Many clinicians are prescribing the gabapentinoid drugs pregabalin (Lyrica) and gabapentin (Neurontin) for off-label treatment of pain, despite a lack of supporting data or approval from the Food and Drug Administration, according to investigators.

Over the past 15 years, use of gabapentinoids has tripled, a level of growth that cannot be explained by prescriptions for approved indications, reported coauthors Christopher W. Goodman, MD, and Allan S. Brett, MD, of the University of South Carolina, Columbia. Instead, clinicians are turning to gabapentinoids, partly as an option to substitute for opioids, which now have greater prescribing restrictions as a result of the current opioid crisis.

Ingram Publishing/Thinkstock

Although clinicians may cite guidelines that support off-label use of gabapentinoids for pain, the investigators warned that many of these recommendations stand on shaky ground.

“Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses,” the investigators wrote in a clinical review published online March 25 in JAMA Internal Medicine.

The investigators narrowed down 677 publications to 84 papers describing the use of gabapentinoids for outpatient noncancer pain syndromes for which they are not FDA approved; 54 for gabapentin and 30 for pregabalin. In the domain of analgesia, both agents are currently FDA-approved for postherpetic neuralgia, while pregabalin is additionally approved for pain associated with fibromyalgia and neuropathic pain from diabetic neuropathy and spinal cord injury. Indications in reviewed studies ranged broadly, from conditions somewhat related to those currently approved, such as unspecified neuropathy, to dissimilar conditions, such as chronic pancreatitis and burn injury.

The investigators summarized findings from randomized clinical trials while using case studies to illustrate potential problems with off-label use. In addition, they reviewed the history of gabapentinoids and sources of recommendations for off-label use, such as guidelines and previous review articles.

Six major findings were reported: (1) evidence supporting gabapentin for diabetic neuropathy pain is “mixed at best”; (2) evidence supporting gabapentin for nondiabetic neuropathies is very limited; (3) evidence does not support gabapentinoids for radiculopathy or low back pain; (4) gabapentin has minimal benefit for fibromyalgia pain, based on minimal evidence; (5) evidence does not support gabapentinoids for acute herpes zoster pain; and (6) in almost all studies for other painful indications, gabapentinoids were ineffective or “associated with small analgesic effects that were statistically significant but of questionable clinical importance.”

Case studies complemented this overview, highlighting related clinical dilemmas that the investigators encounter “repeatedly” during inpatient and outpatient care. Along with off-label use, such as gabapentinoid prescriptions for acute sciatica, the investigators reported cases in which neuropathy was diagnosed in place of nonspecific lower body pain to facilitate gabapentin prescription. They also described apparent disregard for risks of polypharmacy in prescriptions for elderly patients and rote use of gabapentinoids in patients with diabetic neuropathy who did not have sufficient discomfort to warrant prescription.

The investigators also cited a number of problems with the language of reviews and guidelines involving gabapentinoids.

“The wording in many guidelines and review articles reinforces an inflated view of gabapentinoid effectiveness or fails to distinguish carefully between evidence-based and non–evidence-based recommendations,” they wrote, adding that clinicians may have misconceptions about neuropathic pain. “One unintended effect of the broad definition [of neuropathic pain] might be to create a mistaken perception that an effective drug for one type of neuropathic pain is effective for all neuropathic pain, regardless of underlying etiology or mechanism,” the investigators suggested.

Another facet of prescribing behavior could be explained in economic terms. Pregabalin, sold under the brand name Lyrica, is considerably more expensive than gabapentin; however, the investigators warned that the similarity of these agents does not equate with interchangeability, noting differences in bioavailability and rate of absorption.

“Unfortunately, published direct comparisons between the 2 drugs in double-blind studies of patients with chronic noncancer pain are virtually nonexistent,” the investigators wrote.

In addition to questionable effectiveness of gabapentinoids for off-label chronic noncancer pain syndromes, Dr. Goodman and Dr. Brett noted that the drugs produce a “substantial incidence of dizziness, somnolence, and gait disturbance.”

They also described a new trend of gabapentinoid abuse and diversion, which may not be surprising, considering that gabapentinoids are reported to augment opioid-induced euphoria.

“Evidence of misuse of gabapentinoids is accumulating and likely related to the opioid epidemic. A recent review article reported an overall population prevalence of gabapentinoid ‘misuse and abuse’ as high as 1%, with substantially higher prevalence noted among patients with opioid use disorders,” the investigators wrote. “This trend is troubling, particularly because concomitant use of opioids and gabapentinoids is associated with increased odds of opioid-related death. Whether these concerns apply to patients receiving long-term prescribed opioid therapy is unclear.”

In the era of the opioid crisis, the investigators acknowledged that many clinicians have serious concerns about adequately treating chronic noncancer pain.

“Comprehensive management of pain in primary care settings is difficult. It requires time and resources that are frequently unavailable,” the investigators wrote. “Many patients with chronic pain have limited or no access to high-quality pain practices or to nonpharmacologic interventions, such as cognitive behavior therapy.”

The investigators reported no external funding or conflicts of interest.

SOURCE: Goodman CW et al. JAMA Intern Med. 2019 Mar 25. doi: 10.1001/jamainternmed.2019.0086

Many clinicians are prescribing the gabapentinoid drugs pregabalin (Lyrica) and gabapentin (Neurontin) for off-label treatment of pain, despite a lack of supporting data or approval from the Food and Drug Administration, according to investigators.

Over the past 15 years, use of gabapentinoids has tripled, a level of growth that cannot be explained by prescriptions for approved indications, reported coauthors Christopher W. Goodman, MD, and Allan S. Brett, MD, of the University of South Carolina, Columbia. Instead, clinicians are turning to gabapentinoids, partly as an option to substitute for opioids, which now have greater prescribing restrictions as a result of the current opioid crisis.

Ingram Publishing/Thinkstock

Although clinicians may cite guidelines that support off-label use of gabapentinoids for pain, the investigators warned that many of these recommendations stand on shaky ground.

“Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses,” the investigators wrote in a clinical review published online March 25 in JAMA Internal Medicine.

The investigators narrowed down 677 publications to 84 papers describing the use of gabapentinoids for outpatient noncancer pain syndromes for which they are not FDA approved; 54 for gabapentin and 30 for pregabalin. In the domain of analgesia, both agents are currently FDA-approved for postherpetic neuralgia, while pregabalin is additionally approved for pain associated with fibromyalgia and neuropathic pain from diabetic neuropathy and spinal cord injury. Indications in reviewed studies ranged broadly, from conditions somewhat related to those currently approved, such as unspecified neuropathy, to dissimilar conditions, such as chronic pancreatitis and burn injury.

The investigators summarized findings from randomized clinical trials while using case studies to illustrate potential problems with off-label use. In addition, they reviewed the history of gabapentinoids and sources of recommendations for off-label use, such as guidelines and previous review articles.

Six major findings were reported: (1) evidence supporting gabapentin for diabetic neuropathy pain is “mixed at best”; (2) evidence supporting gabapentin for nondiabetic neuropathies is very limited; (3) evidence does not support gabapentinoids for radiculopathy or low back pain; (4) gabapentin has minimal benefit for fibromyalgia pain, based on minimal evidence; (5) evidence does not support gabapentinoids for acute herpes zoster pain; and (6) in almost all studies for other painful indications, gabapentinoids were ineffective or “associated with small analgesic effects that were statistically significant but of questionable clinical importance.”

Case studies complemented this overview, highlighting related clinical dilemmas that the investigators encounter “repeatedly” during inpatient and outpatient care. Along with off-label use, such as gabapentinoid prescriptions for acute sciatica, the investigators reported cases in which neuropathy was diagnosed in place of nonspecific lower body pain to facilitate gabapentin prescription. They also described apparent disregard for risks of polypharmacy in prescriptions for elderly patients and rote use of gabapentinoids in patients with diabetic neuropathy who did not have sufficient discomfort to warrant prescription.

The investigators also cited a number of problems with the language of reviews and guidelines involving gabapentinoids.

