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Veterans Found Relief From Chronic Pain Through Telehealth Mindfulness
TOPLINE:
METHODOLOGY:
- Researchers conducted a randomized clinical trial of 811 veterans who had moderate to severe chronic pain and were recruited from three Veterans Affairs facilities in the United States.
- Participants were divided into three groups: Group MBI (270), self-paced MBI (271), and usual care (270), with interventions lasting 8 weeks.
- The primary outcome was pain-related function measured using a scale on interference from pain in areas like mood, walking, work, relationships, and sleep at 10 weeks, 6 months, and 1 year.
- Secondary outcomes included pain intensity, anxiety, fatigue, sleep disturbance, participation in social roles and activities, depression, and posttraumatic stress disorder (PTSD).
TAKEAWAY:
- Pain-related function significantly improved in participants in both the MBI groups versus usual care group, with a mean difference of −0.4 (95% CI, −0.7 to −0.2) for group MBI and −0.7 (95% CI, −1.0 to −0.4) for self-paced MBI (P < .001).
- Compared with the usual care group, both the MBI groups had significantly improved secondary outcomes, including pain intensity, depression, and PTSD.
- The probability of achieving 30% improvement in pain-related function was higher for group MBI at 10 weeks and 6 months and for self-paced MBI at all three timepoints.
- No significant differences were found between the MBI groups for primary and secondary outcomes.
IN PRACTICE:
“The viability and similarity of both these approaches for delivering MBIs increase patient options for meeting their individual needs and could help accelerate and improve the implementation of nonpharmacological pain treatment in health care systems,” the study authors wrote.
SOURCE:
The study was led by Diana J. Burgess, PhD, of the Center for Care Delivery and Outcomes Research, VA Health Systems Research in Minneapolis, Minnesota, and published online in JAMA Internal Medicine.
LIMITATIONS:
The trial was not designed to compare less resource-intensive MBIs with more intensive mindfulness-based stress reduction programs or in-person MBIs. The study did not address cost-effectiveness or control for time, attention, and other contextual factors. The high nonresponse rate (81%) to initial recruitment may have affected the generalizability of the findings.
DISCLOSURES:
The study was supported by the Pain Management Collaboratory–Pragmatic Clinical Trials Demonstration. Various authors reported grants from the National Center for Complementary and Integrative Health and the National Institute of Nursing Research.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a randomized clinical trial of 811 veterans who had moderate to severe chronic pain and were recruited from three Veterans Affairs facilities in the United States.
- Participants were divided into three groups: Group MBI (270), self-paced MBI (271), and usual care (270), with interventions lasting 8 weeks.
- The primary outcome was pain-related function measured using a scale on interference from pain in areas like mood, walking, work, relationships, and sleep at 10 weeks, 6 months, and 1 year.
- Secondary outcomes included pain intensity, anxiety, fatigue, sleep disturbance, participation in social roles and activities, depression, and posttraumatic stress disorder (PTSD).
TAKEAWAY:
- Pain-related function significantly improved in participants in both the MBI groups versus usual care group, with a mean difference of −0.4 (95% CI, −0.7 to −0.2) for group MBI and −0.7 (95% CI, −1.0 to −0.4) for self-paced MBI (P < .001).
- Compared with the usual care group, both the MBI groups had significantly improved secondary outcomes, including pain intensity, depression, and PTSD.
- The probability of achieving 30% improvement in pain-related function was higher for group MBI at 10 weeks and 6 months and for self-paced MBI at all three timepoints.
- No significant differences were found between the MBI groups for primary and secondary outcomes.
IN PRACTICE:
“The viability and similarity of both these approaches for delivering MBIs increase patient options for meeting their individual needs and could help accelerate and improve the implementation of nonpharmacological pain treatment in health care systems,” the study authors wrote.
SOURCE:
The study was led by Diana J. Burgess, PhD, of the Center for Care Delivery and Outcomes Research, VA Health Systems Research in Minneapolis, Minnesota, and published online in JAMA Internal Medicine.
LIMITATIONS:
The trial was not designed to compare less resource-intensive MBIs with more intensive mindfulness-based stress reduction programs or in-person MBIs. The study did not address cost-effectiveness or control for time, attention, and other contextual factors. The high nonresponse rate (81%) to initial recruitment may have affected the generalizability of the findings.
