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New blood biomarker to detect early dementia?
Investigators found that plasma concentrations of 2-aminoethyl dihydrogen phosphate and taurine could distinguish adults with early-stage Alzheimer’s disease from cognitively normal adults.
“Our biomarker for early-stage Alzheimer’s disease represents new thinking and is unique from the amyloid-beta and p-tau molecules that are currently being investigated to diagnose AD,” Sandra Banack, PhD, senior scientist, Brain Chemistry Labs, Jackson, Wyoming, told this news organization.
If further studies pan out, Dr. Banack said this biomarker could “easily be transformed into a test to aid clinical evaluations for Alzheimer’s disease.”
The study was published online in PLOS ONE.
New drug target?
The researchers measured concentrations of 2-aminoethyl dihydrogen phosphate and taurine in blood plasma samples in 25 patients (21 men; mean age, 71) with a clinical diagnosis of early-stage Alzheimer’s based on a Clinical Dementia Rating (CDR) score of 0.5, suggesting very mild cognitive impairment, and 25 healthy controls (20 men; mean age, 39).
The concentration of 2-aminoethyl dihydrogen phosphate, normalized by the concentration of taurine, reliably distinguished blood samples of early-stage Alzheimer’s patients from controls in a blinded analysis.
This biomarker “could lead to new understanding of [AD] and lead to new drug candidates,” Dr. Banack told this news organization.
The researchers note that 2-aminoethyl dihydrogen phosphate plays an important role in the structure and function of cellular membranes.
Physiologic effects of increased 2-aminoethyl dihydrogen phosphate concentrations in the blood are not known. However, in one study, concentrations of this molecule were found to be significantly lower in the temporal cortex, frontal cortex, and hippocampus (40%) in patients with Alzheimer’s disease, compared with controls.
“New biomarkers take time before they can be implemented in the clinic. The next step will be to repeat the experiments using a large sample size of AD patient blood samples,” Dr. Banack told this news organization.
The study team is looking to source a larger sample size of AD blood samples to replicate these findings. They are also examining this biomarker relative to other neurodegenerative diseases.
“If verified with larger sample sizes, the quantification of 2-aminoethyl dihydrogen phosphate could potentially assist in the diagnosis of early-stage Alzheimer’s disease when used in conjunction with the patient’s CDR score and other potential AD biomarkers,” Dr. Banack and colleagues say.
Caveats, cautionary notes
Commenting on the findings, Rebecca M. Edelmayer, PhD, Alzheimer’s Association senior director of scientific engagement, said the study is “interesting, though very small-scale and very preliminary.”
Dr. Edelmayer said one “major limitation” is that participants did not have their Alzheimer’s diagnosis confirmed with “gold standard biomarkers. They have been diagnosed based only on their cognitive and behavioral symptoms.”
She also cautioned that the study population is not representative – either of the general public or people living with Alzheimer’s disease.
For example, 41 out of all 50 samples are from men, “though we know women are disproportionately impacted by Alzheimer’s.”
“There is a mismatch in the age of the study groups,” Dr. Edelmayer noted. The mean age of controls in the study was 39 and the mean age of people with dementia was 71. Race or ethnicity and other demographic information is also unclear from the article.
“There is an urgent need for simple, inexpensive, noninvasive and easily available diagnostic tools for Alzheimer’s, such as a blood test. A simple blood test for Alzheimer’s would be a great advance for individuals with – and at risk for – the disease, families, doctors, and researchers,” Dr. Edelmayer said.
“Bottom line,” Dr. Edelmayer continued, “these results need to be further tested and verified in long-term, large-scale studies with diverse populations that are representative of those living with Alzheimer’s disease.”
This research was supported by the William Stamps Farish Fund and the Josephine P. & John J. Louis Foundation. Brain Chemistry Labs has applied for a patent related to this research. Dr. Edelmayer has no relevant disclosures.
A version of this article first appeared on Medscape.com.
Investigators found that plasma concentrations of 2-aminoethyl dihydrogen phosphate and taurine could distinguish adults with early-stage Alzheimer’s disease from cognitively normal adults.
“Our biomarker for early-stage Alzheimer’s disease represents new thinking and is unique from the amyloid-beta and p-tau molecules that are currently being investigated to diagnose AD,” Sandra Banack, PhD, senior scientist, Brain Chemistry Labs, Jackson, Wyoming, told this news organization.
If further studies pan out, Dr. Banack said this biomarker could “easily be transformed into a test to aid clinical evaluations for Alzheimer’s disease.”
The study was published online in PLOS ONE.
New drug target?
The researchers measured concentrations of 2-aminoethyl dihydrogen phosphate and taurine in blood plasma samples in 25 patients (21 men; mean age, 71) with a clinical diagnosis of early-stage Alzheimer’s based on a Clinical Dementia Rating (CDR) score of 0.5, suggesting very mild cognitive impairment, and 25 healthy controls (20 men; mean age, 39).
The concentration of 2-aminoethyl dihydrogen phosphate, normalized by the concentration of taurine, reliably distinguished blood samples of early-stage Alzheimer’s patients from controls in a blinded analysis.
This biomarker “could lead to new understanding of [AD] and lead to new drug candidates,” Dr. Banack told this news organization.
The researchers note that 2-aminoethyl dihydrogen phosphate plays an important role in the structure and function of cellular membranes.
Physiologic effects of increased 2-aminoethyl dihydrogen phosphate concentrations in the blood are not known. However, in one study, concentrations of this molecule were found to be significantly lower in the temporal cortex, frontal cortex, and hippocampus (40%) in patients with Alzheimer’s disease, compared with controls.
“New biomarkers take time before they can be implemented in the clinic. The next step will be to repeat the experiments using a large sample size of AD patient blood samples,” Dr. Banack told this news organization.
The study team is looking to source a larger sample size of AD blood samples to replicate these findings. They are also examining this biomarker relative to other neurodegenerative diseases.
“If verified with larger sample sizes, the quantification of 2-aminoethyl dihydrogen phosphate could potentially assist in the diagnosis of early-stage Alzheimer’s disease when used in conjunction with the patient’s CDR score and other potential AD biomarkers,” Dr. Banack and colleagues say.
Caveats, cautionary notes
Commenting on the findings, Rebecca M. Edelmayer, PhD, Alzheimer’s Association senior director of scientific engagement, said the study is “interesting, though very small-scale and very preliminary.”
Dr. Edelmayer said one “major limitation” is that participants did not have their Alzheimer’s diagnosis confirmed with “gold standard biomarkers. They have been diagnosed based only on their cognitive and behavioral symptoms.”
She also cautioned that the study population is not representative – either of the general public or people living with Alzheimer’s disease.
For example, 41 out of all 50 samples are from men, “though we know women are disproportionately impacted by Alzheimer’s.”
“There is a mismatch in the age of the study groups,” Dr. Edelmayer noted. The mean age of controls in the study was 39 and the mean age of people with dementia was 71. Race or ethnicity and other demographic information is also unclear from the article.
“There is an urgent need for simple, inexpensive, noninvasive and easily available diagnostic tools for Alzheimer’s, such as a blood test. A simple blood test for Alzheimer’s would be a great advance for individuals with – and at risk for – the disease, families, doctors, and researchers,” Dr. Edelmayer said.
“Bottom line,” Dr. Edelmayer continued, “these results need to be further tested and verified in long-term, large-scale studies with diverse populations that are representative of those living with Alzheimer’s disease.”
This research was supported by the William Stamps Farish Fund and the Josephine P. & John J. Louis Foundation. Brain Chemistry Labs has applied for a patent related to this research. Dr. Edelmayer has no relevant disclosures.
A version of this article first appeared on Medscape.com.
Investigators found that plasma concentrations of 2-aminoethyl dihydrogen phosphate and taurine could distinguish adults with early-stage Alzheimer’s disease from cognitively normal adults.
“Our biomarker for early-stage Alzheimer’s disease represents new thinking and is unique from the amyloid-beta and p-tau molecules that are currently being investigated to diagnose AD,” Sandra Banack, PhD, senior scientist, Brain Chemistry Labs, Jackson, Wyoming, told this news organization.
If further studies pan out, Dr. Banack said this biomarker could “easily be transformed into a test to aid clinical evaluations for Alzheimer’s disease.”
The study was published online in PLOS ONE.
New drug target?
The researchers measured concentrations of 2-aminoethyl dihydrogen phosphate and taurine in blood plasma samples in 25 patients (21 men; mean age, 71) with a clinical diagnosis of early-stage Alzheimer’s based on a Clinical Dementia Rating (CDR) score of 0.5, suggesting very mild cognitive impairment, and 25 healthy controls (20 men; mean age, 39).
The concentration of 2-aminoethyl dihydrogen phosphate, normalized by the concentration of taurine, reliably distinguished blood samples of early-stage Alzheimer’s patients from controls in a blinded analysis.
This biomarker “could lead to new understanding of [AD] and lead to new drug candidates,” Dr. Banack told this news organization.
The researchers note that 2-aminoethyl dihydrogen phosphate plays an important role in the structure and function of cellular membranes.
Physiologic effects of increased 2-aminoethyl dihydrogen phosphate concentrations in the blood are not known. However, in one study, concentrations of this molecule were found to be significantly lower in the temporal cortex, frontal cortex, and hippocampus (40%) in patients with Alzheimer’s disease, compared with controls.
