User login
Psychedelic drug therapy a potential ‘breakthrough’ for alcohol dependence
Results from the first randomized, placebo-controlled trial of psilocybin for alcohol dependence showed that during the 8 months after first treatment dose, participants who received psilocybin had less than half as many heavy drinking days as their counterparts who received placebo.
In addition, 7 months after the last dose of medication, twice as many psilocybin-treated patients as placebo-treated patients were abstinent.
The effects observed with psilocybin were “considerably larger” than those of currently approved treatments for AUD, senior investigator Michael Bogenschutz, MD, psychiatrist and director of the NYU Langone Center for Psychedelic Medicine, New York, said during an Aug. 24 press briefing.
If the findings hold up in future trials, psilocybin will be a “real breakthrough” in the treatment of the condition, Dr. Bogenschutz said.
The findings were published online in JAMA Psychiatry.
83% reduction in drinking days
The study included 93 adults (mean age, 46 years) with alcohol dependence who consumed an average of seven drinks on the days they drank and had had at least four heavy drinking days during the month prior to treatment.
Of the participants, 48 were randomly assigned to receive two doses of psilocybin, and 45 were assigned to receive an antihistamine (diphenhydramine) placebo. Study medication was administered during 2 day-long sessions at week 4 and week 8.
The participants also received 12 psychotherapy sessions over a 12-week period. All were assessed at intervals from the beginning of the study until 32 weeks after the first medication session.
The primary outcome was percentage of days in which the patient drank heavily during the 32-week period following first medication dose. Heavy drinking was defined as having five or more drinks in a day for a man and four or more drinks in a day for a woman.
The percentage of heavy drinking days during the 32-week period was 9.7% for the psilocybin group and 23.6% for the placebo group, for a mean difference of 13.9% (P = .01).
“Compared to their baseline before the study, after receiving medication, the psilocybin group decreased their heavy drinking days by 83%, while the placebo group reduced their heavy drinking by 51%,” Dr. Bogenschutz reported.
During the last month of follow-up, which was 7 months after the final dose of study medication, 48% of the psilocybin group were entirely abstinent vs. 24% of the placebo group.
“It is remarkable that the effects of psilocybin treatment persisted for 7 months after people received the last dose of medication. This suggests that psilocybin is treating the underlying disorder of alcohol addiction rather than merely treating symptoms,” Dr. Bogenschutz noted.
Total alcohol consumption and problems related to alcohol use were also significantly less in the psilocybin group.
‘Encouraged and hopeful’
Adverse events related to psilocybin were mostly mild, self-limiting, and consistent with other recent trials that evaluated the drug’s effects in various conditions.
However, the current investigators note that they implemented measures to ensure safety, including careful medical and psychiatric screening, therapy, and monitoring that was provided by well-trained therapists, including a licensed psychiatrist. In addition, medications were available to treat acute psychiatric reactions.
A cited limitation of the study was that blinding was not maintained because the average intensity of experience with psilocybin was high, whereas it was low with diphenhydramine.
This difference undermined the masking of treatment such that more than 90% of participants and therapists correctly guessed the treatment assignment.
Another limitation was that objective measures to validate self-reported drinking outcomes were available for only 54% of study participants.
Despite these limitations, the study builds on earlier work by the NYU team that showed that two doses of psilocybin taken over a period of 8 weeks significantly reduced alcohol use and cravings in patients with AUD.
“We’re very encouraged by these findings and hopeful about where they could lead. Personally, it’s been very meaningful and rewarding for me to do this work and inspiring to witness the remarkable recoveries that some of our participants have experienced,” Dr. Bogenschutz told briefing attendees.
Urgent need
The authors of an accompanying editorial note that novel medications for alcohol dependence are “sorely needed. Recent renewed interest in the potential of hallucinogens for treating psychiatric disorders, including AUD, represents a potential move in that direction.”
Henry Kranzler, MD, and Emily Hartwell, PhD, both with the Center for Studies of Addiction, University of Pennsylvania, Philadelphia, write that the new findings “underscore the potential of developing psilocybin as an addition to the alcohol treatment pharmacopeia.”
They question, however, the feasibility of using hallucinogens in routine clinical practice because intensive psychotherapy, such as that provided in this study, requires a significant investment of time and labor.
“Such concomitant therapy, if necessary to realize the therapeutic benefits of psilocybin for treating AUD, could limit its uptake by clinicians,” Dr. Kranzler and Dr. Hartwell write.
The study was funded by the Heffter Research Institute and by individual donations from Carey and Claudia Turnbull, Dr. Efrem Nulman, Rodrigo Niño, and Cody Swift. Dr. Bogenschutz reports having received research funds from and serving as a consultant to Mind Medicine, the Multidisciplinary Association for Psychedelic Studies, B. More, AJNA Labs, Beckley Psytech, Journey Colab, and Bright Minds Biosciences. Dr. Kranzler and Dr. Hartwell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from the first randomized, placebo-controlled trial of psilocybin for alcohol dependence showed that during the 8 months after first treatment dose, participants who received psilocybin had less than half as many heavy drinking days as their counterparts who received placebo.
In addition, 7 months after the last dose of medication, twice as many psilocybin-treated patients as placebo-treated patients were abstinent.
The effects observed with psilocybin were “considerably larger” than those of currently approved treatments for AUD, senior investigator Michael Bogenschutz, MD, psychiatrist and director of the NYU Langone Center for Psychedelic Medicine, New York, said during an Aug. 24 press briefing.
If the findings hold up in future trials, psilocybin will be a “real breakthrough” in the treatment of the condition, Dr. Bogenschutz said.
The findings were published online in JAMA Psychiatry.
83% reduction in drinking days
The study included 93 adults (mean age, 46 years) with alcohol dependence who consumed an average of seven drinks on the days they drank and had had at least four heavy drinking days during the month prior to treatment.
Of the participants, 48 were randomly assigned to receive two doses of psilocybin, and 45 were assigned to receive an antihistamine (diphenhydramine) placebo. Study medication was administered during 2 day-long sessions at week 4 and week 8.
The participants also received 12 psychotherapy sessions over a 12-week period. All were assessed at intervals from the beginning of the study until 32 weeks after the first medication session.
The primary outcome was percentage of days in which the patient drank heavily during the 32-week period following first medication dose. Heavy drinking was defined as having five or more drinks in a day for a man and four or more drinks in a day for a woman.
The percentage of heavy drinking days during the 32-week period was 9.7% for the psilocybin group and 23.6% for the placebo group, for a mean difference of 13.9% (P = .01).
“Compared to their baseline before the study, after receiving medication, the psilocybin group decreased their heavy drinking days by 83%, while the placebo group reduced their heavy drinking by 51%,” Dr. Bogenschutz reported.
During the last month of follow-up, which was 7 months after the final dose of study medication, 48% of the psilocybin group were entirely abstinent vs. 24% of the placebo group.
“It is remarkable that the effects of psilocybin treatment persisted for 7 months after people received the last dose of medication. This suggests that psilocybin is treating the underlying disorder of alcohol addiction rather than merely treating symptoms,” Dr. Bogenschutz noted.
Total alcohol consumption and problems related to alcohol use were also significantly less in the psilocybin group.
‘Encouraged and hopeful’
Adverse events related to psilocybin were mostly mild, self-limiting, and consistent with other recent trials that evaluated the drug’s effects in various conditions.
However, the current investigators note that they implemented measures to ensure safety, including careful medical and psychiatric screening, therapy, and monitoring that was provided by well-trained therapists, including a licensed psychiatrist. In addition, medications were available to treat acute psychiatric reactions.
A cited limitation of the study was that blinding was not maintained because the average intensity of experience with psilocybin was high, whereas it was low with diphenhydramine.
This difference undermined the masking of treatment such that more than 90% of participants and therapists correctly guessed the treatment assignment.
Another limitation was that objective measures to validate self-reported drinking outcomes were available for only 54% of study participants.
Despite these limitations, the study builds on earlier work by the NYU team that showed that two doses of psilocybin taken over a period of 8 weeks significantly reduced alcohol use and cravings in patients with AUD.
“We’re very encouraged by these findings and hopeful about where they could lead. Personally, it’s been very meaningful and rewarding for me to do this work and inspiring to witness the remarkable recoveries that some of our participants have experienced,” Dr. Bogenschutz told briefing attendees.
Urgent need
The authors of an accompanying editorial note that novel medications for alcohol dependence are “sorely needed. Recent renewed interest in the potential of hallucinogens for treating psychiatric disorders, including AUD, represents a potential move in that direction.”
Henry Kranzler, MD, and Emily Hartwell, PhD, both with the Center for Studies of Addiction, University of Pennsylvania, Philadelphia, write that the new findings “underscore the potential of developing psilocybin as an addition to the alcohol treatment pharmacopeia.”
They question, however, the feasibility of using hallucinogens in routine clinical practice because intensive psychotherapy, such as that provided in this study, requires a significant investment of time and labor.
“Such concomitant therapy, if necessary to realize the therapeutic benefits of psilocybin for treating AUD, could limit its uptake by clinicians,” Dr. Kranzler and Dr. Hartwell write.
The study was funded by the Heffter Research Institute and by individual donations from Carey and Claudia Turnbull, Dr. Efrem Nulman, Rodrigo Niño, and Cody Swift. Dr. Bogenschutz reports having received research funds from and serving as a consultant to Mind Medicine, the Multidisciplinary Association for Psychedelic Studies, B. More, AJNA Labs, Beckley Psytech, Journey Colab, and Bright Minds Biosciences. Dr. Kranzler and Dr. Hartwell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Results from the first randomized, placebo-controlled trial of psilocybin for alcohol dependence showed that during the 8 months after first treatment dose, participants who received psilocybin had less than half as many heavy drinking days as their counterparts who received placebo.
In addition, 7 months after the last dose of medication, twice as many psilocybin-treated patients as placebo-treated patients were abstinent.
The effects observed with psilocybin were “considerably larger” than those of currently approved treatments for AUD, senior investigator Michael Bogenschutz, MD, psychiatrist and director of the NYU Langone Center for Psychedelic Medicine, New York, said during an Aug. 24 press briefing.
If the findings hold up in future trials, psilocybin will be a “real breakthrough” in the treatment of the condition, Dr. Bogenschutz said.
The findings were published online in JAMA Psychiatry.
83% reduction in drinking days
The study included 93 adults (mean age, 46 years) with alcohol dependence who consumed an average of seven drinks on the days they drank and had had at least four heavy drinking days during the month prior to treatment.
Of the participants, 48 were randomly assigned to receive two doses of psilocybin, and 45 were assigned to receive an antihistamine (diphenhydramine) placebo. Study medication was administered during 2 day-long sessions at week 4 and week 8.
The participants also received 12 psychotherapy sessions over a 12-week period. All were assessed at intervals from the beginning of the study until 32 weeks after the first medication session.
The primary outcome was percentage of days in which the patient drank heavily during the 32-week period following first medication dose. Heavy drinking was defined as having five or more drinks in a day for a man and four or more drinks in a day for a woman.
The percentage of heavy drinking days during the 32-week period was 9.7% for the psilocybin group and 23.6% for the placebo group, for a mean difference of 13.9% (P = .01).
“Compared to their baseline before the study, after receiving medication, the psilocybin group decreased their heavy drinking days by 83%, while the placebo group reduced their heavy drinking by 51%,” Dr. Bogenschutz reported.
During the last month of follow-up, which was 7 months after the final dose of study medication, 48% of the psilocybin group were entirely abstinent vs. 24% of the placebo group.
“It is remarkable that the effects of psilocybin treatment persisted for 7 months after people received the last dose of medication. This suggests that psilocybin is treating the underlying disorder of alcohol addiction rather than merely treating symptoms,” Dr. Bogenschutz noted.
Total alcohol consumption and problems related to alcohol use were also significantly less in the psilocybin group.
‘Encouraged and hopeful’
Adverse events related to psilocybin were mostly mild, self-limiting, and consistent with other recent trials that evaluated the drug’s effects in various conditions.
However, the current investigators note that they implemented measures to ensure safety, including careful medical and psychiatric screening, therapy, and monitoring that was provided by well-trained therapists, including a licensed psychiatrist. In addition, medications were available to treat acute psychiatric reactions.
A cited limitation of the study was that blinding was not maintained because the average intensity of experience with psilocybin was high, whereas it was low with diphenhydramine.
