Diana Mahoney

Annual estimates of influenza-associated deaths from 1976-2007 varied substantially by season, influenza virus type, underlying cause of death, and age group, according to revised statistical models, the Centers for Disease Control and Prevention reported August 27 in its Morbidity and Mortality Weekly Report.

The “incredible variation” indicates that using a single, average estimate insufficiently communicates the mortality burden of influenza, Dr. David Shay, medical officer with the CDC’s National Center for Immunization and Respiratory Diseases, said in a media briefing.

With a low of 3,349 estimated deaths in 1986-87 and a high of 48,614 deaths in 2003-2004, the estimated annual rate of influenza-associated deaths in the United States from 1976-2007 ranged from 1.4 to 16.7 deaths per 100,000 persons, according to the new models, which update the CDC’s previously published estimates for 1976-2003 and include new data from 2006-2007.

Because of the wide variability across influenza seasons, “it is relatively meaningless to try to summarize [influenza burden] with one number,” Dr. Shay stressed. “There are very few average seasons, so providing a simple average fails to communicate the impact of flu in an understandable fashion.”

For this reason, the CDC advises quantifying influenza-associated deaths in the context of circulating virus strains and underlying causes of death among age groups. Toward this end, the influenza-associated mortality estimates in the CDC’s revised models are provided for three age groups (younger than 19 years, 19–64 years, and 65 years or older) and for two categories of underlying cause of death codes: pneumonia and influenza causes and respiratory and circulatory causes.

For pneumonia and influenza causes, the respective estimated annual average of influenza-associated deaths and the rate of influenza-associated deaths per 100,000 people were 6,309 and 2.4 for the U.S. population overall; 97 and 0.1 for persons younger than 19 years; 666 and 0.4 for adults age 19-64 years; and 5,546 and 17.0 for adults 65 years and older, the report states.

For deaths with underlying respiratory and circulatory causes, the respective estimated number and rate of influenza-associated deaths per 100,000 was 23,607 and 9.0 for the U.S. population overall; 124 and 0.2 for persons younger than age 19 years; 2,385 and 1.5 among adults age 19–64 years; and 21,098 and 66.1 among adults age 65 years and older (MMWR 2010;33:1057-62).

For both causes, “the average mortality rates for the 22 seasons during which influenza A(H3N2) was a prominent strain were 2.7 times higher than for the nine seasons that it was not,” the authors reported. “The average annual number of influenza-associated deaths during influenza A(H3N2) prominent seasons was 7,722 for pneumonia and influenza causes and 28,909 for respiratory and circulatory causes, compared with 2,856 deaths for pneumonia and influenza causes and 10,648 deaths for respiratory and circulatory causes in seasons in which it was not.”

The numbers “confirm that influenza has a substantial burden of mortality each year, but also that the burden can change substantially from year to year,” Dr. Shay stated.

The findings represented in the revised model are limited by a number of factors, including the failure to account for co-circulating pathogens such as respiratory syncytial virus; the possibility that changing virus surveillance data may reduce the relevance of comparing estimates over time; and the possibility that the increase in the number of adults older than age 65 years during the study period could have contributed to an increase in influenza-associated mortality, according to the authors. Also, because the models rely on national death certificate data through 2007, preliminary estimates of 2009 influenza A(H1N1)-associated deaths are not comparable, they wrote.

Annual estimates of influenza-associated deaths from 1976-2007 varied substantially by season, influenza virus type, underlying cause of death, and age group, according to revised statistical models, the Centers for Disease Control and Prevention reported August 27 in its Morbidity and Mortality Weekly Report.

The “incredible variation” indicates that using a single, average estimate insufficiently communicates the mortality burden of influenza, Dr. David Shay, medical officer with the CDC’s National Center for Immunization and Respiratory Diseases, said in a media briefing.

With a low of 3,349 estimated deaths in 1986-87 and a high of 48,614 deaths in 2003-2004, the estimated annual rate of influenza-associated deaths in the United States from 1976-2007 ranged from 1.4 to 16.7 deaths per 100,000 persons, according to the new models, which update the CDC’s previously published estimates for 1976-2003 and include new data from 2006-2007.

Because of the wide variability across influenza seasons, “it is relatively meaningless to try to summarize [influenza burden] with one number,” Dr. Shay stressed. “There are very few average seasons, so providing a simple average fails to communicate the impact of flu in an understandable fashion.”

For this reason, the CDC advises quantifying influenza-associated deaths in the context of circulating virus strains and underlying causes of death among age groups. Toward this end, the influenza-associated mortality estimates in the CDC’s revised models are provided for three age groups (younger than 19 years, 19–64 years, and 65 years or older) and for two categories of underlying cause of death codes: pneumonia and influenza causes and respiratory and circulatory causes.

For pneumonia and influenza causes, the respective estimated annual average of influenza-associated deaths and the rate of influenza-associated deaths per 100,000 people were 6,309 and 2.4 for the U.S. population overall; 97 and 0.1 for persons younger than 19 years; 666 and 0.4 for adults age 19-64 years; and 5,546 and 17.0 for adults 65 years and older, the report states.

For deaths with underlying respiratory and circulatory causes, the respective estimated number and rate of influenza-associated deaths per 100,000 was 23,607 and 9.0 for the U.S. population overall; 124 and 0.2 for persons younger than age 19 years; 2,385 and 1.5 among adults age 19–64 years; and 21,098 and 66.1 among adults age 65 years and older (MMWR 2010;33:1057-62).

For both causes, “the average mortality rates for the 22 seasons during which influenza A(H3N2) was a prominent strain were 2.7 times higher than for the nine seasons that it was not,” the authors reported. “The average annual number of influenza-associated deaths during influenza A(H3N2) prominent seasons was 7,722 for pneumonia and influenza causes and 28,909 for respiratory and circulatory causes, compared with 2,856 deaths for pneumonia and influenza causes and 10,648 deaths for respiratory and circulatory causes in seasons in which it was not.”

The numbers “confirm that influenza has a substantial burden of mortality each year, but also that the burden can change substantially from year to year,” Dr. Shay stated.

The findings represented in the revised model are limited by a number of factors, including the failure to account for co-circulating pathogens such as respiratory syncytial virus; the possibility that changing virus surveillance data may reduce the relevance of comparing estimates over time; and the possibility that the increase in the number of adults older than age 65 years during the study period could have contributed to an increase in influenza-associated mortality, according to the authors. Also, because the models rely on national death certificate data through 2007, preliminary estimates of 2009 influenza A(H1N1)-associated deaths are not comparable, they wrote.

Annual estimates of influenza-associated deaths from 1976-2007 varied substantially by season, influenza virus type, underlying cause of death, and age group, according to revised statistical models, the Centers for Disease Control and Prevention reported August 27 in its Morbidity and Mortality Weekly Report.

The “incredible variation” indicates that using a single, average estimate insufficiently communicates the mortality burden of influenza, Dr. David Shay, medical officer with the CDC’s National Center for Immunization and Respiratory Diseases, said in a media briefing.

With a low of 3,349 estimated deaths in 1986-87 and a high of 48,614 deaths in 2003-2004, the estimated annual rate of influenza-associated deaths in the United States from 1976-2007 ranged from 1.4 to 16.7 deaths per 100,000 persons, according to the new models, which update the CDC’s previously published estimates for 1976-2003 and include new data from 2006-2007.

Because of the wide variability across influenza seasons, “it is relatively meaningless to try to summarize [influenza burden] with one number,” Dr. Shay stressed. “There are very few average seasons, so providing a simple average fails to communicate the impact of flu in an understandable fashion.”

For this reason, the CDC advises quantifying influenza-associated deaths in the context of circulating virus strains and underlying causes of death among age groups. Toward this end, the influenza-associated mortality estimates in the CDC’s revised models are provided for three age groups (younger than 19 years, 19–64 years, and 65 years or older) and for two categories of underlying cause of death codes: pneumonia and influenza causes and respiratory and circulatory causes.

For pneumonia and influenza causes, the respective estimated annual average of influenza-associated deaths and the rate of influenza-associated deaths per 100,000 people were 6,309 and 2.4 for the U.S. population overall; 97 and 0.1 for persons younger than 19 years; 666 and 0.4 for adults age 19-64 years; and 5,546 and 17.0 for adults 65 years and older, the report states.

For deaths with underlying respiratory and circulatory causes, the respective estimated number and rate of influenza-associated deaths per 100,000 was 23,607 and 9.0 for the U.S. population overall; 124 and 0.2 for persons younger than age 19 years; 2,385 and 1.5 among adults age 19–64 years; and 21,098 and 66.1 among adults age 65 years and older (MMWR 2010;33:1057-62).

For both causes, “the average mortality rates for the 22 seasons during which influenza A(H3N2) was a prominent strain were 2.7 times higher than for the nine seasons that it was not,” the authors reported. “The average annual number of influenza-associated deaths during influenza A(H3N2) prominent seasons was 7,722 for pneumonia and influenza causes and 28,909 for respiratory and circulatory causes, compared with 2,856 deaths for pneumonia and influenza causes and 10,648 deaths for respiratory and circulatory causes in seasons in which it was not.”

The numbers “confirm that influenza has a substantial burden of mortality each year, but also that the burden can change substantially from year to year,” Dr. Shay stated.

The findings represented in the revised model are limited by a number of factors, including the failure to account for co-circulating pathogens such as respiratory syncytial virus; the possibility that changing virus surveillance data may reduce the relevance of comparing estimates over time; and the possibility that the increase in the number of adults older than age 65 years during the study period could have contributed to an increase in influenza-associated mortality, according to the authors. Also, because the models rely on national death certificate data through 2007, preliminary estimates of 2009 influenza A(H1N1)-associated deaths are not comparable, they wrote.

BOSTON – “Outward Bound on steroids” is how psychiatrist Col. Elspeth Cameron Ritchie, MC, USA, describes one of the U.S. Army’s most recent initiatives designed to foster resiliency among soldiers with repeated deployments to Iraq and Afghanistan.

Called Warrior Adventure Quest (WAQ), the program uses high-intensity, extreme sports and a debriefing tool “to provide soldier/leader/unit mitigation and coping skills that can address unresolved transition issues, and build unit cohesion and morale, contributing to combat readiness,” Dr. Ritchie said at the conference on posttraumatic stress disorder and traumatic brain injury sponsored by the Massachusetts General Hospital Psychiatry Academy.

Through such activities as kayaking, bungee jumping, rock climbing, white-water rafting, skiing, and snowboarding, the program aims to channel the adrenaline rush that becomes second nature to redeploying soldiers and sometimes leads to reckless, dangerous behaviors, said Dr. Ritchie, director of behavioral health proponency in the Office of the Army Surgeon General. She stressed that the rate of deaths that occur within the first year of returning from combat – often as a result of accidents involving high speed, alcohol, or both – “is unacceptably high.”

In fact, according to the U.S. Army Combat Readiness/Safety Center, between October 2001 and October 2009, 287 soldiers died as a result of motor vehicle and personal injury accidents within 1 year of returning from deployment. About 21%of these deaths occurred within the first 30 days post deployment and about 67% within 180 days post deployment.

For this reason, WAQ targets soldiers during the reset phase of a deployment cycle, typically within the first 120 days of a unit’s return home, according to the Army Family, Morale, Welfare and Recreation Command (FMWRC), which created the intervention.

The most important aspect of the WAQ program is what comes after the adrenaline-pumping activities: the Battlemind After Actions Review (AAR). Battlemind, the Army’s psychological resiliency building program, is designed to help soldiers recognize and respond to fear during combat, then mitigate the cumulative effects of a sustained combat environment and become mentally prepared to reintegrate during the redeployment, postdeployment, and reset periods of the deployment cycle, Dr. Ritchie said.

In the WAQ program, the Battlemind principles are implemented through the AAR debriefing process. For example, soldiers discuss the day’s events and the connections between the activities and those they experience in the combat environment. Sharing thoughts on their experiences, as well as their feelings about being home, helps soldiers work through the range of postdeployment emotions, she said.

In addition to the physical outlets that they provide, the WAQ activities are designed to bring cohesion to a unit through teamwork, and develop individual and unit resiliency through “horizontal and vertical bonding” with respect to rank structure and “esprit de corps,” Dr. Ritchie noted.

The intervention also is meant to enhance soldiers’ personal development during “dwell time” – the period between deployments during which their mental health is especially vulnerable, she said. “We have hard data that shows troops need more dwell time – that it takes at least 2 years and optimally 3 years for a soldier to come back to baseline in terms of mental health. Unfortunately, [with the ongoing crises in Iraq and Afghanistan and no withdrawal of troops], soldiers are being redeployed much sooner, she said. “So until something changes, we have to focus our efforts on developing soldiers’ inner strength to help make sure they are emotionally prepared.”

Early indicators suggest that the WAQ program has been well received. “Analysis from the program’s survey data showed a 19.8% increase in the general perception of unit cohesion, a 12.8% increase in the perception that Army leadership cares for its soldiers, a 22.5% increase in the number of soldiers who viewed outdoor recreation as a means of relieving stress, and a 46.5% increase in the number of soldiers who will use the [WAQ] Outdoor Recreation Centers in future outdoor adventure activities,” according to Staff Sgt. Brenton Bulrice, FMWRC WAQ representative.

“Although WAQ might not be the answer to all postcombat issues such as [posttraumatic stress disorder] and [traumatic brain injury], its holistic approach should serve as a model as the Army continues to identify and create programs to honor and empower soldiers who are reluctant to reach out for professional help,” Staff Sgt. Bulrice wrote in an article for the U.S. Army MWR Web site.

Importantly, the program provides an informal screening tool by enabling leaders to identify soldiers who might need additional help, Staff Sgt. Bulrice wrote. “WAQ has formed close bonds and working relationships with many Army organizations” such as the Army Medical Command, Combat Readiness and Safety Center, and Army Substance Abuse Program. Through these collaborations, WAQ is able to track statistical data about participants and how WAQ has initiated positive changes in their behavior, he stated.

 

The WAQ program is one of many recent military initiatives aimed at supporting the mental health needs of servicemen and women, including periodic health assessments, postdeployment health assessments within 30 days of returning from deployment, and reassessments in 3-6 months for every soldier to screen for mental health problems, Dr. Ritchie said.

