team reports in an article online March 15 in The BMJ.

The prevalence of resistance was highest for ampicillin, ranging from 41% in Switzerland to 100% in Ghana and Nigeria.

Resistance to co-trimoxazole and trimethoprim was 30% in OECD countries and 67% in Saudi Arabia, the only non-OECD country for which rates were available.

Pooled prevalences of resistance to ciprofloxacin and ceftazidime were around 2% in OECD countries but over 26% in non-OECD countries.

For all time periods analyzed, the odds of resistance were greater in children exposed to antibiotics than in those who were unexposed.

"The Infectious Diseases Society of America (IDSA) in collaboration with the European Society for Microbiology and Infectious Diseases (ESCMID) recommend that an antibiotic should be selected for first line empirical treatment of urinary tract infection only if the local prevalence of resistance is less than 20%," the researchers note.

"According to these guidelines, our review suggests ampicillin, co-trimoxazole, and trimethoprim are no longer suitable first line treatment options for urinary tract infection in many OECD countries and that as a result many guidelines, such as those published by the National Institute for Health and Care Excellence (NICE), might need updating," they write. "In non-OECD countries, resistance to all first line antibiotics specified for urinary tract infections was in excess of 20%, suggesting that choices of first line treatment might need to be re-evaluated in less well developed countries."

"We are not able to advise clinicians on which antibiotic is best to prescribe as this often depends on the individual case," Bryce and Dr. Costelloe said. "Clinicians should, however, adhere to local or national guidelines wherever possible, which is why it is of great importance that such guidelines are kept up to date and reflect current resistance rates."

"Clinicians may also wish to consider the antibiotic history of the child when they present to primary care with symptoms of an infection, especially in light of the suggestion of our results that previous treatment with an antibiotic is associated with resistance to that same antibiotic, and that this association may be present up to 6 months post treatment," they added.

Dr. Grant Russell from Monash University in Melbourne, Australia, wrote an editorial accompanying the report. He told Reuters Health by email, "I found the extent of the resistance (and the fact that it covered all of the regularly used empiric antibiotics) both concerning and surprising. The fact that choices are diminishing is disturbing, and the fact that the situation is dire in the developing world is deeply troubling."

"We need to do what we can do to prevent bacterial infections, and when treating them to consider that effective antibiotics are a finite resource," he said. "We all have a responsibility in attempting to conserve that resource."

"No new classes of antibiotics have been developed in the last 30 years - this and the dire situation in both the developed and the developing world suggests that the 'global problem' of antibiotic resistance is going to become more and more of an issue in years and decades to come," Dr. Russell concluded.

Cord blood donation

Photo courtesy of NHS

VALENCIA, SPAIN—The expanded umbilical cord blood (UCB) product NiCord can provide clinical benefits in patients with high-risk hematologic malignancies, according to data presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation.

NiCord consists of cells from a single UCB unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.

The data showed that patients transplanted with NiCord had fewer moderate to severe bacterial infections and shorter hospital stays than patients who received standard UCB transplants.

“We saw a significant reduction in serious bacterial infections during the first 100 days in the NiCord group,” said Mitchell Horwitz, MD, of the Duke University School of Medicine in Durham, North Carolina.

“This is encouraging because this type of infection is a major cause of early death following UCB transplantation. We also saw a significant reduction in hospitalization time in the NiCord group, indicating a faster recovery of these patients in comparison to those transplanted with standard umbilical cord blood.”

These results were presented at the meeting as abstract O090. The research was funded by Gamida Cell, the company developing NiCord.

Dr Horwitz and his colleagues analyzed 18 patients with high-risk hematologic malignancies—most with acute leukemia or myelodysplastic syndromes (90%)—who were transplanted with NiCord.

Ten of the patients received NiCord with a second, unmanipulated UCB unit, and 8 patients received NiCord as a single UCB graft.

The researchers compared these patients to 101 patients who received standard single or double UCB transplants at Duke University from January 2005 to March 2015.

Patients in both groups received a total body irradiation-based myeloablative preparative regimen.

The median time to neutrophil engraftment was significantly shorter in the NiCord group than the control group—12.5 days and 27 days, respectively (P<0.001).

All 18 patients in the Nicord group and 100 patients in the control group had at least 1 infection.

Patients in the NiCord group had a significantly lower incidence of grade 2-3 bacterial infections than patients in the control group—22% and 54%, respectively (P=0.015).

However, there was no significant difference between the groups with regard to grade 2-3 viral infections (39% and 35%, respectively, P=0.729), fungal infections (0% and 5%, respectively, P=1.0), or non-microbiologically defined infections (0% and 17%, respectively, P=0.072).

In the first 100 days after transplant, patients in the NiCord group spent significantly more days out of the hospital than patients in the control group. The median number of days for each group was 74 and 53, respectively (P=0.002).

“These results demonstrate that the rapid hematopoietic recovery from NiCord transplantation results in clinical benefit, in comparison to similar site controls,” Dr Horwitz concluded.

Cord blood donation

Photo courtesy of NHS

VALENCIA, SPAIN—The expanded umbilical cord blood (UCB) product NiCord can provide clinical benefits in patients with high-risk hematologic malignancies, according to data presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation.

NiCord consists of cells from a single UCB unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.

The data showed that patients transplanted with NiCord had fewer moderate to severe bacterial infections and shorter hospital stays than patients who received standard UCB transplants.

“We saw a significant reduction in serious bacterial infections during the first 100 days in the NiCord group,” said Mitchell Horwitz, MD, of the Duke University School of Medicine in Durham, North Carolina.

“This is encouraging because this type of infection is a major cause of early death following UCB transplantation. We also saw a significant reduction in hospitalization time in the NiCord group, indicating a faster recovery of these patients in comparison to those transplanted with standard umbilical cord blood.”

These results were presented at the meeting as abstract O090. The research was funded by Gamida Cell, the company developing NiCord.

Dr Horwitz and his colleagues analyzed 18 patients with high-risk hematologic malignancies—most with acute leukemia or myelodysplastic syndromes (90%)—who were transplanted with NiCord.

Ten of the patients received NiCord with a second, unmanipulated UCB unit, and 8 patients received NiCord as a single UCB graft.

The researchers compared these patients to 101 patients who received standard single or double UCB transplants at Duke University from January 2005 to March 2015.

Patients in both groups received a total body irradiation-based myeloablative preparative regimen.

The median time to neutrophil engraftment was significantly shorter in the NiCord group than the control group—12.5 days and 27 days, respectively (P<0.001).

All 18 patients in the Nicord group and 100 patients in the control group had at least 1 infection.

Patients in the NiCord group had a significantly lower incidence of grade 2-3 bacterial infections than patients in the control group—22% and 54%, respectively (P=0.015).

However, there was no significant difference between the groups with regard to grade 2-3 viral infections (39% and 35%, respectively, P=0.729), fungal infections (0% and 5%, respectively, P=1.0), or non-microbiologically defined infections (0% and 17%, respectively, P=0.072).

In the first 100 days after transplant, patients in the NiCord group spent significantly more days out of the hospital than patients in the control group. The median number of days for each group was 74 and 53, respectively (P=0.002).