“The wording in many guidelines and review articles reinforces an inflated view of gabapentinoid effectiveness or fails to distinguish carefully between evidence-based and non–evidence-based recommendations,” they wrote, adding that clinicians may have misconceptions about neuropathic pain. “One unintended effect of the broad definition [of neuropathic pain] might be to create a mistaken perception that an effective drug for one type of neuropathic pain is effective for all neuropathic pain, regardless of underlying etiology or mechanism,” the investigators suggested.

Another facet of prescribing behavior could be explained in economic terms. Pregabalin, sold under the brand name Lyrica, is considerably more expensive than gabapentin; however, the investigators warned that the similarity of these agents does not equate with interchangeability, noting differences in bioavailability and rate of absorption.

“Unfortunately, published direct comparisons between the 2 drugs in double-blind studies of patients with chronic noncancer pain are virtually nonexistent,” the investigators wrote.

In addition to questionable effectiveness of gabapentinoids for off-label chronic noncancer pain syndromes, Dr. Goodman and Dr. Brett noted that the drugs produce a “substantial incidence of dizziness, somnolence, and gait disturbance.”

They also described a new trend of gabapentinoid abuse and diversion, which may not be surprising, considering that gabapentinoids are reported to augment opioid-induced euphoria.

“Evidence of misuse of gabapentinoids is accumulating and likely related to the opioid epidemic. A recent review article reported an overall population prevalence of gabapentinoid ‘misuse and abuse’ as high as 1%, with substantially higher prevalence noted among patients with opioid use disorders,” the investigators wrote. “This trend is troubling, particularly because concomitant use of opioids and gabapentinoids is associated with increased odds of opioid-related death. Whether these concerns apply to patients receiving long-term prescribed opioid therapy is unclear.”

In the era of the opioid crisis, the investigators acknowledged that many clinicians have serious concerns about adequately treating chronic noncancer pain.

“Comprehensive management of pain in primary care settings is difficult. It requires time and resources that are frequently unavailable,” the investigators wrote. “Many patients with chronic pain have limited or no access to high-quality pain practices or to nonpharmacologic interventions, such as cognitive behavior therapy.”

The investigators reported no external funding or conflicts of interest.

SOURCE: Goodman CW et al. JAMA Intern Med. 2019 Mar 25. doi: 10.1001/jamainternmed.2019.0086

Many clinicians are prescribing the gabapentinoid drugs pregabalin (Lyrica) and gabapentin (Neurontin) for off-label treatment of pain, despite a lack of supporting data or approval from the Food and Drug Administration, according to investigators.

Over the past 15 years, use of gabapentinoids has tripled, a level of growth that cannot be explained by prescriptions for approved indications, reported coauthors Christopher W. Goodman, MD, and Allan S. Brett, MD, of the University of South Carolina, Columbia. Instead, clinicians are turning to gabapentinoids, partly as an option to substitute for opioids, which now have greater prescribing restrictions as a result of the current opioid crisis.

Ingram Publishing/Thinkstock

Although clinicians may cite guidelines that support off-label use of gabapentinoids for pain, the investigators warned that many of these recommendations stand on shaky ground.

“Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses,” the investigators wrote in a clinical review published online March 25 in JAMA Internal Medicine.

The investigators narrowed down 677 publications to 84 papers describing the use of gabapentinoids for outpatient noncancer pain syndromes for which they are not FDA approved; 54 for gabapentin and 30 for pregabalin. In the domain of analgesia, both agents are currently FDA-approved for postherpetic neuralgia, while pregabalin is additionally approved for pain associated with fibromyalgia and neuropathic pain from diabetic neuropathy and spinal cord injury. Indications in reviewed studies ranged broadly, from conditions somewhat related to those currently approved, such as unspecified neuropathy, to dissimilar conditions, such as chronic pancreatitis and burn injury.

The investigators summarized findings from randomized clinical trials while using case studies to illustrate potential problems with off-label use. In addition, they reviewed the history of gabapentinoids and sources of recommendations for off-label use, such as guidelines and previous review articles.

Six major findings were reported: (1) evidence supporting gabapentin for diabetic neuropathy pain is “mixed at best”; (2) evidence supporting gabapentin for nondiabetic neuropathies is very limited; (3) evidence does not support gabapentinoids for radiculopathy or low back pain; (4) gabapentin has minimal benefit for fibromyalgia pain, based on minimal evidence; (5) evidence does not support gabapentinoids for acute herpes zoster pain; and (6) in almost all studies for other painful indications, gabapentinoids were ineffective or “associated with small analgesic effects that were statistically significant but of questionable clinical importance.”

Case studies complemented this overview, highlighting related clinical dilemmas that the investigators encounter “repeatedly” during inpatient and outpatient care. Along with off-label use, such as gabapentinoid prescriptions for acute sciatica, the investigators reported cases in which neuropathy was diagnosed in place of nonspecific lower body pain to facilitate gabapentin prescription. They also described apparent disregard for risks of polypharmacy in prescriptions for elderly patients and rote use of gabapentinoids in patients with diabetic neuropathy who did not have sufficient discomfort to warrant prescription.

The investigators also cited a number of problems with the language of reviews and guidelines involving gabapentinoids.

“The wording in many guidelines and review articles reinforces an inflated view of gabapentinoid effectiveness or fails to distinguish carefully between evidence-based and non–evidence-based recommendations,” they wrote, adding that clinicians may have misconceptions about neuropathic pain. “One unintended effect of the broad definition [of neuropathic pain] might be to create a mistaken perception that an effective drug for one type of neuropathic pain is effective for all neuropathic pain, regardless of underlying etiology or mechanism,” the investigators suggested.

Another facet of prescribing behavior could be explained in economic terms. Pregabalin, sold under the brand name Lyrica, is considerably more expensive than gabapentin; however, the investigators warned that the similarity of these agents does not equate with interchangeability, noting differences in bioavailability and rate of absorption.

“Unfortunately, published direct comparisons between the 2 drugs in double-blind studies of patients with chronic noncancer pain are virtually nonexistent,” the investigators wrote.

In addition to questionable effectiveness of gabapentinoids for off-label chronic noncancer pain syndromes, Dr. Goodman and Dr. Brett noted that the drugs produce a “substantial incidence of dizziness, somnolence, and gait disturbance.”

They also described a new trend of gabapentinoid abuse and diversion, which may not be surprising, considering that gabapentinoids are reported to augment opioid-induced euphoria.

“Evidence of misuse of gabapentinoids is accumulating and likely related to the opioid epidemic. A recent review article reported an overall population prevalence of gabapentinoid ‘misuse and abuse’ as high as 1%, with substantially higher prevalence noted among patients with opioid use disorders,” the investigators wrote. “This trend is troubling, particularly because concomitant use of opioids and gabapentinoids is associated with increased odds of opioid-related death. Whether these concerns apply to patients receiving long-term prescribed opioid therapy is unclear.”

In the era of the opioid crisis, the investigators acknowledged that many clinicians have serious concerns about adequately treating chronic noncancer pain.

“Comprehensive management of pain in primary care settings is difficult. It requires time and resources that are frequently unavailable,” the investigators wrote. “Many patients with chronic pain have limited or no access to high-quality pain practices or to nonpharmacologic interventions, such as cognitive behavior therapy.”

The investigators reported no external funding or conflicts of interest.

SOURCE: Goodman CW et al. JAMA Intern Med. 2019 Mar 25. doi: 10.1001/jamainternmed.2019.0086

SEATTLE – A long-acting, injectable combination of the novel integrase inhibitor cabotegravir (CAB) and the second-generation nonnucleoside reverse transcriptase inhibitor rilpivirine (RPV) was noninferior to dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) in one phase 3 study (FLAIR) and to three-drug oral antiretroviral therapy (ART) more broadly in the companion ATLAS phase 3 study. Patient acceptance of the injectable formulation was surprisingly high, although researchers admitted there was likely some selection bias because patients already interested in receiving an injection would have been predisposed to entering the trials.