“New biomarkers take time before they can be implemented in the clinic. The next step will be to repeat the experiments using a large sample size of AD patient blood samples,” Dr. Banack told this news organization.
The study team is looking to source a larger sample size of AD blood samples to replicate these findings. They are also examining this biomarker relative to other neurodegenerative diseases.
“If verified with larger sample sizes, the quantification of 2-aminoethyl dihydrogen phosphate could potentially assist in the diagnosis of early-stage Alzheimer’s disease when used in conjunction with the patient’s CDR score and other potential AD biomarkers,” Dr. Banack and colleagues say.
Caveats, cautionary notes
Commenting on the findings, Rebecca M. Edelmayer, PhD, Alzheimer’s Association senior director of scientific engagement, said the study is “interesting, though very small-scale and very preliminary.”
Dr. Edelmayer said one “major limitation” is that participants did not have their Alzheimer’s diagnosis confirmed with “gold standard biomarkers. They have been diagnosed based only on their cognitive and behavioral symptoms.”
She also cautioned that the study population is not representative – either of the general public or people living with Alzheimer’s disease.
For example, 41 out of all 50 samples are from men, “though we know women are disproportionately impacted by Alzheimer’s.”
“There is a mismatch in the age of the study groups,” Dr. Edelmayer noted. The mean age of controls in the study was 39 and the mean age of people with dementia was 71. Race or ethnicity and other demographic information is also unclear from the article.
“There is an urgent need for simple, inexpensive, noninvasive and easily available diagnostic tools for Alzheimer’s, such as a blood test. A simple blood test for Alzheimer’s would be a great advance for individuals with – and at risk for – the disease, families, doctors, and researchers,” Dr. Edelmayer said.
“Bottom line,” Dr. Edelmayer continued, “these results need to be further tested and verified in long-term, large-scale studies with diverse populations that are representative of those living with Alzheimer’s disease.”
This research was supported by the William Stamps Farish Fund and the Josephine P. & John J. Louis Foundation. Brain Chemistry Labs has applied for a patent related to this research. Dr. Edelmayer has no relevant disclosures.
A version of this article first appeared on Medscape.com.
FDA clears mavacamten (Camzyos) for obstructive hypertrophic cardiomyopathy
The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).
Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.
“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
‘Revolutionary’ change
The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.
In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.
The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.
Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.
“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.
The product information for mavacamten includes a boxed warning citing a risk for heart failure.
Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.
Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.
Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.
Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).
Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.
“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
‘Revolutionary’ change
The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.
In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.
The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.
Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.
“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.
The product information for mavacamten includes a boxed warning citing a risk for heart failure.
Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.
Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.
Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.
Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).
Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.
“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
‘Revolutionary’ change
The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.
In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.
The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.
Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.
“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.
The product information for mavacamten includes a boxed warning citing a risk for heart failure.
Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.
Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.
Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.
Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
FDA warns of pump defect with Medtronic HVAD system
Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals.
Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.
This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Pump thrombosis
Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.
All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.
Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.
The FDA does not recommend the elective removal of properly functioning systems.
“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.
Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.
If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.
For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.
The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals.
Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.
This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Pump thrombosis
Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.
All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.
Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.
The FDA does not recommend the elective removal of properly functioning systems.
“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.
Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.
If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.
For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.
The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals.
Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.
This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Pump thrombosis
Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.
All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.
Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.
The FDA does not recommend the elective removal of properly functioning systems.
“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.
Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.
If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.
For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.
The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Implant may alleviate sleep apnea in teens with Down syndrome
Upper airway hypoglossal nerve stimulation is safe and effective in adolescents with Down syndrome and severe persistent obstructive sleep apnea (OSA) occurring after adenotonsillectomy and who couldn’t tolerate positive airway pressure, early research suggests.
In a phase I study, 42 adolescents received a surgically implanted device that moves the tongue forward during sleep. Results at 1-year follow-up showed 66% “responded well” to treatment and showed a drop in apnea-hypopnea index (AHI) of at least 50%.
“Parents came back to us and said not only is the sleep better but my child seems to be doing better during the day,” lead investigator Christopher Hartnick, MD, director of the Division of Pediatric Otolaryngology and the Pediatric Airway, Voice, and Swallowing Center at Massachusetts Eye and Ear, Boston, told this news organization.
The findings were published online in JAMA Otolaryngology – Head and Neck Surgery.
Limited options
Upper airway simulation has been shown previously to be effective for adults with OSA, but up until now, the process has not been evaluated in children.
The device used in the current study “stimulates the hypoglossal nerve to protrude the tongue and open the airway on inspiration during sleep,” the investigators note.
“Hypoglossal nerve stimulation may be a particularly suitable therapy for patients with Down syndrome because it can augment neuromuscular airway tone and reduce anatomical obstruction at the base of the tongue, a common site of residual obstruction in children with Down syndrome,” they add.
“This study was born out of the frustration of not having an effective treatment option for children with Down syndrome who struggle with sleep apnea,” Dr. Hartnick said in a news release.
A total of 42 adolescents (67% male; mean age, 15 years) with Down syndrome and persistent severe OSA after adenotonsillectomy were implanted with the hypoglossal nerve stimulator. All were followed for 12 months.
The surgery was safe, with the most common adverse event being temporary tongue discomfort in five patients (12%). This typically resolved in weeks, the researchers note.
High response, adherence rates
Results showed response rates and adherence to therapy was high. The mean duration of nightly therapy was 9 hours, with 40 children (95.2%) using the device at least 4 hours every night.
The implant was also effective, with a mean decrease in AHI of 12.9 events per hour (95% confidence interval, –17.0 to –8.7 events per hour).
Nearly two-thirds of the children had at least a 50% reduction in their AHI, while roughly three-fourths had a 12-month follow-up AHI of less than 10 events per hour.
There were also significant improvements in polysomnographic and parent-reported quality of life outcomes 12 months after the implant, including improvement in sleep and daily functioning, behavior, and language.
“Sleep apnea remains one of the most common conditions that I grapple with working with patients with Down syndrome and their families,” co-investigator Brian Skotko, MD, Emma Campbell endowed chair on Down syndrome at Massachusetts General Hospital, Boston, said in the release.
“Until now, so many of our patients had run out of treatment options, and their health and well-being were declining. Now, with the hypoglossal nerve stimulator treatment, we may have an effective and safe way to treat apnea and maximize brain health for people with Down syndrome,” Dr. Skotko added.
Dr. Hartnick and Dr. Skotko have received a $4 million, 5-year grant from the National Institutes of Health to assess whether upper airway stimulation might help cognition in children with Down syndrome.
Landmark investigation
Co-authors of an invited commentary said they “applaud” the researchers for their “landmark” investigation, which demonstrated a response to upper airway stimulation in children with Down syndrome and OSA that is on par with what has been achieved in adults with OSA.
“They have established the safety of the procedure; however, future research is necessary to optimize the results of implant,” write Norman Friedman, MD, and Katherine Green, MD, both from the department of otolaryngology – head and neck surgery, University of Colorado School of Medicine, Aurora.
“Further assessment regarding patient selection and the systematic preoperative identification of potential barriers that might affect successful use of therapy will be beneficial to improve longitudinal outcomes and success in this population that is uniquely different from the adult cohorts that have received implants to date,” they add.
The study was funded by Inspire Medical Systems, which provided eight devices for the study but otherwise did not have a role in its design and conduct. The LuMind IDSC Down Syndrome Foundation also provided funding for the study. Dr. Hartnick and the editorialists have disclosed no relevant financial relationships. A complete list of disclosures for the other investigators is available in the original article.
A version of this article first appeared on Medscape.com.
Upper airway hypoglossal nerve stimulation is safe and effective in adolescents with Down syndrome and severe persistent obstructive sleep apnea (OSA) occurring after adenotonsillectomy and who couldn’t tolerate positive airway pressure, early research suggests.
In a phase I study, 42 adolescents received a surgically implanted device that moves the tongue forward during sleep. Results at 1-year follow-up showed 66% “responded well” to treatment and showed a drop in apnea-hypopnea index (AHI) of at least 50%.
“Parents came back to us and said not only is the sleep better but my child seems to be doing better during the day,” lead investigator Christopher Hartnick, MD, director of the Division of Pediatric Otolaryngology and the Pediatric Airway, Voice, and Swallowing Center at Massachusetts Eye and Ear, Boston, told this news organization.
The findings were published online in JAMA Otolaryngology – Head and Neck Surgery.
Limited options
Upper airway simulation has been shown previously to be effective for adults with OSA, but up until now, the process has not been evaluated in children.
The device used in the current study “stimulates the hypoglossal nerve to protrude the tongue and open the airway on inspiration during sleep,” the investigators note.
“Hypoglossal nerve stimulation may be a particularly suitable therapy for patients with Down syndrome because it can augment neuromuscular airway tone and reduce anatomical obstruction at the base of the tongue, a common site of residual obstruction in children with Down syndrome,” they add.
“This study was born out of the frustration of not having an effective treatment option for children with Down syndrome who struggle with sleep apnea,” Dr. Hartnick said in a news release.
A total of 42 adolescents (67% male; mean age, 15 years) with Down syndrome and persistent severe OSA after adenotonsillectomy were implanted with the hypoglossal nerve stimulator. All were followed for 12 months.
The surgery was safe, with the most common adverse event being temporary tongue discomfort in five patients (12%). This typically resolved in weeks, the researchers note.