“These results demonstrate that the rapid hematopoietic recovery from NiCord transplantation results in clinical benefit, in comparison to similar site controls,” Dr Horwitz concluded.

Cord blood donation

Photo courtesy of NHS

VALENCIA, SPAIN—The expanded umbilical cord blood (UCB) product NiCord can provide clinical benefits in patients with high-risk hematologic malignancies, according to data presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation.

NiCord consists of cells from a single UCB unit cultured in nicotinamide—a vitamin B derivative—and cytokines that are typically used for expansion—thrombopoietin, interleukin 6, FLT3 ligand, and stem cell factor.

The data showed that patients transplanted with NiCord had fewer moderate to severe bacterial infections and shorter hospital stays than patients who received standard UCB transplants.

“We saw a significant reduction in serious bacterial infections during the first 100 days in the NiCord group,” said Mitchell Horwitz, MD, of the Duke University School of Medicine in Durham, North Carolina.

“This is encouraging because this type of infection is a major cause of early death following UCB transplantation. We also saw a significant reduction in hospitalization time in the NiCord group, indicating a faster recovery of these patients in comparison to those transplanted with standard umbilical cord blood.”

These results were presented at the meeting as abstract O090. The research was funded by Gamida Cell, the company developing NiCord.

Dr Horwitz and his colleagues analyzed 18 patients with high-risk hematologic malignancies—most with acute leukemia or myelodysplastic syndromes (90%)—who were transplanted with NiCord.

Ten of the patients received NiCord with a second, unmanipulated UCB unit, and 8 patients received NiCord as a single UCB graft.

The researchers compared these patients to 101 patients who received standard single or double UCB transplants at Duke University from January 2005 to March 2015.

Patients in both groups received a total body irradiation-based myeloablative preparative regimen.

The median time to neutrophil engraftment was significantly shorter in the NiCord group than the control group—12.5 days and 27 days, respectively (P<0.001).

All 18 patients in the Nicord group and 100 patients in the control group had at least 1 infection.

Patients in the NiCord group had a significantly lower incidence of grade 2-3 bacterial infections than patients in the control group—22% and 54%, respectively (P=0.015).

However, there was no significant difference between the groups with regard to grade 2-3 viral infections (39% and 35%, respectively, P=0.729), fungal infections (0% and 5%, respectively, P=1.0), or non-microbiologically defined infections (0% and 17%, respectively, P=0.072).

In the first 100 days after transplant, patients in the NiCord group spent significantly more days out of the hospital than patients in the control group. The median number of days for each group was 74 and 53, respectively (P=0.002).

“These results demonstrate that the rapid hematopoietic recovery from NiCord transplantation results in clinical benefit, in comparison to similar site controls,” Dr Horwitz concluded.

Ticagrelor tablets

Photo courtesy of AstraZeneca

CHICAGO—Long-term use of dual antiplatelet therapy (DAPT) can benefit patients with a history of myocardial infarction (MI) and peripheral artery disease (PAD), according to data presented at the American College of Cardiology’s 65th Annual Scientific Session.

The data were from a subanalysis of the PEGASUS-TIMI 54 trial, in which researchers evaluated long-term use of aspirin, with or without the antiplatelet agent ticagrelor, in patients with a history of MI and at least 1 additional risk factor for thrombotic cardiovascular (CV) events.

The analysis suggested that, in stable patients with a history of MI, concomitant PAD is associated with a higher risk of major adverse cardiac events (MACE).

However, long-term DAPT with ticagrelor and aspirin can reduce the incidence of MACE in these patients, when compared to aspirin plus a placebo.

These results were presented as abstract 907-04 and simultaneously published in the Journal of American College of Cardiology. The trial was sponsored by AstraZeneca, the company developing ticagrelor.

Patients in the PEGASUS-TIMI 54 trial were randomized to receive aspirin plus twice-daily doses of ticagrelor at 90 mg, ticagrelor at 60 mg, or placebo.

The study’s primary efficacy endpoint was the incidence of MACE, which was defined as a composite of CV death, MI, or stroke.

The subanalysis showed that the 1143 patients with a prior MI and PAD had a higher incidence of MACE at 3 years than patients without PAD—19.3% and 8.4%, respectively (P<0.001).

The increased risk of MACE in patients with PAD persisted after the researchers adjusted for differences in patient characteristics at baseline. The hazard ratio (HR) was 1.60 (95% CI 1.20-2.13, P=0.0013).

Patients with PAD had a higher risk of CV death (HR 1.84, 95% CI 1.16-2.94, P=0.0102), stroke (HR 2.31, 95% CI 1.26–4.25, P=0.0071), and mortality (HR 2.05, 95% CI 1.43-2.94, P<0.001) than patients without PAD.

Patients who received DAPT (ticagrelor at either dose plus aspirin) had a lower risk of MACE at 3 years than patients who received placebo plus aspirin. This was true for patients with PAD (HR 0.75, 95% CI 0.55-1.01) and without it (HR 0.86, 95% CI 0.77-0.96, P-interaction=0.41).

However, because of their higher absolute risk of MACE, patients with PAD had a greater absolute risk reduction (4.1%) than patients without PAD.

The risk of TIMI major bleeding was not significantly higher in patients with PAD than in those without it (HR 1.57, 95% CI 0.47-5.22, P=0.46).

For patients with PAD, TIMI major bleeding occurred more frequently with ticagrelor at 90 mg plus aspirin than with placebo plus aspirin (HR 1.46, 95% CI 0.39-5.43, P=0.57) and with ticagrelor at 60 mg plus aspirin than with placebo plus aspirin (HR 1.18, 95% CI 0.29-4.70, P=0.82), though the differences were not significant.

“Patients with prior MI and PAD are at further heightened risk of ischemic events relative to patients with prior MI and no PAD, even when accounting for other risk factors,” said study investigator Marc Bonaca, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“Because of their heightened ischemic risk, patients in the subgroup analysis with a prior MI and PAD appear to have a higher absolute risk reduction with ticagrelor than those without. These findings may be helpful to clinicians in identifying patients with prior MI who they feel could benefit from prolonged therapy with ticagrelor.”

Ticagrelor tablets

Photo courtesy of AstraZeneca

CHICAGO—Long-term use of dual antiplatelet therapy (DAPT) can benefit patients with a history of myocardial infarction (MI) and peripheral artery disease (PAD), according to data presented at the American College of Cardiology’s 65th Annual Scientific Session.

The data were from a subanalysis of the PEGASUS-TIMI 54 trial, in which researchers evaluated long-term use of aspirin, with or without the antiplatelet agent ticagrelor, in patients with a history of MI and at least 1 additional risk factor for thrombotic cardiovascular (CV) events.

The analysis suggested that, in stable patients with a history of MI, concomitant PAD is associated with a higher risk of major adverse cardiac events (MACE).

However, long-term DAPT with ticagrelor and aspirin can reduce the incidence of MACE in these patients, when compared to aspirin plus a placebo.

These results were presented as abstract 907-04 and simultaneously published in the Journal of American College of Cardiology. The trial was sponsored by AstraZeneca, the company developing ticagrelor.

Patients in the PEGASUS-TIMI 54 trial were randomized to receive aspirin plus twice-daily doses of ticagrelor at 90 mg, ticagrelor at 60 mg, or placebo.

