HYATTSVILLE, MD – A Food and Drug Administration advisory panel voted against recommending Linhaliq, ciprofloxacin dispersion for inhalation, to treat adult non-cystic fibrosis bronchiectasis (NCFBE) patients who have chronic lung infections with Pseudomonas aeruginosa. 

CDC/Janice Haney Carr

“Two trials that have two very different outcomes – and no matter how we try and explain what the difference was, there was something really missing there,” said advisory committee member Peter Weina, MD, chief of the department of research programs at Walter Reed National Military Medical Center, Bethesda, Md.

NCFBE is often treated with antibacterial drugs, which temporarily reduce inflammation and bacterial load. One of the most common colonizing bacteria in NCFBE infections is P. aeruginosa, which is often associated with increased risk of death and hospital admission. 

Prior studies involving inhaled bacterial drugs such as gentamicin and colistin to treat NCFBE have yielded mixed results, and none has been approved for that indication by the FDA.

The FDA granted cipro DI orphan drug status in June 2011 and fast-track approval in August 2014. Cipro DI’s developer, Aradigm, conducted two phase 3 clinical trials to support inhaled ciprofloxacin for the NCFBE indication.

The two phase 3 clinical trials, ORBIT-3 and ORBIT-4, were nearly identical in design. Patients in both were randomized 2:1 to receive cipro DI or placebo once daily for six cycles of 56 days each. 

The efficacy results of the ORBIT-3 and ORBIT-4 trials were mixed.  In ORBIT-3, there was very little difference between the treatment and placebo arms, with a median difference of 78 days for the primary endpoint of time to first pulmonary exacerbation (PE) (hazard ratio, 0.99; P = .974). ORBIT-3 also showed no difference between treatment and placebo in the frequency of PEs by week 48 of the study (incidence ratio, 0.852). 

In contrast, a marginal treatment effect was observed in ORBIT-4, with a median time difference to first PE of 72 days between the placebo and treatment arms (HR, 0.71; P = .032). ORBIT-4 also demonstrated an ability to reduce the number of PEs (incidence ratio, 0.631) by approximately 36.9% by week 48. 

Adverse events were the most common reason leading to patient discontinuation in both studies, accounting for 13.1% and 5.3% in the treatment arms of ORBIT-3 and ORBIT-4, respectively.

Despite some of the positive findings in ORBIT-4, FDA presenter LaRee Tracy, PhD, of the FDA’s office of biostatistics, voiced concerns about the trial data – specifically, the failure to reach the primary endpoint in ORBIT-3.

“If I were to be a [statistically speaking] ‘strict’ person, I wouldn’t be looking at the frequency of the [secondary] endpoints, because the primary [endpoint] failed,” Dr. Tracy noted. She also voiced concerns about a re-analysis Aradigm conducted after the trial data were unblinded, stating that the changes made to the original analysis plan “lend a lot of concerns for me.”

Both ORBIT-3 and ORBIT-4 presented uncertainties related to the long-term use of cipro DI. The durability of efficacy and safety findings did not extend beyond a year, leaving some committee members wondering about the development of antibiotic resistance in cipro DI-treated patients. In addition, members were concerned that long-term use of cipro DI could limit the utility of systemic fluoroquinolones to treat severe bacterial and pneumonia infections in NCFBE patients.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

This article was updated 1/11/18.

[email protected] 

HYATTSVILLE, MD – A Food and Drug Administration advisory panel voted against recommending Linhaliq, ciprofloxacin dispersion for inhalation, to treat adult non-cystic fibrosis bronchiectasis (NCFBE) patients who have chronic lung infections with Pseudomonas aeruginosa. 

CDC/Janice Haney Carr

“Two trials that have two very different outcomes – and no matter how we try and explain what the difference was, there was something really missing there,” said advisory committee member Peter Weina, MD, chief of the department of research programs at Walter Reed National Military Medical Center, Bethesda, Md.

NCFBE is often treated with antibacterial drugs, which temporarily reduce inflammation and bacterial load. One of the most common colonizing bacteria in NCFBE infections is P. aeruginosa, which is often associated with increased risk of death and hospital admission. 

Prior studies involving inhaled bacterial drugs such as gentamicin and colistin to treat NCFBE have yielded mixed results, and none has been approved for that indication by the FDA.

The FDA granted cipro DI orphan drug status in June 2011 and fast-track approval in August 2014. Cipro DI’s developer, Aradigm, conducted two phase 3 clinical trials to support inhaled ciprofloxacin for the NCFBE indication.

The two phase 3 clinical trials, ORBIT-3 and ORBIT-4, were nearly identical in design. Patients in both were randomized 2:1 to receive cipro DI or placebo once daily for six cycles of 56 days each. 

The efficacy results of the ORBIT-3 and ORBIT-4 trials were mixed.  In ORBIT-3, there was very little difference between the treatment and placebo arms, with a median difference of 78 days for the primary endpoint of time to first pulmonary exacerbation (PE) (hazard ratio, 0.99; P = .974). ORBIT-3 also showed no difference between treatment and placebo in the frequency of PEs by week 48 of the study (incidence ratio, 0.852). 

In contrast, a marginal treatment effect was observed in ORBIT-4, with a median time difference to first PE of 72 days between the placebo and treatment arms (HR, 0.71; P = .032). ORBIT-4 also demonstrated an ability to reduce the number of PEs (incidence ratio, 0.631) by approximately 36.9% by week 48. 

Adverse events were the most common reason leading to patient discontinuation in both studies, accounting for 13.1% and 5.3% in the treatment arms of ORBIT-3 and ORBIT-4, respectively.

Despite some of the positive findings in ORBIT-4, FDA presenter LaRee Tracy, PhD, of the FDA’s office of biostatistics, voiced concerns about the trial data – specifically, the failure to reach the primary endpoint in ORBIT-3.

“If I were to be a [statistically speaking] ‘strict’ person, I wouldn’t be looking at the frequency of the [secondary] endpoints, because the primary [endpoint] failed,” Dr. Tracy noted. She also voiced concerns about a re-analysis Aradigm conducted after the trial data were unblinded, stating that the changes made to the original analysis plan “lend a lot of concerns for me.”

Both ORBIT-3 and ORBIT-4 presented uncertainties related to the long-term use of cipro DI. The durability of efficacy and safety findings did not extend beyond a year, leaving some committee members wondering about the development of antibiotic resistance in cipro DI-treated patients. In addition, members were concerned that long-term use of cipro DI could limit the utility of systemic fluoroquinolones to treat severe bacterial and pneumonia infections in NCFBE patients.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

This article was updated 1/11/18.

[email protected] 

HYATTSVILLE, MD – A Food and Drug Administration advisory panel voted against recommending Linhaliq, ciprofloxacin dispersion for inhalation, to treat adult non-cystic fibrosis bronchiectasis (NCFBE) patients who have chronic lung infections with Pseudomonas aeruginosa. 

CDC/Janice Haney Carr

“Two trials that have two very different outcomes – and no matter how we try and explain what the difference was, there was something really missing there,” said advisory committee member Peter Weina, MD, chief of the department of research programs at Walter Reed National Military Medical Center, Bethesda, Md.

NCFBE is often treated with antibacterial drugs, which temporarily reduce inflammation and bacterial load. One of the most common colonizing bacteria in NCFBE infections is P. aeruginosa, which is often associated with increased risk of death and hospital admission. 