This difference undermined the masking of treatment such that more than 90% of participants and therapists correctly guessed the treatment assignment.
Another limitation was that objective measures to validate self-reported drinking outcomes were available for only 54% of study participants.
Despite these limitations, the study builds on earlier work by the NYU team that showed that two doses of psilocybin taken over a period of 8 weeks significantly reduced alcohol use and cravings in patients with AUD.
“We’re very encouraged by these findings and hopeful about where they could lead. Personally, it’s been very meaningful and rewarding for me to do this work and inspiring to witness the remarkable recoveries that some of our participants have experienced,” Dr. Bogenschutz told briefing attendees.
Urgent need
The authors of an accompanying editorial note that novel medications for alcohol dependence are “sorely needed. Recent renewed interest in the potential of hallucinogens for treating psychiatric disorders, including AUD, represents a potential move in that direction.”
Henry Kranzler, MD, and Emily Hartwell, PhD, both with the Center for Studies of Addiction, University of Pennsylvania, Philadelphia, write that the new findings “underscore the potential of developing psilocybin as an addition to the alcohol treatment pharmacopeia.”
They question, however, the feasibility of using hallucinogens in routine clinical practice because intensive psychotherapy, such as that provided in this study, requires a significant investment of time and labor.
“Such concomitant therapy, if necessary to realize the therapeutic benefits of psilocybin for treating AUD, could limit its uptake by clinicians,” Dr. Kranzler and Dr. Hartwell write.
The study was funded by the Heffter Research Institute and by individual donations from Carey and Claudia Turnbull, Dr. Efrem Nulman, Rodrigo Niño, and Cody Swift. Dr. Bogenschutz reports having received research funds from and serving as a consultant to Mind Medicine, the Multidisciplinary Association for Psychedelic Studies, B. More, AJNA Labs, Beckley Psytech, Journey Colab, and Bright Minds Biosciences. Dr. Kranzler and Dr. Hartwell have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Blood biomarkers predict TBI disability and mortality
, new research suggests.
In new data from the TRACK-TBI study group, high levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) proteins found in glial cells and neurons, respectively, correlated with death and severe injury. Investigators note that measuring these biomarkers may give a more accurate assessment of a patient’s prognosis following TBI.
This study is the “first report of the accuracy of a blood test that can be obtained rapidly on the day of injury to predict neurological recovery at 6 months after injury,” lead author Frederick Korley, MD, PhD, associate professor of emergency medicine at the University of Michigan, Ann Arbor, said in a news release.
The findings were published online in the Lancet Neurology.
Added value
The researchers measured GFAP and UCH-L1 in blood samples taken from 1,696 patients with TBI on the day of their injury, and they assessed patient recovery 6 months later.
The markers were measured using the i-STAT TBI Plasma test (Abbott Labs). The test was approved in 2021 by the U.S. Food and Drug Administration to determine which patients with mild TBI should undergo computed tomography scans.
About two-thirds of the study population were men, and the average age was 39 years. All patients were evaluated at Level I trauma centers for injuries caused primarily by traffic accidents or falls.
Six months following injury, 7% of the patients had died and 14% had an unfavorable outcome, ranging from vegetative state to severe disability requiring daily support. In addition, 67% had incomplete recovery, ranging from moderate disabilities requiring assistance outside of the home to minor disabling neurological or psychological deficits.
Day-of-injury GFAP and UCH-L1 levels had a high probability of predicting death (87% for GFAP and 89% for UCH-L1) and severe disability (86% for both GFAP and UCH-L1) at 6 months, the investigators reported.
The biomarkers were less accurate in predicting incomplete recovery (62% for GFAP and 61% for UCH-L1).
The researchers also assessed the added value of combining the blood biomarkers to current TBI prognostic models that take into account variables such as age, motor score, pupil reactivity, and CT characteristics.
In patients with a Glasgow Coma Scale (GCS) score of 3-12, adding GFAP and UCH-L1 alone or combined to each of the three International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) models significantly increased their accuracy for predicting death (range, 90%-94%) and unfavorable outcome (range, 83%-89%).
In patients with milder TBI (GCS score, 13-15), adding GFAP and UCH-L1 to the UPFRONT prognostic model modestly increased accuracy for predicting incomplete recovery (69%).
‘Important’ findings
Commenting on the study, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said this “critical” study shows that these biomarkers can “predict key outcomes,” including mortality and severe disability. “Thus, in conjunction with clinical evaluations and related data such as neuroimaging, these tests may warrant translation to broader clinical practice, particularly in acute settings,” said Dr. Raji, who was not involved in the research.
Also weighing in, Heidi Fusco, MD, assistant director of the traumatic brain injury program at NYU Langone Rusk Rehabilitation, said the findings are “important.”
“Prognosis after brain injury often is based on the initial presentation, ongoing clinical exams, and neuroimaging; and the addition of biomarkers would contribute to creating a more objective prognostic model,” Dr. Fusco said.
She noted “it’s unclear” whether clinical hospital laboratories would be able to accommodate this type of laboratory drawing.
“It is imperative that clinicians still use the patient history [and] clinical and radiological exam when making clinical decisions for a patient and not just lab values. It would be best to incorporate the GFAP and UCH-L1 into a preexisting prognostic model,” Dr. Fusco said.
The study was funded by the U.S. National Institutes of Health, the National Institute of Neurologic Disorders and Stroke, the U.S. Department of Defense, One Mind, and U.S. Army Medical Research and Development Command. Dr. Korley reported having previously consulted for Abbott Laboratories and has received research funding from Abbott Laboratories, which makes the assays used in the study. Dr. Raji is a consultant for Brainreader ApS and Neurevolution. Dr. Fusco has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In new data from the TRACK-TBI study group, high levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) proteins found in glial cells and neurons, respectively, correlated with death and severe injury. Investigators note that measuring these biomarkers may give a more accurate assessment of a patient’s prognosis following TBI.
This study is the “first report of the accuracy of a blood test that can be obtained rapidly on the day of injury to predict neurological recovery at 6 months after injury,” lead author Frederick Korley, MD, PhD, associate professor of emergency medicine at the University of Michigan, Ann Arbor, said in a news release.
The findings were published online in the Lancet Neurology.
Added value
The researchers measured GFAP and UCH-L1 in blood samples taken from 1,696 patients with TBI on the day of their injury, and they assessed patient recovery 6 months later.
The markers were measured using the i-STAT TBI Plasma test (Abbott Labs). The test was approved in 2021 by the U.S. Food and Drug Administration to determine which patients with mild TBI should undergo computed tomography scans.
About two-thirds of the study population were men, and the average age was 39 years. All patients were evaluated at Level I trauma centers for injuries caused primarily by traffic accidents or falls.
Six months following injury, 7% of the patients had died and 14% had an unfavorable outcome, ranging from vegetative state to severe disability requiring daily support. In addition, 67% had incomplete recovery, ranging from moderate disabilities requiring assistance outside of the home to minor disabling neurological or psychological deficits.
Day-of-injury GFAP and UCH-L1 levels had a high probability of predicting death (87% for GFAP and 89% for UCH-L1) and severe disability (86% for both GFAP and UCH-L1) at 6 months, the investigators reported.
The biomarkers were less accurate in predicting incomplete recovery (62% for GFAP and 61% for UCH-L1).
The researchers also assessed the added value of combining the blood biomarkers to current TBI prognostic models that take into account variables such as age, motor score, pupil reactivity, and CT characteristics.
In patients with a Glasgow Coma Scale (GCS) score of 3-12, adding GFAP and UCH-L1 alone or combined to each of the three International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) models significantly increased their accuracy for predicting death (range, 90%-94%) and unfavorable outcome (range, 83%-89%).
In patients with milder TBI (GCS score, 13-15), adding GFAP and UCH-L1 to the UPFRONT prognostic model modestly increased accuracy for predicting incomplete recovery (69%).
‘Important’ findings
Commenting on the study, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said this “critical” study shows that these biomarkers can “predict key outcomes,” including mortality and severe disability. “Thus, in conjunction with clinical evaluations and related data such as neuroimaging, these tests may warrant translation to broader clinical practice, particularly in acute settings,” said Dr. Raji, who was not involved in the research.
Also weighing in, Heidi Fusco, MD, assistant director of the traumatic brain injury program at NYU Langone Rusk Rehabilitation, said the findings are “important.”
“Prognosis after brain injury often is based on the initial presentation, ongoing clinical exams, and neuroimaging; and the addition of biomarkers would contribute to creating a more objective prognostic model,” Dr. Fusco said.
She noted “it’s unclear” whether clinical hospital laboratories would be able to accommodate this type of laboratory drawing.
“It is imperative that clinicians still use the patient history [and] clinical and radiological exam when making clinical decisions for a patient and not just lab values. It would be best to incorporate the GFAP and UCH-L1 into a preexisting prognostic model,” Dr. Fusco said.
The study was funded by the U.S. National Institutes of Health, the National Institute of Neurologic Disorders and Stroke, the U.S. Department of Defense, One Mind, and U.S. Army Medical Research and Development Command. Dr. Korley reported having previously consulted for Abbott Laboratories and has received research funding from Abbott Laboratories, which makes the assays used in the study. Dr. Raji is a consultant for Brainreader ApS and Neurevolution. Dr. Fusco has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In new data from the TRACK-TBI study group, high levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) proteins found in glial cells and neurons, respectively, correlated with death and severe injury. Investigators note that measuring these biomarkers may give a more accurate assessment of a patient’s prognosis following TBI.
This study is the “first report of the accuracy of a blood test that can be obtained rapidly on the day of injury to predict neurological recovery at 6 months after injury,” lead author Frederick Korley, MD, PhD, associate professor of emergency medicine at the University of Michigan, Ann Arbor, said in a news release.
The findings were published online in the Lancet Neurology.
Added value
The researchers measured GFAP and UCH-L1 in blood samples taken from 1,696 patients with TBI on the day of their injury, and they assessed patient recovery 6 months later.
The markers were measured using the i-STAT TBI Plasma test (Abbott Labs). The test was approved in 2021 by the U.S. Food and Drug Administration to determine which patients with mild TBI should undergo computed tomography scans.
About two-thirds of the study population were men, and the average age was 39 years. All patients were evaluated at Level I trauma centers for injuries caused primarily by traffic accidents or falls.
Six months following injury, 7% of the patients had died and 14% had an unfavorable outcome, ranging from vegetative state to severe disability requiring daily support. In addition, 67% had incomplete recovery, ranging from moderate disabilities requiring assistance outside of the home to minor disabling neurological or psychological deficits.
Day-of-injury GFAP and UCH-L1 levels had a high probability of predicting death (87% for GFAP and 89% for UCH-L1) and severe disability (86% for both GFAP and UCH-L1) at 6 months, the investigators reported.
The biomarkers were less accurate in predicting incomplete recovery (62% for GFAP and 61% for UCH-L1).
The researchers also assessed the added value of combining the blood biomarkers to current TBI prognostic models that take into account variables such as age, motor score, pupil reactivity, and CT characteristics.
In patients with a Glasgow Coma Scale (GCS) score of 3-12, adding GFAP and UCH-L1 alone or combined to each of the three International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) models significantly increased their accuracy for predicting death (range, 90%-94%) and unfavorable outcome (range, 83%-89%).
In patients with milder TBI (GCS score, 13-15), adding GFAP and UCH-L1 to the UPFRONT prognostic model modestly increased accuracy for predicting incomplete recovery (69%).
‘Important’ findings
Commenting on the study, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said this “critical” study shows that these biomarkers can “predict key outcomes,” including mortality and severe disability. “Thus, in conjunction with clinical evaluations and related data such as neuroimaging, these tests may warrant translation to broader clinical practice, particularly in acute settings,” said Dr. Raji, who was not involved in the research.
Also weighing in, Heidi Fusco, MD, assistant director of the traumatic brain injury program at NYU Langone Rusk Rehabilitation, said the findings are “important.”
“Prognosis after brain injury often is based on the initial presentation, ongoing clinical exams, and neuroimaging; and the addition of biomarkers would contribute to creating a more objective prognostic model,” Dr. Fusco said.
She noted “it’s unclear” whether clinical hospital laboratories would be able to accommodate this type of laboratory drawing.
