Current guidelines for disinfecting bronchoscopes may not be adequate to prevent transmission of infection, as researchers found all reprocessed bronchoscopes they observed had residual contamination and over half showed microbial growth, according to results from a recent study in CHEST.

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, and her colleagues wrote in their study. “Shifting toward using sterilized or single-use bronchoscopes could reduce the risk of infection transmission among vulnerable pulmonary patient populations.”

National Institute of Allergy and Infectious Diseases

The researchers inspected 24 reprocessed bronchoscopes used clinically (9 pediatric, 9 therapeutic, 6 endobronchial ultrasound) at three U.S. tertiary care centers in 2017 and compared them with two bronchoscopes that had not been used. Of the bronchoscopes observed, all had residual contamination after manual cleaning and high-level disinfection (HLD). Manually cleaned bronchoscopes had microbial growth in 11 of 20 (55%) samples, while 14 of 24 (58%) of HLD samples contained microbial growth. Upon inspection, the researchers said they discovered “oily residue; dried fluid spots; brown, red, and white residue; scratches; insertion tube buckling; and damaged distal ends,” while internal inspections yielded “fluid, discoloration, scratches, filamentous debris, and dented channels.”

Ms. Ofstead and colleagues noted that, while the first site exceeded national guidelines, sites B and C contained technicians who did not wear personal protective equipment and the sites did not follow national or manufacturer use guidelines, such as passing bronchoscopes “through a window to a clean room for automated cleaning and HLD with peracetic acid in automated endoscope reprocessor,” flushing the bronchoscopes with alcohol, drying them with medical-grade forced air pressure, and storing them in a dedicated clean and dry area. Site A had microbial growth in 20% and 50% of manually cleaned and HLD bronchoscopes, respectively, site B had microbial growth in 100% and 75% of manually cleaned and HLD bronchoscopes, respectively, and site C had microbial growth in 83% and 50% of manually cleaned and HLD bronchoscopes, respectively. Among the microbial species identified were “environmental bacteria and normal flora” such as Bacillus spp and Staphylococcus epidermidis, molds such as Lecanicillium lecanii and Verticillium dahliae, and pathogens such as Stenotrophomonas maltophilia and Escherichia coli/Shigella spp.

“The clinical implications for patients are unknown as the study did not involve assessing patients or reviewing medical records,” Ms. Ofstead and her colleagues wrote. “However, the results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune suppression due to malignancy or chronic disease.”

Ms. Ofstead and three authors are employees of Ofstead & Associates, which received research funding and speaking honoraria from 3M, Advanced Sterilization Products (Johnson & Johnson), Ambu, Auris Health, Boston Scientific, Cogentix, ConvergAscent, Healthmark Industries, Invendo Medical, Medivators, Nanosonics, and STERIS. Dr. Ferguson has received fees from NeuWave Medical and PPD, research grants and personal fees from OncoCyte, and research grants from Concordia and PneumRx. Dr. Sonetti reported no relevant financial disclosures.

SOURCE: Ofstead CL et al. Chest. 2018 May 30. doi: 10.1016/j.chest.2018.04.045.

Current guidelines for disinfecting bronchoscopes may not be adequate to prevent transmission of infection, as researchers found all reprocessed bronchoscopes they observed had residual contamination and over half showed microbial growth, according to results from a recent study in CHEST.

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, and her colleagues wrote in their study. “Shifting toward using sterilized or single-use bronchoscopes could reduce the risk of infection transmission among vulnerable pulmonary patient populations.”

National Institute of Allergy and Infectious Diseases

The researchers inspected 24 reprocessed bronchoscopes used clinically (9 pediatric, 9 therapeutic, 6 endobronchial ultrasound) at three U.S. tertiary care centers in 2017 and compared them with two bronchoscopes that had not been used. Of the bronchoscopes observed, all had residual contamination after manual cleaning and high-level disinfection (HLD). Manually cleaned bronchoscopes had microbial growth in 11 of 20 (55%) samples, while 14 of 24 (58%) of HLD samples contained microbial growth. Upon inspection, the researchers said they discovered “oily residue; dried fluid spots; brown, red, and white residue; scratches; insertion tube buckling; and damaged distal ends,” while internal inspections yielded “fluid, discoloration, scratches, filamentous debris, and dented channels.”

Ms. Ofstead and colleagues noted that, while the first site exceeded national guidelines, sites B and C contained technicians who did not wear personal protective equipment and the sites did not follow national or manufacturer use guidelines, such as passing bronchoscopes “through a window to a clean room for automated cleaning and HLD with peracetic acid in automated endoscope reprocessor,” flushing the bronchoscopes with alcohol, drying them with medical-grade forced air pressure, and storing them in a dedicated clean and dry area. Site A had microbial growth in 20% and 50% of manually cleaned and HLD bronchoscopes, respectively, site B had microbial growth in 100% and 75% of manually cleaned and HLD bronchoscopes, respectively, and site C had microbial growth in 83% and 50% of manually cleaned and HLD bronchoscopes, respectively. Among the microbial species identified were “environmental bacteria and normal flora” such as Bacillus spp and Staphylococcus epidermidis, molds such as Lecanicillium lecanii and Verticillium dahliae, and pathogens such as Stenotrophomonas maltophilia and Escherichia coli/Shigella spp.

“The clinical implications for patients are unknown as the study did not involve assessing patients or reviewing medical records,” Ms. Ofstead and her colleagues wrote. “However, the results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune suppression due to malignancy or chronic disease.”

Ms. Ofstead and three authors are employees of Ofstead & Associates, which received research funding and speaking honoraria from 3M, Advanced Sterilization Products (Johnson & Johnson), Ambu, Auris Health, Boston Scientific, Cogentix, ConvergAscent, Healthmark Industries, Invendo Medical, Medivators, Nanosonics, and STERIS. Dr. Ferguson has received fees from NeuWave Medical and PPD, research grants and personal fees from OncoCyte, and research grants from Concordia and PneumRx. Dr. Sonetti reported no relevant financial disclosures.

SOURCE: Ofstead CL et al. Chest. 2018 May 30. doi: 10.1016/j.chest.2018.04.045.

Current guidelines for disinfecting bronchoscopes may not be adequate to prevent transmission of infection, as researchers found all reprocessed bronchoscopes they observed had residual contamination and over half showed microbial growth, according to results from a recent study in CHEST.

“Evidence-based, bronchoscope-specific reprocessing and maintenance guidelines are needed, along with quality management programs to ensure that these complex processes are carried out effectively,” Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, and her colleagues wrote in their study. “Shifting toward using sterilized or single-use bronchoscopes could reduce the risk of infection transmission among vulnerable pulmonary patient populations.”

National Institute of Allergy and Infectious Diseases

The researchers inspected 24 reprocessed bronchoscopes used clinically (9 pediatric, 9 therapeutic, 6 endobronchial ultrasound) at three U.S. tertiary care centers in 2017 and compared them with two bronchoscopes that had not been used. Of the bronchoscopes observed, all had residual contamination after manual cleaning and high-level disinfection (HLD). Manually cleaned bronchoscopes had microbial growth in 11 of 20 (55%) samples, while 14 of 24 (58%) of HLD samples contained microbial growth. Upon inspection, the researchers said they discovered “oily residue; dried fluid spots; brown, red, and white residue; scratches; insertion tube buckling; and damaged distal ends,” while internal inspections yielded “fluid, discoloration, scratches, filamentous debris, and dented channels.”

Ms. Ofstead and colleagues noted that, while the first site exceeded national guidelines, sites B and C contained technicians who did not wear personal protective equipment and the sites did not follow national or manufacturer use guidelines, such as passing bronchoscopes “through a window to a clean room for automated cleaning and HLD with peracetic acid in automated endoscope reprocessor,” flushing the bronchoscopes with alcohol, drying them with medical-grade forced air pressure, and storing them in a dedicated clean and dry area. Site A had microbial growth in 20% and 50% of manually cleaned and HLD bronchoscopes, respectively, site B had microbial growth in 100% and 75% of manually cleaned and HLD bronchoscopes, respectively, and site C had microbial growth in 83% and 50% of manually cleaned and HLD bronchoscopes, respectively. Among the microbial species identified were “environmental bacteria and normal flora” such as Bacillus spp and Staphylococcus epidermidis, molds such as Lecanicillium lecanii and Verticillium dahliae, and pathogens such as Stenotrophomonas maltophilia and Escherichia coli/Shigella spp.

“The clinical implications for patients are unknown as the study did not involve assessing patients or reviewing medical records,” Ms. Ofstead and her colleagues wrote. “However, the results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune suppression due to malignancy or chronic disease.”