Ca-ssis/Thinkstock

Still, the numbers were impressive: 99% of patients who received the intramuscular injection expressed more satisfaction with it than with their previous oral regimen in the FLAIR study, and 98% expressed a similar opinion in the ATLAS study. Circumstantial evidence also suggests there may be some demand, according to Joseph Eron, MD, professor of medicine at the University of North Carolina at Chapel Hill, who commented during a press conference at the Conference on Retroviruses & Opportunistic Infections. “These studies didn’t take a long time to accrue. People were very interested, so it wasn’t as if people had to go around and beat the bushes to try to find people [to participate],” said Dr. Eron, who was not an author on either report.

“My patients tell me that they like not having to worry about taking their pills every day. There may be some relief from the stigma of HIV. You don’t have to think about it,” Susan Swindells, MBBS, medical director of the Specialty Care Clinic at the University of Nebraska Medical Center in Omaha and first author of the ATLAS trial, said during the press conference.

There were some injection site reactions, but they were generally mild and most resolved within 7 days. In the ATLAS study, 75% of participants reported injection site pain, and 1% discontinued as a result. In the FLAIR study, 82% in the CAB/RPV arm experienced an injection site reaction, with a median duration of 3 days; 99% of reactions were grade 1 or 2.

Should the combination achieve regulatory approval, it remains to be seen how challenging it will be to manage patients with monthly injections and ensure they stick to the schedule. The injections must be administered by a health care provider.

“In terms of generalizability outside of the study, it would be a paradigm shift in our therapy,” Chloe Orkin, MBBCh, said at a press conference. Dr. Orkin is the first author on the FLAIR trial report and a consultant in HIV Medicine at Barts Health National Health Service Trust. She pointed to the example of injectable contraception. “It can be done. It’s just that we haven’t done it. It will require some thought,” Dr. Orkin added.

In the ATLAS study, 616 participants taking two nucleoside reverse transcriptase inhibitor (NRTIs) and an integrase inhibitor, a non-NRTI, or a protease inhibitor, were randomized 1:1 to continue their regimen (CART arm) or switch to CAB/RPV, following a 4-week safety monitoring period of oral CAB/RPV. After 48 weeks, 1.6% in the CAB/RPV arm and 1.0% in the CART arm had HIV-1 RNA greater than or equal to 50 copies/mL, which met the prespecified noninferiority margin. Of patients in the CAB/RPV arm, 93% had HIV-1 RNA less than 50 copies/mL at week 48 versus 95% in the CART arm, and the difference was not statistically significant. Grade 3 or 4 events were seen in 11% of CAB/RPV and 7% of CART patients.

The FLAIR study randomized 566 ART-naive patients to receive either CAB/RPV or DTG/ABC/3TC after a 20-week induction phase, followed by a 4-week safety monitoring period for those going into the CAB/RPV arm. At week 48, 2.1% in the CAB/RPV arm and 2.5% in the DTG/ABC/3TC arm had HIV-1 RNA greater than or equal to 50 copies/mL, which met the prespecified noninferiority margin, while 94% in the CAB/RPV arm and 93% in the DTG/ABC/3TC arm had HIV-1 RNA less than 50 copies/mL. Confirmed virologic failure occurred in four patients (1.4%) in the CAB/RPV arm, and three of those patients had mutations in the NNRTI+INSTI domains, while the fourth patient was not tested. Three failures occurred in the DTG/ABC/3TC arm, and none of those patients had INSTI resistance mutations. A total of 82% of CAB/RPV patients had injection site reactions, 99% of which were grade 1 or 2, and the median duration was 3 days.

The ATLAS and FLAIR studies were sponsored by ViiV. Janssen and GlaxoSmithKline were collaborators.

SOURCES: Swindells S et al. CROI 2019, Abstract 139 LB. Orkin C et al. CROI 2019, Abstract 140.

SEATTLE – A long-acting, injectable combination of the novel integrase inhibitor cabotegravir (CAB) and the second-generation nonnucleoside reverse transcriptase inhibitor rilpivirine (RPV) was noninferior to dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) in one phase 3 study (FLAIR) and to three-drug oral antiretroviral therapy (ART) more broadly in the companion ATLAS phase 3 study. Patient acceptance of the injectable formulation was surprisingly high, although researchers admitted there was likely some selection bias because patients already interested in receiving an injection would have been predisposed to entering the trials.

Ca-ssis/Thinkstock

Still, the numbers were impressive: 99% of patients who received the intramuscular injection expressed more satisfaction with it than with their previous oral regimen in the FLAIR study, and 98% expressed a similar opinion in the ATLAS study. Circumstantial evidence also suggests there may be some demand, according to Joseph Eron, MD, professor of medicine at the University of North Carolina at Chapel Hill, who commented during a press conference at the Conference on Retroviruses & Opportunistic Infections. “These studies didn’t take a long time to accrue. People were very interested, so it wasn’t as if people had to go around and beat the bushes to try to find people [to participate],” said Dr. Eron, who was not an author on either report.

“My patients tell me that they like not having to worry about taking their pills every day. There may be some relief from the stigma of HIV. You don’t have to think about it,” Susan Swindells, MBBS, medical director of the Specialty Care Clinic at the University of Nebraska Medical Center in Omaha and first author of the ATLAS trial, said during the press conference.

There were some injection site reactions, but they were generally mild and most resolved within 7 days. In the ATLAS study, 75% of participants reported injection site pain, and 1% discontinued as a result. In the FLAIR study, 82% in the CAB/RPV arm experienced an injection site reaction, with a median duration of 3 days; 99% of reactions were grade 1 or 2.

Should the combination achieve regulatory approval, it remains to be seen how challenging it will be to manage patients with monthly injections and ensure they stick to the schedule. The injections must be administered by a health care provider.

“In terms of generalizability outside of the study, it would be a paradigm shift in our therapy,” Chloe Orkin, MBBCh, said at a press conference. Dr. Orkin is the first author on the FLAIR trial report and a consultant in HIV Medicine at Barts Health National Health Service Trust. She pointed to the example of injectable contraception. “It can be done. It’s just that we haven’t done it. It will require some thought,” Dr. Orkin added.

In the ATLAS study, 616 participants taking two nucleoside reverse transcriptase inhibitor (NRTIs) and an integrase inhibitor, a non-NRTI, or a protease inhibitor, were randomized 1:1 to continue their regimen (CART arm) or switch to CAB/RPV, following a 4-week safety monitoring period of oral CAB/RPV. After 48 weeks, 1.6% in the CAB/RPV arm and 1.0% in the CART arm had HIV-1 RNA greater than or equal to 50 copies/mL, which met the prespecified noninferiority margin. Of patients in the CAB/RPV arm, 93% had HIV-1 RNA less than 50 copies/mL at week 48 versus 95% in the CART arm, and the difference was not statistically significant. Grade 3 or 4 events were seen in 11% of CAB/RPV and 7% of CART patients.

The FLAIR study randomized 566 ART-naive patients to receive either CAB/RPV or DTG/ABC/3TC after a 20-week induction phase, followed by a 4-week safety monitoring period for those going into the CAB/RPV arm. At week 48, 2.1% in the CAB/RPV arm and 2.5% in the DTG/ABC/3TC arm had HIV-1 RNA greater than or equal to 50 copies/mL, which met the prespecified noninferiority margin, while 94% in the CAB/RPV arm and 93% in the DTG/ABC/3TC arm had HIV-1 RNA less than 50 copies/mL. Confirmed virologic failure occurred in four patients (1.4%) in the CAB/RPV arm, and three of those patients had mutations in the NNRTI+INSTI domains, while the fourth patient was not tested. Three failures occurred in the DTG/ABC/3TC arm, and none of those patients had INSTI resistance mutations. A total of 82% of CAB/RPV patients had injection site reactions, 99% of which were grade 1 or 2, and the median duration was 3 days.

The ATLAS and FLAIR studies were sponsored by ViiV. Janssen and GlaxoSmithKline were collaborators.

SOURCES: Swindells S et al. CROI 2019, Abstract 139 LB. Orkin C et al. CROI 2019, Abstract 140.