High response, adherence rates
Results showed response rates and adherence to therapy was high. The mean duration of nightly therapy was 9 hours, with 40 children (95.2%) using the device at least 4 hours every night.
The implant was also effective, with a mean decrease in AHI of 12.9 events per hour (95% confidence interval, –17.0 to –8.7 events per hour).
Nearly two-thirds of the children had at least a 50% reduction in their AHI, while roughly three-fourths had a 12-month follow-up AHI of less than 10 events per hour.
There were also significant improvements in polysomnographic and parent-reported quality of life outcomes 12 months after the implant, including improvement in sleep and daily functioning, behavior, and language.
“Sleep apnea remains one of the most common conditions that I grapple with working with patients with Down syndrome and their families,” co-investigator Brian Skotko, MD, Emma Campbell endowed chair on Down syndrome at Massachusetts General Hospital, Boston, said in the release.
“Until now, so many of our patients had run out of treatment options, and their health and well-being were declining. Now, with the hypoglossal nerve stimulator treatment, we may have an effective and safe way to treat apnea and maximize brain health for people with Down syndrome,” Dr. Skotko added.
Dr. Hartnick and Dr. Skotko have received a $4 million, 5-year grant from the National Institutes of Health to assess whether upper airway stimulation might help cognition in children with Down syndrome.
Landmark investigation
Co-authors of an invited commentary said they “applaud” the researchers for their “landmark” investigation, which demonstrated a response to upper airway stimulation in children with Down syndrome and OSA that is on par with what has been achieved in adults with OSA.
“They have established the safety of the procedure; however, future research is necessary to optimize the results of implant,” write Norman Friedman, MD, and Katherine Green, MD, both from the department of otolaryngology – head and neck surgery, University of Colorado School of Medicine, Aurora.
“Further assessment regarding patient selection and the systematic preoperative identification of potential barriers that might affect successful use of therapy will be beneficial to improve longitudinal outcomes and success in this population that is uniquely different from the adult cohorts that have received implants to date,” they add.
The study was funded by Inspire Medical Systems, which provided eight devices for the study but otherwise did not have a role in its design and conduct. The LuMind IDSC Down Syndrome Foundation also provided funding for the study. Dr. Hartnick and the editorialists have disclosed no relevant financial relationships. A complete list of disclosures for the other investigators is available in the original article.
A version of this article first appeared on Medscape.com.
Upper airway hypoglossal nerve stimulation is safe and effective in adolescents with Down syndrome and severe persistent obstructive sleep apnea (OSA) occurring after adenotonsillectomy and who couldn’t tolerate positive airway pressure, early research suggests.
In a phase I study, 42 adolescents received a surgically implanted device that moves the tongue forward during sleep. Results at 1-year follow-up showed 66% “responded well” to treatment and showed a drop in apnea-hypopnea index (AHI) of at least 50%.
“Parents came back to us and said not only is the sleep better but my child seems to be doing better during the day,” lead investigator Christopher Hartnick, MD, director of the Division of Pediatric Otolaryngology and the Pediatric Airway, Voice, and Swallowing Center at Massachusetts Eye and Ear, Boston, told this news organization.
The findings were published online in JAMA Otolaryngology – Head and Neck Surgery.
Limited options
Upper airway simulation has been shown previously to be effective for adults with OSA, but up until now, the process has not been evaluated in children.
The device used in the current study “stimulates the hypoglossal nerve to protrude the tongue and open the airway on inspiration during sleep,” the investigators note.
“Hypoglossal nerve stimulation may be a particularly suitable therapy for patients with Down syndrome because it can augment neuromuscular airway tone and reduce anatomical obstruction at the base of the tongue, a common site of residual obstruction in children with Down syndrome,” they add.
“This study was born out of the frustration of not having an effective treatment option for children with Down syndrome who struggle with sleep apnea,” Dr. Hartnick said in a news release.
A total of 42 adolescents (67% male; mean age, 15 years) with Down syndrome and persistent severe OSA after adenotonsillectomy were implanted with the hypoglossal nerve stimulator. All were followed for 12 months.
The surgery was safe, with the most common adverse event being temporary tongue discomfort in five patients (12%). This typically resolved in weeks, the researchers note.
High response, adherence rates
Results showed response rates and adherence to therapy was high. The mean duration of nightly therapy was 9 hours, with 40 children (95.2%) using the device at least 4 hours every night.
The implant was also effective, with a mean decrease in AHI of 12.9 events per hour (95% confidence interval, –17.0 to –8.7 events per hour).
Nearly two-thirds of the children had at least a 50% reduction in their AHI, while roughly three-fourths had a 12-month follow-up AHI of less than 10 events per hour.
There were also significant improvements in polysomnographic and parent-reported quality of life outcomes 12 months after the implant, including improvement in sleep and daily functioning, behavior, and language.
“Sleep apnea remains one of the most common conditions that I grapple with working with patients with Down syndrome and their families,” co-investigator Brian Skotko, MD, Emma Campbell endowed chair on Down syndrome at Massachusetts General Hospital, Boston, said in the release.
“Until now, so many of our patients had run out of treatment options, and their health and well-being were declining. Now, with the hypoglossal nerve stimulator treatment, we may have an effective and safe way to treat apnea and maximize brain health for people with Down syndrome,” Dr. Skotko added.
Dr. Hartnick and Dr. Skotko have received a $4 million, 5-year grant from the National Institutes of Health to assess whether upper airway stimulation might help cognition in children with Down syndrome.
Landmark investigation
Co-authors of an invited commentary said they “applaud” the researchers for their “landmark” investigation, which demonstrated a response to upper airway stimulation in children with Down syndrome and OSA that is on par with what has been achieved in adults with OSA.
“They have established the safety of the procedure; however, future research is necessary to optimize the results of implant,” write Norman Friedman, MD, and Katherine Green, MD, both from the department of otolaryngology – head and neck surgery, University of Colorado School of Medicine, Aurora.
“Further assessment regarding patient selection and the systematic preoperative identification of potential barriers that might affect successful use of therapy will be beneficial to improve longitudinal outcomes and success in this population that is uniquely different from the adult cohorts that have received implants to date,” they add.
The study was funded by Inspire Medical Systems, which provided eight devices for the study but otherwise did not have a role in its design and conduct. The LuMind IDSC Down Syndrome Foundation also provided funding for the study. Dr. Hartnick and the editorialists have disclosed no relevant financial relationships. A complete list of disclosures for the other investigators is available in the original article.
A version of this article first appeared on Medscape.com.
Pfizer recalls more quinapril because of potential carcinogen
, the company announced.
The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.
Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.
To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.
“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.
Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.
The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.
Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.
Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.
Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
, the company announced.
The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.
Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.
To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.
“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.
Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.
The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.
Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.
Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.
Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
, the company announced.
The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.
Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.
To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.
“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.
Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.
The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.
Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.
Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.
Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Antidepressant study yields controversial findings
Researchers who conducted the study admit this finding was unexpected, and outside experts say no firm conclusions can be drawn from the research.
“Of course we were surprised by the results,” first author Omar Almohammed, PharmD, PhD, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, told this news organization.
“We were expecting to see some positive impact with the use of antidepressant medications on the HRQoL measures when we compared these patients to patients that did not use antidepressant medications,” Dr. Almohammed said.
The study was published online in PLOS ONE.
Controversial impact on quality of life
Depression is known to harm HRQoL. Despite evidence that antidepressants improve depressed mood, their effect on patients’ overall well-being and HRQoL remains controversial.
The researchers examined the effect of antidepressants on HRQoL in adults with depression using 11 years of data from the U.S. Medical Expenditures Panel Survey (MEPS), a large longitudinal survey that tracks health service use in the United States. HRQoL was measured using the 12-item Short Form Health Survey (SF-12).
On average, about 17.5 million adults were diagnosed with depression each year during the study period (2005-2016). More than half (57.6%) of these patients were treated with antidepressants.
Patients with depression had an average age of 48.3 years. Women made up more than two-thirds of the total sample (68%), and more women than men received antidepressants (61% vs. 52%).
Compared with no antidepressant use, antidepressant use was associated with some improvement on the mental, but not physical, component of the SF-12, the researchers report.
However, difference-in-differences (D-I-D) univariate analysis showed no significant difference between adults using and not using antidepressants in the SF-12 physical (-0.35 vs. -0.34; P = .9,595) or mental component (1.28 vs. 1.13; P = .6,405).
“The multivariate D-I-D analyses ensured the robustness of these results,” the researchers note.
The change in HRQoL observed in patients using antidepressants was not significantly different from that seen among peers not using these drugs, the researchers report.
“We are not saying that antidepressant medications are not helpful at all; HRQoL is only one of many measures intended to assess health outcomes,” Dr. Almohammed told this news organization.
“Based on our research design and data, we can only say that patients who used antidepressant medications did not experience better change in terms of HRQoL compared to patients who did not use antidepressant medications,” he said.
“These patients may have had some improvement on other clinical outcome measures, but that clinical improvement did not have a significant positive impact on HRQoL,” he noted.
“We still recommend that patients continue using their antidepressant medications, but they may want to ask their doctors to provide them with other nonpharmacologic interventions as this may have additional impact on their HRQoL,” Dr. Almohammed said.
