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FDA approves Trulance for chronic idiopathic constipation
Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.
Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.
The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”
Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.
Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.
The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”
Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.
Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.
The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”
Climate change: A call to action for psychiatry
In a recent survey of about 90 psychiatrists attending a national general psychiatry meeting, the overwhelming majority believed that climate change is human caused and the impacts were already or would soon be harming their patients. They expressed an interest in knowing more, reporting that they sometimes had little knowledge about the issues. They also believed that psychiatrists have a role to play in making the case to be better prepared for what our communities are facing. Professional organizations were a desirable choice as a source of information and training.
Because of these responses we, the Climate Psychiatry Alliance, believe that a scientific and well thought out program addressing the mental health impacts of climate disruption with practical advice on how to help our patients and our communities in the face of climate disasters while emphasizing preparedness and prevention, is called for.
As physicians, we are keenly aware of and concerned about the physical harm of extreme weather events causing acute harm, including tornadoes, fires, floods, hurricanes, and so on. We also know about the longer-term chronic conditions, including sea level rise, drought, and permanent and high temperatures.
We also know that the spread of infectious diseases, both old and some new, on us, our children, and even the unborn, is a rising challenge to our communities. The National Academy of Sciences, for example, recently linked the Zika outbreak to a rise in temperature (Proc Nat Acad Sci. 2017;114[1]:119-24). The expanding reach of malaria and the growing incidence of such illnesses as dengue, chikungunya, and Lyme also are linked to higher temperatures.
Though the physical harm from climate disruption is increasingly being discussed, more attention needs to be given to the psychological harm: When the place we call home is burned down, blown away, flooded … when we lose our possessions; maybe our pets, our livelihood; see injuries, illness, and death; the mix of fear, anger, sorrow, and trauma can bring on a full range of psychiatric disorders. Mental health professionals are already seeing posttraumatic stress disorder, depression, and anxiety disorders, as well as an increase in drug and alcohol abuse, violence against women, and child abuse (Ann Glob Health. 2014 Jul-Aug;80[4]:332-44), (Soc Sci Med. 2015;[141]:133-41), (Soc Sci Res. 2013;42[5]:1222-35), (Soc Sci Med. 2017 Jan 6;[175]:161-8).
The link between climate and aggression is clear: For each standard deviation of increased temperature and rainfall, a 4% rise in aggression between individuals and a 14% rise among groups can be expected (Science. 2013 Sep 13;34[6151]:1235367). This is true across all ethnicities and regions. General unrest around the world should come as no surprise to us – nor should its rise in the years ahead, given that temperatures will continue to rise.
The psychological needs and impacts on our communities of exploding numbers of refugees from mounting climate disruption in many areas of the world are of grave concern as the impacts of the upheaval grow ever more profound. The United Nations reports that what we are seeing now and are already unable to address, is just the tip of the iceberg.
Psychiatrists have a special role to play in all of this, because we not only are experts in physical health, we are experts on psychological harm.
We also know that any physical condition or illness carries an attendant emotional toll. Trained in science, we respect the scientific method and the peer-reviewed work that goes into validating what the scientists are telling us.
We know that harm that is entirely accidental is much easier to get over than harm experienced as avoidable. That appropriate action to protect our climate was not taken in time will become more apparent – with fear and anger among patients, families, and communities directed at policy makers and a compounding erosion of trust in our institutions. We must look at how fear, anger, and mistrust drive politics not only in our country but elsewhere since we are now a global village, interconnected.
And we must confront our values: Climate disruption is an issue of social justice, because those who will be hurt the most are from disadvantaged communities, and it is an intergenerational justice issue, because our children will inherit our mistakes. How will we answer these questions?
As experts focused on changing behaviors before it is too late, at confronting denial and resistance in ways that build people up and help influence them to change, and with the standing we have in the community, as psychiatrists we have a unique role to play. We also take seriously that our canon of ethics states our responsibility to serve our communities in ways that enhance their health.
We call upon our professional communities to help us respond to the growing public health crises. Among the many needs: education – putting together trainings for our colleagues and other thought leaders and policy makers that identify the public health burdens and drive action on them; preparedness – advising communities and individuals about how to deal with climate challenges; and prevention – advocating for solutions that reduce our vulnerability with sustainable habits and promote resilience. There is much more for us to uncover and act upon together in the months ahead.
We call upon one another for action, because only collective success will restore our health and keep us safe.