Also, suicide prevention initiatives, provider resiliency training, reunion and reintegration programs, campaigns to reduce the stigma associated with mental health care, and the implementation of telehealth services in the operational environment have been or are being incorporated into the military’s behavioral health armamentarium.

“We’re moving forward, but there is still a long way to go,” Dr. Ritchie said. “All of the low-hanging fruit has been picked here.” What is needed now, she said, are measures that improve access to care, reduce the stigma of seeking care, and engage more military and civilian mental health providers to administer the care.

Dr. Ritchie reported no financial conflicts of interest.

The Warrior Adventure Quest program created by the U.S. Army uses extreme sports such as bungee jumping to help build resiliency among soldiers with repeated deployments to war zones.

Colonel Elspeth Cameron Ritchie

BOSTON – “Outward Bound on steroids” is how psychiatrist Col. Elspeth Cameron Ritchie, MC, USA, describes one of the U.S. Army’s most recent initiatives designed to foster resiliency among soldiers with repeated deployments to Iraq and Afghanistan.

Called Warrior Adventure Quest (WAQ), the program uses high-intensity, extreme sports and a debriefing tool “to provide soldier/leader/unit mitigation and coping skills that can address unresolved transition issues, and build unit cohesion and morale, contributing to combat readiness,” Dr. Ritchie said at the conference on posttraumatic stress disorder and traumatic brain injury sponsored by the Massachusetts General Hospital Psychiatry Academy.

Through such activities as kayaking, bungee jumping, rock climbing, white-water rafting, skiing, and snowboarding, the program aims to channel the adrenaline rush that becomes second nature to redeploying soldiers and sometimes leads to reckless, dangerous behaviors, said Dr. Ritchie, director of behavioral health proponency in the Office of the Army Surgeon General. She stressed that the rate of deaths that occur within the first year of returning from combat – often as a result of accidents involving high speed, alcohol, or both – “is unacceptably high.”

In fact, according to the U.S. Army Combat Readiness/Safety Center, between October 2001 and October 2009, 287 soldiers died as a result of motor vehicle and personal injury accidents within 1 year of returning from deployment. About 21%of these deaths occurred within the first 30 days post deployment and about 67% within 180 days post deployment.

For this reason, WAQ targets soldiers during the reset phase of a deployment cycle, typically within the first 120 days of a unit’s return home, according to the Army Family, Morale, Welfare and Recreation Command (FMWRC), which created the intervention.

The most important aspect of the WAQ program is what comes after the adrenaline-pumping activities: the Battlemind After Actions Review (AAR). Battlemind, the Army’s psychological resiliency building program, is designed to help soldiers recognize and respond to fear during combat, then mitigate the cumulative effects of a sustained combat environment and become mentally prepared to reintegrate during the redeployment, postdeployment, and reset periods of the deployment cycle, Dr. Ritchie said.

In the WAQ program, the Battlemind principles are implemented through the AAR debriefing process. For example, soldiers discuss the day’s events and the connections between the activities and those they experience in the combat environment. Sharing thoughts on their experiences, as well as their feelings about being home, helps soldiers work through the range of postdeployment emotions, she said.

In addition to the physical outlets that they provide, the WAQ activities are designed to bring cohesion to a unit through teamwork, and develop individual and unit resiliency through “horizontal and vertical bonding” with respect to rank structure and “esprit de corps,” Dr. Ritchie noted.

The intervention also is meant to enhance soldiers’ personal development during “dwell time” – the period between deployments during which their mental health is especially vulnerable, she said. “We have hard data that shows troops need more dwell time – that it takes at least 2 years and optimally 3 years for a soldier to come back to baseline in terms of mental health. Unfortunately, [with the ongoing crises in Iraq and Afghanistan and no withdrawal of troops], soldiers are being redeployed much sooner, she said. “So until something changes, we have to focus our efforts on developing soldiers’ inner strength to help make sure they are emotionally prepared.”

Early indicators suggest that the WAQ program has been well received. “Analysis from the program’s survey data showed a 19.8% increase in the general perception of unit cohesion, a 12.8% increase in the perception that Army leadership cares for its soldiers, a 22.5% increase in the number of soldiers who viewed outdoor recreation as a means of relieving stress, and a 46.5% increase in the number of soldiers who will use the [WAQ] Outdoor Recreation Centers in future outdoor adventure activities,” according to Staff Sgt. Brenton Bulrice, FMWRC WAQ representative.

“Although WAQ might not be the answer to all postcombat issues such as [posttraumatic stress disorder] and [traumatic brain injury], its holistic approach should serve as a model as the Army continues to identify and create programs to honor and empower soldiers who are reluctant to reach out for professional help,” Staff Sgt. Bulrice wrote in an article for the U.S. Army MWR Web site.

Importantly, the program provides an informal screening tool by enabling leaders to identify soldiers who might need additional help, Staff Sgt. Bulrice wrote. “WAQ has formed close bonds and working relationships with many Army organizations” such as the Army Medical Command, Combat Readiness and Safety Center, and Army Substance Abuse Program. Through these collaborations, WAQ is able to track statistical data about participants and how WAQ has initiated positive changes in their behavior, he stated.

 

The WAQ program is one of many recent military initiatives aimed at supporting the mental health needs of servicemen and women, including periodic health assessments, postdeployment health assessments within 30 days of returning from deployment, and reassessments in 3-6 months for every soldier to screen for mental health problems, Dr. Ritchie said.

Also, suicide prevention initiatives, provider resiliency training, reunion and reintegration programs, campaigns to reduce the stigma associated with mental health care, and the implementation of telehealth services in the operational environment have been or are being incorporated into the military’s behavioral health armamentarium.

“We’re moving forward, but there is still a long way to go,” Dr. Ritchie said. “All of the low-hanging fruit has been picked here.” What is needed now, she said, are measures that improve access to care, reduce the stigma of seeking care, and engage more military and civilian mental health providers to administer the care.

Dr. Ritchie reported no financial conflicts of interest.

The Warrior Adventure Quest program created by the U.S. Army uses extreme sports such as bungee jumping to help build resiliency among soldiers with repeated deployments to war zones.

Colonel Elspeth Cameron Ritchie

BOSTON – “Outward Bound on steroids” is how psychiatrist Col. Elspeth Cameron Ritchie, MC, USA, describes one of the U.S. Army’s most recent initiatives designed to foster resiliency among soldiers with repeated deployments to Iraq and Afghanistan.

Called Warrior Adventure Quest (WAQ), the program uses high-intensity, extreme sports and a debriefing tool “to provide soldier/leader/unit mitigation and coping skills that can address unresolved transition issues, and build unit cohesion and morale, contributing to combat readiness,” Dr. Ritchie said at the conference on posttraumatic stress disorder and traumatic brain injury sponsored by the Massachusetts General Hospital Psychiatry Academy.

Through such activities as kayaking, bungee jumping, rock climbing, white-water rafting, skiing, and snowboarding, the program aims to channel the adrenaline rush that becomes second nature to redeploying soldiers and sometimes leads to reckless, dangerous behaviors, said Dr. Ritchie, director of behavioral health proponency in the Office of the Army Surgeon General. She stressed that the rate of deaths that occur within the first year of returning from combat – often as a result of accidents involving high speed, alcohol, or both – “is unacceptably high.”

In fact, according to the U.S. Army Combat Readiness/Safety Center, between October 2001 and October 2009, 287 soldiers died as a result of motor vehicle and personal injury accidents within 1 year of returning from deployment. About 21%of these deaths occurred within the first 30 days post deployment and about 67% within 180 days post deployment.

For this reason, WAQ targets soldiers during the reset phase of a deployment cycle, typically within the first 120 days of a unit’s return home, according to the Army Family, Morale, Welfare and Recreation Command (FMWRC), which created the intervention.

The most important aspect of the WAQ program is what comes after the adrenaline-pumping activities: the Battlemind After Actions Review (AAR). Battlemind, the Army’s psychological resiliency building program, is designed to help soldiers recognize and respond to fear during combat, then mitigate the cumulative effects of a sustained combat environment and become mentally prepared to reintegrate during the redeployment, postdeployment, and reset periods of the deployment cycle, Dr. Ritchie said.

In the WAQ program, the Battlemind principles are implemented through the AAR debriefing process. For example, soldiers discuss the day’s events and the connections between the activities and those they experience in the combat environment. Sharing thoughts on their experiences, as well as their feelings about being home, helps soldiers work through the range of postdeployment emotions, she said.

In addition to the physical outlets that they provide, the WAQ activities are designed to bring cohesion to a unit through teamwork, and develop individual and unit resiliency through “horizontal and vertical bonding” with respect to rank structure and “esprit de corps,” Dr. Ritchie noted.

The intervention also is meant to enhance soldiers’ personal development during “dwell time” – the period between deployments during which their mental health is especially vulnerable, she said. “We have hard data that shows troops need more dwell time – that it takes at least 2 years and optimally 3 years for a soldier to come back to baseline in terms of mental health. Unfortunately, [with the ongoing crises in Iraq and Afghanistan and no withdrawal of troops], soldiers are being redeployed much sooner, she said. “So until something changes, we have to focus our efforts on developing soldiers’ inner strength to help make sure they are emotionally prepared.”

Early indicators suggest that the WAQ program has been well received. “Analysis from the program’s survey data showed a 19.8% increase in the general perception of unit cohesion, a 12.8% increase in the perception that Army leadership cares for its soldiers, a 22.5% increase in the number of soldiers who viewed outdoor recreation as a means of relieving stress, and a 46.5% increase in the number of soldiers who will use the [WAQ] Outdoor Recreation Centers in future outdoor adventure activities,” according to Staff Sgt. Brenton Bulrice, FMWRC WAQ representative.

“Although WAQ might not be the answer to all postcombat issues such as [posttraumatic stress disorder] and [traumatic brain injury], its holistic approach should serve as a model as the Army continues to identify and create programs to honor and empower soldiers who are reluctant to reach out for professional help,” Staff Sgt. Bulrice wrote in an article for the U.S. Army MWR Web site.

Importantly, the program provides an informal screening tool by enabling leaders to identify soldiers who might need additional help, Staff Sgt. Bulrice wrote. “WAQ has formed close bonds and working relationships with many Army organizations” such as the Army Medical Command, Combat Readiness and Safety Center, and Army Substance Abuse Program. Through these collaborations, WAQ is able to track statistical data about participants and how WAQ has initiated positive changes in their behavior, he stated.

 

The WAQ program is one of many recent military initiatives aimed at supporting the mental health needs of servicemen and women, including periodic health assessments, postdeployment health assessments within 30 days of returning from deployment, and reassessments in 3-6 months for every soldier to screen for mental health problems, Dr. Ritchie said.

Also, suicide prevention initiatives, provider resiliency training, reunion and reintegration programs, campaigns to reduce the stigma associated with mental health care, and the implementation of telehealth services in the operational environment have been or are being incorporated into the military’s behavioral health armamentarium.

“We’re moving forward, but there is still a long way to go,” Dr. Ritchie said. “All of the low-hanging fruit has been picked here.” What is needed now, she said, are measures that improve access to care, reduce the stigma of seeking care, and engage more military and civilian mental health providers to administer the care.

Dr. Ritchie reported no financial conflicts of interest.

The Warrior Adventure Quest program created by the U.S. Army uses extreme sports such as bungee jumping to help build resiliency among soldiers with repeated deployments to war zones.

Colonel Elspeth Cameron Ritchie

Major Finding: Banded gastric bypass may lead to better weight-loss maintenance compared with the nonbanded procedure in superobese patients.

Data Source: A prospective, randomized, double-blind trial comparing outcomes of 90 obese patients who underwent the Capella banded gastric bypass procedure or the conventional Roux-en-Y gastric bypass.

Disclosures: Dr. Choi reported no conflicts. A coauthor disclosed ties with Ethicon EndoSurgery Inc., Covidien, and Olympus America Inc.

LAS VEGAS — Banded long-limb gastric bypass may result in greater weight loss over time in superobese patients than the traditional, nonbanded gastric bypass, a study has shown.

Data from a prospective, randomized trial comparing the long-term outcomes of the two procedures showed similar initial weight loss for patients in the two groups but a trend toward better maintenance of weight loss at 5 years in the banded group, reported Dr. Jenny Choi.

In addition, patients in the banded group were more likely to experience resolution of gastroesophageal reflux disease relative to those who underwent the less restrictive procedure, she said, noting that there were no differences in the degree of resolution of other comorbidities.

Of the 90 patients with body mass index greater than 50 kg/m

The remaining 44 patients underwent the conventional Roux-en-Y gastric bypass, Dr. Choi explained.

All of the surgeries were performed by the same surgeon, and there were no significant between-group differences in patient body mass index, age, or comorbidities at baseline, she said. Dr. Choi and her colleagues at Columbia University Medical Center in New York collected data on weight loss, improvement or resolution of comorbidities, and complications reported for all of the patients at 12, 24, 36, 48, and 60 months.

“At each of the time points, the banded group consistently had better weight loss, although the difference was not statistically significant,” she said. At 12, 24, 26, and 48 months, the percentage of excess weight loss for the banded and nonbanded groups, respectively, was 63.9% and 56.9%; 65.9% and 59.8%; 63.5% and 55.8%; and 55.3% and 42.6%.

At 60 months, the between-group difference in percentage of excess weight lost (55.4% vs. 47.5%) approached but did not reach statistical significance in the banded group compared with the nonbanded group.

The number of patients who reached a body mass index of less than 35 kg/m

Additionally, “the failure rate [defined as less than 50% of excess weight loss] was 10% in the banded group, compared with 15.7% in the nonbanded group,” she said.

With respect to peak weight loss, weight regain began at 18 months in the nonbanded group and at 24 months in the banded group, said Dr. Choi, who noted a trend toward weight regain in both groups at the 5-year follow-up.

No patient in either of the study groups died, and there were no significant differences between groups in the rates of postoperative complications, Dr. Choi reported.

There were no cases of band erosion or slippage, and although the banded group reported more postoperative emesis and food intolerance, “all were treated conservatively and did not require invasive intervention,” she said.

Although the power of the study's statistical analysis was limited by its small size, and 5-year follow-up data were only available for approximately 25% of the overall study population, the findings suggest that the banded procedure is a reasonable therapeutic option for the superobese population, and it may result in better maintenance of weight loss over time, said Dr. Choi.

“Further follow-up of a larger cohort is needed to better assess the long-term outcomes of the banded and nonbanded procedures,” she said.