Further research is needed to address a “gap in knowledge” about the impact of nondrug interventions – alone or in combination with antidepressant medications – on patients’ HRQoL, Dr. Almohammed added.
Experts weigh in
Several experts weighed in on the study in a statement from the British nonprofit Science Media Center.
Gemma Lewis, PhD, with University College London (UCL), noted that “clinical trials with experimental designs have found that antidepressants improve mental health-related quality of life.”
“In this study, the people who received antidepressants had worse quality of life, and are likely to have been more severely depressed, than those who did not. This type of bias is difficult to eliminate in a naturalistic study like this, which does not involve an experimental design,” Dr. Lewis commented.
Eduard Vieta, PhD, with University of Barcelona, noted the “inability to control for severity of depression between the two different groups is a crucial flaw, and therefore, there is little we can learn from this data.”
Echoing Dr. Vieta, David Curtis, MBBS, MD, PhD, with UCL Genetics Institute, said, “One might well assume that the people who were taking antidepressants had been more severely depressed than those who were not.”
“From this point of view, one could argue that it seems that the antidepressants were effective and that with their use people who had presented with more severe depression did not have markedly reduced quality of life,” Dr. Curtis said.
“However, the reality is that this kind of observational study tells us nothing about causation. For that, clinical trials are required, and numerous such trials have demonstrated that, on average, antidepressants are effective in terms of treating depressive illness and in improving the quality of life of patients with significant depression,” he added.
Michael Sharpe, MD, with University of Oxford, said the study highlights the importance of measuring the long-term outcomes of treatments for depression. “However, this study has no clear implication for the care of patients with depression and certainly should not discourage patients who may benefit from taking these drugs.”
Livia de Picker, MD, PhD, with University of Antwerp, Belgium, said, “What these data do point towards is the persistent treatment gap for depression in the United States, with only 57.6% of patients with major depressive disorder receiving treatment with antidepressants over a 2-year follow-up.”
Funding for the study was provided by King Saud University, Riyadh, Saudi Arabia. Dr. Almohammed, Dr. de Picker, Dr. Curtis, Dr. Lewis, and Dr. Sharpe have disclosed no relevant financial relationships. Dr. Vieta has participated in clinical trials of antidepressants and advisory boards for Angelini, Biogen, Janssen, and Lundbeck.
A version of this article first appeared on Medscape.com.
Researchers who conducted the study admit this finding was unexpected, and outside experts say no firm conclusions can be drawn from the research.
“Of course we were surprised by the results,” first author Omar Almohammed, PharmD, PhD, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, told this news organization.
“We were expecting to see some positive impact with the use of antidepressant medications on the HRQoL measures when we compared these patients to patients that did not use antidepressant medications,” Dr. Almohammed said.
The study was published online in PLOS ONE.
Controversial impact on quality of life
Depression is known to harm HRQoL. Despite evidence that antidepressants improve depressed mood, their effect on patients’ overall well-being and HRQoL remains controversial.
The researchers examined the effect of antidepressants on HRQoL in adults with depression using 11 years of data from the U.S. Medical Expenditures Panel Survey (MEPS), a large longitudinal survey that tracks health service use in the United States. HRQoL was measured using the 12-item Short Form Health Survey (SF-12).
On average, about 17.5 million adults were diagnosed with depression each year during the study period (2005-2016). More than half (57.6%) of these patients were treated with antidepressants.
Patients with depression had an average age of 48.3 years. Women made up more than two-thirds of the total sample (68%), and more women than men received antidepressants (61% vs. 52%).
Compared with no antidepressant use, antidepressant use was associated with some improvement on the mental, but not physical, component of the SF-12, the researchers report.
However, difference-in-differences (D-I-D) univariate analysis showed no significant difference between adults using and not using antidepressants in the SF-12 physical (-0.35 vs. -0.34; P = .9,595) or mental component (1.28 vs. 1.13; P = .6,405).
“The multivariate D-I-D analyses ensured the robustness of these results,” the researchers note.
The change in HRQoL observed in patients using antidepressants was not significantly different from that seen among peers not using these drugs, the researchers report.
“We are not saying that antidepressant medications are not helpful at all; HRQoL is only one of many measures intended to assess health outcomes,” Dr. Almohammed told this news organization.
“Based on our research design and data, we can only say that patients who used antidepressant medications did not experience better change in terms of HRQoL compared to patients who did not use antidepressant medications,” he said.
“These patients may have had some improvement on other clinical outcome measures, but that clinical improvement did not have a significant positive impact on HRQoL,” he noted.
“We still recommend that patients continue using their antidepressant medications, but they may want to ask their doctors to provide them with other nonpharmacologic interventions as this may have additional impact on their HRQoL,” Dr. Almohammed said.
Further research is needed to address a “gap in knowledge” about the impact of nondrug interventions – alone or in combination with antidepressant medications – on patients’ HRQoL, Dr. Almohammed added.
Experts weigh in
Several experts weighed in on the study in a statement from the British nonprofit Science Media Center.
Gemma Lewis, PhD, with University College London (UCL), noted that “clinical trials with experimental designs have found that antidepressants improve mental health-related quality of life.”
“In this study, the people who received antidepressants had worse quality of life, and are likely to have been more severely depressed, than those who did not. This type of bias is difficult to eliminate in a naturalistic study like this, which does not involve an experimental design,” Dr. Lewis commented.
Eduard Vieta, PhD, with University of Barcelona, noted the “inability to control for severity of depression between the two different groups is a crucial flaw, and therefore, there is little we can learn from this data.”
Echoing Dr. Vieta, David Curtis, MBBS, MD, PhD, with UCL Genetics Institute, said, “One might well assume that the people who were taking antidepressants had been more severely depressed than those who were not.”
“From this point of view, one could argue that it seems that the antidepressants were effective and that with their use people who had presented with more severe depression did not have markedly reduced quality of life,” Dr. Curtis said.
“However, the reality is that this kind of observational study tells us nothing about causation. For that, clinical trials are required, and numerous such trials have demonstrated that, on average, antidepressants are effective in terms of treating depressive illness and in improving the quality of life of patients with significant depression,” he added.
Michael Sharpe, MD, with University of Oxford, said the study highlights the importance of measuring the long-term outcomes of treatments for depression. “However, this study has no clear implication for the care of patients with depression and certainly should not discourage patients who may benefit from taking these drugs.”
Livia de Picker, MD, PhD, with University of Antwerp, Belgium, said, “What these data do point towards is the persistent treatment gap for depression in the United States, with only 57.6% of patients with major depressive disorder receiving treatment with antidepressants over a 2-year follow-up.”
Funding for the study was provided by King Saud University, Riyadh, Saudi Arabia. Dr. Almohammed, Dr. de Picker, Dr. Curtis, Dr. Lewis, and Dr. Sharpe have disclosed no relevant financial relationships. Dr. Vieta has participated in clinical trials of antidepressants and advisory boards for Angelini, Biogen, Janssen, and Lundbeck.
A version of this article first appeared on Medscape.com.
Researchers who conducted the study admit this finding was unexpected, and outside experts say no firm conclusions can be drawn from the research.
“Of course we were surprised by the results,” first author Omar Almohammed, PharmD, PhD, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, told this news organization.
“We were expecting to see some positive impact with the use of antidepressant medications on the HRQoL measures when we compared these patients to patients that did not use antidepressant medications,” Dr. Almohammed said.
The study was published online in PLOS ONE.
Controversial impact on quality of life
Depression is known to harm HRQoL. Despite evidence that antidepressants improve depressed mood, their effect on patients’ overall well-being and HRQoL remains controversial.
The researchers examined the effect of antidepressants on HRQoL in adults with depression using 11 years of data from the U.S. Medical Expenditures Panel Survey (MEPS), a large longitudinal survey that tracks health service use in the United States. HRQoL was measured using the 12-item Short Form Health Survey (SF-12).
On average, about 17.5 million adults were diagnosed with depression each year during the study period (2005-2016). More than half (57.6%) of these patients were treated with antidepressants.
Patients with depression had an average age of 48.3 years. Women made up more than two-thirds of the total sample (68%), and more women than men received antidepressants (61% vs. 52%).
Compared with no antidepressant use, antidepressant use was associated with some improvement on the mental, but not physical, component of the SF-12, the researchers report.
However, difference-in-differences (D-I-D) univariate analysis showed no significant difference between adults using and not using antidepressants in the SF-12 physical (-0.35 vs. -0.34; P = .9,595) or mental component (1.28 vs. 1.13; P = .6,405).
“The multivariate D-I-D analyses ensured the robustness of these results,” the researchers note.
The change in HRQoL observed in patients using antidepressants was not significantly different from that seen among peers not using these drugs, the researchers report.
“We are not saying that antidepressant medications are not helpful at all; HRQoL is only one of many measures intended to assess health outcomes,” Dr. Almohammed told this news organization.
“Based on our research design and data, we can only say that patients who used antidepressant medications did not experience better change in terms of HRQoL compared to patients who did not use antidepressant medications,” he said.
“These patients may have had some improvement on other clinical outcome measures, but that clinical improvement did not have a significant positive impact on HRQoL,” he noted.
“We still recommend that patients continue using their antidepressant medications, but they may want to ask their doctors to provide them with other nonpharmacologic interventions as this may have additional impact on their HRQoL,” Dr. Almohammed said.