The study’s primary efficacy endpoint was the incidence of MACE, which was defined as a composite of CV death, MI, or stroke.

The subanalysis showed that the 1143 patients with a prior MI and PAD had a higher incidence of MACE at 3 years than patients without PAD—19.3% and 8.4%, respectively (P<0.001).

The increased risk of MACE in patients with PAD persisted after the researchers adjusted for differences in patient characteristics at baseline. The hazard ratio (HR) was 1.60 (95% CI 1.20-2.13, P=0.0013).

Patients with PAD had a higher risk of CV death (HR 1.84, 95% CI 1.16-2.94, P=0.0102), stroke (HR 2.31, 95% CI 1.26–4.25, P=0.0071), and mortality (HR 2.05, 95% CI 1.43-2.94, P<0.001) than patients without PAD.

Patients who received DAPT (ticagrelor at either dose plus aspirin) had a lower risk of MACE at 3 years than patients who received placebo plus aspirin. This was true for patients with PAD (HR 0.75, 95% CI 0.55-1.01) and without it (HR 0.86, 95% CI 0.77-0.96, P-interaction=0.41).

However, because of their higher absolute risk of MACE, patients with PAD had a greater absolute risk reduction (4.1%) than patients without PAD.

The risk of TIMI major bleeding was not significantly higher in patients with PAD than in those without it (HR 1.57, 95% CI 0.47-5.22, P=0.46).

For patients with PAD, TIMI major bleeding occurred more frequently with ticagrelor at 90 mg plus aspirin than with placebo plus aspirin (HR 1.46, 95% CI 0.39-5.43, P=0.57) and with ticagrelor at 60 mg plus aspirin than with placebo plus aspirin (HR 1.18, 95% CI 0.29-4.70, P=0.82), though the differences were not significant.

“Patients with prior MI and PAD are at further heightened risk of ischemic events relative to patients with prior MI and no PAD, even when accounting for other risk factors,” said study investigator Marc Bonaca, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“Because of their heightened ischemic risk, patients in the subgroup analysis with a prior MI and PAD appear to have a higher absolute risk reduction with ticagrelor than those without. These findings may be helpful to clinicians in identifying patients with prior MI who they feel could benefit from prolonged therapy with ticagrelor.”

Ticagrelor tablets

Photo courtesy of AstraZeneca

CHICAGO—Long-term use of dual antiplatelet therapy (DAPT) can benefit patients with a history of myocardial infarction (MI) and peripheral artery disease (PAD), according to data presented at the American College of Cardiology’s 65th Annual Scientific Session.

The data were from a subanalysis of the PEGASUS-TIMI 54 trial, in which researchers evaluated long-term use of aspirin, with or without the antiplatelet agent ticagrelor, in patients with a history of MI and at least 1 additional risk factor for thrombotic cardiovascular (CV) events.

The analysis suggested that, in stable patients with a history of MI, concomitant PAD is associated with a higher risk of major adverse cardiac events (MACE).

However, long-term DAPT with ticagrelor and aspirin can reduce the incidence of MACE in these patients, when compared to aspirin plus a placebo.

These results were presented as abstract 907-04 and simultaneously published in the Journal of American College of Cardiology. The trial was sponsored by AstraZeneca, the company developing ticagrelor.

Patients in the PEGASUS-TIMI 54 trial were randomized to receive aspirin plus twice-daily doses of ticagrelor at 90 mg, ticagrelor at 60 mg, or placebo.

The study’s primary efficacy endpoint was the incidence of MACE, which was defined as a composite of CV death, MI, or stroke.

The subanalysis showed that the 1143 patients with a prior MI and PAD had a higher incidence of MACE at 3 years than patients without PAD—19.3% and 8.4%, respectively (P<0.001).

The increased risk of MACE in patients with PAD persisted after the researchers adjusted for differences in patient characteristics at baseline. The hazard ratio (HR) was 1.60 (95% CI 1.20-2.13, P=0.0013).

Patients with PAD had a higher risk of CV death (HR 1.84, 95% CI 1.16-2.94, P=0.0102), stroke (HR 2.31, 95% CI 1.26–4.25, P=0.0071), and mortality (HR 2.05, 95% CI 1.43-2.94, P<0.001) than patients without PAD.

Patients who received DAPT (ticagrelor at either dose plus aspirin) had a lower risk of MACE at 3 years than patients who received placebo plus aspirin. This was true for patients with PAD (HR 0.75, 95% CI 0.55-1.01) and without it (HR 0.86, 95% CI 0.77-0.96, P-interaction=0.41).

However, because of their higher absolute risk of MACE, patients with PAD had a greater absolute risk reduction (4.1%) than patients without PAD.

The risk of TIMI major bleeding was not significantly higher in patients with PAD than in those without it (HR 1.57, 95% CI 0.47-5.22, P=0.46).

For patients with PAD, TIMI major bleeding occurred more frequently with ticagrelor at 90 mg plus aspirin than with placebo plus aspirin (HR 1.46, 95% CI 0.39-5.43, P=0.57) and with ticagrelor at 60 mg plus aspirin than with placebo plus aspirin (HR 1.18, 95% CI 0.29-4.70, P=0.82), though the differences were not significant.

“Patients with prior MI and PAD are at further heightened risk of ischemic events relative to patients with prior MI and no PAD, even when accounting for other risk factors,” said study investigator Marc Bonaca, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.

“Because of their heightened ischemic risk, patients in the subgroup analysis with a prior MI and PAD appear to have a higher absolute risk reduction with ticagrelor than those without. These findings may be helpful to clinicians in identifying patients with prior MI who they feel could benefit from prolonged therapy with ticagrelor.”

Chemotherapy drugs

Photo by Bill Branson

Long-term results of the HD2000 trial reveal similar survival rates in patients with previously untreated, aggressive Hodgkin lymphoma (HL) who received 3 different combination treatment regimens.

At 10 years of follow-up, there was no significant difference in overall survival (OS) or progression-free survival (PFS) whether patients received ABVD, BEACOPP, or CEC.

However, patients who received ABVD were significantly less likely than those who received BEACOPP or CEC to develop second malignancies.

Francesco Merli, MD, of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) in Italy, and his colleagues reported these results in the Journal of Clinical Oncology.

The trial enrolled 307 patients with advanced-stage HL. Patients were randomized to receive 1 of 3 treatment regimens:

• Six cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine)
• Four escalated plus 2 standard cycles of BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone)
• Six cycles of CEC (cyclophosphamide, lomustine, vindesine, melphalan, prednisone, epidoxorubicin, vincristine, procarbazine, vinblastine, and bleomycin).

Some patients also received radiotherapy, but there was no significant difference in the proportion of patients receiving radiotherapy across the treatment arms—46% in the ABVD arm, 44% in the BEACOPP arm, and 43% in the CEC arm (P=0.871).

Results

At the end of all therapy, the complete response rate was 84% with ABVD, 91% with BEACOPP, and 83% with CEC.

There were 84 patients who did not achieve a complete response, and salvage data were available for 73 of these patients. Three patients (4%) died before salvage therapy could begin, 26 (36%) received conventional chemotherapy, 40 (55%) received a hematopoietic stem cell transplant, and 4 (5%) received radiotherapy.