Major Finding: Banded gastric bypass may lead to better weight-loss maintenance compared with the nonbanded procedure in superobese patients.

Data Source: A prospective, randomized, double-blind trial comparing outcomes of 90 obese patients who underwent the Capella banded gastric bypass procedure or the conventional Roux-en-Y gastric bypass.

Disclosures: Dr. Choi reported no conflicts. A coauthor disclosed ties with Ethicon EndoSurgery Inc., Covidien, and Olympus America Inc.

LAS VEGAS — Banded long-limb gastric bypass may result in greater weight loss over time in superobese patients than the traditional, nonbanded gastric bypass, a study has shown.

Data from a prospective, randomized trial comparing the long-term outcomes of the two procedures showed similar initial weight loss for patients in the two groups but a trend toward better maintenance of weight loss at 5 years in the banded group, reported Dr. Jenny Choi.

In addition, patients in the banded group were more likely to experience resolution of gastroesophageal reflux disease relative to those who underwent the less restrictive procedure, she said, noting that there were no differences in the degree of resolution of other comorbidities.

Of the 90 patients with body mass index greater than 50 kg/m

The remaining 44 patients underwent the conventional Roux-en-Y gastric bypass, Dr. Choi explained.

All of the surgeries were performed by the same surgeon, and there were no significant between-group differences in patient body mass index, age, or comorbidities at baseline, she said. Dr. Choi and her colleagues at Columbia University Medical Center in New York collected data on weight loss, improvement or resolution of comorbidities, and complications reported for all of the patients at 12, 24, 36, 48, and 60 months.

“At each of the time points, the banded group consistently had better weight loss, although the difference was not statistically significant,” she said. At 12, 24, 26, and 48 months, the percentage of excess weight loss for the banded and nonbanded groups, respectively, was 63.9% and 56.9%; 65.9% and 59.8%; 63.5% and 55.8%; and 55.3% and 42.6%.

At 60 months, the between-group difference in percentage of excess weight lost (55.4% vs. 47.5%) approached but did not reach statistical significance in the banded group compared with the nonbanded group.

The number of patients who reached a body mass index of less than 35 kg/m

Additionally, “the failure rate [defined as less than 50% of excess weight loss] was 10% in the banded group, compared with 15.7% in the nonbanded group,” she said.

With respect to peak weight loss, weight regain began at 18 months in the nonbanded group and at 24 months in the banded group, said Dr. Choi, who noted a trend toward weight regain in both groups at the 5-year follow-up.

No patient in either of the study groups died, and there were no significant differences between groups in the rates of postoperative complications, Dr. Choi reported.

There were no cases of band erosion or slippage, and although the banded group reported more postoperative emesis and food intolerance, “all were treated conservatively and did not require invasive intervention,” she said.

Although the power of the study's statistical analysis was limited by its small size, and 5-year follow-up data were only available for approximately 25% of the overall study population, the findings suggest that the banded procedure is a reasonable therapeutic option for the superobese population, and it may result in better maintenance of weight loss over time, said Dr. Choi.

“Further follow-up of a larger cohort is needed to better assess the long-term outcomes of the banded and nonbanded procedures,” she said.

Major Finding: Banded gastric bypass may lead to better weight-loss maintenance compared with the nonbanded procedure in superobese patients.

Data Source: A prospective, randomized, double-blind trial comparing outcomes of 90 obese patients who underwent the Capella banded gastric bypass procedure or the conventional Roux-en-Y gastric bypass.

Disclosures: Dr. Choi reported no conflicts. A coauthor disclosed ties with Ethicon EndoSurgery Inc., Covidien, and Olympus America Inc.

LAS VEGAS — Banded long-limb gastric bypass may result in greater weight loss over time in superobese patients than the traditional, nonbanded gastric bypass, a study has shown.

Data from a prospective, randomized trial comparing the long-term outcomes of the two procedures showed similar initial weight loss for patients in the two groups but a trend toward better maintenance of weight loss at 5 years in the banded group, reported Dr. Jenny Choi.

In addition, patients in the banded group were more likely to experience resolution of gastroesophageal reflux disease relative to those who underwent the less restrictive procedure, she said, noting that there were no differences in the degree of resolution of other comorbidities.

Of the 90 patients with body mass index greater than 50 kg/m

The remaining 44 patients underwent the conventional Roux-en-Y gastric bypass, Dr. Choi explained.

All of the surgeries were performed by the same surgeon, and there were no significant between-group differences in patient body mass index, age, or comorbidities at baseline, she said. Dr. Choi and her colleagues at Columbia University Medical Center in New York collected data on weight loss, improvement or resolution of comorbidities, and complications reported for all of the patients at 12, 24, 36, 48, and 60 months.

“At each of the time points, the banded group consistently had better weight loss, although the difference was not statistically significant,” she said. At 12, 24, 26, and 48 months, the percentage of excess weight loss for the banded and nonbanded groups, respectively, was 63.9% and 56.9%; 65.9% and 59.8%; 63.5% and 55.8%; and 55.3% and 42.6%.

At 60 months, the between-group difference in percentage of excess weight lost (55.4% vs. 47.5%) approached but did not reach statistical significance in the banded group compared with the nonbanded group.

The number of patients who reached a body mass index of less than 35 kg/m

Additionally, “the failure rate [defined as less than 50% of excess weight loss] was 10% in the banded group, compared with 15.7% in the nonbanded group,” she said.

With respect to peak weight loss, weight regain began at 18 months in the nonbanded group and at 24 months in the banded group, said Dr. Choi, who noted a trend toward weight regain in both groups at the 5-year follow-up.

No patient in either of the study groups died, and there were no significant differences between groups in the rates of postoperative complications, Dr. Choi reported.

There were no cases of band erosion or slippage, and although the banded group reported more postoperative emesis and food intolerance, “all were treated conservatively and did not require invasive intervention,” she said.

Although the power of the study's statistical analysis was limited by its small size, and 5-year follow-up data were only available for approximately 25% of the overall study population, the findings suggest that the banded procedure is a reasonable therapeutic option for the superobese population, and it may result in better maintenance of weight loss over time, said Dr. Choi.

“Further follow-up of a larger cohort is needed to better assess the long-term outcomes of the banded and nonbanded procedures,” she said.

LAS VEGAS — Distal Roux-en-Y gastric bypass surgery led to excellent long-term weight loss in superobese and morbidly obese individuals, but researchers found a high incidence of protein-calorie malnutrition requiring revision, in a study of 49 patients.

Calling the revision rate “unacceptable,” Dr. John M. Kellum said the distal procedure “should not be the primary operation for morbid or superobesity.”

Data on long-term outcomes in American patients who have undergone distal gastric bypass are limited. Dr. Kellum and his colleagues at Virginia Commonwealth University in Richmond evaluated the long-term weight loss and metabolic outcomes of 49 individuals who underwent the procedure from 1985 to 1989 with follow-up of up to 24 years.

Of the 49 patients, 43 were classified as superobese (a body mass index greater than 50 kg/m

All procedures were performed using celiotomy and included a Roux-en-Y gastric bypass with a 30- to 50-mL proximal gastric pouch (stapled in continuity), a biliopancreatic limb extending from the ligament of Treitz to 250 cm from the ileocecal junction, and a common channel of 50-150 cm, Dr. Kellum explained. “It should be noted that, by 1988, surgeons were no longer doing 50-cm common channels because of the unacceptably high incidence of protein-calorie malnutrition,” he said.

One patient died perioperatively of a massive pulmonary embolus. Of the remaining 48 patients, 21 underwent limb-lengthening revisions for protein-calorie malnutrition that was not improved by intermittent total parenteral nutrition (TPN), including 13 of the 23 patients with 50-cm common channels and 8 of the 25 patients with common channels greater than 100 cm, Dr. Kellum said, noting that revision rate difference between the two groups was statistically significant.

Of the 27 patients who did not undergo limb-lengthening revisions, 2 required hospitalization (including 1 who received TPN for 30 days) and 6 received intestinal tube feedings at home. Eight late deaths, from 6 to 19 years after surgery, occurred in this group, Dr. Kellum noted.

For 19 of the 27 patients who did not need revision surgery, more than 5 years of follow-up data showed “excellent long-term weight loss,” with a median BMI of 34.2 at 10 years, said Dr. Kellum. However, the mean levels of serum albumin (3.6 g/dL), iron (24.4 U/dL), and 25-OH vitamin D (14.6 ng/mL) were “unacceptably low.” Because of the small number of patients, the resolution of comorbidities over the long term couldn't be determined, he noted.

Compared in a nonrandomized fashion with the long-term outcomes of a similar group of patients who underwent long-limb gastric bypass starting in 1992, “there was superior weight loss but also a statistically higher incidence of iron deficiency anemia in the distal bypass group, and the rates of [decreased] albumin approached significance by the Student's t-test and reached significance using the Wright subtest,” Dr. Kellum said (Ann. Surg. 1992;215:387-95). “Because of the albumin levels, serum calcium was also significantly lower in the distal bypass group.”

Based on the findings, Dr. Kellum said, “this particular form of distal gastric bypass should not be used as a primary bariatric surgery for morbid or superobesity because of the high revision rate and the high incidence of late metabolic morbidity. Distal Roux-en-Y gastric bypass should be reserved for those patients who have failed conventional proximal gastric bypass [and] who continue to have life-threatening medical conditions.”

Dr. Robert E. Brolin of New Jersey Bariatrics in Plainsboro, who served as the discussant, complimented Dr. Kellum “for reporting what can be perceived as negative results, so similar experiences are not repeated by other surgeons.”

Dr. Brolin also asked Dr. Kellum if malabsorption—achieved either through a shorter biliopancreatic limb or the duodenal switch, which has a larger stomach capacity but similar malabsorptive characteristics to the procedure described—has any role in terms of long-term weight-loss maintenance in severe clinical obesity.

“I still don't think malabsorption should ever be the initial operation,” Dr. Kellum replied. “I believe patients should be followed carefully by dietitians and should maintain regular exercise programs. Doing so leaves some responsibility on the patients rather than depending on the length of the common channel.”

Dr. Kellum reported having no relevant financial conflicts. He noted that one of the study coauthors, Dr. Harvey Sugerman, is editor in chief of Surgery for Obesity and Related Diseases, the journal of the American Society for Metabolic annual meeting of theand Bariatric Surgery.

LAS VEGAS — Distal Roux-en-Y gastric bypass surgery led to excellent long-term weight loss in superobese and morbidly obese individuals, but researchers found a high incidence of protein-calorie malnutrition requiring revision, in a study of 49 patients.

Calling the revision rate “unacceptable,” Dr. John M. Kellum said the distal procedure “should not be the primary operation for morbid or superobesity.”

Data on long-term outcomes in American patients who have undergone distal gastric bypass are limited. Dr. Kellum and his colleagues at Virginia Commonwealth University in Richmond evaluated the long-term weight loss and metabolic outcomes of 49 individuals who underwent the procedure from 1985 to 1989 with follow-up of up to 24 years.

Of the 49 patients, 43 were classified as superobese (a body mass index greater than 50 kg/m

All procedures were performed using celiotomy and included a Roux-en-Y gastric bypass with a 30- to 50-mL proximal gastric pouch (stapled in continuity), a biliopancreatic limb extending from the ligament of Treitz to 250 cm from the ileocecal junction, and a common channel of 50-150 cm, Dr. Kellum explained. “It should be noted that, by 1988, surgeons were no longer doing 50-cm common channels because of the unacceptably high incidence of protein-calorie malnutrition,” he said.

One patient died perioperatively of a massive pulmonary embolus. Of the remaining 48 patients, 21 underwent limb-lengthening revisions for protein-calorie malnutrition that was not improved by intermittent total parenteral nutrition (TPN), including 13 of the 23 patients with 50-cm common channels and 8 of the 25 patients with common channels greater than 100 cm, Dr. Kellum said, noting that revision rate difference between the two groups was statistically significant.

Of the 27 patients who did not undergo limb-lengthening revisions, 2 required hospitalization (including 1 who received TPN for 30 days) and 6 received intestinal tube feedings at home. Eight late deaths, from 6 to 19 years after surgery, occurred in this group, Dr. Kellum noted.

For 19 of the 27 patients who did not need revision surgery, more than 5 years of follow-up data showed “excellent long-term weight loss,” with a median BMI of 34.2 at 10 years, said Dr. Kellum. However, the mean levels of serum albumin (3.6 g/dL), iron (24.4 U/dL), and 25-OH vitamin D (14.6 ng/mL) were “unacceptably low.” Because of the small number of patients, the resolution of comorbidities over the long term couldn't be determined, he noted.

Compared in a nonrandomized fashion with the long-term outcomes of a similar group of patients who underwent long-limb gastric bypass starting in 1992, “there was superior weight loss but also a statistically higher incidence of iron deficiency anemia in the distal bypass group, and the rates of [decreased] albumin approached significance by the Student's t-test and reached significance using the Wright subtest,” Dr. Kellum said (Ann. Surg. 1992;215:387-95). “Because of the albumin levels, serum calcium was also significantly lower in the distal bypass group.”

Based on the findings, Dr. Kellum said, “this particular form of distal gastric bypass should not be used as a primary bariatric surgery for morbid or superobesity because of the high revision rate and the high incidence of late metabolic morbidity. Distal Roux-en-Y gastric bypass should be reserved for those patients who have failed conventional proximal gastric bypass [and] who continue to have life-threatening medical conditions.”

Dr. Robert E. Brolin of New Jersey Bariatrics in Plainsboro, who served as the discussant, complimented Dr. Kellum “for reporting what can be perceived as negative results, so similar experiences are not repeated by other surgeons.”

Dr. Brolin also asked Dr. Kellum if malabsorption—achieved either through a shorter biliopancreatic limb or the duodenal switch, which has a larger stomach capacity but similar malabsorptive characteristics to the procedure described—has any role in terms of long-term weight-loss maintenance in severe clinical obesity.

“I still don't think malabsorption should ever be the initial operation,” Dr. Kellum replied. “I believe patients should be followed carefully by dietitians and should maintain regular exercise programs. Doing so leaves some responsibility on the patients rather than depending on the length of the common channel.”

Dr. Kellum reported having no relevant financial conflicts. He noted that one of the study coauthors, Dr. Harvey Sugerman, is editor in chief of Surgery for Obesity and Related Diseases, the journal of the American Society for Metabolic annual meeting of theand Bariatric Surgery.