Prior studies involving inhaled bacterial drugs such as gentamicin and colistin to treat NCFBE have yielded mixed results, and none has been approved for that indication by the FDA.

The FDA granted cipro DI orphan drug status in June 2011 and fast-track approval in August 2014. Cipro DI’s developer, Aradigm, conducted two phase 3 clinical trials to support inhaled ciprofloxacin for the NCFBE indication.

The two phase 3 clinical trials, ORBIT-3 and ORBIT-4, were nearly identical in design. Patients in both were randomized 2:1 to receive cipro DI or placebo once daily for six cycles of 56 days each. 

The efficacy results of the ORBIT-3 and ORBIT-4 trials were mixed.  In ORBIT-3, there was very little difference between the treatment and placebo arms, with a median difference of 78 days for the primary endpoint of time to first pulmonary exacerbation (PE) (hazard ratio, 0.99; P = .974). ORBIT-3 also showed no difference between treatment and placebo in the frequency of PEs by week 48 of the study (incidence ratio, 0.852). 

In contrast, a marginal treatment effect was observed in ORBIT-4, with a median time difference to first PE of 72 days between the placebo and treatment arms (HR, 0.71; P = .032). ORBIT-4 also demonstrated an ability to reduce the number of PEs (incidence ratio, 0.631) by approximately 36.9% by week 48. 

Adverse events were the most common reason leading to patient discontinuation in both studies, accounting for 13.1% and 5.3% in the treatment arms of ORBIT-3 and ORBIT-4, respectively.

Despite some of the positive findings in ORBIT-4, FDA presenter LaRee Tracy, PhD, of the FDA’s office of biostatistics, voiced concerns about the trial data – specifically, the failure to reach the primary endpoint in ORBIT-3.

“If I were to be a [statistically speaking] ‘strict’ person, I wouldn’t be looking at the frequency of the [secondary] endpoints, because the primary [endpoint] failed,” Dr. Tracy noted. She also voiced concerns about a re-analysis Aradigm conducted after the trial data were unblinded, stating that the changes made to the original analysis plan “lend a lot of concerns for me.”

Both ORBIT-3 and ORBIT-4 presented uncertainties related to the long-term use of cipro DI. The durability of efficacy and safety findings did not extend beyond a year, leaving some committee members wondering about the development of antibiotic resistance in cipro DI-treated patients. In addition, members were concerned that long-term use of cipro DI could limit the utility of systemic fluoroquinolones to treat severe bacterial and pneumonia infections in NCFBE patients.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

This article was updated 1/11/18.

[email protected] 

Addiction used to be considered a moral failing, and the family was blamed for keeping the relative with addictions sick, through behaviors labeled “codependency” and “enabling.” The opioid epidemic can take credit for putting a serious dent in these destructive and stigmatizing notions. When psychiatrists actively include families as educated treatment partners, fatalities are less likely, and the havoc created by addiction on families is mitigated.

Genes and addiction

What causes addiction? Statistics show that Native Americans fare the worst of all minority groups, with death by opiates in whites and Native Americans double or triple the rates of African Americans and Latinos. Reasons put forward for Native American deaths are their vulnerability related to systemic racism, intergenerational trauma, and lack of access to health care. These “reasons” are well known to contribute to poor overall health status of impoverished communities.

Among impoverished white communities, the Monongahela Valley of Pennsylvania has been studied by Katherine McLean, PhD, as an example of postindustrial decay (Int J Drug Policy. 2016;[29]:19-26). Once a global center of steel production, the exodus of jobs, residents, and businesses since the early 1980s is thought to contribute to the high numbers of opioid deaths. A qualitative study of the people with addiction in the deteriorating mill city of McKeesport, Pa., characterized a risk environment hidden behind closed doors, and populated by unprepared, ambivalent overdose “assistants.” These people are “co-drug” users who themselves are reluctant to step forward because of fear of getting in trouble. The participants described the hopelessness and lack of opportunity as driving the use of heroin, with many stating that jobs and community reinvestment are needed to reduce fatalities. This certainly resonates with the Native American experience.

Roots of codependency

The concept of codependency began as a grassroots idea in the 1960s to describe family members, usually wives or mothers, who were deemed excessive in their caring for their husband or son with addiction. The term was used to describe women who had an overresponsibility for relationships, rather than a responsibility to self. Support groups for codependency, such as Co-Dependents Anonymous, Al-Anon/Alateen, Nar-Anon, and Adult Children of Alcoholics, based on the 12-step program model of Alcoholics Anonymous, were established. Codependents were negatively labeled as rescuers, supporters, and confidantes of their family member with substance use disorder. These helpers were described as dependent on the other person’s poor functioning to satisfy their own emotional needs.

In these early descriptions, there was a lack of discussion about possible deeper family dynamics: Inequality in financial independence of each partner, the desire for family stability focusing on the welfare of children, the real possibility that disrupting a relationship might result in violence if the woman was more assertive. Women were blamed for trying to love their spouse out of the addiction. One aspect of codependency is self-sacrifice, which used to be considered an important trait of the good wife but became a negative trait in the 1960s. Recovery from codependence was considered achieved when the wife or mother expressed healthy self-assertiveness. Some scholars did state, however, that they believed that codependency was not a negative trait, but rather a healthy personality trait taken to excess. In most studies, women with high codependency ratings have tended to be unemployed and with lower educations. Their behavior had been considered worthy of a DSM inclusion as a personality disorder, but luckily, this was thwarted.

A family is forced to make some accounting when an individual develops a substance use disorder. If the family tries to maintain equilibrium and keeps things as stable as possible for the sake of maintaining the family unit or the stability of the lives of the children, accommodation will be required. Accommodation minimizes the impact of the addiction: the sober spouse stepping up to complete the roles of the ill relative and in all ways reducing the impact of dysfunction on the family. If you swap out the illness and consider the ill family member as having cancer or respiratory distress, then you reframe the spouse’s “codependence” as the behavior of a caring spouse.

This long preamble is intended to illustrate how little family dynamics have to do with the etiology of addiction. Addiction is a chronic neurobiological disease, and like all diseases, individuals, and couples and families have the option of learning to cope well. We, as psychiatrists, must move away from blaming people (usually women who have less-than-optimal coping skills) and consider how best to engage partners and families in optimal programs.*

Families can benefit from specialist treatment and thus contribute to the recovery process. One example is a telepsychiatry program that aimed to improve family coping skills to cope with relatives who have substance use disorders. The Tele-intervention Model and Monitoring of Families of Drug Users is based on motivational interviewing and stages of change. Families were randomized into the intervention group (n = 163) or the usual treatment (n = 162). After 6 months of follow-up, the family members of the telepsychiatry group were twice as likely to modify their behavior (odds ratio; 2.08; 95% confidence interval, 1.18-3.65) (J Sub Use Misuse. 2017 Jan 28;52[2]:164-74). This model was organized so that each of nine calls had a specific goal to stimulate the family members in their process of change.

Family change and engagement also can occur through Alanon (Subst Use Misuse. 2015; 50[1]:62-71) and the use of the Arise program of Judith Landau, MD, (Landau J et al. Am J Drug Alcohol Abuse. 2000;26[3]:379-98).

In summary, the family can be engaged in treatment and can develop family coping skills to support their relative with this chronic neurobiological disease.

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

*Updated on January 12, 2018.