The median follow-up was 120 months (range, 4 to 169 months), and 295 patients were evaluable.

In a previous analysis, at a median follow-up of 42 months, patients who received BEACOPP had superior PFS compared to patients who received ABVD.

However, in the current analysis, there was no significant difference in PFS between the 3 treatment arms. The 10-year PFS was 69% in the ABVD arm, 75% in the BEACOPP arm, and 76% in the CEC arm (P=0.471).

Likewise, there was no significant difference in OS between the treatment arms. The 10-year OS was 85% in the ABVD arm, 84% in the BEACOPP arm, and 86% in the CEC arm (P=0.892).

There were a total of 13 second malignancies—1 in the ABVD arm and 6 each in the BEACOPP and CEC arms.

The cumulative risk of developing a second malignancy at 10 years was 0.9% in the ABVD arm, 6.6% in the BEACOPP arm, and 6% in the CEC arm. So the risk with either BEACOPP or CEC was significantly higher than with ABVD (P=0.027 and 0.02, respectively).

The researchers said these results suggest BEACOPP provides better disease control than ABVD, but this benefit is counterbalanced by a higher rate of late major events with BEACOPP, particularly second malignancies, which resulted in patient deaths.

So the team concluded that BEACOPP is a viable treatment option for advanced HL, but it should not be considered the standard for all patients because 70% of these patients may be cured with ABVD and limited radiotherapy. A careful assessment of the risk-benefit ratio of the initial treatment choice is warranted.

Chemotherapy drugs

Photo by Bill Branson

Long-term results of the HD2000 trial reveal similar survival rates in patients with previously untreated, aggressive Hodgkin lymphoma (HL) who received 3 different combination treatment regimens.

At 10 years of follow-up, there was no significant difference in overall survival (OS) or progression-free survival (PFS) whether patients received ABVD, BEACOPP, or CEC.

However, patients who received ABVD were significantly less likely than those who received BEACOPP or CEC to develop second malignancies.

Francesco Merli, MD, of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) in Italy, and his colleagues reported these results in the Journal of Clinical Oncology.

The trial enrolled 307 patients with advanced-stage HL. Patients were randomized to receive 1 of 3 treatment regimens:

• Six cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine)
• Four escalated plus 2 standard cycles of BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone)
• Six cycles of CEC (cyclophosphamide, lomustine, vindesine, melphalan, prednisone, epidoxorubicin, vincristine, procarbazine, vinblastine, and bleomycin).

Some patients also received radiotherapy, but there was no significant difference in the proportion of patients receiving radiotherapy across the treatment arms—46% in the ABVD arm, 44% in the BEACOPP arm, and 43% in the CEC arm (P=0.871).

Results

At the end of all therapy, the complete response rate was 84% with ABVD, 91% with BEACOPP, and 83% with CEC.

There were 84 patients who did not achieve a complete response, and salvage data were available for 73 of these patients. Three patients (4%) died before salvage therapy could begin, 26 (36%) received conventional chemotherapy, 40 (55%) received a hematopoietic stem cell transplant, and 4 (5%) received radiotherapy.

The median follow-up was 120 months (range, 4 to 169 months), and 295 patients were evaluable.

In a previous analysis, at a median follow-up of 42 months, patients who received BEACOPP had superior PFS compared to patients who received ABVD.

However, in the current analysis, there was no significant difference in PFS between the 3 treatment arms. The 10-year PFS was 69% in the ABVD arm, 75% in the BEACOPP arm, and 76% in the CEC arm (P=0.471).

Likewise, there was no significant difference in OS between the treatment arms. The 10-year OS was 85% in the ABVD arm, 84% in the BEACOPP arm, and 86% in the CEC arm (P=0.892).

There were a total of 13 second malignancies—1 in the ABVD arm and 6 each in the BEACOPP and CEC arms.

The cumulative risk of developing a second malignancy at 10 years was 0.9% in the ABVD arm, 6.6% in the BEACOPP arm, and 6% in the CEC arm. So the risk with either BEACOPP or CEC was significantly higher than with ABVD (P=0.027 and 0.02, respectively).

The researchers said these results suggest BEACOPP provides better disease control than ABVD, but this benefit is counterbalanced by a higher rate of late major events with BEACOPP, particularly second malignancies, which resulted in patient deaths.

So the team concluded that BEACOPP is a viable treatment option for advanced HL, but it should not be considered the standard for all patients because 70% of these patients may be cured with ABVD and limited radiotherapy. A careful assessment of the risk-benefit ratio of the initial treatment choice is warranted.

Chemotherapy drugs

Photo by Bill Branson

Long-term results of the HD2000 trial reveal similar survival rates in patients with previously untreated, aggressive Hodgkin lymphoma (HL) who received 3 different combination treatment regimens.

At 10 years of follow-up, there was no significant difference in overall survival (OS) or progression-free survival (PFS) whether patients received ABVD, BEACOPP, or CEC.

However, patients who received ABVD were significantly less likely than those who received BEACOPP or CEC to develop second malignancies.

Francesco Merli, MD, of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) in Italy, and his colleagues reported these results in the Journal of Clinical Oncology.

The trial enrolled 307 patients with advanced-stage HL. Patients were randomized to receive 1 of 3 treatment regimens:

• Six cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine)
• Four escalated plus 2 standard cycles of BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone)
• Six cycles of CEC (cyclophosphamide, lomustine, vindesine, melphalan, prednisone, epidoxorubicin, vincristine, procarbazine, vinblastine, and bleomycin).

Some patients also received radiotherapy, but there was no significant difference in the proportion of patients receiving radiotherapy across the treatment arms—46% in the ABVD arm, 44% in the BEACOPP arm, and 43% in the CEC arm (P=0.871).

Results

At the end of all therapy, the complete response rate was 84% with ABVD, 91% with BEACOPP, and 83% with CEC.

There were 84 patients who did not achieve a complete response, and salvage data were available for 73 of these patients. Three patients (4%) died before salvage therapy could begin, 26 (36%) received conventional chemotherapy, 40 (55%) received a hematopoietic stem cell transplant, and 4 (5%) received radiotherapy.

The median follow-up was 120 months (range, 4 to 169 months), and 295 patients were evaluable.

In a previous analysis, at a median follow-up of 42 months, patients who received BEACOPP had superior PFS compared to patients who received ABVD.

However, in the current analysis, there was no significant difference in PFS between the 3 treatment arms. The 10-year PFS was 69% in the ABVD arm, 75% in the BEACOPP arm, and 76% in the CEC arm (P=0.471).

Likewise, there was no significant difference in OS between the treatment arms. The 10-year OS was 85% in the ABVD arm, 84% in the BEACOPP arm, and 86% in the CEC arm (P=0.892).

There were a total of 13 second malignancies—1 in the ABVD arm and 6 each in the BEACOPP and CEC arms.

The cumulative risk of developing a second malignancy at 10 years was 0.9% in the ABVD arm, 6.6% in the BEACOPP arm, and 6% in the CEC arm. So the risk with either BEACOPP or CEC was significantly higher than with ABVD (P=0.027 and 0.02, respectively).

The researchers said these results suggest BEACOPP provides better disease control than ABVD, but this benefit is counterbalanced by a higher rate of late major events with BEACOPP, particularly second malignancies, which resulted in patient deaths.