DISCLOSURES:
The study was supported by the Pain Management Collaboratory–Pragmatic Clinical Trials Demonstration. Various authors reported grants from the National Center for Complementary and Integrative Health and the National Institute of Nursing Research.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a randomized clinical trial of 811 veterans who had moderate to severe chronic pain and were recruited from three Veterans Affairs facilities in the United States.
- Participants were divided into three groups: Group MBI (270), self-paced MBI (271), and usual care (270), with interventions lasting 8 weeks.
- The primary outcome was pain-related function measured using a scale on interference from pain in areas like mood, walking, work, relationships, and sleep at 10 weeks, 6 months, and 1 year.
- Secondary outcomes included pain intensity, anxiety, fatigue, sleep disturbance, participation in social roles and activities, depression, and posttraumatic stress disorder (PTSD).
TAKEAWAY:
- Pain-related function significantly improved in participants in both the MBI groups versus usual care group, with a mean difference of −0.4 (95% CI, −0.7 to −0.2) for group MBI and −0.7 (95% CI, −1.0 to −0.4) for self-paced MBI (P < .001).
- Compared with the usual care group, both the MBI groups had significantly improved secondary outcomes, including pain intensity, depression, and PTSD.
- The probability of achieving 30% improvement in pain-related function was higher for group MBI at 10 weeks and 6 months and for self-paced MBI at all three timepoints.
- No significant differences were found between the MBI groups for primary and secondary outcomes.
IN PRACTICE:
“The viability and similarity of both these approaches for delivering MBIs increase patient options for meeting their individual needs and could help accelerate and improve the implementation of nonpharmacological pain treatment in health care systems,” the study authors wrote.
SOURCE:
The study was led by Diana J. Burgess, PhD, of the Center for Care Delivery and Outcomes Research, VA Health Systems Research in Minneapolis, Minnesota, and published online in JAMA Internal Medicine.
LIMITATIONS:
The trial was not designed to compare less resource-intensive MBIs with more intensive mindfulness-based stress reduction programs or in-person MBIs. The study did not address cost-effectiveness or control for time, attention, and other contextual factors. The high nonresponse rate (81%) to initial recruitment may have affected the generalizability of the findings.
DISCLOSURES:
The study was supported by the Pain Management Collaboratory–Pragmatic Clinical Trials Demonstration. Various authors reported grants from the National Center for Complementary and Integrative Health and the National Institute of Nursing Research.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Is Buprenorphine/Naloxone Safer Than Buprenorphine Alone During Pregnancy?
TOPLINE:
Buprenorphine combined with naloxone during pregnancy is associated with lower risks for neonatal abstinence syndrome and neonatal intensive care unit admission than buprenorphine alone. The study also found no significant differences in major congenital malformations between the two treatments.
METHODOLOGY:
- Researchers conducted a population-based cohort study using healthcare utilization data of people who were insured by Medicaid between 2000 and 2018.
- A total of 8695 pregnant individuals were included, with 3369 exposed to buprenorphine/naloxone and 5326 exposed to buprenorphine alone during the first trimester.
- Outcome measures included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity.
- The study excluded pregnancies with chromosomal anomalies, first-trimester exposure to known teratogens, or methadone use during baseline or the first trimester.
TAKEAWAY:
- According to the authors, buprenorphine/naloxone exposure during pregnancy was associated with a lower risk for neonatal abstinence syndrome (weighted risk ratio [RR], 0.77; 95% CI, 0.70-0.84) than buprenorphine alone.
- The researchers found a modestly lower risk for neonatal intensive care unit admission (weighted RR, 0.91; 95% CI, 0.85-0.98) and small risk for gestational age (weighted RR, 0.86; 95% CI, 0.75-0.98) in the buprenorphine/naloxone group.
- No significant differences were observed between the two groups in major congenital malformations, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery.
IN PRACTICE:
“For the outcomes assessed, compared with buprenorphine alone, buprenorphine combined with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for treatment of OUD in pregnancy, affirming flexibility in collaborative treatment decision-making,” the study authors wrote.