Dr. Van Susteren wrote this commentary on behalf of the Climate Psychiatry Alliance, a professional group dedicated to promoting awareness and action on climate from a mental health perspective. She is a practicing general and forensic psychiatrist in Washington. Dr. Van Susteren serves on the advisory board of the Center for Health and the Global Environment at Harvard T.H. Chan School of Public Health, Boston. She is a former member of the board of directors of the National Wildlife Federation and coauthor of group’s report, “The Psychological Effects of Global Warming on the United States – Why the U.S. Mental Health System is Not Prepared.” In 2006, Dr. Van Susteren sought the Democratic nomination for a U.S. Senate seat in Maryland. Recently, she founded Lucky Planet Foods, a company that provides plant-based, low carbon foods.
In a recent survey of about 90 psychiatrists attending a national general psychiatry meeting, the overwhelming majority believed that climate change is human caused and the impacts were already or would soon be harming their patients. They expressed an interest in knowing more, reporting that they sometimes had little knowledge about the issues. They also believed that psychiatrists have a role to play in making the case to be better prepared for what our communities are facing. Professional organizations were a desirable choice as a source of information and training.
Because of these responses we, the Climate Psychiatry Alliance, believe that a scientific and well thought out program addressing the mental health impacts of climate disruption with practical advice on how to help our patients and our communities in the face of climate disasters while emphasizing preparedness and prevention, is called for.
As physicians, we are keenly aware of and concerned about the physical harm of extreme weather events causing acute harm, including tornadoes, fires, floods, hurricanes, and so on. We also know about the longer-term chronic conditions, including sea level rise, drought, and permanent and high temperatures.
We also know that the spread of infectious diseases, both old and some new, on us, our children, and even the unborn, is a rising challenge to our communities. The National Academy of Sciences, for example, recently linked the Zika outbreak to a rise in temperature (Proc Nat Acad Sci. 2017;114[1]:119-24). The expanding reach of malaria and the growing incidence of such illnesses as dengue, chikungunya, and Lyme also are linked to higher temperatures.
Though the physical harm from climate disruption is increasingly being discussed, more attention needs to be given to the psychological harm: When the place we call home is burned down, blown away, flooded … when we lose our possessions; maybe our pets, our livelihood; see injuries, illness, and death; the mix of fear, anger, sorrow, and trauma can bring on a full range of psychiatric disorders. Mental health professionals are already seeing posttraumatic stress disorder, depression, and anxiety disorders, as well as an increase in drug and alcohol abuse, violence against women, and child abuse (Ann Glob Health. 2014 Jul-Aug;80[4]:332-44), (Soc Sci Med. 2015;[141]:133-41), (Soc Sci Res. 2013;42[5]:1222-35), (Soc Sci Med. 2017 Jan 6;[175]:161-8).
The link between climate and aggression is clear: For each standard deviation of increased temperature and rainfall, a 4% rise in aggression between individuals and a 14% rise among groups can be expected (Science. 2013 Sep 13;34[6151]:1235367). This is true across all ethnicities and regions. General unrest around the world should come as no surprise to us – nor should its rise in the years ahead, given that temperatures will continue to rise.
The psychological needs and impacts on our communities of exploding numbers of refugees from mounting climate disruption in many areas of the world are of grave concern as the impacts of the upheaval grow ever more profound. The United Nations reports that what we are seeing now and are already unable to address, is just the tip of the iceberg.
Psychiatrists have a special role to play in all of this, because we not only are experts in physical health, we are experts on psychological harm.
We also know that any physical condition or illness carries an attendant emotional toll. Trained in science, we respect the scientific method and the peer-reviewed work that goes into validating what the scientists are telling us.
We know that harm that is entirely accidental is much easier to get over than harm experienced as avoidable. That appropriate action to protect our climate was not taken in time will become more apparent – with fear and anger among patients, families, and communities directed at policy makers and a compounding erosion of trust in our institutions. We must look at how fear, anger, and mistrust drive politics not only in our country but elsewhere since we are now a global village, interconnected.
And we must confront our values: Climate disruption is an issue of social justice, because those who will be hurt the most are from disadvantaged communities, and it is an intergenerational justice issue, because our children will inherit our mistakes. How will we answer these questions?