LAS VEGAS — Distal Roux-en-Y gastric bypass surgery led to excellent long-term weight loss in superobese and morbidly obese individuals, but researchers found a high incidence of protein-calorie malnutrition requiring revision, in a study of 49 patients.

Calling the revision rate “unacceptable,” Dr. John M. Kellum said the distal procedure “should not be the primary operation for morbid or superobesity.”

Data on long-term outcomes in American patients who have undergone distal gastric bypass are limited. Dr. Kellum and his colleagues at Virginia Commonwealth University in Richmond evaluated the long-term weight loss and metabolic outcomes of 49 individuals who underwent the procedure from 1985 to 1989 with follow-up of up to 24 years.

Of the 49 patients, 43 were classified as superobese (a body mass index greater than 50 kg/m

All procedures were performed using celiotomy and included a Roux-en-Y gastric bypass with a 30- to 50-mL proximal gastric pouch (stapled in continuity), a biliopancreatic limb extending from the ligament of Treitz to 250 cm from the ileocecal junction, and a common channel of 50-150 cm, Dr. Kellum explained. “It should be noted that, by 1988, surgeons were no longer doing 50-cm common channels because of the unacceptably high incidence of protein-calorie malnutrition,” he said.

One patient died perioperatively of a massive pulmonary embolus. Of the remaining 48 patients, 21 underwent limb-lengthening revisions for protein-calorie malnutrition that was not improved by intermittent total parenteral nutrition (TPN), including 13 of the 23 patients with 50-cm common channels and 8 of the 25 patients with common channels greater than 100 cm, Dr. Kellum said, noting that revision rate difference between the two groups was statistically significant.

Of the 27 patients who did not undergo limb-lengthening revisions, 2 required hospitalization (including 1 who received TPN for 30 days) and 6 received intestinal tube feedings at home. Eight late deaths, from 6 to 19 years after surgery, occurred in this group, Dr. Kellum noted.

For 19 of the 27 patients who did not need revision surgery, more than 5 years of follow-up data showed “excellent long-term weight loss,” with a median BMI of 34.2 at 10 years, said Dr. Kellum. However, the mean levels of serum albumin (3.6 g/dL), iron (24.4 U/dL), and 25-OH vitamin D (14.6 ng/mL) were “unacceptably low.” Because of the small number of patients, the resolution of comorbidities over the long term couldn't be determined, he noted.

Compared in a nonrandomized fashion with the long-term outcomes of a similar group of patients who underwent long-limb gastric bypass starting in 1992, “there was superior weight loss but also a statistically higher incidence of iron deficiency anemia in the distal bypass group, and the rates of [decreased] albumin approached significance by the Student's t-test and reached significance using the Wright subtest,” Dr. Kellum said (Ann. Surg. 1992;215:387-95). “Because of the albumin levels, serum calcium was also significantly lower in the distal bypass group.”

Based on the findings, Dr. Kellum said, “this particular form of distal gastric bypass should not be used as a primary bariatric surgery for morbid or superobesity because of the high revision rate and the high incidence of late metabolic morbidity. Distal Roux-en-Y gastric bypass should be reserved for those patients who have failed conventional proximal gastric bypass [and] who continue to have life-threatening medical conditions.”

Dr. Robert E. Brolin of New Jersey Bariatrics in Plainsboro, who served as the discussant, complimented Dr. Kellum “for reporting what can be perceived as negative results, so similar experiences are not repeated by other surgeons.”

Dr. Brolin also asked Dr. Kellum if malabsorption—achieved either through a shorter biliopancreatic limb or the duodenal switch, which has a larger stomach capacity but similar malabsorptive characteristics to the procedure described—has any role in terms of long-term weight-loss maintenance in severe clinical obesity.

“I still don't think malabsorption should ever be the initial operation,” Dr. Kellum replied. “I believe patients should be followed carefully by dietitians and should maintain regular exercise programs. Doing so leaves some responsibility on the patients rather than depending on the length of the common channel.”

Dr. Kellum reported having no relevant financial conflicts. He noted that one of the study coauthors, Dr. Harvey Sugerman, is editor in chief of Surgery for Obesity and Related Diseases, the journal of the American Society for Metabolic annual meeting of theand Bariatric Surgery.

LAS VEGAS — Distal Roux-en-Y gastric bypass surgery led to excellent long-term weight loss in superobese and morbidly obese individuals, but researchers found a high incidence of protein-calorie malnutrition requiring revision, in a study of 49 patients. Calling the revision rate “unacceptable,” Dr. John M. Kellum said the distal procedure “should not be the primary operation for morbid or superobesity.”

Data on long-term outcomes in American patients who have undergone distal gastric bypass are limited. Dr. Kellum and his colleagues at Virginia Commonwealth University, Richmond, evaluated the long-term weight loss and metabolic outcomes of 49 patients who underwent the procedure in 1985-1989 with follow-up of up to 24 years. Of those 49 patients, 43 were classified as superobese (a body mass index greater than 50 kg/m

All procedures were performed using celiotomy and included a Roux-en-Y gastric bypass with a 30- to 50-mL proximal gastric pouch (stapled in continuity), a biliopancreatic limb extending from the ligament of Treitz to 250 cm from the ileocecal junction, and a common channel of 50-150 cm, Dr. Kellum said. “It should be noted that by 1988, surgeons were no longer doing 50-cm common channels because of the unacceptably high incidence of protein-calorie malnutrition.”

One patient died perioperatively from a massive pulmonary embolus. Of the remaining 48 patients, 21 had limb-lengthening revisions for protein-calorie malnutrition that was not improved by intermittent total parenteral nutrition (TPN), including 13 of the 23 patients with 50-cm common channels and 8 of the 25 patients with common channels greater than 100 cm, Dr. Kellum said. The revision rate difference in the two groups was statistically significant.

Among the 27 patients who did not undergo limb-lengthening revisions, 2 required hospitalization (including 1 who received TPN for 30 days) and 6 received intestinal tube feedings at home. Eight late deaths 6-19 years after surgery occurred in this group, Dr. Kellum noted.

For 19 of the 27 patients who did not need revision surgery, more than 5 years of follow-up data showed “excellent long-term weight loss,” with a median BMI of 34.2 at 10 years, said Dr. Kellum. However, the mean levels of serum albumin (3.6 g/dL), iron (24.4 U/dL), and 25-OH vitamin D (14.6 ng/mL) were “unacceptably low.” Because of the small number of patients, the resolution of comorbidities over the long term couldn't be determined, he said.

Compared in a nonrandomized fashion with the long-term outcomes of a similar group of patients who underwent long-limb gastric bypass starting in 1992, “there was superior weight loss but also a statistically higher incidence of iron deficiency anemia in the distal bypass group, and the rates of [decreased] albumin approached significance by the Student's t-test and reached significance using the Wright subtest,” Dr. Kellum said (Ann. Surg. 1992; 215:387-95). “Because of the albumin levels, serum calcium was also significantly lower in the distal bypass group.”

Based on the findings, Dr. Kellum said, “This particular form of distal gastric bypass should not be used as a primary bariatric surgery for morbid or superobesity because of the high revision rate and the high incidence of late metabolic morbidity. Distal Roux-en-Y gastric bypass should be reserved for those patients who have failed conventional proximal gastric bypass [and] who continue to have life-threatening medical conditions.”

Dr. Robert E. Brolin of New Jersey Bariatrics in Plainsboro, the discussant, asked Dr. Kellum whether malabsorption has any role in terms of long-term weight-loss maintenance in severe clinical obesity. “I still don't think malabsorption should ever be the initial operation,” Dr. Kellum replied.”

Disclosures: Dr. Kellum reported having no financial conflicts of interest with respect to his presentation. He noted that one of the study coauthors, Dr. Harvey Sugerman, is editor in chief of Surgery for Obesity and Related Diseases, the journal of the American Society for Metabolic and Bariatric Surgery.

LAS VEGAS — Distal Roux-en-Y gastric bypass surgery led to excellent long-term weight loss in superobese and morbidly obese individuals, but researchers found a high incidence of protein-calorie malnutrition requiring revision, in a study of 49 patients. Calling the revision rate “unacceptable,” Dr. John M. Kellum said the distal procedure “should not be the primary operation for morbid or superobesity.”

Data on long-term outcomes in American patients who have undergone distal gastric bypass are limited. Dr. Kellum and his colleagues at Virginia Commonwealth University, Richmond, evaluated the long-term weight loss and metabolic outcomes of 49 patients who underwent the procedure in 1985-1989 with follow-up of up to 24 years. Of those 49 patients, 43 were classified as superobese (a body mass index greater than 50 kg/m

All procedures were performed using celiotomy and included a Roux-en-Y gastric bypass with a 30- to 50-mL proximal gastric pouch (stapled in continuity), a biliopancreatic limb extending from the ligament of Treitz to 250 cm from the ileocecal junction, and a common channel of 50-150 cm, Dr. Kellum said. “It should be noted that by 1988, surgeons were no longer doing 50-cm common channels because of the unacceptably high incidence of protein-calorie malnutrition.”

One patient died perioperatively from a massive pulmonary embolus. Of the remaining 48 patients, 21 had limb-lengthening revisions for protein-calorie malnutrition that was not improved by intermittent total parenteral nutrition (TPN), including 13 of the 23 patients with 50-cm common channels and 8 of the 25 patients with common channels greater than 100 cm, Dr. Kellum said. The revision rate difference in the two groups was statistically significant.

Among the 27 patients who did not undergo limb-lengthening revisions, 2 required hospitalization (including 1 who received TPN for 30 days) and 6 received intestinal tube feedings at home. Eight late deaths 6-19 years after surgery occurred in this group, Dr. Kellum noted.

For 19 of the 27 patients who did not need revision surgery, more than 5 years of follow-up data showed “excellent long-term weight loss,” with a median BMI of 34.2 at 10 years, said Dr. Kellum. However, the mean levels of serum albumin (3.6 g/dL), iron (24.4 U/dL), and 25-OH vitamin D (14.6 ng/mL) were “unacceptably low.” Because of the small number of patients, the resolution of comorbidities over the long term couldn't be determined, he said.

Compared in a nonrandomized fashion with the long-term outcomes of a similar group of patients who underwent long-limb gastric bypass starting in 1992, “there was superior weight loss but also a statistically higher incidence of iron deficiency anemia in the distal bypass group, and the rates of [decreased] albumin approached significance by the Student's t-test and reached significance using the Wright subtest,” Dr. Kellum said (Ann. Surg. 1992; 215:387-95). “Because of the albumin levels, serum calcium was also significantly lower in the distal bypass group.”

Based on the findings, Dr. Kellum said, “This particular form of distal gastric bypass should not be used as a primary bariatric surgery for morbid or superobesity because of the high revision rate and the high incidence of late metabolic morbidity. Distal Roux-en-Y gastric bypass should be reserved for those patients who have failed conventional proximal gastric bypass [and] who continue to have life-threatening medical conditions.”

Dr. Robert E. Brolin of New Jersey Bariatrics in Plainsboro, the discussant, asked Dr. Kellum whether malabsorption has any role in terms of long-term weight-loss maintenance in severe clinical obesity. “I still don't think malabsorption should ever be the initial operation,” Dr. Kellum replied.”

Disclosures: Dr. Kellum reported having no financial conflicts of interest with respect to his presentation. He noted that one of the study coauthors, Dr. Harvey Sugerman, is editor in chief of Surgery for Obesity and Related Diseases, the journal of the American Society for Metabolic and Bariatric Surgery.

LAS VEGAS — Distal Roux-en-Y gastric bypass surgery led to excellent long-term weight loss in superobese and morbidly obese individuals, but researchers found a high incidence of protein-calorie malnutrition requiring revision, in a study of 49 patients. Calling the revision rate “unacceptable,” Dr. John M. Kellum said the distal procedure “should not be the primary operation for morbid or superobesity.”

Data on long-term outcomes in American patients who have undergone distal gastric bypass are limited. Dr. Kellum and his colleagues at Virginia Commonwealth University, Richmond, evaluated the long-term weight loss and metabolic outcomes of 49 patients who underwent the procedure in 1985-1989 with follow-up of up to 24 years. Of those 49 patients, 43 were classified as superobese (a body mass index greater than 50 kg/m

All procedures were performed using celiotomy and included a Roux-en-Y gastric bypass with a 30- to 50-mL proximal gastric pouch (stapled in continuity), a biliopancreatic limb extending from the ligament of Treitz to 250 cm from the ileocecal junction, and a common channel of 50-150 cm, Dr. Kellum said. “It should be noted that by 1988, surgeons were no longer doing 50-cm common channels because of the unacceptably high incidence of protein-calorie malnutrition.”

One patient died perioperatively from a massive pulmonary embolus. Of the remaining 48 patients, 21 had limb-lengthening revisions for protein-calorie malnutrition that was not improved by intermittent total parenteral nutrition (TPN), including 13 of the 23 patients with 50-cm common channels and 8 of the 25 patients with common channels greater than 100 cm, Dr. Kellum said. The revision rate difference in the two groups was statistically significant.

Among the 27 patients who did not undergo limb-lengthening revisions, 2 required hospitalization (including 1 who received TPN for 30 days) and 6 received intestinal tube feedings at home. Eight late deaths 6-19 years after surgery occurred in this group, Dr. Kellum noted.

For 19 of the 27 patients who did not need revision surgery, more than 5 years of follow-up data showed “excellent long-term weight loss,” with a median BMI of 34.2 at 10 years, said Dr. Kellum. However, the mean levels of serum albumin (3.6 g/dL), iron (24.4 U/dL), and 25-OH vitamin D (14.6 ng/mL) were “unacceptably low.” Because of the small number of patients, the resolution of comorbidities over the long term couldn't be determined, he said.

Compared in a nonrandomized fashion with the long-term outcomes of a similar group of patients who underwent long-limb gastric bypass starting in 1992, “there was superior weight loss but also a statistically higher incidence of iron deficiency anemia in the distal bypass group, and the rates of [decreased] albumin approached significance by the Student's t-test and reached significance using the Wright subtest,” Dr. Kellum said (Ann. Surg. 1992; 215:387-95). “Because of the albumin levels, serum calcium was also significantly lower in the distal bypass group.”