Addiction used to be considered a moral failing, and the family was blamed for keeping the relative with addictions sick, through behaviors labeled “codependency” and “enabling.” The opioid epidemic can take credit for putting a serious dent in these destructive and stigmatizing notions. When psychiatrists actively include families as educated treatment partners, fatalities are less likely, and the havoc created by addiction on families is mitigated.

Genes and addiction

What causes addiction? Statistics show that Native Americans fare the worst of all minority groups, with death by opiates in whites and Native Americans double or triple the rates of African Americans and Latinos. Reasons put forward for Native American deaths are their vulnerability related to systemic racism, intergenerational trauma, and lack of access to health care. These “reasons” are well known to contribute to poor overall health status of impoverished communities.

Among impoverished white communities, the Monongahela Valley of Pennsylvania has been studied by Katherine McLean, PhD, as an example of postindustrial decay (Int J Drug Policy. 2016;[29]:19-26). Once a global center of steel production, the exodus of jobs, residents, and businesses since the early 1980s is thought to contribute to the high numbers of opioid deaths. A qualitative study of the people with addiction in the deteriorating mill city of McKeesport, Pa., characterized a risk environment hidden behind closed doors, and populated by unprepared, ambivalent overdose “assistants.” These people are “co-drug” users who themselves are reluctant to step forward because of fear of getting in trouble. The participants described the hopelessness and lack of opportunity as driving the use of heroin, with many stating that jobs and community reinvestment are needed to reduce fatalities. This certainly resonates with the Native American experience.

Roots of codependency

The concept of codependency began as a grassroots idea in the 1960s to describe family members, usually wives or mothers, who were deemed excessive in their caring for their husband or son with addiction. The term was used to describe women who had an overresponsibility for relationships, rather than a responsibility to self. Support groups for codependency, such as Co-Dependents Anonymous, Al-Anon/Alateen, Nar-Anon, and Adult Children of Alcoholics, based on the 12-step program model of Alcoholics Anonymous, were established. Codependents were negatively labeled as rescuers, supporters, and confidantes of their family member with substance use disorder. These helpers were described as dependent on the other person’s poor functioning to satisfy their own emotional needs.

In these early descriptions, there was a lack of discussion about possible deeper family dynamics: Inequality in financial independence of each partner, the desire for family stability focusing on the welfare of children, the real possibility that disrupting a relationship might result in violence if the woman was more assertive. Women were blamed for trying to love their spouse out of the addiction. One aspect of codependency is self-sacrifice, which used to be considered an important trait of the good wife but became a negative trait in the 1960s. Recovery from codependence was considered achieved when the wife or mother expressed healthy self-assertiveness. Some scholars did state, however, that they believed that codependency was not a negative trait, but rather a healthy personality trait taken to excess. In most studies, women with high codependency ratings have tended to be unemployed and with lower educations. Their behavior had been considered worthy of a DSM inclusion as a personality disorder, but luckily, this was thwarted.

A family is forced to make some accounting when an individual develops a substance use disorder. If the family tries to maintain equilibrium and keeps things as stable as possible for the sake of maintaining the family unit or the stability of the lives of the children, accommodation will be required. Accommodation minimizes the impact of the addiction: the sober spouse stepping up to complete the roles of the ill relative and in all ways reducing the impact of dysfunction on the family. If you swap out the illness and consider the ill family member as having cancer or respiratory distress, then you reframe the spouse’s “codependence” as the behavior of a caring spouse.

This long preamble is intended to illustrate how little family dynamics have to do with the etiology of addiction. Addiction is a chronic neurobiological disease, and like all diseases, individuals, and couples and families have the option of learning to cope well. We, as psychiatrists, must move away from blaming people (usually women who have less-than-optimal coping skills) and consider how best to engage partners and families in optimal programs.*

Families can benefit from specialist treatment and thus contribute to the recovery process. One example is a telepsychiatry program that aimed to improve family coping skills to cope with relatives who have substance use disorders. The Tele-intervention Model and Monitoring of Families of Drug Users is based on motivational interviewing and stages of change. Families were randomized into the intervention group (n = 163) or the usual treatment (n = 162). After 6 months of follow-up, the family members of the telepsychiatry group were twice as likely to modify their behavior (odds ratio; 2.08; 95% confidence interval, 1.18-3.65) (J Sub Use Misuse. 2017 Jan 28;52[2]:164-74). This model was organized so that each of nine calls had a specific goal to stimulate the family members in their process of change.

Family change and engagement also can occur through Alanon (Subst Use Misuse. 2015; 50[1]:62-71) and the use of the Arise program of Judith Landau, MD, (Landau J et al. Am J Drug Alcohol Abuse. 2000;26[3]:379-98).

In summary, the family can be engaged in treatment and can develop family coping skills to support their relative with this chronic neurobiological disease.

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

*Updated on January 12, 2018.

Addiction used to be considered a moral failing, and the family was blamed for keeping the relative with addictions sick, through behaviors labeled “codependency” and “enabling.” The opioid epidemic can take credit for putting a serious dent in these destructive and stigmatizing notions. When psychiatrists actively include families as educated treatment partners, fatalities are less likely, and the havoc created by addiction on families is mitigated.

Genes and addiction

What causes addiction? Statistics show that Native Americans fare the worst of all minority groups, with death by opiates in whites and Native Americans double or triple the rates of African Americans and Latinos. Reasons put forward for Native American deaths are their vulnerability related to systemic racism, intergenerational trauma, and lack of access to health care. These “reasons” are well known to contribute to poor overall health status of impoverished communities.

Among impoverished white communities, the Monongahela Valley of Pennsylvania has been studied by Katherine McLean, PhD, as an example of postindustrial decay (Int J Drug Policy. 2016;[29]:19-26). Once a global center of steel production, the exodus of jobs, residents, and businesses since the early 1980s is thought to contribute to the high numbers of opioid deaths. A qualitative study of the people with addiction in the deteriorating mill city of McKeesport, Pa., characterized a risk environment hidden behind closed doors, and populated by unprepared, ambivalent overdose “assistants.” These people are “co-drug” users who themselves are reluctant to step forward because of fear of getting in trouble. The participants described the hopelessness and lack of opportunity as driving the use of heroin, with many stating that jobs and community reinvestment are needed to reduce fatalities. This certainly resonates with the Native American experience.

Roots of codependency

The concept of codependency began as a grassroots idea in the 1960s to describe family members, usually wives or mothers, who were deemed excessive in their caring for their husband or son with addiction. The term was used to describe women who had an overresponsibility for relationships, rather than a responsibility to self. Support groups for codependency, such as Co-Dependents Anonymous, Al-Anon/Alateen, Nar-Anon, and Adult Children of Alcoholics, based on the 12-step program model of Alcoholics Anonymous, were established. Codependents were negatively labeled as rescuers, supporters, and confidantes of their family member with substance use disorder. These helpers were described as dependent on the other person’s poor functioning to satisfy their own emotional needs.

In these early descriptions, there was a lack of discussion about possible deeper family dynamics: Inequality in financial independence of each partner, the desire for family stability focusing on the welfare of children, the real possibility that disrupting a relationship might result in violence if the woman was more assertive. Women were blamed for trying to love their spouse out of the addiction. One aspect of codependency is self-sacrifice, which used to be considered an important trait of the good wife but became a negative trait in the 1960s. Recovery from codependence was considered achieved when the wife or mother expressed healthy self-assertiveness. Some scholars did state, however, that they believed that codependency was not a negative trait, but rather a healthy personality trait taken to excess. In most studies, women with high codependency ratings have tended to be unemployed and with lower educations. Their behavior had been considered worthy of a DSM inclusion as a personality disorder, but luckily, this was thwarted.