“It is imperative that clinicians still use the patient history [and] clinical and radiological exam when making clinical decisions for a patient and not just lab values. It would be best to incorporate the GFAP and UCH-L1 into a preexisting prognostic model,” Dr. Fusco said.
The study was funded by the U.S. National Institutes of Health, the National Institute of Neurologic Disorders and Stroke, the U.S. Department of Defense, One Mind, and U.S. Army Medical Research and Development Command. Dr. Korley reported having previously consulted for Abbott Laboratories and has received research funding from Abbott Laboratories, which makes the assays used in the study. Dr. Raji is a consultant for Brainreader ApS and Neurevolution. Dr. Fusco has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET NEUROLOGY
Erlotinib promising for cancer prevention in familial adenomatous polyposis
“If existing data are confirmed and extended through future research, this strategy has the potential for substantial impact on clinical practice by decreasing, delaying, or augmenting endoscopic and surgical interventions as the mainstay for duodenal cancer prevention in this high-risk patient population,” the study team says.
FAP is a rare genetic condition that markedly raises the risk for colorectal polyps and cancer.
“The biological pathway that leads to the development of polyps and colon cancer in patients with FAP is the same biological pathway as patients in the general population,” study investigator Niloy Jewel Samadder, MD, with the Mayo Clinic, Rochester, Minn., said in a news release.
“Our trial looked at opportunities to use chemoprevention agents in patients with FAP to inhibit the development of precancerous polyps in the small bowel and colorectum,” Dr. Samadder explains.
In an earlier study, the researchers found that the combination of the COX-2 inhibitor sulindac (150 mg twice daily) and erlotinib (75 mg daily) reduced duodenal polyp burden.
However, the dual-drug strategy was associated with a relatively high adverse event (AE) rate, which may limit use of the combination for chemoprevention, as reported previously.
This phase 2 study tested whether erlotinib’s AE profile would be improved with a once-weekly dosing schedule while still reducing polyp burden.
The study was first published online in the journal Gut.
In the single-arm, multicenter study, 46 adults with FAP (mean age, 44 years; 48% women) self-administered 350 mg of erlotinib by mouth one time per week for 6 months. All but four participants completed the 6-month study.
After 6 months of weekly erlotinib, duodenal polyp burden was significantly reduced, with a mean percent reduction of 29.6% (95% confidence interval: –39.6% to –19.7%; P < .0001).
The benefit was observed in patients with either Spigelman 2 or Spigelman 3 duodenal polyp burden.
“Though only 12% of patients noted a decrease in Spigelman stage from 3 to 2 associated with therapy, the majority of patients (86%) had stable disease while on treatment,” the study team reports.
GI polyp number (a secondary outcome) was also decreased after 6 months of treatment with erlotinib (median decrease of 30.8%; P = .0256).
While once-weekly erlotinib was “generally” well tolerated, grade 2 or 3 AEs were reported in 72% of patients; two suffered grade 3 toxicity. Nonetheless, the AE rate was significantly more than the expected null hypothesis rate of 50%, the study team states.
Four patients withdrew from the study because of drug-induced AEs, which included grade 3 rash acneiform, grade 2 infections (hand, foot, and mouth disease), grade 1 fatigue, and grade 1 rash acneiform. No grade 4 AEs were reported.
The most common AE was an erlotinib-induced acneiform-like rash, which occurred in 56.5% of study patients. The rash was managed with topical cortisone and/or clindamycin. Additional erlotinib-induced AEs included oral mucositis (6.5%), diarrhea (50%), and nausea (26.1%).
Summing up, Dr. Samadder and colleagues note that FAP “portends a heritable, systemic predisposition to cancer, and the ultimate goal of cancer preventive intervention is to interrupt the development of neoplasia, need for surgery, and ultimately death from cancer, with an acceptable AE profile.”
The findings from this phase 2 trial support further study of erlotinib as “an effective, acceptable cancer preventive agent for FAP-associated gastrointestinal polyposis,” they conclude.
The study was sponsored by the National Cancer Institute. Dr. Samadder is a consultant for Janssen Research and Development, Recursion Pharmaceuticals, and Cancer Prevention Pharmaceuticals.
A version of this article first appeared on Medscape.com.
“If existing data are confirmed and extended through future research, this strategy has the potential for substantial impact on clinical practice by decreasing, delaying, or augmenting endoscopic and surgical interventions as the mainstay for duodenal cancer prevention in this high-risk patient population,” the study team says.
FAP is a rare genetic condition that markedly raises the risk for colorectal polyps and cancer.
“The biological pathway that leads to the development of polyps and colon cancer in patients with FAP is the same biological pathway as patients in the general population,” study investigator Niloy Jewel Samadder, MD, with the Mayo Clinic, Rochester, Minn., said in a news release.
“Our trial looked at opportunities to use chemoprevention agents in patients with FAP to inhibit the development of precancerous polyps in the small bowel and colorectum,” Dr. Samadder explains.
In an earlier study, the researchers found that the combination of the COX-2 inhibitor sulindac (150 mg twice daily) and erlotinib (75 mg daily) reduced duodenal polyp burden.
However, the dual-drug strategy was associated with a relatively high adverse event (AE) rate, which may limit use of the combination for chemoprevention, as reported previously.
This phase 2 study tested whether erlotinib’s AE profile would be improved with a once-weekly dosing schedule while still reducing polyp burden.
The study was first published online in the journal Gut.
In the single-arm, multicenter study, 46 adults with FAP (mean age, 44 years; 48% women) self-administered 350 mg of erlotinib by mouth one time per week for 6 months. All but four participants completed the 6-month study.
After 6 months of weekly erlotinib, duodenal polyp burden was significantly reduced, with a mean percent reduction of 29.6% (95% confidence interval: –39.6% to –19.7%; P < .0001).
The benefit was observed in patients with either Spigelman 2 or Spigelman 3 duodenal polyp burden.
“Though only 12% of patients noted a decrease in Spigelman stage from 3 to 2 associated with therapy, the majority of patients (86%) had stable disease while on treatment,” the study team reports.
GI polyp number (a secondary outcome) was also decreased after 6 months of treatment with erlotinib (median decrease of 30.8%; P = .0256).
While once-weekly erlotinib was “generally” well tolerated, grade 2 or 3 AEs were reported in 72% of patients; two suffered grade 3 toxicity. Nonetheless, the AE rate was significantly more than the expected null hypothesis rate of 50%, the study team states.
Four patients withdrew from the study because of drug-induced AEs, which included grade 3 rash acneiform, grade 2 infections (hand, foot, and mouth disease), grade 1 fatigue, and grade 1 rash acneiform. No grade 4 AEs were reported.
The most common AE was an erlotinib-induced acneiform-like rash, which occurred in 56.5% of study patients. The rash was managed with topical cortisone and/or clindamycin. Additional erlotinib-induced AEs included oral mucositis (6.5%), diarrhea (50%), and nausea (26.1%).
Summing up, Dr. Samadder and colleagues note that FAP “portends a heritable, systemic predisposition to cancer, and the ultimate goal of cancer preventive intervention is to interrupt the development of neoplasia, need for surgery, and ultimately death from cancer, with an acceptable AE profile.”
The findings from this phase 2 trial support further study of erlotinib as “an effective, acceptable cancer preventive agent for FAP-associated gastrointestinal polyposis,” they conclude.
The study was sponsored by the National Cancer Institute. Dr. Samadder is a consultant for Janssen Research and Development, Recursion Pharmaceuticals, and Cancer Prevention Pharmaceuticals.
A version of this article first appeared on Medscape.com.
“If existing data are confirmed and extended through future research, this strategy has the potential for substantial impact on clinical practice by decreasing, delaying, or augmenting endoscopic and surgical interventions as the mainstay for duodenal cancer prevention in this high-risk patient population,” the study team says.
FAP is a rare genetic condition that markedly raises the risk for colorectal polyps and cancer.
“The biological pathway that leads to the development of polyps and colon cancer in patients with FAP is the same biological pathway as patients in the general population,” study investigator Niloy Jewel Samadder, MD, with the Mayo Clinic, Rochester, Minn., said in a news release.
“Our trial looked at opportunities to use chemoprevention agents in patients with FAP to inhibit the development of precancerous polyps in the small bowel and colorectum,” Dr. Samadder explains.
In an earlier study, the researchers found that the combination of the COX-2 inhibitor sulindac (150 mg twice daily) and erlotinib (75 mg daily) reduced duodenal polyp burden.
However, the dual-drug strategy was associated with a relatively high adverse event (AE) rate, which may limit use of the combination for chemoprevention, as reported previously.
This phase 2 study tested whether erlotinib’s AE profile would be improved with a once-weekly dosing schedule while still reducing polyp burden.
The study was first published online in the journal Gut.
In the single-arm, multicenter study, 46 adults with FAP (mean age, 44 years; 48% women) self-administered 350 mg of erlotinib by mouth one time per week for 6 months. All but four participants completed the 6-month study.
After 6 months of weekly erlotinib, duodenal polyp burden was significantly reduced, with a mean percent reduction of 29.6% (95% confidence interval: –39.6% to –19.7%; P < .0001).
The benefit was observed in patients with either Spigelman 2 or Spigelman 3 duodenal polyp burden.
“Though only 12% of patients noted a decrease in Spigelman stage from 3 to 2 associated with therapy, the majority of patients (86%) had stable disease while on treatment,” the study team reports.
GI polyp number (a secondary outcome) was also decreased after 6 months of treatment with erlotinib (median decrease of 30.8%; P = .0256).
While once-weekly erlotinib was “generally” well tolerated, grade 2 or 3 AEs were reported in 72% of patients; two suffered grade 3 toxicity. Nonetheless, the AE rate was significantly more than the expected null hypothesis rate of 50%, the study team states.
Four patients withdrew from the study because of drug-induced AEs, which included grade 3 rash acneiform, grade 2 infections (hand, foot, and mouth disease), grade 1 fatigue, and grade 1 rash acneiform. No grade 4 AEs were reported.
The most common AE was an erlotinib-induced acneiform-like rash, which occurred in 56.5% of study patients. The rash was managed with topical cortisone and/or clindamycin. Additional erlotinib-induced AEs included oral mucositis (6.5%), diarrhea (50%), and nausea (26.1%).
Summing up, Dr. Samadder and colleagues note that FAP “portends a heritable, systemic predisposition to cancer, and the ultimate goal of cancer preventive intervention is to interrupt the development of neoplasia, need for surgery, and ultimately death from cancer, with an acceptable AE profile.”
The findings from this phase 2 trial support further study of erlotinib as “an effective, acceptable cancer preventive agent for FAP-associated gastrointestinal polyposis,” they conclude.
The study was sponsored by the National Cancer Institute. Dr. Samadder is a consultant for Janssen Research and Development, Recursion Pharmaceuticals, and Cancer Prevention Pharmaceuticals.
A version of this article first appeared on Medscape.com.
FROM GUT
Incomplete recovery common 6 months after mild TBI
, new data from the TRACK-TBI study shows.
“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.
“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.
The findings were published online in JAMA Network Open.
The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.
Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).
Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.
Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.
The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.
The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.
“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.
The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new data from the TRACK-TBI study shows.
“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.
“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.
The findings were published online in JAMA Network Open.
The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.
Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).
Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.
Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.
The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.
The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.
“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.
The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new data from the TRACK-TBI study shows.
“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.
“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.
The findings were published online in JAMA Network Open.
The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.
Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).
Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.
Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.
The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.
The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.
“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.
The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Regular physical activity may fight infection, illness from COVID: Study
New research suggests that regular physical activity can help lower the risk of COVID-19 infection and its severity, with a weekly tally of 150 minutes of moderate, or 75 minutes of vigorous, physical activity affording the best protection.
“, with potential benefits to reduce the risk of severe COVID-19,” say Antonio García-Hermoso, PhD, Public University of Navarra, Pamplona, Spain, and colleagues.
“Regular physical activity seemed to be related to a lower risk of COVID-19 infection, Dr. García-Hermoso said in an interview. “There is evidence that regular physical activity might contribute to a more effective immune response, providing enhanced protective immunity to infections, which could explain the relationship between exercise consistency with COVID-19 infection.”
Regular exercise may also help to boost the body’s anti-inflammatory responses, as well as cardiorespiratory and muscular fitness, all of which may explain its beneficial effects on COVID-19 severity, the researchers say.