As experts focused on changing behaviors before it is too late, at confronting denial and resistance in ways that build people up and help influence them to change, and with the standing we have in the community, as psychiatrists we have a unique role to play. We also take seriously that our canon of ethics states our responsibility to serve our communities in ways that enhance their health.
We call upon our professional communities to help us respond to the growing public health crises. Among the many needs: education – putting together trainings for our colleagues and other thought leaders and policy makers that identify the public health burdens and drive action on them; preparedness – advising communities and individuals about how to deal with climate challenges; and prevention – advocating for solutions that reduce our vulnerability with sustainable habits and promote resilience. There is much more for us to uncover and act upon together in the months ahead.
We call upon one another for action, because only collective success will restore our health and keep us safe.
Dr. Van Susteren wrote this commentary on behalf of the Climate Psychiatry Alliance, a professional group dedicated to promoting awareness and action on climate from a mental health perspective. She is a practicing general and forensic psychiatrist in Washington. Dr. Van Susteren serves on the advisory board of the Center for Health and the Global Environment at Harvard T.H. Chan School of Public Health, Boston. She is a former member of the board of directors of the National Wildlife Federation and coauthor of group’s report, “The Psychological Effects of Global Warming on the United States – Why the U.S. Mental Health System is Not Prepared.” In 2006, Dr. Van Susteren sought the Democratic nomination for a U.S. Senate seat in Maryland. Recently, she founded Lucky Planet Foods, a company that provides plant-based, low carbon foods.
In a recent survey of about 90 psychiatrists attending a national general psychiatry meeting, the overwhelming majority believed that climate change is human caused and the impacts were already or would soon be harming their patients. They expressed an interest in knowing more, reporting that they sometimes had little knowledge about the issues. They also believed that psychiatrists have a role to play in making the case to be better prepared for what our communities are facing. Professional organizations were a desirable choice as a source of information and training.
Because of these responses we, the Climate Psychiatry Alliance, believe that a scientific and well thought out program addressing the mental health impacts of climate disruption with practical advice on how to help our patients and our communities in the face of climate disasters while emphasizing preparedness and prevention, is called for.
As physicians, we are keenly aware of and concerned about the physical harm of extreme weather events causing acute harm, including tornadoes, fires, floods, hurricanes, and so on. We also know about the longer-term chronic conditions, including sea level rise, drought, and permanent and high temperatures.
We also know that the spread of infectious diseases, both old and some new, on us, our children, and even the unborn, is a rising challenge to our communities. The National Academy of Sciences, for example, recently linked the Zika outbreak to a rise in temperature (Proc Nat Acad Sci. 2017;114[1]:119-24). The expanding reach of malaria and the growing incidence of such illnesses as dengue, chikungunya, and Lyme also are linked to higher temperatures.
Though the physical harm from climate disruption is increasingly being discussed, more attention needs to be given to the psychological harm: When the place we call home is burned down, blown away, flooded … when we lose our possessions; maybe our pets, our livelihood; see injuries, illness, and death; the mix of fear, anger, sorrow, and trauma can bring on a full range of psychiatric disorders. Mental health professionals are already seeing posttraumatic stress disorder, depression, and anxiety disorders, as well as an increase in drug and alcohol abuse, violence against women, and child abuse (Ann Glob Health. 2014 Jul-Aug;80[4]:332-44), (Soc Sci Med. 2015;[141]:133-41), (Soc Sci Res. 2013;42[5]:1222-35), (Soc Sci Med. 2017 Jan 6;[175]:161-8).
The link between climate and aggression is clear: For each standard deviation of increased temperature and rainfall, a 4% rise in aggression between individuals and a 14% rise among groups can be expected (Science. 2013 Sep 13;34[6151]:1235367). This is true across all ethnicities and regions. General unrest around the world should come as no surprise to us – nor should its rise in the years ahead, given that temperatures will continue to rise.
The psychological needs and impacts on our communities of exploding numbers of refugees from mounting climate disruption in many areas of the world are of grave concern as the impacts of the upheaval grow ever more profound. The United Nations reports that what we are seeing now and are already unable to address, is just the tip of the iceberg.
Psychiatrists have a special role to play in all of this, because we not only are experts in physical health, we are experts on psychological harm.
We also know that any physical condition or illness carries an attendant emotional toll. Trained in science, we respect the scientific method and the peer-reviewed work that goes into validating what the scientists are telling us.