Based on the findings, Dr. Kellum said, “This particular form of distal gastric bypass should not be used as a primary bariatric surgery for morbid or superobesity because of the high revision rate and the high incidence of late metabolic morbidity. Distal Roux-en-Y gastric bypass should be reserved for those patients who have failed conventional proximal gastric bypass [and] who continue to have life-threatening medical conditions.”

Dr. Robert E. Brolin of New Jersey Bariatrics in Plainsboro, the discussant, asked Dr. Kellum whether malabsorption has any role in terms of long-term weight-loss maintenance in severe clinical obesity. “I still don't think malabsorption should ever be the initial operation,” Dr. Kellum replied.”

Disclosures: Dr. Kellum reported having no financial conflicts of interest with respect to his presentation. He noted that one of the study coauthors, Dr. Harvey Sugerman, is editor in chief of Surgery for Obesity and Related Diseases, the journal of the American Society for Metabolic and Bariatric Surgery.

Major Finding: Rates of new-onset comorbidities in the denial and bariatric cohorts, respectively, were 9.2% and 0.3% for diabetes; 41.9% and 0.9% for hypertension; and 19.4% and 0.6% for GERD.

Data Source: A retrospective study comparing comorbidities in 587 bariatric surgery patients with 189 patients who did not undergo surgery.

Disclosures: Dr. Al Harakeh and discussant Dr. John Morton reported having no financial conflicts of interest.

LAS VEGAS — Morbidly obese individuals who do not undergo bariatric surgery because of insurance denials have a higher incidence of new comorbidities over a short follow-up than do surgical patients, despite no significant change in body mass index, a study has shown.

Dr. Ayman B. Al Harakeh and his colleagues at Gundersen Lutheran Medical Foundation in LaCrosse, Wisc., compared the natural history and metabolic consequences of morbid obesity for patients who were denied bariatric surgery and those who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB) at their institution in 2001-2007. The researchers found that the 189 patients who were denied the surgery were significantly more likely to develop new comorbidities (including diabetes, hypertension, obstructive sleep apnea, lipid disorders, and gastroesophageal reflux disease) within a 3-year follow-up period, despite no change in BMI, compared with the 587 patients in the LRYGB cohort. Patients were denied surgery even though they satisfied National Institutes of Health criteria and were deemed appropriate surgical candidates.

The age and sex of patients in the denial and LRYGB cohorts were similar at baseline, as was the initial median BMI (47.3 kg/m

The statistically significant higher prevalence of hypertension, GERD, and lipid disorders in the denial group placed them at higher risk than the surgical group, “yet they were denied surgery that could improve or resolve many of the their obesity-related complications,” Dr. Al Harakeh pointed out.

An assessment of major comorbidities at 36 months after the initial evaluation showed the following rates of new-onset comorbidities in the denial and LRYGB cohorts, respectively: 9.2% and 0.3% for diabetes; 41.9% and 0.9% for hypertension; 34.2% and 0.4% for obstructive sleep apnea; 11.2% and 0.3% for lipid disorders; and 19.4% and 0.6% for GERD, said Dr. Al Harakeh. The respective mean BMIs in the denial and surgery groups at 36 months were 46.8 and 30.5, he said.

Because study data were collected retrospectively, specific reasons for the insurance denials were unavailable, he stated. However, in his experience, denials are frequently arbitrary. In fact, a previous study by Dr. Al Harakeh's colleagues showed that nearly 30% of patients deemed suitable for surgery by the bariatric team in 2001-2005 did not undergo the surgery for insurance-related reasons. According to the investigators, coverage was often denied because the insurer determined that the procedure was not a medical necessity or because the individuals' comorbid conditions were being managed by conventional medicine. “Even though the NIH has clearly defined the criteria for morbid obesity surgery, individual insurers are free to establish their own unique requirements,” the authors wrote (Surg. Obes. Relat. Dis. 2007;3:531-6).

My Take

'Clear and Present Danger' Shown

The high rate of new comorbidity development over a short follow-up period observed in obese patients denied bariatric surgery for insurance reasons demonstrates “a clear and present danger to at-risk obese patients,” according to discussant Dr. John Morton.

Though powerful, the study results may be skewed somewhat by a “surveillance effect,” Dr. Morton suggested. “A lot of these patients don't have primary care available to them, or at least not very good primary care,” he said, noting that perhaps the extensive presurgery evaluation for bariatric procedures “woke people up about the potential problems that could be occurring.” It's reasonable to assume that some of the most prevalent comorbidities observed during the evaluation, such as hypertension, GERD, and sleep apnea, may have been present but undiagnosed previously, he said.

Potential surveillance effect notwithstanding, the findings clearly confirm that failing to intervene “is a recipe for continued progression of comorbidities in these patients and that bariatric surgery is a powerful tertiary prevention measure for comorbidities.”

DR. MORTON is director of bariatric surgery and surgical quality at Stanford Hospital and Clinics in Palo Alto, Calif. He had no financial conflicts to disclose.

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Major Finding: Rates of new-onset comorbidities in the denial and bariatric cohorts, respectively, were 9.2% and 0.3% for diabetes; 41.9% and 0.9% for hypertension; and 19.4% and 0.6% for GERD.

Data Source: A retrospective study comparing comorbidities in 587 bariatric surgery patients with 189 patients who did not undergo surgery.

Disclosures: Dr. Al Harakeh and discussant Dr. John Morton reported having no financial conflicts of interest.

LAS VEGAS — Morbidly obese individuals who do not undergo bariatric surgery because of insurance denials have a higher incidence of new comorbidities over a short follow-up than do surgical patients, despite no significant change in body mass index, a study has shown.

Dr. Ayman B. Al Harakeh and his colleagues at Gundersen Lutheran Medical Foundation in LaCrosse, Wisc., compared the natural history and metabolic consequences of morbid obesity for patients who were denied bariatric surgery and those who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB) at their institution in 2001-2007. The researchers found that the 189 patients who were denied the surgery were significantly more likely to develop new comorbidities (including diabetes, hypertension, obstructive sleep apnea, lipid disorders, and gastroesophageal reflux disease) within a 3-year follow-up period, despite no change in BMI, compared with the 587 patients in the LRYGB cohort. Patients were denied surgery even though they satisfied National Institutes of Health criteria and were deemed appropriate surgical candidates.

The age and sex of patients in the denial and LRYGB cohorts were similar at baseline, as was the initial median BMI (47.3 kg/m

The statistically significant higher prevalence of hypertension, GERD, and lipid disorders in the denial group placed them at higher risk than the surgical group, “yet they were denied surgery that could improve or resolve many of the their obesity-related complications,” Dr. Al Harakeh pointed out.

An assessment of major comorbidities at 36 months after the initial evaluation showed the following rates of new-onset comorbidities in the denial and LRYGB cohorts, respectively: 9.2% and 0.3% for diabetes; 41.9% and 0.9% for hypertension; 34.2% and 0.4% for obstructive sleep apnea; 11.2% and 0.3% for lipid disorders; and 19.4% and 0.6% for GERD, said Dr. Al Harakeh. The respective mean BMIs in the denial and surgery groups at 36 months were 46.8 and 30.5, he said.

Because study data were collected retrospectively, specific reasons for the insurance denials were unavailable, he stated. However, in his experience, denials are frequently arbitrary. In fact, a previous study by Dr. Al Harakeh's colleagues showed that nearly 30% of patients deemed suitable for surgery by the bariatric team in 2001-2005 did not undergo the surgery for insurance-related reasons. According to the investigators, coverage was often denied because the insurer determined that the procedure was not a medical necessity or because the individuals' comorbid conditions were being managed by conventional medicine. “Even though the NIH has clearly defined the criteria for morbid obesity surgery, individual insurers are free to establish their own unique requirements,” the authors wrote (Surg. Obes. Relat. Dis. 2007;3:531-6).

My Take

'Clear and Present Danger' Shown

The high rate of new comorbidity development over a short follow-up period observed in obese patients denied bariatric surgery for insurance reasons demonstrates “a clear and present danger to at-risk obese patients,” according to discussant Dr. John Morton.

Though powerful, the study results may be skewed somewhat by a “surveillance effect,” Dr. Morton suggested. “A lot of these patients don't have primary care available to them, or at least not very good primary care,” he said, noting that perhaps the extensive presurgery evaluation for bariatric procedures “woke people up about the potential problems that could be occurring.” It's reasonable to assume that some of the most prevalent comorbidities observed during the evaluation, such as hypertension, GERD, and sleep apnea, may have been present but undiagnosed previously, he said.

Potential surveillance effect notwithstanding, the findings clearly confirm that failing to intervene “is a recipe for continued progression of comorbidities in these patients and that bariatric surgery is a powerful tertiary prevention measure for comorbidities.”

DR. MORTON is director of bariatric surgery and surgical quality at Stanford Hospital and Clinics in Palo Alto, Calif. He had no financial conflicts to disclose.

Document

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Vitals

Major Finding: Rates of new-onset comorbidities in the denial and bariatric cohorts, respectively, were 9.2% and 0.3% for diabetes; 41.9% and 0.9% for hypertension; and 19.4% and 0.6% for GERD.

Data Source: A retrospective study comparing comorbidities in 587 bariatric surgery patients with 189 patients who did not undergo surgery.

Disclosures: Dr. Al Harakeh and discussant Dr. John Morton reported having no financial conflicts of interest.

LAS VEGAS — Morbidly obese individuals who do not undergo bariatric surgery because of insurance denials have a higher incidence of new comorbidities over a short follow-up than do surgical patients, despite no significant change in body mass index, a study has shown.

Dr. Ayman B. Al Harakeh and his colleagues at Gundersen Lutheran Medical Foundation in LaCrosse, Wisc., compared the natural history and metabolic consequences of morbid obesity for patients who were denied bariatric surgery and those who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB) at their institution in 2001-2007. The researchers found that the 189 patients who were denied the surgery were significantly more likely to develop new comorbidities (including diabetes, hypertension, obstructive sleep apnea, lipid disorders, and gastroesophageal reflux disease) within a 3-year follow-up period, despite no change in BMI, compared with the 587 patients in the LRYGB cohort. Patients were denied surgery even though they satisfied National Institutes of Health criteria and were deemed appropriate surgical candidates.

The age and sex of patients in the denial and LRYGB cohorts were similar at baseline, as was the initial median BMI (47.3 kg/m

The statistically significant higher prevalence of hypertension, GERD, and lipid disorders in the denial group placed them at higher risk than the surgical group, “yet they were denied surgery that could improve or resolve many of the their obesity-related complications,” Dr. Al Harakeh pointed out.

An assessment of major comorbidities at 36 months after the initial evaluation showed the following rates of new-onset comorbidities in the denial and LRYGB cohorts, respectively: 9.2% and 0.3% for diabetes; 41.9% and 0.9% for hypertension; 34.2% and 0.4% for obstructive sleep apnea; 11.2% and 0.3% for lipid disorders; and 19.4% and 0.6% for GERD, said Dr. Al Harakeh. The respective mean BMIs in the denial and surgery groups at 36 months were 46.8 and 30.5, he said.

Because study data were collected retrospectively, specific reasons for the insurance denials were unavailable, he stated. However, in his experience, denials are frequently arbitrary. In fact, a previous study by Dr. Al Harakeh's colleagues showed that nearly 30% of patients deemed suitable for surgery by the bariatric team in 2001-2005 did not undergo the surgery for insurance-related reasons. According to the investigators, coverage was often denied because the insurer determined that the procedure was not a medical necessity or because the individuals' comorbid conditions were being managed by conventional medicine. “Even though the NIH has clearly defined the criteria for morbid obesity surgery, individual insurers are free to establish their own unique requirements,” the authors wrote (Surg. Obes. Relat. Dis. 2007;3:531-6).

My Take

'Clear and Present Danger' Shown

The high rate of new comorbidity development over a short follow-up period observed in obese patients denied bariatric surgery for insurance reasons demonstrates “a clear and present danger to at-risk obese patients,” according to discussant Dr. John Morton.

Though powerful, the study results may be skewed somewhat by a “surveillance effect,” Dr. Morton suggested. “A lot of these patients don't have primary care available to them, or at least not very good primary care,” he said, noting that perhaps the extensive presurgery evaluation for bariatric procedures “woke people up about the potential problems that could be occurring.” It's reasonable to assume that some of the most prevalent comorbidities observed during the evaluation, such as hypertension, GERD, and sleep apnea, may have been present but undiagnosed previously, he said.

Potential surveillance effect notwithstanding, the findings clearly confirm that failing to intervene “is a recipe for continued progression of comorbidities in these patients and that bariatric surgery is a powerful tertiary prevention measure for comorbidities.”

DR. MORTON is director of bariatric surgery and surgical quality at Stanford Hospital and Clinics in Palo Alto, Calif. He had no financial conflicts to disclose.

Document

70685_fx1.sml

Vitals

Major Findings: Death before discharge occurred in 20% of the infants in the lower oxygen saturation, compared with 16% of those in the higher group. In contrast, severe retinopathy among the surviving infants occurred significantly less often in the lower group at 9%, compared with the higher group at 18%.

Data Source: The multicenter Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) comprising 1,316 preterm infants from 24 weeks to 27 weeks and 6 days gestation.

Disclosures: SUPPORT was funded by the National Institutes of Health and by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute. One of the study co-authors, Dr. Krisa P. Van Meurs, disclosed receiving travel expenses from Ikaria Holdings. Dr. Colin Morley disclosed financial relationships with Dräger Medical and Fisher & Paykel.

Using lower target ranges of oxygen saturation in extremely preterm infants reduces the risk of severe retinopathy from oxygen toxicity, but increases the risk of death before discharge, according to one of two trials within the same neonatal study.

In the second trial, continuous positive airway pressure (CPAP) was determined to be an effective alternative to early surfactant administration followed by conventional intubation, with fewer complications.

Researchers in the multicenter Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) used a 2×2 factorial design to compare two target ranges of oxygen saturation in 1,316 infants who were born between 24 weeks and 27 weeks 6 days of gestation. In addition, they compared intubation and surfactant treatment initiated within 1 hour after birth and CPAP treatment initiated in the delivery room with subsequent use of a limited ventilation strategy.

For the oxygen range arm of the study, the infants were randomly assigned to the lower oxygen saturation target range of 85%-89% or the higher target range of 91%-95%. At the same time, they were randomly assigned to receive the oxygen through a ventilator or through a CPAP machine.

