Guidelines

The American Diabetes Association is out with new standard-of-care guidelines that – among other things – reject injectable insulin as the main first-line treatment for type 2 diabetes mellitus (T2DM), debut a cardiac risk calculator, and offer new recommendations regarding medications for patients with kidney disease, clogged arteries, and heart failure.

The ADA’s newly released 2019 Standards of Medical Care in Diabetes “emphasize a patient-centered approach that considers the multiple health and life factors of each person living with diabetes,” said William T. Cefalu, MD, the ADA’s chief scientific, medical, and mission officer, in a statement.

The 193-page guidelines are now available online at the Diabetes Care website and will be available via an app and the print edition of the journal.

Here’s a closer look at a few of the many new and revised recommendations in the 2019 Standards of Care.
 

Diabetes treatment

In a new guideline, the standards of care says glucagonlike peptide–1 (GLP-1) receptor agonists should be “a first-line treatment” – ahead of insulin – “for most [type 2] patients who need the greater efficacy of an injectable medication.”

However, the recommendations note that the “high costs and tolerability issues are important barriers to the use of GLP-1 receptor agonists.”

A new recommendation suggests the use of sodium-glucose cotransporter 2 inhibitors or GLP-1 receptor agonists “with demonstrated cardiovascular disease benefit” in patients with type 2 diabetes who have confirmed atherosclerotic cardiovascular disease.

A related new recommendation says sodium-glucose cotransporter 2 inhibitors are the preferred treatment for these patients who have heart failure or are at high risk of developing it.

In a new recommendation, the ADA suggests that patients with type 2 diabetes and chronic kidney disease potentially take a sodium-glucose cotransporter 2 inhibitor or a GLP-1 receptor agonist, which has been shown to reduce the risk of chronic kidney disease progression, cardiac events, or both.

There’s a greater focus on insulin as the preferred treatment for hyperglycemia in gestational diabetes mellitus “as it does not cross the placenta to a measurable extent.” The ADA also warns against metformin and glyburide as first-line agents because they “both cross the placenta to the fetus.”

Diabetes monitoring and screening

The ADA now recommends use of the American College of Cardiology’s atherosclerotic cardiovascular disease risk calculator, the ASCVD Risk Estimator Plus. The calculator assesses the risk of this disease over 10 years and is “generally a useful tool.”

The ACA recommends screening for cardiac risk factors at least once a year in patients with diabetes.

Physicians are no longer advised to check the feet of patients with diabetes at every visit; now the recommendation is for those at high risk of ulceration only. However, an annual examination of feet is recommended for all patients with diabetes.

The ADA now recommends that patients with type 2 diabetes or prediabetes undergo screening for nonalcoholic steatohepatitis and liver fibrosis if they have elevated liver enzymes or an ultrasound examination shows signs of fatty liver.

Gabapentin is now listed along with pregabalin and duloxetine as first-line drug treatments for neuropathic pain in diabetes.

The American Diabetes Association is out with new standard-of-care guidelines that – among other things – reject injectable insulin as the main first-line treatment for type 2 diabetes mellitus (T2DM), debut a cardiac risk calculator, and offer new recommendations regarding medications for patients with kidney disease, clogged arteries, and heart failure.

The ADA’s newly released 2019 Standards of Medical Care in Diabetes “emphasize a patient-centered approach that considers the multiple health and life factors of each person living with diabetes,” said William T. Cefalu, MD, the ADA’s chief scientific, medical, and mission officer, in a statement.

The 193-page guidelines are now available online at the Diabetes Care website and will be available via an app and the print edition of the journal.

Here’s a closer look at a few of the many new and revised recommendations in the 2019 Standards of Care.
 

Diabetes treatment

In a new guideline, the standards of care says glucagonlike peptide–1 (GLP-1) receptor agonists should be “a first-line treatment” – ahead of insulin – “for most [type 2] patients who need the greater efficacy of an injectable medication.”

However, the recommendations note that the “high costs and tolerability issues are important barriers to the use of GLP-1 receptor agonists.”

A new recommendation suggests the use of sodium-glucose cotransporter 2 inhibitors or GLP-1 receptor agonists “with demonstrated cardiovascular disease benefit” in patients with type 2 diabetes who have confirmed atherosclerotic cardiovascular disease.

A related new recommendation says sodium-glucose cotransporter 2 inhibitors are the preferred treatment for these patients who have heart failure or are at high risk of developing it.

In a new recommendation, the ADA suggests that patients with type 2 diabetes and chronic kidney disease potentially take a sodium-glucose cotransporter 2 inhibitor or a GLP-1 receptor agonist, which has been shown to reduce the risk of chronic kidney disease progression, cardiac events, or both.

There’s a greater focus on insulin as the preferred treatment for hyperglycemia in gestational diabetes mellitus “as it does not cross the placenta to a measurable extent.” The ADA also warns against metformin and glyburide as first-line agents because they “both cross the placenta to the fetus.”

Diabetes monitoring and screening

The ADA now recommends use of the American College of Cardiology’s atherosclerotic cardiovascular disease risk calculator, the ASCVD Risk Estimator Plus. The calculator assesses the risk of this disease over 10 years and is “generally a useful tool.”

The ACA recommends screening for cardiac risk factors at least once a year in patients with diabetes.

Physicians are no longer advised to check the feet of patients with diabetes at every visit; now the recommendation is for those at high risk of ulceration only. However, an annual examination of feet is recommended for all patients with diabetes.

The ADA now recommends that patients with type 2 diabetes or prediabetes undergo screening for nonalcoholic steatohepatitis and liver fibrosis if they have elevated liver enzymes or an ultrasound examination shows signs of fatty liver.

Gabapentin is now listed along with pregabalin and duloxetine as first-line drug treatments for neuropathic pain in diabetes.

The American Diabetes Association is out with new standard-of-care guidelines that – among other things – reject injectable insulin as the main first-line treatment for type 2 diabetes mellitus (T2DM), debut a cardiac risk calculator, and offer new recommendations regarding medications for patients with kidney disease, clogged arteries, and heart failure.

The ADA’s newly released 2019 Standards of Medical Care in Diabetes “emphasize a patient-centered approach that considers the multiple health and life factors of each person living with diabetes,” said William T. Cefalu, MD, the ADA’s chief scientific, medical, and mission officer, in a statement.

The 193-page guidelines are now available online at the Diabetes Care website and will be available via an app and the print edition of the journal.

Here’s a closer look at a few of the many new and revised recommendations in the 2019 Standards of Care.
 

Diabetes treatment

In a new guideline, the standards of care says glucagonlike peptide–1 (GLP-1) receptor agonists should be “a first-line treatment” – ahead of insulin – “for most [type 2] patients who need the greater efficacy of an injectable medication.”

However, the recommendations note that the “high costs and tolerability issues are important barriers to the use of GLP-1 receptor agonists.”

A new recommendation suggests the use of sodium-glucose cotransporter 2 inhibitors or GLP-1 receptor agonists “with demonstrated cardiovascular disease benefit” in patients with type 2 diabetes who have confirmed atherosclerotic cardiovascular disease.

A related new recommendation says sodium-glucose cotransporter 2 inhibitors are the preferred treatment for these patients who have heart failure or are at high risk of developing it.

In a new recommendation, the ADA suggests that patients with type 2 diabetes and chronic kidney disease potentially take a sodium-glucose cotransporter 2 inhibitor or a GLP-1 receptor agonist, which has been shown to reduce the risk of chronic kidney disease progression, cardiac events, or both.

There’s a greater focus on insulin as the preferred treatment for hyperglycemia in gestational diabetes mellitus “as it does not cross the placenta to a measurable extent.” The ADA also warns against metformin and glyburide as first-line agents because they “both cross the placenta to the fetus.”

Diabetes monitoring and screening

The ADA now recommends use of the American College of Cardiology’s atherosclerotic cardiovascular disease risk calculator, the ASCVD Risk Estimator Plus. The calculator assesses the risk of this disease over 10 years and is “generally a useful tool.”

The ACA recommends screening for cardiac risk factors at least once a year in patients with diabetes.

Physicians are no longer advised to check the feet of patients with diabetes at every visit; now the recommendation is for those at high risk of ulceration only. However, an annual examination of feet is recommended for all patients with diabetes.

The ADA now recommends that patients with type 2 diabetes or prediabetes undergo screening for nonalcoholic steatohepatitis and liver fibrosis if they have elevated liver enzymes or an ultrasound examination shows signs of fatty liver.

Gabapentin is now listed along with pregabalin and duloxetine as first-line drug treatments for neuropathic pain in diabetes.

Barcelona – New evidence-based guidelines on posttraumatic stress disorder prevention and treatment from the International Society for Traumatic Stress Studies (ISTSS) highlight an uncomfortable truth: Namely, the basis for early formal intervention of any sort is sorely lacking.

Bruce Jancin/MDedge News

“I’m acutely aware that a lot of people in the mental health field are not aware of the evidence base as it stands at the moment,” Jonathan I. Bisson, MD, said at the annual congress of the European College of Neuropsychopharmacology. “There’s something very human about trying to do something. I think we find it very hard to do nothing following a traumatic event.”

Dr. Bisson, a professor of psychiatry at Cardiff (Wales) University and the chair of the ISTSS guidelines committee, provided an advance look at the ISTSS guidelines, which have since been released.

Secondary prevention of PTSD can entail either blocking development of symptoms after exposure to trauma or treating early emergent PTSD symptoms. Dr. Bisson emphasized that, although multiple exciting prospects are on the horizon for secondary prevention, those interventions need further work before implementation. The ISTSS guidelines, based on the group’s meta-analyses of 361 randomized controlled trials, rated most of the diverse psychosocial, psychological, and pharmacologic interventions that have been proposed or are now actually being used in clinical practice as either “low effect,” “interventions with emerging evidence,” or “insufficient evidence to recommend.” Those interventions are not backed by sufficient evidence of efficacy to be ready for prime time use in clinical practice.

Morever, the potential for iatrogenic harm is very real.

“When we’re considering intervening with somebody, then clearly, we’ve got to be very, very careful because we know that an awful lot of the distress immediately after a traumatic event can be a normal response to a trauma,” the psychiatrist observed. “It’s normal to cry after a bereavement, for example. But should we be pathologizing that, or is that the body’s way of actually bringing itself to terms with something that’s very extreme?

“So we’ve got to be careful in our efforts to shape emotional processing, which might do absolutely nothing – which I’d argue is a problem when we’ve got limited resources because we should be focusing those resources on things that make a difference. Or it could minimize or prevent prolonged distress or pathology, which is what we’re after. Or it could interfere with the adaptive acute stress response – and that’s a real problem and one we’ve got to be very careful about,” Dr. Bisson said. “So ‘primum non nocere’ – first do no harm – should be a principle we adhere to.”

Neurobiology of PTSD

The accepted view of the neurobiology of PTSD is that it represents a failure of the medial prefrontal/anterior cingulate network to regulate activity in the amygdala, with resultant hyperreactivity to threat. Enhanced negative feedback of cortisol occurs. The brain’s response to low cortisol is to increase levels of corticotropin-releasing factor, which has the unwanted consequence of increased locus coeruleus activity and noradrenaline release. The resultant adrenergic surge facilitates the laying down and consolidation of traumatic memories.

Also, low cortisol levels disinhibit retrieval of traumatic memories, so the affected individual thinks more about the trauma. All of this elicits an uncontrolled sympathetic response, so the patient remains in a constant state of hyperarousal characteristic of PTSD.

“In theory we should have some really simple ways to prevent PTSD from occurring if we get in there soon enough: reducing noradrenergic overactivity via alpha2-adrenergic receptor agonism with an agent such as clonidine; postsynaptic beta-adrenergic blocking with a drug such as propranolol; or alpha1-adrenergic receptor blocking, as with prazosin. All of these approaches reduce noradrenergic tone and therefore should be effective, in theory, to prevent PTSD.

“We should also be able to use indirect strategies to reduce noradrenergic overactivity: GABA agents like benzodiazepines, alcohol, and gabapentin oppose noradrenaline action in the amygdala. I’m not suggesting drinking all the time to prevent PTSD, but there’s a strong association in several studies, with about a 50% reduction in rates of PTSD in those who are intoxicated at the time of the trauma,” according to Dr. Bisson.

Unfortunately, to date, none of those pharmacologic approaches have been effective when studied in randomized trials.

One pharmacologic intervention

Only one drug, hydrocortisone, was rated an “intervention with emerging evidence of efficacy” for prevention of PTSD symptoms in adults when given within the first 3 months after a traumatic event. Three placebo-controlled, randomized trials have shown a positive effect.

“It should be said that most of the studies of hydrocortisone have been done in individuals following extreme physical illness, such as septic shock sufferers, so the generalizability is a bit of a question. Nevertheless, it’s the one agent that has meta-analytic evidence of being effective at preventing PTSD, although more research is needed,” Dr. Bisson said.

The ISTSS guidelines concluded there is “insufficient evidence to recommend” escitalopram, propranolol, gabapentin, oxytocin, or docosahexaenoic acid within the first 3 months for prevention or treatment of PTSD symptoms. Results of randomized trials featuring those agents have been “really disappointing” in light of what seems a sound theoretic rationale, he continued.

“We’re really struggling from a pharmacologic perspective to know what to do. I would say we are still at the experimental stage, and there’s no real good evidence that we should give any medication to prevent PTSD,” Dr. Bisson said.
 

Early psychosocial interventions

The ISTSS guidelines rate only two single-session interventions for prevention as rising to the promising level of “emerging evidence” of clinically important benefit: single-session eye movement desensitization and reprocessing (EMDR), which in its multisession format is a well-established treatment with strong evidence of efficacy in established PTSD, and a program known as Group 512 PM, which combines group debriefing with group cohesion–building exercises.