SEATTLE – A long-acting, injectable combination of the novel integrase inhibitor cabotegravir (CAB) and the second-generation nonnucleoside reverse transcriptase inhibitor rilpivirine (RPV) was noninferior to dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) in one phase 3 study (FLAIR) and to three-drug oral antiretroviral therapy (ART) more broadly in the companion ATLAS phase 3 study. Patient acceptance of the injectable formulation was surprisingly high, although researchers admitted there was likely some selection bias because patients already interested in receiving an injection would have been predisposed to entering the trials.

Ca-ssis/Thinkstock

Still, the numbers were impressive: 99% of patients who received the intramuscular injection expressed more satisfaction with it than with their previous oral regimen in the FLAIR study, and 98% expressed a similar opinion in the ATLAS study. Circumstantial evidence also suggests there may be some demand, according to Joseph Eron, MD, professor of medicine at the University of North Carolina at Chapel Hill, who commented during a press conference at the Conference on Retroviruses & Opportunistic Infections. “These studies didn’t take a long time to accrue. People were very interested, so it wasn’t as if people had to go around and beat the bushes to try to find people [to participate],” said Dr. Eron, who was not an author on either report.

“My patients tell me that they like not having to worry about taking their pills every day. There may be some relief from the stigma of HIV. You don’t have to think about it,” Susan Swindells, MBBS, medical director of the Specialty Care Clinic at the University of Nebraska Medical Center in Omaha and first author of the ATLAS trial, said during the press conference.

There were some injection site reactions, but they were generally mild and most resolved within 7 days. In the ATLAS study, 75% of participants reported injection site pain, and 1% discontinued as a result. In the FLAIR study, 82% in the CAB/RPV arm experienced an injection site reaction, with a median duration of 3 days; 99% of reactions were grade 1 or 2.

Should the combination achieve regulatory approval, it remains to be seen how challenging it will be to manage patients with monthly injections and ensure they stick to the schedule. The injections must be administered by a health care provider.

“In terms of generalizability outside of the study, it would be a paradigm shift in our therapy,” Chloe Orkin, MBBCh, said at a press conference. Dr. Orkin is the first author on the FLAIR trial report and a consultant in HIV Medicine at Barts Health National Health Service Trust. She pointed to the example of injectable contraception. “It can be done. It’s just that we haven’t done it. It will require some thought,” Dr. Orkin added.

In the ATLAS study, 616 participants taking two nucleoside reverse transcriptase inhibitor (NRTIs) and an integrase inhibitor, a non-NRTI, or a protease inhibitor, were randomized 1:1 to continue their regimen (CART arm) or switch to CAB/RPV, following a 4-week safety monitoring period of oral CAB/RPV. After 48 weeks, 1.6% in the CAB/RPV arm and 1.0% in the CART arm had HIV-1 RNA greater than or equal to 50 copies/mL, which met the prespecified noninferiority margin. Of patients in the CAB/RPV arm, 93% had HIV-1 RNA less than 50 copies/mL at week 48 versus 95% in the CART arm, and the difference was not statistically significant. Grade 3 or 4 events were seen in 11% of CAB/RPV and 7% of CART patients.

The FLAIR study randomized 566 ART-naive patients to receive either CAB/RPV or DTG/ABC/3TC after a 20-week induction phase, followed by a 4-week safety monitoring period for those going into the CAB/RPV arm. At week 48, 2.1% in the CAB/RPV arm and 2.5% in the DTG/ABC/3TC arm had HIV-1 RNA greater than or equal to 50 copies/mL, which met the prespecified noninferiority margin, while 94% in the CAB/RPV arm and 93% in the DTG/ABC/3TC arm had HIV-1 RNA less than 50 copies/mL. Confirmed virologic failure occurred in four patients (1.4%) in the CAB/RPV arm, and three of those patients had mutations in the NNRTI+INSTI domains, while the fourth patient was not tested. Three failures occurred in the DTG/ABC/3TC arm, and none of those patients had INSTI resistance mutations. A total of 82% of CAB/RPV patients had injection site reactions, 99% of which were grade 1 or 2, and the median duration was 3 days.

The ATLAS and FLAIR studies were sponsored by ViiV. Janssen and GlaxoSmithKline were collaborators.

SOURCES: Swindells S et al. CROI 2019, Abstract 139 LB. Orkin C et al. CROI 2019, Abstract 140.

Q) When my patient was told that she needed dialysis, one of her first questions was, "For how long?" Which got me thinking: How often do dialysis patients regain kidney function? Are some more likely than others to be able to stop dialysis?

Diagnosis with end-stage renal disease (ESRD), which requires dialysis, is a life-changing event. Inevitably, patients ask about their chance of recovery and the likelihood of stopping dialysis. Studies have consistently demonstrated low rates of kidney recovery, ranging from 0.9% to 2.4%.¹

According to the United States Renal Data System (USRDS), from 1995-2006 only 0.9% of ESRD patients regained kidney function resulting in the discontinuation of dialysis.² In one study, Agraharkar and colleagues reviewed the medical records and lab results of patients discharged from a chronic dialysis unit and reported a 1% to 2% rate of kidney recovery. The researchers concluded that closer monitoring of residual kidney function was key to identification of patients with a greater chance of recovery.³ Chu and Folkert noted a recovery rate of 1.0% to 2.4% in a review of large observational studies, concluding that the underlying etiology of the kidney failure was the single most important predictor.⁴ 

Another study of approximately 194,000 patients who started dialysis between 2008-2009 demonstrated much higher rates of sustained recovery: up to 5%. This study showed that patients with kidney failure associated with acute kidney injury (AKI) were more likely to achieve recovery; patients with the AKI diagnosis of acute tubular necrosis had the highest rate of recovery.¹

Similar studies of pediatric patients are rare. One  European study followed 6,574 children who started dialysis before age 15. Within 2 years of dialysis initiation, just 2% showed kidney function recovery. This study also identified underlying etiology as an important predictor of recovery; ischemic kidney failure, hemolytic uremic syndrome, and vasculitis were associated with the greatest chance of recovery.⁵

Despite these recent findings, the prospect of discontinuation of dialysis with a diagnosis of ESRD remains very low. A patient's underlying etiology influences the possibility of recovery; those with AKI tend to have the greatest chance, making close monitoring of residual kidney function essential in this population.³ — MSG

Marlene Shaw-Gallagher, PA-C
Nephrology Division of Michigan Medicine
Assistant Professor at University of Detroit Mercy

Q) When my patient was told that she needed dialysis, one of her first questions was, "For how long?" Which got me thinking: How often do dialysis patients regain kidney function? Are some more likely than others to be able to stop dialysis?

Diagnosis with end-stage renal disease (ESRD), which requires dialysis, is a life-changing event. Inevitably, patients ask about their chance of recovery and the likelihood of stopping dialysis. Studies have consistently demonstrated low rates of kidney recovery, ranging from 0.9% to 2.4%.¹

According to the United States Renal Data System (USRDS), from 1995-2006 only 0.9% of ESRD patients regained kidney function resulting in the discontinuation of dialysis.² In one study, Agraharkar and colleagues reviewed the medical records and lab results of patients discharged from a chronic dialysis unit and reported a 1% to 2% rate of kidney recovery. The researchers concluded that closer monitoring of residual kidney function was key to identification of patients with a greater chance of recovery.³ Chu and Folkert noted a recovery rate of 1.0% to 2.4% in a review of large observational studies, concluding that the underlying etiology of the kidney failure was the single most important predictor.⁴ 

Another study of approximately 194,000 patients who started dialysis between 2008-2009 demonstrated much higher rates of sustained recovery: up to 5%. This study showed that patients with kidney failure associated with acute kidney injury (AKI) were more likely to achieve recovery; patients with the AKI diagnosis of acute tubular necrosis had the highest rate of recovery.¹

Similar studies of pediatric patients are rare. One  European study followed 6,574 children who started dialysis before age 15. Within 2 years of dialysis initiation, just 2% showed kidney function recovery. This study also identified underlying etiology as an important predictor of recovery; ischemic kidney failure, hemolytic uremic syndrome, and vasculitis were associated with the greatest chance of recovery.⁵

Despite these recent findings, the prospect of discontinuation of dialysis with a diagnosis of ESRD remains very low. A patient's underlying etiology influences the possibility of recovery; those with AKI tend to have the greatest chance, making close monitoring of residual kidney function essential in this population.³ — MSG

Marlene Shaw-Gallagher, PA-C
Nephrology Division of Michigan Medicine
Assistant Professor at University of Detroit Mercy

Q) When my patient was told that she needed dialysis, one of her first questions was, "For how long?" Which got me thinking: How often do dialysis patients regain kidney function? Are some more likely than others to be able to stop dialysis?