Further research is needed to address a “gap in knowledge” about the impact of nondrug interventions – alone or in combination with antidepressant medications – on patients’ HRQoL, Dr. Almohammed added.
Experts weigh in
Several experts weighed in on the study in a statement from the British nonprofit Science Media Center.
Gemma Lewis, PhD, with University College London (UCL), noted that “clinical trials with experimental designs have found that antidepressants improve mental health-related quality of life.”
“In this study, the people who received antidepressants had worse quality of life, and are likely to have been more severely depressed, than those who did not. This type of bias is difficult to eliminate in a naturalistic study like this, which does not involve an experimental design,” Dr. Lewis commented.
Eduard Vieta, PhD, with University of Barcelona, noted the “inability to control for severity of depression between the two different groups is a crucial flaw, and therefore, there is little we can learn from this data.”
Echoing Dr. Vieta, David Curtis, MBBS, MD, PhD, with UCL Genetics Institute, said, “One might well assume that the people who were taking antidepressants had been more severely depressed than those who were not.”
“From this point of view, one could argue that it seems that the antidepressants were effective and that with their use people who had presented with more severe depression did not have markedly reduced quality of life,” Dr. Curtis said.
“However, the reality is that this kind of observational study tells us nothing about causation. For that, clinical trials are required, and numerous such trials have demonstrated that, on average, antidepressants are effective in terms of treating depressive illness and in improving the quality of life of patients with significant depression,” he added.
Michael Sharpe, MD, with University of Oxford, said the study highlights the importance of measuring the long-term outcomes of treatments for depression. “However, this study has no clear implication for the care of patients with depression and certainly should not discourage patients who may benefit from taking these drugs.”
Livia de Picker, MD, PhD, with University of Antwerp, Belgium, said, “What these data do point towards is the persistent treatment gap for depression in the United States, with only 57.6% of patients with major depressive disorder receiving treatment with antidepressants over a 2-year follow-up.”
Funding for the study was provided by King Saud University, Riyadh, Saudi Arabia. Dr. Almohammed, Dr. de Picker, Dr. Curtis, Dr. Lewis, and Dr. Sharpe have disclosed no relevant financial relationships. Dr. Vieta has participated in clinical trials of antidepressants and advisory boards for Angelini, Biogen, Janssen, and Lundbeck.
A version of this article first appeared on Medscape.com.
2020 presidential election tied to spike in cardiac events
The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.
The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.
“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.
The study was published in the April issue of JAMA Network Open.
Stress and the heart
In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.
Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.
There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).
There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).
There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.
The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.
“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.
Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.
However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.
There is growing evidence that psychological health contributes to CVD.
Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.
The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.
Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.
The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.
“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.
The study was published in the April issue of JAMA Network Open.
Stress and the heart
In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.
Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.
There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).
There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).
There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.
The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.
“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.
Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.
However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.
There is growing evidence that psychological health contributes to CVD.
Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.
The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.
Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.
The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.
“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.
The study was published in the April issue of JAMA Network Open.
Stress and the heart
In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.
Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.
There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).
There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).
There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.
The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.
“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.
Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.
However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.
There is growing evidence that psychological health contributes to CVD.
Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.
The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.
Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Cancer hospitals often mark up drug prices, ignore price transparency rules
Among those that do provide this information, new research shows that hospitals substantially mark up prices for top-selling cancer therapies relative to acquisition costs. Median drug price markups across NCI centers and payers ranged from nearly 120% to more than 600%.
As a result, “the total price for an entire treatment course could vary on the order of hundreds of thousands of dollars,” Roy Xiao, MD, department of otolaryngology–head and neck surgery, Massachusetts Eye and Ear Infirmary, Boston, said in an interview.
The study was published online in JAMA Internal Medicine.
Manufacturers often price novel anticancer therapies at more than $100,000 per year, but less is known about how much hospitals mark up these prices for patients with private health insurance and how much negotiated prices vary across centers and payers.
Dr. Xiao and colleagues analyzed private payer-specific negotiated prices for the top 25 parenteral cancer therapies by Medicare Part B spending in 2019 using publicly available hospital price transparency files for 61 NCI-designated cancer centers.
Fewer than half of the centers (44.3%) disclosed payer-specific negotiated prices for at least one top-selling cancer drug. Disclosure rates for different drugs ranged from 21.3% (13 centers) for rituximab with hyaluronidase to 42.6% (26 centers) for rituximab, bevacizumab, or leuprolide.
The researchers also found a wide variation in negotiated prices for cancer therapies across hospitals. Across-center price ratios – defined as the ratio between the 90th and 10th percentile median price per unit – ranged from 2.2 ($16 vs. $36 for pembrolizumab 1 mg) and 15.8 ($247 vs. $3,914 for leuprolide 7.5 mg).
Payer-specific prices also varied considerably between payers at the same center. Among all centers, the median within-center price ratios for cancer therapies ranged from 1.8 (brentuximab) to 2.5 (bevacizumab).
As for the extent of cancer therapy markups, median price markups across centers and payers ranged from 118% (sipuleucel-T) to 634% (leuprolide) more than the estimated cost paid by hospitals.
Conservative estimates of acquisition costs and payer-specific prices yielded markups ranging from 42.1% (sipuleucel-T) to 234.1% (leuprolide).
The authors also provided examples of how these variations might affect the total cost of treatment. For instance, the median total price variation across centers to treat metastatic non–small cell lung cancer with pembrolizumab was $168,405. At one institution, the within-center median price variation for daratumumab as third-line therapy for multiple myeloma was $174,225.
To reduce the financial burden of cancer treatment for patients, the authors suggested implementing public policies “to discourage or prevent excessive hospital price markups on parenteral chemotherapeutics.”
To promote hospital compliance with transparency regulations, in January 2022, the Centers for Medicare & Medicare Services increased penalties for nondisclosure from a fixed maximum of $300 per day to up to $5,500 per day, based on hospital bed size, which would total over $2 million per year, Dr. Xiao said in an interview.
“We would expect that this significant financial penalty would encourage more consistent reporting,” he said.
The study had no specific funding. Dr. Xiao has disclosed no relevant disclosures.
A version of this article first appeared on Medscape.com.
Among those that do provide this information, new research shows that hospitals substantially mark up prices for top-selling cancer therapies relative to acquisition costs. Median drug price markups across NCI centers and payers ranged from nearly 120% to more than 600%.
As a result, “the total price for an entire treatment course could vary on the order of hundreds of thousands of dollars,” Roy Xiao, MD, department of otolaryngology–head and neck surgery, Massachusetts Eye and Ear Infirmary, Boston, said in an interview.
The study was published online in JAMA Internal Medicine.
Manufacturers often price novel anticancer therapies at more than $100,000 per year, but less is known about how much hospitals mark up these prices for patients with private health insurance and how much negotiated prices vary across centers and payers.
Dr. Xiao and colleagues analyzed private payer-specific negotiated prices for the top 25 parenteral cancer therapies by Medicare Part B spending in 2019 using publicly available hospital price transparency files for 61 NCI-designated cancer centers.
Fewer than half of the centers (44.3%) disclosed payer-specific negotiated prices for at least one top-selling cancer drug. Disclosure rates for different drugs ranged from 21.3% (13 centers) for rituximab with hyaluronidase to 42.6% (26 centers) for rituximab, bevacizumab, or leuprolide.
The researchers also found a wide variation in negotiated prices for cancer therapies across hospitals. Across-center price ratios – defined as the ratio between the 90th and 10th percentile median price per unit – ranged from 2.2 ($16 vs. $36 for pembrolizumab 1 mg) and 15.8 ($247 vs. $3,914 for leuprolide 7.5 mg).
Payer-specific prices also varied considerably between payers at the same center. Among all centers, the median within-center price ratios for cancer therapies ranged from 1.8 (brentuximab) to 2.5 (bevacizumab).
As for the extent of cancer therapy markups, median price markups across centers and payers ranged from 118% (sipuleucel-T) to 634% (leuprolide) more than the estimated cost paid by hospitals.
Conservative estimates of acquisition costs and payer-specific prices yielded markups ranging from 42.1% (sipuleucel-T) to 234.1% (leuprolide).
The authors also provided examples of how these variations might affect the total cost of treatment. For instance, the median total price variation across centers to treat metastatic non–small cell lung cancer with pembrolizumab was $168,405. At one institution, the within-center median price variation for daratumumab as third-line therapy for multiple myeloma was $174,225.
To reduce the financial burden of cancer treatment for patients, the authors suggested implementing public policies “to discourage or prevent excessive hospital price markups on parenteral chemotherapeutics.”
To promote hospital compliance with transparency regulations, in January 2022, the Centers for Medicare & Medicare Services increased penalties for nondisclosure from a fixed maximum of $300 per day to up to $5,500 per day, based on hospital bed size, which would total over $2 million per year, Dr. Xiao said in an interview.
“We would expect that this significant financial penalty would encourage more consistent reporting,” he said.
The study had no specific funding. Dr. Xiao has disclosed no relevant disclosures.
A version of this article first appeared on Medscape.com.
Among those that do provide this information, new research shows that hospitals substantially mark up prices for top-selling cancer therapies relative to acquisition costs. Median drug price markups across NCI centers and payers ranged from nearly 120% to more than 600%.
As a result, “the total price for an entire treatment course could vary on the order of hundreds of thousands of dollars,” Roy Xiao, MD, department of otolaryngology–head and neck surgery, Massachusetts Eye and Ear Infirmary, Boston, said in an interview.