“Group 512 PM was done in groups of Chinese army personnel helping in recovery efforts following a 2008 earthquake in China that killed 80,000 people. It resulted in nearly a 50% reduction in PTSD versus no debriefing. This cohesion training might be a clue to us as something to work on in the future,” Dr. Bisson said.

The ISTSS guidelines deem there is insufficient evidence to recommend single-session group debriefing, group stress management, heart stress management, group education, trauma-focused counselling, computerized visuospatial task, individual psychoeducation, or individual debriefing.

“In six randomized controlled trials over nearly the last 20 years, we see a strong signal that individual psychological debriefing isn’t effective. So, certainly, going into a room with an individual or a couple and talking about what they’ve been through in great detail and getting them to express their emotions and advising them that’s a normal reaction doesn’t seem to be enough. And rather worryingly, the people who tend to do worse with that sort of intervention are the people who’ve got the most symptoms when they started, so they’re the ones at highest risk of developing PTSD,” Dr. Bisson said.

Multisession prevention interventions such as brief dyadic therapy and self-guided Internet interventions are supported by emerging evidence. Less promising, and with insufficient evidence to recommend, according to the ISTSS, are brief interpersonal therapy, brief individual trauma processing therapy, telephone-based cognitive-behavioral therapy (CBT), and nurse-led intensive care recovery programs.

For multisession early treatment interventions for patients with emerging traumatic stress symptoms within the first 3 months, the new ISTSS guidelines recommend as standard therapy CBT with a trauma focus, EMDR, or cognitive therapy. Stepped or collaborative care is rated as having “low effect.” There is emerging evidence for structured writing interventions and Internet-based guided self-help. And there is insufficient evidence to recommend behavioral activation, Internet virtual reality therapy, telephone-based CBT with a trauma focus, computerized neurobehavioral training, or supportive counseling.

Treating adults with established PTSD

Pharmacotherapy, including fluoxetine, sertraline, paroxetine, and venlafaxine is rated in the guidelines as a low-effect treatment. Quetiapine has emerging evidence of efficacy. Everything else has insufficient evidence.

Psychological therapies such as EMDR, CBT with a trauma focus, prolonged exposure, cognitive therapy, and cognitive processing therapy received strong recommendations. In fact, those are the only interventions in the entire ISTSS guidelines that received a “strong recommendation” rating. A weaker “standard recommendation” is given to CBT without a trauma focus, narrative exposure therapy, present-centered therapy, group CBT with a trauma focus, and guided Internet-based therapy with a trauma focus. Interventions with emerging evidence of efficacy include virtual reality therapy, reconsolidation of traumatic memories, and couples CBT with a trauma focus.
 

Best-practice approach to prevention

“In my view, and what I tell people, is that after a traumatic event I think practical pragmatic support in an empathic manner is the best first step,” Dr. Bisson said. “And it doesn’t have to be provided by a mental health professional. In fact, your family and friends are the best people to provide that. And then, we watchfully wait to see if traumatic stress symptoms emerge. If they do, and particularly if their trajectory is going up, then at about 1 month, I would get in there and deliver a therapy, either CBT with a trauma focus, EMDR, or cognitive therapy with a trauma focus. All of those have a significant positive effect for this group.”

Although he restricted his talk to secondary prevention of PTSD in adults, the ISTSS guidelines also address early intervention in children and adolescents.

Dr. Bisson reported having no financial conflicts of interest regarding his presentation.

[email protected]
 

Barcelona – New evidence-based guidelines on posttraumatic stress disorder prevention and treatment from the International Society for Traumatic Stress Studies (ISTSS) highlight an uncomfortable truth: Namely, the basis for early formal intervention of any sort is sorely lacking.

Bruce Jancin/MDedge News

“I’m acutely aware that a lot of people in the mental health field are not aware of the evidence base as it stands at the moment,” Jonathan I. Bisson, MD, said at the annual congress of the European College of Neuropsychopharmacology. “There’s something very human about trying to do something. I think we find it very hard to do nothing following a traumatic event.”

Dr. Bisson, a professor of psychiatry at Cardiff (Wales) University and the chair of the ISTSS guidelines committee, provided an advance look at the ISTSS guidelines, which have since been released.

Secondary prevention of PTSD can entail either blocking development of symptoms after exposure to trauma or treating early emergent PTSD symptoms. Dr. Bisson emphasized that, although multiple exciting prospects are on the horizon for secondary prevention, those interventions need further work before implementation. The ISTSS guidelines, based on the group’s meta-analyses of 361 randomized controlled trials, rated most of the diverse psychosocial, psychological, and pharmacologic interventions that have been proposed or are now actually being used in clinical practice as either “low effect,” “interventions with emerging evidence,” or “insufficient evidence to recommend.” Those interventions are not backed by sufficient evidence of efficacy to be ready for prime time use in clinical practice.

Morever, the potential for iatrogenic harm is very real.

“When we’re considering intervening with somebody, then clearly, we’ve got to be very, very careful because we know that an awful lot of the distress immediately after a traumatic event can be a normal response to a trauma,” the psychiatrist observed. “It’s normal to cry after a bereavement, for example. But should we be pathologizing that, or is that the body’s way of actually bringing itself to terms with something that’s very extreme?

“So we’ve got to be careful in our efforts to shape emotional processing, which might do absolutely nothing – which I’d argue is a problem when we’ve got limited resources because we should be focusing those resources on things that make a difference. Or it could minimize or prevent prolonged distress or pathology, which is what we’re after. Or it could interfere with the adaptive acute stress response – and that’s a real problem and one we’ve got to be very careful about,” Dr. Bisson said. “So ‘primum non nocere’ – first do no harm – should be a principle we adhere to.”

Neurobiology of PTSD

The accepted view of the neurobiology of PTSD is that it represents a failure of the medial prefrontal/anterior cingulate network to regulate activity in the amygdala, with resultant hyperreactivity to threat. Enhanced negative feedback of cortisol occurs. The brain’s response to low cortisol is to increase levels of corticotropin-releasing factor, which has the unwanted consequence of increased locus coeruleus activity and noradrenaline release. The resultant adrenergic surge facilitates the laying down and consolidation of traumatic memories.

Also, low cortisol levels disinhibit retrieval of traumatic memories, so the affected individual thinks more about the trauma. All of this elicits an uncontrolled sympathetic response, so the patient remains in a constant state of hyperarousal characteristic of PTSD.

“In theory we should have some really simple ways to prevent PTSD from occurring if we get in there soon enough: reducing noradrenergic overactivity via alpha2-adrenergic receptor agonism with an agent such as clonidine; postsynaptic beta-adrenergic blocking with a drug such as propranolol; or alpha1-adrenergic receptor blocking, as with prazosin. All of these approaches reduce noradrenergic tone and therefore should be effective, in theory, to prevent PTSD.

“We should also be able to use indirect strategies to reduce noradrenergic overactivity: GABA agents like benzodiazepines, alcohol, and gabapentin oppose noradrenaline action in the amygdala. I’m not suggesting drinking all the time to prevent PTSD, but there’s a strong association in several studies, with about a 50% reduction in rates of PTSD in those who are intoxicated at the time of the trauma,” according to Dr. Bisson.

Unfortunately, to date, none of those pharmacologic approaches have been effective when studied in randomized trials.

One pharmacologic intervention

Only one drug, hydrocortisone, was rated an “intervention with emerging evidence of efficacy” for prevention of PTSD symptoms in adults when given within the first 3 months after a traumatic event. Three placebo-controlled, randomized trials have shown a positive effect.

“It should be said that most of the studies of hydrocortisone have been done in individuals following extreme physical illness, such as septic shock sufferers, so the generalizability is a bit of a question. Nevertheless, it’s the one agent that has meta-analytic evidence of being effective at preventing PTSD, although more research is needed,” Dr. Bisson said.

The ISTSS guidelines concluded there is “insufficient evidence to recommend” escitalopram, propranolol, gabapentin, oxytocin, or docosahexaenoic acid within the first 3 months for prevention or treatment of PTSD symptoms. Results of randomized trials featuring those agents have been “really disappointing” in light of what seems a sound theoretic rationale, he continued.

“We’re really struggling from a pharmacologic perspective to know what to do. I would say we are still at the experimental stage, and there’s no real good evidence that we should give any medication to prevent PTSD,” Dr. Bisson said.
 

Early psychosocial interventions

The ISTSS guidelines rate only two single-session interventions for prevention as rising to the promising level of “emerging evidence” of clinically important benefit: single-session eye movement desensitization and reprocessing (EMDR), which in its multisession format is a well-established treatment with strong evidence of efficacy in established PTSD, and a program known as Group 512 PM, which combines group debriefing with group cohesion–building exercises.

“Group 512 PM was done in groups of Chinese army personnel helping in recovery efforts following a 2008 earthquake in China that killed 80,000 people. It resulted in nearly a 50% reduction in PTSD versus no debriefing. This cohesion training might be a clue to us as something to work on in the future,” Dr. Bisson said.

The ISTSS guidelines deem there is insufficient evidence to recommend single-session group debriefing, group stress management, heart stress management, group education, trauma-focused counselling, computerized visuospatial task, individual psychoeducation, or individual debriefing.

“In six randomized controlled trials over nearly the last 20 years, we see a strong signal that individual psychological debriefing isn’t effective. So, certainly, going into a room with an individual or a couple and talking about what they’ve been through in great detail and getting them to express their emotions and advising them that’s a normal reaction doesn’t seem to be enough. And rather worryingly, the people who tend to do worse with that sort of intervention are the people who’ve got the most symptoms when they started, so they’re the ones at highest risk of developing PTSD,” Dr. Bisson said.

Multisession prevention interventions such as brief dyadic therapy and self-guided Internet interventions are supported by emerging evidence. Less promising, and with insufficient evidence to recommend, according to the ISTSS, are brief interpersonal therapy, brief individual trauma processing therapy, telephone-based cognitive-behavioral therapy (CBT), and nurse-led intensive care recovery programs.

For multisession early treatment interventions for patients with emerging traumatic stress symptoms within the first 3 months, the new ISTSS guidelines recommend as standard therapy CBT with a trauma focus, EMDR, or cognitive therapy. Stepped or collaborative care is rated as having “low effect.” There is emerging evidence for structured writing interventions and Internet-based guided self-help. And there is insufficient evidence to recommend behavioral activation, Internet virtual reality therapy, telephone-based CBT with a trauma focus, computerized neurobehavioral training, or supportive counseling.

Treating adults with established PTSD

Pharmacotherapy, including fluoxetine, sertraline, paroxetine, and venlafaxine is rated in the guidelines as a low-effect treatment. Quetiapine has emerging evidence of efficacy. Everything else has insufficient evidence.

Psychological therapies such as EMDR, CBT with a trauma focus, prolonged exposure, cognitive therapy, and cognitive processing therapy received strong recommendations. In fact, those are the only interventions in the entire ISTSS guidelines that received a “strong recommendation” rating. A weaker “standard recommendation” is given to CBT without a trauma focus, narrative exposure therapy, present-centered therapy, group CBT with a trauma focus, and guided Internet-based therapy with a trauma focus. Interventions with emerging evidence of efficacy include virtual reality therapy, reconsolidation of traumatic memories, and couples CBT with a trauma focus.
 

Best-practice approach to prevention

“In my view, and what I tell people, is that after a traumatic event I think practical pragmatic support in an empathic manner is the best first step,” Dr. Bisson said. “And it doesn’t have to be provided by a mental health professional. In fact, your family and friends are the best people to provide that. And then, we watchfully wait to see if traumatic stress symptoms emerge. If they do, and particularly if their trajectory is going up, then at about 1 month, I would get in there and deliver a therapy, either CBT with a trauma focus, EMDR, or cognitive therapy with a trauma focus. All of those have a significant positive effect for this group.”

Although he restricted his talk to secondary prevention of PTSD in adults, the ISTSS guidelines also address early intervention in children and adolescents.

Dr. Bisson reported having no financial conflicts of interest regarding his presentation.

[email protected]
 

Barcelona – New evidence-based guidelines on posttraumatic stress disorder prevention and treatment from the International Society for Traumatic Stress Studies (ISTSS) highlight an uncomfortable truth: Namely, the basis for early formal intervention of any sort is sorely lacking.

Bruce Jancin/MDedge News

“I’m acutely aware that a lot of people in the mental health field are not aware of the evidence base as it stands at the moment,” Jonathan I. Bisson, MD, said at the annual congress of the European College of Neuropsychopharmacology. “There’s something very human about trying to do something. I think we find it very hard to do nothing following a traumatic event.”

Dr. Bisson, a professor of psychiatry at Cardiff (Wales) University and the chair of the ISTSS guidelines committee, provided an advance look at the ISTSS guidelines, which have since been released.

Secondary prevention of PTSD can entail either blocking development of symptoms after exposure to trauma or treating early emergent PTSD symptoms. Dr. Bisson emphasized that, although multiple exciting prospects are on the horizon for secondary prevention, those interventions need further work before implementation. The ISTSS guidelines, based on the group’s meta-analyses of 361 randomized controlled trials, rated most of the diverse psychosocial, psychological, and pharmacologic interventions that have been proposed or are now actually being used in clinical practice as either “low effect,” “interventions with emerging evidence,” or “insufficient evidence to recommend.” Those interventions are not backed by sufficient evidence of efficacy to be ready for prime time use in clinical practice.

Morever, the potential for iatrogenic harm is very real.

“When we’re considering intervening with somebody, then clearly, we’ve got to be very, very careful because we know that an awful lot of the distress immediately after a traumatic event can be a normal response to a trauma,” the psychiatrist observed. “It’s normal to cry after a bereavement, for example. But should we be pathologizing that, or is that the body’s way of actually bringing itself to terms with something that’s very extreme?

“So we’ve got to be careful in our efforts to shape emotional processing, which might do absolutely nothing – which I’d argue is a problem when we’ve got limited resources because we should be focusing those resources on things that make a difference. Or it could minimize or prevent prolonged distress or pathology, which is what we’re after. Or it could interfere with the adaptive acute stress response – and that’s a real problem and one we’ve got to be very careful about,” Dr. Bisson said. “So ‘primum non nocere’ – first do no harm – should be a principle we adhere to.”