The primary outcome of the oxygen saturation investigation was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before hospital discharge, or both, wrote Dr. Waldemar A. Carlo of the University of Alabama at Birmingham, and colleagues.

Although there was no overall difference between the two oxygen saturation groups using the composite outcome measure, marked differences were observed when the two components of the measure were considered independently, the authors wrote. Specifically, death before discharge occurred in 20% of the infants in the lower target group compared with 16% of those in the higher group. In contrast, severe retinopathy among the surviving infants occurred significantly less often in the lower group, at 9%, compared with the higher group, at 18%. These findings, the authors note, “add to the concern that oxygen restriction may increase the rate of death among preterm infants.” As such, they advise exercising caution when considering a strategy that targets oxygen levels in the low range (N. Engl. J. Med. 2010;362:1959-69).

For the CPAP vs. early intubation/surfactant study arm, the primary outcome was death or bronchopulmonary dysplasia, defined by the need for supplemental oxygen at 36 weeks, wrote Dr. Neil N. Finer of the University of California at San Diego, and colleagues. After adjusting for gestational age, medical center, and family clustering, the need for supplemental oxygen was similar in both groups, although the CPAP infants less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia than the surfactant group, and they also required fewer days of mechanical ventilation and were more likely to be alive by day 7, the authors wrote.

Considering the lower complication rate, the findings “support consideration of CPAP as an alternative to routine intubation and surfactant administration in preterm infants,” the authors wrote (N. Engl. J. Med. 2010;362:1970-9).

In an accompanying editorial, Dr. Colin J. Morley of the University of Melbourne stressed that caution is warranted in interpreting the “most important outcome” linking the lower target oxygen saturation range and death before discharge. “Additional research is needed to clarify this finding,” he said. “There were no significant differences between the groups in short-term outcomes that have been associated with relative ischemia.”

Major Findings: Death before discharge occurred in 20% of the infants in the lower oxygen saturation, compared with 16% of those in the higher group. In contrast, severe retinopathy among the surviving infants occurred significantly less often in the lower group at 9%, compared with the higher group at 18%.

Data Source: The multicenter Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) comprising 1,316 preterm infants from 24 weeks to 27 weeks and 6 days gestation.

Disclosures: SUPPORT was funded by the National Institutes of Health and by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute. One of the study co-authors, Dr. Krisa P. Van Meurs, disclosed receiving travel expenses from Ikaria Holdings. Dr. Colin Morley disclosed financial relationships with Dräger Medical and Fisher & Paykel.

Using lower target ranges of oxygen saturation in extremely preterm infants reduces the risk of severe retinopathy from oxygen toxicity, but increases the risk of death before discharge, according to one of two trials within the same neonatal study.

In the second trial, continuous positive airway pressure (CPAP) was determined to be an effective alternative to early surfactant administration followed by conventional intubation, with fewer complications.

Researchers in the multicenter Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) used a 2×2 factorial design to compare two target ranges of oxygen saturation in 1,316 infants who were born between 24 weeks and 27 weeks 6 days of gestation. In addition, they compared intubation and surfactant treatment initiated within 1 hour after birth and CPAP treatment initiated in the delivery room with subsequent use of a limited ventilation strategy.

For the oxygen range arm of the study, the infants were randomly assigned to the lower oxygen saturation target range of 85%-89% or the higher target range of 91%-95%. At the same time, they were randomly assigned to receive the oxygen through a ventilator or through a CPAP machine.

The primary outcome of the oxygen saturation investigation was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before hospital discharge, or both, wrote Dr. Waldemar A. Carlo of the University of Alabama at Birmingham, and colleagues.

Although there was no overall difference between the two oxygen saturation groups using the composite outcome measure, marked differences were observed when the two components of the measure were considered independently, the authors wrote. Specifically, death before discharge occurred in 20% of the infants in the lower target group compared with 16% of those in the higher group. In contrast, severe retinopathy among the surviving infants occurred significantly less often in the lower group, at 9%, compared with the higher group, at 18%. These findings, the authors note, “add to the concern that oxygen restriction may increase the rate of death among preterm infants.” As such, they advise exercising caution when considering a strategy that targets oxygen levels in the low range (N. Engl. J. Med. 2010;362:1959-69).

For the CPAP vs. early intubation/surfactant study arm, the primary outcome was death or bronchopulmonary dysplasia, defined by the need for supplemental oxygen at 36 weeks, wrote Dr. Neil N. Finer of the University of California at San Diego, and colleagues. After adjusting for gestational age, medical center, and family clustering, the need for supplemental oxygen was similar in both groups, although the CPAP infants less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia than the surfactant group, and they also required fewer days of mechanical ventilation and were more likely to be alive by day 7, the authors wrote.

Considering the lower complication rate, the findings “support consideration of CPAP as an alternative to routine intubation and surfactant administration in preterm infants,” the authors wrote (N. Engl. J. Med. 2010;362:1970-9).

In an accompanying editorial, Dr. Colin J. Morley of the University of Melbourne stressed that caution is warranted in interpreting the “most important outcome” linking the lower target oxygen saturation range and death before discharge. “Additional research is needed to clarify this finding,” he said. “There were no significant differences between the groups in short-term outcomes that have been associated with relative ischemia.”

Major Findings: Death before discharge occurred in 20% of the infants in the lower oxygen saturation, compared with 16% of those in the higher group. In contrast, severe retinopathy among the surviving infants occurred significantly less often in the lower group at 9%, compared with the higher group at 18%.

Data Source: The multicenter Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) comprising 1,316 preterm infants from 24 weeks to 27 weeks and 6 days gestation.

Disclosures: SUPPORT was funded by the National Institutes of Health and by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute. One of the study co-authors, Dr. Krisa P. Van Meurs, disclosed receiving travel expenses from Ikaria Holdings. Dr. Colin Morley disclosed financial relationships with Dräger Medical and Fisher & Paykel.

Using lower target ranges of oxygen saturation in extremely preterm infants reduces the risk of severe retinopathy from oxygen toxicity, but increases the risk of death before discharge, according to one of two trials within the same neonatal study.

In the second trial, continuous positive airway pressure (CPAP) was determined to be an effective alternative to early surfactant administration followed by conventional intubation, with fewer complications.

Researchers in the multicenter Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) used a 2×2 factorial design to compare two target ranges of oxygen saturation in 1,316 infants who were born between 24 weeks and 27 weeks 6 days of gestation. In addition, they compared intubation and surfactant treatment initiated within 1 hour after birth and CPAP treatment initiated in the delivery room with subsequent use of a limited ventilation strategy.

For the oxygen range arm of the study, the infants were randomly assigned to the lower oxygen saturation target range of 85%-89% or the higher target range of 91%-95%. At the same time, they were randomly assigned to receive the oxygen through a ventilator or through a CPAP machine.

The primary outcome of the oxygen saturation investigation was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before hospital discharge, or both, wrote Dr. Waldemar A. Carlo of the University of Alabama at Birmingham, and colleagues.

Although there was no overall difference between the two oxygen saturation groups using the composite outcome measure, marked differences were observed when the two components of the measure were considered independently, the authors wrote. Specifically, death before discharge occurred in 20% of the infants in the lower target group compared with 16% of those in the higher group. In contrast, severe retinopathy among the surviving infants occurred significantly less often in the lower group, at 9%, compared with the higher group, at 18%. These findings, the authors note, “add to the concern that oxygen restriction may increase the rate of death among preterm infants.” As such, they advise exercising caution when considering a strategy that targets oxygen levels in the low range (N. Engl. J. Med. 2010;362:1959-69).

For the CPAP vs. early intubation/surfactant study arm, the primary outcome was death or bronchopulmonary dysplasia, defined by the need for supplemental oxygen at 36 weeks, wrote Dr. Neil N. Finer of the University of California at San Diego, and colleagues. After adjusting for gestational age, medical center, and family clustering, the need for supplemental oxygen was similar in both groups, although the CPAP infants less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia than the surfactant group, and they also required fewer days of mechanical ventilation and were more likely to be alive by day 7, the authors wrote.

Considering the lower complication rate, the findings “support consideration of CPAP as an alternative to routine intubation and surfactant administration in preterm infants,” the authors wrote (N. Engl. J. Med. 2010;362:1970-9).

In an accompanying editorial, Dr. Colin J. Morley of the University of Melbourne stressed that caution is warranted in interpreting the “most important outcome” linking the lower target oxygen saturation range and death before discharge. “Additional research is needed to clarify this finding,” he said. “There were no significant differences between the groups in short-term outcomes that have been associated with relative ischemia.”

ROME — Immunization with common vaccines is not associated with an increased risk for rheumatoid arthritis, nor does it trigger the autoimmune disease in individuals who have established risk factors, according to an analysis of data that was presented by Camilla Bengtsson.

Using data from the Swedish population-based EIRA (Epidemiological Investigation of Rheumatoid Arthritis) data set and 1,984 healthy matched controls, Ms. Bengtsson, a doctoral candidate at the Karolinska Institute in Stockholm, and her associates compared the 582 individuals in the EIRA data set who had been vaccinated in the 5 years prior to disease onset with the 1,269 RA patients who had not been vaccinated within 5 years prior to disease onset. Among the control subjects, 617 had been vaccinated and 1,367 had not been vaccinated within the preceding 5 years.

Vaccine by vaccine, the odds ratio for developing RA after influenza vaccination was 1.1 (252 RA patients and 279 controls had received the flu vaccine during the period of interest). The OR for RA after tetanus vaccination was 1.0 (170 cases and 179 controls had received that vaccination). The OR was 1.0 for diphtheria vaccination (71 cases/71 controls). For tick-borne encephalitis, the OR was 0.8 (91 cases/122 controls). The OR for hepatitis A, B, and C was 0.9 (105 cases/124 controls). The OR for polio vaccination was 1.1 (29 cases/31 controls). The OR for pneumococcus was 1.0 (22 cases/22 controls). The RA OR for the unvaccinated was 1.0 (1,269 cases/1,367 controls). She reported having no conflicts.

ROME — Immunization with common vaccines is not associated with an increased risk for rheumatoid arthritis, nor does it trigger the autoimmune disease in individuals who have established risk factors, according to an analysis of data that was presented by Camilla Bengtsson.

Using data from the Swedish population-based EIRA (Epidemiological Investigation of Rheumatoid Arthritis) data set and 1,984 healthy matched controls, Ms. Bengtsson, a doctoral candidate at the Karolinska Institute in Stockholm, and her associates compared the 582 individuals in the EIRA data set who had been vaccinated in the 5 years prior to disease onset with the 1,269 RA patients who had not been vaccinated within 5 years prior to disease onset. Among the control subjects, 617 had been vaccinated and 1,367 had not been vaccinated within the preceding 5 years.

Vaccine by vaccine, the odds ratio for developing RA after influenza vaccination was 1.1 (252 RA patients and 279 controls had received the flu vaccine during the period of interest). The OR for RA after tetanus vaccination was 1.0 (170 cases and 179 controls had received that vaccination). The OR was 1.0 for diphtheria vaccination (71 cases/71 controls). For tick-borne encephalitis, the OR was 0.8 (91 cases/122 controls). The OR for hepatitis A, B, and C was 0.9 (105 cases/124 controls). The OR for polio vaccination was 1.1 (29 cases/31 controls). The OR for pneumococcus was 1.0 (22 cases/22 controls). The RA OR for the unvaccinated was 1.0 (1,269 cases/1,367 controls). She reported having no conflicts.

ROME — Immunization with common vaccines is not associated with an increased risk for rheumatoid arthritis, nor does it trigger the autoimmune disease in individuals who have established risk factors, according to an analysis of data that was presented by Camilla Bengtsson.

Using data from the Swedish population-based EIRA (Epidemiological Investigation of Rheumatoid Arthritis) data set and 1,984 healthy matched controls, Ms. Bengtsson, a doctoral candidate at the Karolinska Institute in Stockholm, and her associates compared the 582 individuals in the EIRA data set who had been vaccinated in the 5 years prior to disease onset with the 1,269 RA patients who had not been vaccinated within 5 years prior to disease onset. Among the control subjects, 617 had been vaccinated and 1,367 had not been vaccinated within the preceding 5 years.

Vaccine by vaccine, the odds ratio for developing RA after influenza vaccination was 1.1 (252 RA patients and 279 controls had received the flu vaccine during the period of interest). The OR for RA after tetanus vaccination was 1.0 (170 cases and 179 controls had received that vaccination). The OR was 1.0 for diphtheria vaccination (71 cases/71 controls). For tick-borne encephalitis, the OR was 0.8 (91 cases/122 controls). The OR for hepatitis A, B, and C was 0.9 (105 cases/124 controls). The OR for polio vaccination was 1.1 (29 cases/31 controls). The OR for pneumococcus was 1.0 (22 cases/22 controls). The RA OR for the unvaccinated was 1.0 (1,269 cases/1,367 controls). She reported having no conflicts.

Major Finding: Emergency department visits for nonmedical use of prescription analgesics more than doubled during 2004-2008.

Data Source: A review by the Centers for Disease Control and Prevention of 5-year data on ED visits involving the nonmedical use of prescription drugs from the Substance Abuse and Mental Health Services Administration's Drug Abuse Warning Network.

Disclosures: None were reported.

Emergency department visits for nonmedical use of opioids increased by nearly 112% between 2004 and 2008, with a 29% increase between 2007 and 2008 alone, according to the Centers for Disease Control and Prevention.

Together with the Substance Abuse and Mental Health Services Administration (SAMHSA), the CDC reviewed the latest available 5 years of data on emergency department (ED) visits for nonmedical use of prescription drugs from SAMHSA's Drug Abuse Warning Network (DAWN). ED visits involving nonmedical use of opioid analgesics rose from 144,600 in 2004 to 305,900 in 2008, according to the report published in the CDC's June 18 Morbidity and Mortality Weekly Report. By 2008, the number of ED visits for misused prescription and over-the-counter drugs matched the number of ED visits involving illicit drugs for that year, the report noted (MMWR 2010 June 18;59:705-9).

The DAWN definition of nonmedical use of a prescription or over-the-counter drug includes taking a higher-than-recommended dose, taking a drug that was prescribed for another person, drug-facilitated assault, and misuse or abuse—all of which must be documented in a patient's medical record. It does not include suicide attempts, patients seeking detoxification, and unintentional ingestions, which are tracked in other categories.

