User login
Older women with remitted depression show attention bias for negative information
Older women with a history of major depressive disorder are more likely to direct their attention to negative images than women without history of MDD, researchers report. The findings follow previous research showing that individuals currently depressed or at-risk show a similar attention bias.
The current study examined 33 postmenopausal women aged 45-75 years with an emotion dot probe (EDP) task combined with fMRI scans, in addition to cognitive and depression history screening and several self-rated measures.
“We examined resting-state functional connectivity before the EDP task to assess differences in intrinsic amygdala functional connections to other brain areas between the groups,” wrote Kimberly Albert, PhD, of Vanderbilt University, Nashville, Tenn., and her coauthors (J Affect Disord. 2017 Mar 1;210:49-52).
The women in the study with a history of MDD showed greater attention facilitation to negative images, greater amygdala activity, and greater amygdala-hippocampal functional connectivity than women without a history of MDD.
“Attention bias for negative information can be seen in individuals with past MDD without inducing a negative mood state. Attention bias for negative information may be an ongoing vulnerability for MDD recurrence independent of mood state,” Dr. Albert and her coauthors wrote.
Older women with a history of major depressive disorder are more likely to direct their attention to negative images than women without history of MDD, researchers report. The findings follow previous research showing that individuals currently depressed or at-risk show a similar attention bias.
The current study examined 33 postmenopausal women aged 45-75 years with an emotion dot probe (EDP) task combined with fMRI scans, in addition to cognitive and depression history screening and several self-rated measures.
“We examined resting-state functional connectivity before the EDP task to assess differences in intrinsic amygdala functional connections to other brain areas between the groups,” wrote Kimberly Albert, PhD, of Vanderbilt University, Nashville, Tenn., and her coauthors (J Affect Disord. 2017 Mar 1;210:49-52).
The women in the study with a history of MDD showed greater attention facilitation to negative images, greater amygdala activity, and greater amygdala-hippocampal functional connectivity than women without a history of MDD.
“Attention bias for negative information can be seen in individuals with past MDD without inducing a negative mood state. Attention bias for negative information may be an ongoing vulnerability for MDD recurrence independent of mood state,” Dr. Albert and her coauthors wrote.
Older women with a history of major depressive disorder are more likely to direct their attention to negative images than women without history of MDD, researchers report. The findings follow previous research showing that individuals currently depressed or at-risk show a similar attention bias.
The current study examined 33 postmenopausal women aged 45-75 years with an emotion dot probe (EDP) task combined with fMRI scans, in addition to cognitive and depression history screening and several self-rated measures.
“We examined resting-state functional connectivity before the EDP task to assess differences in intrinsic amygdala functional connections to other brain areas between the groups,” wrote Kimberly Albert, PhD, of Vanderbilt University, Nashville, Tenn., and her coauthors (J Affect Disord. 2017 Mar 1;210:49-52).
The women in the study with a history of MDD showed greater attention facilitation to negative images, greater amygdala activity, and greater amygdala-hippocampal functional connectivity than women without a history of MDD.
“Attention bias for negative information can be seen in individuals with past MDD without inducing a negative mood state. Attention bias for negative information may be an ongoing vulnerability for MDD recurrence independent of mood state,” Dr. Albert and her coauthors wrote.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Triclosan sutures halve surgical site infections in children
The use of triclosan-impregnated sutures reduced by half the incidence of surgical site infections in children, a large randomized study has determined.
Overall, the antibiotic-treated sutures cut the number of these infections by 52%, but they were particularly effective in reducing the risk of deep surgical site infections (SSIs), Marjo Renko, MD, wrote (Lancet Infect Dis. 2017;17[1]:50-7).
The study was conducted in clean wounds in healthy children and in a center that already had a very low rate of surgical site infections (just 5%) – showing that improvement is possible even in optimal care settings, wrote Dr. Renko, of the University of Oulu, Finland, and her colleagues.
“This randomized, controlled study shows that even in low-risk settings, where other prophylactic measures are available to use, triclosan-containing sutures effectively prevented the occurrence of SSIs in children,” the team wrote.
The study cohort comprised 1,633 children aged 7-17 who underwent surgery at a single Finnish hospital from 2010-2014. Most were there for planned surgery (87%); the remainder had emergency surgery. The most common surgical site was musculoskeletal (40%), followed by abdominal wall surgery (about 25%), and urogenital surgery (about 13%). The rest were intraabdominal or procedures on the nervous system, chest, and skin or subcutaneous tissue.
The children were randomized to either plain or triclosan-impregnated sutures. The primary outcome was the occurrence of a superficial or deep surgical site infection, based on Centers for Disease Control and Prevention criteria. The procedures were performed by 69 surgeons.
In a modified intent-to-treat analysis, a surgical site infection occurred in 3% of the triclosan-suture group (20 children) and in 5% of the control suture group (42 children). In the control group, these infections were most often of chest incisions (15%), followed by skin incisions (10%) and nervous system, intraabdominal, and musculoskeletal incisions (8% each). In the triclosan group, the most common site of infection was skin (10%), followed by musculoskeletal (4%), nervous system (2%), and urogenital and abdominal wall incisions (1% each).
Compared with control sutures, triclosan sutures reduced the overall risk of a surgical site infection by 52% (relative risk, 0.48; 95% confidence interval, 0.28-0.80). The number needed to treat to avoid one infection was 36.
The sutures were significantly more effective in reducing deep infections than superficial infections. Superficial infections occurred in 2% of the triclosan group (17) and 4% of the control group (28) – a risk reduction of 39% (RR, 0.61; 95% CI, 0.34-1.09) Deep infections occurred in less than 1% of the triclosan group (3) and 2% of the control group (14) – a risk reduction of 79% (RR, 0.21’ CI, 0.07-0.66).
Infections were associated with an increased incidence of wound dehiscence in the control group (6% vs. 4%), the need for additional antimicrobial agents (7% vs. 2%), and wound revisions (2% vs. less than 1%). Children in the control group also had more outpatient visits (8% vs. 4%) and were more often readmitted because of their infection (2% vs. 1%).
The authors noted that triclosan, in the setting of increased household use, “has raised concerns about the toxic effects of the drug on the human body. Observational studies have reported associations between triclosan exposures and altered thyroid hormone levels, body mass index, and waist circumference.”
Two Norwegian studies found that the drug was associated with inhalation allergies and seasonal allergies.
“Because of the agent’s suspected toxicity and to prevent further development of resistant bacteria, use of triclosan should be restricted and reserved only for medical procedures with adequate evidence,” they noted. However, “SSIs cause much morbidity and mortality after surgical procedures, and economic evaluations recommend the use of triclosan-containing material.”
Dr. Renko received grants from the Alma and K.A. Snellman Foundation, the Finnish Medical Foundation, and the Foundation for Pediatric Research.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
The study by Dr. Marjo Renko and her colleagues is impressive in its sheer numbers, if not so much in its findings, Felix J. Hüttner, MD, and Markus K. Diener, MD, wrote in an accompanying editorial (Lancet Infect Dis. 2017;17[1]:3-4).
“We congratulate the authors on successfully doing a pragmatic, large-scale trial in a difficult setting; randomized controlled trials in children are known to pose specific challenges to researchers. However, the monocenter design raises some concerns about the generalizability of the results.”
Single-center trials can overestimate treatment effects, the colleagues noted. Dr. Renko’s conclusions don’t line up with their own metaanalysis of triclosan-containing sutures for abdominal wall closure. In it, three single-center trials found in favor of the triclosan sutures, but two multicenter trials did not.
The variation in infection rates in each type of surgery is a clue to the difficulty of a one-size-fits-all intervention like the treated sutures. “The differences between the intervention group and the control group vary widely by surgery type – for example, 0% versus 15% for thoracic surgery, compared with 1% versus 1% for surgery of the urinary system and genitals. Thus, triclosan-containing sutures might only be beneficial for specific types of operations and in our opinion, it cannot be concluded that triclosan-containing sutures reduce surgical site infections in all of these indications. Future trials should focus at individual types of pediatric surgery to evaluate a potential beneficial effect.”
Dr. Hüttner and Dr. Diener are surgeons at the University of Heidelberg, Germany. Dr. Hüttner had no financial disclosures. Dr. Diener has received grants from Johnson & Johnson Medical Limited.
The study by Dr. Marjo Renko and her colleagues is impressive in its sheer numbers, if not so much in its findings, Felix J. Hüttner, MD, and Markus K. Diener, MD, wrote in an accompanying editorial (Lancet Infect Dis. 2017;17[1]:3-4).
“We congratulate the authors on successfully doing a pragmatic, large-scale trial in a difficult setting; randomized controlled trials in children are known to pose specific challenges to researchers. However, the monocenter design raises some concerns about the generalizability of the results.”
Single-center trials can overestimate treatment effects, the colleagues noted. Dr. Renko’s conclusions don’t line up with their own metaanalysis of triclosan-containing sutures for abdominal wall closure. In it, three single-center trials found in favor of the triclosan sutures, but two multicenter trials did not.
The variation in infection rates in each type of surgery is a clue to the difficulty of a one-size-fits-all intervention like the treated sutures. “The differences between the intervention group and the control group vary widely by surgery type – for example, 0% versus 15% for thoracic surgery, compared with 1% versus 1% for surgery of the urinary system and genitals. Thus, triclosan-containing sutures might only be beneficial for specific types of operations and in our opinion, it cannot be concluded that triclosan-containing sutures reduce surgical site infections in all of these indications. Future trials should focus at individual types of pediatric surgery to evaluate a potential beneficial effect.”
Dr. Hüttner and Dr. Diener are surgeons at the University of Heidelberg, Germany. Dr. Hüttner had no financial disclosures. Dr. Diener has received grants from Johnson & Johnson Medical Limited.
The study by Dr. Marjo Renko and her colleagues is impressive in its sheer numbers, if not so much in its findings, Felix J. Hüttner, MD, and Markus K. Diener, MD, wrote in an accompanying editorial (Lancet Infect Dis. 2017;17[1]:3-4).
“We congratulate the authors on successfully doing a pragmatic, large-scale trial in a difficult setting; randomized controlled trials in children are known to pose specific challenges to researchers. However, the monocenter design raises some concerns about the generalizability of the results.”
Single-center trials can overestimate treatment effects, the colleagues noted. Dr. Renko’s conclusions don’t line up with their own metaanalysis of triclosan-containing sutures for abdominal wall closure. In it, three single-center trials found in favor of the triclosan sutures, but two multicenter trials did not.
The variation in infection rates in each type of surgery is a clue to the difficulty of a one-size-fits-all intervention like the treated sutures. “The differences between the intervention group and the control group vary widely by surgery type – for example, 0% versus 15% for thoracic surgery, compared with 1% versus 1% for surgery of the urinary system and genitals. Thus, triclosan-containing sutures might only be beneficial for specific types of operations and in our opinion, it cannot be concluded that triclosan-containing sutures reduce surgical site infections in all of these indications. Future trials should focus at individual types of pediatric surgery to evaluate a potential beneficial effect.”
Dr. Hüttner and Dr. Diener are surgeons at the University of Heidelberg, Germany. Dr. Hüttner had no financial disclosures. Dr. Diener has received grants from Johnson & Johnson Medical Limited.
The use of triclosan-impregnated sutures reduced by half the incidence of surgical site infections in children, a large randomized study has determined.
Overall, the antibiotic-treated sutures cut the number of these infections by 52%, but they were particularly effective in reducing the risk of deep surgical site infections (SSIs), Marjo Renko, MD, wrote (Lancet Infect Dis. 2017;17[1]:50-7).
The study was conducted in clean wounds in healthy children and in a center that already had a very low rate of surgical site infections (just 5%) – showing that improvement is possible even in optimal care settings, wrote Dr. Renko, of the University of Oulu, Finland, and her colleagues.
“This randomized, controlled study shows that even in low-risk settings, where other prophylactic measures are available to use, triclosan-containing sutures effectively prevented the occurrence of SSIs in children,” the team wrote.
The study cohort comprised 1,633 children aged 7-17 who underwent surgery at a single Finnish hospital from 2010-2014. Most were there for planned surgery (87%); the remainder had emergency surgery. The most common surgical site was musculoskeletal (40%), followed by abdominal wall surgery (about 25%), and urogenital surgery (about 13%). The rest were intraabdominal or procedures on the nervous system, chest, and skin or subcutaneous tissue.
The children were randomized to either plain or triclosan-impregnated sutures. The primary outcome was the occurrence of a superficial or deep surgical site infection, based on Centers for Disease Control and Prevention criteria. The procedures were performed by 69 surgeons.
In a modified intent-to-treat analysis, a surgical site infection occurred in 3% of the triclosan-suture group (20 children) and in 5% of the control suture group (42 children). In the control group, these infections were most often of chest incisions (15%), followed by skin incisions (10%) and nervous system, intraabdominal, and musculoskeletal incisions (8% each). In the triclosan group, the most common site of infection was skin (10%), followed by musculoskeletal (4%), nervous system (2%), and urogenital and abdominal wall incisions (1% each).
Compared with control sutures, triclosan sutures reduced the overall risk of a surgical site infection by 52% (relative risk, 0.48; 95% confidence interval, 0.28-0.80). The number needed to treat to avoid one infection was 36.
The sutures were significantly more effective in reducing deep infections than superficial infections. Superficial infections occurred in 2% of the triclosan group (17) and 4% of the control group (28) – a risk reduction of 39% (RR, 0.61; 95% CI, 0.34-1.09) Deep infections occurred in less than 1% of the triclosan group (3) and 2% of the control group (14) – a risk reduction of 79% (RR, 0.21’ CI, 0.07-0.66).
Infections were associated with an increased incidence of wound dehiscence in the control group (6% vs. 4%), the need for additional antimicrobial agents (7% vs. 2%), and wound revisions (2% vs. less than 1%). Children in the control group also had more outpatient visits (8% vs. 4%) and were more often readmitted because of their infection (2% vs. 1%).
The authors noted that triclosan, in the setting of increased household use, “has raised concerns about the toxic effects of the drug on the human body. Observational studies have reported associations between triclosan exposures and altered thyroid hormone levels, body mass index, and waist circumference.”
Two Norwegian studies found that the drug was associated with inhalation allergies and seasonal allergies.
“Because of the agent’s suspected toxicity and to prevent further development of resistant bacteria, use of triclosan should be restricted and reserved only for medical procedures with adequate evidence,” they noted. However, “SSIs cause much morbidity and mortality after surgical procedures, and economic evaluations recommend the use of triclosan-containing material.”
Dr. Renko received grants from the Alma and K.A. Snellman Foundation, the Finnish Medical Foundation, and the Foundation for Pediatric Research.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
The use of triclosan-impregnated sutures reduced by half the incidence of surgical site infections in children, a large randomized study has determined.
Overall, the antibiotic-treated sutures cut the number of these infections by 52%, but they were particularly effective in reducing the risk of deep surgical site infections (SSIs), Marjo Renko, MD, wrote (Lancet Infect Dis. 2017;17[1]:50-7).
The study was conducted in clean wounds in healthy children and in a center that already had a very low rate of surgical site infections (just 5%) – showing that improvement is possible even in optimal care settings, wrote Dr. Renko, of the University of Oulu, Finland, and her colleagues.
“This randomized, controlled study shows that even in low-risk settings, where other prophylactic measures are available to use, triclosan-containing sutures effectively prevented the occurrence of SSIs in children,” the team wrote.
The study cohort comprised 1,633 children aged 7-17 who underwent surgery at a single Finnish hospital from 2010-2014. Most were there for planned surgery (87%); the remainder had emergency surgery. The most common surgical site was musculoskeletal (40%), followed by abdominal wall surgery (about 25%), and urogenital surgery (about 13%). The rest were intraabdominal or procedures on the nervous system, chest, and skin or subcutaneous tissue.
The children were randomized to either plain or triclosan-impregnated sutures. The primary outcome was the occurrence of a superficial or deep surgical site infection, based on Centers for Disease Control and Prevention criteria. The procedures were performed by 69 surgeons.
In a modified intent-to-treat analysis, a surgical site infection occurred in 3% of the triclosan-suture group (20 children) and in 5% of the control suture group (42 children). In the control group, these infections were most often of chest incisions (15%), followed by skin incisions (10%) and nervous system, intraabdominal, and musculoskeletal incisions (8% each). In the triclosan group, the most common site of infection was skin (10%), followed by musculoskeletal (4%), nervous system (2%), and urogenital and abdominal wall incisions (1% each).
Compared with control sutures, triclosan sutures reduced the overall risk of a surgical site infection by 52% (relative risk, 0.48; 95% confidence interval, 0.28-0.80). The number needed to treat to avoid one infection was 36.
The sutures were significantly more effective in reducing deep infections than superficial infections. Superficial infections occurred in 2% of the triclosan group (17) and 4% of the control group (28) – a risk reduction of 39% (RR, 0.61; 95% CI, 0.34-1.09) Deep infections occurred in less than 1% of the triclosan group (3) and 2% of the control group (14) – a risk reduction of 79% (RR, 0.21’ CI, 0.07-0.66).
Infections were associated with an increased incidence of wound dehiscence in the control group (6% vs. 4%), the need for additional antimicrobial agents (7% vs. 2%), and wound revisions (2% vs. less than 1%). Children in the control group also had more outpatient visits (8% vs. 4%) and were more often readmitted because of their infection (2% vs. 1%).
The authors noted that triclosan, in the setting of increased household use, “has raised concerns about the toxic effects of the drug on the human body. Observational studies have reported associations between triclosan exposures and altered thyroid hormone levels, body mass index, and waist circumference.”
Two Norwegian studies found that the drug was associated with inhalation allergies and seasonal allergies.
“Because of the agent’s suspected toxicity and to prevent further development of resistant bacteria, use of triclosan should be restricted and reserved only for medical procedures with adequate evidence,” they noted. However, “SSIs cause much morbidity and mortality after surgical procedures, and economic evaluations recommend the use of triclosan-containing material.”
Dr. Renko received grants from the Alma and K.A. Snellman Foundation, the Finnish Medical Foundation, and the Foundation for Pediatric Research.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
FROM LANCET INFECTIOUS DISEASES
Key clinical point:
Major finding: Overall, the sutures were associated with a 52% decrease in SSIs.
Data source: The study randomized 1,633 children undergoing surgery to the triclosan sutures or to a control suture.
Disclosures: Dr. Renko received grants from the Alma and K.A. Snellman Foundation, the Finnish Medical Foundation, and the Foundation for Pediatric Research.
West Nile virus accounted for 95% of domestic arboviral disease in 2015
West Nile virus was the most common cause of domestically acquired arboviral disease in the United States in 2015, according to a report from the Centers for Disease Control and Prevention.
A total of 2,282 cases of arboviral disease were reported to the CDC in 2015. Of those, 2,175 cases were caused by the West Nile virus. Of the patients with WNV, 1,616 were hospitalized because of the disease, and 146 died. Neuroinvasive WNV, which occurred in 1,455 cases, accounted for 1,382 of 1,616 WNV hospitalizations and 142 of 146 deaths.
Of the 107 non-WNV arbovirus cases reported to the CDC, 55 were La Crosse virus, 23 were St. Louis encephalitis, 11 were Jamestown Canyon virus, 7 were Powassan virus, and 6 were eastern equine encephalitis. In addition to La Crosse and Jamestown Canyon, 4 cases of additional California serogroup viruses were reported, as was 1 case of Cache Valley virus.
“Health care providers should consider arboviral infections in the differential diagnosis of cases of aseptic meningitis and encephalitis, obtain appropriate specimens for laboratory testing, and promptly report cases to public health authorities. Because human vaccines against domestic arboviruses are not available, prevention depends on community and household efforts to reduce vector populations, personal protective measures to decrease exposure to mosquitoes and ticks, and screening of blood donors,” the CDC investigators concluded.
Find the full report in the MMWR (doi: 10.15585/mmwr.mm6602a3).
West Nile virus was the most common cause of domestically acquired arboviral disease in the United States in 2015, according to a report from the Centers for Disease Control and Prevention.
A total of 2,282 cases of arboviral disease were reported to the CDC in 2015. Of those, 2,175 cases were caused by the West Nile virus. Of the patients with WNV, 1,616 were hospitalized because of the disease, and 146 died. Neuroinvasive WNV, which occurred in 1,455 cases, accounted for 1,382 of 1,616 WNV hospitalizations and 142 of 146 deaths.
Of the 107 non-WNV arbovirus cases reported to the CDC, 55 were La Crosse virus, 23 were St. Louis encephalitis, 11 were Jamestown Canyon virus, 7 were Powassan virus, and 6 were eastern equine encephalitis. In addition to La Crosse and Jamestown Canyon, 4 cases of additional California serogroup viruses were reported, as was 1 case of Cache Valley virus.
“Health care providers should consider arboviral infections in the differential diagnosis of cases of aseptic meningitis and encephalitis, obtain appropriate specimens for laboratory testing, and promptly report cases to public health authorities. Because human vaccines against domestic arboviruses are not available, prevention depends on community and household efforts to reduce vector populations, personal protective measures to decrease exposure to mosquitoes and ticks, and screening of blood donors,” the CDC investigators concluded.
Find the full report in the MMWR (doi: 10.15585/mmwr.mm6602a3).
West Nile virus was the most common cause of domestically acquired arboviral disease in the United States in 2015, according to a report from the Centers for Disease Control and Prevention.
A total of 2,282 cases of arboviral disease were reported to the CDC in 2015. Of those, 2,175 cases were caused by the West Nile virus. Of the patients with WNV, 1,616 were hospitalized because of the disease, and 146 died. Neuroinvasive WNV, which occurred in 1,455 cases, accounted for 1,382 of 1,616 WNV hospitalizations and 142 of 146 deaths.
Of the 107 non-WNV arbovirus cases reported to the CDC, 55 were La Crosse virus, 23 were St. Louis encephalitis, 11 were Jamestown Canyon virus, 7 were Powassan virus, and 6 were eastern equine encephalitis. In addition to La Crosse and Jamestown Canyon, 4 cases of additional California serogroup viruses were reported, as was 1 case of Cache Valley virus.
“Health care providers should consider arboviral infections in the differential diagnosis of cases of aseptic meningitis and encephalitis, obtain appropriate specimens for laboratory testing, and promptly report cases to public health authorities. Because human vaccines against domestic arboviruses are not available, prevention depends on community and household efforts to reduce vector populations, personal protective measures to decrease exposure to mosquitoes and ticks, and screening of blood donors,” the CDC investigators concluded.
Find the full report in the MMWR (doi: 10.15585/mmwr.mm6602a3).
FROM MORBIDITY AND MORTALITY REPORT
Marijuana calms children with autism
SAN FRANCISCO – About once a month, Antonio Y. Hardan, MD, and his colleagues at the Stanford (Calif.) University Autism and Developmental Disorders Clinic see an autistic child who is using or being prescribed marijuana.
“There are two types or responses we see with marijuana,” said Dr. Hardan, director of the clinic. “Most of the time, it calms the kid down for 2 or 3 hours, which is what you’d expect from marijuana. In one out of 10, I am hearing that parents see improvements in the core features of autism. We have several families who would swear by marijuana, but then 4 or 6 months later, they will change their mind and say it’s not helping as much.
Marijuana is just one of many alternatives families and doctors are trying to improve upon the usual medications and therapies for autism; the range of options being tried speaks to the desperation and frustration of families looking for help. There’s no home run so far; the common denominator for alternatives is anecdotal support but little evidence. Stanford has tried to address the evidence gap and continues to do so.
In 2012, for instance, Dr. Hardan and his colleagues reported a 33 patient study that found that N-acetylcysteine (NAC) – another hopeful candidate in recent years – might curb irritability (Biol Psychiatry. 2012 Jun 1;71[11]:956-61).
The tricky part about NAC is that it’s a dietary supplement, so you can’t be sure of what you’re getting in the store. There were questions at the talk about dose and formulations.
“The one we used in the study is made by BioAdvantex,” a Canadian company. “That’s the one that worked for us. One of the advantages is that every dose is wrapped individually.” NAC is an antioxidant, “so if you expose [it] to oxygen or light, it will get oxidized, and over time be less effective,” said Dr. Hardan, also a professor of psychiatry and behavioral sciences at the university.
Most of the time, NAC is very well tolerated, with only a little bit of flatulence and upset stomach.
Dr. Hardan and his colleagues started with 900 mg in one dose once a day for 4 weeks, then one dose twice a day for 4 weeks, followed by one dose three times daily, in children aged 2-12 years old. With experience, they are going faster now, cutting the 4 week interval to 2. “Some people are [even] more aggressive, which is okay,” he said.
Propranolol is another fashionable option, prescribed by a lot of doctors.
It’s not a new option; about 20 years ago, “we used it in very high dosages, 700-800 mg a day for self-injurious behavior. People wonder how you can go that high; above a dose of 200 mg, there is what we call an ‘escape phenomena’ where the heart will stop responding, and the effects on blood pressure and pulse are minimal,” Dr. Hardan said.
Interest in propranolol over the past 5 years has expanded to anxiety, sensory abnormalities, and other non-specific autism symptoms. “Unfortunately, there are no clinical trials to support that,” he said. The only evidence so far is from a functional MRI study in adults that suggested a little bit more efficient processing on a language task; further investigation is underway.
A lot of parents also are asking for oxytocin, and doctors are prescribing it. Someone in the audience wondered whether it had a role in everyday practice.
“Not at this time,” Dr. Hardan said. “I would suggest waiting a little bit until” results are reported from an ongoing trial. They are due soon, and there might be a subgroup of kids who benefit. Oxytocin seemed to help all-comers recognize facial cues.
Arginine vasopressin might do that, too, and be more specific for autism; Stanford is planning a study to look into it.
Attendees also wanted to know what to do about sleep problems, a common issue in autism.
“I’m aggressive in the treatment of insomnia, especially in single-parent households, because if the kid isn’t sleeping, the parent isn’t sleeping” and they may get irritable and moody, which raises the risk of abuse, Dr. Hardan said.
He starts with melatonin, 1 mg in the evening, and increases it by 1 mg every week to hit a target of 6 mg per night. He hasn’t seen much benefit of going higher. It’s important to remember that melatonin might take up to a week to see the full effect.
If melatonin fails, Dr. Hardan goes up the ladder. Diphenhydramine (Benadryl), benzodiazepines, trazodone (Oleptro), and mirtazapine (Remeron) are among the options. Rarely, there’s a need for quetiapine (Seroquel).
To counter benzodiazepine disinhibition, he asks parents to try them on a good day at home, so the effect of environmental stressors like going to the dentist can be divided out from the drug.
Dr. Hardan cautioned that there is “no evidence at this time to support the use of” lamotrigine (Lamictal). “Please don’t use it; somebody will end up developing” Stevens-Johnson syndrome. “It will be difficult to defend against that.”
Dr. Hardan is an adviser for Roche.
SAN FRANCISCO – About once a month, Antonio Y. Hardan, MD, and his colleagues at the Stanford (Calif.) University Autism and Developmental Disorders Clinic see an autistic child who is using or being prescribed marijuana.
“There are two types or responses we see with marijuana,” said Dr. Hardan, director of the clinic. “Most of the time, it calms the kid down for 2 or 3 hours, which is what you’d expect from marijuana. In one out of 10, I am hearing that parents see improvements in the core features of autism. We have several families who would swear by marijuana, but then 4 or 6 months later, they will change their mind and say it’s not helping as much.
Marijuana is just one of many alternatives families and doctors are trying to improve upon the usual medications and therapies for autism; the range of options being tried speaks to the desperation and frustration of families looking for help. There’s no home run so far; the common denominator for alternatives is anecdotal support but little evidence. Stanford has tried to address the evidence gap and continues to do so.
In 2012, for instance, Dr. Hardan and his colleagues reported a 33 patient study that found that N-acetylcysteine (NAC) – another hopeful candidate in recent years – might curb irritability (Biol Psychiatry. 2012 Jun 1;71[11]:956-61).
The tricky part about NAC is that it’s a dietary supplement, so you can’t be sure of what you’re getting in the store. There were questions at the talk about dose and formulations.
“The one we used in the study is made by BioAdvantex,” a Canadian company. “That’s the one that worked for us. One of the advantages is that every dose is wrapped individually.” NAC is an antioxidant, “so if you expose [it] to oxygen or light, it will get oxidized, and over time be less effective,” said Dr. Hardan, also a professor of psychiatry and behavioral sciences at the university.
Most of the time, NAC is very well tolerated, with only a little bit of flatulence and upset stomach.
Dr. Hardan and his colleagues started with 900 mg in one dose once a day for 4 weeks, then one dose twice a day for 4 weeks, followed by one dose three times daily, in children aged 2-12 years old. With experience, they are going faster now, cutting the 4 week interval to 2. “Some people are [even] more aggressive, which is okay,” he said.
Propranolol is another fashionable option, prescribed by a lot of doctors.
It’s not a new option; about 20 years ago, “we used it in very high dosages, 700-800 mg a day for self-injurious behavior. People wonder how you can go that high; above a dose of 200 mg, there is what we call an ‘escape phenomena’ where the heart will stop responding, and the effects on blood pressure and pulse are minimal,” Dr. Hardan said.
Interest in propranolol over the past 5 years has expanded to anxiety, sensory abnormalities, and other non-specific autism symptoms. “Unfortunately, there are no clinical trials to support that,” he said. The only evidence so far is from a functional MRI study in adults that suggested a little bit more efficient processing on a language task; further investigation is underway.
A lot of parents also are asking for oxytocin, and doctors are prescribing it. Someone in the audience wondered whether it had a role in everyday practice.
“Not at this time,” Dr. Hardan said. “I would suggest waiting a little bit until” results are reported from an ongoing trial. They are due soon, and there might be a subgroup of kids who benefit. Oxytocin seemed to help all-comers recognize facial cues.
Arginine vasopressin might do that, too, and be more specific for autism; Stanford is planning a study to look into it.
Attendees also wanted to know what to do about sleep problems, a common issue in autism.
“I’m aggressive in the treatment of insomnia, especially in single-parent households, because if the kid isn’t sleeping, the parent isn’t sleeping” and they may get irritable and moody, which raises the risk of abuse, Dr. Hardan said.
He starts with melatonin, 1 mg in the evening, and increases it by 1 mg every week to hit a target of 6 mg per night. He hasn’t seen much benefit of going higher. It’s important to remember that melatonin might take up to a week to see the full effect.
If melatonin fails, Dr. Hardan goes up the ladder. Diphenhydramine (Benadryl), benzodiazepines, trazodone (Oleptro), and mirtazapine (Remeron) are among the options. Rarely, there’s a need for quetiapine (Seroquel).
To counter benzodiazepine disinhibition, he asks parents to try them on a good day at home, so the effect of environmental stressors like going to the dentist can be divided out from the drug.
Dr. Hardan cautioned that there is “no evidence at this time to support the use of” lamotrigine (Lamictal). “Please don’t use it; somebody will end up developing” Stevens-Johnson syndrome. “It will be difficult to defend against that.”
Dr. Hardan is an adviser for Roche.
SAN FRANCISCO – About once a month, Antonio Y. Hardan, MD, and his colleagues at the Stanford (Calif.) University Autism and Developmental Disorders Clinic see an autistic child who is using or being prescribed marijuana.
“There are two types or responses we see with marijuana,” said Dr. Hardan, director of the clinic. “Most of the time, it calms the kid down for 2 or 3 hours, which is what you’d expect from marijuana. In one out of 10, I am hearing that parents see improvements in the core features of autism. We have several families who would swear by marijuana, but then 4 or 6 months later, they will change their mind and say it’s not helping as much.
Marijuana is just one of many alternatives families and doctors are trying to improve upon the usual medications and therapies for autism; the range of options being tried speaks to the desperation and frustration of families looking for help. There’s no home run so far; the common denominator for alternatives is anecdotal support but little evidence. Stanford has tried to address the evidence gap and continues to do so.
In 2012, for instance, Dr. Hardan and his colleagues reported a 33 patient study that found that N-acetylcysteine (NAC) – another hopeful candidate in recent years – might curb irritability (Biol Psychiatry. 2012 Jun 1;71[11]:956-61).
The tricky part about NAC is that it’s a dietary supplement, so you can’t be sure of what you’re getting in the store. There were questions at the talk about dose and formulations.
“The one we used in the study is made by BioAdvantex,” a Canadian company. “That’s the one that worked for us. One of the advantages is that every dose is wrapped individually.” NAC is an antioxidant, “so if you expose [it] to oxygen or light, it will get oxidized, and over time be less effective,” said Dr. Hardan, also a professor of psychiatry and behavioral sciences at the university.
Most of the time, NAC is very well tolerated, with only a little bit of flatulence and upset stomach.
Dr. Hardan and his colleagues started with 900 mg in one dose once a day for 4 weeks, then one dose twice a day for 4 weeks, followed by one dose three times daily, in children aged 2-12 years old. With experience, they are going faster now, cutting the 4 week interval to 2. “Some people are [even] more aggressive, which is okay,” he said.
Propranolol is another fashionable option, prescribed by a lot of doctors.
It’s not a new option; about 20 years ago, “we used it in very high dosages, 700-800 mg a day for self-injurious behavior. People wonder how you can go that high; above a dose of 200 mg, there is what we call an ‘escape phenomena’ where the heart will stop responding, and the effects on blood pressure and pulse are minimal,” Dr. Hardan said.
Interest in propranolol over the past 5 years has expanded to anxiety, sensory abnormalities, and other non-specific autism symptoms. “Unfortunately, there are no clinical trials to support that,” he said. The only evidence so far is from a functional MRI study in adults that suggested a little bit more efficient processing on a language task; further investigation is underway.
A lot of parents also are asking for oxytocin, and doctors are prescribing it. Someone in the audience wondered whether it had a role in everyday practice.
“Not at this time,” Dr. Hardan said. “I would suggest waiting a little bit until” results are reported from an ongoing trial. They are due soon, and there might be a subgroup of kids who benefit. Oxytocin seemed to help all-comers recognize facial cues.
Arginine vasopressin might do that, too, and be more specific for autism; Stanford is planning a study to look into it.
Attendees also wanted to know what to do about sleep problems, a common issue in autism.
“I’m aggressive in the treatment of insomnia, especially in single-parent households, because if the kid isn’t sleeping, the parent isn’t sleeping” and they may get irritable and moody, which raises the risk of abuse, Dr. Hardan said.
He starts with melatonin, 1 mg in the evening, and increases it by 1 mg every week to hit a target of 6 mg per night. He hasn’t seen much benefit of going higher. It’s important to remember that melatonin might take up to a week to see the full effect.
If melatonin fails, Dr. Hardan goes up the ladder. Diphenhydramine (Benadryl), benzodiazepines, trazodone (Oleptro), and mirtazapine (Remeron) are among the options. Rarely, there’s a need for quetiapine (Seroquel).
To counter benzodiazepine disinhibition, he asks parents to try them on a good day at home, so the effect of environmental stressors like going to the dentist can be divided out from the drug.
Dr. Hardan cautioned that there is “no evidence at this time to support the use of” lamotrigine (Lamictal). “Please don’t use it; somebody will end up developing” Stevens-Johnson syndrome. “It will be difficult to defend against that.”
Dr. Hardan is an adviser for Roche.
EXPERT ANALYSIS AT THE PSYCHOPHARMACOLOGY UPDATE INSTITUTE
Postpartum depression risk 20 times greater among women with depression history
Women with a history of depression have a risk of postpartum depression that is more than 20 times greater than women without such a history, according to Michael E. Silverman, PhD, and his associates. In addition, pre- and perinatal risk factors also raise the postpartum depression risk, they reported.
In a nationwide prospective cohort study, Dr. Silverman and his associates identified 707,701 women with live singleton births in Sweden from 1997-2008. Results showed that, compared with women without a history of depression, there was a statistically increased risk for postpartum depression in women with a history of depression (relative risk, 21.03; 95% confidence interval, 19.72-22.42).
Pregnancy length and depression history also proved significant in the mothers’ development of postpartum depression. The risk of postpartum depression, for example, was higher among women with a history of depression who gave birth before week 32 (RR, 1.12; 95% CI, 0.73-1.74), compared with women who gave birth before the 32nd week without a depression history (RR, 1.53; 95% CI, 1.12-2.10).
The existence of diabetic disease was another significant factor. Among women with gestational diabetes with a history of depression, the risk of postpartum depression was slightly higher (RR, 1.69; 95% CI, 1.18-2.43) than it was for women in that group without a depression history (RR, 1.67; 95% CI, 1.25-2.23). The differences were more dramatic among women with pregestational diabetes. Those with pregestational diabetes with a history of depression had a far greater risk of developing postpartum depression (RR, 1.49; 95% CI, 1.01-2.21) than did women with pregestational diabetes without a history of depression (RR, 1.16; 95% CI, 0.73-1.83), reported Dr. Silverman, of the department of psychiatry at the Icahn Medicine at Mount Sinai, New York, and his associates.
“For the first time, we show how maternal and obstetric risk factors for [postpartum depression] may differ between new mothers with and without a history of depression,” the investigators wrote. “Never shown before, some of the risks associated with obstetric and perinatal factors are modified by a history of depression, suggesting differences in the etiology of [postpartum depression] between women with and without a personal history of depression.”
Read the full study in Depression and Anxiety (doi: 10.1002/da.22597).
Women with a history of depression have a risk of postpartum depression that is more than 20 times greater than women without such a history, according to Michael E. Silverman, PhD, and his associates. In addition, pre- and perinatal risk factors also raise the postpartum depression risk, they reported.
In a nationwide prospective cohort study, Dr. Silverman and his associates identified 707,701 women with live singleton births in Sweden from 1997-2008. Results showed that, compared with women without a history of depression, there was a statistically increased risk for postpartum depression in women with a history of depression (relative risk, 21.03; 95% confidence interval, 19.72-22.42).
Pregnancy length and depression history also proved significant in the mothers’ development of postpartum depression. The risk of postpartum depression, for example, was higher among women with a history of depression who gave birth before week 32 (RR, 1.12; 95% CI, 0.73-1.74), compared with women who gave birth before the 32nd week without a depression history (RR, 1.53; 95% CI, 1.12-2.10).
The existence of diabetic disease was another significant factor. Among women with gestational diabetes with a history of depression, the risk of postpartum depression was slightly higher (RR, 1.69; 95% CI, 1.18-2.43) than it was for women in that group without a depression history (RR, 1.67; 95% CI, 1.25-2.23). The differences were more dramatic among women with pregestational diabetes. Those with pregestational diabetes with a history of depression had a far greater risk of developing postpartum depression (RR, 1.49; 95% CI, 1.01-2.21) than did women with pregestational diabetes without a history of depression (RR, 1.16; 95% CI, 0.73-1.83), reported Dr. Silverman, of the department of psychiatry at the Icahn Medicine at Mount Sinai, New York, and his associates.
“For the first time, we show how maternal and obstetric risk factors for [postpartum depression] may differ between new mothers with and without a history of depression,” the investigators wrote. “Never shown before, some of the risks associated with obstetric and perinatal factors are modified by a history of depression, suggesting differences in the etiology of [postpartum depression] between women with and without a personal history of depression.”
Read the full study in Depression and Anxiety (doi: 10.1002/da.22597).
Women with a history of depression have a risk of postpartum depression that is more than 20 times greater than women without such a history, according to Michael E. Silverman, PhD, and his associates. In addition, pre- and perinatal risk factors also raise the postpartum depression risk, they reported.
In a nationwide prospective cohort study, Dr. Silverman and his associates identified 707,701 women with live singleton births in Sweden from 1997-2008. Results showed that, compared with women without a history of depression, there was a statistically increased risk for postpartum depression in women with a history of depression (relative risk, 21.03; 95% confidence interval, 19.72-22.42).
Pregnancy length and depression history also proved significant in the mothers’ development of postpartum depression. The risk of postpartum depression, for example, was higher among women with a history of depression who gave birth before week 32 (RR, 1.12; 95% CI, 0.73-1.74), compared with women who gave birth before the 32nd week without a depression history (RR, 1.53; 95% CI, 1.12-2.10).
The existence of diabetic disease was another significant factor. Among women with gestational diabetes with a history of depression, the risk of postpartum depression was slightly higher (RR, 1.69; 95% CI, 1.18-2.43) than it was for women in that group without a depression history (RR, 1.67; 95% CI, 1.25-2.23). The differences were more dramatic among women with pregestational diabetes. Those with pregestational diabetes with a history of depression had a far greater risk of developing postpartum depression (RR, 1.49; 95% CI, 1.01-2.21) than did women with pregestational diabetes without a history of depression (RR, 1.16; 95% CI, 0.73-1.83), reported Dr. Silverman, of the department of psychiatry at the Icahn Medicine at Mount Sinai, New York, and his associates.
“For the first time, we show how maternal and obstetric risk factors for [postpartum depression] may differ between new mothers with and without a history of depression,” the investigators wrote. “Never shown before, some of the risks associated with obstetric and perinatal factors are modified by a history of depression, suggesting differences in the etiology of [postpartum depression] between women with and without a personal history of depression.”
Read the full study in Depression and Anxiety (doi: 10.1002/da.22597).
FROM DEPRESSION AND ANXIETY
Postop incentive spirometry had minimal impact on hypoxemia in bariatric surgery patients
The effect of incentive spirometry (IS) on postoperative hypoxemia in bariatric surgery patients was found to be insignificant, according to a randomized cohort study published in JAMA Surgery.
“At present, postoperative IS is considered the standard of care and is incorporated into standardized bariatric surgery recovery protocols,” wrote the authors of the study, led by Haddon Pantel, MD, of the Lahey Hospital and Medical Center in Burlington, Mass. “However, despite the ubiquitous use of IS in the postoperative period, data on its efficacy are conflicting, and high-quality evidence is lacking.” (JAMA Surg. doi:10.1001/jamasurg.2016.4981)
A total of 224 patients were evenly randomized into one of two cohorts; one cohort received no postoperative IS and acted as the control, while the other received postoperative IS. Patients from each of these cohorts were followed up at 6, 12, and 24 hours to measure SaO2 levels as a sign of hypoxemia, which was defined as a level of under 92%.
No significant differences were observed between the two cohorts at any of the three follow-up periods in terms of SaO2 levels. At 6 hours, hypoxemia incidence rates were 11.9% in the control group and 10.4% in the IS group (P = .72). At the 12-hour follow-up, the control group registered a 5.4% incidence rate, compared with 8.2% for those receiving postoperative IS (P = .40). And finally, at 24-hour follow-up, the control group had a 3.7% rate of hypoxemia, while those in the IS cohort had a 4.6% rate (P = .73). In addition, there were no significant differences observed in the average SaO2 levels between the two cohorts (P = .99, P = .40, and P = .69 at 6, 12, and 24 hours, respectively) nor was there a significantly higher rate of pulmonary complications in one cohort versus the other (P = .24).
The authors concluded, “With health care moving toward a more evidence-based, economically driven, and environmentally sustainable field, this study adds evidence to the concept that IS should not be universally used in all patients undergoing surgery and does not appear to be necessary in elective bariatric surgical procedures.”
The study was funded by Lahey Hospital and Medical Center’s department of general surgery; the authors reported no relevant financial disclosures.
The effect of incentive spirometry (IS) on postoperative hypoxemia in bariatric surgery patients was found to be insignificant, according to a randomized cohort study published in JAMA Surgery.
“At present, postoperative IS is considered the standard of care and is incorporated into standardized bariatric surgery recovery protocols,” wrote the authors of the study, led by Haddon Pantel, MD, of the Lahey Hospital and Medical Center in Burlington, Mass. “However, despite the ubiquitous use of IS in the postoperative period, data on its efficacy are conflicting, and high-quality evidence is lacking.” (JAMA Surg. doi:10.1001/jamasurg.2016.4981)
A total of 224 patients were evenly randomized into one of two cohorts; one cohort received no postoperative IS and acted as the control, while the other received postoperative IS. Patients from each of these cohorts were followed up at 6, 12, and 24 hours to measure SaO2 levels as a sign of hypoxemia, which was defined as a level of under 92%.
No significant differences were observed between the two cohorts at any of the three follow-up periods in terms of SaO2 levels. At 6 hours, hypoxemia incidence rates were 11.9% in the control group and 10.4% in the IS group (P = .72). At the 12-hour follow-up, the control group registered a 5.4% incidence rate, compared with 8.2% for those receiving postoperative IS (P = .40). And finally, at 24-hour follow-up, the control group had a 3.7% rate of hypoxemia, while those in the IS cohort had a 4.6% rate (P = .73). In addition, there were no significant differences observed in the average SaO2 levels between the two cohorts (P = .99, P = .40, and P = .69 at 6, 12, and 24 hours, respectively) nor was there a significantly higher rate of pulmonary complications in one cohort versus the other (P = .24).
The authors concluded, “With health care moving toward a more evidence-based, economically driven, and environmentally sustainable field, this study adds evidence to the concept that IS should not be universally used in all patients undergoing surgery and does not appear to be necessary in elective bariatric surgical procedures.”
The study was funded by Lahey Hospital and Medical Center’s department of general surgery; the authors reported no relevant financial disclosures.
The effect of incentive spirometry (IS) on postoperative hypoxemia in bariatric surgery patients was found to be insignificant, according to a randomized cohort study published in JAMA Surgery.
“At present, postoperative IS is considered the standard of care and is incorporated into standardized bariatric surgery recovery protocols,” wrote the authors of the study, led by Haddon Pantel, MD, of the Lahey Hospital and Medical Center in Burlington, Mass. “However, despite the ubiquitous use of IS in the postoperative period, data on its efficacy are conflicting, and high-quality evidence is lacking.” (JAMA Surg. doi:10.1001/jamasurg.2016.4981)
A total of 224 patients were evenly randomized into one of two cohorts; one cohort received no postoperative IS and acted as the control, while the other received postoperative IS. Patients from each of these cohorts were followed up at 6, 12, and 24 hours to measure SaO2 levels as a sign of hypoxemia, which was defined as a level of under 92%.
No significant differences were observed between the two cohorts at any of the three follow-up periods in terms of SaO2 levels. At 6 hours, hypoxemia incidence rates were 11.9% in the control group and 10.4% in the IS group (P = .72). At the 12-hour follow-up, the control group registered a 5.4% incidence rate, compared with 8.2% for those receiving postoperative IS (P = .40). And finally, at 24-hour follow-up, the control group had a 3.7% rate of hypoxemia, while those in the IS cohort had a 4.6% rate (P = .73). In addition, there were no significant differences observed in the average SaO2 levels between the two cohorts (P = .99, P = .40, and P = .69 at 6, 12, and 24 hours, respectively) nor was there a significantly higher rate of pulmonary complications in one cohort versus the other (P = .24).
The authors concluded, “With health care moving toward a more evidence-based, economically driven, and environmentally sustainable field, this study adds evidence to the concept that IS should not be universally used in all patients undergoing surgery and does not appear to be necessary in elective bariatric surgical procedures.”
The study was funded by Lahey Hospital and Medical Center’s department of general surgery; the authors reported no relevant financial disclosures.
FROM JAMA SURGERY
Key clinical point:
Major finding: No significant difference in hypoxemia frequency was found between postoperative IS and control cohorts at 6, 12, and 24-hour follow-ups (P = .72, .40, and .73, respectively).
Data source: A randomized, noninferiority cohort study of 224 bariatric surgery patients during May 2015 through June 2016.
Disclosures: Study funded by Lahey Hospital and Medical Center; authors reported no relevant financial disclosures.
MTX side effects limit patient use
Side effects in conjunction with inadequate disease control lead patients with plaque psoriasis to discontinue methotrexate (MTX) treatment, Dr. Marisol Otero and her colleagues reported.
The investigators identified 85 adult patients with plaque psoriasis from the Continuous Assessment of Psoriasis Treatment Use Registry With Methotrexate (MTX-CAPTURE) who had been treated with MTX for up to of 5.2 years. All had been started on MTX in accordance with Dutch and European guidelines.
Dose adjustments during treatment were made at physicians’ discretion and most patients (84) received folic acid supplements to protect against gastrointestinal side effects. Patients were required to have at least one follow up session with their physician during the study, according to Dr. Otero of the department of dermatology at Radboud University, Nijmegen, the Netherlands, and her colleagues.
At the end of 5 years, 55 patients (64.7%) had discontinued MTX, defined as cessation of MTX for more than 90 days or addition of another systemic psoriasis medication (Br J Dermatol. doi: 10.1111/bjd.15305).
Of the patients who discontinued treatment, 19 (34.5%) did so solely because of side effects, 14 (25.5%) discontinued because of lack of efficacy, and 7 (12.7%) cited the combination of side effects and ineffectiveness. Nine (16.4%) decided to end treatment for other reasons including personal decision, desire for pregnancy, and clinically inactive disease. Six (10.9%) were lost to for follow-up.
Side effects alone were the primary determinant in drug survival, with an overall drug survival rate for MTX of 1.8 years, Dr. Otero noted.
“It was remarkable that discontinuation due to side effects and ineffectiveness, were both common, while our hypothesis was that drug survival of MTX would be mainly limited by side effects,” the investigators said. “Side effects alone or in combination with inadequate disease control were more important in the context of treatment discontinuation than inadequate disease control solely.”
Side effects in conjunction with inadequate disease control lead patients with plaque psoriasis to discontinue methotrexate (MTX) treatment, Dr. Marisol Otero and her colleagues reported.
The investigators identified 85 adult patients with plaque psoriasis from the Continuous Assessment of Psoriasis Treatment Use Registry With Methotrexate (MTX-CAPTURE) who had been treated with MTX for up to of 5.2 years. All had been started on MTX in accordance with Dutch and European guidelines.
Dose adjustments during treatment were made at physicians’ discretion and most patients (84) received folic acid supplements to protect against gastrointestinal side effects. Patients were required to have at least one follow up session with their physician during the study, according to Dr. Otero of the department of dermatology at Radboud University, Nijmegen, the Netherlands, and her colleagues.
At the end of 5 years, 55 patients (64.7%) had discontinued MTX, defined as cessation of MTX for more than 90 days or addition of another systemic psoriasis medication (Br J Dermatol. doi: 10.1111/bjd.15305).
Of the patients who discontinued treatment, 19 (34.5%) did so solely because of side effects, 14 (25.5%) discontinued because of lack of efficacy, and 7 (12.7%) cited the combination of side effects and ineffectiveness. Nine (16.4%) decided to end treatment for other reasons including personal decision, desire for pregnancy, and clinically inactive disease. Six (10.9%) were lost to for follow-up.
Side effects alone were the primary determinant in drug survival, with an overall drug survival rate for MTX of 1.8 years, Dr. Otero noted.
“It was remarkable that discontinuation due to side effects and ineffectiveness, were both common, while our hypothesis was that drug survival of MTX would be mainly limited by side effects,” the investigators said. “Side effects alone or in combination with inadequate disease control were more important in the context of treatment discontinuation than inadequate disease control solely.”
Side effects in conjunction with inadequate disease control lead patients with plaque psoriasis to discontinue methotrexate (MTX) treatment, Dr. Marisol Otero and her colleagues reported.
The investigators identified 85 adult patients with plaque psoriasis from the Continuous Assessment of Psoriasis Treatment Use Registry With Methotrexate (MTX-CAPTURE) who had been treated with MTX for up to of 5.2 years. All had been started on MTX in accordance with Dutch and European guidelines.
Dose adjustments during treatment were made at physicians’ discretion and most patients (84) received folic acid supplements to protect against gastrointestinal side effects. Patients were required to have at least one follow up session with their physician during the study, according to Dr. Otero of the department of dermatology at Radboud University, Nijmegen, the Netherlands, and her colleagues.
At the end of 5 years, 55 patients (64.7%) had discontinued MTX, defined as cessation of MTX for more than 90 days or addition of another systemic psoriasis medication (Br J Dermatol. doi: 10.1111/bjd.15305).
Of the patients who discontinued treatment, 19 (34.5%) did so solely because of side effects, 14 (25.5%) discontinued because of lack of efficacy, and 7 (12.7%) cited the combination of side effects and ineffectiveness. Nine (16.4%) decided to end treatment for other reasons including personal decision, desire for pregnancy, and clinically inactive disease. Six (10.9%) were lost to for follow-up.
Side effects alone were the primary determinant in drug survival, with an overall drug survival rate for MTX of 1.8 years, Dr. Otero noted.
“It was remarkable that discontinuation due to side effects and ineffectiveness, were both common, while our hypothesis was that drug survival of MTX would be mainly limited by side effects,” the investigators said. “Side effects alone or in combination with inadequate disease control were more important in the context of treatment discontinuation than inadequate disease control solely.”
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point:
Major finding: More than one-third (34.5%) of patients stopped MTX because of side effects while more than a quarter (25.5%) did so due to lack of efficacy.
Data source: Analysis of 85 patients from a prospective noninterventional daily practice registry.
Disclosures: The study received no external funding. Dr. Otero has worked as a consultant for Eli Lilly. Other investigators reported consultancies and/or clinical trial work with multiple major pharmaceutical companies.
5% dextrose speeds induced-labor delivery
LAS VEGAS – Adding 5% dextrose to the hydrating solution given to women undergoing induced labor safely led to a median 76-minute decrease in labor duration in a single-center randomized study.
Normal saline with 5% dextrose “should be considered the default solute during labor induction in nulliparous women,” Josianne Paré, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “The uterus is a muscle, and glucose is its main energy substrate.”
During January 2013 to January 2015, women who met these criteria and required induction received either normal saline or normal saline plus 5% dextrose when they began their oxytocin drip, at a rate of 250 mL/hour.
Treatment with the assigned hydrating solutions continued until delivery or C-section. Participants averaged 28 years old, their average body mass index was 26 kg/m2 and average birth weight was about 3,450 g.
The study’s primary outcome was total duration of labor. This was a median of 423 minutes in 96 women who received dextrose and were available for analysis, and a median of 499 minutes in 97 evaluable women who received the saline control, a median difference of 76 minutes that was statistically significant, Dr. Paré reported. Most of the difference in labor duration happened during the first stage, which showed a median 70-minute reduction between the control group and the women receiving dextrose.
“These results support findings from prior studies. Women need glucose during labor,” Elliott Main, MD, commented in an interview. “There is no evidence for a need to exclude glucose from intravenous fluids. Adding some form of glucose is not standard practice today, but the time has come to do it, either by adding glucose to hydrating fluid or have women in labor eat and drink more,” said Dr. Main, medical director of the California Maternal Quality Care Collaborative in Stanford.
Dr. Paré reported having no financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
LAS VEGAS – Adding 5% dextrose to the hydrating solution given to women undergoing induced labor safely led to a median 76-minute decrease in labor duration in a single-center randomized study.
Normal saline with 5% dextrose “should be considered the default solute during labor induction in nulliparous women,” Josianne Paré, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “The uterus is a muscle, and glucose is its main energy substrate.”
During January 2013 to January 2015, women who met these criteria and required induction received either normal saline or normal saline plus 5% dextrose when they began their oxytocin drip, at a rate of 250 mL/hour.
Treatment with the assigned hydrating solutions continued until delivery or C-section. Participants averaged 28 years old, their average body mass index was 26 kg/m2 and average birth weight was about 3,450 g.
The study’s primary outcome was total duration of labor. This was a median of 423 minutes in 96 women who received dextrose and were available for analysis, and a median of 499 minutes in 97 evaluable women who received the saline control, a median difference of 76 minutes that was statistically significant, Dr. Paré reported. Most of the difference in labor duration happened during the first stage, which showed a median 70-minute reduction between the control group and the women receiving dextrose.
“These results support findings from prior studies. Women need glucose during labor,” Elliott Main, MD, commented in an interview. “There is no evidence for a need to exclude glucose from intravenous fluids. Adding some form of glucose is not standard practice today, but the time has come to do it, either by adding glucose to hydrating fluid or have women in labor eat and drink more,” said Dr. Main, medical director of the California Maternal Quality Care Collaborative in Stanford.
Dr. Paré reported having no financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
LAS VEGAS – Adding 5% dextrose to the hydrating solution given to women undergoing induced labor safely led to a median 76-minute decrease in labor duration in a single-center randomized study.
Normal saline with 5% dextrose “should be considered the default solute during labor induction in nulliparous women,” Josianne Paré, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. “The uterus is a muscle, and glucose is its main energy substrate.”
During January 2013 to January 2015, women who met these criteria and required induction received either normal saline or normal saline plus 5% dextrose when they began their oxytocin drip, at a rate of 250 mL/hour.
Treatment with the assigned hydrating solutions continued until delivery or C-section. Participants averaged 28 years old, their average body mass index was 26 kg/m2 and average birth weight was about 3,450 g.
The study’s primary outcome was total duration of labor. This was a median of 423 minutes in 96 women who received dextrose and were available for analysis, and a median of 499 minutes in 97 evaluable women who received the saline control, a median difference of 76 minutes that was statistically significant, Dr. Paré reported. Most of the difference in labor duration happened during the first stage, which showed a median 70-minute reduction between the control group and the women receiving dextrose.
“These results support findings from prior studies. Women need glucose during labor,” Elliott Main, MD, commented in an interview. “There is no evidence for a need to exclude glucose from intravenous fluids. Adding some form of glucose is not standard practice today, but the time has come to do it, either by adding glucose to hydrating fluid or have women in labor eat and drink more,” said Dr. Main, medical director of the California Maternal Quality Care Collaborative in Stanford.
Dr. Paré reported having no financial disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Median labor duration fell by 76 minutes among women who received 5% dextrose, compared with controls.
Data source: DEXTRONS, a single-center, randomized study that enrolled 200 pregnant women.
Disclosures: Dr. Paré reported having no financial disclosures.
Universal cervical length screening reduces preterm birth rate
LAS VEGAS – Universal cervical length screening by transvaginal ultrasound in a low-risk cohort resulted in a significant reduction in spontaneous preterm births.
In a single-center retrospective cohort study of more than 13,000 deliveries, the overall preterm birth rate decreased from 3.8% to 2.4% on implementation of universal cervical length screening (P less than .001).
Screening reduced the numbers of both early and late preterm birth rates. Preterm births occurring earlier than 28 weeks’ gestation dropped from 0.3% to 0.1% (P = .04); preterm births before 34 weeks dropped from 1% to 0.5% (P less than .001); and preterm births before 37 weeks dropped from 2.5% to 1.8% (P = .004).
The data were presented by Alex Argyelan, MD, an ob.gyn. resident at St. Joseph Mercy Hospital–Ann Arbor, Mich., at the Annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Argyelan noted that the current Society for Maternal-Fetal Medicine (SMFM) position regarding cervical length screening is that it should not yet be universally mandated for singleton pregnancies without a prior history of preterm birth. However, a 2016 SMFM guideline stated, “Nonetheless, implementation of such a screening strategy can be viewed as reasonable and can be considered by individual practitioners.” This statement was made, he said, in recognition of the fact that “a sonographic short cervix is a powerful predictor of spontaneous preterm birth,” and that progesterone administration for gravid women with shortening cervixes can, for many, forestall spontaneous preterm labor.
First author Pooja Mittal Green, MD, a maternal-fetal medicine specialist at St. Joseph Mercy Hospital, and her associates looked at preterm delivery data before and after implementation of a universal cervical length screening protocol at a single tertiary referral center. The data collection period spanned from January 2013 to May 2014, with implementation of universal cervical length screening in October 2014.
A total of 13,396 women were included in the study, with a small minority of just 0.5% having experienced a prior spontaneous preterm birth. The mean patient age was just under 30 years; most patients were white, mirroring the demographics of the county where the study took place. Pre- and postintervention patient characteristics did not vary significantly.
Almost all patients agreed to cervical length screening by ultrasound, with the numbers climbing from 93% during the first year after implementing the universal screening protocol, to 99.2% in 2016.
All of the sonographers participating in the study were Cervical Length Education and Review (CLEAR) certified, and the institution’s lead sonographer carried out a ongoing quality assurance program.
A shortened cervix (25 mm or less) was found in a total of 114 women (1.7%) who underwent cervical length screening. According to the protocol, if maternal cervical length was 25 mm or less, women were offered treatment to attempt to stave off preterm delivery, according to the usual standard of care.
For women with no prior history of preterm delivery, treatment was vaginal progesterone. For women who had a prior preterm birth, cervical cerclage was offered, as well as vaginal progesterone if the patient was not already on 17-alpha-hydroxyprogesterone caproate.
The determination whether spontaneous preterm birth had occurred was made by reviewing labor and delivery birth logs, with a subsequent individual chart review to make sure that the delivery happened after either spontaneous labor or preterm premature rupture of membranes.
Only women who received prenatal care at the study institution were included in the study, and women who had not received any prenatal care were excluded.
Dr. Argyelan and his colleagues did not see any significant differences between the preterm and term delivery groups in maternal age, body mass index, or ethnicity.
“Among spontaneous preterm deliveries in low-risk women, the proportion of deliveries before 34 weeks was decreased” after the intervention, said Dr. Argyelan, who reported seeing a decrease from 28% early (less than 34 weeks’ gestation) preterm births before the intervention to 17% after the intervention.
In response to an audience question, Dr. Argyelan noted that his institution charges $186 for an ultrasound examination that includes assessment of cervical length, saying, “We have not had significant issues being reimbursed.”
Another audience member asked what the institution policy had been before the universal screening program was implemented. “Before the universal screening study, there was a policy of screening those with a history of preterm birth; also, if sonographers saw what looked like a short cervix on transabdominal exam, then they would do a transvaginal scan to further assess the cervix,” Dr. Argyelan said.
Dr. Argyelan reported having no financial disclosures.
koakes@frontlinemedcom.com
On Twitter @karioakes
LAS VEGAS – Universal cervical length screening by transvaginal ultrasound in a low-risk cohort resulted in a significant reduction in spontaneous preterm births.
In a single-center retrospective cohort study of more than 13,000 deliveries, the overall preterm birth rate decreased from 3.8% to 2.4% on implementation of universal cervical length screening (P less than .001).
Screening reduced the numbers of both early and late preterm birth rates. Preterm births occurring earlier than 28 weeks’ gestation dropped from 0.3% to 0.1% (P = .04); preterm births before 34 weeks dropped from 1% to 0.5% (P less than .001); and preterm births before 37 weeks dropped from 2.5% to 1.8% (P = .004).
The data were presented by Alex Argyelan, MD, an ob.gyn. resident at St. Joseph Mercy Hospital–Ann Arbor, Mich., at the Annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Argyelan noted that the current Society for Maternal-Fetal Medicine (SMFM) position regarding cervical length screening is that it should not yet be universally mandated for singleton pregnancies without a prior history of preterm birth. However, a 2016 SMFM guideline stated, “Nonetheless, implementation of such a screening strategy can be viewed as reasonable and can be considered by individual practitioners.” This statement was made, he said, in recognition of the fact that “a sonographic short cervix is a powerful predictor of spontaneous preterm birth,” and that progesterone administration for gravid women with shortening cervixes can, for many, forestall spontaneous preterm labor.
First author Pooja Mittal Green, MD, a maternal-fetal medicine specialist at St. Joseph Mercy Hospital, and her associates looked at preterm delivery data before and after implementation of a universal cervical length screening protocol at a single tertiary referral center. The data collection period spanned from January 2013 to May 2014, with implementation of universal cervical length screening in October 2014.
A total of 13,396 women were included in the study, with a small minority of just 0.5% having experienced a prior spontaneous preterm birth. The mean patient age was just under 30 years; most patients were white, mirroring the demographics of the county where the study took place. Pre- and postintervention patient characteristics did not vary significantly.
Almost all patients agreed to cervical length screening by ultrasound, with the numbers climbing from 93% during the first year after implementing the universal screening protocol, to 99.2% in 2016.
All of the sonographers participating in the study were Cervical Length Education and Review (CLEAR) certified, and the institution’s lead sonographer carried out a ongoing quality assurance program.
A shortened cervix (25 mm or less) was found in a total of 114 women (1.7%) who underwent cervical length screening. According to the protocol, if maternal cervical length was 25 mm or less, women were offered treatment to attempt to stave off preterm delivery, according to the usual standard of care.
For women with no prior history of preterm delivery, treatment was vaginal progesterone. For women who had a prior preterm birth, cervical cerclage was offered, as well as vaginal progesterone if the patient was not already on 17-alpha-hydroxyprogesterone caproate.
The determination whether spontaneous preterm birth had occurred was made by reviewing labor and delivery birth logs, with a subsequent individual chart review to make sure that the delivery happened after either spontaneous labor or preterm premature rupture of membranes.
Only women who received prenatal care at the study institution were included in the study, and women who had not received any prenatal care were excluded.
Dr. Argyelan and his colleagues did not see any significant differences between the preterm and term delivery groups in maternal age, body mass index, or ethnicity.
“Among spontaneous preterm deliveries in low-risk women, the proportion of deliveries before 34 weeks was decreased” after the intervention, said Dr. Argyelan, who reported seeing a decrease from 28% early (less than 34 weeks’ gestation) preterm births before the intervention to 17% after the intervention.
In response to an audience question, Dr. Argyelan noted that his institution charges $186 for an ultrasound examination that includes assessment of cervical length, saying, “We have not had significant issues being reimbursed.”
Another audience member asked what the institution policy had been before the universal screening program was implemented. “Before the universal screening study, there was a policy of screening those with a history of preterm birth; also, if sonographers saw what looked like a short cervix on transabdominal exam, then they would do a transvaginal scan to further assess the cervix,” Dr. Argyelan said.
Dr. Argyelan reported having no financial disclosures.
koakes@frontlinemedcom.com
On Twitter @karioakes
LAS VEGAS – Universal cervical length screening by transvaginal ultrasound in a low-risk cohort resulted in a significant reduction in spontaneous preterm births.
In a single-center retrospective cohort study of more than 13,000 deliveries, the overall preterm birth rate decreased from 3.8% to 2.4% on implementation of universal cervical length screening (P less than .001).
Screening reduced the numbers of both early and late preterm birth rates. Preterm births occurring earlier than 28 weeks’ gestation dropped from 0.3% to 0.1% (P = .04); preterm births before 34 weeks dropped from 1% to 0.5% (P less than .001); and preterm births before 37 weeks dropped from 2.5% to 1.8% (P = .004).
The data were presented by Alex Argyelan, MD, an ob.gyn. resident at St. Joseph Mercy Hospital–Ann Arbor, Mich., at the Annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. Dr. Argyelan noted that the current Society for Maternal-Fetal Medicine (SMFM) position regarding cervical length screening is that it should not yet be universally mandated for singleton pregnancies without a prior history of preterm birth. However, a 2016 SMFM guideline stated, “Nonetheless, implementation of such a screening strategy can be viewed as reasonable and can be considered by individual practitioners.” This statement was made, he said, in recognition of the fact that “a sonographic short cervix is a powerful predictor of spontaneous preterm birth,” and that progesterone administration for gravid women with shortening cervixes can, for many, forestall spontaneous preterm labor.
First author Pooja Mittal Green, MD, a maternal-fetal medicine specialist at St. Joseph Mercy Hospital, and her associates looked at preterm delivery data before and after implementation of a universal cervical length screening protocol at a single tertiary referral center. The data collection period spanned from January 2013 to May 2014, with implementation of universal cervical length screening in October 2014.
A total of 13,396 women were included in the study, with a small minority of just 0.5% having experienced a prior spontaneous preterm birth. The mean patient age was just under 30 years; most patients were white, mirroring the demographics of the county where the study took place. Pre- and postintervention patient characteristics did not vary significantly.
Almost all patients agreed to cervical length screening by ultrasound, with the numbers climbing from 93% during the first year after implementing the universal screening protocol, to 99.2% in 2016.
All of the sonographers participating in the study were Cervical Length Education and Review (CLEAR) certified, and the institution’s lead sonographer carried out a ongoing quality assurance program.
A shortened cervix (25 mm or less) was found in a total of 114 women (1.7%) who underwent cervical length screening. According to the protocol, if maternal cervical length was 25 mm or less, women were offered treatment to attempt to stave off preterm delivery, according to the usual standard of care.
For women with no prior history of preterm delivery, treatment was vaginal progesterone. For women who had a prior preterm birth, cervical cerclage was offered, as well as vaginal progesterone if the patient was not already on 17-alpha-hydroxyprogesterone caproate.
The determination whether spontaneous preterm birth had occurred was made by reviewing labor and delivery birth logs, with a subsequent individual chart review to make sure that the delivery happened after either spontaneous labor or preterm premature rupture of membranes.
Only women who received prenatal care at the study institution were included in the study, and women who had not received any prenatal care were excluded.
Dr. Argyelan and his colleagues did not see any significant differences between the preterm and term delivery groups in maternal age, body mass index, or ethnicity.
“Among spontaneous preterm deliveries in low-risk women, the proportion of deliveries before 34 weeks was decreased” after the intervention, said Dr. Argyelan, who reported seeing a decrease from 28% early (less than 34 weeks’ gestation) preterm births before the intervention to 17% after the intervention.
In response to an audience question, Dr. Argyelan noted that his institution charges $186 for an ultrasound examination that includes assessment of cervical length, saying, “We have not had significant issues being reimbursed.”
Another audience member asked what the institution policy had been before the universal screening program was implemented. “Before the universal screening study, there was a policy of screening those with a history of preterm birth; also, if sonographers saw what looked like a short cervix on transabdominal exam, then they would do a transvaginal scan to further assess the cervix,” Dr. Argyelan said.
Dr. Argyelan reported having no financial disclosures.
koakes@frontlinemedcom.com
On Twitter @karioakes
AT THE ANNUAL PREGNANCY MEETING
Key clinical point:
Major finding: Preterm births dropped from 3.8% to 2.4% (P less than .001) after implementing a universal cervical length screening program.
Data source: Retrospective single-site cohort study of 13,396 singleton pregnancies.
Disclosures: Dr. Argyelan reported having no financial disclosures.
CHMP recommends lenalidomide maintenance
Photo courtesy of Celgene
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a new indication for lenalidomide (Revlimid®).
The CHMP advised the European Commission (EC) to approve the use of lenalidomide as maintenance therapy in adults who had newly diagnosed multiple myeloma (MM) prior to receiving an autologous stem cell transplant (ASCT).
If approved by the EC, lenalidomide will be the first licensed maintenance treatment available to this patient population in the European Union.
The EC, which generally follows the CHMP’s recommendations, is expected to make its final decision on this use of lenalidomide in approximately 2 months.
If approval is granted, detailed conditions for the use of lenalidomide will be described in the Summary of Product Characteristics, which will be published in the revised European Public Assessment Report.
Lenalidomide is a product of Celgene.
The CHMP’s recommendation to approve lenalidomide as maintenance in MM was based on the results of 2 cooperative group-led studies, CALGB 10010410 and IFM 2005-0211. Results from both studies were published in NEJM in May 2012.
CALGB 100104 was a phase 3, double-blind study of 460 patients with newly diagnosed MM undergoing ASCT. The patients received continuous daily treatment with lenalidomide or placebo until relapse.
IFM 2005-02 was a phase 3, double-blind study of 614 patients newly diagnosed with MM. The patients were randomized to receive a 2-month consolidation regimen post-ASCT of lenalidomide monotherapy, followed by continuous daily treatment with lenalidomide or placebo until relapse.
“Studies show that maintenance treatment after ASCT with Revlimid may help control residual malignant cells and delay tumor growth by enhancing immune function,” said Michel Attal, MD, of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud in France.
“Our primary goal is to delay disease progression for as long as possible, and we have seen in several independent studies that Revlimid maintenance after ASCT can halve the risk of disease progression by sustaining the response.” 
Photo courtesy of Celgene
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a new indication for lenalidomide (Revlimid®).
The CHMP advised the European Commission (EC) to approve the use of lenalidomide as maintenance therapy in adults who had newly diagnosed multiple myeloma (MM) prior to receiving an autologous stem cell transplant (ASCT).
If approved by the EC, lenalidomide will be the first licensed maintenance treatment available to this patient population in the European Union.
The EC, which generally follows the CHMP’s recommendations, is expected to make its final decision on this use of lenalidomide in approximately 2 months.
If approval is granted, detailed conditions for the use of lenalidomide will be described in the Summary of Product Characteristics, which will be published in the revised European Public Assessment Report.
Lenalidomide is a product of Celgene.
The CHMP’s recommendation to approve lenalidomide as maintenance in MM was based on the results of 2 cooperative group-led studies, CALGB 10010410 and IFM 2005-0211. Results from both studies were published in NEJM in May 2012.
CALGB 100104 was a phase 3, double-blind study of 460 patients with newly diagnosed MM undergoing ASCT. The patients received continuous daily treatment with lenalidomide or placebo until relapse.
IFM 2005-02 was a phase 3, double-blind study of 614 patients newly diagnosed with MM. The patients were randomized to receive a 2-month consolidation regimen post-ASCT of lenalidomide monotherapy, followed by continuous daily treatment with lenalidomide or placebo until relapse.
“Studies show that maintenance treatment after ASCT with Revlimid may help control residual malignant cells and delay tumor growth by enhancing immune function,” said Michel Attal, MD, of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud in France.
“Our primary goal is to delay disease progression for as long as possible, and we have seen in several independent studies that Revlimid maintenance after ASCT can halve the risk of disease progression by sustaining the response.”
Photo courtesy of Celgene
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a new indication for lenalidomide (Revlimid®).
The CHMP advised the European Commission (EC) to approve the use of lenalidomide as maintenance therapy in adults who had newly diagnosed multiple myeloma (MM) prior to receiving an autologous stem cell transplant (ASCT).
If approved by the EC, lenalidomide will be the first licensed maintenance treatment available to this patient population in the European Union.
The EC, which generally follows the CHMP’s recommendations, is expected to make its final decision on this use of lenalidomide in approximately 2 months.
If approval is granted, detailed conditions for the use of lenalidomide will be described in the Summary of Product Characteristics, which will be published in the revised European Public Assessment Report.
Lenalidomide is a product of Celgene.
The CHMP’s recommendation to approve lenalidomide as maintenance in MM was based on the results of 2 cooperative group-led studies, CALGB 10010410 and IFM 2005-0211. Results from both studies were published in NEJM in May 2012.
CALGB 100104 was a phase 3, double-blind study of 460 patients with newly diagnosed MM undergoing ASCT. The patients received continuous daily treatment with lenalidomide or placebo until relapse.
IFM 2005-02 was a phase 3, double-blind study of 614 patients newly diagnosed with MM. The patients were randomized to receive a 2-month consolidation regimen post-ASCT of lenalidomide monotherapy, followed by continuous daily treatment with lenalidomide or placebo until relapse.
“Studies show that maintenance treatment after ASCT with Revlimid may help control residual malignant cells and delay tumor growth by enhancing immune function,” said Michel Attal, MD, of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud in France.
“Our primary goal is to delay disease progression for as long as possible, and we have seen in several independent studies that Revlimid maintenance after ASCT can halve the risk of disease progression by sustaining the response.”