Neurobiology of PTSD

The accepted view of the neurobiology of PTSD is that it represents a failure of the medial prefrontal/anterior cingulate network to regulate activity in the amygdala, with resultant hyperreactivity to threat. Enhanced negative feedback of cortisol occurs. The brain’s response to low cortisol is to increase levels of corticotropin-releasing factor, which has the unwanted consequence of increased locus coeruleus activity and noradrenaline release. The resultant adrenergic surge facilitates the laying down and consolidation of traumatic memories.

Also, low cortisol levels disinhibit retrieval of traumatic memories, so the affected individual thinks more about the trauma. All of this elicits an uncontrolled sympathetic response, so the patient remains in a constant state of hyperarousal characteristic of PTSD.

“In theory we should have some really simple ways to prevent PTSD from occurring if we get in there soon enough: reducing noradrenergic overactivity via alpha2-adrenergic receptor agonism with an agent such as clonidine; postsynaptic beta-adrenergic blocking with a drug such as propranolol; or alpha1-adrenergic receptor blocking, as with prazosin. All of these approaches reduce noradrenergic tone and therefore should be effective, in theory, to prevent PTSD.

“We should also be able to use indirect strategies to reduce noradrenergic overactivity: GABA agents like benzodiazepines, alcohol, and gabapentin oppose noradrenaline action in the amygdala. I’m not suggesting drinking all the time to prevent PTSD, but there’s a strong association in several studies, with about a 50% reduction in rates of PTSD in those who are intoxicated at the time of the trauma,” according to Dr. Bisson.

Unfortunately, to date, none of those pharmacologic approaches have been effective when studied in randomized trials.

One pharmacologic intervention

Only one drug, hydrocortisone, was rated an “intervention with emerging evidence of efficacy” for prevention of PTSD symptoms in adults when given within the first 3 months after a traumatic event. Three placebo-controlled, randomized trials have shown a positive effect.

“It should be said that most of the studies of hydrocortisone have been done in individuals following extreme physical illness, such as septic shock sufferers, so the generalizability is a bit of a question. Nevertheless, it’s the one agent that has meta-analytic evidence of being effective at preventing PTSD, although more research is needed,” Dr. Bisson said.

The ISTSS guidelines concluded there is “insufficient evidence to recommend” escitalopram, propranolol, gabapentin, oxytocin, or docosahexaenoic acid within the first 3 months for prevention or treatment of PTSD symptoms. Results of randomized trials featuring those agents have been “really disappointing” in light of what seems a sound theoretic rationale, he continued.

“We’re really struggling from a pharmacologic perspective to know what to do. I would say we are still at the experimental stage, and there’s no real good evidence that we should give any medication to prevent PTSD,” Dr. Bisson said.
 

Early psychosocial interventions

The ISTSS guidelines rate only two single-session interventions for prevention as rising to the promising level of “emerging evidence” of clinically important benefit: single-session eye movement desensitization and reprocessing (EMDR), which in its multisession format is a well-established treatment with strong evidence of efficacy in established PTSD, and a program known as Group 512 PM, which combines group debriefing with group cohesion–building exercises.

“Group 512 PM was done in groups of Chinese army personnel helping in recovery efforts following a 2008 earthquake in China that killed 80,000 people. It resulted in nearly a 50% reduction in PTSD versus no debriefing. This cohesion training might be a clue to us as something to work on in the future,” Dr. Bisson said.

The ISTSS guidelines deem there is insufficient evidence to recommend single-session group debriefing, group stress management, heart stress management, group education, trauma-focused counselling, computerized visuospatial task, individual psychoeducation, or individual debriefing.

“In six randomized controlled trials over nearly the last 20 years, we see a strong signal that individual psychological debriefing isn’t effective. So, certainly, going into a room with an individual or a couple and talking about what they’ve been through in great detail and getting them to express their emotions and advising them that’s a normal reaction doesn’t seem to be enough. And rather worryingly, the people who tend to do worse with that sort of intervention are the people who’ve got the most symptoms when they started, so they’re the ones at highest risk of developing PTSD,” Dr. Bisson said.

Multisession prevention interventions such as brief dyadic therapy and self-guided Internet interventions are supported by emerging evidence. Less promising, and with insufficient evidence to recommend, according to the ISTSS, are brief interpersonal therapy, brief individual trauma processing therapy, telephone-based cognitive-behavioral therapy (CBT), and nurse-led intensive care recovery programs.

For multisession early treatment interventions for patients with emerging traumatic stress symptoms within the first 3 months, the new ISTSS guidelines recommend as standard therapy CBT with a trauma focus, EMDR, or cognitive therapy. Stepped or collaborative care is rated as having “low effect.” There is emerging evidence for structured writing interventions and Internet-based guided self-help. And there is insufficient evidence to recommend behavioral activation, Internet virtual reality therapy, telephone-based CBT with a trauma focus, computerized neurobehavioral training, or supportive counseling.

Treating adults with established PTSD

Pharmacotherapy, including fluoxetine, sertraline, paroxetine, and venlafaxine is rated in the guidelines as a low-effect treatment. Quetiapine has emerging evidence of efficacy. Everything else has insufficient evidence.

Psychological therapies such as EMDR, CBT with a trauma focus, prolonged exposure, cognitive therapy, and cognitive processing therapy received strong recommendations. In fact, those are the only interventions in the entire ISTSS guidelines that received a “strong recommendation” rating. A weaker “standard recommendation” is given to CBT without a trauma focus, narrative exposure therapy, present-centered therapy, group CBT with a trauma focus, and guided Internet-based therapy with a trauma focus. Interventions with emerging evidence of efficacy include virtual reality therapy, reconsolidation of traumatic memories, and couples CBT with a trauma focus.
 

Best-practice approach to prevention

“In my view, and what I tell people, is that after a traumatic event I think practical pragmatic support in an empathic manner is the best first step,” Dr. Bisson said. “And it doesn’t have to be provided by a mental health professional. In fact, your family and friends are the best people to provide that. And then, we watchfully wait to see if traumatic stress symptoms emerge. If they do, and particularly if their trajectory is going up, then at about 1 month, I would get in there and deliver a therapy, either CBT with a trauma focus, EMDR, or cognitive therapy with a trauma focus. All of those have a significant positive effect for this group.”

Although he restricted his talk to secondary prevention of PTSD in adults, the ISTSS guidelines also address early intervention in children and adolescents.

Dr. Bisson reported having no financial conflicts of interest regarding his presentation.

[email protected]
 

The American College of Rheumatology and the National Psoriasis Foundation have released a joint treatment guideline for psoriatic arthritis that, for the first time, includes a conditional recommendation to use tumor necrosis factor–inhibitor(TNFi) biologics over methotrexate and other oral small molecules as a first-line therapy in patients with active disease.

“The available low-quality evidence is inconclusive regarding the efficacy of OSMs [oral small molecules] in management of PsA, whereas there is moderate-quality evidence of the benefits of TNFi biologics, in particular regarding their impact on the prevention of disease progression and joint damage,” wrote the panel of authors, who were led by Jasvinder A. Singh, MD, of the University of Alabama at Birmingham. “In making their recommendation, the panel recognized the cost implications, but put considerations of quality of evidence for benefit over other considerations. This guideline provides recommendations for early and aggressive therapy in patients with newly diagnosed PsA.”

The 28-page guideline, published online Nov. 30 in the Journal of Psoriasis and Psoriatic Arthritis and also in Arthritis Care & Research and Arthritis & Rheumatology, is the first set of PsA-specific recommendations to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for RA and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

Based on the GRADE methodology and consensus building, the guideline authors crafted recommendations for eight different clinical scenarios, including the initial treatment of patients with active PsA who have not received either OSMs or other treatments; treatment of patients with active PsA despite treatment with an OSM; treatment of patients with active PsA despite treatment with a TNFi biologic either as monotherapy or in combination with methotrexate; treatment of patients with active PsA despite treatment with an interleukin (IL)-17 inhibitor or IL-12/23 inhibitor monotherapy; treatment of patients with active PsA including treat-to-target, active axial disease, enthesitis, or active inflammatory bowel disease; treatment of patients with active PsA and comorbidities, including concomitant diabetes and recurrent serious infections; vaccination in patients with active PsA; and treatment of patients with active PsA with nonpharmacologic interventions such as yoga and weight loss. Most of the treatment recommendations are conditional based on very low to moderate quality evidence. “Health care providers and patients must take into consideration all active disease domains, comorbidities, and the patient’s functional status in choosing the optimal therapy for an individual at a given point in time,” the authors emphasized.

Only five of the recommendations are listed as strong, including smoking cessation. Three of the strong recommendations concern adult patients with active PsA and concomitant active inflammatory bowel disease despite treatment with an OSM. They are “switch to a monoclonal antibody TNFi biologic over a TNFi biologic soluble receptor biologic,” “switch to a TNFi monoclonal antibody biologic over an IL-7i biologic,” and “switch to an IL-12/23i biologic over switching to an IL-17i biologic.”

The process of creating the guideline included input from a panel of nine adults who provided the authors with perspective on their values and preferences. “The concept of treat-to-target was challenging for patients,” the authors noted. “Although they saw value in improved outcomes, they also thought this strategy could increase costs to the patient (e.g., copayments, time traveling to more frequent appointments, etc.) and potentially increase adverse events. Therefore, a detailed conversation with the patient is needed to make decisions regarding treat-to-target.”

The authors concluded the guideline by calling for more comparative data to inform treatment selection in the future. “Several ongoing trials, including a trial to compare a TNFi biologic combination therapy with a TNFi biologic monotherapy and MTX monotherapy, will inform treatment decisions,” they wrote. “We anticipate future updates to the guideline when new evidence is available.”

Dr. Singh, who is also a staff rheumatologist at the Birmingham (Ala.) Veterans Affairs Medical Center, led development of the 2012 and 2015 ACR treatment guidelines for RA. He has received consulting fees from a variety of companies marketing rheumatologic drugs as well as research support from Takeda and Savient. The other guideline authors reported having numerous financial ties to industry.

[email protected]

SOURCE: Singh J et al. Arthritis Care Res. 2018 Nov 30. doi: 10.1002/acr.23789.

The American College of Rheumatology and the National Psoriasis Foundation have released a joint treatment guideline for psoriatic arthritis that, for the first time, includes a conditional recommendation to use tumor necrosis factor–inhibitor(TNFi) biologics over methotrexate and other oral small molecules as a first-line therapy in patients with active disease.

“The available low-quality evidence is inconclusive regarding the efficacy of OSMs [oral small molecules] in management of PsA, whereas there is moderate-quality evidence of the benefits of TNFi biologics, in particular regarding their impact on the prevention of disease progression and joint damage,” wrote the panel of authors, who were led by Jasvinder A. Singh, MD, of the University of Alabama at Birmingham. “In making their recommendation, the panel recognized the cost implications, but put considerations of quality of evidence for benefit over other considerations. This guideline provides recommendations for early and aggressive therapy in patients with newly diagnosed PsA.”

The 28-page guideline, published online Nov. 30 in the Journal of Psoriasis and Psoriatic Arthritis and also in Arthritis Care & Research and Arthritis & Rheumatology, is the first set of PsA-specific recommendations to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for RA and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

Based on the GRADE methodology and consensus building, the guideline authors crafted recommendations for eight different clinical scenarios, including the initial treatment of patients with active PsA who have not received either OSMs or other treatments; treatment of patients with active PsA despite treatment with an OSM; treatment of patients with active PsA despite treatment with a TNFi biologic either as monotherapy or in combination with methotrexate; treatment of patients with active PsA despite treatment with an interleukin (IL)-17 inhibitor or IL-12/23 inhibitor monotherapy; treatment of patients with active PsA including treat-to-target, active axial disease, enthesitis, or active inflammatory bowel disease; treatment of patients with active PsA and comorbidities, including concomitant diabetes and recurrent serious infections; vaccination in patients with active PsA; and treatment of patients with active PsA with nonpharmacologic interventions such as yoga and weight loss. Most of the treatment recommendations are conditional based on very low to moderate quality evidence. “Health care providers and patients must take into consideration all active disease domains, comorbidities, and the patient’s functional status in choosing the optimal therapy for an individual at a given point in time,” the authors emphasized.

Only five of the recommendations are listed as strong, including smoking cessation. Three of the strong recommendations concern adult patients with active PsA and concomitant active inflammatory bowel disease despite treatment with an OSM. They are “switch to a monoclonal antibody TNFi biologic over a TNFi biologic soluble receptor biologic,” “switch to a TNFi monoclonal antibody biologic over an IL-7i biologic,” and “switch to an IL-12/23i biologic over switching to an IL-17i biologic.”

The process of creating the guideline included input from a panel of nine adults who provided the authors with perspective on their values and preferences. “The concept of treat-to-target was challenging for patients,” the authors noted. “Although they saw value in improved outcomes, they also thought this strategy could increase costs to the patient (e.g., copayments, time traveling to more frequent appointments, etc.) and potentially increase adverse events. Therefore, a detailed conversation with the patient is needed to make decisions regarding treat-to-target.”

The authors concluded the guideline by calling for more comparative data to inform treatment selection in the future. “Several ongoing trials, including a trial to compare a TNFi biologic combination therapy with a TNFi biologic monotherapy and MTX monotherapy, will inform treatment decisions,” they wrote. “We anticipate future updates to the guideline when new evidence is available.”

Dr. Singh, who is also a staff rheumatologist at the Birmingham (Ala.) Veterans Affairs Medical Center, led development of the 2012 and 2015 ACR treatment guidelines for RA. He has received consulting fees from a variety of companies marketing rheumatologic drugs as well as research support from Takeda and Savient. The other guideline authors reported having numerous financial ties to industry.