Ms. Ofstead and three authors are employees of Ofstead & Associates, which received research funding and speaking honoraria from 3M, Advanced Sterilization Products (Johnson & Johnson), Ambu, Auris Health, Boston Scientific, Cogentix, ConvergAscent, Healthmark Industries, Invendo Medical, Medivators, Nanosonics, and STERIS. Dr. Ferguson has received fees from NeuWave Medical and PPD, research grants and personal fees from OncoCyte, and research grants from Concordia and PneumRx. Dr. Sonetti reported no relevant financial disclosures.

SOURCE: Ofstead CL et al. Chest. 2018 May 30. doi: 10.1016/j.chest.2018.04.045.

About one-third of U.S. adults may be using prescription medications that have depression as a possible side effect, results of a cross-sectional survey study suggest.

Use of multiple medications with depression as a possible side effect was associated with greater likelihood of concurrent depression, authors of the study reported in JAMA.

“The results suggest that physicians should consider discussing these associations with their patients who are prescribed medications that have depression as a potential adverse effect,” said authors, including Dima Mazen Qato, PharmD, MPH, PhD, Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago.

The study included data from 26,192 adults who participated in the National Health and Nutrition Examination Survey between 2005 and 2014. The mean age of participants was 46.2 years, 51.1% were women, and 7.6% reported depression.

Overall, 37.2% of participants reported using medications that had depression as an adverse effect. Use of those medications has increased over time, from 35.0% in 2005-2006 to 38.4% in 2013-2014 (P = .03 for the trend), investigators reported.

Likewise, the proportion of people using at least three medications with depression as a potential side effect, increased from 6.9% to 9.5% from the 2005-2006 to 2013-2014 time period (P = .001), they added.

The prevalence of depression increased with the number of medications with depression as a side effect, in an analysis that excluded antidepressant users. Prevalence was just 4.7% for people who did not use them, up to 15% for those using three or more, a 10.7 percentage point difference, authors noted.

In all, U.S. adults reported more than 200 different medications associated with depression or suicidal symptoms as adverse effects, said Dr. Qato and co-authors.

The most common, aside from antidepressants, which as a class have a black-box warning for risk of depression, were antihypertensive medications, analgesics, hormonal contraceptives, and proton pump inhibitors. Some are over-the-counter medications that are not labeled indicating depression risk: “Many patients may therefore not be aware of the greater likelihood of concurrent depression associated with these commonly used medications,” Dr. Qato and co-authors wrote.

Dr. Qato reported serving as a consultant for Public Citizen’s Health Research Group, and said she is supported in part by the Robert Wood Johnson Foundation. One co-author reported a grant from Janssen Scientific Affairs, LLC, to Columbia University Medical Center. 

[email protected]

SOURCE: Qato DM, et al. JAMA
 

About one-third of U.S. adults may be using prescription medications that have depression as a possible side effect, results of a cross-sectional survey study suggest.

Use of multiple medications with depression as a possible side effect was associated with greater likelihood of concurrent depression, authors of the study reported in JAMA.

“The results suggest that physicians should consider discussing these associations with their patients who are prescribed medications that have depression as a potential adverse effect,” said authors, including Dima Mazen Qato, PharmD, MPH, PhD, Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago.

The study included data from 26,192 adults who participated in the National Health and Nutrition Examination Survey between 2005 and 2014. The mean age of participants was 46.2 years, 51.1% were women, and 7.6% reported depression.

Overall, 37.2% of participants reported using medications that had depression as an adverse effect. Use of those medications has increased over time, from 35.0% in 2005-2006 to 38.4% in 2013-2014 (P = .03 for the trend), investigators reported.

Likewise, the proportion of people using at least three medications with depression as a potential side effect, increased from 6.9% to 9.5% from the 2005-2006 to 2013-2014 time period (P = .001), they added.

The prevalence of depression increased with the number of medications with depression as a side effect, in an analysis that excluded antidepressant users. Prevalence was just 4.7% for people who did not use them, up to 15% for those using three or more, a 10.7 percentage point difference, authors noted.

In all, U.S. adults reported more than 200 different medications associated with depression or suicidal symptoms as adverse effects, said Dr. Qato and co-authors.

The most common, aside from antidepressants, which as a class have a black-box warning for risk of depression, were antihypertensive medications, analgesics, hormonal contraceptives, and proton pump inhibitors. Some are over-the-counter medications that are not labeled indicating depression risk: “Many patients may therefore not be aware of the greater likelihood of concurrent depression associated with these commonly used medications,” Dr. Qato and co-authors wrote.

Dr. Qato reported serving as a consultant for Public Citizen’s Health Research Group, and said she is supported in part by the Robert Wood Johnson Foundation. One co-author reported a grant from Janssen Scientific Affairs, LLC, to Columbia University Medical Center. 

[email protected]

SOURCE: Qato DM, et al. JAMA
 

About one-third of U.S. adults may be using prescription medications that have depression as a possible side effect, results of a cross-sectional survey study suggest.

Use of multiple medications with depression as a possible side effect was associated with greater likelihood of concurrent depression, authors of the study reported in JAMA.

“The results suggest that physicians should consider discussing these associations with their patients who are prescribed medications that have depression as a potential adverse effect,” said authors, including Dima Mazen Qato, PharmD, MPH, PhD, Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago.

The study included data from 26,192 adults who participated in the National Health and Nutrition Examination Survey between 2005 and 2014. The mean age of participants was 46.2 years, 51.1% were women, and 7.6% reported depression.

Overall, 37.2% of participants reported using medications that had depression as an adverse effect. Use of those medications has increased over time, from 35.0% in 2005-2006 to 38.4% in 2013-2014 (P = .03 for the trend), investigators reported.

Likewise, the proportion of people using at least three medications with depression as a potential side effect, increased from 6.9% to 9.5% from the 2005-2006 to 2013-2014 time period (P = .001), they added.

The prevalence of depression increased with the number of medications with depression as a side effect, in an analysis that excluded antidepressant users. Prevalence was just 4.7% for people who did not use them, up to 15% for those using three or more, a 10.7 percentage point difference, authors noted.

In all, U.S. adults reported more than 200 different medications associated with depression or suicidal symptoms as adverse effects, said Dr. Qato and co-authors.

The most common, aside from antidepressants, which as a class have a black-box warning for risk of depression, were antihypertensive medications, analgesics, hormonal contraceptives, and proton pump inhibitors. Some are over-the-counter medications that are not labeled indicating depression risk: “Many patients may therefore not be aware of the greater likelihood of concurrent depression associated with these commonly used medications,” Dr. Qato and co-authors wrote.

Dr. Qato reported serving as a consultant for Public Citizen’s Health Research Group, and said she is supported in part by the Robert Wood Johnson Foundation. One co-author reported a grant from Janssen Scientific Affairs, LLC, to Columbia University Medical Center. 

[email protected]

SOURCE: Qato DM, et al. JAMA
 

Use of oral fluconazole during pregnancy is not associated with an increase in risk of stillbirth or neonatal death, results of a large European cohort study suggest.

The rate of stillbirths was 2.7 per 1,000 fluconazole-exposed pregnancies, versus 3.6 per 1,000 unexposed pregnancies (hazard ratio, 0.76, 95% confidence interval, 0.52-1.10), investigators reported based on an analysis of national registry data including nearly 1.5 million recent pregnancies in Sweden and Norway.

Neonatal deaths occurred in 1.2 per 1,000 exposed pregnancies and 1.7 per 1,000 unexposed pregnancies, investigators added in the report, which appeared in JAMA.

Results were not different for doses of 300 mg or less versus more than 300 mg, said senior researcher Björn Pasternak, MD, PhD, of Karolinska Institutet, Stockholm, and his co-authors.

“Although the data on fluconazole use in pregnancy suggest no increased risk of stillbirth, additional studies should be conducted and the collective body of data scrutinized by drug authorities before recommendations to guide clinical decision making are made, and weighed against the benefits of therapy,” the investigators wrote. 

About 4% of pregnant women in the United States take oral fluconazole, even though it is generally discouraged during pregnancy due to concerns that its use may be associated with stillbirth in a previous Danish nationwide register-based study, published in JAMA.

In 2016, investigators similarly found no increased risk of stillbirth in 2,215 fluconazole-exposed women, though they noted the outcome was “relatively rare and the results therefore imprecise.” In a sensitivity analysis, they did find an association between higher doses of fluconazole (i.e., above 300 mg) and stillbirth, with a hazard ratio of 4.10 (95% CI, 1.89-8.90).