So the team concluded that BEACOPP is a viable treatment option for advanced HL, but it should not be considered the standard for all patients because 70% of these patients may be cured with ABVD and limited radiotherapy. A careful assessment of the risk-benefit ratio of the initial treatment choice is warranted.

Team performing surgery

Photo by Piotr Bodzek

CHICAGO—Updated results from the RE-VERSE AD trial suggest idarucizumab, a humanized antibody fragment, can reverse the anticoagulant effect of dabigatran in emergency settings.

In this ongoing phase 3 trial, idarucizumab has normalized diluted thrombin time (dTT) and ecarin clotting time (ECT) in a majority of patients with uncontrolled or life-threatening bleeding and patients who required emergency surgery or an invasive procedure.

In addition, researchers said there have been no safety concerns related to idarucizumab in this trial.

These results were presented at the American College of Cardiology’s 65th Annual Scientific Session (abstract 1130M-05). The study was sponsored by Boehringer Ingelheim, the company that developed idarucizumab and dabigatran.

“The data from this new RE-VERSE AD interim analysis, of the first 123 patients, support earlier findings that show idarucizumab reverses the anticoagulant effect of dabigatran, including reversal in critically ill, high-risk patients in emergency care,” said Charles Pollack, MD, of Thomas Jefferson University in Philadelphia, Pennsylvania.

Dr Pollack and his colleagues presented data on 123 patients—66 with uncontrolled or life-threatening bleeding complications (Group A) and 57 patients requiring emergency surgery or an invasive procedure (Group B).

All of these patients received 5 g of idarucizumab. The primary endpoint of the study is the degree to which idarucizumab reversed the anticoagulant effect of dabigatran within 4 hours, measured by dTT and ECT.

Overall, 94 patients were evaluable for dTT and 112 for ECT. So 97% of evaluable patients (91/94) achieved full reversal of dTT, and 87% (97/112) achieved full reversal of ECT.

Among evaluable patients in Group A (n=48), the median subjective investigator-reported time to cessation of bleeding was 9.8 hours. For 92% of patients (44/48), bleeding stopped within 72 hours of idarucizumab administration.

Among evaluable patients in Group B (n=52), the mean time to surgery was 1.7 hours after receiving idarucizumab. Normal hemostasis during surgery was reported in 92% of patients (48/52).

Thromboembolic events occurred in 5 patients after idarucizumab administration—1 each at 48 hours, 7 days, 9 days, 13 days, and 24 days. None of these patients were receiving antithrombotic therapy at the time of their event.

However, most patients in both groups restarted anticoagulation after receiving idarucizumab—47 of 66 patients in Group A and 49 of 57 patients in Group B.

There were a total of 26 deaths—13 in each group. All of the deaths appeared to be related to the original reason for emergency admission to the hospital and/or to comorbidities.

Team performing surgery

Photo by Piotr Bodzek

CHICAGO—Updated results from the RE-VERSE AD trial suggest idarucizumab, a humanized antibody fragment, can reverse the anticoagulant effect of dabigatran in emergency settings.

In this ongoing phase 3 trial, idarucizumab has normalized diluted thrombin time (dTT) and ecarin clotting time (ECT) in a majority of patients with uncontrolled or life-threatening bleeding and patients who required emergency surgery or an invasive procedure.

In addition, researchers said there have been no safety concerns related to idarucizumab in this trial.

These results were presented at the American College of Cardiology’s 65th Annual Scientific Session (abstract 1130M-05). The study was sponsored by Boehringer Ingelheim, the company that developed idarucizumab and dabigatran.

“The data from this new RE-VERSE AD interim analysis, of the first 123 patients, support earlier findings that show idarucizumab reverses the anticoagulant effect of dabigatran, including reversal in critically ill, high-risk patients in emergency care,” said Charles Pollack, MD, of Thomas Jefferson University in Philadelphia, Pennsylvania.

Dr Pollack and his colleagues presented data on 123 patients—66 with uncontrolled or life-threatening bleeding complications (Group A) and 57 patients requiring emergency surgery or an invasive procedure (Group B).

All of these patients received 5 g of idarucizumab. The primary endpoint of the study is the degree to which idarucizumab reversed the anticoagulant effect of dabigatran within 4 hours, measured by dTT and ECT.

Overall, 94 patients were evaluable for dTT and 112 for ECT. So 97% of evaluable patients (91/94) achieved full reversal of dTT, and 87% (97/112) achieved full reversal of ECT.

Among evaluable patients in Group A (n=48), the median subjective investigator-reported time to cessation of bleeding was 9.8 hours. For 92% of patients (44/48), bleeding stopped within 72 hours of idarucizumab administration.

Among evaluable patients in Group B (n=52), the mean time to surgery was 1.7 hours after receiving idarucizumab. Normal hemostasis during surgery was reported in 92% of patients (48/52).

Thromboembolic events occurred in 5 patients after idarucizumab administration—1 each at 48 hours, 7 days, 9 days, 13 days, and 24 days. None of these patients were receiving antithrombotic therapy at the time of their event.

However, most patients in both groups restarted anticoagulation after receiving idarucizumab—47 of 66 patients in Group A and 49 of 57 patients in Group B.

There were a total of 26 deaths—13 in each group. All of the deaths appeared to be related to the original reason for emergency admission to the hospital and/or to comorbidities.

Team performing surgery

Photo by Piotr Bodzek

CHICAGO—Updated results from the RE-VERSE AD trial suggest idarucizumab, a humanized antibody fragment, can reverse the anticoagulant effect of dabigatran in emergency settings.

In this ongoing phase 3 trial, idarucizumab has normalized diluted thrombin time (dTT) and ecarin clotting time (ECT) in a majority of patients with uncontrolled or life-threatening bleeding and patients who required emergency surgery or an invasive procedure.

In addition, researchers said there have been no safety concerns related to idarucizumab in this trial.

These results were presented at the American College of Cardiology’s 65th Annual Scientific Session (abstract 1130M-05). The study was sponsored by Boehringer Ingelheim, the company that developed idarucizumab and dabigatran.

“The data from this new RE-VERSE AD interim analysis, of the first 123 patients, support earlier findings that show idarucizumab reverses the anticoagulant effect of dabigatran, including reversal in critically ill, high-risk patients in emergency care,” said Charles Pollack, MD, of Thomas Jefferson University in Philadelphia, Pennsylvania.

Dr Pollack and his colleagues presented data on 123 patients—66 with uncontrolled or life-threatening bleeding complications (Group A) and 57 patients requiring emergency surgery or an invasive procedure (Group B).

All of these patients received 5 g of idarucizumab. The primary endpoint of the study is the degree to which idarucizumab reversed the anticoagulant effect of dabigatran within 4 hours, measured by dTT and ECT.

Overall, 94 patients were evaluable for dTT and 112 for ECT. So 97% of evaluable patients (91/94) achieved full reversal of dTT, and 87% (97/112) achieved full reversal of ECT.

Among evaluable patients in Group A (n=48), the median subjective investigator-reported time to cessation of bleeding was 9.8 hours. For 92% of patients (44/48), bleeding stopped within 72 hours of idarucizumab administration.