The study was published online in the British Journal of Sports Medicine.
Strong protection from COVID?
A growing body of evidence suggests that increased physical activity may modulate the course of COVID-19 infection and reduce the risk of poor outcomes. The new analysis is the first to systematically evaluate and pool data on the effect of regular physical activity on COVID-19 outcomes.
The findings are based on data from 16 studies with over 1.8 million adults (53% women, mean age 53 years).
Individuals who included regular physical activity in their weekly routine had an 11% lower risk for infection with SARS-CoV-2 (hazard ratio, 0.89; 95% confidence interval, 0.84-0.95), compared with inactive peers.
The physically active adults also had a 36% (HR, 0.64; 95% CI, 0.54-0.76) lower risk of being hospitalized, a 44% (HR, 0.66; 95% CI, 0.58-0.77) lower risk for severe COVID-19 illness, and a 43% (HR, 0.57; 95% CI, 0.46-0.71) lower risk of dying from COVID-19 than their inactive peers.
The greatest protective effect occurs with achieving at least 500 metabolic equivalent of task (MET) minutes per week of physical activity – equivalent to 150 minutes of moderate-intensity or 75 min of vigorous-intensity physical activity per week – with no added benefit beyond this level.
The researchers caution that the analysis included observational studies, differing study designs, subjective assessments of physical activity levels, and concerned only the Beta and Delta variants of SARS-CoV-2, not Omicron.
Despite these limitations, the researchers say their findings “may help guide physicians and health care policymakers in making recommendations and developing guidelines with respect to the degree of physical activity that can help reduce the risk of infectivity, hospitalization, severity, and mortality of COVID-19 at both the individual and the population level, especially in high-risk patients.”
Helpful, but not a panacea
Reached for comment, Sean Heffron, MD, a preventive cardiologist and assistant professor of medicine at NYU Langone Health, New York, said the study “supports the well-established nonlinear association of increasing physical activity with adverse outcomes from a diverse array of diseases, including infectious diseases, such as COVID-19.”
The observation is not particularly surprising, he said.
“It is as I would suspect. They compiled data from a large number of studies published over the past several years that all had consistent findings,” Dr. Heffron said.
“The take-away from a public health standpoint is that being physically active improves health in myriad ways. That being said, it is not a panacea, so additional measures (masking, vaccinations, etc.) are important for everyone,” he said.
Also weighing in, Joseph Herrera, DO, chair of the department of rehabilitation for Mount Sinai Health System, New York, said, “If you are physically fit, your body is more resilient and better prepared to handle the stressors of COVID or any other disease process.”
For now, however, the question of whether physical fitness is actually protective against COVID remains unclear. “I’m just not sure right now,” Dr. Herrera said in an interview.
He said he has treated athletes in professional sports – including the National Football League and Major League Baseball – and some of them have had long COVID and have not returned to play. “These are athletes at the peak of fitness and their career.”
Nonetheless, Dr. Herrera said a good public health message in general is to stay fit or get fit.
“That’s something I preach all the time,” he told this news organization.
Dr. García-Hermoso agreed. “In contrast to the vast majority of drugs, exercise is free of adverse effects. It’s time to consider exercise as medicine. It’s never too late to start being physically active.”
The study had no specific funding. Dr. García-Hermoso, Dr. Heffron, and Dr. Herrera have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New research suggests that regular physical activity can help lower the risk of COVID-19 infection and its severity, with a weekly tally of 150 minutes of moderate, or 75 minutes of vigorous, physical activity affording the best protection.
“, with potential benefits to reduce the risk of severe COVID-19,” say Antonio García-Hermoso, PhD, Public University of Navarra, Pamplona, Spain, and colleagues.
“Regular physical activity seemed to be related to a lower risk of COVID-19 infection, Dr. García-Hermoso said in an interview. “There is evidence that regular physical activity might contribute to a more effective immune response, providing enhanced protective immunity to infections, which could explain the relationship between exercise consistency with COVID-19 infection.”
Regular exercise may also help to boost the body’s anti-inflammatory responses, as well as cardiorespiratory and muscular fitness, all of which may explain its beneficial effects on COVID-19 severity, the researchers say.
The study was published online in the British Journal of Sports Medicine.
Strong protection from COVID?
A growing body of evidence suggests that increased physical activity may modulate the course of COVID-19 infection and reduce the risk of poor outcomes. The new analysis is the first to systematically evaluate and pool data on the effect of regular physical activity on COVID-19 outcomes.
The findings are based on data from 16 studies with over 1.8 million adults (53% women, mean age 53 years).
Individuals who included regular physical activity in their weekly routine had an 11% lower risk for infection with SARS-CoV-2 (hazard ratio, 0.89; 95% confidence interval, 0.84-0.95), compared with inactive peers.
The physically active adults also had a 36% (HR, 0.64; 95% CI, 0.54-0.76) lower risk of being hospitalized, a 44% (HR, 0.66; 95% CI, 0.58-0.77) lower risk for severe COVID-19 illness, and a 43% (HR, 0.57; 95% CI, 0.46-0.71) lower risk of dying from COVID-19 than their inactive peers.
The greatest protective effect occurs with achieving at least 500 metabolic equivalent of task (MET) minutes per week of physical activity – equivalent to 150 minutes of moderate-intensity or 75 min of vigorous-intensity physical activity per week – with no added benefit beyond this level.
The researchers caution that the analysis included observational studies, differing study designs, subjective assessments of physical activity levels, and concerned only the Beta and Delta variants of SARS-CoV-2, not Omicron.
Despite these limitations, the researchers say their findings “may help guide physicians and health care policymakers in making recommendations and developing guidelines with respect to the degree of physical activity that can help reduce the risk of infectivity, hospitalization, severity, and mortality of COVID-19 at both the individual and the population level, especially in high-risk patients.”
Helpful, but not a panacea
Reached for comment, Sean Heffron, MD, a preventive cardiologist and assistant professor of medicine at NYU Langone Health, New York, said the study “supports the well-established nonlinear association of increasing physical activity with adverse outcomes from a diverse array of diseases, including infectious diseases, such as COVID-19.”
The observation is not particularly surprising, he said.
“It is as I would suspect. They compiled data from a large number of studies published over the past several years that all had consistent findings,” Dr. Heffron said.
“The take-away from a public health standpoint is that being physically active improves health in myriad ways. That being said, it is not a panacea, so additional measures (masking, vaccinations, etc.) are important for everyone,” he said.
Also weighing in, Joseph Herrera, DO, chair of the department of rehabilitation for Mount Sinai Health System, New York, said, “If you are physically fit, your body is more resilient and better prepared to handle the stressors of COVID or any other disease process.”
For now, however, the question of whether physical fitness is actually protective against COVID remains unclear. “I’m just not sure right now,” Dr. Herrera said in an interview.
He said he has treated athletes in professional sports – including the National Football League and Major League Baseball – and some of them have had long COVID and have not returned to play. “These are athletes at the peak of fitness and their career.”
Nonetheless, Dr. Herrera said a good public health message in general is to stay fit or get fit.
“That’s something I preach all the time,” he told this news organization.
Dr. García-Hermoso agreed. “In contrast to the vast majority of drugs, exercise is free of adverse effects. It’s time to consider exercise as medicine. It’s never too late to start being physically active.”
The study had no specific funding. Dr. García-Hermoso, Dr. Heffron, and Dr. Herrera have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New research suggests that regular physical activity can help lower the risk of COVID-19 infection and its severity, with a weekly tally of 150 minutes of moderate, or 75 minutes of vigorous, physical activity affording the best protection.
“, with potential benefits to reduce the risk of severe COVID-19,” say Antonio García-Hermoso, PhD, Public University of Navarra, Pamplona, Spain, and colleagues.
“Regular physical activity seemed to be related to a lower risk of COVID-19 infection, Dr. García-Hermoso said in an interview. “There is evidence that regular physical activity might contribute to a more effective immune response, providing enhanced protective immunity to infections, which could explain the relationship between exercise consistency with COVID-19 infection.”
Regular exercise may also help to boost the body’s anti-inflammatory responses, as well as cardiorespiratory and muscular fitness, all of which may explain its beneficial effects on COVID-19 severity, the researchers say.
The study was published online in the British Journal of Sports Medicine.
Strong protection from COVID?
A growing body of evidence suggests that increased physical activity may modulate the course of COVID-19 infection and reduce the risk of poor outcomes. The new analysis is the first to systematically evaluate and pool data on the effect of regular physical activity on COVID-19 outcomes.
The findings are based on data from 16 studies with over 1.8 million adults (53% women, mean age 53 years).
Individuals who included regular physical activity in their weekly routine had an 11% lower risk for infection with SARS-CoV-2 (hazard ratio, 0.89; 95% confidence interval, 0.84-0.95), compared with inactive peers.
The physically active adults also had a 36% (HR, 0.64; 95% CI, 0.54-0.76) lower risk of being hospitalized, a 44% (HR, 0.66; 95% CI, 0.58-0.77) lower risk for severe COVID-19 illness, and a 43% (HR, 0.57; 95% CI, 0.46-0.71) lower risk of dying from COVID-19 than their inactive peers.
The greatest protective effect occurs with achieving at least 500 metabolic equivalent of task (MET) minutes per week of physical activity – equivalent to 150 minutes of moderate-intensity or 75 min of vigorous-intensity physical activity per week – with no added benefit beyond this level.
The researchers caution that the analysis included observational studies, differing study designs, subjective assessments of physical activity levels, and concerned only the Beta and Delta variants of SARS-CoV-2, not Omicron.
Despite these limitations, the researchers say their findings “may help guide physicians and health care policymakers in making recommendations and developing guidelines with respect to the degree of physical activity that can help reduce the risk of infectivity, hospitalization, severity, and mortality of COVID-19 at both the individual and the population level, especially in high-risk patients.”
Helpful, but not a panacea
Reached for comment, Sean Heffron, MD, a preventive cardiologist and assistant professor of medicine at NYU Langone Health, New York, said the study “supports the well-established nonlinear association of increasing physical activity with adverse outcomes from a diverse array of diseases, including infectious diseases, such as COVID-19.”
The observation is not particularly surprising, he said.
“It is as I would suspect. They compiled data from a large number of studies published over the past several years that all had consistent findings,” Dr. Heffron said.
“The take-away from a public health standpoint is that being physically active improves health in myriad ways. That being said, it is not a panacea, so additional measures (masking, vaccinations, etc.) are important for everyone,” he said.
Also weighing in, Joseph Herrera, DO, chair of the department of rehabilitation for Mount Sinai Health System, New York, said, “If you are physically fit, your body is more resilient and better prepared to handle the stressors of COVID or any other disease process.”
For now, however, the question of whether physical fitness is actually protective against COVID remains unclear. “I’m just not sure right now,” Dr. Herrera said in an interview.
He said he has treated athletes in professional sports – including the National Football League and Major League Baseball – and some of them have had long COVID and have not returned to play. “These are athletes at the peak of fitness and their career.”
Nonetheless, Dr. Herrera said a good public health message in general is to stay fit or get fit.
“That’s something I preach all the time,” he told this news organization.
Dr. García-Hermoso agreed. “In contrast to the vast majority of drugs, exercise is free of adverse effects. It’s time to consider exercise as medicine. It’s never too late to start being physically active.”
The study had no specific funding. Dr. García-Hermoso, Dr. Heffron, and Dr. Herrera have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BRITISH JOURNAL OF SPORTS MEDICINE
FDA clears new neurostimulation system for chronic pain
The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.
“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.
The system also has therapy settings accessed with a mobile device.
Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
Game changer?
The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.
More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.
Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.
“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.
“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.
A version of this article first appeared on Medscape.com.
The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.
“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.
The system also has therapy settings accessed with a mobile device.
Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
Game changer?
The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.
More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.
Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.
“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.
“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.
A version of this article first appeared on Medscape.com.
The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.
“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.
The system also has therapy settings accessed with a mobile device.
Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
Game changer?
The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.
More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.
Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.
“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.
“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.
A version of this article first appeared on Medscape.com.
Are artificial sweeteners really harmless?
New research discounts the long-held notion that aspartame and other nonnutritive sweeteners (NNS) have no effect on the human body.
Researchers found that these sugar substitutes are not metabolically inert and can alter the gut microbiome in a way that can influence blood glucose levels.