The stillbirth analysis in the present study included 10,669 fluconazole-exposed pregnancies from Sweden and Norway, though the number exposed to higher doses was small, Dr. Pasterak and co-authors said in their report.

Although more research and deliberation is needed, this new study does add one novel endpoint to the literature: “The outcome of neonatal death has not been reported previously, to our knowledge.” 

Their study was supported by the Thrasher Research Fund, the Magnus Bergvall Foundation, and the Karolinska Institutet Research Foundation. Dr. Pasternak and co-authors reported no conflicts of interest.

[email protected]

SOURCE: Pasternak B, et al. JAMA. 2018 Jun 12;319:22.
 

Use of oral fluconazole during pregnancy is not associated with an increase in risk of stillbirth or neonatal death, results of a large European cohort study suggest.

The rate of stillbirths was 2.7 per 1,000 fluconazole-exposed pregnancies, versus 3.6 per 1,000 unexposed pregnancies (hazard ratio, 0.76, 95% confidence interval, 0.52-1.10), investigators reported based on an analysis of national registry data including nearly 1.5 million recent pregnancies in Sweden and Norway.

Neonatal deaths occurred in 1.2 per 1,000 exposed pregnancies and 1.7 per 1,000 unexposed pregnancies, investigators added in the report, which appeared in JAMA.

Results were not different for doses of 300 mg or less versus more than 300 mg, said senior researcher Björn Pasternak, MD, PhD, of Karolinska Institutet, Stockholm, and his co-authors.

“Although the data on fluconazole use in pregnancy suggest no increased risk of stillbirth, additional studies should be conducted and the collective body of data scrutinized by drug authorities before recommendations to guide clinical decision making are made, and weighed against the benefits of therapy,” the investigators wrote. 

About 4% of pregnant women in the United States take oral fluconazole, even though it is generally discouraged during pregnancy due to concerns that its use may be associated with stillbirth in a previous Danish nationwide register-based study, published in JAMA.

In 2016, investigators similarly found no increased risk of stillbirth in 2,215 fluconazole-exposed women, though they noted the outcome was “relatively rare and the results therefore imprecise.” In a sensitivity analysis, they did find an association between higher doses of fluconazole (i.e., above 300 mg) and stillbirth, with a hazard ratio of 4.10 (95% CI, 1.89-8.90).

The stillbirth analysis in the present study included 10,669 fluconazole-exposed pregnancies from Sweden and Norway, though the number exposed to higher doses was small, Dr. Pasterak and co-authors said in their report.

Although more research and deliberation is needed, this new study does add one novel endpoint to the literature: “The outcome of neonatal death has not been reported previously, to our knowledge.” 

Their study was supported by the Thrasher Research Fund, the Magnus Bergvall Foundation, and the Karolinska Institutet Research Foundation. Dr. Pasternak and co-authors reported no conflicts of interest.

[email protected]

SOURCE: Pasternak B, et al. JAMA. 2018 Jun 12;319:22.
 

Use of oral fluconazole during pregnancy is not associated with an increase in risk of stillbirth or neonatal death, results of a large European cohort study suggest.

The rate of stillbirths was 2.7 per 1,000 fluconazole-exposed pregnancies, versus 3.6 per 1,000 unexposed pregnancies (hazard ratio, 0.76, 95% confidence interval, 0.52-1.10), investigators reported based on an analysis of national registry data including nearly 1.5 million recent pregnancies in Sweden and Norway.

Neonatal deaths occurred in 1.2 per 1,000 exposed pregnancies and 1.7 per 1,000 unexposed pregnancies, investigators added in the report, which appeared in JAMA.

Results were not different for doses of 300 mg or less versus more than 300 mg, said senior researcher Björn Pasternak, MD, PhD, of Karolinska Institutet, Stockholm, and his co-authors.

“Although the data on fluconazole use in pregnancy suggest no increased risk of stillbirth, additional studies should be conducted and the collective body of data scrutinized by drug authorities before recommendations to guide clinical decision making are made, and weighed against the benefits of therapy,” the investigators wrote. 

About 4% of pregnant women in the United States take oral fluconazole, even though it is generally discouraged during pregnancy due to concerns that its use may be associated with stillbirth in a previous Danish nationwide register-based study, published in JAMA.

In 2016, investigators similarly found no increased risk of stillbirth in 2,215 fluconazole-exposed women, though they noted the outcome was “relatively rare and the results therefore imprecise.” In a sensitivity analysis, they did find an association between higher doses of fluconazole (i.e., above 300 mg) and stillbirth, with a hazard ratio of 4.10 (95% CI, 1.89-8.90).

The stillbirth analysis in the present study included 10,669 fluconazole-exposed pregnancies from Sweden and Norway, though the number exposed to higher doses was small, Dr. Pasterak and co-authors said in their report.

Although more research and deliberation is needed, this new study does add one novel endpoint to the literature: “The outcome of neonatal death has not been reported previously, to our knowledge.” 

Their study was supported by the Thrasher Research Fund, the Magnus Bergvall Foundation, and the Karolinska Institutet Research Foundation. Dr. Pasternak and co-authors reported no conflicts of interest.

[email protected]

SOURCE: Pasternak B, et al. JAMA. 2018 Jun 12;319:22.
 

LOS ANGELES—Adverse childhood experiences increase the likelihood of chronic insufficient sleep in adulthood, according to data presented at the 70th Annual Meeting of the American Academy of Neurology. This study emphasizes the importance of childhood health and a need to identify psychologic challenges in adults with sleep difficulties, particularly given the established importance of sleep dysregulation for cognitive and physical health, said Kelly Sullivan, PhD, MSPH, Assistant Professor of Epidemiology at Jiann-Ping Hsu College of Public Health at Georgia Southern University in Statesboro, Georgia.

Long-term prospective studies have suggested that adverse childhood experiences such as abuse, neglect, and household challenges (ie, divorced or separated parents, or living with someone who served time in a prison, jail, or other correctional facility) are associated with mental health challenges and unhealthy behaviors (ie, smoking, alcohol or drug use). These experiences have also been associated with conditions such as heart disease, cancer, and stroke.

Analyzing Data From a Nationwide Survey

To assess the association of adverse childhood experiences and subsequent insufficient sleep among a large group of adults in the United States, Dr. Sullivan and colleagues analyzed data from the 2011 Behavioral Risk Factor Surveillance System, a nationwide survey conducted by the Centers for Disease Control and Prevention.

Study participants were age 18 or older, were US residents, and were not incarcerated or institutionalized. For this study, participants completed standardized questionnaires to report childhood experiences of abuse, neglect, household challenges, and sleep time. Researchers calculated the total adverse childhood experiences score by summing the number of different experiences that patients reported, regardless of their severity or frequency.

The sleep questionnaire asked participants to provide an estimate of how many hours of sleep they get in a 24-hour period, not including naps. These questionnaires were categorized based on whether participants reported having optimum sleep (seven to nine hours of sleep per night), or insufficient sleep (less than six hours of sleep per night). Finally, the investigators adjusted for standard demographic covariates (age, sex, race, education and income) and stratified the analysis by decade of age.

Adverse Childhood Experiences Increased Odds of Insufficient Sleep

Data were available for 22,403 adults (mean age, 46.66). In all, 14,587 (65%) study participants reported optimum sleep duration, 2,069 (9%) participants reported insufficient sleep duration, and 216 (1%) participants reported sleep durations of 10 or more hours. The total number of adverse childhood experiences was associated with the odds of insufficient sleep. Each adverse childhood experience increased the odds of insufficient sleep by more than 20%.

The association held for each decade of age through the 60s. The magnitude of this association, however, lessened with age. Participants who were in their 20s at the time of their survey had the strongest association between their adverse experiences and their likelihood of insufficient sleep.

Adults with three or more adverse childhood experiences were twice as likely to report insufficient sleep versus normal sleep duration, as were those with five or more adverse childhood experiences. Long sleep duration was not associated with total adverse childhood experiences.

“Longitudinal studies would help us to have a better idea of the individual impact over the life course,” Dr. Sullivan concluded.

—Erica Tricarico

LOS ANGELES—Adverse childhood experiences increase the likelihood of chronic insufficient sleep in adulthood, according to data presented at the 70th Annual Meeting of the American Academy of Neurology. This study emphasizes the importance of childhood health and a need to identify psychologic challenges in adults with sleep difficulties, particularly given the established importance of sleep dysregulation for cognitive and physical health, said Kelly Sullivan, PhD, MSPH, Assistant Professor of Epidemiology at Jiann-Ping Hsu College of Public Health at Georgia Southern University in Statesboro, Georgia.