Among evaluable patients in Group B (n=52), the mean time to surgery was 1.7 hours after receiving idarucizumab. Normal hemostasis during surgery was reported in 92% of patients (48/52).

Thromboembolic events occurred in 5 patients after idarucizumab administration—1 each at 48 hours, 7 days, 9 days, 13 days, and 24 days. None of these patients were receiving antithrombotic therapy at the time of their event.

However, most patients in both groups restarted anticoagulation after receiving idarucizumab—47 of 66 patients in Group A and 49 of 57 patients in Group B.

There were a total of 26 deaths—13 in each group. All of the deaths appeared to be related to the original reason for emergency admission to the hospital and/or to comorbidities.

PHILADELPHIA – Nonalcoholic fatty liver disease is on the rise worldwide, but many clinicians are unaware of how to recognize this potentially fatal condition, in part because it can be difficult to separate from common comorbidities such as obesity and diabetes.

In an interview at the Digestive Diseases: New Advances 2016 meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey, Dr. Zobair M. Younossi, chairman of the department of medicine at Inova Fairfax (Va.) Hospital, discussed what clinicians should know in order to screen for and treat this disease.

Dr. Younossi said he is a consultant to Conatus Pharmaceuticals, Enterome Bioscience, and Gilead, and on the advisory boards of Janssen, Salix Pharmaceuticals, and Vertex Pharmaceuticals.

Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Nonalcoholic fatty liver disease is on the rise worldwide, but many clinicians are unaware of how to recognize this potentially fatal condition, in part because it can be difficult to separate from common comorbidities such as obesity and diabetes.

In an interview at the Digestive Diseases: New Advances 2016 meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey, Dr. Zobair M. Younossi, chairman of the department of medicine at Inova Fairfax (Va.) Hospital, discussed what clinicians should know in order to screen for and treat this disease.

Dr. Younossi said he is a consultant to Conatus Pharmaceuticals, Enterome Bioscience, and Gilead, and on the advisory boards of Janssen, Salix Pharmaceuticals, and Vertex Pharmaceuticals.

Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Nonalcoholic fatty liver disease is on the rise worldwide, but many clinicians are unaware of how to recognize this potentially fatal condition, in part because it can be difficult to separate from common comorbidities such as obesity and diabetes.

In an interview at the Digestive Diseases: New Advances 2016 meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey, Dr. Zobair M. Younossi, chairman of the department of medicine at Inova Fairfax (Va.) Hospital, discussed what clinicians should know in order to screen for and treat this disease.

Dr. Younossi said he is a consultant to Conatus Pharmaceuticals, Enterome Bioscience, and Gilead, and on the advisory boards of Janssen, Salix Pharmaceuticals, and Vertex Pharmaceuticals.

Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

Adding a chemotherapy combination to radiation therapy for initial treatment of low-grade gliomas significantly improved overall survival and progression-free survival, regardless of the tumor type, investigators report in the New England Journal of Medicine.

Grade 2 glioma patients who received radiation plus the combination of procarbazine, lomustine (also called CCNU), and vincristine (PCV) had a longer median overall survival than those who received radiation alone (13.3 vs. 7.8 years; hazard ratio for death, 0.59; P = .003). Of those who received radiation plus chemotherapy, the progression-free survival rate at 10 years was 51%, compared with 21% for the group who received radiation alone, Dr. Jan Buckner and his colleagues report (N Engl J Med. 2016;374:1344-55. doi: 10.1056/NEJMoa1500925).

“The magnitude of treatment benefit from combined chemotherapy plus radiation therapy is substantial, but the toxic effects are greater than those observed with radiation therapy alone,” wrote Dr. Buckner, professor of oncology at the Mayo Clinic, Rochester, Minn., and associates. Patients who received radiation plus PCV had more toxic side effects from their therapy, though most effects were grade 1 and 2.

For this study, 254 patients were randomized, with 128 assigned to radiotherapy alone, and 126 assigned to radiotherapy plus PCV. A total of 126 patients in the radiotherapy arm were included in the analysis, with one patient not receiving the intervention and 14 patients lost to follow-up at some point during the 10 years of the study. In the radiotherapy plus PCV arm, 125 patients were eligible for evaluation, and all of those patients were included in the analysis. Twenty-six patients in this arm were lost to follow-up, and 72 patients discontinued the intervention in this arm (this figure included four patients who died).

Tumor types included in the study were grade 2 astrocytoma, oligoastrocytoma, or oligodendroglioma.

Patients were included if they were between 18 and 39 years of age and had received a subtotal resection or biopsy of their tumor, or if they were 40 years of age or older and had any resection or biopsy of their tumor. Exclusion criteria included previous radiation to the head or neck, any previous chemotherapy, significant pulmonary disease, and a 5-year history of other cancers except cervical cancer in situ and non-melanoma skin cancer. Tumors could not have spread to noncontiguous leptomeninges, and patients could not have gliomatosis cerebri. Patients had to have a Karnofsky performance score of 60 or higher, and a neurological function score of 3 or less.

Dr. Buckner and his collaborators also assessed tumors for IDH1 mutational status by performing immunostaining with the mutation-specific monoclonal antibody IDH1 R132H; appropriate tissue was available for testing in slightly less than half of the patients in each study arm. The mutation was present in 35/57 patients (61%) in the radiotherapy-only arm, and 36/56 patients (64%) in the radiotherapy plus PCV arm. Patients with oligodendroglioma were most likely to have IDH1 R132H mutations. Sample sizes were too small to determine the effect of other IDH mutations or co-deletion of chromosome arms 1p and 19q.

In multivariable analysis, the presence of the IDH1 R132H mutation was identified as an independent prognostic factor for better overall survival (OS) and progression-free survival (PFS), regardless of the treatment administered. Those with the mutation still benefited significantly from receiving radiotherapy plus PCV rather than radiotherapy alone (P = .02 for OS, P less than .001 for PFS).

Exploratory analysis that broke down OS and PFS by cancer type showed that “the superiority of radiation therapy plus chemotherapy over radiation therapy alone was seen with all histologic diagnoses, although the difference did not reach significance among patients with astrocytoma,” wrote Dr. Buckner and his collaborators.

When all patients lost to follow-up in both groups were assessed as having died, the sensitivity analysis still showed benefit for radiotherapy plus PCV (HR for death, compared with radiotherapy alone, 0.72; P = .03).

The value of the long-term follow-up, wrote Dr. Buckner and his colleagues, was that “The separation of the progression-free survival curves of the two treatment groups did not begin until 2 to 3 years after randomization, although approximately 25% of the patients in each group had disease progression by then.”

Dr. Buckner and his collaborators emphasized that the patient-physician team should consider all factors in making treatment decisions, saying, “Patients and their physicians will have to weigh whether the longer survival justified the more toxic therapeutic approach.“

[email protected]

On Twitter @karioakes

Adding a chemotherapy combination to radiation therapy for initial treatment of low-grade gliomas significantly improved overall survival and progression-free survival, regardless of the tumor type, investigators report in the New England Journal of Medicine.