[email protected]

SOURCE: Singh J et al. Arthritis Care Res. 2018 Nov 30. doi: 10.1002/acr.23789.

The American College of Rheumatology and the National Psoriasis Foundation have released a joint treatment guideline for psoriatic arthritis that, for the first time, includes a conditional recommendation to use tumor necrosis factor–inhibitor(TNFi) biologics over methotrexate and other oral small molecules as a first-line therapy in patients with active disease.

“The available low-quality evidence is inconclusive regarding the efficacy of OSMs [oral small molecules] in management of PsA, whereas there is moderate-quality evidence of the benefits of TNFi biologics, in particular regarding their impact on the prevention of disease progression and joint damage,” wrote the panel of authors, who were led by Jasvinder A. Singh, MD, of the University of Alabama at Birmingham. “In making their recommendation, the panel recognized the cost implications, but put considerations of quality of evidence for benefit over other considerations. This guideline provides recommendations for early and aggressive therapy in patients with newly diagnosed PsA.”

The 28-page guideline, published online Nov. 30 in the Journal of Psoriasis and Psoriatic Arthritis and also in Arthritis Care & Research and Arthritis & Rheumatology, is the first set of PsA-specific recommendations to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for RA and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

Based on the GRADE methodology and consensus building, the guideline authors crafted recommendations for eight different clinical scenarios, including the initial treatment of patients with active PsA who have not received either OSMs or other treatments; treatment of patients with active PsA despite treatment with an OSM; treatment of patients with active PsA despite treatment with a TNFi biologic either as monotherapy or in combination with methotrexate; treatment of patients with active PsA despite treatment with an interleukin (IL)-17 inhibitor or IL-12/23 inhibitor monotherapy; treatment of patients with active PsA including treat-to-target, active axial disease, enthesitis, or active inflammatory bowel disease; treatment of patients with active PsA and comorbidities, including concomitant diabetes and recurrent serious infections; vaccination in patients with active PsA; and treatment of patients with active PsA with nonpharmacologic interventions such as yoga and weight loss. Most of the treatment recommendations are conditional based on very low to moderate quality evidence. “Health care providers and patients must take into consideration all active disease domains, comorbidities, and the patient’s functional status in choosing the optimal therapy for an individual at a given point in time,” the authors emphasized.

Only five of the recommendations are listed as strong, including smoking cessation. Three of the strong recommendations concern adult patients with active PsA and concomitant active inflammatory bowel disease despite treatment with an OSM. They are “switch to a monoclonal antibody TNFi biologic over a TNFi biologic soluble receptor biologic,” “switch to a TNFi monoclonal antibody biologic over an IL-7i biologic,” and “switch to an IL-12/23i biologic over switching to an IL-17i biologic.”

The process of creating the guideline included input from a panel of nine adults who provided the authors with perspective on their values and preferences. “The concept of treat-to-target was challenging for patients,” the authors noted. “Although they saw value in improved outcomes, they also thought this strategy could increase costs to the patient (e.g., copayments, time traveling to more frequent appointments, etc.) and potentially increase adverse events. Therefore, a detailed conversation with the patient is needed to make decisions regarding treat-to-target.”

The authors concluded the guideline by calling for more comparative data to inform treatment selection in the future. “Several ongoing trials, including a trial to compare a TNFi biologic combination therapy with a TNFi biologic monotherapy and MTX monotherapy, will inform treatment decisions,” they wrote. “We anticipate future updates to the guideline when new evidence is available.”

Dr. Singh, who is also a staff rheumatologist at the Birmingham (Ala.) Veterans Affairs Medical Center, led development of the 2012 and 2015 ACR treatment guidelines for RA. He has received consulting fees from a variety of companies marketing rheumatologic drugs as well as research support from Takeda and Savient. The other guideline authors reported having numerous financial ties to industry.

[email protected]

SOURCE: Singh J et al. Arthritis Care Res. 2018 Nov 30. doi: 10.1002/acr.23789.

Recent advances in the management of peripheral artery disease (PAD) have resulted in new guideline creation in both the United States and Europe.

Vizualis/Thinkstock

While there is considerable consensus between the guidelines, there are multiple differences in emphasis and a differing approach to the types and quality of evidence used to back recommendations, according to a comparative review published in the Journal of the American College of Cardiology. The American Heart Association and American College of Cardiology, together with other organizations, issued an update to their previous guidelines on the management and diagnosis of lower extremity PAD in 2016. In 2017, the European Society of Cardiology in conjunction with the European Society for Vascular Surgery updated their own comprehensive guidelines.

Both the U.S. and the European guidelines stress the importance of lowering risk factors for PAD. This includes stopping smoking, lipid and blood pressure management, and controlling glucose, according to Aaron P. Kithcart, MD, of Brigham and Women’s Hospital, Boston, and Joshua A. Beckman, MD, of Vanderbilt University, Nashville, Tenn.

However, the U.S. guidelines focus more on moderating lifestyle factors, including the pursuit of regular physical activity and the use of supervised exercise, whereas the European guidelines focus considerable attention on recommendations for revascularization in patients with limb-threatening ischemia.

Perhaps the major source of variation between the two sets of guidelines, according to the reviewers, are based upon the intended audiences: “The American document limits its focus to PAD but is applicable to practitioners of every background, whereas the European guideline extends the discussion to all PADs to include carotid and vertebral, upper extremities, mesenteric, and renal arteries in addition to lower-extremity artery disease; but is designed to be a source for cardiologists.”

Accordingly, the ESC/ESVS guidelines approach medical therapy with a more holistic flavor, whereas the ACC/AHA guidelines are specific to the lower-extremity complications of atherosclerosis, according to the reviewers.

Both sets of guidelines come to the conclusion that there is a need for more evidence to identify patients who are at the greatest risk of tissue loss, but overall they differ in their approach to available data. The ACC/AHA is more inclusive of smaller, well-done nonrandomized studies, whereas the ESC/ESVS relegates small studies to Level of Evidence: C. “We believe this difference drives the variation of therapeutic recommendations more than any other factor,” the authors note.

More randomized studies would align recommendations across both organizations, according to Dr. Kithcart and Dr. Beckman (JACC 2018;72:2789-801).

“The management of PAD has progressed a great deal over the last decade. ... Several clinical trials over the coming years should help clarify how revascularization should be approached, and which patients are most likely to benefit. Until then, maintaining good cardiovascular health, including regular physical activity, smoking cessation, lipid-lowering therapy, blood pressure management, and glucose control have the most benefit in patients with PAD,” the researchers concluded.

Dr. Beckman served as a consultant for several pharmaceutical companies, and on the data and safety monitoring board for Bayer and Novartis. Dr. Kithcart reported that he has no relevant conflicts.

[email protected]

SOURCE: Kithcart, AP et al. JACC 2018;72:2789-801.

Recent advances in the management of peripheral artery disease (PAD) have resulted in new guideline creation in both the United States and Europe.

Vizualis/Thinkstock

While there is considerable consensus between the guidelines, there are multiple differences in emphasis and a differing approach to the types and quality of evidence used to back recommendations, according to a comparative review published in the Journal of the American College of Cardiology. The American Heart Association and American College of Cardiology, together with other organizations, issued an update to their previous guidelines on the management and diagnosis of lower extremity PAD in 2016. In 2017, the European Society of Cardiology in conjunction with the European Society for Vascular Surgery updated their own comprehensive guidelines.

Both the U.S. and the European guidelines stress the importance of lowering risk factors for PAD. This includes stopping smoking, lipid and blood pressure management, and controlling glucose, according to Aaron P. Kithcart, MD, of Brigham and Women’s Hospital, Boston, and Joshua A. Beckman, MD, of Vanderbilt University, Nashville, Tenn.

However, the U.S. guidelines focus more on moderating lifestyle factors, including the pursuit of regular physical activity and the use of supervised exercise, whereas the European guidelines focus considerable attention on recommendations for revascularization in patients with limb-threatening ischemia.

Perhaps the major source of variation between the two sets of guidelines, according to the reviewers, are based upon the intended audiences: “The American document limits its focus to PAD but is applicable to practitioners of every background, whereas the European guideline extends the discussion to all PADs to include carotid and vertebral, upper extremities, mesenteric, and renal arteries in addition to lower-extremity artery disease; but is designed to be a source for cardiologists.”

Accordingly, the ESC/ESVS guidelines approach medical therapy with a more holistic flavor, whereas the ACC/AHA guidelines are specific to the lower-extremity complications of atherosclerosis, according to the reviewers.

Both sets of guidelines come to the conclusion that there is a need for more evidence to identify patients who are at the greatest risk of tissue loss, but overall they differ in their approach to available data. The ACC/AHA is more inclusive of smaller, well-done nonrandomized studies, whereas the ESC/ESVS relegates small studies to Level of Evidence: C. “We believe this difference drives the variation of therapeutic recommendations more than any other factor,” the authors note.

More randomized studies would align recommendations across both organizations, according to Dr. Kithcart and Dr. Beckman (JACC 2018;72:2789-801).

“The management of PAD has progressed a great deal over the last decade. ... Several clinical trials over the coming years should help clarify how revascularization should be approached, and which patients are most likely to benefit. Until then, maintaining good cardiovascular health, including regular physical activity, smoking cessation, lipid-lowering therapy, blood pressure management, and glucose control have the most benefit in patients with PAD,” the researchers concluded.

Dr. Beckman served as a consultant for several pharmaceutical companies, and on the data and safety monitoring board for Bayer and Novartis. Dr. Kithcart reported that he has no relevant conflicts.

[email protected]

SOURCE: Kithcart, AP et al. JACC 2018;72:2789-801.

Recent advances in the management of peripheral artery disease (PAD) have resulted in new guideline creation in both the United States and Europe.

Vizualis/Thinkstock

While there is considerable consensus between the guidelines, there are multiple differences in emphasis and a differing approach to the types and quality of evidence used to back recommendations, according to a comparative review published in the Journal of the American College of Cardiology. The American Heart Association and American College of Cardiology, together with other organizations, issued an update to their previous guidelines on the management and diagnosis of lower extremity PAD in 2016. In 2017, the European Society of Cardiology in conjunction with the European Society for Vascular Surgery updated their own comprehensive guidelines.

Both the U.S. and the European guidelines stress the importance of lowering risk factors for PAD. This includes stopping smoking, lipid and blood pressure management, and controlling glucose, according to Aaron P. Kithcart, MD, of Brigham and Women’s Hospital, Boston, and Joshua A. Beckman, MD, of Vanderbilt University, Nashville, Tenn.

However, the U.S. guidelines focus more on moderating lifestyle factors, including the pursuit of regular physical activity and the use of supervised exercise, whereas the European guidelines focus considerable attention on recommendations for revascularization in patients with limb-threatening ischemia.

Perhaps the major source of variation between the two sets of guidelines, according to the reviewers, are based upon the intended audiences: “The American document limits its focus to PAD but is applicable to practitioners of every background, whereas the European guideline extends the discussion to all PADs to include carotid and vertebral, upper extremities, mesenteric, and renal arteries in addition to lower-extremity artery disease; but is designed to be a source for cardiologists.”

Accordingly, the ESC/ESVS guidelines approach medical therapy with a more holistic flavor, whereas the ACC/AHA guidelines are specific to the lower-extremity complications of atherosclerosis, according to the reviewers.

Both sets of guidelines come to the conclusion that there is a need for more evidence to identify patients who are at the greatest risk of tissue loss, but overall they differ in their approach to available data. The ACC/AHA is more inclusive of smaller, well-done nonrandomized studies, whereas the ESC/ESVS relegates small studies to Level of Evidence: C. “We believe this difference drives the variation of therapeutic recommendations more than any other factor,” the authors note.

More randomized studies would align recommendations across both organizations, according to Dr. Kithcart and Dr. Beckman (JACC 2018;72:2789-801).

“The management of PAD has progressed a great deal over the last decade. ... Several clinical trials over the coming years should help clarify how revascularization should be approached, and which patients are most likely to benefit. Until then, maintaining good cardiovascular health, including regular physical activity, smoking cessation, lipid-lowering therapy, blood pressure management, and glucose control have the most benefit in patients with PAD,” the researchers concluded.

Dr. Beckman served as a consultant for several pharmaceutical companies, and on the data and safety monitoring board for Bayer and Novartis. Dr. Kithcart reported that he has no relevant conflicts.

[email protected]

SOURCE: Kithcart, AP et al. JACC 2018;72:2789-801.

San Diego – State-of-the-art guidelines for treating sickle cell disease are actively being developed and could be released as early as the spring of 2019, according to Robert Liem, MD, chair of the American Society of Hematology coordination panel for the initiative.

The new clinical practice recommendations will expand on 2014 guidelines published by the National Heart, Lung, and Blood Institute in a way that will help both hematologists and nonhematologists who take care of patients with sickle cell disease, Dr. Liem said in a video interview at the annual meeting of the American Society of Hematology.

Five different guidelines are under development to cover different aspects of acute and chronic complications of sickle cell disease, including pain, cardiopulmonary and kidney disease, cerebrovascular disease, transfusion support, and stem cell transplantation.

Watch the video to learn more about the guideline effort from the perspective of Dr. Liem, who is also the director of the Comprehensive Sickle Cell Program at the Ann & Robert H. Lurie Children’s Hospital of Chicago.

San Diego – State-of-the-art guidelines for treating sickle cell disease are actively being developed and could be released as early as the spring of 2019, according to Robert Liem, MD, chair of the American Society of Hematology coordination panel for the initiative.

The new clinical practice recommendations will expand on 2014 guidelines published by the National Heart, Lung, and Blood Institute in a way that will help both hematologists and nonhematologists who take care of patients with sickle cell disease, Dr. Liem said in a video interview at the annual meeting of the American Society of Hematology.

Five different guidelines are under development to cover different aspects of acute and chronic complications of sickle cell disease, including pain, cardiopulmonary and kidney disease, cerebrovascular disease, transfusion support, and stem cell transplantation.