Long-term prospective studies have suggested that adverse childhood experiences such as abuse, neglect, and household challenges (ie, divorced or separated parents, or living with someone who served time in a prison, jail, or other correctional facility) are associated with mental health challenges and unhealthy behaviors (ie, smoking, alcohol or drug use). These experiences have also been associated with conditions such as heart disease, cancer, and stroke.

Analyzing Data From a Nationwide Survey

To assess the association of adverse childhood experiences and subsequent insufficient sleep among a large group of adults in the United States, Dr. Sullivan and colleagues analyzed data from the 2011 Behavioral Risk Factor Surveillance System, a nationwide survey conducted by the Centers for Disease Control and Prevention.

Study participants were age 18 or older, were US residents, and were not incarcerated or institutionalized. For this study, participants completed standardized questionnaires to report childhood experiences of abuse, neglect, household challenges, and sleep time. Researchers calculated the total adverse childhood experiences score by summing the number of different experiences that patients reported, regardless of their severity or frequency.

The sleep questionnaire asked participants to provide an estimate of how many hours of sleep they get in a 24-hour period, not including naps. These questionnaires were categorized based on whether participants reported having optimum sleep (seven to nine hours of sleep per night), or insufficient sleep (less than six hours of sleep per night). Finally, the investigators adjusted for standard demographic covariates (age, sex, race, education and income) and stratified the analysis by decade of age.

Adverse Childhood Experiences Increased Odds of Insufficient Sleep

Data were available for 22,403 adults (mean age, 46.66). In all, 14,587 (65%) study participants reported optimum sleep duration, 2,069 (9%) participants reported insufficient sleep duration, and 216 (1%) participants reported sleep durations of 10 or more hours. The total number of adverse childhood experiences was associated with the odds of insufficient sleep. Each adverse childhood experience increased the odds of insufficient sleep by more than 20%.

The association held for each decade of age through the 60s. The magnitude of this association, however, lessened with age. Participants who were in their 20s at the time of their survey had the strongest association between their adverse experiences and their likelihood of insufficient sleep.

Adults with three or more adverse childhood experiences were twice as likely to report insufficient sleep versus normal sleep duration, as were those with five or more adverse childhood experiences. Long sleep duration was not associated with total adverse childhood experiences.

“Longitudinal studies would help us to have a better idea of the individual impact over the life course,” Dr. Sullivan concluded.

—Erica Tricarico

LOS ANGELES—Adverse childhood experiences increase the likelihood of chronic insufficient sleep in adulthood, according to data presented at the 70th Annual Meeting of the American Academy of Neurology. This study emphasizes the importance of childhood health and a need to identify psychologic challenges in adults with sleep difficulties, particularly given the established importance of sleep dysregulation for cognitive and physical health, said Kelly Sullivan, PhD, MSPH, Assistant Professor of Epidemiology at Jiann-Ping Hsu College of Public Health at Georgia Southern University in Statesboro, Georgia.

Long-term prospective studies have suggested that adverse childhood experiences such as abuse, neglect, and household challenges (ie, divorced or separated parents, or living with someone who served time in a prison, jail, or other correctional facility) are associated with mental health challenges and unhealthy behaviors (ie, smoking, alcohol or drug use). These experiences have also been associated with conditions such as heart disease, cancer, and stroke.

Analyzing Data From a Nationwide Survey

To assess the association of adverse childhood experiences and subsequent insufficient sleep among a large group of adults in the United States, Dr. Sullivan and colleagues analyzed data from the 2011 Behavioral Risk Factor Surveillance System, a nationwide survey conducted by the Centers for Disease Control and Prevention.

Study participants were age 18 or older, were US residents, and were not incarcerated or institutionalized. For this study, participants completed standardized questionnaires to report childhood experiences of abuse, neglect, household challenges, and sleep time. Researchers calculated the total adverse childhood experiences score by summing the number of different experiences that patients reported, regardless of their severity or frequency.

The sleep questionnaire asked participants to provide an estimate of how many hours of sleep they get in a 24-hour period, not including naps. These questionnaires were categorized based on whether participants reported having optimum sleep (seven to nine hours of sleep per night), or insufficient sleep (less than six hours of sleep per night). Finally, the investigators adjusted for standard demographic covariates (age, sex, race, education and income) and stratified the analysis by decade of age.

Adverse Childhood Experiences Increased Odds of Insufficient Sleep

Data were available for 22,403 adults (mean age, 46.66). In all, 14,587 (65%) study participants reported optimum sleep duration, 2,069 (9%) participants reported insufficient sleep duration, and 216 (1%) participants reported sleep durations of 10 or more hours. The total number of adverse childhood experiences was associated with the odds of insufficient sleep. Each adverse childhood experience increased the odds of insufficient sleep by more than 20%.

The association held for each decade of age through the 60s. The magnitude of this association, however, lessened with age. Participants who were in their 20s at the time of their survey had the strongest association between their adverse experiences and their likelihood of insufficient sleep.

Adults with three or more adverse childhood experiences were twice as likely to report insufficient sleep versus normal sleep duration, as were those with five or more adverse childhood experiences. Long sleep duration was not associated with total adverse childhood experiences.

“Longitudinal studies would help us to have a better idea of the individual impact over the life course,” Dr. Sullivan concluded.

—Erica Tricarico

Better treatments for opioid addiction and enhanced approaches to pain management headline a new effort to address the opioid crisis lead by the National Institutes of Health.

The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.

“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.

HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.

“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”

The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.

For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”

[email protected]
 

SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.

Better treatments for opioid addiction and enhanced approaches to pain management headline a new effort to address the opioid crisis lead by the National Institutes of Health.

The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.

“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.

HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.

“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”

The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.

For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”

[email protected]
 

SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.

Better treatments for opioid addiction and enhanced approaches to pain management headline a new effort to address the opioid crisis lead by the National Institutes of Health.

The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.

“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.

HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.

“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”

The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.

For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”

[email protected]
 

SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.

LIVERPOOL, ENGLAND – Treatment with the investigational drug upadacitinib resulted in higher percentages of patients with active rheumatoid arthritis achieving good disease control within 12 weeks than did treatment with placebo in a phase 3 trial.

Two-thirds of patients met American College of Rheumatology 20% (ACR 20) response criteria, and almost half (48%) achieved a Disease Activity Score in 28 Joints–C-reactive protein (DAS28-CRP) of 3.2 or less versus 17% of placebo-treated patients (P less than .001).

All patients had been given upadacitinib on top of their existing conventional synthetic disease-modifying antirheumatic drug therapy because they had not been fully responding to csDMARDs alone.

“Onset of action was rapid: By week 1 significantly more patients achieved ACR 20 on upadacitinib at both doses versus placebo,” the study’s investigators noted in a poster presentation given at the British Society for Rheumatology annual conference. Significant improvements in DAS28-CRP and Clinical Disease Activity Index (CDAI) were also seen as early as week 1.

Gerd R. Burmester, MD, of Charité-Universitätsmedizin, Berlin, and associates reported the results of the SELECT-NEXT study, one of six global phase 3 studies testing the efficacy and safety of upadacitinib targeting “a range of different patient populations” with RA; together the trials include more than 4,500 patients.

Upadacitinib (ABT-494) is a selective Janus kinase (JAK)-1 inhibitor and is also in phase 3 trials for the treatment of psoriatic arthritis and Crohn’s disease, as well as being tested as a potential treatment for axial spondyloarthritis, giant cell arteritis, ulcerative colitis, and atopic dermatitis.

SELECT-NEXT consists of two phases, the first of which has been completed and was reported at the meeting. Phase 1 consisted of randomized, double-blind treatment with upadacitinib 15 mg or 30 mg once daily or matching placebo. After the coprimary endpoint assessment of ACR 20 and DAS28-CRP was undertaken at 12 weeks, the trial entered its second phase: This is a blinded-extension phase that will last up to 5 years and during which patients randomized to upadacitinib will continue their treatment, and the patients randomized to placebo will split into two groups and be treated with one or the other dose of upadacitinib.

The study included 661 patients who had been treated with csDMARDs for at least 3 months but still had swollen and tender joint counts of six or higher and high-sensitivity CRP levels of 3 mg/L or higher. At entry, patients were allowed to continue on up to two csDMARDs; stable-dose steroids (less than 10 mg/week), nonsteroidal anti-inflammatory drugs, and acetaminophen were also allowed.