The study was published online in JAMA Internal Medicine.
Manufacturers often price novel anticancer therapies at more than $100,000 per year, but less is known about how much hospitals mark up these prices for patients with private health insurance and how much negotiated prices vary across centers and payers.
Dr. Xiao and colleagues analyzed private payer-specific negotiated prices for the top 25 parenteral cancer therapies by Medicare Part B spending in 2019 using publicly available hospital price transparency files for 61 NCI-designated cancer centers.
Fewer than half of the centers (44.3%) disclosed payer-specific negotiated prices for at least one top-selling cancer drug. Disclosure rates for different drugs ranged from 21.3% (13 centers) for rituximab with hyaluronidase to 42.6% (26 centers) for rituximab, bevacizumab, or leuprolide.
The researchers also found a wide variation in negotiated prices for cancer therapies across hospitals. Across-center price ratios – defined as the ratio between the 90th and 10th percentile median price per unit – ranged from 2.2 ($16 vs. $36 for pembrolizumab 1 mg) and 15.8 ($247 vs. $3,914 for leuprolide 7.5 mg).
Payer-specific prices also varied considerably between payers at the same center. Among all centers, the median within-center price ratios for cancer therapies ranged from 1.8 (brentuximab) to 2.5 (bevacizumab).
As for the extent of cancer therapy markups, median price markups across centers and payers ranged from 118% (sipuleucel-T) to 634% (leuprolide) more than the estimated cost paid by hospitals.
Conservative estimates of acquisition costs and payer-specific prices yielded markups ranging from 42.1% (sipuleucel-T) to 234.1% (leuprolide).
The authors also provided examples of how these variations might affect the total cost of treatment. For instance, the median total price variation across centers to treat metastatic non–small cell lung cancer with pembrolizumab was $168,405. At one institution, the within-center median price variation for daratumumab as third-line therapy for multiple myeloma was $174,225.
To reduce the financial burden of cancer treatment for patients, the authors suggested implementing public policies “to discourage or prevent excessive hospital price markups on parenteral chemotherapeutics.”
To promote hospital compliance with transparency regulations, in January 2022, the Centers for Medicare & Medicare Services increased penalties for nondisclosure from a fixed maximum of $300 per day to up to $5,500 per day, based on hospital bed size, which would total over $2 million per year, Dr. Xiao said in an interview.
“We would expect that this significant financial penalty would encourage more consistent reporting,” he said.
The study had no specific funding. Dr. Xiao has disclosed no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE
Mental illness tied to COVID-19 breakthrough infection
“Psychiatric disorders remained significantly associated with incident breakthrough infections above and beyond sociodemographic and medical factors, suggesting that mental health is important to consider in conjunction with other risk factors,” wrote the investigators, led by Aoife O’Donovan, PhD, University of California, San Francisco.
Individuals with psychiatric disorders “should be prioritized for booster vaccinations and other critical preventive efforts, including increased SARS-CoV-2 screening, public health campaigns, or COVID-19 discussions during clinical care,” they added.
The study was published online in JAMA Network Open.
Elderly most vulnerable
The researchers reviewed the records of 263,697 veterans who were fully vaccinated against COVID-19.
Just over a half (51.4%) had one or more psychiatric diagnoses within the last 5 years and 14.8% developed breakthrough COVID-19 infections, confirmed by a positive SARS-CoV-2 test.
Psychiatric diagnoses among the veterans included depression, posttraumatic stress, anxiety, adjustment disorder, substance use disorder, bipolar disorder, psychosis, ADHD, dissociation, and eating disorders.
In the overall sample, a history of any psychiatric disorder was associated with a 7% higher incidence of breakthrough COVID-19 infection in models adjusted for potential confounders (adjusted relative risk, 1.07; 95% confidence interval, 1.05-1.09) and a 3% higher incidence in models additionally adjusted for underlying medical comorbidities and smoking (aRR, 1.03; 95% CI, 1.01-1.05).
Most psychiatric disorders were associated with a higher incidence of breakthrough infection, with the highest relative risk observed for substance use disorders (aRR, 1.16; 95% CI, 1.12 -1.21) and adjustment disorder (aRR, 1.13; 95% CI, 1.10-1.16) in fully adjusted models.
Older vaccinated veterans with psychiatric illnesses appear to be most vulnerable to COVID-19 reinfection.
In veterans aged 65 and older, all psychiatric disorders were associated with an increased incidence of breakthrough infection, with increases in the incidence rate ranging from 3% to 24% in fully adjusted models.
In the younger veterans, in contrast, only anxiety, adjustment, and substance use disorders were associated with an increased incidence of breakthrough infection in fully adjusted models.
Psychotic disorders were associated with a 10% lower incidence of breakthrough infection among younger veterans, perhaps because of greater social isolation, the researchers said.
Risky behavior or impaired immunity?
“Although some of the larger observed effect sizes are compelling at an individual level, even the relatively modest effect sizes may have a large effect at the population level when considering the high prevalence of psychiatric disorders and the global reach and scale of the pandemic,” Dr. O’Donovan and colleagues wrote.
They noted that psychiatric disorders, including depression, schizophrenia, and bipolar disorders, have been associated with impaired cellular immunity and blunted response to vaccines. Therefore, it’s possible that those with psychiatric disorders have poorer responses to COVID-19 vaccination.
It’s also possible that immunity following vaccination wanes more quickly or more strongly in people with psychiatric disorders and they could have less protection against new variants, they added.
Patients with psychiatric disorders could be more apt to engage in risky behaviors for contracting COVID-19, which could also increase the risk for breakthrough infection, they said.
The study was supported by a UCSF Department of Psychiatry Rapid Award and UCSF Faculty Resource Fund Award. Dr. O’Donovan reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Psychiatric disorders remained significantly associated with incident breakthrough infections above and beyond sociodemographic and medical factors, suggesting that mental health is important to consider in conjunction with other risk factors,” wrote the investigators, led by Aoife O’Donovan, PhD, University of California, San Francisco.
Individuals with psychiatric disorders “should be prioritized for booster vaccinations and other critical preventive efforts, including increased SARS-CoV-2 screening, public health campaigns, or COVID-19 discussions during clinical care,” they added.
The study was published online in JAMA Network Open.
Elderly most vulnerable
The researchers reviewed the records of 263,697 veterans who were fully vaccinated against COVID-19.
Just over a half (51.4%) had one or more psychiatric diagnoses within the last 5 years and 14.8% developed breakthrough COVID-19 infections, confirmed by a positive SARS-CoV-2 test.
Psychiatric diagnoses among the veterans included depression, posttraumatic stress, anxiety, adjustment disorder, substance use disorder, bipolar disorder, psychosis, ADHD, dissociation, and eating disorders.
In the overall sample, a history of any psychiatric disorder was associated with a 7% higher incidence of breakthrough COVID-19 infection in models adjusted for potential confounders (adjusted relative risk, 1.07; 95% confidence interval, 1.05-1.09) and a 3% higher incidence in models additionally adjusted for underlying medical comorbidities and smoking (aRR, 1.03; 95% CI, 1.01-1.05).
Most psychiatric disorders were associated with a higher incidence of breakthrough infection, with the highest relative risk observed for substance use disorders (aRR, 1.16; 95% CI, 1.12 -1.21) and adjustment disorder (aRR, 1.13; 95% CI, 1.10-1.16) in fully adjusted models.
Older vaccinated veterans with psychiatric illnesses appear to be most vulnerable to COVID-19 reinfection.
In veterans aged 65 and older, all psychiatric disorders were associated with an increased incidence of breakthrough infection, with increases in the incidence rate ranging from 3% to 24% in fully adjusted models.
In the younger veterans, in contrast, only anxiety, adjustment, and substance use disorders were associated with an increased incidence of breakthrough infection in fully adjusted models.
Psychotic disorders were associated with a 10% lower incidence of breakthrough infection among younger veterans, perhaps because of greater social isolation, the researchers said.
Risky behavior or impaired immunity?
“Although some of the larger observed effect sizes are compelling at an individual level, even the relatively modest effect sizes may have a large effect at the population level when considering the high prevalence of psychiatric disorders and the global reach and scale of the pandemic,” Dr. O’Donovan and colleagues wrote.
They noted that psychiatric disorders, including depression, schizophrenia, and bipolar disorders, have been associated with impaired cellular immunity and blunted response to vaccines. Therefore, it’s possible that those with psychiatric disorders have poorer responses to COVID-19 vaccination.
It’s also possible that immunity following vaccination wanes more quickly or more strongly in people with psychiatric disorders and they could have less protection against new variants, they added.
Patients with psychiatric disorders could be more apt to engage in risky behaviors for contracting COVID-19, which could also increase the risk for breakthrough infection, they said.
The study was supported by a UCSF Department of Psychiatry Rapid Award and UCSF Faculty Resource Fund Award. Dr. O’Donovan reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Psychiatric disorders remained significantly associated with incident breakthrough infections above and beyond sociodemographic and medical factors, suggesting that mental health is important to consider in conjunction with other risk factors,” wrote the investigators, led by Aoife O’Donovan, PhD, University of California, San Francisco.
Individuals with psychiatric disorders “should be prioritized for booster vaccinations and other critical preventive efforts, including increased SARS-CoV-2 screening, public health campaigns, or COVID-19 discussions during clinical care,” they added.