Diagnosis with end-stage renal disease (ESRD), which requires dialysis, is a life-changing event. Inevitably, patients ask about their chance of recovery and the likelihood of stopping dialysis. Studies have consistently demonstrated low rates of kidney recovery, ranging from 0.9% to 2.4%.¹

According to the United States Renal Data System (USRDS), from 1995-2006 only 0.9% of ESRD patients regained kidney function resulting in the discontinuation of dialysis.² In one study, Agraharkar and colleagues reviewed the medical records and lab results of patients discharged from a chronic dialysis unit and reported a 1% to 2% rate of kidney recovery. The researchers concluded that closer monitoring of residual kidney function was key to identification of patients with a greater chance of recovery.³ Chu and Folkert noted a recovery rate of 1.0% to 2.4% in a review of large observational studies, concluding that the underlying etiology of the kidney failure was the single most important predictor.⁴ 

Another study of approximately 194,000 patients who started dialysis between 2008-2009 demonstrated much higher rates of sustained recovery: up to 5%. This study showed that patients with kidney failure associated with acute kidney injury (AKI) were more likely to achieve recovery; patients with the AKI diagnosis of acute tubular necrosis had the highest rate of recovery.¹

Similar studies of pediatric patients are rare. One  European study followed 6,574 children who started dialysis before age 15. Within 2 years of dialysis initiation, just 2% showed kidney function recovery. This study also identified underlying etiology as an important predictor of recovery; ischemic kidney failure, hemolytic uremic syndrome, and vasculitis were associated with the greatest chance of recovery.⁵

Despite these recent findings, the prospect of discontinuation of dialysis with a diagnosis of ESRD remains very low. A patient's underlying etiology influences the possibility of recovery; those with AKI tend to have the greatest chance, making close monitoring of residual kidney function essential in this population.³ — MSG

Marlene Shaw-Gallagher, PA-C
Nephrology Division of Michigan Medicine
Assistant Professor at University of Detroit Mercy

The findings suggest that a universal “test-and-treat” strategy could be “an important addition to our toolbox of proven HIV prevention modalities,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored study, Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART), was conducted from 2013 to 2018 in 21 urban and peri-urban communities in Zambia and South Africa, each with about 50,000 residents.

The communities were grouped as 7 “triplets” matched by geographic location and estimated HIV prevalence. The first group received annual house-to-house voluntary HIV testing and counseling, linkage to care for those testing positive, and the offer of a suite of proven prevention measures for those who tested negative. The second group received the same services as the first except treatment was offered according to national guidelines. The third group served as a control and received HIV prevention and testing services according to the local standard of care and HIV treatment according to national guidelines.

At the start of the study, the national guidelines for HIV treatment in Zambia and South Africa specified starting ART when the CD4+ T-cell count had declined to 350 cells/µL. In 2014, that threshold was raised to 500 cells/µL. In 2016, both countries recommended that everyone diagnosed with HIV begin ART immediately regardless of CD4+ T-cell count. Consequently, the first and second groups received the same intervention during the last 2 years of the study.

The researchers also recruited a random sample of about 2,300 adults from each community and visited them once a year for 3 years to collect data and test blood.

In the first 3 years, during nearly 40,000 person-years of follow-up, 553 people developed HIV infection (1.4 infections per 100 person-years). HIV incidence was 7% lower in group 1 than in the control group, although the difference was not statistically significant. However, HIV incidence was 30% lower in group 2 compared with that in the control group—a highly statistically significant and consistent result. (The researchers can’t explain why new HIV infections didn’t decline in all the communities where people who tested positive were offered immediate treatment.)

Of participants who tested positive by year 2, 72% of group 1, 68% of group 2, and 60% of the control group had achieved viral suppression.

The findings suggest that a universal “test-and-treat” strategy could be “an important addition to our toolbox of proven HIV prevention modalities,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored study, Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART), was conducted from 2013 to 2018 in 21 urban and peri-urban communities in Zambia and South Africa, each with about 50,000 residents.

The communities were grouped as 7 “triplets” matched by geographic location and estimated HIV prevalence. The first group received annual house-to-house voluntary HIV testing and counseling, linkage to care for those testing positive, and the offer of a suite of proven prevention measures for those who tested negative. The second group received the same services as the first except treatment was offered according to national guidelines. The third group served as a control and received HIV prevention and testing services according to the local standard of care and HIV treatment according to national guidelines.

At the start of the study, the national guidelines for HIV treatment in Zambia and South Africa specified starting ART when the CD4+ T-cell count had declined to 350 cells/µL. In 2014, that threshold was raised to 500 cells/µL. In 2016, both countries recommended that everyone diagnosed with HIV begin ART immediately regardless of CD4+ T-cell count. Consequently, the first and second groups received the same intervention during the last 2 years of the study.

The researchers also recruited a random sample of about 2,300 adults from each community and visited them once a year for 3 years to collect data and test blood.

In the first 3 years, during nearly 40,000 person-years of follow-up, 553 people developed HIV infection (1.4 infections per 100 person-years). HIV incidence was 7% lower in group 1 than in the control group, although the difference was not statistically significant. However, HIV incidence was 30% lower in group 2 compared with that in the control group—a highly statistically significant and consistent result. (The researchers can’t explain why new HIV infections didn’t decline in all the communities where people who tested positive were offered immediate treatment.)

Of participants who tested positive by year 2, 72% of group 1, 68% of group 2, and 60% of the control group had achieved viral suppression.

The findings suggest that a universal “test-and-treat” strategy could be “an important addition to our toolbox of proven HIV prevention modalities,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored study, Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART), was conducted from 2013 to 2018 in 21 urban and peri-urban communities in Zambia and South Africa, each with about 50,000 residents.

The communities were grouped as 7 “triplets” matched by geographic location and estimated HIV prevalence. The first group received annual house-to-house voluntary HIV testing and counseling, linkage to care for those testing positive, and the offer of a suite of proven prevention measures for those who tested negative. The second group received the same services as the first except treatment was offered according to national guidelines. The third group served as a control and received HIV prevention and testing services according to the local standard of care and HIV treatment according to national guidelines.

At the start of the study, the national guidelines for HIV treatment in Zambia and South Africa specified starting ART when the CD4+ T-cell count had declined to 350 cells/µL. In 2014, that threshold was raised to 500 cells/µL. In 2016, both countries recommended that everyone diagnosed with HIV begin ART immediately regardless of CD4+ T-cell count. Consequently, the first and second groups received the same intervention during the last 2 years of the study.

The researchers also recruited a random sample of about 2,300 adults from each community and visited them once a year for 3 years to collect data and test blood.

In the first 3 years, during nearly 40,000 person-years of follow-up, 553 people developed HIV infection (1.4 infections per 100 person-years). HIV incidence was 7% lower in group 1 than in the control group, although the difference was not statistically significant. However, HIV incidence was 30% lower in group 2 compared with that in the control group—a highly statistically significant and consistent result. (The researchers can’t explain why new HIV infections didn’t decline in all the communities where people who tested positive were offered immediate treatment.)

Of participants who tested positive by year 2, 72% of group 1, 68% of group 2, and 60% of the control group had achieved viral suppression.

Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.

American Heart Association

As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.

Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.

Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.

Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.

The statement makes six major recommendations:

• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.

Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.

• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.

• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.

• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.

• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.

• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.

Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”

The statement used no external funding, and the authors had no disclosures or conflicts of interest.

SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282

Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.

American Heart Association

As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.

Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.

Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.

Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.

The statement makes six major recommendations:

• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.

Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.

• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.

• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.

• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.

• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.

• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.

Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”

The statement used no external funding, and the authors had no disclosures or conflicts of interest.

SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282

Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.

American Heart Association

As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.

Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.

Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.

Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.

The statement makes six major recommendations:

• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.

Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.

• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.

• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.

• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.

• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.

• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.

Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”

The statement used no external funding, and the authors had no disclosures or conflicts of interest.

SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282

Interested in advocacy but not sure how or whether you have time in your busy schedule? AGA has an array of options for how you can be active in advocacy. Some take as little as 5 minutes.

Letter writing. AGA uses GovPredict, an online advocacy platform that allows members to contact their member of Congress with just a few clicks. AGA develops messages on significant pieces of legislation, key efforts in Congress or on issues being advanced by federal agencies that have a great impact on gastroenterology. AGA’s ongoing letter writing campaigns can always be found on www.gastro.org/advocacy but be sure to keep an eye out for advocacy emails, AGA eDigest, and social media, so you do not miss your opportunity to take action on timely issues. AGA encourages its members to share letter writing campaigns with their colleagues, as well as posting them on social media.

Meetings with your member of Congress. In-person meetings are an excellent opportunity to share with your member of Congress, or their staff, how the issues that impact gastroenterology affect you, your patients, and your practice. AGA has a plethora of resources to help you set up a meeting with your member of Congress, including up-to-date issue briefs, tips and tricks for productive meetings, and webinars on how to host an on-site visit. AGA staff is always more than happy to help you arrange a meeting either in Washington, DC, or your home state. If you are interested in arranging a meeting with your member of Congress, please contact AGA Public Policy Coordinator, Jonathan Sollish, at jsollish@gastro.org or 240-482-3228.

AGA PAC. AGA PAC is a voluntary, nonpartisan political organization affiliated with and supported by AGA. The only political action committee supported by a national gastroenterology society, its mission is to give gastroenterologists a greater presence on Capitol Hill and a more effective voice in policy discussions. AGA PAC supports candidates who support our policy priorities, such as fair reimbursement, cutting regulatory red tape, supporting patient protections, and access to specialty care, and sustained federal funding of digestive disease research. If you are interested in learning more, contact AGA Government and Political Affairs Manager, Navneet Buttar, at nbuttar@gastro.org or 240-482-3221.

Congressional Advocates Program. This grassroots program is aimed at establishing a stronger foundation for our current and future advocacy initiatives by creating state teams to work on advocacy on the local, state, and national levels. Participation can include a wide variety of activities, ranging from creating educational posts on social media to meeting with members of Congress. Members of the Congressional Advocates Program are mentored and receive advocacy training by AGA leadership and staff. Participating members receive an AGA Congressional Advocate Program Certificate, a Digestive Disease Week^® (DDW) badge ribbon, policy badge on the AGA Community, and recognition on AGA’s website. Applications for the next cycle will be released in 2019.



ginews@gastro.org

Interested in advocacy but not sure how or whether you have time in your busy schedule? AGA has an array of options for how you can be active in advocacy. Some take as little as 5 minutes.

Letter writing. AGA uses GovPredict, an online advocacy platform that allows members to contact their member of Congress with just a few clicks. AGA develops messages on significant pieces of legislation, key efforts in Congress or on issues being advanced by federal agencies that have a great impact on gastroenterology. AGA’s ongoing letter writing campaigns can always be found on www.gastro.org/advocacy but be sure to keep an eye out for advocacy emails, AGA eDigest, and social media, so you do not miss your opportunity to take action on timely issues. AGA encourages its members to share letter writing campaigns with their colleagues, as well as posting them on social media.

Meetings with your member of Congress. In-person meetings are an excellent opportunity to share with your member of Congress, or their staff, how the issues that impact gastroenterology affect you, your patients, and your practice. AGA has a plethora of resources to help you set up a meeting with your member of Congress, including up-to-date issue briefs, tips and tricks for productive meetings, and webinars on how to host an on-site visit. AGA staff is always more than happy to help you arrange a meeting either in Washington, DC, or your home state. If you are interested in arranging a meeting with your member of Congress, please contact AGA Public Policy Coordinator, Jonathan Sollish, at jsollish@gastro.org or 240-482-3228.

AGA PAC. AGA PAC is a voluntary, nonpartisan political organization affiliated with and supported by AGA. The only political action committee supported by a national gastroenterology society, its mission is to give gastroenterologists a greater presence on Capitol Hill and a more effective voice in policy discussions. AGA PAC supports candidates who support our policy priorities, such as fair reimbursement, cutting regulatory red tape, supporting patient protections, and access to specialty care, and sustained federal funding of digestive disease research. If you are interested in learning more, contact AGA Government and Political Affairs Manager, Navneet Buttar, at nbuttar@gastro.org or 240-482-3221.

Congressional Advocates Program. This grassroots program is aimed at establishing a stronger foundation for our current and future advocacy initiatives by creating state teams to work on advocacy on the local, state, and national levels. Participation can include a wide variety of activities, ranging from creating educational posts on social media to meeting with members of Congress. Members of the Congressional Advocates Program are mentored and receive advocacy training by AGA leadership and staff. Participating members receive an AGA Congressional Advocate Program Certificate, a Digestive Disease Week^® (DDW) badge ribbon, policy badge on the AGA Community, and recognition on AGA’s website. Applications for the next cycle will be released in 2019.



ginews@gastro.org

Interested in advocacy but not sure how or whether you have time in your busy schedule? AGA has an array of options for how you can be active in advocacy. Some take as little as 5 minutes.

Letter writing. AGA uses GovPredict, an online advocacy platform that allows members to contact their member of Congress with just a few clicks. AGA develops messages on significant pieces of legislation, key efforts in Congress or on issues being advanced by federal agencies that have a great impact on gastroenterology. AGA’s ongoing letter writing campaigns can always be found on www.gastro.org/advocacy but be sure to keep an eye out for advocacy emails, AGA eDigest, and social media, so you do not miss your opportunity to take action on timely issues. AGA encourages its members to share letter writing campaigns with their colleagues, as well as posting them on social media.

Meetings with your member of Congress. In-person meetings are an excellent opportunity to share with your member of Congress, or their staff, how the issues that impact gastroenterology affect you, your patients, and your practice. AGA has a plethora of resources to help you set up a meeting with your member of Congress, including up-to-date issue briefs, tips and tricks for productive meetings, and webinars on how to host an on-site visit. AGA staff is always more than happy to help you arrange a meeting either in Washington, DC, or your home state. If you are interested in arranging a meeting with your member of Congress, please contact AGA Public Policy Coordinator, Jonathan Sollish, at jsollish@gastro.org or 240-482-3228.

AGA PAC. AGA PAC is a voluntary, nonpartisan political organization affiliated with and supported by AGA. The only political action committee supported by a national gastroenterology society, its mission is to give gastroenterologists a greater presence on Capitol Hill and a more effective voice in policy discussions. AGA PAC supports candidates who support our policy priorities, such as fair reimbursement, cutting regulatory red tape, supporting patient protections, and access to specialty care, and sustained federal funding of digestive disease research. If you are interested in learning more, contact AGA Government and Political Affairs Manager, Navneet Buttar, at nbuttar@gastro.org or 240-482-3221.

Congressional Advocates Program. This grassroots program is aimed at establishing a stronger foundation for our current and future advocacy initiatives by creating state teams to work on advocacy on the local, state, and national levels. Participation can include a wide variety of activities, ranging from creating educational posts on social media to meeting with members of Congress. Members of the Congressional Advocates Program are mentored and receive advocacy training by AGA leadership and staff. Participating members receive an AGA Congressional Advocate Program Certificate, a Digestive Disease Week^® (DDW) badge ribbon, policy badge on the AGA Community, and recognition on AGA’s website. Applications for the next cycle will be released in 2019.



ginews@gastro.org

Sheila E. Crowe, MD, AGAF, chair of the nominating committee, is pleased to announce that John M. Inadomi, MD, AGAF, joins the presidential line up for AGA.