“Significant changes from baseline in several patient-reported outcomes were observed,” with the active treatment versus placebo, the investigators observed. Indeed, by week 12, morning stiffness was reduced by an average of 85 minutes in patients taking upadacitinib versus a decrease of 34 minutes in the placebo group. Significant (P less than .01) improvements were also seen in Short-Form 36–Mental Component scores, they reported.

Furthermore, more patients taking the active treatment than placebo achieved clinical remission by 12 weeks.

“The safety and tolerability profile was consistent with observations in the phase 2 studies,” Dr. Burmester and associates observed. The most frequently reported adverse events in more than 3% of patients were nasopharyngitis, upper respiratory infection, headache, urinary tract infection, cough, nausea, and diarrhea.

Serious adverse events and those leading to discontinuation were both higher in the two upadacitinib groups versus placebo, at 2.7% and 5.9% for the 30-mg dose, 4.1% and 3.2% for the 15-mg dose, and 2.3% and 3.2% for placebo. Of note, infections occurred in a 31.5% of patients on 30 mg, 29.0% on 15 mg, and 21.3% on placebo, and hepatic disorders occurred in 2.7% of patients on 30 mg, 1.8% on 15 mg, and 2.3% on placebo. One (0.5%) patient taking the 30-mg dose had a major cardiovascular event and two (0.9%) patients in the 15-mg group had other adjudicated cardiovascular events.

The study was sponsored and run by Abbvie. The study authors acknowledged receiving research support or consulting fees from Abbvie or being employees of the company.

SOURCE: Burmester GR et al.; BSR 2018 Rheumatology. 2018;57[Suppl. 3]:key075.466.

LIVERPOOL, ENGLAND – Treatment with the investigational drug upadacitinib resulted in higher percentages of patients with active rheumatoid arthritis achieving good disease control within 12 weeks than did treatment with placebo in a phase 3 trial.

Two-thirds of patients met American College of Rheumatology 20% (ACR 20) response criteria, and almost half (48%) achieved a Disease Activity Score in 28 Joints–C-reactive protein (DAS28-CRP) of 3.2 or less versus 17% of placebo-treated patients (P less than .001).

All patients had been given upadacitinib on top of their existing conventional synthetic disease-modifying antirheumatic drug therapy because they had not been fully responding to csDMARDs alone.

“Onset of action was rapid: By week 1 significantly more patients achieved ACR 20 on upadacitinib at both doses versus placebo,” the study’s investigators noted in a poster presentation given at the British Society for Rheumatology annual conference. Significant improvements in DAS28-CRP and Clinical Disease Activity Index (CDAI) were also seen as early as week 1.

Gerd R. Burmester, MD, of Charité-Universitätsmedizin, Berlin, and associates reported the results of the SELECT-NEXT study, one of six global phase 3 studies testing the efficacy and safety of upadacitinib targeting “a range of different patient populations” with RA; together the trials include more than 4,500 patients.

Upadacitinib (ABT-494) is a selective Janus kinase (JAK)-1 inhibitor and is also in phase 3 trials for the treatment of psoriatic arthritis and Crohn’s disease, as well as being tested as a potential treatment for axial spondyloarthritis, giant cell arteritis, ulcerative colitis, and atopic dermatitis.

SELECT-NEXT consists of two phases, the first of which has been completed and was reported at the meeting. Phase 1 consisted of randomized, double-blind treatment with upadacitinib 15 mg or 30 mg once daily or matching placebo. After the coprimary endpoint assessment of ACR 20 and DAS28-CRP was undertaken at 12 weeks, the trial entered its second phase: This is a blinded-extension phase that will last up to 5 years and during which patients randomized to upadacitinib will continue their treatment, and the patients randomized to placebo will split into two groups and be treated with one or the other dose of upadacitinib.

The study included 661 patients who had been treated with csDMARDs for at least 3 months but still had swollen and tender joint counts of six or higher and high-sensitivity CRP levels of 3 mg/L or higher. At entry, patients were allowed to continue on up to two csDMARDs; stable-dose steroids (less than 10 mg/week), nonsteroidal anti-inflammatory drugs, and acetaminophen were also allowed.

“Significant changes from baseline in several patient-reported outcomes were observed,” with the active treatment versus placebo, the investigators observed. Indeed, by week 12, morning stiffness was reduced by an average of 85 minutes in patients taking upadacitinib versus a decrease of 34 minutes in the placebo group. Significant (P less than .01) improvements were also seen in Short-Form 36–Mental Component scores, they reported.

Furthermore, more patients taking the active treatment than placebo achieved clinical remission by 12 weeks.

“The safety and tolerability profile was consistent with observations in the phase 2 studies,” Dr. Burmester and associates observed. The most frequently reported adverse events in more than 3% of patients were nasopharyngitis, upper respiratory infection, headache, urinary tract infection, cough, nausea, and diarrhea.

Serious adverse events and those leading to discontinuation were both higher in the two upadacitinib groups versus placebo, at 2.7% and 5.9% for the 30-mg dose, 4.1% and 3.2% for the 15-mg dose, and 2.3% and 3.2% for placebo. Of note, infections occurred in a 31.5% of patients on 30 mg, 29.0% on 15 mg, and 21.3% on placebo, and hepatic disorders occurred in 2.7% of patients on 30 mg, 1.8% on 15 mg, and 2.3% on placebo. One (0.5%) patient taking the 30-mg dose had a major cardiovascular event and two (0.9%) patients in the 15-mg group had other adjudicated cardiovascular events.

The study was sponsored and run by Abbvie. The study authors acknowledged receiving research support or consulting fees from Abbvie or being employees of the company.

SOURCE: Burmester GR et al.; BSR 2018 Rheumatology. 2018;57[Suppl. 3]:key075.466.

LIVERPOOL, ENGLAND – Treatment with the investigational drug upadacitinib resulted in higher percentages of patients with active rheumatoid arthritis achieving good disease control within 12 weeks than did treatment with placebo in a phase 3 trial.

Two-thirds of patients met American College of Rheumatology 20% (ACR 20) response criteria, and almost half (48%) achieved a Disease Activity Score in 28 Joints–C-reactive protein (DAS28-CRP) of 3.2 or less versus 17% of placebo-treated patients (P less than .001).

All patients had been given upadacitinib on top of their existing conventional synthetic disease-modifying antirheumatic drug therapy because they had not been fully responding to csDMARDs alone.

“Onset of action was rapid: By week 1 significantly more patients achieved ACR 20 on upadacitinib at both doses versus placebo,” the study’s investigators noted in a poster presentation given at the British Society for Rheumatology annual conference. Significant improvements in DAS28-CRP and Clinical Disease Activity Index (CDAI) were also seen as early as week 1.

Gerd R. Burmester, MD, of Charité-Universitätsmedizin, Berlin, and associates reported the results of the SELECT-NEXT study, one of six global phase 3 studies testing the efficacy and safety of upadacitinib targeting “a range of different patient populations” with RA; together the trials include more than 4,500 patients.

Upadacitinib (ABT-494) is a selective Janus kinase (JAK)-1 inhibitor and is also in phase 3 trials for the treatment of psoriatic arthritis and Crohn’s disease, as well as being tested as a potential treatment for axial spondyloarthritis, giant cell arteritis, ulcerative colitis, and atopic dermatitis.

SELECT-NEXT consists of two phases, the first of which has been completed and was reported at the meeting. Phase 1 consisted of randomized, double-blind treatment with upadacitinib 15 mg or 30 mg once daily or matching placebo. After the coprimary endpoint assessment of ACR 20 and DAS28-CRP was undertaken at 12 weeks, the trial entered its second phase: This is a blinded-extension phase that will last up to 5 years and during which patients randomized to upadacitinib will continue their treatment, and the patients randomized to placebo will split into two groups and be treated with one or the other dose of upadacitinib.

The study included 661 patients who had been treated with csDMARDs for at least 3 months but still had swollen and tender joint counts of six or higher and high-sensitivity CRP levels of 3 mg/L or higher. At entry, patients were allowed to continue on up to two csDMARDs; stable-dose steroids (less than 10 mg/week), nonsteroidal anti-inflammatory drugs, and acetaminophen were also allowed.

“Significant changes from baseline in several patient-reported outcomes were observed,” with the active treatment versus placebo, the investigators observed. Indeed, by week 12, morning stiffness was reduced by an average of 85 minutes in patients taking upadacitinib versus a decrease of 34 minutes in the placebo group. Significant (P less than .01) improvements were also seen in Short-Form 36–Mental Component scores, they reported.