SOURCE:
The study was led by Loreen Straub, MD, MS, of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston. It was published online in JAMA.
LIMITATIONS:
Some potential confounders, such as alcohol use and cigarette smoking, may not have been recorded in claims data. The findings for many of the neonatal and maternal outcomes suggest that confounding by unmeasured factors is an unlikely explanation for the associations observed. Individuals identified as exposed based on filled prescriptions might not have used the medication. The study used outcome algorithms with relatively high positive predictive values to minimize outcome misclassification. The cohort was restricted to live births to enable linkage to infants and to assess neonatal outcomes.
DISCLOSURES:
Various authors reported receiving grants and personal fees from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Drug Abuse, Roche, Moderna, Takeda, and Janssen Global, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Buprenorphine combined with naloxone during pregnancy is associated with lower risks for neonatal abstinence syndrome and neonatal intensive care unit admission than buprenorphine alone. The study also found no significant differences in major congenital malformations between the two treatments.
METHODOLOGY:
- Researchers conducted a population-based cohort study using healthcare utilization data of people who were insured by Medicaid between 2000 and 2018.
- A total of 8695 pregnant individuals were included, with 3369 exposed to buprenorphine/naloxone and 5326 exposed to buprenorphine alone during the first trimester.
- Outcome measures included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity.
- The study excluded pregnancies with chromosomal anomalies, first-trimester exposure to known teratogens, or methadone use during baseline or the first trimester.
TAKEAWAY:
- According to the authors, buprenorphine/naloxone exposure during pregnancy was associated with a lower risk for neonatal abstinence syndrome (weighted risk ratio [RR], 0.77; 95% CI, 0.70-0.84) than buprenorphine alone.
- The researchers found a modestly lower risk for neonatal intensive care unit admission (weighted RR, 0.91; 95% CI, 0.85-0.98) and small risk for gestational age (weighted RR, 0.86; 95% CI, 0.75-0.98) in the buprenorphine/naloxone group.
- No significant differences were observed between the two groups in major congenital malformations, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery.
IN PRACTICE:
“For the outcomes assessed, compared with buprenorphine alone, buprenorphine combined with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for treatment of OUD in pregnancy, affirming flexibility in collaborative treatment decision-making,” the study authors wrote.
SOURCE:
The study was led by Loreen Straub, MD, MS, of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston. It was published online in JAMA.
LIMITATIONS:
Some potential confounders, such as alcohol use and cigarette smoking, may not have been recorded in claims data. The findings for many of the neonatal and maternal outcomes suggest that confounding by unmeasured factors is an unlikely explanation for the associations observed. Individuals identified as exposed based on filled prescriptions might not have used the medication. The study used outcome algorithms with relatively high positive predictive values to minimize outcome misclassification. The cohort was restricted to live births to enable linkage to infants and to assess neonatal outcomes.
DISCLOSURES:
Various authors reported receiving grants and personal fees from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Drug Abuse, Roche, Moderna, Takeda, and Janssen Global, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Buprenorphine combined with naloxone during pregnancy is associated with lower risks for neonatal abstinence syndrome and neonatal intensive care unit admission than buprenorphine alone. The study also found no significant differences in major congenital malformations between the two treatments.
METHODOLOGY:
- Researchers conducted a population-based cohort study using healthcare utilization data of people who were insured by Medicaid between 2000 and 2018.
- A total of 8695 pregnant individuals were included, with 3369 exposed to buprenorphine/naloxone and 5326 exposed to buprenorphine alone during the first trimester.
- Outcome measures included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity.
- The study excluded pregnancies with chromosomal anomalies, first-trimester exposure to known teratogens, or methadone use during baseline or the first trimester.
TAKEAWAY:
- According to the authors, buprenorphine/naloxone exposure during pregnancy was associated with a lower risk for neonatal abstinence syndrome (weighted risk ratio [RR], 0.77; 95% CI, 0.70-0.84) than buprenorphine alone.
- The researchers found a modestly lower risk for neonatal intensive care unit admission (weighted RR, 0.91; 95% CI, 0.85-0.98) and small risk for gestational age (weighted RR, 0.86; 95% CI, 0.75-0.98) in the buprenorphine/naloxone group.