We know that harm that is entirely accidental is much easier to get over than harm experienced as avoidable. That appropriate action to protect our climate was not taken in time will become more apparent – with fear and anger among patients, families, and communities directed at policy makers and a compounding erosion of trust in our institutions. We must look at how fear, anger, and mistrust drive politics not only in our country but elsewhere since we are now a global village, interconnected.
And we must confront our values: Climate disruption is an issue of social justice, because those who will be hurt the most are from disadvantaged communities, and it is an intergenerational justice issue, because our children will inherit our mistakes. How will we answer these questions?
As experts focused on changing behaviors before it is too late, at confronting denial and resistance in ways that build people up and help influence them to change, and with the standing we have in the community, as psychiatrists we have a unique role to play. We also take seriously that our canon of ethics states our responsibility to serve our communities in ways that enhance their health.
We call upon our professional communities to help us respond to the growing public health crises. Among the many needs: education – putting together trainings for our colleagues and other thought leaders and policy makers that identify the public health burdens and drive action on them; preparedness – advising communities and individuals about how to deal with climate challenges; and prevention – advocating for solutions that reduce our vulnerability with sustainable habits and promote resilience. There is much more for us to uncover and act upon together in the months ahead.
We call upon one another for action, because only collective success will restore our health and keep us safe.
Dr. Van Susteren wrote this commentary on behalf of the Climate Psychiatry Alliance, a professional group dedicated to promoting awareness and action on climate from a mental health perspective. She is a practicing general and forensic psychiatrist in Washington. Dr. Van Susteren serves on the advisory board of the Center for Health and the Global Environment at Harvard T.H. Chan School of Public Health, Boston. She is a former member of the board of directors of the National Wildlife Federation and coauthor of group’s report, “The Psychological Effects of Global Warming on the United States – Why the U.S. Mental Health System is Not Prepared.” In 2006, Dr. Van Susteren sought the Democratic nomination for a U.S. Senate seat in Maryland. Recently, she founded Lucky Planet Foods, a company that provides plant-based, low carbon foods.
Bone fractures more likely to occur in psoriasis, PsA patients
Individuals who have psoriasis or psoriatic arthritis are at a significantly higher risk of also suffering bone fractures, particularly in their hip and vertebrae, according to a new study published in the Annals of the Rheumatic Diseases.
“To our knowledge, these are the first population-based estimates of the risk for incident fracture and osteoporosis in patients with psoriasis and/or PsA [psoriatic arthritis] and the first longitudinal cohort study to address this issue,” wrote the authors of the study, led by Alexis Ogdie-Beatty, MD, of the University of Pennsylvania in Philadelphia (Ann Rheum Dis. 2017 Jan 16. doi: 10.1136/annrheumdis-2016-210441).
A total of 9,788 PsA and 158,323 psoriasis patients were included in the study, along with 39,306 RA patients and 821,834 individuals from the general population. Psoriasis patients were divided into groups classified as mild (n = 149,809) or severe (n = 8,514). The average age of each cohort ranged from nearly 47 years to almost 59 years, with all cohorts comprising mostly females, ranging from about 51% to 69%.
“We found that the risk for any fracture in patients with PsA and severe psoriasis was similar to RA [but] patients with PsA and psoriasis had an increased incidence of fracture compared with the general population by 7%-26%,” the authors explained. “The incidence of vertebral fracture was also increased in patients with severe psoriasis and while hip fracture was elevated in both psoriasis groups, it was only statistically significant in patients with mild psoriasis relative to matched controls after adjusting for risk factors for osteoporosis.”
Dr. Ogdie-Beatty and her colleagues found that all of the conditions conferred an elevated risk for fractures anywhere in the body when compared with the general population, reaching hazard ratios of 1.16 (95% confidence interval, 1.06-1.27) for people with PsA, 1.07 (95% CI, 1.05-1.10) for mild psoriasis, 1.26 for severe psoriasis (95% CI, 1.15-1.39), and 1.23 for RA (95% CI, 1.18-1.28). The risk for hip fractures was only significantly higher for mild (hazard ratio, 1.13; 95% CI, 1.04-1.22) and severe psoriasis (HR, 1.21; 95% CI, 0.88-1.66), and RA (HR, 1.55; 95% CI, 1.40-1.72). Individuals with PsA did not have a significantly higher risk for vertebral fractures (HR, 1.07; 95% CI, 0.66-1.72), whereas those with mild psoriasis (HR, 1.17; 95% CI, 1.03-1.33), severe psoriasis (HR, 2.23; 95% CI, 1.54-3.22), or RA did (HR, 1.53; 95% CI, 1.30-1.80). Each of these models were fully adjusted for multiple different osteoporosis risk factors, although they were all commonly adjusted for age, sex, atrial fibrillation, diabetes, chronic obstructive pulmonary disease, stroke, SSRI use, tricyclic antidepressant use, oral steroids, smoking, and categorical body mass index.