Furthermore, more patients taking the active treatment than placebo achieved clinical remission by 12 weeks.

“The safety and tolerability profile was consistent with observations in the phase 2 studies,” Dr. Burmester and associates observed. The most frequently reported adverse events in more than 3% of patients were nasopharyngitis, upper respiratory infection, headache, urinary tract infection, cough, nausea, and diarrhea.

Serious adverse events and those leading to discontinuation were both higher in the two upadacitinib groups versus placebo, at 2.7% and 5.9% for the 30-mg dose, 4.1% and 3.2% for the 15-mg dose, and 2.3% and 3.2% for placebo. Of note, infections occurred in a 31.5% of patients on 30 mg, 29.0% on 15 mg, and 21.3% on placebo, and hepatic disorders occurred in 2.7% of patients on 30 mg, 1.8% on 15 mg, and 2.3% on placebo. One (0.5%) patient taking the 30-mg dose had a major cardiovascular event and two (0.9%) patients in the 15-mg group had other adjudicated cardiovascular events.

The study was sponsored and run by Abbvie. The study authors acknowledged receiving research support or consulting fees from Abbvie or being employees of the company.

SOURCE: Burmester GR et al.; BSR 2018 Rheumatology. 2018;57[Suppl. 3]:key075.466.

Insurance denials of direct-acting antiviral (DAA) prescriptions remain high and have increased over time, according to a prospective cohort study.

About one in three patients had lack of fill approval by insurers, contributing to a continued lack of access to hepatitis C virus (HCV) therapy across insurance types, despite availability of new, highly effective regimens and relaxation of restrictions on reimbursement, according to Charitha Gowda, MD, of Ohio State University, Columbus, and her coauthors.

“To achieve the goal of HCV elimination, access to antiviral treatment must be improved,” they wrote.

The study by Dr. Gowda and colleagues included 9,025 patients in 45 states who had a DAA prescription submitted to one large, independent pharmacy provider between January 2016 and April 2017. Of those patients, most (4,702) were covered by Medicaid, while 2,502 were covered commercially, and 1,821 were covered by Medicare.

Over the 16-month study period, 3,200 patients (35.5%) had an absolute denial of treatment, defined as lack of fill approval by the insurer.

Absolute denials were significantly more frequent in patients with commercial insurance (52.4%), as compared with Medicaid (34.5%) and Medicare (14.7%).

Absolute denials increased significantly over the 16-month study period, from 27.7% in the first quarter evaluated to 43.8% in the last, researchers noted, adding that each insurance type had a significant increase in absolute denials over time.

While DAAs are associated with very high cure rates, their high costs have led to restrictions to access by both private and public insurers. However, over the past few years, restrictions in DAA reimbursement have been relaxed in a variety of settings because of advocacy efforts, greater price competition, and class action lawsuits/threats of legal action, Dr. Gowda and colleagues noted.

“The reason for this higher than expected denial rate is unclear, but may be due to attempts to treat chronic HCV-infected patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist,” Dr. Gowda and colleagues wrote in their report.

The study was supported by the Penn Center for AIDS Research and the National Institutes of Health. Dr. Gowda had no conflicts of interest to report. Two coauthors reported grant support and/or advisory board fees from Gilead.

SOURCE: Gowda C et al. Open Forum Infect Dis. 2018 Jun 7 doi: 10.1093/ofid/ofy076.

Insurance denials of direct-acting antiviral (DAA) prescriptions remain high and have increased over time, according to a prospective cohort study.

About one in three patients had lack of fill approval by insurers, contributing to a continued lack of access to hepatitis C virus (HCV) therapy across insurance types, despite availability of new, highly effective regimens and relaxation of restrictions on reimbursement, according to Charitha Gowda, MD, of Ohio State University, Columbus, and her coauthors.

“To achieve the goal of HCV elimination, access to antiviral treatment must be improved,” they wrote.

The study by Dr. Gowda and colleagues included 9,025 patients in 45 states who had a DAA prescription submitted to one large, independent pharmacy provider between January 2016 and April 2017. Of those patients, most (4,702) were covered by Medicaid, while 2,502 were covered commercially, and 1,821 were covered by Medicare.

Over the 16-month study period, 3,200 patients (35.5%) had an absolute denial of treatment, defined as lack of fill approval by the insurer.

Absolute denials were significantly more frequent in patients with commercial insurance (52.4%), as compared with Medicaid (34.5%) and Medicare (14.7%).

Absolute denials increased significantly over the 16-month study period, from 27.7% in the first quarter evaluated to 43.8% in the last, researchers noted, adding that each insurance type had a significant increase in absolute denials over time.

While DAAs are associated with very high cure rates, their high costs have led to restrictions to access by both private and public insurers. However, over the past few years, restrictions in DAA reimbursement have been relaxed in a variety of settings because of advocacy efforts, greater price competition, and class action lawsuits/threats of legal action, Dr. Gowda and colleagues noted.

“The reason for this higher than expected denial rate is unclear, but may be due to attempts to treat chronic HCV-infected patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist,” Dr. Gowda and colleagues wrote in their report.

The study was supported by the Penn Center for AIDS Research and the National Institutes of Health. Dr. Gowda had no conflicts of interest to report. Two coauthors reported grant support and/or advisory board fees from Gilead.

SOURCE: Gowda C et al. Open Forum Infect Dis. 2018 Jun 7 doi: 10.1093/ofid/ofy076.

Insurance denials of direct-acting antiviral (DAA) prescriptions remain high and have increased over time, according to a prospective cohort study.

About one in three patients had lack of fill approval by insurers, contributing to a continued lack of access to hepatitis C virus (HCV) therapy across insurance types, despite availability of new, highly effective regimens and relaxation of restrictions on reimbursement, according to Charitha Gowda, MD, of Ohio State University, Columbus, and her coauthors.

“To achieve the goal of HCV elimination, access to antiviral treatment must be improved,” they wrote.

The study by Dr. Gowda and colleagues included 9,025 patients in 45 states who had a DAA prescription submitted to one large, independent pharmacy provider between January 2016 and April 2017. Of those patients, most (4,702) were covered by Medicaid, while 2,502 were covered commercially, and 1,821 were covered by Medicare.

Over the 16-month study period, 3,200 patients (35.5%) had an absolute denial of treatment, defined as lack of fill approval by the insurer.

Absolute denials were significantly more frequent in patients with commercial insurance (52.4%), as compared with Medicaid (34.5%) and Medicare (14.7%).

Absolute denials increased significantly over the 16-month study period, from 27.7% in the first quarter evaluated to 43.8% in the last, researchers noted, adding that each insurance type had a significant increase in absolute denials over time.

While DAAs are associated with very high cure rates, their high costs have led to restrictions to access by both private and public insurers. However, over the past few years, restrictions in DAA reimbursement have been relaxed in a variety of settings because of advocacy efforts, greater price competition, and class action lawsuits/threats of legal action, Dr. Gowda and colleagues noted.

“The reason for this higher than expected denial rate is unclear, but may be due to attempts to treat chronic HCV-infected patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist,” Dr. Gowda and colleagues wrote in their report.

The study was supported by the Penn Center for AIDS Research and the National Institutes of Health. Dr. Gowda had no conflicts of interest to report. Two coauthors reported grant support and/or advisory board fees from Gilead.

SOURCE: Gowda C et al. Open Forum Infect Dis. 2018 Jun 7 doi: 10.1093/ofid/ofy076.

WASHINGTON – Tenapanor, a first-in-class agent showed efficacy and safety for treating patients with constipation-predominant irritable bowel syndrome in a phase 3 multicenter, U.S. trial with 593 patients.

These data combined with results from an already reported additional phase 3 trial and a phase 2 study will go to the Food and Drug Administration later in 2018 in an application for marketing approval for tenapanor, William D. Chey, MD, said at the annual Digestive Disease Week.^®

Mitchel L. Zoler/MDedge News

“Tenapanor may represent a novel, effective treatment option” for patients with constipation-predominant irritable bowel syndrome (IBS-C), said Dr. Chey, a professor of medicine and director of the GI Physiology Laboratory at the University of Michigan in Ann Arbor.

The study results met the trial’s primary endpoint, the percentage of patients with a combined response consisting of at least a 30% drop from baseline in reported abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for 6 of the first 12 weeks of treatment. This combined response occurred in 37% of patients treated with tenapanor at a dosage of 50 mg orally b.i.d., compared with a 24% rate among the placebo-control patients, a statistically significant difference, Dr. Chey reported.