The study was published online in JAMA Network Open.
Elderly most vulnerable
The researchers reviewed the records of 263,697 veterans who were fully vaccinated against COVID-19.
Just over a half (51.4%) had one or more psychiatric diagnoses within the last 5 years and 14.8% developed breakthrough COVID-19 infections, confirmed by a positive SARS-CoV-2 test.
Psychiatric diagnoses among the veterans included depression, posttraumatic stress, anxiety, adjustment disorder, substance use disorder, bipolar disorder, psychosis, ADHD, dissociation, and eating disorders.
In the overall sample, a history of any psychiatric disorder was associated with a 7% higher incidence of breakthrough COVID-19 infection in models adjusted for potential confounders (adjusted relative risk, 1.07; 95% confidence interval, 1.05-1.09) and a 3% higher incidence in models additionally adjusted for underlying medical comorbidities and smoking (aRR, 1.03; 95% CI, 1.01-1.05).
Most psychiatric disorders were associated with a higher incidence of breakthrough infection, with the highest relative risk observed for substance use disorders (aRR, 1.16; 95% CI, 1.12 -1.21) and adjustment disorder (aRR, 1.13; 95% CI, 1.10-1.16) in fully adjusted models.
Older vaccinated veterans with psychiatric illnesses appear to be most vulnerable to COVID-19 reinfection.
In veterans aged 65 and older, all psychiatric disorders were associated with an increased incidence of breakthrough infection, with increases in the incidence rate ranging from 3% to 24% in fully adjusted models.
In the younger veterans, in contrast, only anxiety, adjustment, and substance use disorders were associated with an increased incidence of breakthrough infection in fully adjusted models.
Psychotic disorders were associated with a 10% lower incidence of breakthrough infection among younger veterans, perhaps because of greater social isolation, the researchers said.
Risky behavior or impaired immunity?
“Although some of the larger observed effect sizes are compelling at an individual level, even the relatively modest effect sizes may have a large effect at the population level when considering the high prevalence of psychiatric disorders and the global reach and scale of the pandemic,” Dr. O’Donovan and colleagues wrote.
They noted that psychiatric disorders, including depression, schizophrenia, and bipolar disorders, have been associated with impaired cellular immunity and blunted response to vaccines. Therefore, it’s possible that those with psychiatric disorders have poorer responses to COVID-19 vaccination.
It’s also possible that immunity following vaccination wanes more quickly or more strongly in people with psychiatric disorders and they could have less protection against new variants, they added.
Patients with psychiatric disorders could be more apt to engage in risky behaviors for contracting COVID-19, which could also increase the risk for breakthrough infection, they said.
The study was supported by a UCSF Department of Psychiatry Rapid Award and UCSF Faculty Resource Fund Award. Dr. O’Donovan reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Can pickle juice help ease cirrhotic cramps?
In the trial, patients with cirrhotic cramps who sipped pickle brine at the onset of a muscle cramp saw a significant decrease in cramp severity relative to peers who sipped tap water when the cramp hit.
“The acid (vinegar) in the brine triggers a nerve reflex to stop the cramp when it hits the throat. This is why only a sip is needed,” lead investigator Elliot Tapper, MD, division of gastroenterology and hepatology, University of Michigan, Ann Arbor, told this news organization. The study was published online April 13 in American Journal of Gastroenterology.
Common and bothersome
Cramps are common in adults with cirrhosis, irrespective of disease severity. They can sometimes last for hours, and treatment options are limited.
In a prior study, 1 tablespoon of pickle juice rapidly stopped experimentally induced cramps.
“This is something that athletes use, and kidney doctors often recommend to their patients, so it is nothing unique to cirrhosis,” Dr. Tapper said.
The PICCLES trial involved 74 adults (mean age, 56.6 years) with at least 4 muscle cramps in the prior month. In the cohort, 54% were men, and 41% had ascites.
The median cramp frequency was 11-12 per month, with an average cramp severity of more than 4 out of 10 on the Visual Analog Scale (VAS) for cramps.
Some patients were receiving medications for their cramps at baseline, such as magnesium, potassium, baclofen, vitamin E, taurine, and gabapentin/pregabalin.
Thirty-eight patients were randomly allocated to sip pickle juice and 36 to sip tap water at the onset of a muscle cramp.
The proportion of cramps treated was similar in the pickle juice and tap water groups (77% and 72%). More patients in the pickle juice group said their cramps were aborted by the intervention (69% vs. 40%).
The primary outcome was the change in cramp severity at 28-days VAS for cramps. Cramps were assessed 10 times over 28 days using interactive text messages.
Pickle juice was associated with a larger average reduction in cramp severity than tap water (–2.25 points vs. –0.36 on the VAS-cramps), a difference that was statistically significant (P = .03).
There were no significant changes in the proportion of days with cramp severity of more than 5 on the VAS, or on sleep quality or health-related quality of life.
Because pickle juice contains sodium, the researchers also assessed weight change as a safety outcome. They found no significant differences in weight change between the two groups overall or in the subset with ascites.
Pickle juice is a “safe option that can stop painful cramps,” Dr. Tapper said in an interview, but was “disheartened” that it did not improve quality of life.
Dr. Tapper encourages patients with cramps to ask their doctor about pickle juice and doctors to ask their patients about muscle cramps.
“Awareness of a patient’s cramps is often lacking. Asking about cramps is not routine but could be the most important advance relating to this study,” he said.
While sips of pickle juice are “unlikely to cause harm,” Dr. Tapper said, he is “a little nervous about advising patients to address their complex needs alone. [Doctors] are there to think through the root causes and help make adjustments that could prevent the cramps in the first place,” he said.
Outside experts weigh in
This news organization reached out to several outside experts for their perspective on the study.
Nancy Reau, MD, professor of internal medicine, associate director of solid organ transplantation, and section chief of hepatology. Rush University Medical Center, Chicago, noted that interventions to manage and prevent muscle cramps are “important, as cramping is common in cirrhosis and strongly affects quality of life.”
Dr. Reau cautioned that while pickle juice “sounds benign, it does have a lot of salt. Despite the salt content, this study didn’t show any difference between patients with and without ascites.
“However, cramping is more common in our patients with sarcopenia and those on diuretics for fluid management and it would be easy to see how this might impact fluid management,” Dr. Reau noted.
“Given that it is the acid (not the salt) in the pickle juice, there might be low salt alternatives,” Dr. Reau said.
Echoing Dr. Reau, Ankur Shah, MD, division of kidney disease and hypertension, Brown University, Providence, R.I., noted that “overuse of pickle juice could place patients at risk of developing high blood pressure and fluid overload, and pickle juice should be included in the sodium restriction guidance given to patients with high blood pressure and heart failure.”
In this study, however, the individual dose consumed was low, Dr. Shah noted.
He said the study “elegantly provides evidence to support the practice of sipping pickle juice for cramping.”
The authors should be “applauded for studying a simple solution with the most rigorous of methodologies, a randomized controlled trial,” Dr. Shah added.
“This simple treatment may be helpful to patients far beyond those with just cirrhosis, and expect future studies to explore this treatment in other populations,” Dr. Shah said in an interview.
Paul Martin, MD, chief of the division of digestive health and liver diseases and Mandel Chair in Gastroenterology, University of Miami, noted that, while muscle cramps can have a major impact on quality of life, “in terms of some of the other complications of cirrhosis that health care providers are dealing with, they may seem relatively innocuous, but obviously patients have a slightly different interpretation because of the effect cramps can have on sleep and so on.
“There have been a variety of home remedies to treat muscle cramps, but this study is intriguing as it suggests that pickle juice, which is freely available, helps mitigate the severity of the cramps. However, it’s unclear whether it prevents cramps,” Dr. Martin said in an interview.
Given that the study is getting traction on Twitter, Dr. Martin encouraged health care providers to be aware of the study and prepared to answer questions from patients.
The study had no specific funding. Dr. Tapper has served as a consultant to Novartis, Axcella, and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has received unrestricted research grants from Gilead and Valeant. Dr. Reau, Dr. Shah, and Dr. Martin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In the trial, patients with cirrhotic cramps who sipped pickle brine at the onset of a muscle cramp saw a significant decrease in cramp severity relative to peers who sipped tap water when the cramp hit.
“The acid (vinegar) in the brine triggers a nerve reflex to stop the cramp when it hits the throat. This is why only a sip is needed,” lead investigator Elliot Tapper, MD, division of gastroenterology and hepatology, University of Michigan, Ann Arbor, told this news organization. The study was published online April 13 in American Journal of Gastroenterology.
Common and bothersome
Cramps are common in adults with cirrhosis, irrespective of disease severity. They can sometimes last for hours, and treatment options are limited.
In a prior study, 1 tablespoon of pickle juice rapidly stopped experimentally induced cramps.
“This is something that athletes use, and kidney doctors often recommend to their patients, so it is nothing unique to cirrhosis,” Dr. Tapper said.
The PICCLES trial involved 74 adults (mean age, 56.6 years) with at least 4 muscle cramps in the prior month. In the cohort, 54% were men, and 41% had ascites.
The median cramp frequency was 11-12 per month, with an average cramp severity of more than 4 out of 10 on the Visual Analog Scale (VAS) for cramps.
