User login
New CPR guide sets compression limits, scratches vasopressin
New guidelines on cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) set upper limits on chest compression rate and depth, add naloxone to the care of suspected opioid abusers, and remove vasopressin from the advanced cardiac life support (ACLS) algorithm.
The American Heart Association published its revised guidelines Oct. 15 in Circulation. The AHA released its previous guidelines in 2010.
“Everyone has a role to play in the chain of survival – from bystanders to dispatchers, emergency responders to health care providers,” Dr. Mark Creager said in a statement. “When everyone knows their role, knows CPR, and works together, we can dramatically improve cardiac arrest victims’ chances of survival,” said Dr. Creager, AHA president and director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H.
The 2015 guidelines’ new recommendations include the following:
• Resuscitation pathways. The guidelines note that the resuscitation pathways are very different for patients who experience cardiac arrest present in either a hospital setting (IHCA) or out-of-hospital setting (OHCA). In OHCA, the patient depends on lay rescuers to not only recognize the situation but also call for help, initiate CPR, and, if available, administer defibrillation until emergency medical personnel arrive. However, IHCA involves prevention of cardiac arrest and smooth delivery of care in a multidisciplinary setting.
• Layperson CPR. Untrained lay rescuers should provide compression-only CPR for OHCA. Trained lay rescuers who are able to provide rescue breaths should begin CPR with compressions followed by breaths at a ratio of 30 compressions to two breaths. Compression-only CPR is easier to perform for untrained lay rescuers, the guidelines note, and survival rates are similar using CPR with or without rescue breaths in adult cardiac arrest with a cardiac etiology.
• Compression rate and depth. The new guidelines set upper limits on chest compression depth and heart rate, recommending a compression rate of 100-120 compressions per minute with a depth of at least 2 inches, not to exceed 2.4 inches in adults.
• Social media dispatching. Despite limited evidence, the guideline authors said that it may be reasonable for communities to use social media technologies to alert lay rescuers with mobile phones about nearby OHCA cases.
• Naloxone and opioid addiction. Also new to the guidelines is the recommended use of naloxone for patients with suspected or known opioid addiction by appropriately trained lay rescuers or basic life support (BLS) providers.
• CPR training. The guidelines highlight several changes to simplify health care provider training in CPR. For example, trained rescuers can simultaneously perform some tasks to reduce the time to initiate chest compressions. Likewise, in a team of trained rescuers, multiple steps such as activating the emergency response system, chest compression, ventilation, and defibrillator retrieval can be accomplished simultaneously.
• High-quality CPR. Finally, the guidelines focus on emphasizing high-quality CPR with adequate compression rate and depth, complete chest recoil, few interruptions to compressions, and appropriate ventilation.
The guidelines offer several changes to advanced cardiac life support (ACLS). The algorithm was simplified by removing vasopressin, because the authors note that “the combined use of vasopressin and epinephrine offers no advantage to using standard-dose epinephrine in cardiac arrest.”
Likewise, the guidelines note conflicting studies to support the use of lidocaine after return of spontaneous circulation (ROSC). “However, the initiation or continuation of lidocaine may be considered immediately after ROSC from VF/pulseless ventricular tachycardia cardiac arrest,” the guideline authors wrote. Finally, the guidelines highlight updates in post–cardiac arrest care, including a wider range of target temperatures, between 32° C and 36° C, to be maintained for at least 24 hours in comatose adults with ROSC after cardiac arrest. In comparison, the 2010 guidelines called for a target temperature range of 32° C to 34° C for 12-24 hours. The guidelines also detail new updates for acute coronary syndrome, pediatric BLS, pediatric ACLS, and neonatal resuscitation.
As the AHA updates its CPR guidelines, it’s also important for lay rescuers and health providers to update their own training, noted Dr. Clifton Callaway, chair of the AHA’s Emergency Cardiovascular Care (ECC) committee.
“Research shows resuscitation skills can decline within a few months after training – far before the 2-year period in which basic and advanced life support skills are currently evaluated,” cautioned Dr. Callaway, professor of emergency medicine at the University of Pittsburgh. “Frequent training with shorter intervals of basic and advanced cardiovascular life support skills may be helpful for providers who are likely to encounter a cardiac arrest to ensure the patient receives high-quality CPR,” he added.
New guidelines on cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) set upper limits on chest compression rate and depth, add naloxone to the care of suspected opioid abusers, and remove vasopressin from the advanced cardiac life support (ACLS) algorithm.
The American Heart Association published its revised guidelines Oct. 15 in Circulation. The AHA released its previous guidelines in 2010.
“Everyone has a role to play in the chain of survival – from bystanders to dispatchers, emergency responders to health care providers,” Dr. Mark Creager said in a statement. “When everyone knows their role, knows CPR, and works together, we can dramatically improve cardiac arrest victims’ chances of survival,” said Dr. Creager, AHA president and director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H.
The 2015 guidelines’ new recommendations include the following:
• Resuscitation pathways. The guidelines note that the resuscitation pathways are very different for patients who experience cardiac arrest present in either a hospital setting (IHCA) or out-of-hospital setting (OHCA). In OHCA, the patient depends on lay rescuers to not only recognize the situation but also call for help, initiate CPR, and, if available, administer defibrillation until emergency medical personnel arrive. However, IHCA involves prevention of cardiac arrest and smooth delivery of care in a multidisciplinary setting.
• Layperson CPR. Untrained lay rescuers should provide compression-only CPR for OHCA. Trained lay rescuers who are able to provide rescue breaths should begin CPR with compressions followed by breaths at a ratio of 30 compressions to two breaths. Compression-only CPR is easier to perform for untrained lay rescuers, the guidelines note, and survival rates are similar using CPR with or without rescue breaths in adult cardiac arrest with a cardiac etiology.
• Compression rate and depth. The new guidelines set upper limits on chest compression depth and heart rate, recommending a compression rate of 100-120 compressions per minute with a depth of at least 2 inches, not to exceed 2.4 inches in adults.
• Social media dispatching. Despite limited evidence, the guideline authors said that it may be reasonable for communities to use social media technologies to alert lay rescuers with mobile phones about nearby OHCA cases.
• Naloxone and opioid addiction. Also new to the guidelines is the recommended use of naloxone for patients with suspected or known opioid addiction by appropriately trained lay rescuers or basic life support (BLS) providers.
• CPR training. The guidelines highlight several changes to simplify health care provider training in CPR. For example, trained rescuers can simultaneously perform some tasks to reduce the time to initiate chest compressions. Likewise, in a team of trained rescuers, multiple steps such as activating the emergency response system, chest compression, ventilation, and defibrillator retrieval can be accomplished simultaneously.
• High-quality CPR. Finally, the guidelines focus on emphasizing high-quality CPR with adequate compression rate and depth, complete chest recoil, few interruptions to compressions, and appropriate ventilation.
The guidelines offer several changes to advanced cardiac life support (ACLS). The algorithm was simplified by removing vasopressin, because the authors note that “the combined use of vasopressin and epinephrine offers no advantage to using standard-dose epinephrine in cardiac arrest.”
Likewise, the guidelines note conflicting studies to support the use of lidocaine after return of spontaneous circulation (ROSC). “However, the initiation or continuation of lidocaine may be considered immediately after ROSC from VF/pulseless ventricular tachycardia cardiac arrest,” the guideline authors wrote. Finally, the guidelines highlight updates in post–cardiac arrest care, including a wider range of target temperatures, between 32° C and 36° C, to be maintained for at least 24 hours in comatose adults with ROSC after cardiac arrest. In comparison, the 2010 guidelines called for a target temperature range of 32° C to 34° C for 12-24 hours. The guidelines also detail new updates for acute coronary syndrome, pediatric BLS, pediatric ACLS, and neonatal resuscitation.
As the AHA updates its CPR guidelines, it’s also important for lay rescuers and health providers to update their own training, noted Dr. Clifton Callaway, chair of the AHA’s Emergency Cardiovascular Care (ECC) committee.
“Research shows resuscitation skills can decline within a few months after training – far before the 2-year period in which basic and advanced life support skills are currently evaluated,” cautioned Dr. Callaway, professor of emergency medicine at the University of Pittsburgh. “Frequent training with shorter intervals of basic and advanced cardiovascular life support skills may be helpful for providers who are likely to encounter a cardiac arrest to ensure the patient receives high-quality CPR,” he added.
New guidelines on cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) set upper limits on chest compression rate and depth, add naloxone to the care of suspected opioid abusers, and remove vasopressin from the advanced cardiac life support (ACLS) algorithm.
The American Heart Association published its revised guidelines Oct. 15 in Circulation. The AHA released its previous guidelines in 2010.
“Everyone has a role to play in the chain of survival – from bystanders to dispatchers, emergency responders to health care providers,” Dr. Mark Creager said in a statement. “When everyone knows their role, knows CPR, and works together, we can dramatically improve cardiac arrest victims’ chances of survival,” said Dr. Creager, AHA president and director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H.
The 2015 guidelines’ new recommendations include the following:
• Resuscitation pathways. The guidelines note that the resuscitation pathways are very different for patients who experience cardiac arrest present in either a hospital setting (IHCA) or out-of-hospital setting (OHCA). In OHCA, the patient depends on lay rescuers to not only recognize the situation but also call for help, initiate CPR, and, if available, administer defibrillation until emergency medical personnel arrive. However, IHCA involves prevention of cardiac arrest and smooth delivery of care in a multidisciplinary setting.
• Layperson CPR. Untrained lay rescuers should provide compression-only CPR for OHCA. Trained lay rescuers who are able to provide rescue breaths should begin CPR with compressions followed by breaths at a ratio of 30 compressions to two breaths. Compression-only CPR is easier to perform for untrained lay rescuers, the guidelines note, and survival rates are similar using CPR with or without rescue breaths in adult cardiac arrest with a cardiac etiology.
• Compression rate and depth. The new guidelines set upper limits on chest compression depth and heart rate, recommending a compression rate of 100-120 compressions per minute with a depth of at least 2 inches, not to exceed 2.4 inches in adults.
• Social media dispatching. Despite limited evidence, the guideline authors said that it may be reasonable for communities to use social media technologies to alert lay rescuers with mobile phones about nearby OHCA cases.
• Naloxone and opioid addiction. Also new to the guidelines is the recommended use of naloxone for patients with suspected or known opioid addiction by appropriately trained lay rescuers or basic life support (BLS) providers.
• CPR training. The guidelines highlight several changes to simplify health care provider training in CPR. For example, trained rescuers can simultaneously perform some tasks to reduce the time to initiate chest compressions. Likewise, in a team of trained rescuers, multiple steps such as activating the emergency response system, chest compression, ventilation, and defibrillator retrieval can be accomplished simultaneously.
• High-quality CPR. Finally, the guidelines focus on emphasizing high-quality CPR with adequate compression rate and depth, complete chest recoil, few interruptions to compressions, and appropriate ventilation.
The guidelines offer several changes to advanced cardiac life support (ACLS). The algorithm was simplified by removing vasopressin, because the authors note that “the combined use of vasopressin and epinephrine offers no advantage to using standard-dose epinephrine in cardiac arrest.”
Likewise, the guidelines note conflicting studies to support the use of lidocaine after return of spontaneous circulation (ROSC). “However, the initiation or continuation of lidocaine may be considered immediately after ROSC from VF/pulseless ventricular tachycardia cardiac arrest,” the guideline authors wrote. Finally, the guidelines highlight updates in post–cardiac arrest care, including a wider range of target temperatures, between 32° C and 36° C, to be maintained for at least 24 hours in comatose adults with ROSC after cardiac arrest. In comparison, the 2010 guidelines called for a target temperature range of 32° C to 34° C for 12-24 hours. The guidelines also detail new updates for acute coronary syndrome, pediatric BLS, pediatric ACLS, and neonatal resuscitation.
As the AHA updates its CPR guidelines, it’s also important for lay rescuers and health providers to update their own training, noted Dr. Clifton Callaway, chair of the AHA’s Emergency Cardiovascular Care (ECC) committee.
“Research shows resuscitation skills can decline within a few months after training – far before the 2-year period in which basic and advanced life support skills are currently evaluated,” cautioned Dr. Callaway, professor of emergency medicine at the University of Pittsburgh. “Frequent training with shorter intervals of basic and advanced cardiovascular life support skills may be helpful for providers who are likely to encounter a cardiac arrest to ensure the patient receives high-quality CPR,” he added.
FROM CIRCULATION
Heart failure risk reduced with higher levels of physical activity
Physical activity reduces heart failure risk, and the more exertion, the stronger the effect, according to a meta-analysis published online Oct. 5 in Circulation.
“Walking 30 minutes a day as recommended in the U.S. physical activity guidelines, may not be good enough – significantly more physical activity may be necessary to reduce the risk of heart failure,” Dr. Jarett D. Berry, senior author of the study, said in a press release.
Although physical inactivity has been implicated as a contributing factor in cardiovascular disease and coronary heart disease, a comprehensive analysis of the literature on the relationship of physical activity and heart failure risk has not previously been conducted, said Dr. Berry of the University of Texas Southwest Medical School in Dallas, and his colleagues. They conducted a meta-analysis of prospective cohort studies on the relationship of physical activity and heart failure in participants 18 years or older. They presented results by category of physical activity, using a random effects model, and by quantity of metabolic equivalent (MET)-minimum per week.
Twelve cohort studies with 20,203 heart failure events and 370,460 study participants during an average follow-up of 13 years were included in the meta-analysis.
Heart failure risk was 30% lower in the highest category of physical activity versus the lowest level of physical activity in a pooled analysis of hazard ratios. That risk was also reduced by 22% and 15% in moderate and light categories of physical activity, compared with the lowest, respectively (Circulation. 2015 Oct 5. doi: 10.1161/circulationaha.115.015853). All differences were statistically significant.
Subgroup analysis showed similar correlations between high levels of physical activity and reduced heart failure risk even with different ages, sex, and geographic locations.
As measured quantitatively, participants who engaged in the minimal recommended level of physical activity (500 MET mins/week) had a 10% lower risk of heart failure, compared with no physical activity, a 19% lower risk with twice the recommended level of physical activity, and a 35% lower risk with four times the recommended level of physical activity), all statistically significant differences.
Dr. Berry continued in the press release, “If you look at the general population, we’ve had tremendous success in reducing coronary heart disease over the last 30 years. But heart failure rates have not declined enough. The findings from the present study suggest that higher levels of physical activity may help combat this growing burden of heart failure.”
The authors report no conflicts of interest. Dr. Berry received funding from the Dedman Family Scholar in Clinical Care endowment at the University of Texas Southwestern Medical Center from the American Heart Association prevention network.
Dr. Berry received funding from the Dedman Family Scholar in Clinical Care endowment at the University of Texas Southwestern Medical Center from the American Heart Association prevention network. The authors report no conflicts of interest.
Physical activity reduces heart failure risk, and the more exertion, the stronger the effect, according to a meta-analysis published online Oct. 5 in Circulation.
“Walking 30 minutes a day as recommended in the U.S. physical activity guidelines, may not be good enough – significantly more physical activity may be necessary to reduce the risk of heart failure,” Dr. Jarett D. Berry, senior author of the study, said in a press release.
Although physical inactivity has been implicated as a contributing factor in cardiovascular disease and coronary heart disease, a comprehensive analysis of the literature on the relationship of physical activity and heart failure risk has not previously been conducted, said Dr. Berry of the University of Texas Southwest Medical School in Dallas, and his colleagues. They conducted a meta-analysis of prospective cohort studies on the relationship of physical activity and heart failure in participants 18 years or older. They presented results by category of physical activity, using a random effects model, and by quantity of metabolic equivalent (MET)-minimum per week.
Twelve cohort studies with 20,203 heart failure events and 370,460 study participants during an average follow-up of 13 years were included in the meta-analysis.
Heart failure risk was 30% lower in the highest category of physical activity versus the lowest level of physical activity in a pooled analysis of hazard ratios. That risk was also reduced by 22% and 15% in moderate and light categories of physical activity, compared with the lowest, respectively (Circulation. 2015 Oct 5. doi: 10.1161/circulationaha.115.015853). All differences were statistically significant.
Subgroup analysis showed similar correlations between high levels of physical activity and reduced heart failure risk even with different ages, sex, and geographic locations.
As measured quantitatively, participants who engaged in the minimal recommended level of physical activity (500 MET mins/week) had a 10% lower risk of heart failure, compared with no physical activity, a 19% lower risk with twice the recommended level of physical activity, and a 35% lower risk with four times the recommended level of physical activity), all statistically significant differences.
Dr. Berry continued in the press release, “If you look at the general population, we’ve had tremendous success in reducing coronary heart disease over the last 30 years. But heart failure rates have not declined enough. The findings from the present study suggest that higher levels of physical activity may help combat this growing burden of heart failure.”
The authors report no conflicts of interest. Dr. Berry received funding from the Dedman Family Scholar in Clinical Care endowment at the University of Texas Southwestern Medical Center from the American Heart Association prevention network.
Dr. Berry received funding from the Dedman Family Scholar in Clinical Care endowment at the University of Texas Southwestern Medical Center from the American Heart Association prevention network. The authors report no conflicts of interest.
Physical activity reduces heart failure risk, and the more exertion, the stronger the effect, according to a meta-analysis published online Oct. 5 in Circulation.
“Walking 30 minutes a day as recommended in the U.S. physical activity guidelines, may not be good enough – significantly more physical activity may be necessary to reduce the risk of heart failure,” Dr. Jarett D. Berry, senior author of the study, said in a press release.
Although physical inactivity has been implicated as a contributing factor in cardiovascular disease and coronary heart disease, a comprehensive analysis of the literature on the relationship of physical activity and heart failure risk has not previously been conducted, said Dr. Berry of the University of Texas Southwest Medical School in Dallas, and his colleagues. They conducted a meta-analysis of prospective cohort studies on the relationship of physical activity and heart failure in participants 18 years or older. They presented results by category of physical activity, using a random effects model, and by quantity of metabolic equivalent (MET)-minimum per week.
Twelve cohort studies with 20,203 heart failure events and 370,460 study participants during an average follow-up of 13 years were included in the meta-analysis.
Heart failure risk was 30% lower in the highest category of physical activity versus the lowest level of physical activity in a pooled analysis of hazard ratios. That risk was also reduced by 22% and 15% in moderate and light categories of physical activity, compared with the lowest, respectively (Circulation. 2015 Oct 5. doi: 10.1161/circulationaha.115.015853). All differences were statistically significant.
Subgroup analysis showed similar correlations between high levels of physical activity and reduced heart failure risk even with different ages, sex, and geographic locations.
As measured quantitatively, participants who engaged in the minimal recommended level of physical activity (500 MET mins/week) had a 10% lower risk of heart failure, compared with no physical activity, a 19% lower risk with twice the recommended level of physical activity, and a 35% lower risk with four times the recommended level of physical activity), all statistically significant differences.
Dr. Berry continued in the press release, “If you look at the general population, we’ve had tremendous success in reducing coronary heart disease over the last 30 years. But heart failure rates have not declined enough. The findings from the present study suggest that higher levels of physical activity may help combat this growing burden of heart failure.”
The authors report no conflicts of interest. Dr. Berry received funding from the Dedman Family Scholar in Clinical Care endowment at the University of Texas Southwestern Medical Center from the American Heart Association prevention network.
Dr. Berry received funding from the Dedman Family Scholar in Clinical Care endowment at the University of Texas Southwestern Medical Center from the American Heart Association prevention network. The authors report no conflicts of interest.
FROM CIRCULATION
Key clinical point: Heart failure risk and physical activity have an inverse, dose-response relationship.
Major finding: Participants who engaged in the minimal recommended level of physical activity had a 10% lower risk of heart failure, compared with no physical activity, a 19% lower risk with two times that level, and 35% lower risk with four times the level.
Data source: A meta-analysis of prospective cohort studies on the relationship of physical activity and heart failure in participants 18 years or older.
Disclosures: Dr. Berry received funding from the Dedman Family Scholar in Clinical Care endowment at the University of Texas Southwestern Medical Center from the American Heart Association prevention network. The authors report no conflicts of interest.
Improvements seen in adolescent psoriasis with ustekinumab
The CADMUS trial showed improvements in moderate to severe psoriasis in adolescent patients 12 years or older treated with ustekinumab, a study showed.
Treatment of psoriasis in pediatric patients is complicated by the limited number of approved treatments, despite approximately one-third of patients developing psoriasis before the age of 20 years. A human monoclonal antibody that targets the p40 subunit of interleukin-12/23, known as ustekinumab, was found to be effective and safe in moderate to severe psoriasis in adults.
Dr. Ian Landells of Memorial University of Newfoundland in St. John’s and his colleagues presented the results of the CADMUS trial, a randomized phase III trial of ustekinumab for active psoriasis in patients aged 12-17 years (J Am Acad Dermatol. 2015;73:594-603).
Patients aged 12-17 years with moderate to severe plaque psoriasis as defined by a Physician’s Global Assessment (PGA) score of greater than or equal to 3, a Psoriasis Area and Severity Index (PASI) of greater than or equal to 12, or 10% or more of body surface area involved for at least 6 months were included in the study.
The investigators conducted a multicenter, double-blind placebo-controlled trial with patients randomly assigned to weight-based standard dosing (SD) or weight-based half-standard dosing (HSD) at weeks 0, 4, and 16, then every 12 weeks until week 40. Conversely, participants could receive placebo at weeks 0 and 4 with crossover at week 12 and 16, then every 12 weeks until week 40 with either SD or HSD. Early escape to topical steroids at week 8 to week 12 for patients with a PASI increase to more than 50% above baseline was considered.
The primary endpoint of the study was the proportion of patients who achieved a PGA 0/1 by week 12. Secondary endpoints included the proportion of patients with 75% improvement by PASI (PASI 75) and 90% improvement by PASI (PASI 90) at 12 weeks, and change in the Children’s Dermatology Life Quality Index (CDLQI) at 12 weeks.
Between March 2010 and January 2014, 110 patients were included in the study: 36 randomly assigned to weight-based SD ustekinumab, 37 to weight-based HSD, and 37 to placebo, with 18 participants crossing over to SD and 19 participants crossing over to HSD. One participant each from the HSD and SD achieved early escape at 8 weeks. A total of nine participants (8%) discontinued the study because of adverse events (n = 3), death in an automobile accident (n = 1), or an unsatisfactory response (n = 5).
After 12 weeks, there were significantly more participants receiving either SD (69%) or HSD (68%) achieving a PGA of 0/1 vs. placebo (5%, P less than .001 for both doses). About one-third of the treatment participants achieved a PGA of 0/1 by week 4. Likewise, in the treatment group, significantly more participants achieved a PGA of 0 by week 12 (SD, 47%; HSD, 32%; placebo, 3%; P less than .001 for both doses).
When treatment response by PASI was assessed, a PASI 75 and PASI 90 were achieved significantly more often in the treatment groups (P less than .001 for both) than among controls. A PASI score of 0 (cleared) was achieved in 39% of the SD group and 22% of the HSD group vs. 3% with placebo (P less than .001 and P = .014, respectively).
Participants treated with ustekinumab demonstrated improvements in quality of life that were maintained at 52 weeks.
At week 12, 44% of the SD group, 51% of the HSD group, and 57% of the placebo group reported one or more adverse events. At the conclusion of the study at week 60, 82% of the participants had reported adverse events. Most of the adverse events were under the category of infections and infestations, which the authors noted were consistent with those observed in adults treated with ustekinumab.
Dr. Landells and his colleagues wrote, “Patients in both the HSD and SD ustekinumab groups experienced robust and clinically meaningful improvements in disease activity.”
The study was funded by Janssen Research and Development. The authors reported multiple financial disclosures.
The CADMUS trial showed improvements in moderate to severe psoriasis in adolescent patients 12 years or older treated with ustekinumab, a study showed.
Treatment of psoriasis in pediatric patients is complicated by the limited number of approved treatments, despite approximately one-third of patients developing psoriasis before the age of 20 years. A human monoclonal antibody that targets the p40 subunit of interleukin-12/23, known as ustekinumab, was found to be effective and safe in moderate to severe psoriasis in adults.
Dr. Ian Landells of Memorial University of Newfoundland in St. John’s and his colleagues presented the results of the CADMUS trial, a randomized phase III trial of ustekinumab for active psoriasis in patients aged 12-17 years (J Am Acad Dermatol. 2015;73:594-603).
Patients aged 12-17 years with moderate to severe plaque psoriasis as defined by a Physician’s Global Assessment (PGA) score of greater than or equal to 3, a Psoriasis Area and Severity Index (PASI) of greater than or equal to 12, or 10% or more of body surface area involved for at least 6 months were included in the study.
The investigators conducted a multicenter, double-blind placebo-controlled trial with patients randomly assigned to weight-based standard dosing (SD) or weight-based half-standard dosing (HSD) at weeks 0, 4, and 16, then every 12 weeks until week 40. Conversely, participants could receive placebo at weeks 0 and 4 with crossover at week 12 and 16, then every 12 weeks until week 40 with either SD or HSD. Early escape to topical steroids at week 8 to week 12 for patients with a PASI increase to more than 50% above baseline was considered.
The primary endpoint of the study was the proportion of patients who achieved a PGA 0/1 by week 12. Secondary endpoints included the proportion of patients with 75% improvement by PASI (PASI 75) and 90% improvement by PASI (PASI 90) at 12 weeks, and change in the Children’s Dermatology Life Quality Index (CDLQI) at 12 weeks.
Between March 2010 and January 2014, 110 patients were included in the study: 36 randomly assigned to weight-based SD ustekinumab, 37 to weight-based HSD, and 37 to placebo, with 18 participants crossing over to SD and 19 participants crossing over to HSD. One participant each from the HSD and SD achieved early escape at 8 weeks. A total of nine participants (8%) discontinued the study because of adverse events (n = 3), death in an automobile accident (n = 1), or an unsatisfactory response (n = 5).
After 12 weeks, there were significantly more participants receiving either SD (69%) or HSD (68%) achieving a PGA of 0/1 vs. placebo (5%, P less than .001 for both doses). About one-third of the treatment participants achieved a PGA of 0/1 by week 4. Likewise, in the treatment group, significantly more participants achieved a PGA of 0 by week 12 (SD, 47%; HSD, 32%; placebo, 3%; P less than .001 for both doses).
When treatment response by PASI was assessed, a PASI 75 and PASI 90 were achieved significantly more often in the treatment groups (P less than .001 for both) than among controls. A PASI score of 0 (cleared) was achieved in 39% of the SD group and 22% of the HSD group vs. 3% with placebo (P less than .001 and P = .014, respectively).
Participants treated with ustekinumab demonstrated improvements in quality of life that were maintained at 52 weeks.
At week 12, 44% of the SD group, 51% of the HSD group, and 57% of the placebo group reported one or more adverse events. At the conclusion of the study at week 60, 82% of the participants had reported adverse events. Most of the adverse events were under the category of infections and infestations, which the authors noted were consistent with those observed in adults treated with ustekinumab.
Dr. Landells and his colleagues wrote, “Patients in both the HSD and SD ustekinumab groups experienced robust and clinically meaningful improvements in disease activity.”
The study was funded by Janssen Research and Development. The authors reported multiple financial disclosures.
The CADMUS trial showed improvements in moderate to severe psoriasis in adolescent patients 12 years or older treated with ustekinumab, a study showed.
Treatment of psoriasis in pediatric patients is complicated by the limited number of approved treatments, despite approximately one-third of patients developing psoriasis before the age of 20 years. A human monoclonal antibody that targets the p40 subunit of interleukin-12/23, known as ustekinumab, was found to be effective and safe in moderate to severe psoriasis in adults.
Dr. Ian Landells of Memorial University of Newfoundland in St. John’s and his colleagues presented the results of the CADMUS trial, a randomized phase III trial of ustekinumab for active psoriasis in patients aged 12-17 years (J Am Acad Dermatol. 2015;73:594-603).
Patients aged 12-17 years with moderate to severe plaque psoriasis as defined by a Physician’s Global Assessment (PGA) score of greater than or equal to 3, a Psoriasis Area and Severity Index (PASI) of greater than or equal to 12, or 10% or more of body surface area involved for at least 6 months were included in the study.
The investigators conducted a multicenter, double-blind placebo-controlled trial with patients randomly assigned to weight-based standard dosing (SD) or weight-based half-standard dosing (HSD) at weeks 0, 4, and 16, then every 12 weeks until week 40. Conversely, participants could receive placebo at weeks 0 and 4 with crossover at week 12 and 16, then every 12 weeks until week 40 with either SD or HSD. Early escape to topical steroids at week 8 to week 12 for patients with a PASI increase to more than 50% above baseline was considered.
The primary endpoint of the study was the proportion of patients who achieved a PGA 0/1 by week 12. Secondary endpoints included the proportion of patients with 75% improvement by PASI (PASI 75) and 90% improvement by PASI (PASI 90) at 12 weeks, and change in the Children’s Dermatology Life Quality Index (CDLQI) at 12 weeks.
Between March 2010 and January 2014, 110 patients were included in the study: 36 randomly assigned to weight-based SD ustekinumab, 37 to weight-based HSD, and 37 to placebo, with 18 participants crossing over to SD and 19 participants crossing over to HSD. One participant each from the HSD and SD achieved early escape at 8 weeks. A total of nine participants (8%) discontinued the study because of adverse events (n = 3), death in an automobile accident (n = 1), or an unsatisfactory response (n = 5).
After 12 weeks, there were significantly more participants receiving either SD (69%) or HSD (68%) achieving a PGA of 0/1 vs. placebo (5%, P less than .001 for both doses). About one-third of the treatment participants achieved a PGA of 0/1 by week 4. Likewise, in the treatment group, significantly more participants achieved a PGA of 0 by week 12 (SD, 47%; HSD, 32%; placebo, 3%; P less than .001 for both doses).
When treatment response by PASI was assessed, a PASI 75 and PASI 90 were achieved significantly more often in the treatment groups (P less than .001 for both) than among controls. A PASI score of 0 (cleared) was achieved in 39% of the SD group and 22% of the HSD group vs. 3% with placebo (P less than .001 and P = .014, respectively).
Participants treated with ustekinumab demonstrated improvements in quality of life that were maintained at 52 weeks.
At week 12, 44% of the SD group, 51% of the HSD group, and 57% of the placebo group reported one or more adverse events. At the conclusion of the study at week 60, 82% of the participants had reported adverse events. Most of the adverse events were under the category of infections and infestations, which the authors noted were consistent with those observed in adults treated with ustekinumab.
Dr. Landells and his colleagues wrote, “Patients in both the HSD and SD ustekinumab groups experienced robust and clinically meaningful improvements in disease activity.”
The study was funded by Janssen Research and Development. The authors reported multiple financial disclosures.
FROM JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Key clinical point: The CADMUS trial showed improvements in moderate to severe psoriasis in adolescent patients treated with ustekinumab.
Major finding: There were significantly more participants treated with weight-based standard-dose (69%) or half-standard-dose (68%) ustekinumab who achieved a PGA of 0/1 vs. placebo (5%) at 12 weeks.
Data source: A multicenter, double-blind placebo-controlled trial with patients randomly assigned to standard dosing or half-standard dosing based on weight or placebo with crossover.
Disclosures: The study was funded by Janssen Research and Development. The authors reported multiple financial disclosures.
Topical Fluorouracil Shows Long-term Benefit for Actinic Keratoses
One course of topical fluorouracil cream reduced the need for localized treatments and the number of actinic keratoses (AK) over a mean follow-up of 2.6 years in the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial.
These results “indicate that treating a patient with a single course of fluorouracil would reduce the subsequent number of spot treatments and benefit care of patients with multiple AKs for longer than 2 years,” concluded Dr. Hyemin Pomerantz of the department of dermatoepidemiology at the Providence (R.I.) VA Medical Center and his coauthors. Previous studies on treating AKs with topical fluorouracil have followed up participants for less than 6 months, they pointed out (JAMA Dermatol. 2015;9:952-60).
In the randomized, double-blinded, placebo-controlled study, conducted from 2009 to 2011 at 12 VA dermatology clinics, participants received topical fluorouracil cream, 5%, or a vehicle control cream, applied twice a day for 4 weeks, and were followed up for a mean of 2.6 years. There were no significant differences in the baseline characteristics of the 468 participants randomized to receive fluorouracil cream and the 464 participants randomized to receive the control cream.
The mean total AK count on the face and ears in both groups was about 11. At 6 months, the mean number of AKs per participant had dropped to 3 in the fluorouracil group (a 73% reduction from baseline) vs. a mean of 8.1 in the control group, a 24% reduction from baseline (P less than .001). Over the study period, those treated with fluorouracil had significantly fewer AKs. Over the entire study, there was not a significant difference in the number of hypertrophic AKs between the two groups, although the number of hypertrophic AKs was lower in the treatment group at 6 months.
During the study period, more participants treated with fluorouracil had complete clearance of AKs on the face and ears, compared with the control group (P less than .001). Finally, the fluorouracil group required 2 spot treatments per visit per participant vs. 3.9 in the control group (P less than .001).
“Our findings highlight the long-term efficacy of topical fluorouracil cream in treating and preventing AKs. A single course of topical fluorouracil cream, 5%, treatment led to a sustained reduction of the number of AKs and subsequent AK treatments,” in the population of patients at high risk for basal cell and squamous cell carcinomas, the authors wrote.
The study was supported by the Office of Research and Development Cooperative Studies Program at the Department of Veterans Affairs. Three of the authors reported several disclosures, including serving as a consultant to several pharmaceutical companies; the others, including the lead author, had no disclosures.
One course of topical fluorouracil cream reduced the need for localized treatments and the number of actinic keratoses (AK) over a mean follow-up of 2.6 years in the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial.
These results “indicate that treating a patient with a single course of fluorouracil would reduce the subsequent number of spot treatments and benefit care of patients with multiple AKs for longer than 2 years,” concluded Dr. Hyemin Pomerantz of the department of dermatoepidemiology at the Providence (R.I.) VA Medical Center and his coauthors. Previous studies on treating AKs with topical fluorouracil have followed up participants for less than 6 months, they pointed out (JAMA Dermatol. 2015;9:952-60).
In the randomized, double-blinded, placebo-controlled study, conducted from 2009 to 2011 at 12 VA dermatology clinics, participants received topical fluorouracil cream, 5%, or a vehicle control cream, applied twice a day for 4 weeks, and were followed up for a mean of 2.6 years. There were no significant differences in the baseline characteristics of the 468 participants randomized to receive fluorouracil cream and the 464 participants randomized to receive the control cream.
The mean total AK count on the face and ears in both groups was about 11. At 6 months, the mean number of AKs per participant had dropped to 3 in the fluorouracil group (a 73% reduction from baseline) vs. a mean of 8.1 in the control group, a 24% reduction from baseline (P less than .001). Over the study period, those treated with fluorouracil had significantly fewer AKs. Over the entire study, there was not a significant difference in the number of hypertrophic AKs between the two groups, although the number of hypertrophic AKs was lower in the treatment group at 6 months.
During the study period, more participants treated with fluorouracil had complete clearance of AKs on the face and ears, compared with the control group (P less than .001). Finally, the fluorouracil group required 2 spot treatments per visit per participant vs. 3.9 in the control group (P less than .001).
“Our findings highlight the long-term efficacy of topical fluorouracil cream in treating and preventing AKs. A single course of topical fluorouracil cream, 5%, treatment led to a sustained reduction of the number of AKs and subsequent AK treatments,” in the population of patients at high risk for basal cell and squamous cell carcinomas, the authors wrote.
The study was supported by the Office of Research and Development Cooperative Studies Program at the Department of Veterans Affairs. Three of the authors reported several disclosures, including serving as a consultant to several pharmaceutical companies; the others, including the lead author, had no disclosures.
One course of topical fluorouracil cream reduced the need for localized treatments and the number of actinic keratoses (AK) over a mean follow-up of 2.6 years in the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial.
These results “indicate that treating a patient with a single course of fluorouracil would reduce the subsequent number of spot treatments and benefit care of patients with multiple AKs for longer than 2 years,” concluded Dr. Hyemin Pomerantz of the department of dermatoepidemiology at the Providence (R.I.) VA Medical Center and his coauthors. Previous studies on treating AKs with topical fluorouracil have followed up participants for less than 6 months, they pointed out (JAMA Dermatol. 2015;9:952-60).
In the randomized, double-blinded, placebo-controlled study, conducted from 2009 to 2011 at 12 VA dermatology clinics, participants received topical fluorouracil cream, 5%, or a vehicle control cream, applied twice a day for 4 weeks, and were followed up for a mean of 2.6 years. There were no significant differences in the baseline characteristics of the 468 participants randomized to receive fluorouracil cream and the 464 participants randomized to receive the control cream.
The mean total AK count on the face and ears in both groups was about 11. At 6 months, the mean number of AKs per participant had dropped to 3 in the fluorouracil group (a 73% reduction from baseline) vs. a mean of 8.1 in the control group, a 24% reduction from baseline (P less than .001). Over the study period, those treated with fluorouracil had significantly fewer AKs. Over the entire study, there was not a significant difference in the number of hypertrophic AKs between the two groups, although the number of hypertrophic AKs was lower in the treatment group at 6 months.
During the study period, more participants treated with fluorouracil had complete clearance of AKs on the face and ears, compared with the control group (P less than .001). Finally, the fluorouracil group required 2 spot treatments per visit per participant vs. 3.9 in the control group (P less than .001).
“Our findings highlight the long-term efficacy of topical fluorouracil cream in treating and preventing AKs. A single course of topical fluorouracil cream, 5%, treatment led to a sustained reduction of the number of AKs and subsequent AK treatments,” in the population of patients at high risk for basal cell and squamous cell carcinomas, the authors wrote.
The study was supported by the Office of Research and Development Cooperative Studies Program at the Department of Veterans Affairs. Three of the authors reported several disclosures, including serving as a consultant to several pharmaceutical companies; the others, including the lead author, had no disclosures.
FROM JAMA DERMATOLOGY
Topical Fluorouracil Shows Long-term Benefit for Actinic Keratoses
One course of topical fluorouracil cream reduced the need for localized treatments and the number of actinic keratoses (AK) over a mean follow-up of 2.6 years in the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial.
These results “indicate that treating a patient with a single course of fluorouracil would reduce the subsequent number of spot treatments and benefit care of patients with multiple AKs for longer than 2 years,” concluded Dr. Hyemin Pomerantz of the department of dermatoepidemiology at the Providence (R.I.) VA Medical Center and his coauthors. Previous studies on treating AKs with topical fluorouracil have followed up participants for less than 6 months, they pointed out (JAMA Dermatol. 2015;9:952-60).
In the randomized, double-blinded, placebo-controlled study, conducted from 2009 to 2011 at 12 VA dermatology clinics, participants received topical fluorouracil cream, 5%, or a vehicle control cream, applied twice a day for 4 weeks, and were followed up for a mean of 2.6 years. There were no significant differences in the baseline characteristics of the 468 participants randomized to receive fluorouracil cream and the 464 participants randomized to receive the control cream.
The mean total AK count on the face and ears in both groups was about 11. At 6 months, the mean number of AKs per participant had dropped to 3 in the fluorouracil group (a 73% reduction from baseline) vs. a mean of 8.1 in the control group, a 24% reduction from baseline (P less than .001). Over the study period, those treated with fluorouracil had significantly fewer AKs. Over the entire study, there was not a significant difference in the number of hypertrophic AKs between the two groups, although the number of hypertrophic AKs was lower in the treatment group at 6 months.
During the study period, more participants treated with fluorouracil had complete clearance of AKs on the face and ears, compared with the control group (P less than .001). Finally, the fluorouracil group required 2 spot treatments per visit per participant vs. 3.9 in the control group (P less than .001).
“Our findings highlight the long-term efficacy of topical fluorouracil cream in treating and preventing AKs. A single course of topical fluorouracil cream, 5%, treatment led to a sustained reduction of the number of AKs and subsequent AK treatments,” in the population of patients at high risk for basal cell and squamous cell carcinomas, the authors wrote.
The study was supported by the Office of Research and Development Cooperative Studies Program at the Department of Veterans Affairs. Three of the authors reported several disclosures, including serving as a consultant to several pharmaceutical companies; the others, including the lead author, had no disclosures.
One course of topical fluorouracil cream reduced the need for localized treatments and the number of actinic keratoses (AK) over a mean follow-up of 2.6 years in the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial.
These results “indicate that treating a patient with a single course of fluorouracil would reduce the subsequent number of spot treatments and benefit care of patients with multiple AKs for longer than 2 years,” concluded Dr. Hyemin Pomerantz of the department of dermatoepidemiology at the Providence (R.I.) VA Medical Center and his coauthors. Previous studies on treating AKs with topical fluorouracil have followed up participants for less than 6 months, they pointed out (JAMA Dermatol. 2015;9:952-60).
In the randomized, double-blinded, placebo-controlled study, conducted from 2009 to 2011 at 12 VA dermatology clinics, participants received topical fluorouracil cream, 5%, or a vehicle control cream, applied twice a day for 4 weeks, and were followed up for a mean of 2.6 years. There were no significant differences in the baseline characteristics of the 468 participants randomized to receive fluorouracil cream and the 464 participants randomized to receive the control cream.
The mean total AK count on the face and ears in both groups was about 11. At 6 months, the mean number of AKs per participant had dropped to 3 in the fluorouracil group (a 73% reduction from baseline) vs. a mean of 8.1 in the control group, a 24% reduction from baseline (P less than .001). Over the study period, those treated with fluorouracil had significantly fewer AKs. Over the entire study, there was not a significant difference in the number of hypertrophic AKs between the two groups, although the number of hypertrophic AKs was lower in the treatment group at 6 months.
During the study period, more participants treated with fluorouracil had complete clearance of AKs on the face and ears, compared with the control group (P less than .001). Finally, the fluorouracil group required 2 spot treatments per visit per participant vs. 3.9 in the control group (P less than .001).
“Our findings highlight the long-term efficacy of topical fluorouracil cream in treating and preventing AKs. A single course of topical fluorouracil cream, 5%, treatment led to a sustained reduction of the number of AKs and subsequent AK treatments,” in the population of patients at high risk for basal cell and squamous cell carcinomas, the authors wrote.
The study was supported by the Office of Research and Development Cooperative Studies Program at the Department of Veterans Affairs. Three of the authors reported several disclosures, including serving as a consultant to several pharmaceutical companies; the others, including the lead author, had no disclosures.
One course of topical fluorouracil cream reduced the need for localized treatments and the number of actinic keratoses (AK) over a mean follow-up of 2.6 years in the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) trial.
These results “indicate that treating a patient with a single course of fluorouracil would reduce the subsequent number of spot treatments and benefit care of patients with multiple AKs for longer than 2 years,” concluded Dr. Hyemin Pomerantz of the department of dermatoepidemiology at the Providence (R.I.) VA Medical Center and his coauthors. Previous studies on treating AKs with topical fluorouracil have followed up participants for less than 6 months, they pointed out (JAMA Dermatol. 2015;9:952-60).
In the randomized, double-blinded, placebo-controlled study, conducted from 2009 to 2011 at 12 VA dermatology clinics, participants received topical fluorouracil cream, 5%, or a vehicle control cream, applied twice a day for 4 weeks, and were followed up for a mean of 2.6 years. There were no significant differences in the baseline characteristics of the 468 participants randomized to receive fluorouracil cream and the 464 participants randomized to receive the control cream.
The mean total AK count on the face and ears in both groups was about 11. At 6 months, the mean number of AKs per participant had dropped to 3 in the fluorouracil group (a 73% reduction from baseline) vs. a mean of 8.1 in the control group, a 24% reduction from baseline (P less than .001). Over the study period, those treated with fluorouracil had significantly fewer AKs. Over the entire study, there was not a significant difference in the number of hypertrophic AKs between the two groups, although the number of hypertrophic AKs was lower in the treatment group at 6 months.
During the study period, more participants treated with fluorouracil had complete clearance of AKs on the face and ears, compared with the control group (P less than .001). Finally, the fluorouracil group required 2 spot treatments per visit per participant vs. 3.9 in the control group (P less than .001).
“Our findings highlight the long-term efficacy of topical fluorouracil cream in treating and preventing AKs. A single course of topical fluorouracil cream, 5%, treatment led to a sustained reduction of the number of AKs and subsequent AK treatments,” in the population of patients at high risk for basal cell and squamous cell carcinomas, the authors wrote.
The study was supported by the Office of Research and Development Cooperative Studies Program at the Department of Veterans Affairs. Three of the authors reported several disclosures, including serving as a consultant to several pharmaceutical companies; the others, including the lead author, had no disclosures.
FROM JAMA DERMATOLOGY
Small number of pregnant women report binge drinking
About 3% of pregnant women report binge drinking, according to data published in the Sept. 25 edition of the Morbidity and Mortality Weekly Report.
Cheryl H. Tan of the Centers for Disease Control and Prevention, Atlanta, and her colleagues analyzed data from the 2011-2013 Behavior Risk Factor Surveillance System (BRFSS) to understand the prevalence of binge drinking and any alcohol use in nonpregnant and pregnant women aged 18-44 years. The BRFSS is a telephone survey conducted with random-digit dialing to collect data on risk behaviors. The researchers analyzed data from 206,481 women, 8,383 of whom were pregnant at the time of the survey (MMWR. 2015;64[37]1042-6).
During the study period, there was a 10.2% prevalence of any alcohol use in pregnant women and a 3.1% prevalence of binge drinking (four or more drinks on one occasion, at least once in 30 days).
A higher prevalence of any alcohol consumption was reported in pregnant women aged 35-44 years (18.6%), those with a college degree (13%), and unmarried women (12.9%). Unmarried pregnant women had a prevalence of binge drinking 4.6 times the prevalence among married pregnant women.
Pregnant women who said they engaged in binge drinking reported more binge drinking episodes than did nonpregnant women (average of 4.6 episodes vs. 3.1; P = 0.044), despite an overall higher prevalence of binge drinking in nonpregnant women.
“One possible explanation for this might be that women who binge drink during pregnancy are more likely to be alcohol-dependent than the average female binge drinker, and therefore binge drink more frequently,” the researchers wrote.
Among the nonpregnant survey respondents, the prevalence of binge drinking was 18.2%, with 53.6% reporting any alcohol use. Nonpregnant women aged 18-20 years who reported binge drinking had the highest intensity with 7.1 drinks and the highest frequency with 3.9 episodes of binge drinking.
The authors noted several limitations of the study, including possible underreporting of pregnancy status because of unknown pregnancy, underreporting of alcohol use in self-reported surveys, and possible selection bias based on a response rate of less than 50%. Also, the method of collecting data for the BRFSS was changed in 2011, which limited the ability to compare the current data with earlier data.
“Healthcare professionals can support these efforts by implementing alcohol screening and brief interventions in their primary care practices, and informing women that there is no known safe level of alcohol consumption when they are pregnant or might be pregnant,” the researchers wrote.
About 3% of pregnant women report binge drinking, according to data published in the Sept. 25 edition of the Morbidity and Mortality Weekly Report.
Cheryl H. Tan of the Centers for Disease Control and Prevention, Atlanta, and her colleagues analyzed data from the 2011-2013 Behavior Risk Factor Surveillance System (BRFSS) to understand the prevalence of binge drinking and any alcohol use in nonpregnant and pregnant women aged 18-44 years. The BRFSS is a telephone survey conducted with random-digit dialing to collect data on risk behaviors. The researchers analyzed data from 206,481 women, 8,383 of whom were pregnant at the time of the survey (MMWR. 2015;64[37]1042-6).
During the study period, there was a 10.2% prevalence of any alcohol use in pregnant women and a 3.1% prevalence of binge drinking (four or more drinks on one occasion, at least once in 30 days).
A higher prevalence of any alcohol consumption was reported in pregnant women aged 35-44 years (18.6%), those with a college degree (13%), and unmarried women (12.9%). Unmarried pregnant women had a prevalence of binge drinking 4.6 times the prevalence among married pregnant women.
Pregnant women who said they engaged in binge drinking reported more binge drinking episodes than did nonpregnant women (average of 4.6 episodes vs. 3.1; P = 0.044), despite an overall higher prevalence of binge drinking in nonpregnant women.
“One possible explanation for this might be that women who binge drink during pregnancy are more likely to be alcohol-dependent than the average female binge drinker, and therefore binge drink more frequently,” the researchers wrote.
Among the nonpregnant survey respondents, the prevalence of binge drinking was 18.2%, with 53.6% reporting any alcohol use. Nonpregnant women aged 18-20 years who reported binge drinking had the highest intensity with 7.1 drinks and the highest frequency with 3.9 episodes of binge drinking.
The authors noted several limitations of the study, including possible underreporting of pregnancy status because of unknown pregnancy, underreporting of alcohol use in self-reported surveys, and possible selection bias based on a response rate of less than 50%. Also, the method of collecting data for the BRFSS was changed in 2011, which limited the ability to compare the current data with earlier data.
“Healthcare professionals can support these efforts by implementing alcohol screening and brief interventions in their primary care practices, and informing women that there is no known safe level of alcohol consumption when they are pregnant or might be pregnant,” the researchers wrote.
About 3% of pregnant women report binge drinking, according to data published in the Sept. 25 edition of the Morbidity and Mortality Weekly Report.
Cheryl H. Tan of the Centers for Disease Control and Prevention, Atlanta, and her colleagues analyzed data from the 2011-2013 Behavior Risk Factor Surveillance System (BRFSS) to understand the prevalence of binge drinking and any alcohol use in nonpregnant and pregnant women aged 18-44 years. The BRFSS is a telephone survey conducted with random-digit dialing to collect data on risk behaviors. The researchers analyzed data from 206,481 women, 8,383 of whom were pregnant at the time of the survey (MMWR. 2015;64[37]1042-6).
During the study period, there was a 10.2% prevalence of any alcohol use in pregnant women and a 3.1% prevalence of binge drinking (four or more drinks on one occasion, at least once in 30 days).
A higher prevalence of any alcohol consumption was reported in pregnant women aged 35-44 years (18.6%), those with a college degree (13%), and unmarried women (12.9%). Unmarried pregnant women had a prevalence of binge drinking 4.6 times the prevalence among married pregnant women.
Pregnant women who said they engaged in binge drinking reported more binge drinking episodes than did nonpregnant women (average of 4.6 episodes vs. 3.1; P = 0.044), despite an overall higher prevalence of binge drinking in nonpregnant women.
“One possible explanation for this might be that women who binge drink during pregnancy are more likely to be alcohol-dependent than the average female binge drinker, and therefore binge drink more frequently,” the researchers wrote.
Among the nonpregnant survey respondents, the prevalence of binge drinking was 18.2%, with 53.6% reporting any alcohol use. Nonpregnant women aged 18-20 years who reported binge drinking had the highest intensity with 7.1 drinks and the highest frequency with 3.9 episodes of binge drinking.
The authors noted several limitations of the study, including possible underreporting of pregnancy status because of unknown pregnancy, underreporting of alcohol use in self-reported surveys, and possible selection bias based on a response rate of less than 50%. Also, the method of collecting data for the BRFSS was changed in 2011, which limited the ability to compare the current data with earlier data.
“Healthcare professionals can support these efforts by implementing alcohol screening and brief interventions in their primary care practices, and informing women that there is no known safe level of alcohol consumption when they are pregnant or might be pregnant,” the researchers wrote.
FROM MMWR
Team care recommended for pregnant women with genetic conditions
The American College of Obstetricians and Gynecologists is calling on ob.gyns. to work with a multidisciplinary team when managing pregnancy in women with genetic conditions.
“Preconception, prenatal, and postpartum management of women with genetic conditions can be complex, but a multidisciplinary approach to patient care can lead to optimal outcomes for both mother and baby,” Dr. Joseph R. Biggio Jr., chair of ACOG’s Committee on Genetics, said in a statement.
In its first-ever guidance on genetic conditions in pregnancy, the ACOG Committee on Genetics outlined the key features of certain maternal genetic conditions, including cystic fibrosis, Marfan syndrome, neurofibromatosis type 1, tuberous sclerosis, autosomal dominant polycystic kidney disease, classic phenylketonuria, Noonan syndrome, and myotonic dystrophy type 1 (Obstet Gynecol. 2015;126:e49-51.).
Women with genetic conditions, and those at risk for genetic conditions, should have a preconception evaluation with a multidisciplinary team of caregivers that includes a genetic specialist, an obstetrician, and a maternal-fetal medicine specialist, according to the new recommendations. This evaluation aids in the development of a care plan and is also an opportunity to discuss risks to the mother and the neonate, partner carrier screening, and options for prenatal or preimplantation genetic diagnosis.
Depending on the genetic condition, the preconception care plan may include surgical or medical management prior to or during pregnancy. In other cases, the risk of mortality or morbidity is significantly elevated, and discussion of pregnancy avoidance may be considered.
Whether to discontinue medications with potentially teratogenic effects should involve a “thorough discussion with the appropriate members of the multidisciplinary team to review the risks, benefits, and therapeutic alternatives,” the ACOG committee members wrote.
Once pregnant, a woman with a genetic condition should have an initial prenatal examination early in the first trimester to evaluate pregnancy risks, and for testing and screening, according to ACOG. Further, these patients may require specialist referral at some point during the pregnancy. Finally, certain genetic conditions may place women at risk for potential complications requiring specialized monitoring, assisted delivery, and ongoing postpartum evaluations.
“Given the rarity and complexity of some genetic conditions in pregnancy and their evolving management strategies, a coordinated, multidisciplinary approach to care may provide the best opportunity to improve maternal and fetal outcomes,” the committee members wrote.
The American College of Obstetricians and Gynecologists is calling on ob.gyns. to work with a multidisciplinary team when managing pregnancy in women with genetic conditions.
“Preconception, prenatal, and postpartum management of women with genetic conditions can be complex, but a multidisciplinary approach to patient care can lead to optimal outcomes for both mother and baby,” Dr. Joseph R. Biggio Jr., chair of ACOG’s Committee on Genetics, said in a statement.
In its first-ever guidance on genetic conditions in pregnancy, the ACOG Committee on Genetics outlined the key features of certain maternal genetic conditions, including cystic fibrosis, Marfan syndrome, neurofibromatosis type 1, tuberous sclerosis, autosomal dominant polycystic kidney disease, classic phenylketonuria, Noonan syndrome, and myotonic dystrophy type 1 (Obstet Gynecol. 2015;126:e49-51.).
Women with genetic conditions, and those at risk for genetic conditions, should have a preconception evaluation with a multidisciplinary team of caregivers that includes a genetic specialist, an obstetrician, and a maternal-fetal medicine specialist, according to the new recommendations. This evaluation aids in the development of a care plan and is also an opportunity to discuss risks to the mother and the neonate, partner carrier screening, and options for prenatal or preimplantation genetic diagnosis.
Depending on the genetic condition, the preconception care plan may include surgical or medical management prior to or during pregnancy. In other cases, the risk of mortality or morbidity is significantly elevated, and discussion of pregnancy avoidance may be considered.
Whether to discontinue medications with potentially teratogenic effects should involve a “thorough discussion with the appropriate members of the multidisciplinary team to review the risks, benefits, and therapeutic alternatives,” the ACOG committee members wrote.
Once pregnant, a woman with a genetic condition should have an initial prenatal examination early in the first trimester to evaluate pregnancy risks, and for testing and screening, according to ACOG. Further, these patients may require specialist referral at some point during the pregnancy. Finally, certain genetic conditions may place women at risk for potential complications requiring specialized monitoring, assisted delivery, and ongoing postpartum evaluations.
“Given the rarity and complexity of some genetic conditions in pregnancy and their evolving management strategies, a coordinated, multidisciplinary approach to care may provide the best opportunity to improve maternal and fetal outcomes,” the committee members wrote.
The American College of Obstetricians and Gynecologists is calling on ob.gyns. to work with a multidisciplinary team when managing pregnancy in women with genetic conditions.
“Preconception, prenatal, and postpartum management of women with genetic conditions can be complex, but a multidisciplinary approach to patient care can lead to optimal outcomes for both mother and baby,” Dr. Joseph R. Biggio Jr., chair of ACOG’s Committee on Genetics, said in a statement.
In its first-ever guidance on genetic conditions in pregnancy, the ACOG Committee on Genetics outlined the key features of certain maternal genetic conditions, including cystic fibrosis, Marfan syndrome, neurofibromatosis type 1, tuberous sclerosis, autosomal dominant polycystic kidney disease, classic phenylketonuria, Noonan syndrome, and myotonic dystrophy type 1 (Obstet Gynecol. 2015;126:e49-51.).
Women with genetic conditions, and those at risk for genetic conditions, should have a preconception evaluation with a multidisciplinary team of caregivers that includes a genetic specialist, an obstetrician, and a maternal-fetal medicine specialist, according to the new recommendations. This evaluation aids in the development of a care plan and is also an opportunity to discuss risks to the mother and the neonate, partner carrier screening, and options for prenatal or preimplantation genetic diagnosis.
Depending on the genetic condition, the preconception care plan may include surgical or medical management prior to or during pregnancy. In other cases, the risk of mortality or morbidity is significantly elevated, and discussion of pregnancy avoidance may be considered.
Whether to discontinue medications with potentially teratogenic effects should involve a “thorough discussion with the appropriate members of the multidisciplinary team to review the risks, benefits, and therapeutic alternatives,” the ACOG committee members wrote.
Once pregnant, a woman with a genetic condition should have an initial prenatal examination early in the first trimester to evaluate pregnancy risks, and for testing and screening, according to ACOG. Further, these patients may require specialist referral at some point during the pregnancy. Finally, certain genetic conditions may place women at risk for potential complications requiring specialized monitoring, assisted delivery, and ongoing postpartum evaluations.
“Given the rarity and complexity of some genetic conditions in pregnancy and their evolving management strategies, a coordinated, multidisciplinary approach to care may provide the best opportunity to improve maternal and fetal outcomes,” the committee members wrote.
Asthma exacerbations seen in 32% of patients within 2 years of drug step-down
Nearly a third of patients have asthma exacerbation in the 2 years after medication step-down, according to a new study published in the September issue of Chest.
With the goal of using the least amount of medication to control asthma, guidelines recommend considering medication step-down after 3 months of stabilized asthma. However, there is limited evidence backing these recommendations, especially when it comes to understanding the long-term outcomes after asthma medication step-down.
Dr. Matthew A. Rank of the division of allergy, asthma, and clinical immunology at the Mayo Clinic in Scottsdale, Ariz., and colleagues analyzed the long-term outcomes of patients after asthma medication step-down.
The investigators conducted a retrospective claims-based analysis using data obtained from the Optum Labs Data Warehouse which contains information from more than 100 million deidentified patients with Medicare Advantage or commercial insurance plans (Chest. 2015;148[3]:630-39). .
Data was extracted on patients who had an asthma diagnosis code between 2000 and 2012 with continuous medical and pharmacy coverage for 3 or more years during the study period and with a history of medication step-down.
Investigators defined a medication step-down as greater or equal to 50% decrease in asthma controller medication between evaluations. Stability was defined as not having an asthma exacerbation requiring care in the hospital or ED, or systemic corticosteroids and claiming fewer than two rescue inhalers prescriptions in the 4 month study period.
The study cohort was divided into four asthma stability groups: 0-3 months, 4-7 months, 8-11 months, and greater to or equal to 12 months of stability.
Of the 26,292 individuals included in the study, 32% developed an asthma exacerbation during the 2 years after medication step-down. There was a strong association between the risk of developing an asthma exacerbation during the 2-year study period and the length of asthma stability prior to medication step-down. For instance, 44% in participants with less than 4 months of stability, 34% with 4-7 months of stability, 30% with 8-11 months of stability, and 21% with more than 12 months of stability (P less than .001).
In addition, study participants who were women, were black, were younger than 19 years old, had a Charlson comorbidity index great than or equal to 1, and at least two outpatient visits for asthma were significantly associated with a shorter interval to asthma exacerbation (P less than.001 for all variables).
Finally, most study participants had a hospital or ED visit, systemic corticosteroids, two rescue inhalers in a 4-month period, or needed to return to baseline asthma controller treatment. The authors suggest that this is evidence that most of the cohort continued to have underlying asthma during the 2-year study period. Furthermore, 33% of participants with less than 4 months of stability required return to baseline treatment versus 8%, 13%, and 15% for more than 12 months of stability, 8-11 months, and 4-7 months, respectively.
Among the limitations noted by the authors: Data were from insured patients, data did not indicate if step-down involved consultation with a health care provider, and the cohort did not include patients who did not step-down as a comparison.
“Individuals and their providers can cautiously apply the data from this study to decisions about stepping down asthma medications. The novel insights from this analysis that contribute to this decision making process are consideration to the length of stability prior to step-down and the rate of asthma exacerbations in the 24 months following step-down,” the authors wrote.
The study was funded by the Mayo Foundation for Medical Education and Research. The authors report no disclosures.
Nearly a third of patients have asthma exacerbation in the 2 years after medication step-down, according to a new study published in the September issue of Chest.
With the goal of using the least amount of medication to control asthma, guidelines recommend considering medication step-down after 3 months of stabilized asthma. However, there is limited evidence backing these recommendations, especially when it comes to understanding the long-term outcomes after asthma medication step-down.
Dr. Matthew A. Rank of the division of allergy, asthma, and clinical immunology at the Mayo Clinic in Scottsdale, Ariz., and colleagues analyzed the long-term outcomes of patients after asthma medication step-down.
The investigators conducted a retrospective claims-based analysis using data obtained from the Optum Labs Data Warehouse which contains information from more than 100 million deidentified patients with Medicare Advantage or commercial insurance plans (Chest. 2015;148[3]:630-39). .
Data was extracted on patients who had an asthma diagnosis code between 2000 and 2012 with continuous medical and pharmacy coverage for 3 or more years during the study period and with a history of medication step-down.
Investigators defined a medication step-down as greater or equal to 50% decrease in asthma controller medication between evaluations. Stability was defined as not having an asthma exacerbation requiring care in the hospital or ED, or systemic corticosteroids and claiming fewer than two rescue inhalers prescriptions in the 4 month study period.
The study cohort was divided into four asthma stability groups: 0-3 months, 4-7 months, 8-11 months, and greater to or equal to 12 months of stability.
Of the 26,292 individuals included in the study, 32% developed an asthma exacerbation during the 2 years after medication step-down. There was a strong association between the risk of developing an asthma exacerbation during the 2-year study period and the length of asthma stability prior to medication step-down. For instance, 44% in participants with less than 4 months of stability, 34% with 4-7 months of stability, 30% with 8-11 months of stability, and 21% with more than 12 months of stability (P less than .001).
In addition, study participants who were women, were black, were younger than 19 years old, had a Charlson comorbidity index great than or equal to 1, and at least two outpatient visits for asthma were significantly associated with a shorter interval to asthma exacerbation (P less than.001 for all variables).
Finally, most study participants had a hospital or ED visit, systemic corticosteroids, two rescue inhalers in a 4-month period, or needed to return to baseline asthma controller treatment. The authors suggest that this is evidence that most of the cohort continued to have underlying asthma during the 2-year study period. Furthermore, 33% of participants with less than 4 months of stability required return to baseline treatment versus 8%, 13%, and 15% for more than 12 months of stability, 8-11 months, and 4-7 months, respectively.
Among the limitations noted by the authors: Data were from insured patients, data did not indicate if step-down involved consultation with a health care provider, and the cohort did not include patients who did not step-down as a comparison.
“Individuals and their providers can cautiously apply the data from this study to decisions about stepping down asthma medications. The novel insights from this analysis that contribute to this decision making process are consideration to the length of stability prior to step-down and the rate of asthma exacerbations in the 24 months following step-down,” the authors wrote.
The study was funded by the Mayo Foundation for Medical Education and Research. The authors report no disclosures.
Nearly a third of patients have asthma exacerbation in the 2 years after medication step-down, according to a new study published in the September issue of Chest.
With the goal of using the least amount of medication to control asthma, guidelines recommend considering medication step-down after 3 months of stabilized asthma. However, there is limited evidence backing these recommendations, especially when it comes to understanding the long-term outcomes after asthma medication step-down.
Dr. Matthew A. Rank of the division of allergy, asthma, and clinical immunology at the Mayo Clinic in Scottsdale, Ariz., and colleagues analyzed the long-term outcomes of patients after asthma medication step-down.
The investigators conducted a retrospective claims-based analysis using data obtained from the Optum Labs Data Warehouse which contains information from more than 100 million deidentified patients with Medicare Advantage or commercial insurance plans (Chest. 2015;148[3]:630-39). .
Data was extracted on patients who had an asthma diagnosis code between 2000 and 2012 with continuous medical and pharmacy coverage for 3 or more years during the study period and with a history of medication step-down.
Investigators defined a medication step-down as greater or equal to 50% decrease in asthma controller medication between evaluations. Stability was defined as not having an asthma exacerbation requiring care in the hospital or ED, or systemic corticosteroids and claiming fewer than two rescue inhalers prescriptions in the 4 month study period.
The study cohort was divided into four asthma stability groups: 0-3 months, 4-7 months, 8-11 months, and greater to or equal to 12 months of stability.
Of the 26,292 individuals included in the study, 32% developed an asthma exacerbation during the 2 years after medication step-down. There was a strong association between the risk of developing an asthma exacerbation during the 2-year study period and the length of asthma stability prior to medication step-down. For instance, 44% in participants with less than 4 months of stability, 34% with 4-7 months of stability, 30% with 8-11 months of stability, and 21% with more than 12 months of stability (P less than .001).
In addition, study participants who were women, were black, were younger than 19 years old, had a Charlson comorbidity index great than or equal to 1, and at least two outpatient visits for asthma were significantly associated with a shorter interval to asthma exacerbation (P less than.001 for all variables).
Finally, most study participants had a hospital or ED visit, systemic corticosteroids, two rescue inhalers in a 4-month period, or needed to return to baseline asthma controller treatment. The authors suggest that this is evidence that most of the cohort continued to have underlying asthma during the 2-year study period. Furthermore, 33% of participants with less than 4 months of stability required return to baseline treatment versus 8%, 13%, and 15% for more than 12 months of stability, 8-11 months, and 4-7 months, respectively.
Among the limitations noted by the authors: Data were from insured patients, data did not indicate if step-down involved consultation with a health care provider, and the cohort did not include patients who did not step-down as a comparison.
“Individuals and their providers can cautiously apply the data from this study to decisions about stepping down asthma medications. The novel insights from this analysis that contribute to this decision making process are consideration to the length of stability prior to step-down and the rate of asthma exacerbations in the 24 months following step-down,” the authors wrote.
The study was funded by the Mayo Foundation for Medical Education and Research. The authors report no disclosures.
FROM CHEST
Key clinical point: Asthma exacerbation occurred in 32% of patients in the 2 years after medication step-down.
Major finding: Of the 26,292 individuals, 32% developed an asthma exacerbation during the 2 years after medication step-down. There was a strong association between the risk of developing an asthma exacerbation and the length of asthma stability prior to medication step-down.
Data source: A retrospective claims-based analysis using data obtained from the Optum Labs Data Warehouse.
Disclosures: The study was funded by the Mayo Foundation for Medical Education and Research. The authors report no disclosures.
No difference in long-term cost for diabetes treatment with bariatric surgery
There was no difference in long-term health care cost between conventional treatment and bariatric surgery in patients with diabetes, according to a study published in the Lancet online Sept. 17.
Elevated body mass index is associated with an increased risk of diabetes. However, devising effective lifestyle interventions to reduce weight in the severely obese remains a challenge. Data from the Swedish Obese Subjects (SOS) study have demonstrated prevention and remission of type 2 diabetes after bariatric surgery.
Catherine Keating, Ph.D., of the Deakin Health Economics and Baker IDI Heart and Diabetes Institute in Melbourne, and her associates sought to quantify the health care costs during a 15-year period for obese patients treated with bariatric surgery versus conventional treatment.
Data on prescription drug costs were obtained by questionnaires from participants in the SOS study and the Swedish Prescribed Drug Register. The Swedish National Patient Register was used to obtain data on the outpatient and inpatient visits. The participants were followed for up to 15 years.
The original SOS study was a prospective study that compared treatment outcomes and costs in two groups of obese adults: those who underwent bariatric surgery versus a control cohort who received conventional obesity management. The participants ranged from 37 to 60 years old with BMIs of greater than 34 kg/m2 in men and greater than 38 in women. Conventional treatment included behavior modification, lifestyle intervention, or no treatment.
The definition of diabetes was based on a self-report of taking diabetes drugs or a fasting glucose measurement.
After exclusions, 4,030 participants were included; of these, 2,836 were euglycemic, 591 had prediabetes, and 603 were diabetic, the investigators reported (Lancet 2015 Sep 16 [doi: 10.1016/
S2213-8587(15)00290-9]).
Patients in the bariatric surgery groups were on average 6.2 kg heavier (P less than .0001) and 1.5 years younger (P less than .0001) than were the controls. After the 15-year follow-up, weight loss was 16 kg greater in the diabetes subgroup, 18 kg greater in the prediabetes subgroup, and 20 kg greater in the euglycemia subgroup who had bariatric surgery versus conventional treatment (P less than .0001 for all).
After 15 years, the aggregated drug costs were not different between the conventional treatment group and the bariatric surgery group in patients with euglycemia. However, drug costs were lower in the prediabetic participants who had surgery versus conventional treatment (P = .007). Similarly, patients with diabetes who underwent bariatric surgery incurred lower drug costs after 15 years (P less than .0001).
The inpatient hospital costs after 15 years were greater in the surgery group for all glucose levels versus conventional treatment (mean, $51,225 vs. $25,313; P less than .0001).
There were no differences in outpatient costs demonstrated between the glucose subgroups. However, in the diabetes group, there were wide confidence intervals associated with outpatient costs that were thought to be secondary to end-stage renal disease visits.
Finally, the total cost of health care for the euglycemic group was higher in those who underwent surgery versus conventional treatment (P less than .0001). The prediabetic subgroup also incurred a higher total health care cost for surgery versus conventional treatment (P less than .0001). However, there were no differences in total health care cost for patients with diabetes who had surgery versus conventional treatment ($88,572 vs. $79,967, P less than .090).
The total cost was also higher in patients with diabetes for more than 1 year who had surgical intervention versus those who got conventional treatment (P less than .011). However, patients with diabetes for less than 1 year did not show differences in total cost when treated with surgery versus conventional treatments (P less than .476)
“In this study, we show that for obese patients with type 2 diabetes, the upfront costs of bariatric surgery seem to be largely offset by prevention of future health care and drug use,” the authors wrote. In addition, “long-term health care cost results support prioritization of patients with obesity and type 2 diabetes for bariatric surgery.”
This study was supported by a grant from AFA Forsakring. The authors reported multiple disclosures.
Bariatric surgery should be considered, irrespective of body mas index, in patients whose diabetes is not under control, despite the use of medications and lifestyle interventions.
Since the start of the SOS study, bariatric surgery has changed, and present day surgical costs would be lower.
Dr. Ricardo Cohen is affiliated with the Center for Obesity and Diabetes in Sao Paulo, Brazil. These comments were taken from an accompanying editorial (Lancet 2015 Sep 16 [doi: 10.1016/S2213-8587(15)00320-4]). No conflicts of interests were declared.
Bariatric surgery should be considered, irrespective of body mas index, in patients whose diabetes is not under control, despite the use of medications and lifestyle interventions.
Since the start of the SOS study, bariatric surgery has changed, and present day surgical costs would be lower.
Dr. Ricardo Cohen is affiliated with the Center for Obesity and Diabetes in Sao Paulo, Brazil. These comments were taken from an accompanying editorial (Lancet 2015 Sep 16 [doi: 10.1016/S2213-8587(15)00320-4]). No conflicts of interests were declared.
Bariatric surgery should be considered, irrespective of body mas index, in patients whose diabetes is not under control, despite the use of medications and lifestyle interventions.
Since the start of the SOS study, bariatric surgery has changed, and present day surgical costs would be lower.
Dr. Ricardo Cohen is affiliated with the Center for Obesity and Diabetes in Sao Paulo, Brazil. These comments were taken from an accompanying editorial (Lancet 2015 Sep 16 [doi: 10.1016/S2213-8587(15)00320-4]). No conflicts of interests were declared.
There was no difference in long-term health care cost between conventional treatment and bariatric surgery in patients with diabetes, according to a study published in the Lancet online Sept. 17.
Elevated body mass index is associated with an increased risk of diabetes. However, devising effective lifestyle interventions to reduce weight in the severely obese remains a challenge. Data from the Swedish Obese Subjects (SOS) study have demonstrated prevention and remission of type 2 diabetes after bariatric surgery.
Catherine Keating, Ph.D., of the Deakin Health Economics and Baker IDI Heart and Diabetes Institute in Melbourne, and her associates sought to quantify the health care costs during a 15-year period for obese patients treated with bariatric surgery versus conventional treatment.
Data on prescription drug costs were obtained by questionnaires from participants in the SOS study and the Swedish Prescribed Drug Register. The Swedish National Patient Register was used to obtain data on the outpatient and inpatient visits. The participants were followed for up to 15 years.
The original SOS study was a prospective study that compared treatment outcomes and costs in two groups of obese adults: those who underwent bariatric surgery versus a control cohort who received conventional obesity management. The participants ranged from 37 to 60 years old with BMIs of greater than 34 kg/m2 in men and greater than 38 in women. Conventional treatment included behavior modification, lifestyle intervention, or no treatment.
The definition of diabetes was based on a self-report of taking diabetes drugs or a fasting glucose measurement.
After exclusions, 4,030 participants were included; of these, 2,836 were euglycemic, 591 had prediabetes, and 603 were diabetic, the investigators reported (Lancet 2015 Sep 16 [doi: 10.1016/
S2213-8587(15)00290-9]).
Patients in the bariatric surgery groups were on average 6.2 kg heavier (P less than .0001) and 1.5 years younger (P less than .0001) than were the controls. After the 15-year follow-up, weight loss was 16 kg greater in the diabetes subgroup, 18 kg greater in the prediabetes subgroup, and 20 kg greater in the euglycemia subgroup who had bariatric surgery versus conventional treatment (P less than .0001 for all).
After 15 years, the aggregated drug costs were not different between the conventional treatment group and the bariatric surgery group in patients with euglycemia. However, drug costs were lower in the prediabetic participants who had surgery versus conventional treatment (P = .007). Similarly, patients with diabetes who underwent bariatric surgery incurred lower drug costs after 15 years (P less than .0001).
The inpatient hospital costs after 15 years were greater in the surgery group for all glucose levels versus conventional treatment (mean, $51,225 vs. $25,313; P less than .0001).
There were no differences in outpatient costs demonstrated between the glucose subgroups. However, in the diabetes group, there were wide confidence intervals associated with outpatient costs that were thought to be secondary to end-stage renal disease visits.
Finally, the total cost of health care for the euglycemic group was higher in those who underwent surgery versus conventional treatment (P less than .0001). The prediabetic subgroup also incurred a higher total health care cost for surgery versus conventional treatment (P less than .0001). However, there were no differences in total health care cost for patients with diabetes who had surgery versus conventional treatment ($88,572 vs. $79,967, P less than .090).
The total cost was also higher in patients with diabetes for more than 1 year who had surgical intervention versus those who got conventional treatment (P less than .011). However, patients with diabetes for less than 1 year did not show differences in total cost when treated with surgery versus conventional treatments (P less than .476)
“In this study, we show that for obese patients with type 2 diabetes, the upfront costs of bariatric surgery seem to be largely offset by prevention of future health care and drug use,” the authors wrote. In addition, “long-term health care cost results support prioritization of patients with obesity and type 2 diabetes for bariatric surgery.”
This study was supported by a grant from AFA Forsakring. The authors reported multiple disclosures.
There was no difference in long-term health care cost between conventional treatment and bariatric surgery in patients with diabetes, according to a study published in the Lancet online Sept. 17.
Elevated body mass index is associated with an increased risk of diabetes. However, devising effective lifestyle interventions to reduce weight in the severely obese remains a challenge. Data from the Swedish Obese Subjects (SOS) study have demonstrated prevention and remission of type 2 diabetes after bariatric surgery.
Catherine Keating, Ph.D., of the Deakin Health Economics and Baker IDI Heart and Diabetes Institute in Melbourne, and her associates sought to quantify the health care costs during a 15-year period for obese patients treated with bariatric surgery versus conventional treatment.
Data on prescription drug costs were obtained by questionnaires from participants in the SOS study and the Swedish Prescribed Drug Register. The Swedish National Patient Register was used to obtain data on the outpatient and inpatient visits. The participants were followed for up to 15 years.
The original SOS study was a prospective study that compared treatment outcomes and costs in two groups of obese adults: those who underwent bariatric surgery versus a control cohort who received conventional obesity management. The participants ranged from 37 to 60 years old with BMIs of greater than 34 kg/m2 in men and greater than 38 in women. Conventional treatment included behavior modification, lifestyle intervention, or no treatment.
The definition of diabetes was based on a self-report of taking diabetes drugs or a fasting glucose measurement.
After exclusions, 4,030 participants were included; of these, 2,836 were euglycemic, 591 had prediabetes, and 603 were diabetic, the investigators reported (Lancet 2015 Sep 16 [doi: 10.1016/
S2213-8587(15)00290-9]).
Patients in the bariatric surgery groups were on average 6.2 kg heavier (P less than .0001) and 1.5 years younger (P less than .0001) than were the controls. After the 15-year follow-up, weight loss was 16 kg greater in the diabetes subgroup, 18 kg greater in the prediabetes subgroup, and 20 kg greater in the euglycemia subgroup who had bariatric surgery versus conventional treatment (P less than .0001 for all).
After 15 years, the aggregated drug costs were not different between the conventional treatment group and the bariatric surgery group in patients with euglycemia. However, drug costs were lower in the prediabetic participants who had surgery versus conventional treatment (P = .007). Similarly, patients with diabetes who underwent bariatric surgery incurred lower drug costs after 15 years (P less than .0001).
The inpatient hospital costs after 15 years were greater in the surgery group for all glucose levels versus conventional treatment (mean, $51,225 vs. $25,313; P less than .0001).
There were no differences in outpatient costs demonstrated between the glucose subgroups. However, in the diabetes group, there were wide confidence intervals associated with outpatient costs that were thought to be secondary to end-stage renal disease visits.
Finally, the total cost of health care for the euglycemic group was higher in those who underwent surgery versus conventional treatment (P less than .0001). The prediabetic subgroup also incurred a higher total health care cost for surgery versus conventional treatment (P less than .0001). However, there were no differences in total health care cost for patients with diabetes who had surgery versus conventional treatment ($88,572 vs. $79,967, P less than .090).
The total cost was also higher in patients with diabetes for more than 1 year who had surgical intervention versus those who got conventional treatment (P less than .011). However, patients with diabetes for less than 1 year did not show differences in total cost when treated with surgery versus conventional treatments (P less than .476)
“In this study, we show that for obese patients with type 2 diabetes, the upfront costs of bariatric surgery seem to be largely offset by prevention of future health care and drug use,” the authors wrote. In addition, “long-term health care cost results support prioritization of patients with obesity and type 2 diabetes for bariatric surgery.”
This study was supported by a grant from AFA Forsakring. The authors reported multiple disclosures.
THE LANCET
Key clinical point: There was no difference in long-term health care cost between conventional treatment and bariatric surgery in patients with diabetes.
Major finding: There was no difference in total health care cost for patients with diabetes who received surgery versus conventional treatment ($88,572 vs. $79,967, P = .090).
Data source: A 15-year follow-up of Swedish Obese Subjects study participants with additional data obtained on drug costs and inpatient and outpatient visits.
Disclosures: This study was supported by a grant from AFA Forsakring. The authors reported multiple disclosures.
Coating on Endovascular Devices Could Cause Stroke or Death
NEW YORK - Coating on endovascular devices is associated with embolization and microvascular occlusion leading to purpura or livedo racemosa, according to a new report.
Dr. Alina Bridges, of the Department of Dermatology at Mayo Clinic in Rochester, Minnesota, said by email that the study was conducted "to make clinicians and pathologists aware of this underrecognized phenomenon of iatrogenic hydrophilic polymer gel embolization that can involve the skin and present with purpura."
The phenomenon "has distinctive microscopic morphology and potential for internal organ involvement," she added.
Endovascular devices commonly are coated with hydrophilic polymer gels to improve maneuverability and prevent vasospasm. However, there are reports of the coating embolizing, resulting
in severe reactions such as stroke, pulmonary infarction, and death.
Dr. Bridges and colleagues presented a case study of eight patients with livedo racemosa and purpura after an endovascular procedure. The patients had punch biopsies obtained with hematoxylin-eosin-stained sections.
The study subjects were between 58 and 81 years old, most were men and most had previous endovascular procedures and multiple comorbidities, according to an article online August 11 in the Journal of the American Academy of Dermatology.
In all but one patient, the cutaneous lesions were unilateral and all but two were asymptomatic. Six patients presented with livedo racemosa and two with purpura.
All cases demonstrated pauci-inflammatory occlusion in the mid-dermal and small superficial vessels. Likewise, histopathologic evidence was consistent with previously reported cases of emboli secondary to hydrophilic gel polymer.
There was no evidence of embolic sequela to the organs in three patients. However, one patient died of unknown reasons and four patients experienced postoperative complications including spinal cord ischemia, acute kidney injury, and cerebral infarction. In all cases, the cutaneous manifestations resolved without intervention.
The authors say they suspect the incidence of this type of embolization is underrecognized, especially with the common use of hydrophilic polymer gel coatings.
"This report highlights the importance of awareness of this rare iatrogenic complication and the importance of investigating a patient's clinical history to determine if there had been recent exposure to an intravascular device with a hydrophilic coating," Dr. Bridges said.
"While the use of polymer-coated devices offers several advantages, clinicians must be aware of their potential complications, including stroke, myocardial and pulmonary infarction, gangrene, and/or death," she said.
The authors reported no funding or conflicts of interest.
NEW YORK - Coating on endovascular devices is associated with embolization and microvascular occlusion leading to purpura or livedo racemosa, according to a new report.
Dr. Alina Bridges, of the Department of Dermatology at Mayo Clinic in Rochester, Minnesota, said by email that the study was conducted "to make clinicians and pathologists aware of this underrecognized phenomenon of iatrogenic hydrophilic polymer gel embolization that can involve the skin and present with purpura."
The phenomenon "has distinctive microscopic morphology and potential for internal organ involvement," she added.
Endovascular devices commonly are coated with hydrophilic polymer gels to improve maneuverability and prevent vasospasm. However, there are reports of the coating embolizing, resulting
in severe reactions such as stroke, pulmonary infarction, and death.
Dr. Bridges and colleagues presented a case study of eight patients with livedo racemosa and purpura after an endovascular procedure. The patients had punch biopsies obtained with hematoxylin-eosin-stained sections.
The study subjects were between 58 and 81 years old, most were men and most had previous endovascular procedures and multiple comorbidities, according to an article online August 11 in the Journal of the American Academy of Dermatology.
In all but one patient, the cutaneous lesions were unilateral and all but two were asymptomatic. Six patients presented with livedo racemosa and two with purpura.
All cases demonstrated pauci-inflammatory occlusion in the mid-dermal and small superficial vessels. Likewise, histopathologic evidence was consistent with previously reported cases of emboli secondary to hydrophilic gel polymer.
There was no evidence of embolic sequela to the organs in three patients. However, one patient died of unknown reasons and four patients experienced postoperative complications including spinal cord ischemia, acute kidney injury, and cerebral infarction. In all cases, the cutaneous manifestations resolved without intervention.
The authors say they suspect the incidence of this type of embolization is underrecognized, especially with the common use of hydrophilic polymer gel coatings.
"This report highlights the importance of awareness of this rare iatrogenic complication and the importance of investigating a patient's clinical history to determine if there had been recent exposure to an intravascular device with a hydrophilic coating," Dr. Bridges said.
"While the use of polymer-coated devices offers several advantages, clinicians must be aware of their potential complications, including stroke, myocardial and pulmonary infarction, gangrene, and/or death," she said.
The authors reported no funding or conflicts of interest.
NEW YORK - Coating on endovascular devices is associated with embolization and microvascular occlusion leading to purpura or livedo racemosa, according to a new report.
Dr. Alina Bridges, of the Department of Dermatology at Mayo Clinic in Rochester, Minnesota, said by email that the study was conducted "to make clinicians and pathologists aware of this underrecognized phenomenon of iatrogenic hydrophilic polymer gel embolization that can involve the skin and present with purpura."
The phenomenon "has distinctive microscopic morphology and potential for internal organ involvement," she added.
Endovascular devices commonly are coated with hydrophilic polymer gels to improve maneuverability and prevent vasospasm. However, there are reports of the coating embolizing, resulting
in severe reactions such as stroke, pulmonary infarction, and death.
Dr. Bridges and colleagues presented a case study of eight patients with livedo racemosa and purpura after an endovascular procedure. The patients had punch biopsies obtained with hematoxylin-eosin-stained sections.
The study subjects were between 58 and 81 years old, most were men and most had previous endovascular procedures and multiple comorbidities, according to an article online August 11 in the Journal of the American Academy of Dermatology.
In all but one patient, the cutaneous lesions were unilateral and all but two were asymptomatic. Six patients presented with livedo racemosa and two with purpura.
All cases demonstrated pauci-inflammatory occlusion in the mid-dermal and small superficial vessels. Likewise, histopathologic evidence was consistent with previously reported cases of emboli secondary to hydrophilic gel polymer.
There was no evidence of embolic sequela to the organs in three patients. However, one patient died of unknown reasons and four patients experienced postoperative complications including spinal cord ischemia, acute kidney injury, and cerebral infarction. In all cases, the cutaneous manifestations resolved without intervention.
The authors say they suspect the incidence of this type of embolization is underrecognized, especially with the common use of hydrophilic polymer gel coatings.
"This report highlights the importance of awareness of this rare iatrogenic complication and the importance of investigating a patient's clinical history to determine if there had been recent exposure to an intravascular device with a hydrophilic coating," Dr. Bridges said.
"While the use of polymer-coated devices offers several advantages, clinicians must be aware of their potential complications, including stroke, myocardial and pulmonary infarction, gangrene, and/or death," she said.
The authors reported no funding or conflicts of interest.