The highest numbers of ED visits involving prescription drugs in this review were for oxycodone, hydrocodone, and methadone, each of which showed significant increases during the 5-year study. Among these drugs, the greatest increase was noted for oxycodone, with an estimated 41,700 ED visits in 2004 and 105,200 ED visits in 2008, representing a 144% increase.

Additionally, ED visits for nonmedical use of benzodiazepines increased 89%, from 143,500 in 2004 to 271,700 in 2008, with significant increases observed for each of the individual benzodiazepine drugs reviewed, including alprazolam, clonazepam, diazepam, and lorazepam. Significant increases were also noted for ED visits involving the sleep aid zolpidem and the muscle relaxant carisoprodol.

Peak visit rates for both opioids and benzodiazepines were observed in the age ranges 21-24 and 25-29 years, which represents a shift from previous report periods, in which peak visit rates were seen in the 30- to 34- and 35- to 44-year age ranges, according to an editorial note accompanying the report.

“As late as 2006, the peak mortality rate for fatal drug overdoses involving opioid analgesics had been in the 35-54 years age group,” according to the note.

The 5-year increase in ED visits probably reflects “substantial increases in the prescribing of these classes of drugs,” the CDC authors suggested. “The increase also might reflect an increase in the rate of nonmedical use of prescription drugs per 1,000 prescriptions, as has been observed for selected opioids.”

The report is limited by a number of factors, according to the authors. “First, the drugs involved in ED visits might not all be identified and documented. The extent to which ED staff members document drug involvement might have increased over time,” they wrote.

Additionally, information on the motivation behind nonmedical drug use might be incomplete, for instance by not noting a suicide attempt; population-based rates cannot be used to establish per-patient or per-prescription risk; and the distinction between nonmedical and medical reasons for taking drugs is not always clear, particularly when other drugs are involved.

Despite these limitations, “these increases in nonmedical use of pharmaceuticals suggest that previous prevention measures, such as provider and patient education and restrictions on use of specific formulations, have not been adequate,” the authors wrote.

Additional interventions, including more systematic provider education, universal use by providers of prescription-drug monitoring programs, routine monitoring of insurance claims information, and stepped up efforts by providers and insurers to intervene at signs of drug misuse are “urgently needed,” they stressed.

Major Finding: Emergency department visits for nonmedical use of prescription analgesics more than doubled during 2004-2008.

Data Source: A review by the Centers for Disease Control and Prevention of 5-year data on ED visits involving the nonmedical use of prescription drugs from the Substance Abuse and Mental Health Services Administration's Drug Abuse Warning Network.

Disclosures: None were reported.

Emergency department visits for nonmedical use of opioids increased by nearly 112% between 2004 and 2008, with a 29% increase between 2007 and 2008 alone, according to the Centers for Disease Control and Prevention.

Together with the Substance Abuse and Mental Health Services Administration (SAMHSA), the CDC reviewed the latest available 5 years of data on emergency department (ED) visits for nonmedical use of prescription drugs from SAMHSA's Drug Abuse Warning Network (DAWN). ED visits involving nonmedical use of opioid analgesics rose from 144,600 in 2004 to 305,900 in 2008, according to the report published in the CDC's June 18 Morbidity and Mortality Weekly Report. By 2008, the number of ED visits for misused prescription and over-the-counter drugs matched the number of ED visits involving illicit drugs for that year, the report noted (MMWR 2010 June 18;59:705-9).

The DAWN definition of nonmedical use of a prescription or over-the-counter drug includes taking a higher-than-recommended dose, taking a drug that was prescribed for another person, drug-facilitated assault, and misuse or abuse—all of which must be documented in a patient's medical record. It does not include suicide attempts, patients seeking detoxification, and unintentional ingestions, which are tracked in other categories.

The highest numbers of ED visits involving prescription drugs in this review were for oxycodone, hydrocodone, and methadone, each of which showed significant increases during the 5-year study. Among these drugs, the greatest increase was noted for oxycodone, with an estimated 41,700 ED visits in 2004 and 105,200 ED visits in 2008, representing a 144% increase.

Additionally, ED visits for nonmedical use of benzodiazepines increased 89%, from 143,500 in 2004 to 271,700 in 2008, with significant increases observed for each of the individual benzodiazepine drugs reviewed, including alprazolam, clonazepam, diazepam, and lorazepam. Significant increases were also noted for ED visits involving the sleep aid zolpidem and the muscle relaxant carisoprodol.

Peak visit rates for both opioids and benzodiazepines were observed in the age ranges 21-24 and 25-29 years, which represents a shift from previous report periods, in which peak visit rates were seen in the 30- to 34- and 35- to 44-year age ranges, according to an editorial note accompanying the report.

“As late as 2006, the peak mortality rate for fatal drug overdoses involving opioid analgesics had been in the 35-54 years age group,” according to the note.

The 5-year increase in ED visits probably reflects “substantial increases in the prescribing of these classes of drugs,” the CDC authors suggested. “The increase also might reflect an increase in the rate of nonmedical use of prescription drugs per 1,000 prescriptions, as has been observed for selected opioids.”

The report is limited by a number of factors, according to the authors. “First, the drugs involved in ED visits might not all be identified and documented. The extent to which ED staff members document drug involvement might have increased over time,” they wrote.

Additionally, information on the motivation behind nonmedical drug use might be incomplete, for instance by not noting a suicide attempt; population-based rates cannot be used to establish per-patient or per-prescription risk; and the distinction between nonmedical and medical reasons for taking drugs is not always clear, particularly when other drugs are involved.

Despite these limitations, “these increases in nonmedical use of pharmaceuticals suggest that previous prevention measures, such as provider and patient education and restrictions on use of specific formulations, have not been adequate,” the authors wrote.

Additional interventions, including more systematic provider education, universal use by providers of prescription-drug monitoring programs, routine monitoring of insurance claims information, and stepped up efforts by providers and insurers to intervene at signs of drug misuse are “urgently needed,” they stressed.

Major Finding: Emergency department visits for nonmedical use of prescription analgesics more than doubled during 2004-2008.

Data Source: A review by the Centers for Disease Control and Prevention of 5-year data on ED visits involving the nonmedical use of prescription drugs from the Substance Abuse and Mental Health Services Administration's Drug Abuse Warning Network.

Disclosures: None were reported.

Emergency department visits for nonmedical use of opioids increased by nearly 112% between 2004 and 2008, with a 29% increase between 2007 and 2008 alone, according to the Centers for Disease Control and Prevention.

Together with the Substance Abuse and Mental Health Services Administration (SAMHSA), the CDC reviewed the latest available 5 years of data on emergency department (ED) visits for nonmedical use of prescription drugs from SAMHSA's Drug Abuse Warning Network (DAWN). ED visits involving nonmedical use of opioid analgesics rose from 144,600 in 2004 to 305,900 in 2008, according to the report published in the CDC's June 18 Morbidity and Mortality Weekly Report. By 2008, the number of ED visits for misused prescription and over-the-counter drugs matched the number of ED visits involving illicit drugs for that year, the report noted (MMWR 2010 June 18;59:705-9).

The DAWN definition of nonmedical use of a prescription or over-the-counter drug includes taking a higher-than-recommended dose, taking a drug that was prescribed for another person, drug-facilitated assault, and misuse or abuse—all of which must be documented in a patient's medical record. It does not include suicide attempts, patients seeking detoxification, and unintentional ingestions, which are tracked in other categories.

The highest numbers of ED visits involving prescription drugs in this review were for oxycodone, hydrocodone, and methadone, each of which showed significant increases during the 5-year study. Among these drugs, the greatest increase was noted for oxycodone, with an estimated 41,700 ED visits in 2004 and 105,200 ED visits in 2008, representing a 144% increase.

Additionally, ED visits for nonmedical use of benzodiazepines increased 89%, from 143,500 in 2004 to 271,700 in 2008, with significant increases observed for each of the individual benzodiazepine drugs reviewed, including alprazolam, clonazepam, diazepam, and lorazepam. Significant increases were also noted for ED visits involving the sleep aid zolpidem and the muscle relaxant carisoprodol.

Peak visit rates for both opioids and benzodiazepines were observed in the age ranges 21-24 and 25-29 years, which represents a shift from previous report periods, in which peak visit rates were seen in the 30- to 34- and 35- to 44-year age ranges, according to an editorial note accompanying the report.

“As late as 2006, the peak mortality rate for fatal drug overdoses involving opioid analgesics had been in the 35-54 years age group,” according to the note.

The 5-year increase in ED visits probably reflects “substantial increases in the prescribing of these classes of drugs,” the CDC authors suggested. “The increase also might reflect an increase in the rate of nonmedical use of prescription drugs per 1,000 prescriptions, as has been observed for selected opioids.”

The report is limited by a number of factors, according to the authors. “First, the drugs involved in ED visits might not all be identified and documented. The extent to which ED staff members document drug involvement might have increased over time,” they wrote.

Additionally, information on the motivation behind nonmedical drug use might be incomplete, for instance by not noting a suicide attempt; population-based rates cannot be used to establish per-patient or per-prescription risk; and the distinction between nonmedical and medical reasons for taking drugs is not always clear, particularly when other drugs are involved.

Despite these limitations, “these increases in nonmedical use of pharmaceuticals suggest that previous prevention measures, such as provider and patient education and restrictions on use of specific formulations, have not been adequate,” the authors wrote.

Additional interventions, including more systematic provider education, universal use by providers of prescription-drug monitoring programs, routine monitoring of insurance claims information, and stepped up efforts by providers and insurers to intervene at signs of drug misuse are “urgently needed,” they stressed.

Major Finding: Patients taking angiotensin receptor blockers had a significantly higher risk of new cancer occurrence (7.2%) than did patients not on ARBs (6.0%), with a risk ratio of 1.08.

Data Source: A meta-analysis of nine randomized controlled trials of ARBs that included data on new cancer occurrence, solid organ cancer occurrence, and cancer deaths.

Disclosures: Study investigators disclosed various financial relationships with Pfizer, AstraZeneca, Ranbaxy, Centocor Research and Development, Cordis/Johnson & Johnson, Daiichi-Sankyo, Medicines Company, Medtronic Vascular, Portola, Schering-Plough, Accumetrics, Sanofi-Aventis, Novartis, and ARCA Biopharma.

Angiotensin-receptor II blockers are associated with a modestly increased risk of new cancer diagnoses, according to a meta-analysis of randomized controlled trials.

The limited amount of new cancer data in the available literature, however, precludes the calculation of exact cancer risk associated with each individual agent in this class of drugs, wrote lead investigator Dr. Ilke Sipahi and his colleagues at Case Western Reserve University in Cleveland.

Angiotensin receptor II blockers (ARBs) are commonly used for the treatment of hypertension, heart failure, and diabetic neuropathy. Because a number of several large ARB trials have been completed since 2003, when “an unexpected finding” of significantly higher fatal cancers among patients taking the ARB candesartan was observed in a study assessing the drug's efficacy in heart failure (Lancet 2003;362:759-66), Dr. Sipahi and his colleagues designed a meta-analysis of the published randomized controlled trials of drugs in this class to examine their effect on the occurrence of new cancers.

Secondary objectives included the determination of whether ARBs are associated with the occurrence of specific solid-organ cancers and cancer deaths, they wrote.

The meta-analysis included studies published before November 2009 in which an ARB was given in at least one group. Only those studies that enrolled least 100 patients and had a minimum 1 year follow-up were considered, according to the authors. Of the trials that fit these criteria and reported cancer data, five (61,590 patients) had new-cancer data available and were included for the evaluation of the primary outcome of new cancer occurrence. Additionally, for consideration of the secondary outcomes, five trials that reported data on common types of solid organ cancers (68,402 patients) and eight trials that reported data on cancer deaths (93,515) were evaluated, the authors wrote, noting that nine trials were included overall (Lancet Oncol. 2010 [doi:10.1016/S1470-2045(10)70142-6]).

For the primary outcome of cancer recurrence, patients who were randomized to ARB treatment had a 7.2% risk of new cancer occurrence, compared with a 6.0% risk among patients in the control groups, which is a statistically significant difference. An analysis of three of the trials in which cancer was a prespecified end point and cancer data were rigorously collected also showed a significant increase in risk of cancer with ARBs, they wrote.

Because the ARB telmisartan was used as the study drug in 86% of the patients randomized to an ARB, the investigators conducted a meta-analysis of three of the trials looking at this drug, which showed an increase in new cancer occurrence of borderline significance. Analyses looking specifically at patients on background ACE inhibitor therapy and looking at patients without concomitant ACE inhibitor treatment showed significant increases in new cancer occurrences.

For a secondary outcome of the occurrence of specific solid organ cancers, the “meta-analysis showed an increase in relative risk for the occurrence of new lung cancer in patients randomized to an ARB compared with control,” the authors wrote. “This effect was also seen in the subgroup of patients who received background ACE-inhibitor therapy.” While there was an excess of prostate cancer in the ARB groups in all five trials, it was not significant in meta-analysis, they stated.

When evaluating for cancer deaths, the authors wrote, “there was no significant difference in cancer deaths between patients randomized to ARBs and those randomized to control for the duration of the follow-up.”

The clinical significance of the “modest but significant” increased risk of new cancer occurrence is unknown, the authors conceded. “The finding of a 1.2% increase in absolute risk of cancer over an average of 4 years needs to be interpreted in view of the estimated 41% lifetime cancer risk,” they wrote.

Importantly, because new cancer data were available for only three of seven FDA-approved ARBs, and because most of the patients included in the meta-analysis received telmisartan, “it is not possible to draw conclusions about the exact risk of cancer associated with each particular drug,” the authors stated, nor is it known whether the remaining four ARBs are associated with an increased risk of new cancers.

 

The mechanism for the possible increase in new cancer occurrences associated with ARBs is uncertain, according the authors. Although experimental studies using cancer cell lines and mouse models have implicated the renin-angiotensin system in the regulation of cell proliferation, tumor growth, angiogenesis, and metastasis, and evidence shows that both angiotensin II type-1 blockade with ARB and direct stimulation of angiotensin II type-2 are capable of stimulating tumor angiogenesis in vivo, the authors wrote, “the relevance of these observations in human malignancy is largely unknown.”