A family is forced to make some accounting when an individual develops a substance use disorder. If the family tries to maintain equilibrium and keeps things as stable as possible for the sake of maintaining the family unit or the stability of the lives of the children, accommodation will be required. Accommodation minimizes the impact of the addiction: the sober spouse stepping up to complete the roles of the ill relative and in all ways reducing the impact of dysfunction on the family. If you swap out the illness and consider the ill family member as having cancer or respiratory distress, then you reframe the spouse’s “codependence” as the behavior of a caring spouse.

This long preamble is intended to illustrate how little family dynamics have to do with the etiology of addiction. Addiction is a chronic neurobiological disease, and like all diseases, individuals, and couples and families have the option of learning to cope well. We, as psychiatrists, must move away from blaming people (usually women who have less-than-optimal coping skills) and consider how best to engage partners and families in optimal programs.*

Families can benefit from specialist treatment and thus contribute to the recovery process. One example is a telepsychiatry program that aimed to improve family coping skills to cope with relatives who have substance use disorders. The Tele-intervention Model and Monitoring of Families of Drug Users is based on motivational interviewing and stages of change. Families were randomized into the intervention group (n = 163) or the usual treatment (n = 162). After 6 months of follow-up, the family members of the telepsychiatry group were twice as likely to modify their behavior (odds ratio; 2.08; 95% confidence interval, 1.18-3.65) (J Sub Use Misuse. 2017 Jan 28;52[2]:164-74). This model was organized so that each of nine calls had a specific goal to stimulate the family members in their process of change.

Family change and engagement also can occur through Alanon (Subst Use Misuse. 2015; 50[1]:62-71) and the use of the Arise program of Judith Landau, MD, (Landau J et al. Am J Drug Alcohol Abuse. 2000;26[3]:379-98).

In summary, the family can be engaged in treatment and can develop family coping skills to support their relative with this chronic neurobiological disease.

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

*Updated on January 12, 2018.

The ability of Clostridium difficile ribotype 027 (RT027) to metabolize the sugar trehalose, a common food additive, has increased the virulence of C. difficile infections, a study showed.

“Out of several carbon sources identified that supported CD2015 growth [epidemic RT027 isolate], we found the disaccharide trehalose increased the growth yield of CD2015 by approximately fivefold, compared with a non-RT027 strain,” according to James Collins, PhD, of Baylor University, Houston, and his colleagues. The increased growth of the epidemic strain of C. difficile observed by Dr. Collins and his team demonstrates that trehalose is a robust carbon source for C. difficile bacterium.

cjc2nd/Wikimedia Commons/CC ASA-3.0

[email protected]

SOURCE: Collins J et al. Nature. 2018 Jan 3. doi: 10.1038/nature25178.

Fecal microbiota transplantation (FMT) is a promising new treatment for recurring C. diff infections. The AGA FMT National Registry — conducted in collaboration with the Crohn’s and Colitis Foundation, the Infectious Diseases Society of America, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition — will allow physicians and patients to report back on outcomes of the FMT procedure. This data will help answer critical questions about the longer-term health effects of FMT and guide future use. Learn more at www.gastro.org/FMTRegistry.

The ability of Clostridium difficile ribotype 027 (RT027) to metabolize the sugar trehalose, a common food additive, has increased the virulence of C. difficile infections, a study showed.

“Out of several carbon sources identified that supported CD2015 growth [epidemic RT027 isolate], we found the disaccharide trehalose increased the growth yield of CD2015 by approximately fivefold, compared with a non-RT027 strain,” according to James Collins, PhD, of Baylor University, Houston, and his colleagues. The increased growth of the epidemic strain of C. difficile observed by Dr. Collins and his team demonstrates that trehalose is a robust carbon source for C. difficile bacterium.

cjc2nd/Wikimedia Commons/CC ASA-3.0

[email protected]

SOURCE: Collins J et al. Nature. 2018 Jan 3. doi: 10.1038/nature25178.

Fecal microbiota transplantation (FMT) is a promising new treatment for recurring C. diff infections. The AGA FMT National Registry — conducted in collaboration with the Crohn’s and Colitis Foundation, the Infectious Diseases Society of America, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition — will allow physicians and patients to report back on outcomes of the FMT procedure. This data will help answer critical questions about the longer-term health effects of FMT and guide future use. Learn more at www.gastro.org/FMTRegistry.

The ability of Clostridium difficile ribotype 027 (RT027) to metabolize the sugar trehalose, a common food additive, has increased the virulence of C. difficile infections, a study showed.

“Out of several carbon sources identified that supported CD2015 growth [epidemic RT027 isolate], we found the disaccharide trehalose increased the growth yield of CD2015 by approximately fivefold, compared with a non-RT027 strain,” according to James Collins, PhD, of Baylor University, Houston, and his colleagues. The increased growth of the epidemic strain of C. difficile observed by Dr. Collins and his team demonstrates that trehalose is a robust carbon source for C. difficile bacterium.

cjc2nd/Wikimedia Commons/CC ASA-3.0

[email protected]

SOURCE: Collins J et al. Nature. 2018 Jan 3. doi: 10.1038/nature25178.

Fecal microbiota transplantation (FMT) is a promising new treatment for recurring C. diff infections. The AGA FMT National Registry — conducted in collaboration with the Crohn’s and Colitis Foundation, the Infectious Diseases Society of America, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition — will allow physicians and patients to report back on outcomes of the FMT procedure. This data will help answer critical questions about the longer-term health effects of FMT and guide future use. Learn more at www.gastro.org/FMTRegistry.

Recent references to "EVR" coding changes weren't typos. We really meant "EVR" and not the "EVAR" with which we are all familiar. That's because there's been a change in vascular surgery acronyms. EVAR – Endovascular Aneurysm Repair – has become EVR – Endovascular Repair. The change was made by the CPT (Current Procedural Terminology) Editorial Panel and the SVS Coding Committee, as recent treatment strategies are not confined to the aorta.

We know EVR doesn't flow as trippingly off the tongue. Still, as the telephone operator used to say when informing a caller of a change in a phone number, "Please ... make a note of it."

Recent references to "EVR" coding changes weren't typos. We really meant "EVR" and not the "EVAR" with which we are all familiar. That's because there's been a change in vascular surgery acronyms. EVAR – Endovascular Aneurysm Repair – has become EVR – Endovascular Repair. The change was made by the CPT (Current Procedural Terminology) Editorial Panel and the SVS Coding Committee, as recent treatment strategies are not confined to the aorta.

We know EVR doesn't flow as trippingly off the tongue. Still, as the telephone operator used to say when informing a caller of a change in a phone number, "Please ... make a note of it."

Recent references to "EVR" coding changes weren't typos. We really meant "EVR" and not the "EVAR" with which we are all familiar. That's because there's been a change in vascular surgery acronyms. EVAR – Endovascular Aneurysm Repair – has become EVR – Endovascular Repair. The change was made by the CPT (Current Procedural Terminology) Editorial Panel and the SVS Coding Committee, as recent treatment strategies are not confined to the aorta.