John M. Inadomi, MD, AGAF

The AGA Nominating Committee also appointed the following slate of councillors, which is subject to membership vote.
 

Maria T. Abreu, MD, AGAF

David A. Katzka, MD

Pending approval by the voting membership, all board members begin their terms after DDW 2019. The voting membership will be sent a ballot to approve the slate of officers on or before March 21, 2019, with a response date of no later than April 20, 2019.

Thank you to our nominating committee members, pictured here at a well-deserved dinner after their committee work was completed.

ginews@gastro.org

Sheila E. Crowe, MD, AGAF, chair of the nominating committee, is pleased to announce that John M. Inadomi, MD, AGAF, joins the presidential line up for AGA.

John M. Inadomi, MD, AGAF

The AGA Nominating Committee also appointed the following slate of councillors, which is subject to membership vote.
 

Maria T. Abreu, MD, AGAF

David A. Katzka, MD

Pending approval by the voting membership, all board members begin their terms after DDW 2019. The voting membership will be sent a ballot to approve the slate of officers on or before March 21, 2019, with a response date of no later than April 20, 2019.

Thank you to our nominating committee members, pictured here at a well-deserved dinner after their committee work was completed.

ginews@gastro.org

Sheila E. Crowe, MD, AGAF, chair of the nominating committee, is pleased to announce that John M. Inadomi, MD, AGAF, joins the presidential line up for AGA.

John M. Inadomi, MD, AGAF

The AGA Nominating Committee also appointed the following slate of councillors, which is subject to membership vote.
 

Maria T. Abreu, MD, AGAF

David A. Katzka, MD

Pending approval by the voting membership, all board members begin their terms after DDW 2019. The voting membership will be sent a ballot to approve the slate of officers on or before March 21, 2019, with a response date of no later than April 20, 2019.

Thank you to our nominating committee members, pictured here at a well-deserved dinner after their committee work was completed.

ginews@gastro.org

As the hospitalist tried to position the portable video laryngoscope properly in the airway of the critically ill “patient,” HM19 faculty moderator Brian Kaufman, MD, professor of medicine, anesthesiology, and neurology at New York University (NYU) School of Medicine, issued a word of caution: Rotating it into position should be done gently or there’s a risk of tearing tissue.

Lou Ferraro, Park South Photography

Lou Ferraro, Park South Photography

As the hospitalist tried to position the portable video laryngoscope properly in the airway of the critically ill “patient,” HM19 faculty moderator Brian Kaufman, MD, professor of medicine, anesthesiology, and neurology at New York University (NYU) School of Medicine, issued a word of caution: Rotating it into position should be done gently or there’s a risk of tearing tissue.

Lou Ferraro, Park South Photography

Lou Ferraro, Park South Photography

As the hospitalist tried to position the portable video laryngoscope properly in the airway of the critically ill “patient,” HM19 faculty moderator Brian Kaufman, MD, professor of medicine, anesthesiology, and neurology at New York University (NYU) School of Medicine, issued a word of caution: Rotating it into position should be done gently or there’s a risk of tearing tissue.

Lou Ferraro, Park South Photography

Lou Ferraro, Park South Photography

NEW ORLEANS – The incidence of pulmonary embolism diagnosed in hospitalized U.S. patients nearly doubled during the period 2004-2015 based on data collected by the National Inpatient Sample.

During 2004-2015 the incidence of all diagnosed pulmonary embolism (PE), based on discharge diagnoses, rose from 5.4 cases/1,000 hospitalized patients in 2004 to 9.7 cases/1,000 hospitalized patients in 2015, an 80% increase, Joshua B. Goldberg, MD said at the annual meeting of the American College of Cardiology. The incidence of major PE – defined as a patient who needed vasopressor treatment, mechanical ventilation, or had nonseptic shock – rose from 7.9% of all hospitalized PE diagnoses in 2004 to 9.7% in 2015, a 23% relative increase.

Mitchel L. Zoler/MDedge News

The data also documented a shifting pattern of treatment for all hospitalized patients with PE, and especially among patients with major PE. During the study period, treatment with systemic thrombolysis for all PE rose nearly threefold, and catheter-directed therapy began to show a steady rise in use from 0.2% of all patients in 2011 (and before) to 1% of all patients by 2015. Surgical intervention remained lightly used throughout, with about 0.2% of all PE patients undergoing surgery annually.

Most of these intervention options focused on patients with major PE. Among patients in this subgroup with more severe disease, use of one of these three types of interventions rose from 6% in 2004 to 12% in 2015, mostly driven by a rise in systemic thrombolysis, which jumped from 3% of major PE in 2004 to 9% in 2015. However, the efficacy of systemic thrombolysis in patients with major PE remains suspect. In 2004, 39% of patients with major PE treated with systemic thrombolysis died in hospital; in 2015 the number was 47%. “The data don’t support using systemic thrombolysis to treat major PE; the mortality is high,” noted Dr. Goldberg, a cardiothoracic surgeon at Westchester Medical Center in Valhalla, N.Y.

Although catheter-directed therapy began to be much more widely used in U.S. practice starting in about 2015, during the period studied its use for major PE held fairly steady at roughly 2%-3%, but this approach also showed substantial shortcomings for the major PE population. These sicker patients treated with catheter-directed therapy had 37% mortality in 2004 and a 31% mortality in 2015, a difference that was not statistically significant. In general, PE patients enrolled in the catheter-directed therapy trials were not as sick as the major PE patients who get treated with surgery in routine practice, Dr. Goldberg said in an interview.

The data showed much better performance using surgery, although only 1,237 patients of the entire group of 713,083 PE patients studied in the database underwent surgical embolectomy. Overall, in-hospital mortality in these patients was 22%, but in a time trend analysis, mortality among all PE patients treated with surgery fell from 32% in 2004 to 14% in 2015; among patients with major PE treated with surgery, mortality fell from 52% in 2004 to 21% in 2015.

Dr. Goldberg attributed the success of surgery in severe PE patients to the definitive nature of embolectomy and the concurrent use of extracorporeal membrane oxygenation that helps stabilize acutely ill PE patients. He also cited refinements that surgery underwent during the 2004-2015 period based on the experience managing chronic thromboembolic pulmonary hypertension, including routine use of cardiopulmonary bypass during surgery. “Very high risk [PE] patients should go straight to surgery, unless the patient is at high risk for surgery because of conditions like prior sternotomy or very advanced age, in which case catheter-directed therapy may be a safer option, he said. He cited a recent 5% death rate after surgery at his center among patients with major PE who did not require cardiopulmonary resuscitation.

The database Dr. Goldberg and his collaborator reviewed included 12,735 patients treated by systemic thrombolysis, and 2,595 treated by catheter-directed therapy. Patients averaged 63 years old. The most common indicator of major PE was mechanical ventilation, used on 8% of all PE patients in the study. Non-septic shock occurred in 2%, and just under 1% needed vasopressor treatment.

Published guidelines on PE management from several medical groups are “vague and have numerous caveats,” Dr. Goldberg said. He is participating in an update to the 2011 PE management statement from the American College of Cardiology and American Heart Association (Circulation. 2011 April 26;123[16]:1788-1830).

The study received no commercial funding. Dr. Goldberg had no disclosures.

mzoler@mdedge.com

SOURCE: Haider A et al. J Amer Coll Cardiol. 2019 March;73:9[suppl 1]: doi: 10.1016/S0735-1097(19)32507-0

NEW ORLEANS – The incidence of pulmonary embolism diagnosed in hospitalized U.S. patients nearly doubled during the period 2004-2015 based on data collected by the National Inpatient Sample.

During 2004-2015 the incidence of all diagnosed pulmonary embolism (PE), based on discharge diagnoses, rose from 5.4 cases/1,000 hospitalized patients in 2004 to 9.7 cases/1,000 hospitalized patients in 2015, an 80% increase, Joshua B. Goldberg, MD said at the annual meeting of the American College of Cardiology. The incidence of major PE – defined as a patient who needed vasopressor treatment, mechanical ventilation, or had nonseptic shock – rose from 7.9% of all hospitalized PE diagnoses in 2004 to 9.7% in 2015, a 23% relative increase.