- No significant differences were observed between the two groups in major congenital malformations, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery.
IN PRACTICE:
“For the outcomes assessed, compared with buprenorphine alone, buprenorphine combined with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for treatment of OUD in pregnancy, affirming flexibility in collaborative treatment decision-making,” the study authors wrote.
SOURCE:
The study was led by Loreen Straub, MD, MS, of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston. It was published online in JAMA.
LIMITATIONS:
Some potential confounders, such as alcohol use and cigarette smoking, may not have been recorded in claims data. The findings for many of the neonatal and maternal outcomes suggest that confounding by unmeasured factors is an unlikely explanation for the associations observed. Individuals identified as exposed based on filled prescriptions might not have used the medication. The study used outcome algorithms with relatively high positive predictive values to minimize outcome misclassification. The cohort was restricted to live births to enable linkage to infants and to assess neonatal outcomes.
DISCLOSURES:
Various authors reported receiving grants and personal fees from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Drug Abuse, Roche, Moderna, Takeda, and Janssen Global, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Lower Edoxaban Dose Cuts Bleeding Risk in Elderly Atrial Fibrillation Patients
TOPLINE:
Lowering the dose of edoxaban to 30 mg in patients 80 years of age and older with atrial fibrillation (AF) reduces major bleeding events without increasing ischemic events.
METHODOLOGY:
- Researchers conducted a parallel design, double-blind clinical trial of 21,105 patients with AF.
- Nearly 3000 patients aged 80 years and older were included in the secondary analysis, focusing on edoxaban, 60 mg vs 30 mg, and edoxaban 30 mg vs warfarin.
- The primary outcome was a composite of death, stroke or systemic embolism, and major bleeding, with secondary outcomes including ischemic stroke and all-cause death.
- People were excluded from the study if they had moderate or severe mitral stenosis, a mechanical heart valve, a high risk for bleeding, or were on antiplatelet drugs.
TAKEAWAY:
- Participants without dose-reduction criteria who received edoxaban 30 mg had lower rates of major bleeding than those who received 60 mg (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03).
- Rates of major gastrointestinal hemorrhage were higher with edoxaban 60 mg than with 30 mg (HR, 2.24; 95% CI, 1.29-3.90; P = .004).
- People who took edoxaban 30 mg had a 17% lower risk for all-cause death than those who received warfarin (HR, 0.83; 95% CI, 0.70-1.00; P = .046).
- In a little over 2400 participants with or without dose-reduction criteria, those receiving edoxaban 30 mg had the lower risk for major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001) and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046); risk for stroke or systemic embolism was comparable between the two drugs.
IN PRACTICE:
“These data suggest that lower-dose anticoagulants, such as edoxaban, 30 mg once daily, may be considered in all patients 80 years and older with AF irrespective of dose-reduction criteria,” the study authors wrote.
SOURCE:
The study was led by André Zimerman, MD, PhD, of Brigham and Women’s Hospital and the Department of Medicine at Harvard Medical School in Boston. It was published online in JAMA Cardiology. The study was funded by Daiichi Sankyo for the TIMI Study Group.
LIMITATIONS:
The study did not adjust for multiple comparisons, increasing the risk for type I and type II errors. Additionally, the trial participants may represent a more compliant subset of the target population, which could influence the results.
DISCLOSURES:
Various authors reported receiving grants, consultant fees, and consulting fees from AstraZeneca, Merck, Novartis, Amgen, Boehringer Ingelheim/Lilly, and Cardurion Pharmaceuticals, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Lowering the dose of edoxaban to 30 mg in patients 80 years of age and older with atrial fibrillation (AF) reduces major bleeding events without increasing ischemic events.
METHODOLOGY:
- Researchers conducted a parallel design, double-blind clinical trial of 21,105 patients with AF.
- Nearly 3000 patients aged 80 years and older were included in the secondary analysis, focusing on edoxaban, 60 mg vs 30 mg, and edoxaban 30 mg vs warfarin.
- The primary outcome was a composite of death, stroke or systemic embolism, and major bleeding, with secondary outcomes including ischemic stroke and all-cause death.
- People were excluded from the study if they had moderate or severe mitral stenosis, a mechanical heart valve, a high risk for bleeding, or were on antiplatelet drugs.