Individual coauthors disclosed receiving funding for their work from the National Institutes of Health, as well as grants from the Department of Veterans Affairs and the Rheumatology Research Foundation. Three of the authors reported receiving payment for continuing medical education work related to psoriatic arthritis or psoriasis.
Individuals who have psoriasis or psoriatic arthritis are at a significantly higher risk of also suffering bone fractures, particularly in their hip and vertebrae, according to a new study published in the Annals of the Rheumatic Diseases.
“To our knowledge, these are the first population-based estimates of the risk for incident fracture and osteoporosis in patients with psoriasis and/or PsA [psoriatic arthritis] and the first longitudinal cohort study to address this issue,” wrote the authors of the study, led by Alexis Ogdie-Beatty, MD, of the University of Pennsylvania in Philadelphia (Ann Rheum Dis. 2017 Jan 16. doi: 10.1136/annrheumdis-2016-210441).
A total of 9,788 PsA and 158,323 psoriasis patients were included in the study, along with 39,306 RA patients and 821,834 individuals from the general population. Psoriasis patients were divided into groups classified as mild (n = 149,809) or severe (n = 8,514). The average age of each cohort ranged from nearly 47 years to almost 59 years, with all cohorts comprising mostly females, ranging from about 51% to 69%.
“We found that the risk for any fracture in patients with PsA and severe psoriasis was similar to RA [but] patients with PsA and psoriasis had an increased incidence of fracture compared with the general population by 7%-26%,” the authors explained. “The incidence of vertebral fracture was also increased in patients with severe psoriasis and while hip fracture was elevated in both psoriasis groups, it was only statistically significant in patients with mild psoriasis relative to matched controls after adjusting for risk factors for osteoporosis.”
Dr. Ogdie-Beatty and her colleagues found that all of the conditions conferred an elevated risk for fractures anywhere in the body when compared with the general population, reaching hazard ratios of 1.16 (95% confidence interval, 1.06-1.27) for people with PsA, 1.07 (95% CI, 1.05-1.10) for mild psoriasis, 1.26 for severe psoriasis (95% CI, 1.15-1.39), and 1.23 for RA (95% CI, 1.18-1.28). The risk for hip fractures was only significantly higher for mild (hazard ratio, 1.13; 95% CI, 1.04-1.22) and severe psoriasis (HR, 1.21; 95% CI, 0.88-1.66), and RA (HR, 1.55; 95% CI, 1.40-1.72). Individuals with PsA did not have a significantly higher risk for vertebral fractures (HR, 1.07; 95% CI, 0.66-1.72), whereas those with mild psoriasis (HR, 1.17; 95% CI, 1.03-1.33), severe psoriasis (HR, 2.23; 95% CI, 1.54-3.22), or RA did (HR, 1.53; 95% CI, 1.30-1.80). Each of these models were fully adjusted for multiple different osteoporosis risk factors, although they were all commonly adjusted for age, sex, atrial fibrillation, diabetes, chronic obstructive pulmonary disease, stroke, SSRI use, tricyclic antidepressant use, oral steroids, smoking, and categorical body mass index.
Individual coauthors disclosed receiving funding for their work from the National Institutes of Health, as well as grants from the Department of Veterans Affairs and the Rheumatology Research Foundation. Three of the authors reported receiving payment for continuing medical education work related to psoriatic arthritis or psoriasis.
Individuals who have psoriasis or psoriatic arthritis are at a significantly higher risk of also suffering bone fractures, particularly in their hip and vertebrae, according to a new study published in the Annals of the Rheumatic Diseases.
“To our knowledge, these are the first population-based estimates of the risk for incident fracture and osteoporosis in patients with psoriasis and/or PsA [psoriatic arthritis] and the first longitudinal cohort study to address this issue,” wrote the authors of the study, led by Alexis Ogdie-Beatty, MD, of the University of Pennsylvania in Philadelphia (Ann Rheum Dis. 2017 Jan 16. doi: 10.1136/annrheumdis-2016-210441).