The study was published online in the journal Cell.
Gut reaction?
Several years ago, a team led by Eran Elinav, MD, PhD, an immunologist and microbiome researcher at the Weizmann Institute of Science, Rehovot, Israel, observed that these sweeteners affect the microbiome of mice in ways that could affect glycemic responses.
They have now confirmed this observation in a randomized controlled trial with 120 healthy adults.
Each sweetener “significantly and distinctly” altered stool and oral microbiome, and two of them (saccharin and sucralose) significantly impaired glucose tolerance, the researchers reported.
“Importantly, by performing extensive fecal transplantation of human microbiomes into germ-free mice, we demonstrate a causal and individualized link between NNS-altered microbiomes and glucose intolerance developing in non–NNS-consuming recipient mice,” they said.
They noted that the effects of these sweeteners will likely vary from person to person because of the unique composition of an individual’s microbiome.
“We need to raise awareness of the fact that NNS are not inert to the human body as we originally believed. With that said, the clinical health implications of the changes they may elicit in humans remain unknown and merit future long-term studies,” Dr. Elinav said in a news release.
For now, Dr. Elinav said it’s his personal view that “drinking only water seems to be the best solution.”
Weighing the evidence
Several experts weighed in on the results in a statement from the U.K. nonprofit organization, Science Media Centre.
Duane Mellor, PhD, RD, RNutr, registered dietitian and senior teaching fellow, Aston University, Birmingham, England, notes that the study does not show a link between all NNS and higher blood glucose levels in the long term (only after a glucose tolerance test).
“It did suggest, though, that some individuals who do not normally consume sweeteners may not tolerate glucose as well after consuming six sachets of either saccharin or sucralose mixed with glucose per day,” Dr. Mellor says.
Kim Barrett, PhD, distinguished professor of physiology and membrane biology, University of California, Davis, concurs, saying “this well-designed study indicates the potential for NNS to have adverse effects in at least some individuals.”
The study also does not provide any information about how people who normally consume sweeteners or people with either type 1 or type 2 diabetes respond to NNS.
“Therefore, for some people, it is likely to be a better option and more sustainable approach to use sweeteners as a ‘stepping stone’ allowing them to reduce the amount of added sugar in foods and drinks, to reduce their sugar intake and still enjoy what they eat and drink, on the way to reducing both added sugar and sweeteners in their diet,” Dr. Mellor suggests.
Kevin McConway, PhD, with the Open University, Milton Keynes, England, said it’s “important to understand that the research is not saying that these sweeteners are worse for us, in heath terms, than sugar.
“But exactly what the health consequences of all this, if any, might be is a subject for future research,” Dr. McConway added.
Kathy Redfern, PhD, lecturer in human nutrition, University of Plymouth (England) agrees.
“We still have a lot to learn about the human microbiome, and although this study suggests two of the sweeteners tested in this study (sucralose and saccharin) significantly affected glucose tolerance, these deviations were small,” she says.
The International Sweeteners Association also weighs in, saying, “No conclusions about the effects of low/no calorie sweeteners on glucose control or overall health can be extrapolated from this study for the general population or for people who typically consume sweeteners, including people living with diabetes.”
They add “a recent review of the literature concluded that there is clear evidence that changes in the diet unrelated to low/no calorie sweeteners consumption are likely the major determinants of change in gut microbiota.”
Nevertheless, Dr. Redfern says the results “warrant further investigation to assess how small changes in glucose tolerance in response to NNS consumption may influence longer-term glucose tolerance and risk for metabolic complications, such as type 2 diabetes.”
The study had no specific funding. Dr. Elinav is a scientific founder of DayTwo and BiomX, a paid consultant to Hello Inside and Aposense, and a member of the scientific advisory board of Cell. Dr. Mellor has provided consultancy to the International Sweetener Agency and has worked on projects funded by the Food Standards Agency that investigated the health effects of aspartame. Dr. Barrett, Dr. McConway, and Dr. Redfern report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 8/29/22.
New research discounts the long-held notion that aspartame and other nonnutritive sweeteners (NNS) have no effect on the human body.
Researchers found that these sugar substitutes are not metabolically inert and can alter the gut microbiome in a way that can influence blood glucose levels.
The study was published online in the journal Cell.
Gut reaction?
Several years ago, a team led by Eran Elinav, MD, PhD, an immunologist and microbiome researcher at the Weizmann Institute of Science, Rehovot, Israel, observed that these sweeteners affect the microbiome of mice in ways that could affect glycemic responses.
They have now confirmed this observation in a randomized controlled trial with 120 healthy adults.
Each sweetener “significantly and distinctly” altered stool and oral microbiome, and two of them (saccharin and sucralose) significantly impaired glucose tolerance, the researchers reported.
“Importantly, by performing extensive fecal transplantation of human microbiomes into germ-free mice, we demonstrate a causal and individualized link between NNS-altered microbiomes and glucose intolerance developing in non–NNS-consuming recipient mice,” they said.
They noted that the effects of these sweeteners will likely vary from person to person because of the unique composition of an individual’s microbiome.
“We need to raise awareness of the fact that NNS are not inert to the human body as we originally believed. With that said, the clinical health implications of the changes they may elicit in humans remain unknown and merit future long-term studies,” Dr. Elinav said in a news release.
For now, Dr. Elinav said it’s his personal view that “drinking only water seems to be the best solution.”
Weighing the evidence
Several experts weighed in on the results in a statement from the U.K. nonprofit organization, Science Media Centre.
Duane Mellor, PhD, RD, RNutr, registered dietitian and senior teaching fellow, Aston University, Birmingham, England, notes that the study does not show a link between all NNS and higher blood glucose levels in the long term (only after a glucose tolerance test).
“It did suggest, though, that some individuals who do not normally consume sweeteners may not tolerate glucose as well after consuming six sachets of either saccharin or sucralose mixed with glucose per day,” Dr. Mellor says.
Kim Barrett, PhD, distinguished professor of physiology and membrane biology, University of California, Davis, concurs, saying “this well-designed study indicates the potential for NNS to have adverse effects in at least some individuals.”
The study also does not provide any information about how people who normally consume sweeteners or people with either type 1 or type 2 diabetes respond to NNS.
“Therefore, for some people, it is likely to be a better option and more sustainable approach to use sweeteners as a ‘stepping stone’ allowing them to reduce the amount of added sugar in foods and drinks, to reduce their sugar intake and still enjoy what they eat and drink, on the way to reducing both added sugar and sweeteners in their diet,” Dr. Mellor suggests.
Kevin McConway, PhD, with the Open University, Milton Keynes, England, said it’s “important to understand that the research is not saying that these sweeteners are worse for us, in heath terms, than sugar.
“But exactly what the health consequences of all this, if any, might be is a subject for future research,” Dr. McConway added.
Kathy Redfern, PhD, lecturer in human nutrition, University of Plymouth (England) agrees.
“We still have a lot to learn about the human microbiome, and although this study suggests two of the sweeteners tested in this study (sucralose and saccharin) significantly affected glucose tolerance, these deviations were small,” she says.
The International Sweeteners Association also weighs in, saying, “No conclusions about the effects of low/no calorie sweeteners on glucose control or overall health can be extrapolated from this study for the general population or for people who typically consume sweeteners, including people living with diabetes.”
They add “a recent review of the literature concluded that there is clear evidence that changes in the diet unrelated to low/no calorie sweeteners consumption are likely the major determinants of change in gut microbiota.”
Nevertheless, Dr. Redfern says the results “warrant further investigation to assess how small changes in glucose tolerance in response to NNS consumption may influence longer-term glucose tolerance and risk for metabolic complications, such as type 2 diabetes.”
The study had no specific funding. Dr. Elinav is a scientific founder of DayTwo and BiomX, a paid consultant to Hello Inside and Aposense, and a member of the scientific advisory board of Cell. Dr. Mellor has provided consultancy to the International Sweetener Agency and has worked on projects funded by the Food Standards Agency that investigated the health effects of aspartame. Dr. Barrett, Dr. McConway, and Dr. Redfern report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 8/29/22.
New research discounts the long-held notion that aspartame and other nonnutritive sweeteners (NNS) have no effect on the human body.
Researchers found that these sugar substitutes are not metabolically inert and can alter the gut microbiome in a way that can influence blood glucose levels.
The study was published online in the journal Cell.
Gut reaction?
Several years ago, a team led by Eran Elinav, MD, PhD, an immunologist and microbiome researcher at the Weizmann Institute of Science, Rehovot, Israel, observed that these sweeteners affect the microbiome of mice in ways that could affect glycemic responses.
They have now confirmed this observation in a randomized controlled trial with 120 healthy adults.
Each sweetener “significantly and distinctly” altered stool and oral microbiome, and two of them (saccharin and sucralose) significantly impaired glucose tolerance, the researchers reported.
“Importantly, by performing extensive fecal transplantation of human microbiomes into germ-free mice, we demonstrate a causal and individualized link between NNS-altered microbiomes and glucose intolerance developing in non–NNS-consuming recipient mice,” they said.
They noted that the effects of these sweeteners will likely vary from person to person because of the unique composition of an individual’s microbiome.
“We need to raise awareness of the fact that NNS are not inert to the human body as we originally believed. With that said, the clinical health implications of the changes they may elicit in humans remain unknown and merit future long-term studies,” Dr. Elinav said in a news release.
For now, Dr. Elinav said it’s his personal view that “drinking only water seems to be the best solution.”
Weighing the evidence
Several experts weighed in on the results in a statement from the U.K. nonprofit organization, Science Media Centre.
Duane Mellor, PhD, RD, RNutr, registered dietitian and senior teaching fellow, Aston University, Birmingham, England, notes that the study does not show a link between all NNS and higher blood glucose levels in the long term (only after a glucose tolerance test).
“It did suggest, though, that some individuals who do not normally consume sweeteners may not tolerate glucose as well after consuming six sachets of either saccharin or sucralose mixed with glucose per day,” Dr. Mellor says.
Kim Barrett, PhD, distinguished professor of physiology and membrane biology, University of California, Davis, concurs, saying “this well-designed study indicates the potential for NNS to have adverse effects in at least some individuals.”
The study also does not provide any information about how people who normally consume sweeteners or people with either type 1 or type 2 diabetes respond to NNS.
“Therefore, for some people, it is likely to be a better option and more sustainable approach to use sweeteners as a ‘stepping stone’ allowing them to reduce the amount of added sugar in foods and drinks, to reduce their sugar intake and still enjoy what they eat and drink, on the way to reducing both added sugar and sweeteners in their diet,” Dr. Mellor suggests.
Kevin McConway, PhD, with the Open University, Milton Keynes, England, said it’s “important to understand that the research is not saying that these sweeteners are worse for us, in heath terms, than sugar.
“But exactly what the health consequences of all this, if any, might be is a subject for future research,” Dr. McConway added.
Kathy Redfern, PhD, lecturer in human nutrition, University of Plymouth (England) agrees.
“We still have a lot to learn about the human microbiome, and although this study suggests two of the sweeteners tested in this study (sucralose and saccharin) significantly affected glucose tolerance, these deviations were small,” she says.
The International Sweeteners Association also weighs in, saying, “No conclusions about the effects of low/no calorie sweeteners on glucose control or overall health can be extrapolated from this study for the general population or for people who typically consume sweeteners, including people living with diabetes.”
They add “a recent review of the literature concluded that there is clear evidence that changes in the diet unrelated to low/no calorie sweeteners consumption are likely the major determinants of change in gut microbiota.”
Nevertheless, Dr. Redfern says the results “warrant further investigation to assess how small changes in glucose tolerance in response to NNS consumption may influence longer-term glucose tolerance and risk for metabolic complications, such as type 2 diabetes.”
The study had no specific funding. Dr. Elinav is a scientific founder of DayTwo and BiomX, a paid consultant to Hello Inside and Aposense, and a member of the scientific advisory board of Cell. Dr. Mellor has provided consultancy to the International Sweetener Agency and has worked on projects funded by the Food Standards Agency that investigated the health effects of aspartame. Dr. Barrett, Dr. McConway, and Dr. Redfern report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 8/29/22.
FDA approves ‘rapid-acting’ oral drug for major depression
The U.S. Food and Drug Administration has approved the first oral N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder (MDD) in adults, its manufacturer has announced.