Watch the video to learn more about the guideline effort from the perspective of Dr. Liem, who is also the director of the Comprehensive Sickle Cell Program at the Ann & Robert H. Lurie Children’s Hospital of Chicago.

San Diego – State-of-the-art guidelines for treating sickle cell disease are actively being developed and could be released as early as the spring of 2019, according to Robert Liem, MD, chair of the American Society of Hematology coordination panel for the initiative.

The new clinical practice recommendations will expand on 2014 guidelines published by the National Heart, Lung, and Blood Institute in a way that will help both hematologists and nonhematologists who take care of patients with sickle cell disease, Dr. Liem said in a video interview at the annual meeting of the American Society of Hematology.

Five different guidelines are under development to cover different aspects of acute and chronic complications of sickle cell disease, including pain, cardiopulmonary and kidney disease, cerebrovascular disease, transfusion support, and stem cell transplantation.

Watch the video to learn more about the guideline effort from the perspective of Dr. Liem, who is also the director of the Comprehensive Sickle Cell Program at the Ann & Robert H. Lurie Children’s Hospital of Chicago.

People with primary central nervous system lymphoma (PCNSL) should be offered entry into clinical trials whenever possible, say the authors of the British Society for Haematology’s guidelines for the diagnosis and management of primary central nervous system diffuse large B‐cell lymphoma.

PCNSL, implicated in some 3% of all brain tumors, is complex to diagnose and treat. People with suspected PCNSL must receive quick and coordinated attention from a multidisciplinary team of neurologists, hematologist-oncologists, and ocular specialists, according to the guidelines, published in the British Journal of Haematology.

Christopher P. Fox, MD, of the Nottingham (England) University Hospitals NHS Trust, and his colleagues, stress the importance of early multidisciplinary attention, aggressive induction treatment, helping patients into trials, universal screening for eye involvement, attaining histological diagnoses in addition to imaging findings, and avoidance or discontinuation of any corticosteroids before biopsy, as even a short course of steroids can impede diagnosis.

The guidelines incorporate findings from studies published since the society’s last comprehensive PCNSL guideline was issued more than a decade ago.

Dr. Fox and his colleagues say definitive treatment for PCNSL – induction of remission followed by consolidation – should start within 2 weeks of diagnosis and that a treatment regimen should be chosen according to a patient’s physiological fitness, not age. The fittest patients, who have better organ function and fewer comorbidities, should be eligible for intensive combination immunochemotherapy incorporating high-dose methotrexate (optimally four cycles of HD-MTX, cytarabine, thiotepa, and rituximab). Those deemed unfit for this regimen should be offered induction treatment with HD-MTX, rituximab and procarbazine, the guidelines’ authors say.

If patients cannot tolerate HD-MTX, oral chemotherapy and/or whole-brain radiotherapy may be offered. Response should be assessed with contrast-enhanced magnetic resonance imaging.

Consolidation therapy should be initiated after induction for all patients with nonprogressive disease, and high-dose thiotepa-based chemotherapy with autologous stem cell transplant is the recommended first-line option for consolidation. Response to consolidation, again measured with contrast-enhanced MRI, should be carried out at between 1 and 2 months after therapy is completed, and patients should be referred for neuropsychological testing to assess cognitive function.

Patients with relapsed or refractory disease should be approached with maximum urgency – the guidelines offer an algorithm for retreatment options – and offered clinical trial entry wherever possible.

The PCNSL guideline writing process was sponsored by the British Society for Haematology, and some coauthors, including the lead author, disclosed receiving fees from pharmaceutical manufacturers Adienne or F. Hoffman-La Roche.

[email protected]

SOURCE: Fox et al. Br J Haematol. 2018 Nov 23 doi: 10.1111/bjh.15661.

People with primary central nervous system lymphoma (PCNSL) should be offered entry into clinical trials whenever possible, say the authors of the British Society for Haematology’s guidelines for the diagnosis and management of primary central nervous system diffuse large B‐cell lymphoma.

PCNSL, implicated in some 3% of all brain tumors, is complex to diagnose and treat. People with suspected PCNSL must receive quick and coordinated attention from a multidisciplinary team of neurologists, hematologist-oncologists, and ocular specialists, according to the guidelines, published in the British Journal of Haematology.

Christopher P. Fox, MD, of the Nottingham (England) University Hospitals NHS Trust, and his colleagues, stress the importance of early multidisciplinary attention, aggressive induction treatment, helping patients into trials, universal screening for eye involvement, attaining histological diagnoses in addition to imaging findings, and avoidance or discontinuation of any corticosteroids before biopsy, as even a short course of steroids can impede diagnosis.

The guidelines incorporate findings from studies published since the society’s last comprehensive PCNSL guideline was issued more than a decade ago.

Dr. Fox and his colleagues say definitive treatment for PCNSL – induction of remission followed by consolidation – should start within 2 weeks of diagnosis and that a treatment regimen should be chosen according to a patient’s physiological fitness, not age. The fittest patients, who have better organ function and fewer comorbidities, should be eligible for intensive combination immunochemotherapy incorporating high-dose methotrexate (optimally four cycles of HD-MTX, cytarabine, thiotepa, and rituximab). Those deemed unfit for this regimen should be offered induction treatment with HD-MTX, rituximab and procarbazine, the guidelines’ authors say.

If patients cannot tolerate HD-MTX, oral chemotherapy and/or whole-brain radiotherapy may be offered. Response should be assessed with contrast-enhanced magnetic resonance imaging.

Consolidation therapy should be initiated after induction for all patients with nonprogressive disease, and high-dose thiotepa-based chemotherapy with autologous stem cell transplant is the recommended first-line option for consolidation. Response to consolidation, again measured with contrast-enhanced MRI, should be carried out at between 1 and 2 months after therapy is completed, and patients should be referred for neuropsychological testing to assess cognitive function.

Patients with relapsed or refractory disease should be approached with maximum urgency – the guidelines offer an algorithm for retreatment options – and offered clinical trial entry wherever possible.

The PCNSL guideline writing process was sponsored by the British Society for Haematology, and some coauthors, including the lead author, disclosed receiving fees from pharmaceutical manufacturers Adienne or F. Hoffman-La Roche.

[email protected]

SOURCE: Fox et al. Br J Haematol. 2018 Nov 23 doi: 10.1111/bjh.15661.

People with primary central nervous system lymphoma (PCNSL) should be offered entry into clinical trials whenever possible, say the authors of the British Society for Haematology’s guidelines for the diagnosis and management of primary central nervous system diffuse large B‐cell lymphoma.

PCNSL, implicated in some 3% of all brain tumors, is complex to diagnose and treat. People with suspected PCNSL must receive quick and coordinated attention from a multidisciplinary team of neurologists, hematologist-oncologists, and ocular specialists, according to the guidelines, published in the British Journal of Haematology.

Christopher P. Fox, MD, of the Nottingham (England) University Hospitals NHS Trust, and his colleagues, stress the importance of early multidisciplinary attention, aggressive induction treatment, helping patients into trials, universal screening for eye involvement, attaining histological diagnoses in addition to imaging findings, and avoidance or discontinuation of any corticosteroids before biopsy, as even a short course of steroids can impede diagnosis.

The guidelines incorporate findings from studies published since the society’s last comprehensive PCNSL guideline was issued more than a decade ago.

Dr. Fox and his colleagues say definitive treatment for PCNSL – induction of remission followed by consolidation – should start within 2 weeks of diagnosis and that a treatment regimen should be chosen according to a patient’s physiological fitness, not age. The fittest patients, who have better organ function and fewer comorbidities, should be eligible for intensive combination immunochemotherapy incorporating high-dose methotrexate (optimally four cycles of HD-MTX, cytarabine, thiotepa, and rituximab). Those deemed unfit for this regimen should be offered induction treatment with HD-MTX, rituximab and procarbazine, the guidelines’ authors say.

If patients cannot tolerate HD-MTX, oral chemotherapy and/or whole-brain radiotherapy may be offered. Response should be assessed with contrast-enhanced magnetic resonance imaging.

Consolidation therapy should be initiated after induction for all patients with nonprogressive disease, and high-dose thiotepa-based chemotherapy with autologous stem cell transplant is the recommended first-line option for consolidation. Response to consolidation, again measured with contrast-enhanced MRI, should be carried out at between 1 and 2 months after therapy is completed, and patients should be referred for neuropsychological testing to assess cognitive function.

Patients with relapsed or refractory disease should be approached with maximum urgency – the guidelines offer an algorithm for retreatment options – and offered clinical trial entry wherever possible.

The PCNSL guideline writing process was sponsored by the British Society for Haematology, and some coauthors, including the lead author, disclosed receiving fees from pharmaceutical manufacturers Adienne or F. Hoffman-La Roche.

[email protected]

SOURCE: Fox et al. Br J Haematol. 2018 Nov 23 doi: 10.1111/bjh.15661.

The American Society of Hematology has released a new set of guidelines for the prevention, diagnosis, and management of venous thromboembolism.

The new guidelines, released on Nov. 27, contain more than 150 individual recommendations, including sections devoted to managing venous thromboembolism (VTE) during pregnancy and in pediatric patients. Guideline highlights cited by some of the writing-panel participants included a high reliance on low-molecular-weight heparin (LMWH) agents as the preferred treatment for many patients, reliance on the D-dimer test to rule out VTE in patients with a low pretest probability of disease, and reliance on the 4Ts score to identify patients with heparin-induced thrombocytopenia.

The guidelines took more than 3 years to develop, an effort that began in 2015.

An updated set of VTE guidelines were needed because clinicians now have a “greater understanding of risk factors” for VTE as well as having “more options available for treating VTE, including new medications,” Adam C. Cuker, MD, cochair of the guideline-writing group and a hematologist and thrombosis specialist at the University of Pennsylvania, Philadelphia, said during a webcast to unveil the new guidelines.

Prevention

For preventing VTE in hospitalized medical patients the guidelines recommended initial assessment of the patient’s risk for both VTE and bleeding. Patients with a high bleeding risk who need VTE prevention should preferentially receive mechanical prophylaxis, either compression stockings or pneumatic sleeves. But in patients with a high VTE risk and an “acceptable” bleeding risk, prophylaxis with an anticoagulant is preferred over mechanical measures, said Mary Cushman, MD, professor and medical director of the thrombosis and hemostasis program at the University of Vermont, Burlington.

For prevention of VTE in medical inpatients, LMWH is preferred over unfractionated heparin because of its once-daily dosing and fewer complications, said Dr. Cushman, a member of the writing group. The panel also endorsed LMWH over a direct-acting oral anticoagulant, both during hospitalization and following discharge. The guidelines for prevention in medical patients explicitly “recommended against” using a direct-acting oral anticoagulant “over other treatments” both for hospitalized medical patients and after discharge, and the guidelines further recommend against extended prophylaxis after discharge with any other anticoagulant.

Another important takeaway from the prevention section was a statement that combining both mechanical and medical prophylaxis was not needed for medical inpatients. And once patients are discharged, if they take a long air trip they have no need for compression stockings or aspirin if their risk for thrombosis is not elevated. People with a “substantially increased” thrombosis risk “may benefit” from compression stockings or treatment with LMWH, Dr. Cushman said.

Diagnosis

For diagnosis, Wendy Lim, MD, highlighted the need for first categorizing patients as having a low or high probability for VTE, a judgment that can aid the accuracy of the diagnosis and helps avoid unnecessary testing.

For patients with low pretest probability, the guidelines recommended the D-dimer test as the best first step. Further testing isn’t needed when the D-dimer is negative, noted Dr. Lim, a hematologist and professor at McMaster University, Hamilton, Ont.

The guidelines also recommended using ventilation-perfusion scintigraphy (V/Q scan) for imaging a pulmonary embolism over a CT scan, which uses more radiation. But V/Q scans are not ideal for assessing older patients or patients with lung disease, Dr. Lim cautioned.

Management

Management of VTE should occur, when feasible, through a specialized anticoagulation management service center, which can provide care that is best suited to the complexities of anticoagulation therapy. But it’s a level of care that many U.S. patients don’t currently receive and hence is an area ripe for growth, said Daniel M. Witt, PharmD, professor and vice-chair of pharmacotherapy at the University of Utah, Salt Lake City.

CDC/Janice Carr

The guidelines recommended against bridging therapy with LMWH for most patients who need to stop warfarin when undergoing an invasive procedure. The guidelines also called for “thoughtful” use of anticoagulant reversal agents and advised that patients who survive a major bleed while on anticoagulation should often resume the anticoagulant once they are stabilized.

For patients who develop heparin-induced thrombocytopenia, the 4Ts score is the best way to make a more accurate diagnosis and boost the prospects for recovery, said Dr. Cuker (Blood. 2012 Nov 15;120[20]:4160-7). The guidelines cite several agents now available to treat this common complication, which affects about 1% of the 12 million Americans treated with heparin annually: argatroban, bivalirudin, danaparoid, fondaparinux, apixaban, dabigatran, edoxaban, and rivaroxaban.

ASH has a VTE website with links to detailed information for each of the guideline subcategories: prophylaxis in medical patients, diagnosis, therapy, heparin-induced thrombocytopenia, VTE in pregnancy, and VTE in children. The website indicates that additional guidelines will soon be released on managing VTE in patients with cancer, in patients with thrombophilia, and for prophylaxis in surgical patients, as well as further information on treatment. A spokesperson for ASH said that these additional documents will post sometime in 2019.

At the time of the release, the guidelines panel published six articles in the journal Blood Advances that detailed the guidelines and their documentation.