A total of 9,788 PsA and 158,323 psoriasis patients were included in the study, along with 39,306 RA patients and 821,834 individuals from the general population. Psoriasis patients were divided into groups classified as mild (n = 149,809) or severe (n = 8,514). The average age of each cohort ranged from nearly 47 years to almost 59 years, with all cohorts comprising mostly females, ranging from about 51% to 69%.
“We found that the risk for any fracture in patients with PsA and severe psoriasis was similar to RA [but] patients with PsA and psoriasis had an increased incidence of fracture compared with the general population by 7%-26%,” the authors explained. “The incidence of vertebral fracture was also increased in patients with severe psoriasis and while hip fracture was elevated in both psoriasis groups, it was only statistically significant in patients with mild psoriasis relative to matched controls after adjusting for risk factors for osteoporosis.”
Dr. Ogdie-Beatty and her colleagues found that all of the conditions conferred an elevated risk for fractures anywhere in the body when compared with the general population, reaching hazard ratios of 1.16 (95% confidence interval, 1.06-1.27) for people with PsA, 1.07 (95% CI, 1.05-1.10) for mild psoriasis, 1.26 for severe psoriasis (95% CI, 1.15-1.39), and 1.23 for RA (95% CI, 1.18-1.28). The risk for hip fractures was only significantly higher for mild (hazard ratio, 1.13; 95% CI, 1.04-1.22) and severe psoriasis (HR, 1.21; 95% CI, 0.88-1.66), and RA (HR, 1.55; 95% CI, 1.40-1.72). Individuals with PsA did not have a significantly higher risk for vertebral fractures (HR, 1.07; 95% CI, 0.66-1.72), whereas those with mild psoriasis (HR, 1.17; 95% CI, 1.03-1.33), severe psoriasis (HR, 2.23; 95% CI, 1.54-3.22), or RA did (HR, 1.53; 95% CI, 1.30-1.80). Each of these models were fully adjusted for multiple different osteoporosis risk factors, although they were all commonly adjusted for age, sex, atrial fibrillation, diabetes, chronic obstructive pulmonary disease, stroke, SSRI use, tricyclic antidepressant use, oral steroids, smoking, and categorical body mass index.
Individual coauthors disclosed receiving funding for their work from the National Institutes of Health, as well as grants from the Department of Veterans Affairs and the Rheumatology Research Foundation. Three of the authors reported receiving payment for continuing medical education work related to psoriatic arthritis or psoriasis.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point:
Major finding: The risk of fracture for patients with PsA and psoriasis had a risk of fracture that was increased by 7%-26% in comparison with the general U.K. population.
Data source: Population-based, longitudinal cohort study of 9,788 PsA patients and 158,323 psoriasis patients in the United Kingdom during 1994-2014.
Disclosures: Individual coauthors disclosed receiving funding for their work from the National Institutes of Health, as well as grants from the Department of Veterans Affairs and the Rheumatology Research Foundation. Three of the authors reported receiving payment for continuing medical education work related to psoriatic arthritis or psoriasis.
Nivolumab effective in PD-L1–deficient lung cancers
VIENNA – The oncologic immunotherapy drug nivolumab works by binding PD-1 receptors, but PD-L1 ligand levels in lung cancers do not predict how responsive patients are to the drug.
“While enhanced clinical activity with nivolumab correlates with increasing tumor PD-L1 expression, nivolumab-treated patients with little or no PD-L1 expression have a comparable probability of response, more durable responses, comparable overall survival, and fewer treatment-related adverse events, compared with patients treated with docetaxel,” Solange Peters, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
But a more detailed assessment of the survival data by Dr. Peters showed an unexpected pattern of an early hazard among the nivolumab patients. During the first 3 months on randomized treatment, 15 more patients died in the nivolumab arm than in the docetaxel arm. This quickly reversed during months 4-6 on treatment, when nine more patients died on docetaxel than on nivolumab, Dr. Peters reported. By 12 months after the onset of treatment, overall survival was 51% in the nivolumab group and 39% among those randomized to docetaxel.
A post hoc analysis showed a trend to a higher risk for death during the first 3 months of nivolumab treatment among patients with poorer prognostic features, more aggressive disease, and low or no tumor expression of PD-L1, Dr. Peters said.