Auvelity (Axsome Therapeutics) is a proprietary extended-release oral tablet containing dextromethorphan (45 mg) and bupropion (105 mg).
,” the company said in a news release.
“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile,” Maurizio Fava, MD, psychiatrist-in-chief, Massachusetts General Hospital, Boston, added in the release.
‘Milestone’ in depression treatment?
Dr. Fava noted that nearly two-thirds of patients treated with currently available antidepressants fail to respond adequately, and those who do may not achieve clinically meaningful responses for up to 6-8 weeks.
“Given the debilitating nature of depression, the efficacy of Auvelity observed at 1 week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition,” he said.
The company noted the drug was studied in a comprehensive clinical program that included more than 1,100 patients with MDD.
The efficacy of the drug was demonstrated in the GEMINI placebo-controlled study – with confirmatory evidence provided by the ASCEND study, which compared it with bupropion sustained-release tablets.
Axsome said it expects to launch the new oral medication in the fourth quarter of this year. It is not approved for use in children.
The full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved the first oral N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder (MDD) in adults, its manufacturer has announced.
Auvelity (Axsome Therapeutics) is a proprietary extended-release oral tablet containing dextromethorphan (45 mg) and bupropion (105 mg).
,” the company said in a news release.
“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile,” Maurizio Fava, MD, psychiatrist-in-chief, Massachusetts General Hospital, Boston, added in the release.
‘Milestone’ in depression treatment?
Dr. Fava noted that nearly two-thirds of patients treated with currently available antidepressants fail to respond adequately, and those who do may not achieve clinically meaningful responses for up to 6-8 weeks.
“Given the debilitating nature of depression, the efficacy of Auvelity observed at 1 week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition,” he said.
The company noted the drug was studied in a comprehensive clinical program that included more than 1,100 patients with MDD.
The efficacy of the drug was demonstrated in the GEMINI placebo-controlled study – with confirmatory evidence provided by the ASCEND study, which compared it with bupropion sustained-release tablets.
Axsome said it expects to launch the new oral medication in the fourth quarter of this year. It is not approved for use in children.
The full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved the first oral N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder (MDD) in adults, its manufacturer has announced.
Auvelity (Axsome Therapeutics) is a proprietary extended-release oral tablet containing dextromethorphan (45 mg) and bupropion (105 mg).
,” the company said in a news release.
“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile,” Maurizio Fava, MD, psychiatrist-in-chief, Massachusetts General Hospital, Boston, added in the release.
‘Milestone’ in depression treatment?
Dr. Fava noted that nearly two-thirds of patients treated with currently available antidepressants fail to respond adequately, and those who do may not achieve clinically meaningful responses for up to 6-8 weeks.
“Given the debilitating nature of depression, the efficacy of Auvelity observed at 1 week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition,” he said.
The company noted the drug was studied in a comprehensive clinical program that included more than 1,100 patients with MDD.
The efficacy of the drug was demonstrated in the GEMINI placebo-controlled study – with confirmatory evidence provided by the ASCEND study, which compared it with bupropion sustained-release tablets.
Axsome said it expects to launch the new oral medication in the fourth quarter of this year. It is not approved for use in children.
The full prescribing information and medication guide are available online.
A version of this article first appeared on Medscape.com.
Can folic acid halt or reverse progression of gastric precancerous conditions?
Folic acid supplementation can improve histopathologic aspects of gastric precancerous conditions (GPC), including gastric mucosal atrophy and intestinal metaplasia, according to results of a meta-analysis of relevant research.
The results, say the authors, provide evidence for the potential clinical use of folic acid in the management of GPC.
“We believe doctors can try to use folic acid to halt or reverse progression of gastric precancerous conditions, thereby reducing the incidence rate of gastric cancer,” investigator Jinhao Zeng, PhD, with Hospital of Chengdu University of Traditional Chinese Medicine, said in an interview.
Dr. Zeng cautioned, however, that the number of relevant studies “remains relatively inadequate, and the results should be interpreted with caution.”
David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, who wasn’t involved in the study, also urged caution in interpreting the results.
“Overall, folate supplementation is unlikely to be harmful, but these data should not be used as justification for risk reduction,” Dr. Johnson said in an interview.
The study was published online in BMC Gastroenterology.
Examining prevention, treatment effects
The study is believed to be the first meta-analysis to examine the effects of folic acid on prevention and treatment for patients with GPC. The analysis included 13 randomized controlled trials that had a total of 1,252 adults with GPC living in China.
A meta-analysis of five studies showed a statistically significant positive treatment effect of folic acid supplementation on gastric mucosal atrophy (relative risk, 1.61; 95% confidence interval 1.07 – 2.41), Dr. Zeng and colleagues reported.
A meta-analysis of two trials showed a statistically significant effect of folic acid on reversal of intestinal metaplasia (RR, 1.77; 95% CI, 1.32-2.37), they also found.
“Our study indicates that folic acid has a beneficial effect in the treatment of pathological changes of GPC when the dose was maintained at 20-30 mg/d and the duration of treatment was maintained at 3-6 months,” they wrote.
Folic acid supplementation did not appear to be effective for GPC symptom relief.
The authors said that, in a separate analysis, they confirmed that folic acid can inhibit development of gastric mucosal carcinogenesis by affecting the levels of gastrin and pepsinogen.
More study needed
Commenting on the study, Judith Kim, MD, division of gastroenterology and hepatology, New York University Langone Health, said prior studies have evaluated whether folic acid supplementation is associated with a lower risk of gastric cancer, but the results have been “mixed and inconclusive.”
“While there have been prior meta-analyses on folic acid and gastric cancer, this study is noteworthy, as it evaluated the impact of folic acid on precancerous lesions, for which there is no current treatment,” Dr. Kim said.
“Currently, there is no recommendation for folic acid supplementation for the treatment or prevention of GPC and gastric cancer,” Dr. Kim said. “There has been interest in folic acid as a chemopreventive agent, given its potential protective role against DNA damage, but randomized control trials have yet to confirm these benefits.”
The analysis by Dr. Zeng and colleagues “supports the need for larger randomized controlled trials to further study this association,” Dr. Kim said.
“Given the study’s small size and limitation to a Chinese population (who have a higher incidence of precancerous lesions and gastric cancer than the general US population), I would caution against folic acid use for the sole purpose of GPC prevention, as there could be negative side effects of supplementation,” she advised.
The study was supported by the National Natural Science Foundation of China, the Hospital of Chengdu University of Traditional Chinese Medicine, and Project of Sichuan Administration of Traditional Chinese Medicine. Dr. Zeng, Dr. Johnson, and Dr. Kim reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Folic acid supplementation can improve histopathologic aspects of gastric precancerous conditions (GPC), including gastric mucosal atrophy and intestinal metaplasia, according to results of a meta-analysis of relevant research.
The results, say the authors, provide evidence for the potential clinical use of folic acid in the management of GPC.
“We believe doctors can try to use folic acid to halt or reverse progression of gastric precancerous conditions, thereby reducing the incidence rate of gastric cancer,” investigator Jinhao Zeng, PhD, with Hospital of Chengdu University of Traditional Chinese Medicine, said in an interview.
Dr. Zeng cautioned, however, that the number of relevant studies “remains relatively inadequate, and the results should be interpreted with caution.”
David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, who wasn’t involved in the study, also urged caution in interpreting the results.
“Overall, folate supplementation is unlikely to be harmful, but these data should not be used as justification for risk reduction,” Dr. Johnson said in an interview.
The study was published online in BMC Gastroenterology.
Examining prevention, treatment effects
The study is believed to be the first meta-analysis to examine the effects of folic acid on prevention and treatment for patients with GPC. The analysis included 13 randomized controlled trials that had a total of 1,252 adults with GPC living in China.
A meta-analysis of five studies showed a statistically significant positive treatment effect of folic acid supplementation on gastric mucosal atrophy (relative risk, 1.61; 95% confidence interval 1.07 – 2.41), Dr. Zeng and colleagues reported.
A meta-analysis of two trials showed a statistically significant effect of folic acid on reversal of intestinal metaplasia (RR, 1.77; 95% CI, 1.32-2.37), they also found.
“Our study indicates that folic acid has a beneficial effect in the treatment of pathological changes of GPC when the dose was maintained at 20-30 mg/d and the duration of treatment was maintained at 3-6 months,” they wrote.
Folic acid supplementation did not appear to be effective for GPC symptom relief.
The authors said that, in a separate analysis, they confirmed that folic acid can inhibit development of gastric mucosal carcinogenesis by affecting the levels of gastrin and pepsinogen.
More study needed
Commenting on the study, Judith Kim, MD, division of gastroenterology and hepatology, New York University Langone Health, said prior studies have evaluated whether folic acid supplementation is associated with a lower risk of gastric cancer, but the results have been “mixed and inconclusive.”
“While there have been prior meta-analyses on folic acid and gastric cancer, this study is noteworthy, as it evaluated the impact of folic acid on precancerous lesions, for which there is no current treatment,” Dr. Kim said.
“Currently, there is no recommendation for folic acid supplementation for the treatment or prevention of GPC and gastric cancer,” Dr. Kim said. “There has been interest in folic acid as a chemopreventive agent, given its potential protective role against DNA damage, but randomized control trials have yet to confirm these benefits.”
The analysis by Dr. Zeng and colleagues “supports the need for larger randomized controlled trials to further study this association,” Dr. Kim said.
“Given the study’s small size and limitation to a Chinese population (who have a higher incidence of precancerous lesions and gastric cancer than the general US population), I would caution against folic acid use for the sole purpose of GPC prevention, as there could be negative side effects of supplementation,” she advised.
The study was supported by the National Natural Science Foundation of China, the Hospital of Chengdu University of Traditional Chinese Medicine, and Project of Sichuan Administration of Traditional Chinese Medicine. Dr. Zeng, Dr. Johnson, and Dr. Kim reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Folic acid supplementation can improve histopathologic aspects of gastric precancerous conditions (GPC), including gastric mucosal atrophy and intestinal metaplasia, according to results of a meta-analysis of relevant research.
The results, say the authors, provide evidence for the potential clinical use of folic acid in the management of GPC.
“We believe doctors can try to use folic acid to halt or reverse progression of gastric precancerous conditions, thereby reducing the incidence rate of gastric cancer,” investigator Jinhao Zeng, PhD, with Hospital of Chengdu University of Traditional Chinese Medicine, said in an interview.
Dr. Zeng cautioned, however, that the number of relevant studies “remains relatively inadequate, and the results should be interpreted with caution.”
David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, who wasn’t involved in the study, also urged caution in interpreting the results.
“Overall, folate supplementation is unlikely to be harmful, but these data should not be used as justification for risk reduction,” Dr. Johnson said in an interview.
The study was published online in BMC Gastroenterology.
Examining prevention, treatment effects
The study is believed to be the first meta-analysis to examine the effects of folic acid on prevention and treatment for patients with GPC. The analysis included 13 randomized controlled trials that had a total of 1,252 adults with GPC living in China.
A meta-analysis of five studies showed a statistically significant positive treatment effect of folic acid supplementation on gastric mucosal atrophy (relative risk, 1.61; 95% confidence interval 1.07 – 2.41), Dr. Zeng and colleagues reported.
A meta-analysis of two trials showed a statistically significant effect of folic acid on reversal of intestinal metaplasia (RR, 1.77; 95% CI, 1.32-2.37), they also found.
“Our study indicates that folic acid has a beneficial effect in the treatment of pathological changes of GPC when the dose was maintained at 20-30 mg/d and the duration of treatment was maintained at 3-6 months,” they wrote.
Folic acid supplementation did not appear to be effective for GPC symptom relief.
The authors said that, in a separate analysis, they confirmed that folic acid can inhibit development of gastric mucosal carcinogenesis by affecting the levels of gastrin and pepsinogen.
More study needed
Commenting on the study, Judith Kim, MD, division of gastroenterology and hepatology, New York University Langone Health, said prior studies have evaluated whether folic acid supplementation is associated with a lower risk of gastric cancer, but the results have been “mixed and inconclusive.”
“While there have been prior meta-analyses on folic acid and gastric cancer, this study is noteworthy, as it evaluated the impact of folic acid on precancerous lesions, for which there is no current treatment,” Dr. Kim said.