The most common adverse effect seen in the tenapanor-treated patients was diarrhea, which occurred in 16% of the drug-treated patients and in 4% of controls. “I think diarrhea is an expected adverse effect,” Dr. Chey said. Overall, treatment-related adverse effects occurred in 23% of tenapanor-treated patients and in 9% of controls, serious adverse effects occurred in 4% of patients on tenapanor and in 3% of controls, and adverse effects leading to treatment discontinuation occurred in 8% on tenapanor and in 1% of controls. Aside from diarrhea, the other most common adverse effects linked with tenapanor treatment were abdominal distension, in 3%, and flatulence, also in 3%.

Tenapanor is an inhibitor of sodium/hydrogen exchanger isoform 3, the predominant intestinal sodium transporter. Through this inhibition tenapanor reduces sodium uptake in the gut, causing increased intestinal fluid volume and shorter transit time and thereby softening stool consistency and increasing bowel movement frequency. Dr. Chey and his colleagues previously reported results from a phase 2 study of tenapanor (Am J Gastroenterol. 2017 Feb;112[2]:763-74), and from a phase 3 study with 606 patients reported at a meeting in late 2017. Results from these two studies were similar to those from the new study.

The current study, A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2) enrolled 593 patients at 114 U.S. centers. Enrolled patients met the Rome III criteria for IBS-C and had an average CSMB frequency of less than 3/week. The researchers treated and followed patients for 26 weeks, although the primary endpoint occurred after 12 weeks on treatment, and 481 of the enrolled patients remained in the study through 26 weeks. At baseline, patients had an average of 0.12 CSBM/week and an average abdominal pain score of 6.26, indicative of moderate to severe abdominal pain. These characteristics identified the enrolled patients as being “on the more severe spectrum of what we see in clinical practice,” Dr. Chey noted.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Tenapanor, a first-in-class agent showed efficacy and safety for treating patients with constipation-predominant irritable bowel syndrome in a phase 3 multicenter, U.S. trial with 593 patients.

These data combined with results from an already reported additional phase 3 trial and a phase 2 study will go to the Food and Drug Administration later in 2018 in an application for marketing approval for tenapanor, William D. Chey, MD, said at the annual Digestive Disease Week.^®

Mitchel L. Zoler/MDedge News

“Tenapanor may represent a novel, effective treatment option” for patients with constipation-predominant irritable bowel syndrome (IBS-C), said Dr. Chey, a professor of medicine and director of the GI Physiology Laboratory at the University of Michigan in Ann Arbor.

The study results met the trial’s primary endpoint, the percentage of patients with a combined response consisting of at least a 30% drop from baseline in reported abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for 6 of the first 12 weeks of treatment. This combined response occurred in 37% of patients treated with tenapanor at a dosage of 50 mg orally b.i.d., compared with a 24% rate among the placebo-control patients, a statistically significant difference, Dr. Chey reported.

The most common adverse effect seen in the tenapanor-treated patients was diarrhea, which occurred in 16% of the drug-treated patients and in 4% of controls. “I think diarrhea is an expected adverse effect,” Dr. Chey said. Overall, treatment-related adverse effects occurred in 23% of tenapanor-treated patients and in 9% of controls, serious adverse effects occurred in 4% of patients on tenapanor and in 3% of controls, and adverse effects leading to treatment discontinuation occurred in 8% on tenapanor and in 1% of controls. Aside from diarrhea, the other most common adverse effects linked with tenapanor treatment were abdominal distension, in 3%, and flatulence, also in 3%.

Tenapanor is an inhibitor of sodium/hydrogen exchanger isoform 3, the predominant intestinal sodium transporter. Through this inhibition tenapanor reduces sodium uptake in the gut, causing increased intestinal fluid volume and shorter transit time and thereby softening stool consistency and increasing bowel movement frequency. Dr. Chey and his colleagues previously reported results from a phase 2 study of tenapanor (Am J Gastroenterol. 2017 Feb;112[2]:763-74), and from a phase 3 study with 606 patients reported at a meeting in late 2017. Results from these two studies were similar to those from the new study.

The current study, A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2) enrolled 593 patients at 114 U.S. centers. Enrolled patients met the Rome III criteria for IBS-C and had an average CSMB frequency of less than 3/week. The researchers treated and followed patients for 26 weeks, although the primary endpoint occurred after 12 weeks on treatment, and 481 of the enrolled patients remained in the study through 26 weeks. At baseline, patients had an average of 0.12 CSBM/week and an average abdominal pain score of 6.26, indicative of moderate to severe abdominal pain. These characteristics identified the enrolled patients as being “on the more severe spectrum of what we see in clinical practice,” Dr. Chey noted.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Tenapanor, a first-in-class agent showed efficacy and safety for treating patients with constipation-predominant irritable bowel syndrome in a phase 3 multicenter, U.S. trial with 593 patients.

These data combined with results from an already reported additional phase 3 trial and a phase 2 study will go to the Food and Drug Administration later in 2018 in an application for marketing approval for tenapanor, William D. Chey, MD, said at the annual Digestive Disease Week.^®

Mitchel L. Zoler/MDedge News

“Tenapanor may represent a novel, effective treatment option” for patients with constipation-predominant irritable bowel syndrome (IBS-C), said Dr. Chey, a professor of medicine and director of the GI Physiology Laboratory at the University of Michigan in Ann Arbor.

The study results met the trial’s primary endpoint, the percentage of patients with a combined response consisting of at least a 30% drop from baseline in reported abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for 6 of the first 12 weeks of treatment. This combined response occurred in 37% of patients treated with tenapanor at a dosage of 50 mg orally b.i.d., compared with a 24% rate among the placebo-control patients, a statistically significant difference, Dr. Chey reported.

The most common adverse effect seen in the tenapanor-treated patients was diarrhea, which occurred in 16% of the drug-treated patients and in 4% of controls. “I think diarrhea is an expected adverse effect,” Dr. Chey said. Overall, treatment-related adverse effects occurred in 23% of tenapanor-treated patients and in 9% of controls, serious adverse effects occurred in 4% of patients on tenapanor and in 3% of controls, and adverse effects leading to treatment discontinuation occurred in 8% on tenapanor and in 1% of controls. Aside from diarrhea, the other most common adverse effects linked with tenapanor treatment were abdominal distension, in 3%, and flatulence, also in 3%.

Tenapanor is an inhibitor of sodium/hydrogen exchanger isoform 3, the predominant intestinal sodium transporter. Through this inhibition tenapanor reduces sodium uptake in the gut, causing increased intestinal fluid volume and shorter transit time and thereby softening stool consistency and increasing bowel movement frequency. Dr. Chey and his colleagues previously reported results from a phase 2 study of tenapanor (Am J Gastroenterol. 2017 Feb;112[2]:763-74), and from a phase 3 study with 606 patients reported at a meeting in late 2017. Results from these two studies were similar to those from the new study.

The current study, A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C (T3MPO-2) enrolled 593 patients at 114 U.S. centers. Enrolled patients met the Rome III criteria for IBS-C and had an average CSMB frequency of less than 3/week. The researchers treated and followed patients for 26 weeks, although the primary endpoint occurred after 12 weeks on treatment, and 481 of the enrolled patients remained in the study through 26 weeks. At baseline, patients had an average of 0.12 CSBM/week and an average abdominal pain score of 6.26, indicative of moderate to severe abdominal pain. These characteristics identified the enrolled patients as being “on the more severe spectrum of what we see in clinical practice,” Dr. Chey noted.

[email protected]

On Twitter @mitchelzoler

People with mental and/or substance abuse disorders are more than twice as likely to smoke cigarettes as people without those disorders, and are more likely to die of a smoking-related illness than from a behavioral health condition. Yet many people are not screened for tobacco use in behavioral health facilities. According to the Centers for Disease Control and Prevention (CDC) and Substance Abuse and Mental Health Services Administration (SAMHSA), in 2016, only half of mental health treatment facilities and 64% of substance abuse treatment facilities reported screening patients for tobacco use.

Even fewer facilities provide counseling and treatments. Only 38% of mental health facilities offer tobacco cessation counseling, 25% offer nicotine replacement therapy (NRT), and 22% offer non-nicotine cessation medications. Of substance abuse treatment facilities, 47% offer tobacco cessation counseling, 26% offer NRT, and 20% offer non-nicotine cessation medications. Oklahoma and New York had the highest percentage of programs. 