We know EVR doesn't flow as trippingly off the tongue. Still, as the telephone operator used to say when informing a caller of a change in a phone number, "Please ... make a note of it."

• VAM travel scholarships (Feb. 1): The scholarships (General Surgery Resident/Medical Student Travel Scholarship and Diversity Medical Student Travel Scholarship) are for medical students and residents for the Vascular Annual Meeting. Recipients will be able to meet other students and residents plus talk with members and leaders of the vascular surgical community. Applicants get complimentary meeting registration plus financial resources to help defray travel costs. 
• Student Research Fellowship (Feb. 1): Sponsored by the SVS Foundation, this award seeks to introduce the student to the application of rigorous scientific methods to clinical problems and underlying biologic processes important to patients with vascular disease.

• VAM travel scholarships (Feb. 1): The scholarships (General Surgery Resident/Medical Student Travel Scholarship and Diversity Medical Student Travel Scholarship) are for medical students and residents for the Vascular Annual Meeting. Recipients will be able to meet other students and residents plus talk with members and leaders of the vascular surgical community. Applicants get complimentary meeting registration plus financial resources to help defray travel costs. 
• Student Research Fellowship (Feb. 1): Sponsored by the SVS Foundation, this award seeks to introduce the student to the application of rigorous scientific methods to clinical problems and underlying biologic processes important to patients with vascular disease.

• VAM travel scholarships (Feb. 1): The scholarships (General Surgery Resident/Medical Student Travel Scholarship and Diversity Medical Student Travel Scholarship) are for medical students and residents for the Vascular Annual Meeting. Recipients will be able to meet other students and residents plus talk with members and leaders of the vascular surgical community. Applicants get complimentary meeting registration plus financial resources to help defray travel costs. 
• Student Research Fellowship (Feb. 1): Sponsored by the SVS Foundation, this award seeks to introduce the student to the application of rigorous scientific methods to clinical problems and underlying biologic processes important to patients with vascular disease.

The deadline is Wednesday, Jan. 17, for two important research endeavors related to the 2018 Vascular Annual Meeting: abstract submissions and the Resident Research Award. This year's VAM will be June 20 to 23 at the Hynes Convention Center in Boston. Following a full day of programming on Wednesday, June 20, plenary sessions are set for June 21-23. Exhibits will be June 21-22. VAM registration and housing are scheduled to open in early March 2018.

Abstract Submission: Abstracts must be submitted by 3 p.m. Wednesday (CST), Jan. 17.

Resident Research Award (Jan. 17): The recipient will showcase his or her work at the 2018 Vascular Annual Meeting. This award is an excellent opportunity for surgical trainees in vascular research laboratories to be recognized and rewarded for their research efforts. The winner receives a $5,000 award and the VAM presentation opportunity.

The deadline is Wednesday, Jan. 17, for two important research endeavors related to the 2018 Vascular Annual Meeting: abstract submissions and the Resident Research Award. This year's VAM will be June 20 to 23 at the Hynes Convention Center in Boston. Following a full day of programming on Wednesday, June 20, plenary sessions are set for June 21-23. Exhibits will be June 21-22. VAM registration and housing are scheduled to open in early March 2018.

Abstract Submission: Abstracts must be submitted by 3 p.m. Wednesday (CST), Jan. 17.

Resident Research Award (Jan. 17): The recipient will showcase his or her work at the 2018 Vascular Annual Meeting. This award is an excellent opportunity for surgical trainees in vascular research laboratories to be recognized and rewarded for their research efforts. The winner receives a $5,000 award and the VAM presentation opportunity.

The deadline is Wednesday, Jan. 17, for two important research endeavors related to the 2018 Vascular Annual Meeting: abstract submissions and the Resident Research Award. This year's VAM will be June 20 to 23 at the Hynes Convention Center in Boston. Following a full day of programming on Wednesday, June 20, plenary sessions are set for June 21-23. Exhibits will be June 21-22. VAM registration and housing are scheduled to open in early March 2018.

Abstract Submission: Abstracts must be submitted by 3 p.m. Wednesday (CST), Jan. 17.

Resident Research Award (Jan. 17): The recipient will showcase his or her work at the 2018 Vascular Annual Meeting. This award is an excellent opportunity for surgical trainees in vascular research laboratories to be recognized and rewarded for their research efforts. The winner receives a $5,000 award and the VAM presentation opportunity.

The Trump administration early on Jan. 11 initiated a pivotal change in the Medicaid program, announcing that for the first time the federal government will allow states to test work requirements as a condition for coverage.

The announcement came in a 10-page memo with detailed directions about how states can reshape the federal-state health program for low-income people.

The document says who should be excluded from the new work requirements – including children and people being treated for opioid abuse – and offers suggestions as to what counts as “work.” Besides employment, it can include job training, volunteering, or caring for a close relative.

“Medicaid needs to be more flexible so that states can best address the needs of this population,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said in a press release. “Our fundamental goal is to make a positive and lasting difference in the health and wellness of our beneficiaries.”

Adding a work requirement to Medicaid would mark one of the biggest changes to the program since its inception in 1966. It is likely to prompt a lawsuit from patient advocacy groups, which claim the requirement is inconsistent with Medicaid’s objectives and would require an act of Congress.

Republicans have been pushing for the change since the Affordable Care Act added millions of so called “able-bodied” adults to Medicaid. It allowed states to provide coverage to anyone earning up to 138% of the federal poverty level (about $16,600 for an individual).

The Obama administration turned down several state requests to add a work requirement.

Ten states have applied for a federal waiver to add a work requirement – Arizona, Arkansas, Indiana, Kansas, Kentucky, Maine, New Hampshire, North Carolina, Utah and Wisconsin. Officials in several other states have said they are interested in the idea.

An HHS official, who spoke on the condition of anonymity because the official had not been authorized to discuss the developments, said the agency may approve Kentucky’s request as early asJan. 12. Gov. Matt Bevin, a Republican, first sought to add such a provision in 2016. The current request would require able-bodied adults without dependents to work at least 20 hours a week.

Kentucky, which has some of the poorest counties in the country, has seen its Medicaid enrollment double in the past 3 years after the state expanded eligibility under the ACA.

While more than 74 million people are enrolled in Medicaid, only a small fraction would be affected by the work requirement. That’s because children – who make up nearly half of Medicaid enrollees – are excluded. So are the more than 10 million people on Medicaid because they have a disability.

More than 4 in 10 adults with Medicaid coverage already work full time, and most others either go to school, take care of a relative, or are too sick to work.

Still, critics fear a work requirement could have a chilling effect on people signing up for Medicaid or make it harder for people to get coverage.

But work requirements have strong public backing. About 70% of Americans say they support states imposing a work requirement on non-disabled adults, according to a Kaiser Family Foundation poll last year.

The Trump administration, along with many Republican leaders in Congress, has long supported such a move. The failed efforts in the House to replace Obamacare included a work requirement for Medicaid.

In its guidance to states, CMS said they should consider how some communities have high unemployment rates and whether enrollees need to care for young children and elderly families.

CMS also advised states to make work requirements for Medicaid similar than those used with food stamps to “reduce the burden on both states and beneficiaries.”

“This new guidance paves the way for states to demonstrate how their ideas will improve the health of Medicaid beneficiaries, as well as potentially improve their economic well-being,” Brian Neale, CMS deputy administrator and director for the Center for Medicaid and CHIP Services, said in the press release.