“Currently, there is no recommendation for folic acid supplementation for the treatment or prevention of GPC and gastric cancer,” Dr. Kim said. “There has been interest in folic acid as a chemopreventive agent, given its potential protective role against DNA damage, but randomized control trials have yet to confirm these benefits.”
The analysis by Dr. Zeng and colleagues “supports the need for larger randomized controlled trials to further study this association,” Dr. Kim said.
“Given the study’s small size and limitation to a Chinese population (who have a higher incidence of precancerous lesions and gastric cancer than the general US population), I would caution against folic acid use for the sole purpose of GPC prevention, as there could be negative side effects of supplementation,” she advised.
The study was supported by the National Natural Science Foundation of China, the Hospital of Chengdu University of Traditional Chinese Medicine, and Project of Sichuan Administration of Traditional Chinese Medicine. Dr. Zeng, Dr. Johnson, and Dr. Kim reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BMC GASTROENTEROLOGY
AHA statement outlines symptoms of common heart diseases
Symptoms of six common cardiovascular diseases (CVD) – acute coronary syndromes, heart failure, valvular disorders, stroke, rhythm disorders, and peripheral vascular disease – often overlap and may vary over time and by sex, the American Heart Association noted in a new scientific statement.
“Symptoms of these cardiovascular diseases can profoundly affect quality of life, and a clear understanding of them is critical for effective diagnosis and treatment decisions,” Corrine Y. Jurgens, PhD, chair of the writing committee, said in a news release.
This scientific statement is a “compendium detailing the symptoms associated with CVD, similarities or differences in symptoms among the conditions, and sex differences in symptom presentation and reporting,” said Dr. Jurgens, associate professor at Connell School of Nursing, Boston College.
The new statement was published online in Circulation.
The writing group noted that measuring CVD symptoms can be challenging because of their subjective nature. Symptoms may go unrecognized or unreported if people don’t think they are important or are related to an existing health condition.
“Some people may not consider symptoms like fatigue, sleep disturbance, weight gain, and depression as important or related to cardiovascular disease. However, research indicates that subtle symptoms such as these may predict acute events and the need for hospitalization,” Dr. Jurgens said.
ACS – chest pain and associated symptoms
The writing group noted that chest pain is the most frequently reported symptom of ACS and has often been described as substernal pressure or discomfort and may radiate to the jaw, shoulder, arm, or upper back.
The most common co-occurring symptoms are dyspnea, diaphoresis, unusual fatigue, nausea, and lightheadedness. Women are more likely than men to report additional symptoms outside of chest pain.
As a result, they have often been labeled “atypical.” However, a recent AHA advisory notes that this label may have been caused by the lack of women included in the clinical trials from which the symptom lists were derived.
The writing group said there is a need to “harmonize” ACS symptom measurement in research. The current lack of harmonization of ACS symptom measurement in research hampers growth in cumulative evidence.
“Therefore, little can be done to synthesize salient findings about symptoms across ischemic heart disease/ACS studies and to incorporate evidence-based information about symptoms into treatment guidelines and patient education materials,” they cautioned.
Heart failure
Turning to heart failure (HF), the writing group noted that dyspnea is the classic symptom and a common reason adults seek medical care.
However, early, more subtle symptoms should be recognized. These include gastrointestinal symptoms such as upset stomach, nausea, vomiting, and loss of appetite; fatigue; exercise intolerance; insomnia; pain (chest and otherwise); mood disturbances (primarily depression and anxiety); and cognitive dysfunction (brain fog, memory problems).
Women with HF report a wider variety of symptoms, are more likely to have depression and anxiety, and report a lower quality of life, compared with men with HF.
“It is important to account for dyspnea heterogeneity in both clinical practice and research by using nuanced measures and probing questions to capture this common and multifaceted symptom,” the writing group said.
“Monitoring symptoms on a spectrum, versus present or not present, with reliable and valid measures may enhance clinical care by identifying more quickly those who may be at risk for poor outcomes, such as lower quality of life, hospitalization, or death,” Dr. Jurgens added.
“Ultimately, we have work to do in terms of determining who needs more frequent monitoring or intervention to avert poor HF outcomes,” she said.
Valvular heart disease
Valvular heart disease is a frequent cause of HF, with symptoms generally indistinguishable from other HF causes. Rheumatic heart disease is still prevalent in low- and middle-income countries but has largely disappeared in high-income countries, with population aging and cardiomyopathies now key drivers of valve disease.
In the absence of acute severe valve dysfunction, patients generally have a prolonged asymptomatic period, followed by a period of progressive symptoms, resulting from the valve lesion itself or secondary myocardial remodeling and dysfunction, the writing group said.
Symptoms of aortic valve disease often differ between men and women. Aortic stenosis is typically silent for years. As stenosis progresses, women report dyspnea and exercise intolerance more often than men. Women are also more likely to be physically frail and to have a higher New York Heart Association class (III/IV) than men. Men are more likely to have chest pain.
“Given the importance of symptom assessment, more work is needed to determine the incremental value of quantitative symptom measurement as an aid to clinical management,” the writing group said.
Stroke
For clinicians, classic stroke symptoms (face drooping, arm weakness, speech difficulty), in addition to nonclassic symptoms, such as partial sensory deficit, dysarthria, vertigo, and diplopia, should be considered for activating a stroke response team, the group says.
A systematic review and meta-analysis revealed that women with stroke were more likely to present with nonfocal symptoms (for example, headache, altered mentality, and coma/stupor) than men, they noted.
To enhance public education about stroke symptoms and to facilitate the diagnosis and treatment of stroke, they say research is needed to better understand the presentation of stroke symptoms by other select demographic characteristics including race and ethnicity, age, and stroke subtype.
Poststroke screening should include assessment for anxiety, depression, fatigue, and pain, the writing group said.
Rhythm disorders
Turning to rhythm disorders, the writing group wrote that cardiac arrhythmias, including atrial fibrillation (AFib), atrial flutter, supraventricular tachycardia, bradyarrhythmia, and ventricular tachycardia, present with common symptoms.
Palpitations are a characteristic symptom of many cardiac arrhythmias. The most common cardiac arrhythmia, AFib, may present with palpitations or less specific symptoms (fatigue, dyspnea, dizziness) that occur with a broad range of rhythm disorders. Chest pain, dizziness, presyncope/syncope, and anxiety occur less frequently in AFib, the group said.
Palpitations are considered the typical symptom presentation for AFib, yet patients with new-onset AFib often present with nonspecific symptoms or no symptoms, they pointed out.
Women and younger individuals with AFib typically present with palpitations, whereas men are more commonly asymptomatic. Older age also increases the likelihood of a nonclassic or asymptomatic presentation of AFib.
Despite non-Hispanic Black individuals being at lower risk for development of AFib, research suggests that Black patients are burdened more with palpitations, dyspnea on exertion, exercise intolerance, dizziness, dyspnea at rest, and chest discomfort, compared with White or Hispanic patients.
Peripheral vascular disease
Classic claudication occurs in roughly one-third of patients with peripheral arterial disease (PAD) and is defined as calf pain that occurs in one or both legs with exertion (walking), does not begin at rest, and resolves within 10 minutes of standing still or rest.
However, non–calf exercise pain is reported more frequently than classic claudication symptoms. Women with PAD are more likely to have nonclassic symptoms or an absence of symptoms.
Assessing symptoms at rest, during exercise, and during recovery can assist with classifying symptoms as ischemic or not, the writing group said.
PAD with symptoms is associated with an increased risk for myocardial infarction and stroke, with men at higher risk than women.
Similar to PAD, peripheral venous disease (PVD) can be symptomatic or asymptomatic. Clinical classification of PVD includes symptoms such as leg pain, aching, fatigue, heaviness, cramping, tightness, restless legs syndrome, and skin irritation.
“Measuring vascular symptoms includes assessing quality of life and activity limitations, as well as the psychological impact of the disease. However, existing measures are often based on the clinician’s appraisal rather than the individual’s self-reported symptoms and severity of symptoms,” Dr. Jurgens commented.
Watch for depression
Finally, the writing group highlighted the importance of depression in cardiac patients, which occurs at about twice the rate, compared with people without any medical condition (10% vs. 5%).
In a prior statement, the AHA said depression should be considered a risk factor for worse outcomes in patients with ACS or CVD diagnosis.
The new statement highlights that people with persistent chest pain, people with HF, as well as stroke survivors and people with PAD commonly have depression and/or anxiety. In addition, cognitive changes after a stroke may affect how and whether symptoms are experienced or noticed.
While symptom relief is an important part of managing CVD, it’s also important to recognize that “factors such as depression and cognitive function may affect symptom detection and reporting,” Dr. Jurgens said.
“Monitoring and measuring symptoms with tools that appropriately account for depression and cognitive function may help to improve patient care by identifying more quickly people who may be at higher risk,” she added.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing; the Council on Hypertension; and the Stroke Council. The research had no commercial funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Symptoms of six common cardiovascular diseases (CVD) – acute coronary syndromes, heart failure, valvular disorders, stroke, rhythm disorders, and peripheral vascular disease – often overlap and may vary over time and by sex, the American Heart Association noted in a new scientific statement.
“Symptoms of these cardiovascular diseases can profoundly affect quality of life, and a clear understanding of them is critical for effective diagnosis and treatment decisions,” Corrine Y. Jurgens, PhD, chair of the writing committee, said in a news release.
This scientific statement is a “compendium detailing the symptoms associated with CVD, similarities or differences in symptoms among the conditions, and sex differences in symptom presentation and reporting,” said Dr. Jurgens, associate professor at Connell School of Nursing, Boston College.
The new statement was published online in Circulation.
The writing group noted that measuring CVD symptoms can be challenging because of their subjective nature. Symptoms may go unrecognized or unreported if people don’t think they are important or are related to an existing health condition.
“Some people may not consider symptoms like fatigue, sleep disturbance, weight gain, and depression as important or related to cardiovascular disease. However, research indicates that subtle symptoms such as these may predict acute events and the need for hospitalization,” Dr. Jurgens said.
ACS – chest pain and associated symptoms
The writing group noted that chest pain is the most frequently reported symptom of ACS and has often been described as substernal pressure or discomfort and may radiate to the jaw, shoulder, arm, or upper back.
The most common co-occurring symptoms are dyspnea, diaphoresis, unusual fatigue, nausea, and lightheadedness. Women are more likely than men to report additional symptoms outside of chest pain.
As a result, they have often been labeled “atypical.” However, a recent AHA advisory notes that this label may have been caused by the lack of women included in the clinical trials from which the symptom lists were derived.
The writing group said there is a need to “harmonize” ACS symptom measurement in research. The current lack of harmonization of ACS symptom measurement in research hampers growth in cumulative evidence.
“Therefore, little can be done to synthesize salient findings about symptoms across ischemic heart disease/ACS studies and to incorporate evidence-based information about symptoms into treatment guidelines and patient education materials,” they cautioned.
Heart failure
Turning to heart failure (HF), the writing group noted that dyspnea is the classic symptom and a common reason adults seek medical care.
However, early, more subtle symptoms should be recognized. These include gastrointestinal symptoms such as upset stomach, nausea, vomiting, and loss of appetite; fatigue; exercise intolerance; insomnia; pain (chest and otherwise); mood disturbances (primarily depression and anxiety); and cognitive dysfunction (brain fog, memory problems).
Women with HF report a wider variety of symptoms, are more likely to have depression and anxiety, and report a lower quality of life, compared with men with HF.
“It is important to account for dyspnea heterogeneity in both clinical practice and research by using nuanced measures and probing questions to capture this common and multifaceted symptom,” the writing group said.
“Monitoring symptoms on a spectrum, versus present or not present, with reliable and valid measures may enhance clinical care by identifying more quickly those who may be at risk for poor outcomes, such as lower quality of life, hospitalization, or death,” Dr. Jurgens added.
“Ultimately, we have work to do in terms of determining who needs more frequent monitoring or intervention to avert poor HF outcomes,” she said.
Valvular heart disease
Valvular heart disease is a frequent cause of HF, with symptoms generally indistinguishable from other HF causes. Rheumatic heart disease is still prevalent in low- and middle-income countries but has largely disappeared in high-income countries, with population aging and cardiomyopathies now key drivers of valve disease.
In the absence of acute severe valve dysfunction, patients generally have a prolonged asymptomatic period, followed by a period of progressive symptoms, resulting from the valve lesion itself or secondary myocardial remodeling and dysfunction, the writing group said.