Although patients with tumors with high levels of PD-L1 expression had the best response rate to nivolumab, patients with no PD-L1 expression had a response to nivolumab that was roughly equivalent to the response to docetaxel among patients randomized to chemotherapy. “Deep and durable responses were seen to nivolumab irrespective of the level of PD-L1 expression,” she said. Among patients with tumors that had a less than 1% rate of PD-L1 expression, the objective response rate was 9% with nivolumab and 15% with docetaxel. Among patients with tumors that had a PD-L1 expression rate of 1% or greater, the objective responses rate was 31% with nivolumab and 12% with docetaxel.
In a landmark analysis that excluded patients who died during the first 3 months on treatment, the pattern of responses to nivolumab and its advantage over docetaxel were similar among patients with no or low PD-L1 expression and among all patients enrolled in the study. In this landmark analysis, the hazard ratio for death after 3 months was reduced with nivolumab treatment by 34% among patients with no or low PD-L1 expression and by 31% in the entire study population, Dr. Peters reported.
CheckMate057 was funded by Bristol-Myers Squibb, the company that markets nivolumab (Opdivo). Dr. Peters has been a consultant to Bristol-Myers Squibb and to several other drug companies.
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On Twitter @mitchelzoler
The new analyses reported by Dr. Peters addressed the question of whether patients who receive nivolumab in place of docetaxel are disadvantaged during the first 3 months of treatment. The data showed that in CheckMate057 an excess of 15 patients died in the group randomized to receive nivolumab during the first 3 months on treatment, compared with the control patients treated with docetaxel. This is concerning. Ideally, we’d like to see the patients treated with immunotherapy respond right away, but it takes time for immunotherapy to have an effect.
In almost all immunotherapy studies, a high proportion of patients, often about a third, progress during the first 2-3 months on treatment. It will be important to identify these patients and try new treatment approaches such as combined immunotherapies or a combination of chemotherapy with immunotherapy.
The early excess mortality of 15 patients with nivolumab seen in CheckMate057 must be viewed in context. It represents just 5% of patients randomized to receive nivolumab, and hence this finding should not influence clinical practice. Nivolumab treatment produced a very strong treatment benefit overall during follow-up at 12 and 18 months, compared with docetaxel in this study.
Immunotherapy agents like nivolumab have another advantage, compared with standard chemotherapy drugs, beyond better efficacy in selected patients. Immunotherapy drugs are also generally safer than chemotherapy agents, producing fewer adverse effects. For that reason alone, immunotherapy is preferred as long as its efficacy is comparable to that of chemotherapy. Even in patients with a tumor that does not express PD-L1, and even though some non–small cell lung cancer patients will die early when put on immunotherapy, overall opinion in the clinical community favors a drug like nivolumab over chemotherapy because of its better safety.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Roche, Boehringer-Ingelheim, BMS, Merck/MSD, Merck Serono, and Celgene; he has received honoraria from Roche and Merck; and he has received travel grants from Roche and BMS. He made these comments as the designated discussant for the report and in an interview.
The new analyses reported by Dr. Peters addressed the question of whether patients who receive nivolumab in place of docetaxel are disadvantaged during the first 3 months of treatment. The data showed that in CheckMate057 an excess of 15 patients died in the group randomized to receive nivolumab during the first 3 months on treatment, compared with the control patients treated with docetaxel. This is concerning. Ideally, we’d like to see the patients treated with immunotherapy respond right away, but it takes time for immunotherapy to have an effect.
In almost all immunotherapy studies, a high proportion of patients, often about a third, progress during the first 2-3 months on treatment. It will be important to identify these patients and try new treatment approaches such as combined immunotherapies or a combination of chemotherapy with immunotherapy.
The early excess mortality of 15 patients with nivolumab seen in CheckMate057 must be viewed in context. It represents just 5% of patients randomized to receive nivolumab, and hence this finding should not influence clinical practice. Nivolumab treatment produced a very strong treatment benefit overall during follow-up at 12 and 18 months, compared with docetaxel in this study.