Grade 2 glioma patients who received radiation plus the combination of procarbazine, lomustine (also called CCNU), and vincristine (PCV) had a longer median overall survival than those who received radiation alone (13.3 vs. 7.8 years; hazard ratio for death, 0.59; P = .003). Of those who received radiation plus chemotherapy, the progression-free survival rate at 10 years was 51%, compared with 21% for the group who received radiation alone, Dr. Jan Buckner and his colleagues report (N Engl J Med. 2016;374:1344-55. doi: 10.1056/NEJMoa1500925).

“The magnitude of treatment benefit from combined chemotherapy plus radiation therapy is substantial, but the toxic effects are greater than those observed with radiation therapy alone,” wrote Dr. Buckner, professor of oncology at the Mayo Clinic, Rochester, Minn., and associates. Patients who received radiation plus PCV had more toxic side effects from their therapy, though most effects were grade 1 and 2.

For this study, 254 patients were randomized, with 128 assigned to radiotherapy alone, and 126 assigned to radiotherapy plus PCV. A total of 126 patients in the radiotherapy arm were included in the analysis, with one patient not receiving the intervention and 14 patients lost to follow-up at some point during the 10 years of the study. In the radiotherapy plus PCV arm, 125 patients were eligible for evaluation, and all of those patients were included in the analysis. Twenty-six patients in this arm were lost to follow-up, and 72 patients discontinued the intervention in this arm (this figure included four patients who died).

Tumor types included in the study were grade 2 astrocytoma, oligoastrocytoma, or oligodendroglioma.

Patients were included if they were between 18 and 39 years of age and had received a subtotal resection or biopsy of their tumor, or if they were 40 years of age or older and had any resection or biopsy of their tumor. Exclusion criteria included previous radiation to the head or neck, any previous chemotherapy, significant pulmonary disease, and a 5-year history of other cancers except cervical cancer in situ and non-melanoma skin cancer. Tumors could not have spread to noncontiguous leptomeninges, and patients could not have gliomatosis cerebri. Patients had to have a Karnofsky performance score of 60 or higher, and a neurological function score of 3 or less.

Dr. Buckner and his collaborators also assessed tumors for IDH1 mutational status by performing immunostaining with the mutation-specific monoclonal antibody IDH1 R132H; appropriate tissue was available for testing in slightly less than half of the patients in each study arm. The mutation was present in 35/57 patients (61%) in the radiotherapy-only arm, and 36/56 patients (64%) in the radiotherapy plus PCV arm. Patients with oligodendroglioma were most likely to have IDH1 R132H mutations. Sample sizes were too small to determine the effect of other IDH mutations or co-deletion of chromosome arms 1p and 19q.

In multivariable analysis, the presence of the IDH1 R132H mutation was identified as an independent prognostic factor for better overall survival (OS) and progression-free survival (PFS), regardless of the treatment administered. Those with the mutation still benefited significantly from receiving radiotherapy plus PCV rather than radiotherapy alone (P = .02 for OS, P less than .001 for PFS).

Exploratory analysis that broke down OS and PFS by cancer type showed that “the superiority of radiation therapy plus chemotherapy over radiation therapy alone was seen with all histologic diagnoses, although the difference did not reach significance among patients with astrocytoma,” wrote Dr. Buckner and his collaborators.

When all patients lost to follow-up in both groups were assessed as having died, the sensitivity analysis still showed benefit for radiotherapy plus PCV (HR for death, compared with radiotherapy alone, 0.72; P = .03).

The value of the long-term follow-up, wrote Dr. Buckner and his colleagues, was that “The separation of the progression-free survival curves of the two treatment groups did not begin until 2 to 3 years after randomization, although approximately 25% of the patients in each group had disease progression by then.”

Dr. Buckner and his collaborators emphasized that the patient-physician team should consider all factors in making treatment decisions, saying, “Patients and their physicians will have to weigh whether the longer survival justified the more toxic therapeutic approach.“

[email protected]

On Twitter @karioakes

Adding a chemotherapy combination to radiation therapy for initial treatment of low-grade gliomas significantly improved overall survival and progression-free survival, regardless of the tumor type, investigators report in the New England Journal of Medicine.

Grade 2 glioma patients who received radiation plus the combination of procarbazine, lomustine (also called CCNU), and vincristine (PCV) had a longer median overall survival than those who received radiation alone (13.3 vs. 7.8 years; hazard ratio for death, 0.59; P = .003). Of those who received radiation plus chemotherapy, the progression-free survival rate at 10 years was 51%, compared with 21% for the group who received radiation alone, Dr. Jan Buckner and his colleagues report (N Engl J Med. 2016;374:1344-55. doi: 10.1056/NEJMoa1500925).

“The magnitude of treatment benefit from combined chemotherapy plus radiation therapy is substantial, but the toxic effects are greater than those observed with radiation therapy alone,” wrote Dr. Buckner, professor of oncology at the Mayo Clinic, Rochester, Minn., and associates. Patients who received radiation plus PCV had more toxic side effects from their therapy, though most effects were grade 1 and 2.

For this study, 254 patients were randomized, with 128 assigned to radiotherapy alone, and 126 assigned to radiotherapy plus PCV. A total of 126 patients in the radiotherapy arm were included in the analysis, with one patient not receiving the intervention and 14 patients lost to follow-up at some point during the 10 years of the study. In the radiotherapy plus PCV arm, 125 patients were eligible for evaluation, and all of those patients were included in the analysis. Twenty-six patients in this arm were lost to follow-up, and 72 patients discontinued the intervention in this arm (this figure included four patients who died).

Tumor types included in the study were grade 2 astrocytoma, oligoastrocytoma, or oligodendroglioma.

Patients were included if they were between 18 and 39 years of age and had received a subtotal resection or biopsy of their tumor, or if they were 40 years of age or older and had any resection or biopsy of their tumor. Exclusion criteria included previous radiation to the head or neck, any previous chemotherapy, significant pulmonary disease, and a 5-year history of other cancers except cervical cancer in situ and non-melanoma skin cancer. Tumors could not have spread to noncontiguous leptomeninges, and patients could not have gliomatosis cerebri. Patients had to have a Karnofsky performance score of 60 or higher, and a neurological function score of 3 or less.

Dr. Buckner and his collaborators also assessed tumors for IDH1 mutational status by performing immunostaining with the mutation-specific monoclonal antibody IDH1 R132H; appropriate tissue was available for testing in slightly less than half of the patients in each study arm. The mutation was present in 35/57 patients (61%) in the radiotherapy-only arm, and 36/56 patients (64%) in the radiotherapy plus PCV arm. Patients with oligodendroglioma were most likely to have IDH1 R132H mutations. Sample sizes were too small to determine the effect of other IDH mutations or co-deletion of chromosome arms 1p and 19q.

In multivariable analysis, the presence of the IDH1 R132H mutation was identified as an independent prognostic factor for better overall survival (OS) and progression-free survival (PFS), regardless of the treatment administered. Those with the mutation still benefited significantly from receiving radiotherapy plus PCV rather than radiotherapy alone (P = .02 for OS, P less than .001 for PFS).

Exploratory analysis that broke down OS and PFS by cancer type showed that “the superiority of radiation therapy plus chemotherapy over radiation therapy alone was seen with all histologic diagnoses, although the difference did not reach significance among patients with astrocytoma,” wrote Dr. Buckner and his collaborators.