Ms. Verma, who has said she doesn’t think Medicaid should become a way of life for people who are not disabled, said the new guidance shows how the administration is trying to give states more flexibility in running Medicaid.

“Our policy guidance was in response to states that asked us for the flexibility they need to improve their programs and to help people in achieving greater well-being and self-sufficiency,” she said.

Ms. Verma, who worked with Kentucky and Indiana on their work requirement waivers as a health consultant before joining the Trump administration, recused herself from the decision on those states’ waiver requests.


Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration early on Jan. 11 initiated a pivotal change in the Medicaid program, announcing that for the first time the federal government will allow states to test work requirements as a condition for coverage.

The announcement came in a 10-page memo with detailed directions about how states can reshape the federal-state health program for low-income people.

The document says who should be excluded from the new work requirements – including children and people being treated for opioid abuse – and offers suggestions as to what counts as “work.” Besides employment, it can include job training, volunteering, or caring for a close relative.

“Medicaid needs to be more flexible so that states can best address the needs of this population,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said in a press release. “Our fundamental goal is to make a positive and lasting difference in the health and wellness of our beneficiaries.”

Adding a work requirement to Medicaid would mark one of the biggest changes to the program since its inception in 1966. It is likely to prompt a lawsuit from patient advocacy groups, which claim the requirement is inconsistent with Medicaid’s objectives and would require an act of Congress.

Republicans have been pushing for the change since the Affordable Care Act added millions of so called “able-bodied” adults to Medicaid. It allowed states to provide coverage to anyone earning up to 138% of the federal poverty level (about $16,600 for an individual).

The Obama administration turned down several state requests to add a work requirement.

Ten states have applied for a federal waiver to add a work requirement – Arizona, Arkansas, Indiana, Kansas, Kentucky, Maine, New Hampshire, North Carolina, Utah and Wisconsin. Officials in several other states have said they are interested in the idea.

An HHS official, who spoke on the condition of anonymity because the official had not been authorized to discuss the developments, said the agency may approve Kentucky’s request as early asJan. 12. Gov. Matt Bevin, a Republican, first sought to add such a provision in 2016. The current request would require able-bodied adults without dependents to work at least 20 hours a week.

Kentucky, which has some of the poorest counties in the country, has seen its Medicaid enrollment double in the past 3 years after the state expanded eligibility under the ACA.

While more than 74 million people are enrolled in Medicaid, only a small fraction would be affected by the work requirement. That’s because children – who make up nearly half of Medicaid enrollees – are excluded. So are the more than 10 million people on Medicaid because they have a disability.

More than 4 in 10 adults with Medicaid coverage already work full time, and most others either go to school, take care of a relative, or are too sick to work.

Still, critics fear a work requirement could have a chilling effect on people signing up for Medicaid or make it harder for people to get coverage.

But work requirements have strong public backing. About 70% of Americans say they support states imposing a work requirement on non-disabled adults, according to a Kaiser Family Foundation poll last year.

The Trump administration, along with many Republican leaders in Congress, has long supported such a move. The failed efforts in the House to replace Obamacare included a work requirement for Medicaid.

In its guidance to states, CMS said they should consider how some communities have high unemployment rates and whether enrollees need to care for young children and elderly families.

CMS also advised states to make work requirements for Medicaid similar than those used with food stamps to “reduce the burden on both states and beneficiaries.”

“This new guidance paves the way for states to demonstrate how their ideas will improve the health of Medicaid beneficiaries, as well as potentially improve their economic well-being,” Brian Neale, CMS deputy administrator and director for the Center for Medicaid and CHIP Services, said in the press release.

Ms. Verma, who has said she doesn’t think Medicaid should become a way of life for people who are not disabled, said the new guidance shows how the administration is trying to give states more flexibility in running Medicaid.

“Our policy guidance was in response to states that asked us for the flexibility they need to improve their programs and to help people in achieving greater well-being and self-sufficiency,” she said.

Ms. Verma, who worked with Kentucky and Indiana on their work requirement waivers as a health consultant before joining the Trump administration, recused herself from the decision on those states’ waiver requests.


Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration early on Jan. 11 initiated a pivotal change in the Medicaid program, announcing that for the first time the federal government will allow states to test work requirements as a condition for coverage.

The announcement came in a 10-page memo with detailed directions about how states can reshape the federal-state health program for low-income people.

The document says who should be excluded from the new work requirements – including children and people being treated for opioid abuse – and offers suggestions as to what counts as “work.” Besides employment, it can include job training, volunteering, or caring for a close relative.

“Medicaid needs to be more flexible so that states can best address the needs of this population,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said in a press release. “Our fundamental goal is to make a positive and lasting difference in the health and wellness of our beneficiaries.”

Adding a work requirement to Medicaid would mark one of the biggest changes to the program since its inception in 1966. It is likely to prompt a lawsuit from patient advocacy groups, which claim the requirement is inconsistent with Medicaid’s objectives and would require an act of Congress.

Republicans have been pushing for the change since the Affordable Care Act added millions of so called “able-bodied” adults to Medicaid. It allowed states to provide coverage to anyone earning up to 138% of the federal poverty level (about $16,600 for an individual).

The Obama administration turned down several state requests to add a work requirement.

Ten states have applied for a federal waiver to add a work requirement – Arizona, Arkansas, Indiana, Kansas, Kentucky, Maine, New Hampshire, North Carolina, Utah and Wisconsin. Officials in several other states have said they are interested in the idea.

An HHS official, who spoke on the condition of anonymity because the official had not been authorized to discuss the developments, said the agency may approve Kentucky’s request as early asJan. 12. Gov. Matt Bevin, a Republican, first sought to add such a provision in 2016. The current request would require able-bodied adults without dependents to work at least 20 hours a week.

Kentucky, which has some of the poorest counties in the country, has seen its Medicaid enrollment double in the past 3 years after the state expanded eligibility under the ACA.

While more than 74 million people are enrolled in Medicaid, only a small fraction would be affected by the work requirement. That’s because children – who make up nearly half of Medicaid enrollees – are excluded. So are the more than 10 million people on Medicaid because they have a disability.

More than 4 in 10 adults with Medicaid coverage already work full time, and most others either go to school, take care of a relative, or are too sick to work.

Still, critics fear a work requirement could have a chilling effect on people signing up for Medicaid or make it harder for people to get coverage.

But work requirements have strong public backing. About 70% of Americans say they support states imposing a work requirement on non-disabled adults, according to a Kaiser Family Foundation poll last year.

The Trump administration, along with many Republican leaders in Congress, has long supported such a move. The failed efforts in the House to replace Obamacare included a work requirement for Medicaid.

In its guidance to states, CMS said they should consider how some communities have high unemployment rates and whether enrollees need to care for young children and elderly families.

CMS also advised states to make work requirements for Medicaid similar than those used with food stamps to “reduce the burden on both states and beneficiaries.”

“This new guidance paves the way for states to demonstrate how their ideas will improve the health of Medicaid beneficiaries, as well as potentially improve their economic well-being,” Brian Neale, CMS deputy administrator and director for the Center for Medicaid and CHIP Services, said in the press release.

Ms. Verma, who has said she doesn’t think Medicaid should become a way of life for people who are not disabled, said the new guidance shows how the administration is trying to give states more flexibility in running Medicaid.