TAKEAWAY:
- Participants without dose-reduction criteria who received edoxaban 30 mg had lower rates of major bleeding than those who received 60 mg (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03).
- Rates of major gastrointestinal hemorrhage were higher with edoxaban 60 mg than with 30 mg (HR, 2.24; 95% CI, 1.29-3.90; P = .004).
- People who took edoxaban 30 mg had a 17% lower risk for all-cause death than those who received warfarin (HR, 0.83; 95% CI, 0.70-1.00; P = .046).
- In a little over 2400 participants with or without dose-reduction criteria, those receiving edoxaban 30 mg had the lower risk for major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001) and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046); risk for stroke or systemic embolism was comparable between the two drugs.
IN PRACTICE:
“These data suggest that lower-dose anticoagulants, such as edoxaban, 30 mg once daily, may be considered in all patients 80 years and older with AF irrespective of dose-reduction criteria,” the study authors wrote.
SOURCE:
The study was led by André Zimerman, MD, PhD, of Brigham and Women’s Hospital and the Department of Medicine at Harvard Medical School in Boston. It was published online in JAMA Cardiology. The study was funded by Daiichi Sankyo for the TIMI Study Group.
LIMITATIONS:
The study did not adjust for multiple comparisons, increasing the risk for type I and type II errors. Additionally, the trial participants may represent a more compliant subset of the target population, which could influence the results.
DISCLOSURES:
Various authors reported receiving grants, consultant fees, and consulting fees from AstraZeneca, Merck, Novartis, Amgen, Boehringer Ingelheim/Lilly, and Cardurion Pharmaceuticals, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Lowering the dose of edoxaban to 30 mg in patients 80 years of age and older with atrial fibrillation (AF) reduces major bleeding events without increasing ischemic events.
METHODOLOGY:
- Researchers conducted a parallel design, double-blind clinical trial of 21,105 patients with AF.
- Nearly 3000 patients aged 80 years and older were included in the secondary analysis, focusing on edoxaban, 60 mg vs 30 mg, and edoxaban 30 mg vs warfarin.
- The primary outcome was a composite of death, stroke or systemic embolism, and major bleeding, with secondary outcomes including ischemic stroke and all-cause death.
- People were excluded from the study if they had moderate or severe mitral stenosis, a mechanical heart valve, a high risk for bleeding, or were on antiplatelet drugs.
TAKEAWAY:
- Participants without dose-reduction criteria who received edoxaban 30 mg had lower rates of major bleeding than those who received 60 mg (hazard ratio [HR], 1.57; 95% CI, 1.04-2.38; P = .03).
- Rates of major gastrointestinal hemorrhage were higher with edoxaban 60 mg than with 30 mg (HR, 2.24; 95% CI, 1.29-3.90; P = .004).
- People who took edoxaban 30 mg had a 17% lower risk for all-cause death than those who received warfarin (HR, 0.83; 95% CI, 0.70-1.00; P = .046).
- In a little over 2400 participants with or without dose-reduction criteria, those receiving edoxaban 30 mg had the lower risk for major bleeding (HR, 0.59; 95% CI, 0.45-0.77; P < .001) and death (HR, 0.83; 95% CI, 0.70-1.00; P = .046); risk for stroke or systemic embolism was comparable between the two drugs.
IN PRACTICE:
“These data suggest that lower-dose anticoagulants, such as edoxaban, 30 mg once daily, may be considered in all patients 80 years and older with AF irrespective of dose-reduction criteria,” the study authors wrote.
SOURCE:
The study was led by André Zimerman, MD, PhD, of Brigham and Women’s Hospital and the Department of Medicine at Harvard Medical School in Boston. It was published online in JAMA Cardiology. The study was funded by Daiichi Sankyo for the TIMI Study Group.
LIMITATIONS:
The study did not adjust for multiple comparisons, increasing the risk for type I and type II errors. Additionally, the trial participants may represent a more compliant subset of the target population, which could influence the results.
DISCLOSURES:
Various authors reported receiving grants, consultant fees, and consulting fees from AstraZeneca, Merck, Novartis, Amgen, Boehringer Ingelheim/Lilly, and Cardurion Pharmaceuticals, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.