When all patients lost to follow-up in both groups were assessed as having died, the sensitivity analysis still showed benefit for radiotherapy plus PCV (HR for death, compared with radiotherapy alone, 0.72; P = .03).

The value of the long-term follow-up, wrote Dr. Buckner and his colleagues, was that “The separation of the progression-free survival curves of the two treatment groups did not begin until 2 to 3 years after randomization, although approximately 25% of the patients in each group had disease progression by then.”

Dr. Buckner and his collaborators emphasized that the patient-physician team should consider all factors in making treatment decisions, saying, “Patients and their physicians will have to weigh whether the longer survival justified the more toxic therapeutic approach.“

[email protected]

On Twitter @karioakes

BOSTON – A random morning serum cortisol above 11.1 mcg/dL safely rules out adrenal insufficiency in both inpatients and outpatients, according to a review of 3,300 adrenal insufficiency work-ups at the Edinburgh Centre for Endocrinology and Diabetes.

The finding could help eliminate the cost and hassle of unnecessary adrenocorticotropic hormone (ACTH) stimulation tests; the investigators estimated that the cut point would eliminate almost half of them without any ill effects. “You can be very confident that patients aren’t insufficient if they are above that line,” with more than 99% sensitivity. If they are below it, “they may be normal, and they may be abnormal.” Below 1.8 mcg/dL, adrenal insufficiency is almost certain, but between the cutoffs, ACTH stimulation is necessary, said lead investigator Dr. Scott Mackenzie, a trainee at the center.

In short, “basal serum cortisol as a screening test ... offers a convenient and accessible means of identifying patients who require further assessment,” he said at the annual meeting of the Endocrine Society.

Similar cut points have been suggested by previous studies, but the Scottish investigation is the first to validate its findings both inside and outside of the hospital.

The team arrived at the 11.1 mcg/dL morning cortisol cut point by comparing basal cortisol levels and synacthen results in 1,628 outpatients. They predefined a sensitivity of more than 99% for adrenal sufficiency to avoid missing anyone with true disease. The cut point’s predictive power was then validated in 875 outpatients and 797 inpatients. Morning basal cortisol levels proved superior to afternoon levels.

The investigators were thinking about cost-effectiveness, but they also wanted to increase screening. “We may be able to reduce the number of adrenal insufficiency cases we are missing because [primary care is] reluctant to send people to the clinic for synacthen tests” due to the cost and inconvenience. As with many locations in the United States, “our practice is to do [ACTH on] everyone.” If there was “a quick and easy 9 a.m. blood test” instead, it would help, Dr. Mackenzie said.

Adrenal insufficiency was on the differential for a wide variety of reasons, including hypogonadism, pituitary issues, prolactinemia, fatigue, hypoglycemia, postural hypotension, and hyponatremia. Most of the patients were middle aged, and they were about evenly split between men and women.

There was no outside funding for the work, and the investigators had no disclosures.

[email protected]

BOSTON – A random morning serum cortisol above 11.1 mcg/dL safely rules out adrenal insufficiency in both inpatients and outpatients, according to a review of 3,300 adrenal insufficiency work-ups at the Edinburgh Centre for Endocrinology and Diabetes.

The finding could help eliminate the cost and hassle of unnecessary adrenocorticotropic hormone (ACTH) stimulation tests; the investigators estimated that the cut point would eliminate almost half of them without any ill effects. “You can be very confident that patients aren’t insufficient if they are above that line,” with more than 99% sensitivity. If they are below it, “they may be normal, and they may be abnormal.” Below 1.8 mcg/dL, adrenal insufficiency is almost certain, but between the cutoffs, ACTH stimulation is necessary, said lead investigator Dr. Scott Mackenzie, a trainee at the center.

In short, “basal serum cortisol as a screening test ... offers a convenient and accessible means of identifying patients who require further assessment,” he said at the annual meeting of the Endocrine Society.

Similar cut points have been suggested by previous studies, but the Scottish investigation is the first to validate its findings both inside and outside of the hospital.

The team arrived at the 11.1 mcg/dL morning cortisol cut point by comparing basal cortisol levels and synacthen results in 1,628 outpatients. They predefined a sensitivity of more than 99% for adrenal sufficiency to avoid missing anyone with true disease. The cut point’s predictive power was then validated in 875 outpatients and 797 inpatients. Morning basal cortisol levels proved superior to afternoon levels.

The investigators were thinking about cost-effectiveness, but they also wanted to increase screening. “We may be able to reduce the number of adrenal insufficiency cases we are missing because [primary care is] reluctant to send people to the clinic for synacthen tests” due to the cost and inconvenience. As with many locations in the United States, “our practice is to do [ACTH on] everyone.” If there was “a quick and easy 9 a.m. blood test” instead, it would help, Dr. Mackenzie said.

Adrenal insufficiency was on the differential for a wide variety of reasons, including hypogonadism, pituitary issues, prolactinemia, fatigue, hypoglycemia, postural hypotension, and hyponatremia. Most of the patients were middle aged, and they were about evenly split between men and women.

There was no outside funding for the work, and the investigators had no disclosures.

[email protected]

BOSTON – A random morning serum cortisol above 11.1 mcg/dL safely rules out adrenal insufficiency in both inpatients and outpatients, according to a review of 3,300 adrenal insufficiency work-ups at the Edinburgh Centre for Endocrinology and Diabetes.

The finding could help eliminate the cost and hassle of unnecessary adrenocorticotropic hormone (ACTH) stimulation tests; the investigators estimated that the cut point would eliminate almost half of them without any ill effects. “You can be very confident that patients aren’t insufficient if they are above that line,” with more than 99% sensitivity. If they are below it, “they may be normal, and they may be abnormal.” Below 1.8 mcg/dL, adrenal insufficiency is almost certain, but between the cutoffs, ACTH stimulation is necessary, said lead investigator Dr. Scott Mackenzie, a trainee at the center.

In short, “basal serum cortisol as a screening test ... offers a convenient and accessible means of identifying patients who require further assessment,” he said at the annual meeting of the Endocrine Society.

Similar cut points have been suggested by previous studies, but the Scottish investigation is the first to validate its findings both inside and outside of the hospital.

The team arrived at the 11.1 mcg/dL morning cortisol cut point by comparing basal cortisol levels and synacthen results in 1,628 outpatients. They predefined a sensitivity of more than 99% for adrenal sufficiency to avoid missing anyone with true disease. The cut point’s predictive power was then validated in 875 outpatients and 797 inpatients. Morning basal cortisol levels proved superior to afternoon levels.

The investigators were thinking about cost-effectiveness, but they also wanted to increase screening. “We may be able to reduce the number of adrenal insufficiency cases we are missing because [primary care is] reluctant to send people to the clinic for synacthen tests” due to the cost and inconvenience. As with many locations in the United States, “our practice is to do [ACTH on] everyone.” If there was “a quick and easy 9 a.m. blood test” instead, it would help, Dr. Mackenzie said.

Adrenal insufficiency was on the differential for a wide variety of reasons, including hypogonadism, pituitary issues, prolactinemia, fatigue, hypoglycemia, postural hypotension, and hyponatremia. Most of the patients were middle aged, and they were about evenly split between men and women.

There was no outside funding for the work, and the investigators had no disclosures.

[email protected]