“Our policy guidance was in response to states that asked us for the flexibility they need to improve their programs and to help people in achieving greater well-being and self-sufficiency,” she said.

Ms. Verma, who worked with Kentucky and Indiana on their work requirement waivers as a health consultant before joining the Trump administration, recused herself from the decision on those states’ waiver requests.


Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Citation: Heazell HE, et al. Association between maternal sleep practices and late stillbirth – findings from a stillbirth case-control study. Published online November 20, 2017. DOI: 10.1111/1471-0528.14967.

Citation: Heazell HE, et al. Association between maternal sleep practices and late stillbirth – findings from a stillbirth case-control study. Published online November 20, 2017. DOI: 10.1111/1471-0528.14967.

Citation: Heazell HE, et al. Association between maternal sleep practices and late stillbirth – findings from a stillbirth case-control study. Published online November 20, 2017. DOI: 10.1111/1471-0528.14967.

The prevalence of normal weight in women entering pregnancy dropped between 2011 and 2015 in all 38 jurisdictions with available data, according to the Centers for Disease Control and Prevention.

The overall prevalence of normal prepregnancy weight declined from 47.3% to 45.1% over that period in 36 states, the District of Columbia, and New York City, which reports natality data separately from New York state. The decreases were statistically significant in 26 states and New York City, the CDC investigators reported (MMWR. 2018 Jan 5;66[51-2]:1402-7).

[email protected]
 

The prevalence of normal weight in women entering pregnancy dropped between 2011 and 2015 in all 38 jurisdictions with available data, according to the Centers for Disease Control and Prevention.

The overall prevalence of normal prepregnancy weight declined from 47.3% to 45.1% over that period in 36 states, the District of Columbia, and New York City, which reports natality data separately from New York state. The decreases were statistically significant in 26 states and New York City, the CDC investigators reported (MMWR. 2018 Jan 5;66[51-2]:1402-7).

[email protected]
 

The prevalence of normal weight in women entering pregnancy dropped between 2011 and 2015 in all 38 jurisdictions with available data, according to the Centers for Disease Control and Prevention.

The overall prevalence of normal prepregnancy weight declined from 47.3% to 45.1% over that period in 36 states, the District of Columbia, and New York City, which reports natality data separately from New York state. The decreases were statistically significant in 26 states and New York City, the CDC investigators reported (MMWR. 2018 Jan 5;66[51-2]:1402-7).

[email protected]
 

Heart disease and stroke are leading causes of death and disability. High blood pressure (BP) is a major risk factor for both.

The 2017 guidelines regarding “Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure” (JNC 7) were recently published, which is an update incorporating new information from studies regarding BP-related risk of cardiovascular disease (CVD) and strategies to improve hypertension (HTN) treatment and control.

Screening for secondary causes of HTN is necessary for new-onset or uncontrolled HTN in adults, including drug-resistant HTN. Screening includes testing for obstructive sleep apnea, which is highly prevalent in this population.

Obstructive sleep apnea is a common chronic condition characterized by recurrent collapse of upper airways during sleep, inducing intermittent episodes of apnea/hypopnea, hypoxemia, and sleep disruption (Pedrosa RP, et al. Chest. 2013;144[5]:1487).

It is estimated to affect 17% of US adults but is overwhelmingly underrecognized and untreated (JAMA. 2012;307[20]:2169). The prevalence is higher in men than women. The major risk factors for OSA are obesity, male sex, and advancing age. Since these conditions oftentimes predispose to and are concomitant with HTN, it can be challenging to determine the independent effects of OSA on the development of HTN.

The relationship between obstructive sleep apnea (OSA) and HTN has been a point of interest for decades, with untreated OSA being associated with an increased risk for developing new-onset HTN (JAMA. 2012;307[20]:2169).

There have been several landmark trials that have sought to determine the extent of a causal relationship between OSAS and HTN. Sleep Heart Health Study (Sleep. 2006;29;1009) was one such study, which was limited by the inability to prove that OSA preceded the onset of HTN.

Wisconsin Sleep Cohort (N Engl J Med. 2000;342:1378) was another landmark prospective longitudinal study that implicates OSA as a possible causal factor in HTN. The notable limitation of the study was the presence of HTN after initial assessment was found to be dependent upon the severity of OSA at baseline.

While these two cohort studies found an association between OSA and HTN, the Vitoria Sleep Cohort out of Spain (Am J Respir Crit Care Med. 2011;184[11]:1299), the third and most recent longitudinal cohort study, looked at younger and thinner patients than the SHHS and the Wisconsin Sleep Cohort, failed to show a significant association between OSA and incident HTN. Methodologic differences may help to explain the disparity in results.

NREM sleep has normal circadian variation of BP, causing “dipping” of both systolic and diastolic BP at night due to decreased sympathetic and increased parasympathetic activity. REM sleep has predominant sympathetic activity and transient nocturnal BP surges.

Key question: Will treatment of OSA appreciably alter BP?

Continuous positive airway pressure (CPAP) is an efficacious treatment of choice for OSA. Interventional trials, though limited by issues related to compliance, have shown CPAP to acutely reduce sympathetic drive and BP during sleep. However, this improvement in BP control is not entirely consistent in all patients with the data being less clear-cut regarding nighttime CPAP therapy and impact on daytime BP.

A randomized controlled trial from Barbe et al suggests that normotensive subjects with severe OSA but without demonstrable daytime sleepiness are immune to the BP-reducing effects of CPAP (Ann Intern Med. 2001;134:1015); those who were objectively sleepy had a more robust response to the BP lowering effects of CPAP with better cardiovascular outcomes among patients who were adherent to CPAP therapy (≥4 hours per night).

Sleep Apnea Cardiovascular Endpoints (SAVE) study looked at CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea (N Engl J Med. 2016;375:919). CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood, but the risk of serious cardiovascular events was not lower among patients who received treatment with CPAP in addition to usual care compared with usual care alone. This study was not powered to provide definitive answers regarding the effects of CPAP on secondary cardiovascular end points, and the use of PAP was less than 4 hours.

A recent systematic review and meta-analysis looked at “Association of Positive Airway Pressure with Cardiovascular Events and Death in Adults with Sleep Apnea” (JAMA. 2017;318(2):156). No significant associations between PAP treatment and a range of cardiovascular events were noted in this meta-analysis.

Dr. Singh is Director, Sleep Disorder and Research Center, Michael E. DeBakey VA Medical Center; and Dr. Singh is Assistant Professor and Dr. Velamuri is Associate Professor, Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine. Houston, Texas.

Heart disease and stroke are leading causes of death and disability. High blood pressure (BP) is a major risk factor for both.

The 2017 guidelines regarding “Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure” (JNC 7) were recently published, which is an update incorporating new information from studies regarding BP-related risk of cardiovascular disease (CVD) and strategies to improve hypertension (HTN) treatment and control.

Screening for secondary causes of HTN is necessary for new-onset or uncontrolled HTN in adults, including drug-resistant HTN. Screening includes testing for obstructive sleep apnea, which is highly prevalent in this population.

Obstructive sleep apnea is a common chronic condition characterized by recurrent collapse of upper airways during sleep, inducing intermittent episodes of apnea/hypopnea, hypoxemia, and sleep disruption (Pedrosa RP, et al. Chest. 2013;144[5]:1487).