On the other hand, 49% of mental health and 33% of substance abuse treatment facilities now have smoke-free campuses in the 50 states, Washington DC, and Puerto Rico. That number varies by state, ranging from 20% of mental health facilities in Idaho to 78% in Oklahoma, and 10% of substance abuse treatment facilities in Idaho to 83% in New York.

Practical steps can boost the availability of smoking cessation screening and programs. The CDC recommends integrating screening and treatment protocols into workflows and electronic health record systems. The CDC also advises providing outreach to behavioral health providers who reinforce the message that patients can benefit from evidence-based cessation treatment.

The report is based on data from the 2016 National Mental Health Services Survey and the 2016 National Survey of Substance Abuse Treatment Services.

People with mental and/or substance abuse disorders are more than twice as likely to smoke cigarettes as people without those disorders, and are more likely to die of a smoking-related illness than from a behavioral health condition. Yet many people are not screened for tobacco use in behavioral health facilities. According to the Centers for Disease Control and Prevention (CDC) and Substance Abuse and Mental Health Services Administration (SAMHSA), in 2016, only half of mental health treatment facilities and 64% of substance abuse treatment facilities reported screening patients for tobacco use.

Even fewer facilities provide counseling and treatments. Only 38% of mental health facilities offer tobacco cessation counseling, 25% offer nicotine replacement therapy (NRT), and 22% offer non-nicotine cessation medications. Of substance abuse treatment facilities, 47% offer tobacco cessation counseling, 26% offer NRT, and 20% offer non-nicotine cessation medications. Oklahoma and New York had the highest percentage of programs. 

On the other hand, 49% of mental health and 33% of substance abuse treatment facilities now have smoke-free campuses in the 50 states, Washington DC, and Puerto Rico. That number varies by state, ranging from 20% of mental health facilities in Idaho to 78% in Oklahoma, and 10% of substance abuse treatment facilities in Idaho to 83% in New York.

Practical steps can boost the availability of smoking cessation screening and programs. The CDC recommends integrating screening and treatment protocols into workflows and electronic health record systems. The CDC also advises providing outreach to behavioral health providers who reinforce the message that patients can benefit from evidence-based cessation treatment.

The report is based on data from the 2016 National Mental Health Services Survey and the 2016 National Survey of Substance Abuse Treatment Services.

People with mental and/or substance abuse disorders are more than twice as likely to smoke cigarettes as people without those disorders, and are more likely to die of a smoking-related illness than from a behavioral health condition. Yet many people are not screened for tobacco use in behavioral health facilities. According to the Centers for Disease Control and Prevention (CDC) and Substance Abuse and Mental Health Services Administration (SAMHSA), in 2016, only half of mental health treatment facilities and 64% of substance abuse treatment facilities reported screening patients for tobacco use.

Even fewer facilities provide counseling and treatments. Only 38% of mental health facilities offer tobacco cessation counseling, 25% offer nicotine replacement therapy (NRT), and 22% offer non-nicotine cessation medications. Of substance abuse treatment facilities, 47% offer tobacco cessation counseling, 26% offer NRT, and 20% offer non-nicotine cessation medications. Oklahoma and New York had the highest percentage of programs. 

On the other hand, 49% of mental health and 33% of substance abuse treatment facilities now have smoke-free campuses in the 50 states, Washington DC, and Puerto Rico. That number varies by state, ranging from 20% of mental health facilities in Idaho to 78% in Oklahoma, and 10% of substance abuse treatment facilities in Idaho to 83% in New York.

Practical steps can boost the availability of smoking cessation screening and programs. The CDC recommends integrating screening and treatment protocols into workflows and electronic health record systems. The CDC also advises providing outreach to behavioral health providers who reinforce the message that patients can benefit from evidence-based cessation treatment.

The report is based on data from the 2016 National Mental Health Services Survey and the 2016 National Survey of Substance Abuse Treatment Services.

Patients who experienced adverse changes in employment status after acute myocardial infarction (AMI) reported increased depression and lower quality of life, according to results published June 12 in Circulation: Cardiovascular Quality and Outcomes.

At 1-year follow-up, 27.4% of patients with adverse employment change scored high on measures of depression, compared with 16.7% of patients who did not experience a change in status. These patients also reported lower health status and difficulty affording medications, wrote Haider J. Warraich, MD, a cardiologist at Duke University in Durham, N.C., and coauthors.

The number of readmissions within the first year was the factor most strongly associated with adverse change in employment. Baseline smoking status, hypertension, and postdischarge bleeding were also significantly associated with adverse change in employment, the authors said.

At 1 year follow-up, patients with an adverse change in employment were more likely than those with no change to report depression (27.4% with PHQ score greater than 3, compared with 16.7% in the no-change group). These patients also reported lower health status (mean EuroQoL score of 73 compared with 78) and moderate to extreme financial hardship with medication costs (41.0% compared with 28.4%), though there was no difference in medication adherence, the authors reported.

The results indicate that, although job loss in acute MI patients has dropped in comparison with previous studies, patients who experience an adverse change in employment are still “at increased risk of depression, lower quality of life, and increased financial hardship with medication costs compared with those who continue working,” the authors wrote.

“These results underscore the need for interventions to address this patient-centered outcome and its health impact,” they concluded.

Daiichi Sankyo and Lilly USA funded TRANSLATE-ACS. This analysis was funded in part by a grant from the National Heart, Lung, and Blood Institute.

SOURCE: Warraich H et al. Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.117.004528.

Patients who experienced adverse changes in employment status after acute myocardial infarction (AMI) reported increased depression and lower quality of life, according to results published June 12 in Circulation: Cardiovascular Quality and Outcomes.

At 1-year follow-up, 27.4% of patients with adverse employment change scored high on measures of depression, compared with 16.7% of patients who did not experience a change in status. These patients also reported lower health status and difficulty affording medications, wrote Haider J. Warraich, MD, a cardiologist at Duke University in Durham, N.C., and coauthors.

The number of readmissions within the first year was the factor most strongly associated with adverse change in employment. Baseline smoking status, hypertension, and postdischarge bleeding were also significantly associated with adverse change in employment, the authors said.

At 1 year follow-up, patients with an adverse change in employment were more likely than those with no change to report depression (27.4% with PHQ score greater than 3, compared with 16.7% in the no-change group). These patients also reported lower health status (mean EuroQoL score of 73 compared with 78) and moderate to extreme financial hardship with medication costs (41.0% compared with 28.4%), though there was no difference in medication adherence, the authors reported.

The results indicate that, although job loss in acute MI patients has dropped in comparison with previous studies, patients who experience an adverse change in employment are still “at increased risk of depression, lower quality of life, and increased financial hardship with medication costs compared with those who continue working,” the authors wrote.

“These results underscore the need for interventions to address this patient-centered outcome and its health impact,” they concluded.

Daiichi Sankyo and Lilly USA funded TRANSLATE-ACS. This analysis was funded in part by a grant from the National Heart, Lung, and Blood Institute.

SOURCE: Warraich H et al. Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.117.004528.

Patients who experienced adverse changes in employment status after acute myocardial infarction (AMI) reported increased depression and lower quality of life, according to results published June 12 in Circulation: Cardiovascular Quality and Outcomes.

At 1-year follow-up, 27.4% of patients with adverse employment change scored high on measures of depression, compared with 16.7% of patients who did not experience a change in status. These patients also reported lower health status and difficulty affording medications, wrote Haider J. Warraich, MD, a cardiologist at Duke University in Durham, N.C., and coauthors.

The number of readmissions within the first year was the factor most strongly associated with adverse change in employment. Baseline smoking status, hypertension, and postdischarge bleeding were also significantly associated with adverse change in employment, the authors said.

At 1 year follow-up, patients with an adverse change in employment were more likely than those with no change to report depression (27.4% with PHQ score greater than 3, compared with 16.7% in the no-change group). These patients also reported lower health status (mean EuroQoL score of 73 compared with 78) and moderate to extreme financial hardship with medication costs (41.0% compared with 28.4%), though there was no difference in medication adherence, the authors reported.

The results indicate that, although job loss in acute MI patients has dropped in comparison with previous studies, patients who experience an adverse change in employment are still “at increased risk of depression, lower quality of life, and increased financial hardship with medication costs compared with those who continue working,” the authors wrote.

“These results underscore the need for interventions to address this patient-centered outcome and its health impact,” they concluded.

Daiichi Sankyo and Lilly USA funded TRANSLATE-ACS. This analysis was funded in part by a grant from the National Heart, Lung, and Blood Institute.

SOURCE: Warraich H et al. Circ Cardiovasc Qual Outcomes. 2018 Jun 12. doi: 10.1161/circoutcomes.117.004528.