Some patients were receiving medications for their cramps at baseline, such as magnesium, potassium, baclofen, vitamin E, taurine, and gabapentin/pregabalin.
Thirty-eight patients were randomly allocated to sip pickle juice and 36 to sip tap water at the onset of a muscle cramp.
The proportion of cramps treated was similar in the pickle juice and tap water groups (77% and 72%). More patients in the pickle juice group said their cramps were aborted by the intervention (69% vs. 40%).
The primary outcome was the change in cramp severity at 28-days VAS for cramps. Cramps were assessed 10 times over 28 days using interactive text messages.
Pickle juice was associated with a larger average reduction in cramp severity than tap water (–2.25 points vs. –0.36 on the VAS-cramps), a difference that was statistically significant (P = .03).
There were no significant changes in the proportion of days with cramp severity of more than 5 on the VAS, or on sleep quality or health-related quality of life.
Because pickle juice contains sodium, the researchers also assessed weight change as a safety outcome. They found no significant differences in weight change between the two groups overall or in the subset with ascites.
Pickle juice is a “safe option that can stop painful cramps,” Dr. Tapper said in an interview, but was “disheartened” that it did not improve quality of life.
Dr. Tapper encourages patients with cramps to ask their doctor about pickle juice and doctors to ask their patients about muscle cramps.
“Awareness of a patient’s cramps is often lacking. Asking about cramps is not routine but could be the most important advance relating to this study,” he said.
While sips of pickle juice are “unlikely to cause harm,” Dr. Tapper said, he is “a little nervous about advising patients to address their complex needs alone. [Doctors] are there to think through the root causes and help make adjustments that could prevent the cramps in the first place,” he said.
Outside experts weigh in
This news organization reached out to several outside experts for their perspective on the study.
Nancy Reau, MD, professor of internal medicine, associate director of solid organ transplantation, and section chief of hepatology. Rush University Medical Center, Chicago, noted that interventions to manage and prevent muscle cramps are “important, as cramping is common in cirrhosis and strongly affects quality of life.”
Dr. Reau cautioned that while pickle juice “sounds benign, it does have a lot of salt. Despite the salt content, this study didn’t show any difference between patients with and without ascites.
“However, cramping is more common in our patients with sarcopenia and those on diuretics for fluid management and it would be easy to see how this might impact fluid management,” Dr. Reau noted.
“Given that it is the acid (not the salt) in the pickle juice, there might be low salt alternatives,” Dr. Reau said.
Echoing Dr. Reau, Ankur Shah, MD, division of kidney disease and hypertension, Brown University, Providence, R.I., noted that “overuse of pickle juice could place patients at risk of developing high blood pressure and fluid overload, and pickle juice should be included in the sodium restriction guidance given to patients with high blood pressure and heart failure.”
In this study, however, the individual dose consumed was low, Dr. Shah noted.
He said the study “elegantly provides evidence to support the practice of sipping pickle juice for cramping.”
The authors should be “applauded for studying a simple solution with the most rigorous of methodologies, a randomized controlled trial,” Dr. Shah added.
“This simple treatment may be helpful to patients far beyond those with just cirrhosis, and expect future studies to explore this treatment in other populations,” Dr. Shah said in an interview.
Paul Martin, MD, chief of the division of digestive health and liver diseases and Mandel Chair in Gastroenterology, University of Miami, noted that, while muscle cramps can have a major impact on quality of life, “in terms of some of the other complications of cirrhosis that health care providers are dealing with, they may seem relatively innocuous, but obviously patients have a slightly different interpretation because of the effect cramps can have on sleep and so on.
“There have been a variety of home remedies to treat muscle cramps, but this study is intriguing as it suggests that pickle juice, which is freely available, helps mitigate the severity of the cramps. However, it’s unclear whether it prevents cramps,” Dr. Martin said in an interview.
Given that the study is getting traction on Twitter, Dr. Martin encouraged health care providers to be aware of the study and prepared to answer questions from patients.
The study had no specific funding. Dr. Tapper has served as a consultant to Novartis, Axcella, and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has received unrestricted research grants from Gilead and Valeant. Dr. Reau, Dr. Shah, and Dr. Martin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In the trial, patients with cirrhotic cramps who sipped pickle brine at the onset of a muscle cramp saw a significant decrease in cramp severity relative to peers who sipped tap water when the cramp hit.
“The acid (vinegar) in the brine triggers a nerve reflex to stop the cramp when it hits the throat. This is why only a sip is needed,” lead investigator Elliot Tapper, MD, division of gastroenterology and hepatology, University of Michigan, Ann Arbor, told this news organization. The study was published online April 13 in American Journal of Gastroenterology.
Common and bothersome
Cramps are common in adults with cirrhosis, irrespective of disease severity. They can sometimes last for hours, and treatment options are limited.
In a prior study, 1 tablespoon of pickle juice rapidly stopped experimentally induced cramps.
“This is something that athletes use, and kidney doctors often recommend to their patients, so it is nothing unique to cirrhosis,” Dr. Tapper said.
The PICCLES trial involved 74 adults (mean age, 56.6 years) with at least 4 muscle cramps in the prior month. In the cohort, 54% were men, and 41% had ascites.
The median cramp frequency was 11-12 per month, with an average cramp severity of more than 4 out of 10 on the Visual Analog Scale (VAS) for cramps.
Some patients were receiving medications for their cramps at baseline, such as magnesium, potassium, baclofen, vitamin E, taurine, and gabapentin/pregabalin.
Thirty-eight patients were randomly allocated to sip pickle juice and 36 to sip tap water at the onset of a muscle cramp.
The proportion of cramps treated was similar in the pickle juice and tap water groups (77% and 72%). More patients in the pickle juice group said their cramps were aborted by the intervention (69% vs. 40%).
The primary outcome was the change in cramp severity at 28-days VAS for cramps. Cramps were assessed 10 times over 28 days using interactive text messages.
Pickle juice was associated with a larger average reduction in cramp severity than tap water (–2.25 points vs. –0.36 on the VAS-cramps), a difference that was statistically significant (P = .03).
There were no significant changes in the proportion of days with cramp severity of more than 5 on the VAS, or on sleep quality or health-related quality of life.
Because pickle juice contains sodium, the researchers also assessed weight change as a safety outcome. They found no significant differences in weight change between the two groups overall or in the subset with ascites.
Pickle juice is a “safe option that can stop painful cramps,” Dr. Tapper said in an interview, but was “disheartened” that it did not improve quality of life.
Dr. Tapper encourages patients with cramps to ask their doctor about pickle juice and doctors to ask their patients about muscle cramps.
“Awareness of a patient’s cramps is often lacking. Asking about cramps is not routine but could be the most important advance relating to this study,” he said.
While sips of pickle juice are “unlikely to cause harm,” Dr. Tapper said, he is “a little nervous about advising patients to address their complex needs alone. [Doctors] are there to think through the root causes and help make adjustments that could prevent the cramps in the first place,” he said.
Outside experts weigh in
This news organization reached out to several outside experts for their perspective on the study.
Nancy Reau, MD, professor of internal medicine, associate director of solid organ transplantation, and section chief of hepatology. Rush University Medical Center, Chicago, noted that interventions to manage and prevent muscle cramps are “important, as cramping is common in cirrhosis and strongly affects quality of life.”
Dr. Reau cautioned that while pickle juice “sounds benign, it does have a lot of salt. Despite the salt content, this study didn’t show any difference between patients with and without ascites.
“However, cramping is more common in our patients with sarcopenia and those on diuretics for fluid management and it would be easy to see how this might impact fluid management,” Dr. Reau noted.
“Given that it is the acid (not the salt) in the pickle juice, there might be low salt alternatives,” Dr. Reau said.
Echoing Dr. Reau, Ankur Shah, MD, division of kidney disease and hypertension, Brown University, Providence, R.I., noted that “overuse of pickle juice could place patients at risk of developing high blood pressure and fluid overload, and pickle juice should be included in the sodium restriction guidance given to patients with high blood pressure and heart failure.”
In this study, however, the individual dose consumed was low, Dr. Shah noted.
He said the study “elegantly provides evidence to support the practice of sipping pickle juice for cramping.”
The authors should be “applauded for studying a simple solution with the most rigorous of methodologies, a randomized controlled trial,” Dr. Shah added.
“This simple treatment may be helpful to patients far beyond those with just cirrhosis, and expect future studies to explore this treatment in other populations,” Dr. Shah said in an interview.
Paul Martin, MD, chief of the division of digestive health and liver diseases and Mandel Chair in Gastroenterology, University of Miami, noted that, while muscle cramps can have a major impact on quality of life, “in terms of some of the other complications of cirrhosis that health care providers are dealing with, they may seem relatively innocuous, but obviously patients have a slightly different interpretation because of the effect cramps can have on sleep and so on.
“There have been a variety of home remedies to treat muscle cramps, but this study is intriguing as it suggests that pickle juice, which is freely available, helps mitigate the severity of the cramps. However, it’s unclear whether it prevents cramps,” Dr. Martin said in an interview.
Given that the study is getting traction on Twitter, Dr. Martin encouraged health care providers to be aware of the study and prepared to answer questions from patients.
The study had no specific funding. Dr. Tapper has served as a consultant to Novartis, Axcella, and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has received unrestricted research grants from Gilead and Valeant. Dr. Reau, Dr. Shah, and Dr. Martin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.