It is estimated to affect 17% of US adults but is overwhelmingly underrecognized and untreated (JAMA. 2012;307[20]:2169). The prevalence is higher in men than women. The major risk factors for OSA are obesity, male sex, and advancing age. Since these conditions oftentimes predispose to and are concomitant with HTN, it can be challenging to determine the independent effects of OSA on the development of HTN.

The relationship between obstructive sleep apnea (OSA) and HTN has been a point of interest for decades, with untreated OSA being associated with an increased risk for developing new-onset HTN (JAMA. 2012;307[20]:2169).

There have been several landmark trials that have sought to determine the extent of a causal relationship between OSAS and HTN. Sleep Heart Health Study (Sleep. 2006;29;1009) was one such study, which was limited by the inability to prove that OSA preceded the onset of HTN.

Wisconsin Sleep Cohort (N Engl J Med. 2000;342:1378) was another landmark prospective longitudinal study that implicates OSA as a possible causal factor in HTN. The notable limitation of the study was the presence of HTN after initial assessment was found to be dependent upon the severity of OSA at baseline.

While these two cohort studies found an association between OSA and HTN, the Vitoria Sleep Cohort out of Spain (Am J Respir Crit Care Med. 2011;184[11]:1299), the third and most recent longitudinal cohort study, looked at younger and thinner patients than the SHHS and the Wisconsin Sleep Cohort, failed to show a significant association between OSA and incident HTN. Methodologic differences may help to explain the disparity in results.

NREM sleep has normal circadian variation of BP, causing “dipping” of both systolic and diastolic BP at night due to decreased sympathetic and increased parasympathetic activity. REM sleep has predominant sympathetic activity and transient nocturnal BP surges.

Key question: Will treatment of OSA appreciably alter BP?

Continuous positive airway pressure (CPAP) is an efficacious treatment of choice for OSA. Interventional trials, though limited by issues related to compliance, have shown CPAP to acutely reduce sympathetic drive and BP during sleep. However, this improvement in BP control is not entirely consistent in all patients with the data being less clear-cut regarding nighttime CPAP therapy and impact on daytime BP.

A randomized controlled trial from Barbe et al suggests that normotensive subjects with severe OSA but without demonstrable daytime sleepiness are immune to the BP-reducing effects of CPAP (Ann Intern Med. 2001;134:1015); those who were objectively sleepy had a more robust response to the BP lowering effects of CPAP with better cardiovascular outcomes among patients who were adherent to CPAP therapy (≥4 hours per night).

Sleep Apnea Cardiovascular Endpoints (SAVE) study looked at CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea (N Engl J Med. 2016;375:919). CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood, but the risk of serious cardiovascular events was not lower among patients who received treatment with CPAP in addition to usual care compared with usual care alone. This study was not powered to provide definitive answers regarding the effects of CPAP on secondary cardiovascular end points, and the use of PAP was less than 4 hours.

A recent systematic review and meta-analysis looked at “Association of Positive Airway Pressure with Cardiovascular Events and Death in Adults with Sleep Apnea” (JAMA. 2017;318(2):156). No significant associations between PAP treatment and a range of cardiovascular events were noted in this meta-analysis.

Dr. Singh is Director, Sleep Disorder and Research Center, Michael E. DeBakey VA Medical Center; and Dr. Singh is Assistant Professor and Dr. Velamuri is Associate Professor, Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine. Houston, Texas.

Heart disease and stroke are leading causes of death and disability. High blood pressure (BP) is a major risk factor for both.

The 2017 guidelines regarding “Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure” (JNC 7) were recently published, which is an update incorporating new information from studies regarding BP-related risk of cardiovascular disease (CVD) and strategies to improve hypertension (HTN) treatment and control.

Screening for secondary causes of HTN is necessary for new-onset or uncontrolled HTN in adults, including drug-resistant HTN. Screening includes testing for obstructive sleep apnea, which is highly prevalent in this population.

Obstructive sleep apnea is a common chronic condition characterized by recurrent collapse of upper airways during sleep, inducing intermittent episodes of apnea/hypopnea, hypoxemia, and sleep disruption (Pedrosa RP, et al. Chest. 2013;144[5]:1487).

It is estimated to affect 17% of US adults but is overwhelmingly underrecognized and untreated (JAMA. 2012;307[20]:2169). The prevalence is higher in men than women. The major risk factors for OSA are obesity, male sex, and advancing age. Since these conditions oftentimes predispose to and are concomitant with HTN, it can be challenging to determine the independent effects of OSA on the development of HTN.

The relationship between obstructive sleep apnea (OSA) and HTN has been a point of interest for decades, with untreated OSA being associated with an increased risk for developing new-onset HTN (JAMA. 2012;307[20]:2169).

There have been several landmark trials that have sought to determine the extent of a causal relationship between OSAS and HTN. Sleep Heart Health Study (Sleep. 2006;29;1009) was one such study, which was limited by the inability to prove that OSA preceded the onset of HTN.

Wisconsin Sleep Cohort (N Engl J Med. 2000;342:1378) was another landmark prospective longitudinal study that implicates OSA as a possible causal factor in HTN. The notable limitation of the study was the presence of HTN after initial assessment was found to be dependent upon the severity of OSA at baseline.

While these two cohort studies found an association between OSA and HTN, the Vitoria Sleep Cohort out of Spain (Am J Respir Crit Care Med. 2011;184[11]:1299), the third and most recent longitudinal cohort study, looked at younger and thinner patients than the SHHS and the Wisconsin Sleep Cohort, failed to show a significant association between OSA and incident HTN. Methodologic differences may help to explain the disparity in results.

NREM sleep has normal circadian variation of BP, causing “dipping” of both systolic and diastolic BP at night due to decreased sympathetic and increased parasympathetic activity. REM sleep has predominant sympathetic activity and transient nocturnal BP surges.

Key question: Will treatment of OSA appreciably alter BP?

Continuous positive airway pressure (CPAP) is an efficacious treatment of choice for OSA. Interventional trials, though limited by issues related to compliance, have shown CPAP to acutely reduce sympathetic drive and BP during sleep. However, this improvement in BP control is not entirely consistent in all patients with the data being less clear-cut regarding nighttime CPAP therapy and impact on daytime BP.

A randomized controlled trial from Barbe et al suggests that normotensive subjects with severe OSA but without demonstrable daytime sleepiness are immune to the BP-reducing effects of CPAP (Ann Intern Med. 2001;134:1015); those who were objectively sleepy had a more robust response to the BP lowering effects of CPAP with better cardiovascular outcomes among patients who were adherent to CPAP therapy (≥4 hours per night).

Sleep Apnea Cardiovascular Endpoints (SAVE) study looked at CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea (N Engl J Med. 2016;375:919). CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood, but the risk of serious cardiovascular events was not lower among patients who received treatment with CPAP in addition to usual care compared with usual care alone. This study was not powered to provide definitive answers regarding the effects of CPAP on secondary cardiovascular end points, and the use of PAP was less than 4 hours.

A recent systematic review and meta-analysis looked at “Association of Positive Airway Pressure with Cardiovascular Events and Death in Adults with Sleep Apnea” (JAMA. 2017;318(2):156). No significant associations between PAP treatment and a range of cardiovascular events were noted in this meta-analysis.

Dr. Singh is Director, Sleep Disorder and Research Center, Michael E. DeBakey VA Medical Center; and Dr. Singh is Assistant Professor and Dr. Velamuri is Associate Professor, Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine. Houston, Texas.