Mitchel L. Zoler/MDedge News

The data also documented a shifting pattern of treatment for all hospitalized patients with PE, and especially among patients with major PE. During the study period, treatment with systemic thrombolysis for all PE rose nearly threefold, and catheter-directed therapy began to show a steady rise in use from 0.2% of all patients in 2011 (and before) to 1% of all patients by 2015. Surgical intervention remained lightly used throughout, with about 0.2% of all PE patients undergoing surgery annually.

Most of these intervention options focused on patients with major PE. Among patients in this subgroup with more severe disease, use of one of these three types of interventions rose from 6% in 2004 to 12% in 2015, mostly driven by a rise in systemic thrombolysis, which jumped from 3% of major PE in 2004 to 9% in 2015. However, the efficacy of systemic thrombolysis in patients with major PE remains suspect. In 2004, 39% of patients with major PE treated with systemic thrombolysis died in hospital; in 2015 the number was 47%. “The data don’t support using systemic thrombolysis to treat major PE; the mortality is high,” noted Dr. Goldberg, a cardiothoracic surgeon at Westchester Medical Center in Valhalla, N.Y.

Although catheter-directed therapy began to be much more widely used in U.S. practice starting in about 2015, during the period studied its use for major PE held fairly steady at roughly 2%-3%, but this approach also showed substantial shortcomings for the major PE population. These sicker patients treated with catheter-directed therapy had 37% mortality in 2004 and a 31% mortality in 2015, a difference that was not statistically significant. In general, PE patients enrolled in the catheter-directed therapy trials were not as sick as the major PE patients who get treated with surgery in routine practice, Dr. Goldberg said in an interview.

The data showed much better performance using surgery, although only 1,237 patients of the entire group of 713,083 PE patients studied in the database underwent surgical embolectomy. Overall, in-hospital mortality in these patients was 22%, but in a time trend analysis, mortality among all PE patients treated with surgery fell from 32% in 2004 to 14% in 2015; among patients with major PE treated with surgery, mortality fell from 52% in 2004 to 21% in 2015.

Dr. Goldberg attributed the success of surgery in severe PE patients to the definitive nature of embolectomy and the concurrent use of extracorporeal membrane oxygenation that helps stabilize acutely ill PE patients. He also cited refinements that surgery underwent during the 2004-2015 period based on the experience managing chronic thromboembolic pulmonary hypertension, including routine use of cardiopulmonary bypass during surgery. “Very high risk [PE] patients should go straight to surgery, unless the patient is at high risk for surgery because of conditions like prior sternotomy or very advanced age, in which case catheter-directed therapy may be a safer option, he said. He cited a recent 5% death rate after surgery at his center among patients with major PE who did not require cardiopulmonary resuscitation.

The database Dr. Goldberg and his collaborator reviewed included 12,735 patients treated by systemic thrombolysis, and 2,595 treated by catheter-directed therapy. Patients averaged 63 years old. The most common indicator of major PE was mechanical ventilation, used on 8% of all PE patients in the study. Non-septic shock occurred in 2%, and just under 1% needed vasopressor treatment.

Published guidelines on PE management from several medical groups are “vague and have numerous caveats,” Dr. Goldberg said. He is participating in an update to the 2011 PE management statement from the American College of Cardiology and American Heart Association (Circulation. 2011 April 26;123[16]:1788-1830).

The study received no commercial funding. Dr. Goldberg had no disclosures.

mzoler@mdedge.com

SOURCE: Haider A et al. J Amer Coll Cardiol. 2019 March;73:9[suppl 1]: doi: 10.1016/S0735-1097(19)32507-0

NEW ORLEANS – The incidence of pulmonary embolism diagnosed in hospitalized U.S. patients nearly doubled during the period 2004-2015 based on data collected by the National Inpatient Sample.

During 2004-2015 the incidence of all diagnosed pulmonary embolism (PE), based on discharge diagnoses, rose from 5.4 cases/1,000 hospitalized patients in 2004 to 9.7 cases/1,000 hospitalized patients in 2015, an 80% increase, Joshua B. Goldberg, MD said at the annual meeting of the American College of Cardiology. The incidence of major PE – defined as a patient who needed vasopressor treatment, mechanical ventilation, or had nonseptic shock – rose from 7.9% of all hospitalized PE diagnoses in 2004 to 9.7% in 2015, a 23% relative increase.

Mitchel L. Zoler/MDedge News

The data also documented a shifting pattern of treatment for all hospitalized patients with PE, and especially among patients with major PE. During the study period, treatment with systemic thrombolysis for all PE rose nearly threefold, and catheter-directed therapy began to show a steady rise in use from 0.2% of all patients in 2011 (and before) to 1% of all patients by 2015. Surgical intervention remained lightly used throughout, with about 0.2% of all PE patients undergoing surgery annually.

Most of these intervention options focused on patients with major PE. Among patients in this subgroup with more severe disease, use of one of these three types of interventions rose from 6% in 2004 to 12% in 2015, mostly driven by a rise in systemic thrombolysis, which jumped from 3% of major PE in 2004 to 9% in 2015. However, the efficacy of systemic thrombolysis in patients with major PE remains suspect. In 2004, 39% of patients with major PE treated with systemic thrombolysis died in hospital; in 2015 the number was 47%. “The data don’t support using systemic thrombolysis to treat major PE; the mortality is high,” noted Dr. Goldberg, a cardiothoracic surgeon at Westchester Medical Center in Valhalla, N.Y.

Although catheter-directed therapy began to be much more widely used in U.S. practice starting in about 2015, during the period studied its use for major PE held fairly steady at roughly 2%-3%, but this approach also showed substantial shortcomings for the major PE population. These sicker patients treated with catheter-directed therapy had 37% mortality in 2004 and a 31% mortality in 2015, a difference that was not statistically significant. In general, PE patients enrolled in the catheter-directed therapy trials were not as sick as the major PE patients who get treated with surgery in routine practice, Dr. Goldberg said in an interview.

The data showed much better performance using surgery, although only 1,237 patients of the entire group of 713,083 PE patients studied in the database underwent surgical embolectomy. Overall, in-hospital mortality in these patients was 22%, but in a time trend analysis, mortality among all PE patients treated with surgery fell from 32% in 2004 to 14% in 2015; among patients with major PE treated with surgery, mortality fell from 52% in 2004 to 21% in 2015.

Dr. Goldberg attributed the success of surgery in severe PE patients to the definitive nature of embolectomy and the concurrent use of extracorporeal membrane oxygenation that helps stabilize acutely ill PE patients. He also cited refinements that surgery underwent during the 2004-2015 period based on the experience managing chronic thromboembolic pulmonary hypertension, including routine use of cardiopulmonary bypass during surgery. “Very high risk [PE] patients should go straight to surgery, unless the patient is at high risk for surgery because of conditions like prior sternotomy or very advanced age, in which case catheter-directed therapy may be a safer option, he said. He cited a recent 5% death rate after surgery at his center among patients with major PE who did not require cardiopulmonary resuscitation.

The database Dr. Goldberg and his collaborator reviewed included 12,735 patients treated by systemic thrombolysis, and 2,595 treated by catheter-directed therapy. Patients averaged 63 years old. The most common indicator of major PE was mechanical ventilation, used on 8% of all PE patients in the study. Non-septic shock occurred in 2%, and just under 1% needed vasopressor treatment.

Published guidelines on PE management from several medical groups are “vague and have numerous caveats,” Dr. Goldberg said. He is participating in an update to the 2011 PE management statement from the American College of Cardiology and American Heart Association (Circulation. 2011 April 26;123[16]:1788-1830).

The study received no commercial funding. Dr. Goldberg had no disclosures.

mzoler@mdedge.com

SOURCE: Haider A et al. J Amer Coll Cardiol. 2019 March;73:9[suppl 1]: doi: 10.1016/S0735-1097(19)32507-0