Although the findings of this study are limited by the fact that the pooled results come from trials not designed to explore cancer outcomes as the primary end point and by the lack of individual patient level cancer data, “meta-analysis can be useful in providing insights into issues of safety and rare adverse events that might provide the hypothesis for a prospective trial,” the authors wrote, noting that the findings “warrant further investigation.”

My Take

Dealing With Drug Safety Questions

The meta-analysis linking angiotensin receptor blockers with an increased risk of incident cancer raises crucial drug safety questions.

While the meta-analysis has its strengths—particularly its size, the thoroughness of the literature search, and the application of appropriate filters to exclude potentially unreliable data—there are also important weaknesses, including the study's post hoc nature and the fact that the trials were not designed to explore cancer outcomes,” leading the investigators to be “appropriately cautious” in their interpretation of the data.

Until regulators review the possible association between ARB use and cancer and report their findings, “we should use ARBs, particularly telmisartan, with greater caution. ARBs can be reserved for patients with intolerance to ACE inhibitors.” Using ARBs more selectively will also save money, “since nearly all ARBs are proprietary while ACE inhibitors are generic.”

STEVEN E. NISSEN, M.D., is chair of the department of cardiovascular medicine at the Cleveland Clinic. His remarks were made in an accompanying commentary (Lancet Oncol. 2010 [doi:10.1016/S1470-2045(10)70142-X]). He has received research support for clinical trials from Pfizer, Astra Zeneca, Novartis, Novo Nordisk Roche, Daiichi-Sankyo, Takeda, Sanofi-Aventis, Resverlogix, and Eli Lilly. He consults for many pharmaceutical companies, but requires them to donate all honoraria or consulting fees directly to charity.

Document

70750_fx1.sml

Vitals

Major Finding: Patients taking angiotensin receptor blockers had a significantly higher risk of new cancer occurrence (7.2%) than did patients not on ARBs (6.0%), with a risk ratio of 1.08.

Data Source: A meta-analysis of nine randomized controlled trials of ARBs that included data on new cancer occurrence, solid organ cancer occurrence, and cancer deaths.

Disclosures: Study investigators disclosed various financial relationships with Pfizer, AstraZeneca, Ranbaxy, Centocor Research and Development, Cordis/Johnson & Johnson, Daiichi-Sankyo, Medicines Company, Medtronic Vascular, Portola, Schering-Plough, Accumetrics, Sanofi-Aventis, Novartis, and ARCA Biopharma.

Angiotensin-receptor II blockers are associated with a modestly increased risk of new cancer diagnoses, according to a meta-analysis of randomized controlled trials.

The limited amount of new cancer data in the available literature, however, precludes the calculation of exact cancer risk associated with each individual agent in this class of drugs, wrote lead investigator Dr. Ilke Sipahi and his colleagues at Case Western Reserve University in Cleveland.

Angiotensin receptor II blockers (ARBs) are commonly used for the treatment of hypertension, heart failure, and diabetic neuropathy. Because a number of several large ARB trials have been completed since 2003, when “an unexpected finding” of significantly higher fatal cancers among patients taking the ARB candesartan was observed in a study assessing the drug's efficacy in heart failure (Lancet 2003;362:759-66), Dr. Sipahi and his colleagues designed a meta-analysis of the published randomized controlled trials of drugs in this class to examine their effect on the occurrence of new cancers.

Secondary objectives included the determination of whether ARBs are associated with the occurrence of specific solid-organ cancers and cancer deaths, they wrote.

The meta-analysis included studies published before November 2009 in which an ARB was given in at least one group. Only those studies that enrolled least 100 patients and had a minimum 1 year follow-up were considered, according to the authors. Of the trials that fit these criteria and reported cancer data, five (61,590 patients) had new-cancer data available and were included for the evaluation of the primary outcome of new cancer occurrence. Additionally, for consideration of the secondary outcomes, five trials that reported data on common types of solid organ cancers (68,402 patients) and eight trials that reported data on cancer deaths (93,515) were evaluated, the authors wrote, noting that nine trials were included overall (Lancet Oncol. 2010 [doi:10.1016/S1470-2045(10)70142-6]).

For the primary outcome of cancer recurrence, patients who were randomized to ARB treatment had a 7.2% risk of new cancer occurrence, compared with a 6.0% risk among patients in the control groups, which is a statistically significant difference. An analysis of three of the trials in which cancer was a prespecified end point and cancer data were rigorously collected also showed a significant increase in risk of cancer with ARBs, they wrote.

Because the ARB telmisartan was used as the study drug in 86% of the patients randomized to an ARB, the investigators conducted a meta-analysis of three of the trials looking at this drug, which showed an increase in new cancer occurrence of borderline significance. Analyses looking specifically at patients on background ACE inhibitor therapy and looking at patients without concomitant ACE inhibitor treatment showed significant increases in new cancer occurrences.

For a secondary outcome of the occurrence of specific solid organ cancers, the “meta-analysis showed an increase in relative risk for the occurrence of new lung cancer in patients randomized to an ARB compared with control,” the authors wrote. “This effect was also seen in the subgroup of patients who received background ACE-inhibitor therapy.” While there was an excess of prostate cancer in the ARB groups in all five trials, it was not significant in meta-analysis, they stated.

When evaluating for cancer deaths, the authors wrote, “there was no significant difference in cancer deaths between patients randomized to ARBs and those randomized to control for the duration of the follow-up.”

The clinical significance of the “modest but significant” increased risk of new cancer occurrence is unknown, the authors conceded. “The finding of a 1.2% increase in absolute risk of cancer over an average of 4 years needs to be interpreted in view of the estimated 41% lifetime cancer risk,” they wrote.

Importantly, because new cancer data were available for only three of seven FDA-approved ARBs, and because most of the patients included in the meta-analysis received telmisartan, “it is not possible to draw conclusions about the exact risk of cancer associated with each particular drug,” the authors stated, nor is it known whether the remaining four ARBs are associated with an increased risk of new cancers.

 

The mechanism for the possible increase in new cancer occurrences associated with ARBs is uncertain, according the authors. Although experimental studies using cancer cell lines and mouse models have implicated the renin-angiotensin system in the regulation of cell proliferation, tumor growth, angiogenesis, and metastasis, and evidence shows that both angiotensin II type-1 blockade with ARB and direct stimulation of angiotensin II type-2 are capable of stimulating tumor angiogenesis in vivo, the authors wrote, “the relevance of these observations in human malignancy is largely unknown.”

Although the findings of this study are limited by the fact that the pooled results come from trials not designed to explore cancer outcomes as the primary end point and by the lack of individual patient level cancer data, “meta-analysis can be useful in providing insights into issues of safety and rare adverse events that might provide the hypothesis for a prospective trial,” the authors wrote, noting that the findings “warrant further investigation.”

My Take

Dealing With Drug Safety Questions

The meta-analysis linking angiotensin receptor blockers with an increased risk of incident cancer raises crucial drug safety questions.

While the meta-analysis has its strengths—particularly its size, the thoroughness of the literature search, and the application of appropriate filters to exclude potentially unreliable data—there are also important weaknesses, including the study's post hoc nature and the fact that the trials were not designed to explore cancer outcomes,” leading the investigators to be “appropriately cautious” in their interpretation of the data.

Until regulators review the possible association between ARB use and cancer and report their findings, “we should use ARBs, particularly telmisartan, with greater caution. ARBs can be reserved for patients with intolerance to ACE inhibitors.” Using ARBs more selectively will also save money, “since nearly all ARBs are proprietary while ACE inhibitors are generic.”

STEVEN E. NISSEN, M.D., is chair of the department of cardiovascular medicine at the Cleveland Clinic. His remarks were made in an accompanying commentary (Lancet Oncol. 2010 [doi:10.1016/S1470-2045(10)70142-X]). He has received research support for clinical trials from Pfizer, Astra Zeneca, Novartis, Novo Nordisk Roche, Daiichi-Sankyo, Takeda, Sanofi-Aventis, Resverlogix, and Eli Lilly. He consults for many pharmaceutical companies, but requires them to donate all honoraria or consulting fees directly to charity.

Document

70750_fx1.sml

Vitals

Major Finding: Patients taking angiotensin receptor blockers had a significantly higher risk of new cancer occurrence (7.2%) than did patients not on ARBs (6.0%), with a risk ratio of 1.08.

Data Source: A meta-analysis of nine randomized controlled trials of ARBs that included data on new cancer occurrence, solid organ cancer occurrence, and cancer deaths.

Disclosures: Study investigators disclosed various financial relationships with Pfizer, AstraZeneca, Ranbaxy, Centocor Research and Development, Cordis/Johnson & Johnson, Daiichi-Sankyo, Medicines Company, Medtronic Vascular, Portola, Schering-Plough, Accumetrics, Sanofi-Aventis, Novartis, and ARCA Biopharma.

Angiotensin-receptor II blockers are associated with a modestly increased risk of new cancer diagnoses, according to a meta-analysis of randomized controlled trials.

The limited amount of new cancer data in the available literature, however, precludes the calculation of exact cancer risk associated with each individual agent in this class of drugs, wrote lead investigator Dr. Ilke Sipahi and his colleagues at Case Western Reserve University in Cleveland.

Angiotensin receptor II blockers (ARBs) are commonly used for the treatment of hypertension, heart failure, and diabetic neuropathy. Because a number of several large ARB trials have been completed since 2003, when “an unexpected finding” of significantly higher fatal cancers among patients taking the ARB candesartan was observed in a study assessing the drug's efficacy in heart failure (Lancet 2003;362:759-66), Dr. Sipahi and his colleagues designed a meta-analysis of the published randomized controlled trials of drugs in this class to examine their effect on the occurrence of new cancers.

Secondary objectives included the determination of whether ARBs are associated with the occurrence of specific solid-organ cancers and cancer deaths, they wrote.

The meta-analysis included studies published before November 2009 in which an ARB was given in at least one group. Only those studies that enrolled least 100 patients and had a minimum 1 year follow-up were considered, according to the authors. Of the trials that fit these criteria and reported cancer data, five (61,590 patients) had new-cancer data available and were included for the evaluation of the primary outcome of new cancer occurrence. Additionally, for consideration of the secondary outcomes, five trials that reported data on common types of solid organ cancers (68,402 patients) and eight trials that reported data on cancer deaths (93,515) were evaluated, the authors wrote, noting that nine trials were included overall (Lancet Oncol. 2010 [doi:10.1016/S1470-2045(10)70142-6]).

For the primary outcome of cancer recurrence, patients who were randomized to ARB treatment had a 7.2% risk of new cancer occurrence, compared with a 6.0% risk among patients in the control groups, which is a statistically significant difference. An analysis of three of the trials in which cancer was a prespecified end point and cancer data were rigorously collected also showed a significant increase in risk of cancer with ARBs, they wrote.

Because the ARB telmisartan was used as the study drug in 86% of the patients randomized to an ARB, the investigators conducted a meta-analysis of three of the trials looking at this drug, which showed an increase in new cancer occurrence of borderline significance. Analyses looking specifically at patients on background ACE inhibitor therapy and looking at patients without concomitant ACE inhibitor treatment showed significant increases in new cancer occurrences.

For a secondary outcome of the occurrence of specific solid organ cancers, the “meta-analysis showed an increase in relative risk for the occurrence of new lung cancer in patients randomized to an ARB compared with control,” the authors wrote. “This effect was also seen in the subgroup of patients who received background ACE-inhibitor therapy.” While there was an excess of prostate cancer in the ARB groups in all five trials, it was not significant in meta-analysis, they stated.

When evaluating for cancer deaths, the authors wrote, “there was no significant difference in cancer deaths between patients randomized to ARBs and those randomized to control for the duration of the follow-up.”

The clinical significance of the “modest but significant” increased risk of new cancer occurrence is unknown, the authors conceded. “The finding of a 1.2% increase in absolute risk of cancer over an average of 4 years needs to be interpreted in view of the estimated 41% lifetime cancer risk,” they wrote.

Importantly, because new cancer data were available for only three of seven FDA-approved ARBs, and because most of the patients included in the meta-analysis received telmisartan, “it is not possible to draw conclusions about the exact risk of cancer associated with each particular drug,” the authors stated, nor is it known whether the remaining four ARBs are associated with an increased risk of new cancers.

 

The mechanism for the possible increase in new cancer occurrences associated with ARBs is uncertain, according the authors. Although experimental studies using cancer cell lines and mouse models have implicated the renin-angiotensin system in the regulation of cell proliferation, tumor growth, angiogenesis, and metastasis, and evidence shows that both angiotensin II type-1 blockade with ARB and direct stimulation of angiotensin II type-2 are capable of stimulating tumor angiogenesis in vivo, the authors wrote, “the relevance of these observations in human malignancy is largely unknown.”

Although the findings of this study are limited by the fact that the pooled results come from trials not designed to explore cancer outcomes as the primary end point and by the lack of individual patient level cancer data, “meta-analysis can be useful in providing insights into issues of safety and rare adverse events that might provide the hypothesis for a prospective trial,” the authors wrote, noting that the findings “warrant further investigation.”

My Take

Dealing With Drug Safety Questions

The meta-analysis linking angiotensin receptor blockers with an increased risk of incident cancer raises crucial drug safety questions.

While the meta-analysis has its strengths—particularly its size, the thoroughness of the literature search, and the application of appropriate filters to exclude potentially unreliable data—there are also important weaknesses, including the study's post hoc nature and the fact that the trials were not designed to explore cancer outcomes,” leading the investigators to be “appropriately cautious” in their interpretation of the data.

Until regulators review the possible association between ARB use and cancer and report their findings, “we should use ARBs, particularly telmisartan, with greater caution. ARBs can be reserved for patients with intolerance to ACE inhibitors.” Using ARBs more selectively will also save money, “since nearly all ARBs are proprietary while ACE inhibitors are generic.”

STEVEN E. NISSEN, M.D., is chair of the department of cardiovascular medicine at the Cleveland Clinic. His remarks were made in an accompanying commentary (Lancet Oncol. 2010 [doi:10.1016/S1470-2045(10)70142-X]). He has received research support for clinical trials from Pfizer, Astra Zeneca, Novartis, Novo Nordisk Roche, Daiichi-Sankyo, Takeda, Sanofi-Aventis, Resverlogix, and Eli Lilly. He consults for many pharmaceutical companies, but requires them to donate all honoraria or consulting fees directly to charity.

Document

70750_fx1.sml

Vitals