The articles include prophylaxis of medical patients (Blood Advances. 2018 Nov 27;2[22]:3198-225), diagnosis (Blood Advances. 2018 Nov 27;2[22]:3226-56), anticoagulation therapy (Blood Advances. 2018 Nov 27;2[22]:3257-91), pediatrics (Blood Advances. 2018 Nov 27;2[22]:3292-316), pregnancy (Blood Advances. 2018 Nov 27;2[22]:3317-59), and heparin-induced thrombocytopenia (Blood Advances. 2018 Nov 27;2[22]:3360-92).

Dr. Cushman, Dr. Lim, and Dr. Witt reported having no relevant disclosures. Dr. Cuker reported receiving research support from T2 Biosystems.

[email protected]

The American Society of Hematology has released a new set of guidelines for the prevention, diagnosis, and management of venous thromboembolism.

The new guidelines, released on Nov. 27, contain more than 150 individual recommendations, including sections devoted to managing venous thromboembolism (VTE) during pregnancy and in pediatric patients. Guideline highlights cited by some of the writing-panel participants included a high reliance on low-molecular-weight heparin (LMWH) agents as the preferred treatment for many patients, reliance on the D-dimer test to rule out VTE in patients with a low pretest probability of disease, and reliance on the 4Ts score to identify patients with heparin-induced thrombocytopenia.

The guidelines took more than 3 years to develop, an effort that began in 2015.

An updated set of VTE guidelines were needed because clinicians now have a “greater understanding of risk factors” for VTE as well as having “more options available for treating VTE, including new medications,” Adam C. Cuker, MD, cochair of the guideline-writing group and a hematologist and thrombosis specialist at the University of Pennsylvania, Philadelphia, said during a webcast to unveil the new guidelines.

Prevention

For preventing VTE in hospitalized medical patients the guidelines recommended initial assessment of the patient’s risk for both VTE and bleeding. Patients with a high bleeding risk who need VTE prevention should preferentially receive mechanical prophylaxis, either compression stockings or pneumatic sleeves. But in patients with a high VTE risk and an “acceptable” bleeding risk, prophylaxis with an anticoagulant is preferred over mechanical measures, said Mary Cushman, MD, professor and medical director of the thrombosis and hemostasis program at the University of Vermont, Burlington.

For prevention of VTE in medical inpatients, LMWH is preferred over unfractionated heparin because of its once-daily dosing and fewer complications, said Dr. Cushman, a member of the writing group. The panel also endorsed LMWH over a direct-acting oral anticoagulant, both during hospitalization and following discharge. The guidelines for prevention in medical patients explicitly “recommended against” using a direct-acting oral anticoagulant “over other treatments” both for hospitalized medical patients and after discharge, and the guidelines further recommend against extended prophylaxis after discharge with any other anticoagulant.

Another important takeaway from the prevention section was a statement that combining both mechanical and medical prophylaxis was not needed for medical inpatients. And once patients are discharged, if they take a long air trip they have no need for compression stockings or aspirin if their risk for thrombosis is not elevated. People with a “substantially increased” thrombosis risk “may benefit” from compression stockings or treatment with LMWH, Dr. Cushman said.

Diagnosis

For diagnosis, Wendy Lim, MD, highlighted the need for first categorizing patients as having a low or high probability for VTE, a judgment that can aid the accuracy of the diagnosis and helps avoid unnecessary testing.

For patients with low pretest probability, the guidelines recommended the D-dimer test as the best first step. Further testing isn’t needed when the D-dimer is negative, noted Dr. Lim, a hematologist and professor at McMaster University, Hamilton, Ont.

The guidelines also recommended using ventilation-perfusion scintigraphy (V/Q scan) for imaging a pulmonary embolism over a CT scan, which uses more radiation. But V/Q scans are not ideal for assessing older patients or patients with lung disease, Dr. Lim cautioned.

Management

Management of VTE should occur, when feasible, through a specialized anticoagulation management service center, which can provide care that is best suited to the complexities of anticoagulation therapy. But it’s a level of care that many U.S. patients don’t currently receive and hence is an area ripe for growth, said Daniel M. Witt, PharmD, professor and vice-chair of pharmacotherapy at the University of Utah, Salt Lake City.

CDC/Janice Carr

The guidelines recommended against bridging therapy with LMWH for most patients who need to stop warfarin when undergoing an invasive procedure. The guidelines also called for “thoughtful” use of anticoagulant reversal agents and advised that patients who survive a major bleed while on anticoagulation should often resume the anticoagulant once they are stabilized.

For patients who develop heparin-induced thrombocytopenia, the 4Ts score is the best way to make a more accurate diagnosis and boost the prospects for recovery, said Dr. Cuker (Blood. 2012 Nov 15;120[20]:4160-7). The guidelines cite several agents now available to treat this common complication, which affects about 1% of the 12 million Americans treated with heparin annually: argatroban, bivalirudin, danaparoid, fondaparinux, apixaban, dabigatran, edoxaban, and rivaroxaban.

ASH has a VTE website with links to detailed information for each of the guideline subcategories: prophylaxis in medical patients, diagnosis, therapy, heparin-induced thrombocytopenia, VTE in pregnancy, and VTE in children. The website indicates that additional guidelines will soon be released on managing VTE in patients with cancer, in patients with thrombophilia, and for prophylaxis in surgical patients, as well as further information on treatment. A spokesperson for ASH said that these additional documents will post sometime in 2019.

At the time of the release, the guidelines panel published six articles in the journal Blood Advances that detailed the guidelines and their documentation.

The articles include prophylaxis of medical patients (Blood Advances. 2018 Nov 27;2[22]:3198-225), diagnosis (Blood Advances. 2018 Nov 27;2[22]:3226-56), anticoagulation therapy (Blood Advances. 2018 Nov 27;2[22]:3257-91), pediatrics (Blood Advances. 2018 Nov 27;2[22]:3292-316), pregnancy (Blood Advances. 2018 Nov 27;2[22]:3317-59), and heparin-induced thrombocytopenia (Blood Advances. 2018 Nov 27;2[22]:3360-92).

Dr. Cushman, Dr. Lim, and Dr. Witt reported having no relevant disclosures. Dr. Cuker reported receiving research support from T2 Biosystems.

[email protected]

The American Society of Hematology has released a new set of guidelines for the prevention, diagnosis, and management of venous thromboembolism.

The new guidelines, released on Nov. 27, contain more than 150 individual recommendations, including sections devoted to managing venous thromboembolism (VTE) during pregnancy and in pediatric patients. Guideline highlights cited by some of the writing-panel participants included a high reliance on low-molecular-weight heparin (LMWH) agents as the preferred treatment for many patients, reliance on the D-dimer test to rule out VTE in patients with a low pretest probability of disease, and reliance on the 4Ts score to identify patients with heparin-induced thrombocytopenia.

The guidelines took more than 3 years to develop, an effort that began in 2015.

An updated set of VTE guidelines were needed because clinicians now have a “greater understanding of risk factors” for VTE as well as having “more options available for treating VTE, including new medications,” Adam C. Cuker, MD, cochair of the guideline-writing group and a hematologist and thrombosis specialist at the University of Pennsylvania, Philadelphia, said during a webcast to unveil the new guidelines.

Prevention

For preventing VTE in hospitalized medical patients the guidelines recommended initial assessment of the patient’s risk for both VTE and bleeding. Patients with a high bleeding risk who need VTE prevention should preferentially receive mechanical prophylaxis, either compression stockings or pneumatic sleeves. But in patients with a high VTE risk and an “acceptable” bleeding risk, prophylaxis with an anticoagulant is preferred over mechanical measures, said Mary Cushman, MD, professor and medical director of the thrombosis and hemostasis program at the University of Vermont, Burlington.

For prevention of VTE in medical inpatients, LMWH is preferred over unfractionated heparin because of its once-daily dosing and fewer complications, said Dr. Cushman, a member of the writing group. The panel also endorsed LMWH over a direct-acting oral anticoagulant, both during hospitalization and following discharge. The guidelines for prevention in medical patients explicitly “recommended against” using a direct-acting oral anticoagulant “over other treatments” both for hospitalized medical patients and after discharge, and the guidelines further recommend against extended prophylaxis after discharge with any other anticoagulant.

Another important takeaway from the prevention section was a statement that combining both mechanical and medical prophylaxis was not needed for medical inpatients. And once patients are discharged, if they take a long air trip they have no need for compression stockings or aspirin if their risk for thrombosis is not elevated. People with a “substantially increased” thrombosis risk “may benefit” from compression stockings or treatment with LMWH, Dr. Cushman said.

Diagnosis

For diagnosis, Wendy Lim, MD, highlighted the need for first categorizing patients as having a low or high probability for VTE, a judgment that can aid the accuracy of the diagnosis and helps avoid unnecessary testing.

For patients with low pretest probability, the guidelines recommended the D-dimer test as the best first step. Further testing isn’t needed when the D-dimer is negative, noted Dr. Lim, a hematologist and professor at McMaster University, Hamilton, Ont.

The guidelines also recommended using ventilation-perfusion scintigraphy (V/Q scan) for imaging a pulmonary embolism over a CT scan, which uses more radiation. But V/Q scans are not ideal for assessing older patients or patients with lung disease, Dr. Lim cautioned.

Management

Management of VTE should occur, when feasible, through a specialized anticoagulation management service center, which can provide care that is best suited to the complexities of anticoagulation therapy. But it’s a level of care that many U.S. patients don’t currently receive and hence is an area ripe for growth, said Daniel M. Witt, PharmD, professor and vice-chair of pharmacotherapy at the University of Utah, Salt Lake City.

CDC/Janice Carr

The guidelines recommended against bridging therapy with LMWH for most patients who need to stop warfarin when undergoing an invasive procedure. The guidelines also called for “thoughtful” use of anticoagulant reversal agents and advised that patients who survive a major bleed while on anticoagulation should often resume the anticoagulant once they are stabilized.

For patients who develop heparin-induced thrombocytopenia, the 4Ts score is the best way to make a more accurate diagnosis and boost the prospects for recovery, said Dr. Cuker (Blood. 2012 Nov 15;120[20]:4160-7). The guidelines cite several agents now available to treat this common complication, which affects about 1% of the 12 million Americans treated with heparin annually: argatroban, bivalirudin, danaparoid, fondaparinux, apixaban, dabigatran, edoxaban, and rivaroxaban.

ASH has a VTE website with links to detailed information for each of the guideline subcategories: prophylaxis in medical patients, diagnosis, therapy, heparin-induced thrombocytopenia, VTE in pregnancy, and VTE in children. The website indicates that additional guidelines will soon be released on managing VTE in patients with cancer, in patients with thrombophilia, and for prophylaxis in surgical patients, as well as further information on treatment. A spokesperson for ASH said that these additional documents will post sometime in 2019.

At the time of the release, the guidelines panel published six articles in the journal Blood Advances that detailed the guidelines and their documentation.

The articles include prophylaxis of medical patients (Blood Advances. 2018 Nov 27;2[22]:3198-225), diagnosis (Blood Advances. 2018 Nov 27;2[22]:3226-56), anticoagulation therapy (Blood Advances. 2018 Nov 27;2[22]:3257-91), pediatrics (Blood Advances. 2018 Nov 27;2[22]:3292-316), pregnancy (Blood Advances. 2018 Nov 27;2[22]:3317-59), and heparin-induced thrombocytopenia (Blood Advances. 2018 Nov 27;2[22]:3360-92).

Dr. Cushman, Dr. Lim, and Dr. Witt reported having no relevant disclosures. Dr. Cuker reported receiving research support from T2 Biosystems.

[email protected]

The American Diabetes Association’s guidelines for the evaluation and management of pediatric patients with type 2 diabetes differ from those for adults.

“Puberty-related physiologic insulin resistance, particularly in obese youth, may play a role” in the fact that youth are more insulin resistant than adults. Also, type 2 diabetes apparently is “more aggressive in youth than adults, with a faster rate of deterioration of beta-cell function and poorer response to glucose-lowering medications,” wrote Silva Arslanian, MD, from the division of pediatric endocrinology, metabolism, and diabetes mellitus at the University of Pittsburgh, and her colleagues. “Even though our knowledge of youth-onset type 2 diabetes has increased tremendously over the last 2 decades, robust and evidence-based data are still limited regarding diagnostic and therapeutic approaches and prevention of complications.”

The ADA position statement by Dr. Arslanian and her colleagues outlines management of type 2 diabetes in children and youth.

Diagnosis

Children at risk for type 2 diabetes who are overweight or obese should be considered for screening at age 10 years or after puberty, whichever happens first, and repeat testing should occur at least every 3 years for these patients. Pancreatic autoantibody tests should also be considered in this patient population to rule out autoimmune type 1 diabetes, and genetic evaluation should be performed to test for monogenic diabetes, “based on clinical characteristics and presentation,” they wrote.

Use fasting plasma glucose, 2-hour fasting plasma glucose after a 75-g oral glucose tolerance test, or glycosylated hemoglobin (HbA_1C) to test for diabetes or prediabetes. Also consider factors like medication adherence and treatment effects when prescribing glucose-lowering or other medications for overweight or obese children and adolescents with type 2 diabetes.

Lifestyle management

With regard to lifestyle management programs, the intervention should be introduced as a part of diabetes care – aimed at reducing between 7% and 10% of body weight – and be based on a chronic care model. The intervention should include 30-60 minutes of moderate to intense physical activity for 5 days each week, strength training 3 days per week, and incorporate healthy eating plans. Dr. Arslanian and her associates noted there was limited evidence for pharmacotherapy for weight reduction in children and adolescents with type 2 diabetes.

Pharmacologic therapy

Pharmacologic therapy should be started together with lifestyle therapy once a diagnosis is made, according to the recommendations.

Metformin is the preferred initial pharmacologic treatment for patients with normal renal function who are asymptomatic and with HbA_1C levels of less than 8.5%.

Patients with blood glucose greater than or equal to 250 mg/dL and HbA_1C greater than or equal to 8.5% with symptoms such as weight loss, polydipsia, polyuria, or nocturia should receive basal insulin during initiation and titration of metformin.