Symptoms of aortic valve disease often differ between men and women. Aortic stenosis is typically silent for years. As stenosis progresses, women report dyspnea and exercise intolerance more often than men. Women are also more likely to be physically frail and to have a higher New York Heart Association class (III/IV) than men. Men are more likely to have chest pain.
“Given the importance of symptom assessment, more work is needed to determine the incremental value of quantitative symptom measurement as an aid to clinical management,” the writing group said.
Stroke
For clinicians, classic stroke symptoms (face drooping, arm weakness, speech difficulty), in addition to nonclassic symptoms, such as partial sensory deficit, dysarthria, vertigo, and diplopia, should be considered for activating a stroke response team, the group says.
A systematic review and meta-analysis revealed that women with stroke were more likely to present with nonfocal symptoms (for example, headache, altered mentality, and coma/stupor) than men, they noted.
To enhance public education about stroke symptoms and to facilitate the diagnosis and treatment of stroke, they say research is needed to better understand the presentation of stroke symptoms by other select demographic characteristics including race and ethnicity, age, and stroke subtype.
Poststroke screening should include assessment for anxiety, depression, fatigue, and pain, the writing group said.
Rhythm disorders
Turning to rhythm disorders, the writing group wrote that cardiac arrhythmias, including atrial fibrillation (AFib), atrial flutter, supraventricular tachycardia, bradyarrhythmia, and ventricular tachycardia, present with common symptoms.
Palpitations are a characteristic symptom of many cardiac arrhythmias. The most common cardiac arrhythmia, AFib, may present with palpitations or less specific symptoms (fatigue, dyspnea, dizziness) that occur with a broad range of rhythm disorders. Chest pain, dizziness, presyncope/syncope, and anxiety occur less frequently in AFib, the group said.
Palpitations are considered the typical symptom presentation for AFib, yet patients with new-onset AFib often present with nonspecific symptoms or no symptoms, they pointed out.
Women and younger individuals with AFib typically present with palpitations, whereas men are more commonly asymptomatic. Older age also increases the likelihood of a nonclassic or asymptomatic presentation of AFib.
Despite non-Hispanic Black individuals being at lower risk for development of AFib, research suggests that Black patients are burdened more with palpitations, dyspnea on exertion, exercise intolerance, dizziness, dyspnea at rest, and chest discomfort, compared with White or Hispanic patients.
Peripheral vascular disease
Classic claudication occurs in roughly one-third of patients with peripheral arterial disease (PAD) and is defined as calf pain that occurs in one or both legs with exertion (walking), does not begin at rest, and resolves within 10 minutes of standing still or rest.
However, non–calf exercise pain is reported more frequently than classic claudication symptoms. Women with PAD are more likely to have nonclassic symptoms or an absence of symptoms.
Assessing symptoms at rest, during exercise, and during recovery can assist with classifying symptoms as ischemic or not, the writing group said.
PAD with symptoms is associated with an increased risk for myocardial infarction and stroke, with men at higher risk than women.
Similar to PAD, peripheral venous disease (PVD) can be symptomatic or asymptomatic. Clinical classification of PVD includes symptoms such as leg pain, aching, fatigue, heaviness, cramping, tightness, restless legs syndrome, and skin irritation.
“Measuring vascular symptoms includes assessing quality of life and activity limitations, as well as the psychological impact of the disease. However, existing measures are often based on the clinician’s appraisal rather than the individual’s self-reported symptoms and severity of symptoms,” Dr. Jurgens commented.
Watch for depression
Finally, the writing group highlighted the importance of depression in cardiac patients, which occurs at about twice the rate, compared with people without any medical condition (10% vs. 5%).
In a prior statement, the AHA said depression should be considered a risk factor for worse outcomes in patients with ACS or CVD diagnosis.
The new statement highlights that people with persistent chest pain, people with HF, as well as stroke survivors and people with PAD commonly have depression and/or anxiety. In addition, cognitive changes after a stroke may affect how and whether symptoms are experienced or noticed.
While symptom relief is an important part of managing CVD, it’s also important to recognize that “factors such as depression and cognitive function may affect symptom detection and reporting,” Dr. Jurgens said.
“Monitoring and measuring symptoms with tools that appropriately account for depression and cognitive function may help to improve patient care by identifying more quickly people who may be at higher risk,” she added.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing; the Council on Hypertension; and the Stroke Council. The research had no commercial funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Symptoms of six common cardiovascular diseases (CVD) – acute coronary syndromes, heart failure, valvular disorders, stroke, rhythm disorders, and peripheral vascular disease – often overlap and may vary over time and by sex, the American Heart Association noted in a new scientific statement.
“Symptoms of these cardiovascular diseases can profoundly affect quality of life, and a clear understanding of them is critical for effective diagnosis and treatment decisions,” Corrine Y. Jurgens, PhD, chair of the writing committee, said in a news release.
This scientific statement is a “compendium detailing the symptoms associated with CVD, similarities or differences in symptoms among the conditions, and sex differences in symptom presentation and reporting,” said Dr. Jurgens, associate professor at Connell School of Nursing, Boston College.
The new statement was published online in Circulation.
The writing group noted that measuring CVD symptoms can be challenging because of their subjective nature. Symptoms may go unrecognized or unreported if people don’t think they are important or are related to an existing health condition.
“Some people may not consider symptoms like fatigue, sleep disturbance, weight gain, and depression as important or related to cardiovascular disease. However, research indicates that subtle symptoms such as these may predict acute events and the need for hospitalization,” Dr. Jurgens said.
ACS – chest pain and associated symptoms
The writing group noted that chest pain is the most frequently reported symptom of ACS and has often been described as substernal pressure or discomfort and may radiate to the jaw, shoulder, arm, or upper back.
The most common co-occurring symptoms are dyspnea, diaphoresis, unusual fatigue, nausea, and lightheadedness. Women are more likely than men to report additional symptoms outside of chest pain.
As a result, they have often been labeled “atypical.” However, a recent AHA advisory notes that this label may have been caused by the lack of women included in the clinical trials from which the symptom lists were derived.
The writing group said there is a need to “harmonize” ACS symptom measurement in research. The current lack of harmonization of ACS symptom measurement in research hampers growth in cumulative evidence.
“Therefore, little can be done to synthesize salient findings about symptoms across ischemic heart disease/ACS studies and to incorporate evidence-based information about symptoms into treatment guidelines and patient education materials,” they cautioned.
Heart failure
Turning to heart failure (HF), the writing group noted that dyspnea is the classic symptom and a common reason adults seek medical care.
However, early, more subtle symptoms should be recognized. These include gastrointestinal symptoms such as upset stomach, nausea, vomiting, and loss of appetite; fatigue; exercise intolerance; insomnia; pain (chest and otherwise); mood disturbances (primarily depression and anxiety); and cognitive dysfunction (brain fog, memory problems).
Women with HF report a wider variety of symptoms, are more likely to have depression and anxiety, and report a lower quality of life, compared with men with HF.
“It is important to account for dyspnea heterogeneity in both clinical practice and research by using nuanced measures and probing questions to capture this common and multifaceted symptom,” the writing group said.
“Monitoring symptoms on a spectrum, versus present or not present, with reliable and valid measures may enhance clinical care by identifying more quickly those who may be at risk for poor outcomes, such as lower quality of life, hospitalization, or death,” Dr. Jurgens added.
“Ultimately, we have work to do in terms of determining who needs more frequent monitoring or intervention to avert poor HF outcomes,” she said.
Valvular heart disease
Valvular heart disease is a frequent cause of HF, with symptoms generally indistinguishable from other HF causes. Rheumatic heart disease is still prevalent in low- and middle-income countries but has largely disappeared in high-income countries, with population aging and cardiomyopathies now key drivers of valve disease.
In the absence of acute severe valve dysfunction, patients generally have a prolonged asymptomatic period, followed by a period of progressive symptoms, resulting from the valve lesion itself or secondary myocardial remodeling and dysfunction, the writing group said.
Symptoms of aortic valve disease often differ between men and women. Aortic stenosis is typically silent for years. As stenosis progresses, women report dyspnea and exercise intolerance more often than men. Women are also more likely to be physically frail and to have a higher New York Heart Association class (III/IV) than men. Men are more likely to have chest pain.
“Given the importance of symptom assessment, more work is needed to determine the incremental value of quantitative symptom measurement as an aid to clinical management,” the writing group said.
Stroke
For clinicians, classic stroke symptoms (face drooping, arm weakness, speech difficulty), in addition to nonclassic symptoms, such as partial sensory deficit, dysarthria, vertigo, and diplopia, should be considered for activating a stroke response team, the group says.
A systematic review and meta-analysis revealed that women with stroke were more likely to present with nonfocal symptoms (for example, headache, altered mentality, and coma/stupor) than men, they noted.
To enhance public education about stroke symptoms and to facilitate the diagnosis and treatment of stroke, they say research is needed to better understand the presentation of stroke symptoms by other select demographic characteristics including race and ethnicity, age, and stroke subtype.
Poststroke screening should include assessment for anxiety, depression, fatigue, and pain, the writing group said.
Rhythm disorders
Turning to rhythm disorders, the writing group wrote that cardiac arrhythmias, including atrial fibrillation (AFib), atrial flutter, supraventricular tachycardia, bradyarrhythmia, and ventricular tachycardia, present with common symptoms.
Palpitations are a characteristic symptom of many cardiac arrhythmias. The most common cardiac arrhythmia, AFib, may present with palpitations or less specific symptoms (fatigue, dyspnea, dizziness) that occur with a broad range of rhythm disorders. Chest pain, dizziness, presyncope/syncope, and anxiety occur less frequently in AFib, the group said.
Palpitations are considered the typical symptom presentation for AFib, yet patients with new-onset AFib often present with nonspecific symptoms or no symptoms, they pointed out.
Women and younger individuals with AFib typically present with palpitations, whereas men are more commonly asymptomatic. Older age also increases the likelihood of a nonclassic or asymptomatic presentation of AFib.
Despite non-Hispanic Black individuals being at lower risk for development of AFib, research suggests that Black patients are burdened more with palpitations, dyspnea on exertion, exercise intolerance, dizziness, dyspnea at rest, and chest discomfort, compared with White or Hispanic patients.
Peripheral vascular disease
Classic claudication occurs in roughly one-third of patients with peripheral arterial disease (PAD) and is defined as calf pain that occurs in one or both legs with exertion (walking), does not begin at rest, and resolves within 10 minutes of standing still or rest.
However, non–calf exercise pain is reported more frequently than classic claudication symptoms. Women with PAD are more likely to have nonclassic symptoms or an absence of symptoms.
Assessing symptoms at rest, during exercise, and during recovery can assist with classifying symptoms as ischemic or not, the writing group said.
PAD with symptoms is associated with an increased risk for myocardial infarction and stroke, with men at higher risk than women.
Similar to PAD, peripheral venous disease (PVD) can be symptomatic or asymptomatic. Clinical classification of PVD includes symptoms such as leg pain, aching, fatigue, heaviness, cramping, tightness, restless legs syndrome, and skin irritation.
“Measuring vascular symptoms includes assessing quality of life and activity limitations, as well as the psychological impact of the disease. However, existing measures are often based on the clinician’s appraisal rather than the individual’s self-reported symptoms and severity of symptoms,” Dr. Jurgens commented.
Watch for depression
Finally, the writing group highlighted the importance of depression in cardiac patients, which occurs at about twice the rate, compared with people without any medical condition (10% vs. 5%).
In a prior statement, the AHA said depression should be considered a risk factor for worse outcomes in patients with ACS or CVD diagnosis.
The new statement highlights that people with persistent chest pain, people with HF, as well as stroke survivors and people with PAD commonly have depression and/or anxiety. In addition, cognitive changes after a stroke may affect how and whether symptoms are experienced or noticed.
While symptom relief is an important part of managing CVD, it’s also important to recognize that “factors such as depression and cognitive function may affect symptom detection and reporting,” Dr. Jurgens said.
“Monitoring and measuring symptoms with tools that appropriately account for depression and cognitive function may help to improve patient care by identifying more quickly people who may be at higher risk,” she added.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing; the Council on Hypertension; and the Stroke Council. The research had no commercial funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION