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VIDEO: New directions in treating adult ADHD
CHICAGO – What are the most important side effects to be aware of when medically treating adult attention-deficit/hyperactivity disorder? What are the most common comorbidities and how should they be treated? And what is the latest in nonpharmaceutical, as well as emerging medical treatment for what Dr. Anthony L. Rostain, a professor of psychiatry at the University of Pennsylvania, Philadelphia, says is not a disease but a disorder?
In this video interview, recorded at Psychiatry Update 2015, sponsored by Current Psychiatry and the American Academy of Clinical Psychiatrists, Dr. Rostain shares what excites him most about emerging treatments for adult ADHD and what clinicians should be most concerned about when prescribing. He also discusses how ADHD overlaps with Tourette syndrome.
Current Psychiatry and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
CHICAGO – What are the most important side effects to be aware of when medically treating adult attention-deficit/hyperactivity disorder? What are the most common comorbidities and how should they be treated? And what is the latest in nonpharmaceutical, as well as emerging medical treatment for what Dr. Anthony L. Rostain, a professor of psychiatry at the University of Pennsylvania, Philadelphia, says is not a disease but a disorder?
In this video interview, recorded at Psychiatry Update 2015, sponsored by Current Psychiatry and the American Academy of Clinical Psychiatrists, Dr. Rostain shares what excites him most about emerging treatments for adult ADHD and what clinicians should be most concerned about when prescribing. He also discusses how ADHD overlaps with Tourette syndrome.
Current Psychiatry and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
CHICAGO – What are the most important side effects to be aware of when medically treating adult attention-deficit/hyperactivity disorder? What are the most common comorbidities and how should they be treated? And what is the latest in nonpharmaceutical, as well as emerging medical treatment for what Dr. Anthony L. Rostain, a professor of psychiatry at the University of Pennsylvania, Philadelphia, says is not a disease but a disorder?
In this video interview, recorded at Psychiatry Update 2015, sponsored by Current Psychiatry and the American Academy of Clinical Psychiatrists, Dr. Rostain shares what excites him most about emerging treatments for adult ADHD and what clinicians should be most concerned about when prescribing. He also discusses how ADHD overlaps with Tourette syndrome.
Current Psychiatry and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
AT PSYCHIATRY UPDATE 2015
Mortality, outcomes good in AAA repair in octogenarians
SCOTTSDALE, ARIZ.– Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.
Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.
According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting.
“However, whether we should be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria; there were nearly seven men for every woman, all with a median age of 83 years. Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).
Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation–related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.
A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).
Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data were warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”
The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.
“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.
As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost-effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”
“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within 6 months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”
On Twitter @whitneymcknight
This discussion is provocative and raises some interesting points. Obviously cost-effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.
This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.
 |
Dr. Frank J. Veith |
I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.
Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.
This discussion is provocative and raises some interesting points. Obviously cost-effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.
This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.
|
Dr. Frank J. Veith |
I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.
Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.
This discussion is provocative and raises some interesting points. Obviously cost-effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.
This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.
|
Dr. Frank J. Veith |
I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.
Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.
SCOTTSDALE, ARIZ.– Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.
Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.
According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting.
“However, whether we should be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria; there were nearly seven men for every woman, all with a median age of 83 years. Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).
Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation–related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.
A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).
Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data were warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”
The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.
“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.
As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost-effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”
“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within 6 months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ.– Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.
Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.
According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting.
“However, whether we should be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria; there were nearly seven men for every woman, all with a median age of 83 years. Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).
Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation–related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.
A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).
Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data were warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”
The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.
“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.
As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost-effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”
“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within 6 months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”
On Twitter @whitneymcknight
VIDEO: Interventions improve social functioning in schizophrenia
COLORADO SPRINGS – What kinds of early social interventions and cognitive remediation work to improve outcomes in schizophrenia? What’s the importance of stable medication regimens and psychoeducation for family members? Learn the answers to these questions and more in this discussion between Dr. S. Charles Schulz, head of the department of psychiatry at the University of Minnesota, Minneapolis, and his colleague Michael F. Green, Ph.D., who is head of the Green Lab at the University of California, Los Angeles, which was recorded at the International Congress on Schizophrenia Research.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
COLORADO SPRINGS – What kinds of early social interventions and cognitive remediation work to improve outcomes in schizophrenia? What’s the importance of stable medication regimens and psychoeducation for family members? Learn the answers to these questions and more in this discussion between Dr. S. Charles Schulz, head of the department of psychiatry at the University of Minnesota, Minneapolis, and his colleague Michael F. Green, Ph.D., who is head of the Green Lab at the University of California, Los Angeles, which was recorded at the International Congress on Schizophrenia Research.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
COLORADO SPRINGS – What kinds of early social interventions and cognitive remediation work to improve outcomes in schizophrenia? What’s the importance of stable medication regimens and psychoeducation for family members? Learn the answers to these questions and more in this discussion between Dr. S. Charles Schulz, head of the department of psychiatry at the University of Minnesota, Minneapolis, and his colleague Michael F. Green, Ph.D., who is head of the Green Lab at the University of California, Los Angeles, which was recorded at the International Congress on Schizophrenia Research.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE ICSR BIENNIAL MEETING
Try exposure therapy, SSRIs for PTSD
LAS VEGAS– There is no cure for posttraumatic stress disorder, but helping its sufferers reduce symptoms, improve resistance, and achieve a better quality of life is possible.
“We have no idea what the best treatments are for PTSD,” Dr. Charles B. Nemeroff, the Leonard M. Miller Professor, and chairman of the department of psychiatry and behavioral sciences at the University of Miami, told an audience at the annual psychopharmacology update held by the Nevada Psychiatric Association.
Whether to rely upon psychosocial or pharmacologic interventions, or a combination of the two, to help shift PTSD from a debilitating condition into a manageable, chronic one, it is important to understand PTSD as a brain disease. “To accurately treat PTSD, consider it within a neurobiological context,” Dr. Nemeroff said. “Ordinarily, the brain is evolved to deal with stress, but it can be compromised.”
In chronic PTSD, brain studies have shown a noted shrinkage in the hippocampus, contributing to memory impairment, similar to the reduced hippocampal volume in child-abuse victims. Additionally, cortical function in the brain is affected in PTSD, creating difficulty with exercising judgment and good decision making.
“One way to think about PTSD is that the cortex is unable to reign in the limbic system,” Dr. Nemeroff said. “The hippocampus is impaired, the amygdala is hyperactive, and there is a tremendous emotional drive, so the ‘thinking’ part of the brain can’t [overcome] the emotional, reptilian brain.”
The result is that a person remains stuck in a hyperaroused state. “We know that the neurobiological basis for PTSD involves a prolonged, vigilant response to stress [involving] a multitude of brain circuits ... and of course the sympathetic nervous system and the pituitary and adrenal systems,” Dr. Nemeroff said.
Beyond brain changes, a genetic predisposition to PTSD accounts for a third of all cases, while an additional one-third are attributable to additional biological risk factors, according to Dr. Nemeroff (Nature 2011;470:492-7).
Just as with all anxiety-related disorders, women are more PTSD susceptible than are men. One of the “few things everybody agrees on,” Dr. Nemeroff said, is that early-life trauma such as neglect or abuse is a definite risk factor for PTSD, in part because early-life stress is thought to permanently program the brain regions involved in stress- and anxiety-mediation. Add to that, any adult level trauma, and they two “synergize. The more adult trauma coupled with early childhood abuse or neglect, the higher the level of PTSD.”
Meanwhile, poor social support, especially after the occurrence of a traumatic event, is a traditional prognosticator of poor recovery from PTSD, as are a family history of mood disorders, lower I.Q. and education, and experiencing other stressors the year before or after a traumatic event.
Dr. Nemeroff said that although the goals of treatment are reduced core symptoms, improved quality of life and function, strength, and resilience against subsequent stress, “the sad fact of the matter is that we don’t have a clue what the best treatment is, because we have no predictors of treatment response for PTSD.”
The most common treatments for PTSD are selective serotonin reuptake inhibitors (SSRIs), although the best data available suggest that prolonged imaginal exposure therapy is the most effective, Dr. Nemeroff said. It can be provided either virtually or in person, and includes breathing techniques, psychoeducation, and cognitive therapy. The Institute of Medicine gives exposure therapy its highest rating for scientific evidence, said Dr. Nemeroff, who is a board member of the institute.
Pharmacologic treatments approved by the Food and Drug Administration for PTSD treatment include sertraline and paroxetine, although other antidepressants can be prescribed off-label to some effect.
With sertraline, there is a “pretty low bar” of efficacy, according to Dr. Nemeroff, since only a 30% improvement in symptoms was recorded in 60% of study participants for FDA approval. It’s important to remember the treatment-response in PTSD is much slower than in major depression, Dr. Nemeroff said. “It can take as much as 9 months, so don’t give up.”
Combining sertraline with prolonged exposure therapy is even more effective, he said (J. Trauma Stress 2006;19:625-38). Meanwhile, other data show what paroxetine alone performed better than placebo, but the data are mixed for the drug in combination with prolonged exposure therapy (Am. J. Psychiatry 2012;169:80-8), (J. Clin. Psychiatry 2008;69:400-5), (J. Clin. Neurosci. 2008;62:646-52), and (Am. J. Psychiatry 2001;158:1982-8).
Dr. Nemeroff said lately, he has been treating PTSD patients with venlafaxine 450 mg, which is much higher than the usual dose of about 220 mg, with “considerably good results” (Arch. Gen. Psychiatry 2006;63:1158-65).
Improvements in memory and hippocampal volume generally are found with SSRI treatments, as well as reductions in symptom severity, according to Dr. Nemeroff.
For PTSD patients who are struggling with insomnia and other sleep-related problems, Dr. Nemeroff said prazosin has been “phenomenal,” especially in reducing nightmares (Am. J. Psychiatry 2013;170:1003-10).
One drug class to avoid using with PTSD patients is benzodiazepines, he said. “Every study has shown that benzodiazepines in PTSD do not work, and they come with a high rate of substance abuse in this population.”
*Dr. Nemeroff disclosed that he receives research and grant support from the National Institutes of Health. He also serves as a consultant for several companies, including Xhale, Takeda, SK Pharma, Shire, Roche, Lilly, Allergan, Mitsubishi Tanabe Pharma Development America, Taisho Pharmaceutical, Lundbeck, Prismic Pharmaceuticals, and Clintara LLC. He is a stockholder in Xhale, Celgene, Seattle Genetics, Abbvie, Titan Pharmaceuticals, and OPKO Health.
In addition, he holds financial/proprietary interest in patents for method/devices for the transdermal delivery of lithium and for a method of assessing antidepressant drug therapy.
*Correction, 4/10/2015: An earlier version of this story misstated Dr. Nemeroff's disclosures.
On Twitter @whitneymcknight
LAS VEGAS– There is no cure for posttraumatic stress disorder, but helping its sufferers reduce symptoms, improve resistance, and achieve a better quality of life is possible.
“We have no idea what the best treatments are for PTSD,” Dr. Charles B. Nemeroff, the Leonard M. Miller Professor, and chairman of the department of psychiatry and behavioral sciences at the University of Miami, told an audience at the annual psychopharmacology update held by the Nevada Psychiatric Association.
Whether to rely upon psychosocial or pharmacologic interventions, or a combination of the two, to help shift PTSD from a debilitating condition into a manageable, chronic one, it is important to understand PTSD as a brain disease. “To accurately treat PTSD, consider it within a neurobiological context,” Dr. Nemeroff said. “Ordinarily, the brain is evolved to deal with stress, but it can be compromised.”
In chronic PTSD, brain studies have shown a noted shrinkage in the hippocampus, contributing to memory impairment, similar to the reduced hippocampal volume in child-abuse victims. Additionally, cortical function in the brain is affected in PTSD, creating difficulty with exercising judgment and good decision making.
“One way to think about PTSD is that the cortex is unable to reign in the limbic system,” Dr. Nemeroff said. “The hippocampus is impaired, the amygdala is hyperactive, and there is a tremendous emotional drive, so the ‘thinking’ part of the brain can’t [overcome] the emotional, reptilian brain.”
The result is that a person remains stuck in a hyperaroused state. “We know that the neurobiological basis for PTSD involves a prolonged, vigilant response to stress [involving] a multitude of brain circuits ... and of course the sympathetic nervous system and the pituitary and adrenal systems,” Dr. Nemeroff said.
Beyond brain changes, a genetic predisposition to PTSD accounts for a third of all cases, while an additional one-third are attributable to additional biological risk factors, according to Dr. Nemeroff (Nature 2011;470:492-7).
Just as with all anxiety-related disorders, women are more PTSD susceptible than are men. One of the “few things everybody agrees on,” Dr. Nemeroff said, is that early-life trauma such as neglect or abuse is a definite risk factor for PTSD, in part because early-life stress is thought to permanently program the brain regions involved in stress- and anxiety-mediation. Add to that, any adult level trauma, and they two “synergize. The more adult trauma coupled with early childhood abuse or neglect, the higher the level of PTSD.”
Meanwhile, poor social support, especially after the occurrence of a traumatic event, is a traditional prognosticator of poor recovery from PTSD, as are a family history of mood disorders, lower I.Q. and education, and experiencing other stressors the year before or after a traumatic event.
Dr. Nemeroff said that although the goals of treatment are reduced core symptoms, improved quality of life and function, strength, and resilience against subsequent stress, “the sad fact of the matter is that we don’t have a clue what the best treatment is, because we have no predictors of treatment response for PTSD.”
The most common treatments for PTSD are selective serotonin reuptake inhibitors (SSRIs), although the best data available suggest that prolonged imaginal exposure therapy is the most effective, Dr. Nemeroff said. It can be provided either virtually or in person, and includes breathing techniques, psychoeducation, and cognitive therapy. The Institute of Medicine gives exposure therapy its highest rating for scientific evidence, said Dr. Nemeroff, who is a board member of the institute.
Pharmacologic treatments approved by the Food and Drug Administration for PTSD treatment include sertraline and paroxetine, although other antidepressants can be prescribed off-label to some effect.
With sertraline, there is a “pretty low bar” of efficacy, according to Dr. Nemeroff, since only a 30% improvement in symptoms was recorded in 60% of study participants for FDA approval. It’s important to remember the treatment-response in PTSD is much slower than in major depression, Dr. Nemeroff said. “It can take as much as 9 months, so don’t give up.”
Combining sertraline with prolonged exposure therapy is even more effective, he said (J. Trauma Stress 2006;19:625-38). Meanwhile, other data show what paroxetine alone performed better than placebo, but the data are mixed for the drug in combination with prolonged exposure therapy (Am. J. Psychiatry 2012;169:80-8), (J. Clin. Psychiatry 2008;69:400-5), (J. Clin. Neurosci. 2008;62:646-52), and (Am. J. Psychiatry 2001;158:1982-8).
Dr. Nemeroff said lately, he has been treating PTSD patients with venlafaxine 450 mg, which is much higher than the usual dose of about 220 mg, with “considerably good results” (Arch. Gen. Psychiatry 2006;63:1158-65).
Improvements in memory and hippocampal volume generally are found with SSRI treatments, as well as reductions in symptom severity, according to Dr. Nemeroff.
For PTSD patients who are struggling with insomnia and other sleep-related problems, Dr. Nemeroff said prazosin has been “phenomenal,” especially in reducing nightmares (Am. J. Psychiatry 2013;170:1003-10).
One drug class to avoid using with PTSD patients is benzodiazepines, he said. “Every study has shown that benzodiazepines in PTSD do not work, and they come with a high rate of substance abuse in this population.”
*Dr. Nemeroff disclosed that he receives research and grant support from the National Institutes of Health. He also serves as a consultant for several companies, including Xhale, Takeda, SK Pharma, Shire, Roche, Lilly, Allergan, Mitsubishi Tanabe Pharma Development America, Taisho Pharmaceutical, Lundbeck, Prismic Pharmaceuticals, and Clintara LLC. He is a stockholder in Xhale, Celgene, Seattle Genetics, Abbvie, Titan Pharmaceuticals, and OPKO Health.
In addition, he holds financial/proprietary interest in patents for method/devices for the transdermal delivery of lithium and for a method of assessing antidepressant drug therapy.
*Correction, 4/10/2015: An earlier version of this story misstated Dr. Nemeroff's disclosures.
On Twitter @whitneymcknight
LAS VEGAS– There is no cure for posttraumatic stress disorder, but helping its sufferers reduce symptoms, improve resistance, and achieve a better quality of life is possible.
“We have no idea what the best treatments are for PTSD,” Dr. Charles B. Nemeroff, the Leonard M. Miller Professor, and chairman of the department of psychiatry and behavioral sciences at the University of Miami, told an audience at the annual psychopharmacology update held by the Nevada Psychiatric Association.
Whether to rely upon psychosocial or pharmacologic interventions, or a combination of the two, to help shift PTSD from a debilitating condition into a manageable, chronic one, it is important to understand PTSD as a brain disease. “To accurately treat PTSD, consider it within a neurobiological context,” Dr. Nemeroff said. “Ordinarily, the brain is evolved to deal with stress, but it can be compromised.”
In chronic PTSD, brain studies have shown a noted shrinkage in the hippocampus, contributing to memory impairment, similar to the reduced hippocampal volume in child-abuse victims. Additionally, cortical function in the brain is affected in PTSD, creating difficulty with exercising judgment and good decision making.
“One way to think about PTSD is that the cortex is unable to reign in the limbic system,” Dr. Nemeroff said. “The hippocampus is impaired, the amygdala is hyperactive, and there is a tremendous emotional drive, so the ‘thinking’ part of the brain can’t [overcome] the emotional, reptilian brain.”
The result is that a person remains stuck in a hyperaroused state. “We know that the neurobiological basis for PTSD involves a prolonged, vigilant response to stress [involving] a multitude of brain circuits ... and of course the sympathetic nervous system and the pituitary and adrenal systems,” Dr. Nemeroff said.
Beyond brain changes, a genetic predisposition to PTSD accounts for a third of all cases, while an additional one-third are attributable to additional biological risk factors, according to Dr. Nemeroff (Nature 2011;470:492-7).
Just as with all anxiety-related disorders, women are more PTSD susceptible than are men. One of the “few things everybody agrees on,” Dr. Nemeroff said, is that early-life trauma such as neglect or abuse is a definite risk factor for PTSD, in part because early-life stress is thought to permanently program the brain regions involved in stress- and anxiety-mediation. Add to that, any adult level trauma, and they two “synergize. The more adult trauma coupled with early childhood abuse or neglect, the higher the level of PTSD.”
Meanwhile, poor social support, especially after the occurrence of a traumatic event, is a traditional prognosticator of poor recovery from PTSD, as are a family history of mood disorders, lower I.Q. and education, and experiencing other stressors the year before or after a traumatic event.
Dr. Nemeroff said that although the goals of treatment are reduced core symptoms, improved quality of life and function, strength, and resilience against subsequent stress, “the sad fact of the matter is that we don’t have a clue what the best treatment is, because we have no predictors of treatment response for PTSD.”
The most common treatments for PTSD are selective serotonin reuptake inhibitors (SSRIs), although the best data available suggest that prolonged imaginal exposure therapy is the most effective, Dr. Nemeroff said. It can be provided either virtually or in person, and includes breathing techniques, psychoeducation, and cognitive therapy. The Institute of Medicine gives exposure therapy its highest rating for scientific evidence, said Dr. Nemeroff, who is a board member of the institute.
Pharmacologic treatments approved by the Food and Drug Administration for PTSD treatment include sertraline and paroxetine, although other antidepressants can be prescribed off-label to some effect.
With sertraline, there is a “pretty low bar” of efficacy, according to Dr. Nemeroff, since only a 30% improvement in symptoms was recorded in 60% of study participants for FDA approval. It’s important to remember the treatment-response in PTSD is much slower than in major depression, Dr. Nemeroff said. “It can take as much as 9 months, so don’t give up.”
Combining sertraline with prolonged exposure therapy is even more effective, he said (J. Trauma Stress 2006;19:625-38). Meanwhile, other data show what paroxetine alone performed better than placebo, but the data are mixed for the drug in combination with prolonged exposure therapy (Am. J. Psychiatry 2012;169:80-8), (J. Clin. Psychiatry 2008;69:400-5), (J. Clin. Neurosci. 2008;62:646-52), and (Am. J. Psychiatry 2001;158:1982-8).
Dr. Nemeroff said lately, he has been treating PTSD patients with venlafaxine 450 mg, which is much higher than the usual dose of about 220 mg, with “considerably good results” (Arch. Gen. Psychiatry 2006;63:1158-65).
Improvements in memory and hippocampal volume generally are found with SSRI treatments, as well as reductions in symptom severity, according to Dr. Nemeroff.
For PTSD patients who are struggling with insomnia and other sleep-related problems, Dr. Nemeroff said prazosin has been “phenomenal,” especially in reducing nightmares (Am. J. Psychiatry 2013;170:1003-10).
One drug class to avoid using with PTSD patients is benzodiazepines, he said. “Every study has shown that benzodiazepines in PTSD do not work, and they come with a high rate of substance abuse in this population.”
*Dr. Nemeroff disclosed that he receives research and grant support from the National Institutes of Health. He also serves as a consultant for several companies, including Xhale, Takeda, SK Pharma, Shire, Roche, Lilly, Allergan, Mitsubishi Tanabe Pharma Development America, Taisho Pharmaceutical, Lundbeck, Prismic Pharmaceuticals, and Clintara LLC. He is a stockholder in Xhale, Celgene, Seattle Genetics, Abbvie, Titan Pharmaceuticals, and OPKO Health.
In addition, he holds financial/proprietary interest in patents for method/devices for the transdermal delivery of lithium and for a method of assessing antidepressant drug therapy.
*Correction, 4/10/2015: An earlier version of this story misstated Dr. Nemeroff's disclosures.
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE NPA PSYCHOPHARMOCOLOGY UPDATE
VIDEO – ‘Significant recovery’ possible in schizophrenia with cognitive interventions
COLORADO SPRINGS– Many clinicians are unaware that nonpharmacologic interventions can lead to positive results for patients with schizophrenia, according to Dr. Sophia Vinogradov and Dr. Joshua Woolley, psychiatrists from the University of California, San Francisco.
“The one message we have is that there is hope,” Dr. Woolley says in this interview, which was recorded at the biennial meeting of the 15th International Congress on Schizophrenia Research. Patients with schizophrenia can still “live a fulfilling life and have a significant recovery.”
Dr. Vinogradov and Dr. Woolley discuss how clinicians can use cognitive training techniques, cognitive-behavioral therapy, social media, and mobile technology to help ensure positive outcomes where patients see their disease not as a reason to withdraw from society but as an opportunity to engage with others who share similar struggles.
On Twitter @whitneymcknight
COLORADO SPRINGS– Many clinicians are unaware that nonpharmacologic interventions can lead to positive results for patients with schizophrenia, according to Dr. Sophia Vinogradov and Dr. Joshua Woolley, psychiatrists from the University of California, San Francisco.
“The one message we have is that there is hope,” Dr. Woolley says in this interview, which was recorded at the biennial meeting of the 15th International Congress on Schizophrenia Research. Patients with schizophrenia can still “live a fulfilling life and have a significant recovery.”
Dr. Vinogradov and Dr. Woolley discuss how clinicians can use cognitive training techniques, cognitive-behavioral therapy, social media, and mobile technology to help ensure positive outcomes where patients see their disease not as a reason to withdraw from society but as an opportunity to engage with others who share similar struggles.
On Twitter @whitneymcknight
COLORADO SPRINGS– Many clinicians are unaware that nonpharmacologic interventions can lead to positive results for patients with schizophrenia, according to Dr. Sophia Vinogradov and Dr. Joshua Woolley, psychiatrists from the University of California, San Francisco.
“The one message we have is that there is hope,” Dr. Woolley says in this interview, which was recorded at the biennial meeting of the 15th International Congress on Schizophrenia Research. Patients with schizophrenia can still “live a fulfilling life and have a significant recovery.”
Dr. Vinogradov and Dr. Woolley discuss how clinicians can use cognitive training techniques, cognitive-behavioral therapy, social media, and mobile technology to help ensure positive outcomes where patients see their disease not as a reason to withdraw from society but as an opportunity to engage with others who share similar struggles.
On Twitter @whitneymcknight
AT THE INTERNATIONAL CONGRESS ON SCHIZOPHRENIA RESEARCH
VIDEO – ‘Clear’ link between cannabis use and schizophrenia
COLORADO SPRINGS – Not all people who use cannabis will become psychotic, but for those with just the right constellation of risk factors, cannabis can lead to “chronic schizophrenia,” according to Sir Robin M. Murray, professor of psychiatric research at the Institute of Psychiatry at King’s College London.
And although Dr. Murray says “old-fashioned” cannabis can lead to psychosis, it’s the newer, more potent kinds manufactured in the last decade that pose the greatest risk.
In this interview, recorded at the International Congress on Schizophrenia Research, Dr. Murray discusses the evidence establishing the links between psychosis, schizophrenia, and cannabis, and what clinicians can do to help patients who might be at risk. He warns, however, that not everyone will be able to reverse the damage to the brain that cannabis can cause.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
COLORADO SPRINGS – Not all people who use cannabis will become psychotic, but for those with just the right constellation of risk factors, cannabis can lead to “chronic schizophrenia,” according to Sir Robin M. Murray, professor of psychiatric research at the Institute of Psychiatry at King’s College London.
And although Dr. Murray says “old-fashioned” cannabis can lead to psychosis, it’s the newer, more potent kinds manufactured in the last decade that pose the greatest risk.
In this interview, recorded at the International Congress on Schizophrenia Research, Dr. Murray discusses the evidence establishing the links between psychosis, schizophrenia, and cannabis, and what clinicians can do to help patients who might be at risk. He warns, however, that not everyone will be able to reverse the damage to the brain that cannabis can cause.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
COLORADO SPRINGS – Not all people who use cannabis will become psychotic, but for those with just the right constellation of risk factors, cannabis can lead to “chronic schizophrenia,” according to Sir Robin M. Murray, professor of psychiatric research at the Institute of Psychiatry at King’s College London.
And although Dr. Murray says “old-fashioned” cannabis can lead to psychosis, it’s the newer, more potent kinds manufactured in the last decade that pose the greatest risk.
In this interview, recorded at the International Congress on Schizophrenia Research, Dr. Murray discusses the evidence establishing the links between psychosis, schizophrenia, and cannabis, and what clinicians can do to help patients who might be at risk. He warns, however, that not everyone will be able to reverse the damage to the brain that cannabis can cause.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
AT THE INTERNATIONAL CONGRESS ON SCHIZOPHRENIA RESEARCH
Low mortality, good outcomes in octogenarian AAA repair sparks QOL vs. utility debate
SCOTTSDALE, ARIZ. – Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.
Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.
According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting. “However, whether should we be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”
Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria, there were nearly seven men for every woman, all with a median age of 83 years.
Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)
Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).
Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation-related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.
A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).
Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data was warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”
The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.
“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.
Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.
As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”
“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within six months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”
[email protected]
On Twitter @whitneymcknight
This discussion is provocative and raises some interesting points. Obviously cost effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.
This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.
 |
Dr. Frank J. Veith |
I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.
Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.
This discussion is provocative and raises some interesting points. Obviously cost effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.
This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.
|
Dr. Frank J. Veith |
I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.
Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.
This discussion is provocative and raises some interesting points. Obviously cost effectiveness considerations are important, and our country does not have unlimited funds to spend on medical care. And perhaps there are some elderly and frail individuals who should not have their AAAs repaired electively because the risk of rupture during the patients’ remaining months or years of life is small.
This is particularly true if the patient’s AAA is less than 7 cm and his or her anatomy and condition are unsuitable for an easy repair. However, if the AAA is large and threatening, and the patient has the possibility of living several years, elective repair is justified and reasonable – especially if it can be accomplished endovascularly. As someone who is near 80 [years old], I could not feel more strongly about this, and I would maintain this view if I were near 90 and healthy.
|
Dr. Frank J. Veith |
I hold the same view even more strongly regarding a ruptured AAA. In this setting, the alternative management is nontreatment, which is uniformly fatal. The common term “palliative treatment” for such nontreatment is a misleading misnomer. No sane, reasonably healthy elderly patient would knowingly choose such nontreatment when a good alternative with well over an even chance of living a lot longer is offered. That good alternative – again especially if it can be performed endovascularly – should be offered, and our health system should pay for it and compensate by saving money on unnecessary SFA [superficial femoral artery] stents and carotid procedures.
Dr. Frank J. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and is an associate medical editor for Vascular Specialist.
SCOTTSDALE, ARIZ. – Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.
Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.
According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting. “However, whether should we be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”
Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria, there were nearly seven men for every woman, all with a median age of 83 years.
Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)
Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).
Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation-related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.
A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).
Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data was warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”
The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.
“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.
Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.
As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”
“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within six months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”
[email protected]
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – Abdominal aortic aneurysm repair in patients 80 years and older can be performed safely and with good medium-term survival rates, a prospective single-site study has shown.
Perioperative mortality in elective and emergent AAA repair for octogenarians was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.
According to these data, “Patients shouldn’t be turned down for aneurysm repair on the basis of their age alone,” Dr. Christopher M. Lamb, a vascular surgery fellow at the University of California Davis Medical Center in Sacramento, said during a presentation at this year’s Southern Association for Vascular Surgery annual meeting. “However, whether should we be doing these procedures is a different question, and I don’t think these data allow us to answer that question properly.”
Dr. Lamb and his colleagues reviewed the records of 847 consecutive patients aged 80 years or older, seen between April 2005 and February 2014 for any type of AAA repair. Cases were sorted according to whether they were elective, ruptured, or urgent but unruptured. A total of 226 patients met the study’s age criteria, there were nearly seven men for every woman, all with a median age of 83 years.
Of the elective AAA repair arm of the study, 131 patients (116 men) with a median age of 82 years had an endovascular repair, while the rest underwent open surgical repair. The combined 30-day mortality rate for these patients was 2.3%, with no significant difference between either the endovascular aneurysm repair (EVAR) or the open surgical repair (OSR) patients (1.9% vs. 4.2%; P = .458). The median survival of all elective repair patients was 19 months (interquartile range, 10-35), with no difference seen between the two groups (P = .113)
Of the 65 patients (53 men) with ruptured AAA, the median age was 83 years. A third had open repair (32.3%), while the rest had EVAR. The combined 30-day mortality rate was 35.4% but was significantly higher after OSR (52.4% vs. 27.3%; P = .048). The median survival rate was 6 months (IQR, 6-42) when 30-day mortality rates were excluded. The median survival rates in patients who lived longer than 30 days was significantly higher in OSR patients (42.5 months vs. 11 months; P = .019).
Of the 23 men and 7 women with symptomatic but unruptured AAA, all but 1 had EVAR. At 30 days, there was one diverticular perforation-related postoperative death in the EVAR group, which had a median survival rate of 29 months. There being only a single patient in the OSR group obviated a comparative median survival rate analysis.
A subanalysis of the final 20 months of the study showed that 41% of octogenarians seeking any type of AAA repair at the site were rejected (48 rejections vs. 69 repairs). Those who were rejected for repair tended to be older, with a median age of 86 years vs. 83 years for patients who underwent repair (P = .0004).
Dr. Lamb noted that although the findings demonstrate acceptable overall safety rates for the entire cohort, without a control group of patients that did not have AAA repair, it would be hard to draw a definite conclusion about the utility of the findings, and that more data was warranted; however, the potential for limited long-term survival with what previous reports have suggested may include “a reduced quality of life for a good part of it, possibly raises the question that these patients should be treated conservatively, more often.”
The rejection rate data prompted the presentation’s discussant, Dr. William D. Jordan Jr., section chief of vascular surgery at the University of Alabama at Birmingham and the presentation’s discussant, to challenge the findings and asked whether a single surgeon selected the patients.
“You said there is not a selection bias in your study, but I beg to differ. Perhaps all these kinds of studies have a selection bias, and I believe they should. We should select the appropriate patients for the appropriate procedure at the appropriate time, with the appropriate expectation of outcome. Bias in this setting may be seen as good,” Dr. Jordan said.
Dr. Lamb responded that the treatment algorithm at the site for all patients with a confirmed AAA of 5.5 cm or greater included CT imaging that is reviewed by a multidisciplinary team comprising vascular surgeons and interventional radiologists, who then evaluated the patients according to their physiology and anatomy, as well as their comorbidities, with the intention that whenever possible, EVAR rather than open repair would be performed.
As to whether there was a bias toward not repairing AAA in older patients, Dr. Lamb said it was incumbent on any health system to evaluate a procedure’s cost effectiveness, but that, “the life expectancy of a vascular patient is often more limited than I think we’d like to believe ... we don’t know what the natural history of these patients’ life expectancy is. We don’t know from these data what the cause of death was, but anecdotally, we didn’t see hundreds of patients return with ruptured aneurysms after an EVAR.”
“I would truly like to see how many [of these patients] who make it out of the hospital return to normal living within six months,” Dr. Samuel R. Money, chair of surgery at the Mayo Clinic in Scottsdale, Ariz., said in an interview following the presentation. “At some point, the question becomes ‘Can we afford to spend $100,000 dollars to keep a 90-year-old patient alive for 6 more months?’ Can this society sustain the cost of that?”
[email protected]
On Twitter @whitneymcknight
AT THE SAVS ANNUAL MEETING 2015
Key clinical point: EVAR and OSR outcomes for AAA were both shown safe and effective at 30 days and 6 months in patients 80 years and older.
Major finding: Perioperative mortality in elective and emergent AAA repair was 2% and 35%, respectively, with a median survival rate of 19 months in both groups.
Data source: Prospective study of 847 consecutive AAA-repair patients at a single site between May 2005 and February 2014.
Disclosures: Dr. Lamb did not have any relevant disclosures.
Aripiprazole outperforms paliperidone palmitate in head-to-head trial
COLORADO SPRINGS – The once monthly long-acting injectable formulation of the atypical antipsychotic aripiprazole was superior to a similar formulation of paliperidone palmitate in health-related quality-of-life scale total scores in people with schizophrenia, new data show.
The primary results in the head-to-head trial were supported by a significant decrease in Clinical Global Impression Scale (CGI-S) scores, better tolerability, and less treatment-related adverse events.
“The field has longed for such trials that fairly compare available treatments. Both treatments were effective, but aripiprazole once monthly was more effective across almost all measures,” Dr. Steven G. Potkin, the Robert R. Sprague Chair in Brain Imaging and a professor of psychiatry at the University of California, Irvine, and a lead author on the study, said in an interview.
Data from the QUALIFY study were presented at the biennial meeting of the 15th International Congress on Schizophrenia Research.
According to Dr. Potkin, the study is the first to use the quality of life scale to compare the effects of two, once-monthly, long-acting injectables (LAIs) with different modes of action in schizophrenia to determine treatment effects on patients’ overall social experience, work capacity, sense of purpose, curiosity, empathy, motivation, and level of presence in the community.
“The study has meaningful clinical impact, as it addresses some of the more important concerns that individuals with schizophrenia face such as ability to socialize and interact with others,” Dr. Potkin said.
In this phase IIIb, multicenter, international 28-week, randomized, open-label, rater-blinded, parallel group study, Dr. Potkin and his colleagues randomly assigned 295 adults with schizophrenia who were switching form an oral antipsychotic to an injectable one, to receive either the partial dopamine D2 agonist aripiprazole once monthly 400 mg or the dopamine D2 antagonist paliperidone palmitate at equivalent flexible dosing equivalent of 50 mg to 150 mg per month in the European Union and Canada, or 78 mg to 234 mg per month in the United States.
Patients were stable at baseline. Nearly 60% were male, and 44% were obese. Mean age was 42 years. Baseline quality of life scale (QLS) scores for the 148 individuals in the aripiprazole arm were 66.1 (standard deviation, 21.4) and 62.5 (SD, 21.3) for the 147 persons in the paliperidone palmitate arm. The baseline CGI-S scores for both groups was 4.0. Patients were assessed every 4th week.
By week 28, 100 in the aripiprazole arm completed treatment, and 83 completed treatment in the paliperidone palmitate arm.
The mean doses at week 24 were 387.0 +/– standard equivalent 3.4 mg for aripiprazole and 110.3 +/– 3.6 mg for paliperidone palmitate for the E.U. and Canada. The U.S. equivalent was 172 mg.
The primary endpoint of QLS scores at week 28 demonstrated the noninferiority and superiority of once-monthly aripiprazole over paliperidone palmitate. The aripiprazole arm improved QLS scores by 7.47 (SD, 1.53) compared with 2.80 (SD, 1.62) in the other group. The least square mean difference between treatments was 4.67 (95% confidence interval, [0.32; 9.02]; P = .036).
“The study was designed as a noninferiority trial, that is, to determine if aripiprazole 400 mg once monthly was as good as paliperidone palmitate,” Dr. Potkin said. “Not only was the aripiprazole as good as paliperidone palmitate, but indeed it was superior in the important health-related quality of life measures.”
Aripiprazole also significantly bested paliperidone palmitate in the secondary endpoint of improvements in the CGI-S score: –0.75 (SD, 0.07), compared with –0.46 (SD, 0.07). The least square mean difference between treatment was –0.28 (95% CI [–0.48; –0.09]; P = .004).
Adverse events assessed during the oral conversion, LAI-initiation, and LAI-continuation phases were more common in the paliperidone palmitate group during all phases but the initiation phase (51 reported events vs. 55 in the aripiprazole group). Significant adverse events were more common in the paliperidone palmitate group during the continuation phase (8 events vs. 6), and treatment-related adverse events leading to discontinuation of therapy during the continuation phase occurred in 13 of the paliperidone palmitate group vs. 6 in the aripiprazole group.
Insomnia was reported in both groups across all phases, as was weight gain, which was more common in the paliperidone palmitate group during the continuation phase (17 vs. 12).
“The study design represents the choice that clinicians face when deciding which atypical long-acting formulation to recommend to which patient,” Dr. Potkin said. “What I think is clinically relevant is that the primary outcome measure was the patient’s quality of life that includes the patient’s negative symptoms such as lack of empathy, motivation, curiosity, and socialization, and the consequence of these symptoms on everyday functioning. These symptoms are the most important to patients and their loved ones once the initial acute symptom episode has been stabilized.”
This trial was underwritten by Otsuka, makers of Abilify Maintena, and by H. Lundbeck A/S. Dr. Potkin is on the speakers bureau for Otsuka, Forest, and Sunovion, and serves on advisory boards of Alkermes, Forest, Genetech, Lundbeck, Otsuka, Roche, Sunovion, and Takeda.
On Twitter @whitneymcknight
COLORADO SPRINGS – The once monthly long-acting injectable formulation of the atypical antipsychotic aripiprazole was superior to a similar formulation of paliperidone palmitate in health-related quality-of-life scale total scores in people with schizophrenia, new data show.
The primary results in the head-to-head trial were supported by a significant decrease in Clinical Global Impression Scale (CGI-S) scores, better tolerability, and less treatment-related adverse events.
“The field has longed for such trials that fairly compare available treatments. Both treatments were effective, but aripiprazole once monthly was more effective across almost all measures,” Dr. Steven G. Potkin, the Robert R. Sprague Chair in Brain Imaging and a professor of psychiatry at the University of California, Irvine, and a lead author on the study, said in an interview.
Data from the QUALIFY study were presented at the biennial meeting of the 15th International Congress on Schizophrenia Research.
According to Dr. Potkin, the study is the first to use the quality of life scale to compare the effects of two, once-monthly, long-acting injectables (LAIs) with different modes of action in schizophrenia to determine treatment effects on patients’ overall social experience, work capacity, sense of purpose, curiosity, empathy, motivation, and level of presence in the community.
“The study has meaningful clinical impact, as it addresses some of the more important concerns that individuals with schizophrenia face such as ability to socialize and interact with others,” Dr. Potkin said.
In this phase IIIb, multicenter, international 28-week, randomized, open-label, rater-blinded, parallel group study, Dr. Potkin and his colleagues randomly assigned 295 adults with schizophrenia who were switching form an oral antipsychotic to an injectable one, to receive either the partial dopamine D2 agonist aripiprazole once monthly 400 mg or the dopamine D2 antagonist paliperidone palmitate at equivalent flexible dosing equivalent of 50 mg to 150 mg per month in the European Union and Canada, or 78 mg to 234 mg per month in the United States.
Patients were stable at baseline. Nearly 60% were male, and 44% were obese. Mean age was 42 years. Baseline quality of life scale (QLS) scores for the 148 individuals in the aripiprazole arm were 66.1 (standard deviation, 21.4) and 62.5 (SD, 21.3) for the 147 persons in the paliperidone palmitate arm. The baseline CGI-S scores for both groups was 4.0. Patients were assessed every 4th week.
By week 28, 100 in the aripiprazole arm completed treatment, and 83 completed treatment in the paliperidone palmitate arm.
The mean doses at week 24 were 387.0 +/– standard equivalent 3.4 mg for aripiprazole and 110.3 +/– 3.6 mg for paliperidone palmitate for the E.U. and Canada. The U.S. equivalent was 172 mg.
The primary endpoint of QLS scores at week 28 demonstrated the noninferiority and superiority of once-monthly aripiprazole over paliperidone palmitate. The aripiprazole arm improved QLS scores by 7.47 (SD, 1.53) compared with 2.80 (SD, 1.62) in the other group. The least square mean difference between treatments was 4.67 (95% confidence interval, [0.32; 9.02]; P = .036).
“The study was designed as a noninferiority trial, that is, to determine if aripiprazole 400 mg once monthly was as good as paliperidone palmitate,” Dr. Potkin said. “Not only was the aripiprazole as good as paliperidone palmitate, but indeed it was superior in the important health-related quality of life measures.”
Aripiprazole also significantly bested paliperidone palmitate in the secondary endpoint of improvements in the CGI-S score: –0.75 (SD, 0.07), compared with –0.46 (SD, 0.07). The least square mean difference between treatment was –0.28 (95% CI [–0.48; –0.09]; P = .004).
Adverse events assessed during the oral conversion, LAI-initiation, and LAI-continuation phases were more common in the paliperidone palmitate group during all phases but the initiation phase (51 reported events vs. 55 in the aripiprazole group). Significant adverse events were more common in the paliperidone palmitate group during the continuation phase (8 events vs. 6), and treatment-related adverse events leading to discontinuation of therapy during the continuation phase occurred in 13 of the paliperidone palmitate group vs. 6 in the aripiprazole group.
Insomnia was reported in both groups across all phases, as was weight gain, which was more common in the paliperidone palmitate group during the continuation phase (17 vs. 12).
“The study design represents the choice that clinicians face when deciding which atypical long-acting formulation to recommend to which patient,” Dr. Potkin said. “What I think is clinically relevant is that the primary outcome measure was the patient’s quality of life that includes the patient’s negative symptoms such as lack of empathy, motivation, curiosity, and socialization, and the consequence of these symptoms on everyday functioning. These symptoms are the most important to patients and their loved ones once the initial acute symptom episode has been stabilized.”
This trial was underwritten by Otsuka, makers of Abilify Maintena, and by H. Lundbeck A/S. Dr. Potkin is on the speakers bureau for Otsuka, Forest, and Sunovion, and serves on advisory boards of Alkermes, Forest, Genetech, Lundbeck, Otsuka, Roche, Sunovion, and Takeda.
On Twitter @whitneymcknight
COLORADO SPRINGS – The once monthly long-acting injectable formulation of the atypical antipsychotic aripiprazole was superior to a similar formulation of paliperidone palmitate in health-related quality-of-life scale total scores in people with schizophrenia, new data show.
The primary results in the head-to-head trial were supported by a significant decrease in Clinical Global Impression Scale (CGI-S) scores, better tolerability, and less treatment-related adverse events.
“The field has longed for such trials that fairly compare available treatments. Both treatments were effective, but aripiprazole once monthly was more effective across almost all measures,” Dr. Steven G. Potkin, the Robert R. Sprague Chair in Brain Imaging and a professor of psychiatry at the University of California, Irvine, and a lead author on the study, said in an interview.
Data from the QUALIFY study were presented at the biennial meeting of the 15th International Congress on Schizophrenia Research.
According to Dr. Potkin, the study is the first to use the quality of life scale to compare the effects of two, once-monthly, long-acting injectables (LAIs) with different modes of action in schizophrenia to determine treatment effects on patients’ overall social experience, work capacity, sense of purpose, curiosity, empathy, motivation, and level of presence in the community.
“The study has meaningful clinical impact, as it addresses some of the more important concerns that individuals with schizophrenia face such as ability to socialize and interact with others,” Dr. Potkin said.
In this phase IIIb, multicenter, international 28-week, randomized, open-label, rater-blinded, parallel group study, Dr. Potkin and his colleagues randomly assigned 295 adults with schizophrenia who were switching form an oral antipsychotic to an injectable one, to receive either the partial dopamine D2 agonist aripiprazole once monthly 400 mg or the dopamine D2 antagonist paliperidone palmitate at equivalent flexible dosing equivalent of 50 mg to 150 mg per month in the European Union and Canada, or 78 mg to 234 mg per month in the United States.
Patients were stable at baseline. Nearly 60% were male, and 44% were obese. Mean age was 42 years. Baseline quality of life scale (QLS) scores for the 148 individuals in the aripiprazole arm were 66.1 (standard deviation, 21.4) and 62.5 (SD, 21.3) for the 147 persons in the paliperidone palmitate arm. The baseline CGI-S scores for both groups was 4.0. Patients were assessed every 4th week.
By week 28, 100 in the aripiprazole arm completed treatment, and 83 completed treatment in the paliperidone palmitate arm.
The mean doses at week 24 were 387.0 +/– standard equivalent 3.4 mg for aripiprazole and 110.3 +/– 3.6 mg for paliperidone palmitate for the E.U. and Canada. The U.S. equivalent was 172 mg.
The primary endpoint of QLS scores at week 28 demonstrated the noninferiority and superiority of once-monthly aripiprazole over paliperidone palmitate. The aripiprazole arm improved QLS scores by 7.47 (SD, 1.53) compared with 2.80 (SD, 1.62) in the other group. The least square mean difference between treatments was 4.67 (95% confidence interval, [0.32; 9.02]; P = .036).
“The study was designed as a noninferiority trial, that is, to determine if aripiprazole 400 mg once monthly was as good as paliperidone palmitate,” Dr. Potkin said. “Not only was the aripiprazole as good as paliperidone palmitate, but indeed it was superior in the important health-related quality of life measures.”
Aripiprazole also significantly bested paliperidone palmitate in the secondary endpoint of improvements in the CGI-S score: –0.75 (SD, 0.07), compared with –0.46 (SD, 0.07). The least square mean difference between treatment was –0.28 (95% CI [–0.48; –0.09]; P = .004).
Adverse events assessed during the oral conversion, LAI-initiation, and LAI-continuation phases were more common in the paliperidone palmitate group during all phases but the initiation phase (51 reported events vs. 55 in the aripiprazole group). Significant adverse events were more common in the paliperidone palmitate group during the continuation phase (8 events vs. 6), and treatment-related adverse events leading to discontinuation of therapy during the continuation phase occurred in 13 of the paliperidone palmitate group vs. 6 in the aripiprazole group.
Insomnia was reported in both groups across all phases, as was weight gain, which was more common in the paliperidone palmitate group during the continuation phase (17 vs. 12).
“The study design represents the choice that clinicians face when deciding which atypical long-acting formulation to recommend to which patient,” Dr. Potkin said. “What I think is clinically relevant is that the primary outcome measure was the patient’s quality of life that includes the patient’s negative symptoms such as lack of empathy, motivation, curiosity, and socialization, and the consequence of these symptoms on everyday functioning. These symptoms are the most important to patients and their loved ones once the initial acute symptom episode has been stabilized.”
This trial was underwritten by Otsuka, makers of Abilify Maintena, and by H. Lundbeck A/S. Dr. Potkin is on the speakers bureau for Otsuka, Forest, and Sunovion, and serves on advisory boards of Alkermes, Forest, Genetech, Lundbeck, Otsuka, Roche, Sunovion, and Takeda.
On Twitter @whitneymcknight
AT THE INTERNATIONAL CONGRESS ON SCHIZOPHRENIA RESEARCH
Key clinical point: This trial offers a more complete picture of how different formulations of long-acting injectables (LAIs) will affect patients’ quality of life.
Major finding: LAI aripiprazole outperformed LAI paliperidone palmitate on QLS total score by 4.7 points (95% confidence interval, [0.32; 9.02]; P = .036).
Data source: Phase IIIb, multicenter, international 28-week, randomized, open-label, rater-blinded, parallel group study of 295 patients with schizophrenia.
Disclosures: This trial was underwritten by Otsuka, makers of Abilify Maintena, and by H. Lundbeck A/S. Dr. Potkin is on the speakers bureau for Otsuka, Forest, and Sunovion, and serves on advisory boards of Alkermes, Forest, Genetech, Lundbeck, Otsuka, Roche, Sunovion, and Takeda.
Benzodiazepine reduction without withdrawal symptoms possible in patients with schizophrenia, bipolar disorder
COLORADO SPRINGS – Patients with schizophrenia and bipolar disorder can reduce or even discontinue their reliance on benzodiazepines when kept to a gradually tapered titration, results of a Danish study have shown.
Benzodiazepines often are prescribed to patients with severe mental illnesses to help relieve comorbid anxiety and insomnia. According to Dr. Lone Baandrup, a researcher at the Center for Neuropsychiatric Schizophrenia Research at the Copenhagen University Hospital in Glostrup, Denmark, the treatment is usually meant as a temporary measure during acute episodes, but patients often become addicted.
Dr. Baandrup said in an interview at the biennial meeting of the 15th International Congress on Schizophrenia Research that because it is well established that patients with severe mental illness often suffer from a diminished ability to secrete endogenous melatonin, “we wanted to see if we could facilitate tapering patients off their benzos using a prolonged-release melatonin.”
Dr. Baandrup and her colleagues randomly assigned 86 adults with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder who had been on a daily regimen of an antipsychotic and at least one benzodiazepine derivative for at least 3 months, to receive either prolonged-release melatonin 2 mg daily or matching placebo. In the intention-to-treat analysis, each group was guided by a caregiver to gradually taper their respective daily benzodiazepine dosage.
Participants were examined at baseline and at 8, 16, and 24 weeks, and were monitored weekly by telephone. All participants, researchers, treating clinicians, and outcome assessors were blinded to group assignment.
No significant difference was found between the groups as to mean benzodiazepine dosage at 24 weeks, the study’s primary outcome, but the placebo arm had a greater reduction in benzodiazepine dosage (8.01 mg in the study arm vs. 5.72 mg in placebo; difference between means, –2.29; 95% confidence interval, –5.78-1.21; P = .20).
Nearly half of the placebo group achieved complete cessation of benzodiazepine use, compared with more than one-third of the study group (21 out of 44 vs. 16 out of 42; odds ratio, 0.64; 95% confidence interval, 0.26-1.56; P = .32).
Serious or nonserious adverse events were similar across the groups.
A separate analysis of the data not presented at the conference as to whether melatonin had any effect on subjective sleep measures showed that those in the melatonin group had improved sleep according to the Pittsburgh Sleep Quality Index. When compared with the control group, “the difference was about 2 points, so it was only on the border of clinical significance, but their sleep did not get worse,” Dr. Baandrup said.
The investigators also used the Pittsburgh Sleep Diary to measure whether there were any objective differences in sleep between the melatonin and placebo groups, and found that reducing benzodiazepine use did not result in insomnia. “It remained the same from baseline to follow-up," Dr. Baandrup said. “Many patients are afraid to taper off their benzos because they fear their sleep will worsen, but we didn’t find that.”
Dr. Baandrup did not have any relevant disclosures.
On Twitter @whitneymcknight
COLORADO SPRINGS – Patients with schizophrenia and bipolar disorder can reduce or even discontinue their reliance on benzodiazepines when kept to a gradually tapered titration, results of a Danish study have shown.
Benzodiazepines often are prescribed to patients with severe mental illnesses to help relieve comorbid anxiety and insomnia. According to Dr. Lone Baandrup, a researcher at the Center for Neuropsychiatric Schizophrenia Research at the Copenhagen University Hospital in Glostrup, Denmark, the treatment is usually meant as a temporary measure during acute episodes, but patients often become addicted.
Dr. Baandrup said in an interview at the biennial meeting of the 15th International Congress on Schizophrenia Research that because it is well established that patients with severe mental illness often suffer from a diminished ability to secrete endogenous melatonin, “we wanted to see if we could facilitate tapering patients off their benzos using a prolonged-release melatonin.”
Dr. Baandrup and her colleagues randomly assigned 86 adults with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder who had been on a daily regimen of an antipsychotic and at least one benzodiazepine derivative for at least 3 months, to receive either prolonged-release melatonin 2 mg daily or matching placebo. In the intention-to-treat analysis, each group was guided by a caregiver to gradually taper their respective daily benzodiazepine dosage.
Participants were examined at baseline and at 8, 16, and 24 weeks, and were monitored weekly by telephone. All participants, researchers, treating clinicians, and outcome assessors were blinded to group assignment.
No significant difference was found between the groups as to mean benzodiazepine dosage at 24 weeks, the study’s primary outcome, but the placebo arm had a greater reduction in benzodiazepine dosage (8.01 mg in the study arm vs. 5.72 mg in placebo; difference between means, –2.29; 95% confidence interval, –5.78-1.21; P = .20).
Nearly half of the placebo group achieved complete cessation of benzodiazepine use, compared with more than one-third of the study group (21 out of 44 vs. 16 out of 42; odds ratio, 0.64; 95% confidence interval, 0.26-1.56; P = .32).
Serious or nonserious adverse events were similar across the groups.
A separate analysis of the data not presented at the conference as to whether melatonin had any effect on subjective sleep measures showed that those in the melatonin group had improved sleep according to the Pittsburgh Sleep Quality Index. When compared with the control group, “the difference was about 2 points, so it was only on the border of clinical significance, but their sleep did not get worse,” Dr. Baandrup said.
The investigators also used the Pittsburgh Sleep Diary to measure whether there were any objective differences in sleep between the melatonin and placebo groups, and found that reducing benzodiazepine use did not result in insomnia. “It remained the same from baseline to follow-up," Dr. Baandrup said. “Many patients are afraid to taper off their benzos because they fear their sleep will worsen, but we didn’t find that.”
Dr. Baandrup did not have any relevant disclosures.
On Twitter @whitneymcknight
COLORADO SPRINGS – Patients with schizophrenia and bipolar disorder can reduce or even discontinue their reliance on benzodiazepines when kept to a gradually tapered titration, results of a Danish study have shown.
Benzodiazepines often are prescribed to patients with severe mental illnesses to help relieve comorbid anxiety and insomnia. According to Dr. Lone Baandrup, a researcher at the Center for Neuropsychiatric Schizophrenia Research at the Copenhagen University Hospital in Glostrup, Denmark, the treatment is usually meant as a temporary measure during acute episodes, but patients often become addicted.
Dr. Baandrup said in an interview at the biennial meeting of the 15th International Congress on Schizophrenia Research that because it is well established that patients with severe mental illness often suffer from a diminished ability to secrete endogenous melatonin, “we wanted to see if we could facilitate tapering patients off their benzos using a prolonged-release melatonin.”
Dr. Baandrup and her colleagues randomly assigned 86 adults with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder who had been on a daily regimen of an antipsychotic and at least one benzodiazepine derivative for at least 3 months, to receive either prolonged-release melatonin 2 mg daily or matching placebo. In the intention-to-treat analysis, each group was guided by a caregiver to gradually taper their respective daily benzodiazepine dosage.
Participants were examined at baseline and at 8, 16, and 24 weeks, and were monitored weekly by telephone. All participants, researchers, treating clinicians, and outcome assessors were blinded to group assignment.
No significant difference was found between the groups as to mean benzodiazepine dosage at 24 weeks, the study’s primary outcome, but the placebo arm had a greater reduction in benzodiazepine dosage (8.01 mg in the study arm vs. 5.72 mg in placebo; difference between means, –2.29; 95% confidence interval, –5.78-1.21; P = .20).
Nearly half of the placebo group achieved complete cessation of benzodiazepine use, compared with more than one-third of the study group (21 out of 44 vs. 16 out of 42; odds ratio, 0.64; 95% confidence interval, 0.26-1.56; P = .32).
Serious or nonserious adverse events were similar across the groups.
A separate analysis of the data not presented at the conference as to whether melatonin had any effect on subjective sleep measures showed that those in the melatonin group had improved sleep according to the Pittsburgh Sleep Quality Index. When compared with the control group, “the difference was about 2 points, so it was only on the border of clinical significance, but their sleep did not get worse,” Dr. Baandrup said.
The investigators also used the Pittsburgh Sleep Diary to measure whether there were any objective differences in sleep between the melatonin and placebo groups, and found that reducing benzodiazepine use did not result in insomnia. “It remained the same from baseline to follow-up," Dr. Baandrup said. “Many patients are afraid to taper off their benzos because they fear their sleep will worsen, but we didn’t find that.”
Dr. Baandrup did not have any relevant disclosures.
On Twitter @whitneymcknight
AT THE INTERNATIONAL CONGRESS ON SCHIZOPHRENIA RESEARCH
Key clinical point: Patients with schizophrenia or bipolar disorder can reduce, or even discontinue, reliance on benzodiazepines when tapered gradually but steadily.
Major finding: No significant difference was found in benzodiazepine reduction rates between patients with psychosis given prolonged-release melatonin and placebo.
Data source: Negative, single-center, blinded parallel study of 86 patients with schizophrenia or bipolar disorder randomly assigned to long-acting melatonin or placebo while reducing their benzodiazepine dosage over 6 months.
Disclosures: Dr. Baandrup did not have any relevant disclosures.
AUDIO: Psychiatry’s Darwinian moment
LAS VEGAS – A more-specific nomenclature of depression would help in the prescribing of better treatments or might prevent it altogether, according to Dr. Vladimir Maletic, a psychiatrist who spoke at this year’s Nevada Psychiatric Association’s annual Psychopharmacology update meeting.
But to do so requires psychiatry to find its own Darwinian moment, where the etiology of depression is made clear. In the conversation with Dr. Maletic, recorded at the meeting, hear his thoughts on the differences between existential and biological depression, how allowing patients to choose their treatment can double their response rate, and the lasting, negative effects on cognition post depression.
On Twitter @whitneymcknight
LAS VEGAS – A more-specific nomenclature of depression would help in the prescribing of better treatments or might prevent it altogether, according to Dr. Vladimir Maletic, a psychiatrist who spoke at this year’s Nevada Psychiatric Association’s annual Psychopharmacology update meeting.
But to do so requires psychiatry to find its own Darwinian moment, where the etiology of depression is made clear. In the conversation with Dr. Maletic, recorded at the meeting, hear his thoughts on the differences between existential and biological depression, how allowing patients to choose their treatment can double their response rate, and the lasting, negative effects on cognition post depression.
On Twitter @whitneymcknight
LAS VEGAS – A more-specific nomenclature of depression would help in the prescribing of better treatments or might prevent it altogether, according to Dr. Vladimir Maletic, a psychiatrist who spoke at this year’s Nevada Psychiatric Association’s annual Psychopharmacology update meeting.
But to do so requires psychiatry to find its own Darwinian moment, where the etiology of depression is made clear. In the conversation with Dr. Maletic, recorded at the meeting, hear his thoughts on the differences between existential and biological depression, how allowing patients to choose their treatment can double their response rate, and the lasting, negative effects on cognition post depression.
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE NPA ANNUAL PSYCHOPHARMACOLOGY UPDATE