Patients with ketosis or ketoacidosis should receive intravenous insulin to address hyperglycemia. Once the acidosis is corrected, initiate metformin with subcutaneous insulin therapy. For patients who are reaching home-based glucose monitoring targets, consider tapering the dose over 2-6 weeks with a 10%-30% reduction in insulin every few days.

In patients where metformin alone is not meeting the glycemic target, consider basal insulin therapy and, if that fails to help achieve glycemic targets, more intensive approaches should be considered, such as metabolic surgery.

Jay Cohen, MD, FACE, medical director at the Endocrine Clinic in Memphis, said in an interview that he agreed with the ADA position statement except for the pharmacologic therapy recommendations.

“The pharmacology therapy is 4 years outdated,” he said. “We routinely use all of the medications that are not Food and Drug Administration [approved] for kids, but are FDA approved for adults.”

He also questioned the ADA’s recommendation to give basal insulin to patients who are insulin resistant.

“Why give insulin if these people are insulin resistant?” said Dr. Cohen, who also is a Clinical Endocrinology News editorial board member. “The oral and injectable noninsulins work fabulously with less weight gain – already a problem for these patients – and less hypoglycemia, less side effects, and better compliance.”

Treatment goals

The HbA_1C goal for children and adolescents with type 2 diabetes is less than 7% when treated with oral agents alone. HbA_1C should be tested every 3 months and should be individualized, according to the ADA recommendations. In some patients, such as those with a shorter diabetes duration, lesser degrees of beta-cell dysfunction, and those who achieve significant weight improvement through lifestyle changes or taking metformin, consider lowering the HbA_1C goal to less than 6.5%.

Give individualized care with regard to home self-monitoring of blood glucose. Also provide patients and their families with “culturally competent” diabetes self-management tools and lifestyle programs. Consider social factors such as housing stability, food insecurity, and financial barriers when making treatment decisions.

Screening for complications

To screen for nephropathy, take BP measurements at every visit and promote lifestyle management to reduce risk of diabetic kidney disease and improve weight loss. After 6 months, if a patient’s BP remains greater than the 95th percentile for their age, gender, and height, ACE inhibitors, or angiotensin receptor blockers are initial therapeutic options, according to the position statement. Other BP-lowering treatments may be added as necessary.

Also monitor protein intake (0.8 g/kg per day) as well as urine albumin/creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) annually. Patients with diabetes and hypertension who are not pregnant should receive an ACE inhibitor or angiotensin receptor blocker if their UACR is modestly elevated (30-299 mg/g creatinine). Such a regimen is strongly recommended if their UACR is above 300 mg/g creatinine and/or if their eGFR is less than 60 mL/min per 1.73 m².

Screening issues

When considering diabetes distress and mental or behavioral health in children and adolescents with type 2 diabetes, use standardized and validated tools to assess symptoms such as depression and disordered eating behaviors. Regularly screen for smoking and alcohol use and provide preconception counseling for female patients of child-bearing age.

Screen for neuropathy, retinopathy, and nonalcoholic fatty liver disease annually and for obstructive sleep apnea at each visit. Lipid testing should be performed annually once patients have achieved glycemic control. Polycystic ovary syndrome should be considered in female patients with type 2 diabetes and treated with metformin together with lifestyle changes to address menstrual cyclicity and hyperandrogenism, the authors recommended.

Dr. Arslanian is on a data monitoring committee for AstraZeneca; data safety monitoring board for Boehringer Ingelheim; and advisory boards for Eli Lilly, Novo Nordisk, and Sanofi-Aventis; and has received research grants from Eli Lilly and Novo Nordisk. Other authors reported various relationships with a number of pharmaceutical companies.

SOURCE: Arslanian S et al. Diabetes Care. 2018 Nov 13. doi: 10.2337/dci18-0052.

The American Diabetes Association’s guidelines for the evaluation and management of pediatric patients with type 2 diabetes differ from those for adults.

“Puberty-related physiologic insulin resistance, particularly in obese youth, may play a role” in the fact that youth are more insulin resistant than adults. Also, type 2 diabetes apparently is “more aggressive in youth than adults, with a faster rate of deterioration of beta-cell function and poorer response to glucose-lowering medications,” wrote Silva Arslanian, MD, from the division of pediatric endocrinology, metabolism, and diabetes mellitus at the University of Pittsburgh, and her colleagues. “Even though our knowledge of youth-onset type 2 diabetes has increased tremendously over the last 2 decades, robust and evidence-based data are still limited regarding diagnostic and therapeutic approaches and prevention of complications.”

The ADA position statement by Dr. Arslanian and her colleagues outlines management of type 2 diabetes in children and youth.

Diagnosis

Children at risk for type 2 diabetes who are overweight or obese should be considered for screening at age 10 years or after puberty, whichever happens first, and repeat testing should occur at least every 3 years for these patients. Pancreatic autoantibody tests should also be considered in this patient population to rule out autoimmune type 1 diabetes, and genetic evaluation should be performed to test for monogenic diabetes, “based on clinical characteristics and presentation,” they wrote.

Use fasting plasma glucose, 2-hour fasting plasma glucose after a 75-g oral glucose tolerance test, or glycosylated hemoglobin (HbA_1C) to test for diabetes or prediabetes. Also consider factors like medication adherence and treatment effects when prescribing glucose-lowering or other medications for overweight or obese children and adolescents with type 2 diabetes.

Lifestyle management

With regard to lifestyle management programs, the intervention should be introduced as a part of diabetes care – aimed at reducing between 7% and 10% of body weight – and be based on a chronic care model. The intervention should include 30-60 minutes of moderate to intense physical activity for 5 days each week, strength training 3 days per week, and incorporate healthy eating plans. Dr. Arslanian and her associates noted there was limited evidence for pharmacotherapy for weight reduction in children and adolescents with type 2 diabetes.

Pharmacologic therapy

Pharmacologic therapy should be started together with lifestyle therapy once a diagnosis is made, according to the recommendations.

Metformin is the preferred initial pharmacologic treatment for patients with normal renal function who are asymptomatic and with HbA_1C levels of less than 8.5%.

Patients with blood glucose greater than or equal to 250 mg/dL and HbA_1C greater than or equal to 8.5% with symptoms such as weight loss, polydipsia, polyuria, or nocturia should receive basal insulin during initiation and titration of metformin.

Patients with ketosis or ketoacidosis should receive intravenous insulin to address hyperglycemia. Once the acidosis is corrected, initiate metformin with subcutaneous insulin therapy. For patients who are reaching home-based glucose monitoring targets, consider tapering the dose over 2-6 weeks with a 10%-30% reduction in insulin every few days.

In patients where metformin alone is not meeting the glycemic target, consider basal insulin therapy and, if that fails to help achieve glycemic targets, more intensive approaches should be considered, such as metabolic surgery.

Jay Cohen, MD, FACE, medical director at the Endocrine Clinic in Memphis, said in an interview that he agreed with the ADA position statement except for the pharmacologic therapy recommendations.

“The pharmacology therapy is 4 years outdated,” he said. “We routinely use all of the medications that are not Food and Drug Administration [approved] for kids, but are FDA approved for adults.”

He also questioned the ADA’s recommendation to give basal insulin to patients who are insulin resistant.

“Why give insulin if these people are insulin resistant?” said Dr. Cohen, who also is a Clinical Endocrinology News editorial board member. “The oral and injectable noninsulins work fabulously with less weight gain – already a problem for these patients – and less hypoglycemia, less side effects, and better compliance.”

Treatment goals

The HbA_1C goal for children and adolescents with type 2 diabetes is less than 7% when treated with oral agents alone. HbA_1C should be tested every 3 months and should be individualized, according to the ADA recommendations. In some patients, such as those with a shorter diabetes duration, lesser degrees of beta-cell dysfunction, and those who achieve significant weight improvement through lifestyle changes or taking metformin, consider lowering the HbA_1C goal to less than 6.5%.

Give individualized care with regard to home self-monitoring of blood glucose. Also provide patients and their families with “culturally competent” diabetes self-management tools and lifestyle programs. Consider social factors such as housing stability, food insecurity, and financial barriers when making treatment decisions.

Screening for complications

To screen for nephropathy, take BP measurements at every visit and promote lifestyle management to reduce risk of diabetic kidney disease and improve weight loss. After 6 months, if a patient’s BP remains greater than the 95th percentile for their age, gender, and height, ACE inhibitors, or angiotensin receptor blockers are initial therapeutic options, according to the position statement. Other BP-lowering treatments may be added as necessary.

Also monitor protein intake (0.8 g/kg per day) as well as urine albumin/creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) annually. Patients with diabetes and hypertension who are not pregnant should receive an ACE inhibitor or angiotensin receptor blocker if their UACR is modestly elevated (30-299 mg/g creatinine). Such a regimen is strongly recommended if their UACR is above 300 mg/g creatinine and/or if their eGFR is less than 60 mL/min per 1.73 m².

Screening issues

When considering diabetes distress and mental or behavioral health in children and adolescents with type 2 diabetes, use standardized and validated tools to assess symptoms such as depression and disordered eating behaviors. Regularly screen for smoking and alcohol use and provide preconception counseling for female patients of child-bearing age.

Screen for neuropathy, retinopathy, and nonalcoholic fatty liver disease annually and for obstructive sleep apnea at each visit. Lipid testing should be performed annually once patients have achieved glycemic control. Polycystic ovary syndrome should be considered in female patients with type 2 diabetes and treated with metformin together with lifestyle changes to address menstrual cyclicity and hyperandrogenism, the authors recommended.

Dr. Arslanian is on a data monitoring committee for AstraZeneca; data safety monitoring board for Boehringer Ingelheim; and advisory boards for Eli Lilly, Novo Nordisk, and Sanofi-Aventis; and has received research grants from Eli Lilly and Novo Nordisk. Other authors reported various relationships with a number of pharmaceutical companies.

SOURCE: Arslanian S et al. Diabetes Care. 2018 Nov 13. doi: 10.2337/dci18-0052.

The American Diabetes Association’s guidelines for the evaluation and management of pediatric patients with type 2 diabetes differ from those for adults.

“Puberty-related physiologic insulin resistance, particularly in obese youth, may play a role” in the fact that youth are more insulin resistant than adults. Also, type 2 diabetes apparently is “more aggressive in youth than adults, with a faster rate of deterioration of beta-cell function and poorer response to glucose-lowering medications,” wrote Silva Arslanian, MD, from the division of pediatric endocrinology, metabolism, and diabetes mellitus at the University of Pittsburgh, and her colleagues. “Even though our knowledge of youth-onset type 2 diabetes has increased tremendously over the last 2 decades, robust and evidence-based data are still limited regarding diagnostic and therapeutic approaches and prevention of complications.”

The ADA position statement by Dr. Arslanian and her colleagues outlines management of type 2 diabetes in children and youth.

Diagnosis

Children at risk for type 2 diabetes who are overweight or obese should be considered for screening at age 10 years or after puberty, whichever happens first, and repeat testing should occur at least every 3 years for these patients. Pancreatic autoantibody tests should also be considered in this patient population to rule out autoimmune type 1 diabetes, and genetic evaluation should be performed to test for monogenic diabetes, “based on clinical characteristics and presentation,” they wrote.

Use fasting plasma glucose, 2-hour fasting plasma glucose after a 75-g oral glucose tolerance test, or glycosylated hemoglobin (HbA_1C) to test for diabetes or prediabetes. Also consider factors like medication adherence and treatment effects when prescribing glucose-lowering or other medications for overweight or obese children and adolescents with type 2 diabetes.

Lifestyle management

With regard to lifestyle management programs, the intervention should be introduced as a part of diabetes care – aimed at reducing between 7% and 10% of body weight – and be based on a chronic care model. The intervention should include 30-60 minutes of moderate to intense physical activity for 5 days each week, strength training 3 days per week, and incorporate healthy eating plans. Dr. Arslanian and her associates noted there was limited evidence for pharmacotherapy for weight reduction in children and adolescents with type 2 diabetes.

Pharmacologic therapy

Pharmacologic therapy should be started together with lifestyle therapy once a diagnosis is made, according to the recommendations.

Metformin is the preferred initial pharmacologic treatment for patients with normal renal function who are asymptomatic and with HbA_1C levels of less than 8.5%.

Patients with blood glucose greater than or equal to 250 mg/dL and HbA_1C greater than or equal to 8.5% with symptoms such as weight loss, polydipsia, polyuria, or nocturia should receive basal insulin during initiation and titration of metformin.

Patients with ketosis or ketoacidosis should receive intravenous insulin to address hyperglycemia. Once the acidosis is corrected, initiate metformin with subcutaneous insulin therapy. For patients who are reaching home-based glucose monitoring targets, consider tapering the dose over 2-6 weeks with a 10%-30% reduction in insulin every few days.

In patients where metformin alone is not meeting the glycemic target, consider basal insulin therapy and, if that fails to help achieve glycemic targets, more intensive approaches should be considered, such as metabolic surgery.

Jay Cohen, MD, FACE, medical director at the Endocrine Clinic in Memphis, said in an interview that he agreed with the ADA position statement except for the pharmacologic therapy recommendations.

“The pharmacology therapy is 4 years outdated,” he said. “We routinely use all of the medications that are not Food and Drug Administration [approved] for kids, but are FDA approved for adults.”

He also questioned the ADA’s recommendation to give basal insulin to patients who are insulin resistant.

“Why give insulin if these people are insulin resistant?” said Dr. Cohen, who also is a Clinical Endocrinology News editorial board member. “The oral and injectable noninsulins work fabulously with less weight gain – already a problem for these patients – and less hypoglycemia, less side effects, and better compliance.”

Treatment goals

The HbA_1C goal for children and adolescents with type 2 diabetes is less than 7% when treated with oral agents alone. HbA_1C should be tested every 3 months and should be individualized, according to the ADA recommendations. In some patients, such as those with a shorter diabetes duration, lesser degrees of beta-cell dysfunction, and those who achieve significant weight improvement through lifestyle changes or taking metformin, consider lowering the HbA_1C goal to less than 6.5%.

Give individualized care with regard to home self-monitoring of blood glucose. Also provide patients and their families with “culturally competent” diabetes self-management tools and lifestyle programs. Consider social factors such as housing stability, food insecurity, and financial barriers when making treatment decisions.

Screening for complications

To screen for nephropathy, take BP measurements at every visit and promote lifestyle management to reduce risk of diabetic kidney disease and improve weight loss. After 6 months, if a patient’s BP remains greater than the 95th percentile for their age, gender, and height, ACE inhibitors, or angiotensin receptor blockers are initial therapeutic options, according to the position statement. Other BP-lowering treatments may be added as necessary.

Also monitor protein intake (0.8 g/kg per day) as well as urine albumin/creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) annually. Patients with diabetes and hypertension who are not pregnant should receive an ACE inhibitor or angiotensin receptor blocker if their UACR is modestly elevated (30-299 mg/g creatinine). Such a regimen is strongly recommended if their UACR is above 300 mg/g creatinine and/or if their eGFR is less than 60 mL/min per 1.73 m².

Screening issues

When considering diabetes distress and mental or behavioral health in children and adolescents with type 2 diabetes, use standardized and validated tools to assess symptoms such as depression and disordered eating behaviors. Regularly screen for smoking and alcohol use and provide preconception counseling for female patients of child-bearing age.

Screen for neuropathy, retinopathy, and nonalcoholic fatty liver disease annually and for obstructive sleep apnea at each visit. Lipid testing should be performed annually once patients have achieved glycemic control. Polycystic ovary syndrome should be considered in female patients with type 2 diabetes and treated with metformin together with lifestyle changes to address menstrual cyclicity and hyperandrogenism, the authors recommended.

Dr. Arslanian is on a data monitoring committee for AstraZeneca; data safety monitoring board for Boehringer Ingelheim; and advisory boards for Eli Lilly, Novo Nordisk, and Sanofi-Aventis; and has received research grants from Eli Lilly and Novo Nordisk. Other authors reported various relationships with a number of pharmaceutical companies.

SOURCE: Arslanian S et al. Diabetes Care. 2018 Nov 13. doi: 10.2337/dci18-0052.

Individuals aged 15-65 years, including pregnant women, should be screened for HIV infection, and those at risk should be given prophylaxis, according to draft recommendations issued by the U.S. Preventive Services Task Force. The screening recommendation extends to younger adolescents and older adults at increased risk for HIV infection. The recommendations are level A.

varnent/Wikimedia Commons/CC BY-SA 3.0

HIV remains a significant public health issue in the United States, with rates rising among individuals aged 25-29 years, although the overall number of cases has dropped slightly, according to the USPSTF report.

HIV prevention is a multistep process that includes not only screening but also wearing condoms during sex and using clean needles and syringes if injecting drugs, the researchers noted.

However, those at high risk for HIV, such as intravenous drug users, can help reduce their risk by taking a daily pill, the researchers wrote.

In an evidence report submitted to the Agency for Healthcare Research and Quality, researchers reviewed the Cochrane databases, MEDLINE, and Embase for studies up to June 2018. Based on data from 11 trials, pre-exposure prophylaxis (PrEP) consisting of antiretroviral therapy was associated with decreased risk of HIV infection, compared with placebo or no PrEP, with consistent effects across risk categories, the investigators noted.

The most common HIV risk factors include man-to-man sexual contact, injection drug use, having sex without a condom, exchanging sex for drugs or money, and having sex with an HIV-infected partner, according to the USPSTF report.

Although PrEP was associated with renal and gastrointestinal adverse effects, most were mild and resolved when the therapy either ended or continued long term. The use of PrEP does not absolve high-risk individuals from observing safety in sex activity and intravenous drug use, the researchers noted.

The Task Force’s draft recommendation statements and draft evidence reviews are available for public comment and are posted on the Task Force website at www.uspreventiveservicestaskforce.org. Comments can be submitted from Nov. 20, 2018, to Dec. 26, 2018, at www.uspreventiveservicestaskforce.org/tfcomment.htm.

Individuals aged 15-65 years, including pregnant women, should be screened for HIV infection, and those at risk should be given prophylaxis, according to draft recommendations issued by the U.S. Preventive Services Task Force. The screening recommendation extends to younger adolescents and older adults at increased risk for HIV infection. The recommendations are level A.

varnent/Wikimedia Commons/CC BY-SA 3.0

HIV remains a significant public health issue in the United States, with rates rising among individuals aged 25-29 years, although the overall number of cases has dropped slightly, according to the USPSTF report.

HIV prevention is a multistep process that includes not only screening but also wearing condoms during sex and using clean needles and syringes if injecting drugs, the researchers noted.

However, those at high risk for HIV, such as intravenous drug users, can help reduce their risk by taking a daily pill, the researchers wrote.

In an evidence report submitted to the Agency for Healthcare Research and Quality, researchers reviewed the Cochrane databases, MEDLINE, and Embase for studies up to June 2018. Based on data from 11 trials, pre-exposure prophylaxis (PrEP) consisting of antiretroviral therapy was associated with decreased risk of HIV infection, compared with placebo or no PrEP, with consistent effects across risk categories, the investigators noted.

The most common HIV risk factors include man-to-man sexual contact, injection drug use, having sex without a condom, exchanging sex for drugs or money, and having sex with an HIV-infected partner, according to the USPSTF report.

Although PrEP was associated with renal and gastrointestinal adverse effects, most were mild and resolved when the therapy either ended or continued long term. The use of PrEP does not absolve high-risk individuals from observing safety in sex activity and intravenous drug use, the researchers noted.

The Task Force’s draft recommendation statements and draft evidence reviews are available for public comment and are posted on the Task Force website at www.uspreventiveservicestaskforce.org. Comments can be submitted from Nov. 20, 2018, to Dec. 26, 2018, at www.uspreventiveservicestaskforce.org/tfcomment.htm.

Individuals aged 15-65 years, including pregnant women, should be screened for HIV infection, and those at risk should be given prophylaxis, according to draft recommendations issued by the U.S. Preventive Services Task Force. The screening recommendation extends to younger adolescents and older adults at increased risk for HIV infection. The recommendations are level A.

varnent/Wikimedia Commons/CC BY-SA 3.0

HIV remains a significant public health issue in the United States, with rates rising among individuals aged 25-29 years, although the overall number of cases has dropped slightly, according to the USPSTF report.

HIV prevention is a multistep process that includes not only screening but also wearing condoms during sex and using clean needles and syringes if injecting drugs, the researchers noted.

However, those at high risk for HIV, such as intravenous drug users, can help reduce their risk by taking a daily pill, the researchers wrote.

In an evidence report submitted to the Agency for Healthcare Research and Quality, researchers reviewed the Cochrane databases, MEDLINE, and Embase for studies up to June 2018. Based on data from 11 trials, pre-exposure prophylaxis (PrEP) consisting of antiretroviral therapy was associated with decreased risk of HIV infection, compared with placebo or no PrEP, with consistent effects across risk categories, the investigators noted.

The most common HIV risk factors include man-to-man sexual contact, injection drug use, having sex without a condom, exchanging sex for drugs or money, and having sex with an HIV-infected partner, according to the USPSTF report.

Although PrEP was associated with renal and gastrointestinal adverse effects, most were mild and resolved when the therapy either ended or continued long term. The use of PrEP does not absolve high-risk individuals from observing safety in sex activity and intravenous drug use, the researchers noted.

The Task Force’s draft recommendation statements and draft evidence reviews are available for public comment and are posted on the Task Force website at www.uspreventiveservicestaskforce.org. Comments can be submitted from Nov. 20, 2018, to Dec. 26, 2018, at www.uspreventiveservicestaskforce.org/tfcomment.htm.

SAN DIEGO – Fewer than a quarter of patients with signs of stage 3 chronic kidney disease (CKD) underwent follow-up testing within 1 year, even though most of these patients underwent repeat cholesterol screening during the same time.

Considering that CKD can be asymptomatic until the late stages, “this is a lost opportunity to get a proper evaluation by a nephrologist,” study coauthor and nephrologist Barbara S. Gillespie, MD, MMS, of Covance, the drug development business of LabCorp, said in an interview. Dr. Gillespie and her colleagues presented their findings at Kidney Week 2018, sponsored by the American Society of Nephrology.

More than 90% of patients with stages 1-3 CKD didn’t know they had the condition, based on 2013-2016 data gathered by the United States Renal Data System . Just 57% of those with stage 4 CKD were aware of their disease.

For the retrospective study, the researchers identified 4.9 million patients (58% were women; mean age was 71) who had estimated glomerular filtration rate (eGFR) results below 60 mL/min per 1.73 m² from 2011 to 2018, based on serum creatinine tests performed at least twice and at least 3 months apart by LabCorp. The researchers tracked the patients for a median 26 months.

Based on the initial results, 92% of the patients had stage 3 CKD, 6% had stage 4, and 2% had stage 5. However, at 1 year, the percentages of overall patients who underwent urine albumin/creatinine ratio, serum phosphorus, and plasma parathyroid hormone were 24%, 12%, and 17%, respectively, lead author Jennifer Ennis, MD, of LabCorp, said in an interview.

Kidney Disease Improving Global Outcomes guidelines from 2012 recommend “assessments of GFR and albuminuria at least annually ... and more often for individuals at higher risk of progression, and/or where measurement will impact therapeutic decisions” (Ann Intern Med. 2013 Jun 4;158[11]:825-30).

Yet 76% of these patients also underwent annual LDL cholesterol screening. “This suggests that the patients were receiving evaluation and treatment for other common conditions, but that CKD may not have been specifically addressed,” Dr. Ennis said.

SOURCE: Ennis JL et al. Kidney Week 2018, Abstract PUB111.

SAN DIEGO – Fewer than a quarter of patients with signs of stage 3 chronic kidney disease (CKD) underwent follow-up testing within 1 year, even though most of these patients underwent repeat cholesterol screening during the same time.

Considering that CKD can be asymptomatic until the late stages, “this is a lost opportunity to get a proper evaluation by a nephrologist,” study coauthor and nephrologist Barbara S. Gillespie, MD, MMS, of Covance, the drug development business of LabCorp, said in an interview. Dr. Gillespie and her colleagues presented their findings at Kidney Week 2018, sponsored by the American Society of Nephrology.

More than 90% of patients with stages 1-3 CKD didn’t know they had the condition, based on 2013-2016 data gathered by the United States Renal Data System . Just 57% of those with stage 4 CKD were aware of their disease.

For the retrospective study, the researchers identified 4.9 million patients (58% were women; mean age was 71) who had estimated glomerular filtration rate (eGFR) results below 60 mL/min per 1.73 m² from 2011 to 2018, based on serum creatinine tests performed at least twice and at least 3 months apart by LabCorp. The researchers tracked the patients for a median 26 months.

Based on the initial results, 92% of the patients had stage 3 CKD, 6% had stage 4, and 2% had stage 5. However, at 1 year, the percentages of overall patients who underwent urine albumin/creatinine ratio, serum phosphorus, and plasma parathyroid hormone were 24%, 12%, and 17%, respectively, lead author Jennifer Ennis, MD, of LabCorp, said in an interview.

Kidney Disease Improving Global Outcomes guidelines from 2012 recommend “assessments of GFR and albuminuria at least annually ... and more often for individuals at higher risk of progression, and/or where measurement will impact therapeutic decisions” (Ann Intern Med. 2013 Jun 4;158[11]:825-30).

Yet 76% of these patients also underwent annual LDL cholesterol screening. “This suggests that the patients were receiving evaluation and treatment for other common conditions, but that CKD may not have been specifically addressed,” Dr. Ennis said.

SOURCE: Ennis JL et al. Kidney Week 2018, Abstract PUB111.

SAN DIEGO – Fewer than a quarter of patients with signs of stage 3 chronic kidney disease (CKD) underwent follow-up testing within 1 year, even though most of these patients underwent repeat cholesterol screening during the same time.

Considering that CKD can be asymptomatic until the late stages, “this is a lost opportunity to get a proper evaluation by a nephrologist,” study coauthor and nephrologist Barbara S. Gillespie, MD, MMS, of Covance, the drug development business of LabCorp, said in an interview. Dr. Gillespie and her colleagues presented their findings at Kidney Week 2018, sponsored by the American Society of Nephrology.

More than 90% of patients with stages 1-3 CKD didn’t know they had the condition, based on 2013-2016 data gathered by the United States Renal Data System . Just 57% of those with stage 4 CKD were aware of their disease.

For the retrospective study, the researchers identified 4.9 million patients (58% were women; mean age was 71) who had estimated glomerular filtration rate (eGFR) results below 60 mL/min per 1.73 m² from 2011 to 2018, based on serum creatinine tests performed at least twice and at least 3 months apart by LabCorp. The researchers tracked the patients for a median 26 months.

Based on the initial results, 92% of the patients had stage 3 CKD, 6% had stage 4, and 2% had stage 5. However, at 1 year, the percentages of overall patients who underwent urine albumin/creatinine ratio, serum phosphorus, and plasma parathyroid hormone were 24%, 12%, and 17%, respectively, lead author Jennifer Ennis, MD, of LabCorp, said in an interview.

Kidney Disease Improving Global Outcomes guidelines from 2012 recommend “assessments of GFR and albuminuria at least annually ... and more often for individuals at higher risk of progression, and/or where measurement will impact therapeutic decisions” (Ann Intern Med. 2013 Jun 4;158[11]:825-30).

Yet 76% of these patients also underwent annual LDL cholesterol screening. “This suggests that the patients were receiving evaluation and treatment for other common conditions, but that CKD may not have been specifically addressed,” Dr. Ennis said.

SOURCE: Ennis JL et al. Kidney Week 2018, Abstract PUB111.