Immunotherapy agents like nivolumab have another advantage, compared with standard chemotherapy drugs, beyond better efficacy in selected patients. Immunotherapy drugs are also generally safer than chemotherapy agents, producing fewer adverse effects. For that reason alone, immunotherapy is preferred as long as its efficacy is comparable to that of chemotherapy. Even in patients with a tumor that does not express PD-L1, and even though some non–small cell lung cancer patients will die early when put on immunotherapy, overall opinion in the clinical community favors a drug like nivolumab over chemotherapy because of its better safety.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Roche, Boehringer-Ingelheim, BMS, Merck/MSD, Merck Serono, and Celgene; he has received honoraria from Roche and Merck; and he has received travel grants from Roche and BMS. He made these comments as the designated discussant for the report and in an interview.
The new analyses reported by Dr. Peters addressed the question of whether patients who receive nivolumab in place of docetaxel are disadvantaged during the first 3 months of treatment. The data showed that in CheckMate057 an excess of 15 patients died in the group randomized to receive nivolumab during the first 3 months on treatment, compared with the control patients treated with docetaxel. This is concerning. Ideally, we’d like to see the patients treated with immunotherapy respond right away, but it takes time for immunotherapy to have an effect.
In almost all immunotherapy studies, a high proportion of patients, often about a third, progress during the first 2-3 months on treatment. It will be important to identify these patients and try new treatment approaches such as combined immunotherapies or a combination of chemotherapy with immunotherapy.
The early excess mortality of 15 patients with nivolumab seen in CheckMate057 must be viewed in context. It represents just 5% of patients randomized to receive nivolumab, and hence this finding should not influence clinical practice. Nivolumab treatment produced a very strong treatment benefit overall during follow-up at 12 and 18 months, compared with docetaxel in this study.
Immunotherapy agents like nivolumab have another advantage, compared with standard chemotherapy drugs, beyond better efficacy in selected patients. Immunotherapy drugs are also generally safer than chemotherapy agents, producing fewer adverse effects. For that reason alone, immunotherapy is preferred as long as its efficacy is comparable to that of chemotherapy. Even in patients with a tumor that does not express PD-L1, and even though some non–small cell lung cancer patients will die early when put on immunotherapy, overall opinion in the clinical community favors a drug like nivolumab over chemotherapy because of its better safety.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Roche, Boehringer-Ingelheim, BMS, Merck/MSD, Merck Serono, and Celgene; he has received honoraria from Roche and Merck; and he has received travel grants from Roche and BMS. He made these comments as the designated discussant for the report and in an interview.
VIENNA – The oncologic immunotherapy drug nivolumab works by binding PD-1 receptors, but PD-L1 ligand levels in lung cancers do not predict how responsive patients are to the drug.
“While enhanced clinical activity with nivolumab correlates with increasing tumor PD-L1 expression, nivolumab-treated patients with little or no PD-L1 expression have a comparable probability of response, more durable responses, comparable overall survival, and fewer treatment-related adverse events, compared with patients treated with docetaxel,” Solange Peters, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
But a more detailed assessment of the survival data by Dr. Peters showed an unexpected pattern of an early hazard among the nivolumab patients. During the first 3 months on randomized treatment, 15 more patients died in the nivolumab arm than in the docetaxel arm. This quickly reversed during months 4-6 on treatment, when nine more patients died on docetaxel than on nivolumab, Dr. Peters reported. By 12 months after the onset of treatment, overall survival was 51% in the nivolumab group and 39% among those randomized to docetaxel.
A post hoc analysis showed a trend to a higher risk for death during the first 3 months of nivolumab treatment among patients with poorer prognostic features, more aggressive disease, and low or no tumor expression of PD-L1, Dr. Peters said.
Although patients with tumors with high levels of PD-L1 expression had the best response rate to nivolumab, patients with no PD-L1 expression had a response to nivolumab that was roughly equivalent to the response to docetaxel among patients randomized to chemotherapy. “Deep and durable responses were seen to nivolumab irrespective of the level of PD-L1 expression,” she said. Among patients with tumors that had a less than 1% rate of PD-L1 expression, the objective response rate was 9% with nivolumab and 15% with docetaxel. Among patients with tumors that had a PD-L1 expression rate of 1% or greater, the objective responses rate was 31% with nivolumab and 12% with docetaxel.
In a landmark analysis that excluded patients who died during the first 3 months on treatment, the pattern of responses to nivolumab and its advantage over docetaxel were similar among patients with no or low PD-L1 expression and among all patients enrolled in the study. In this landmark analysis, the hazard ratio for death after 3 months was reduced with nivolumab treatment by 34% among patients with no or low PD-L1 expression and by 31% in the entire study population, Dr. Peters reported.
CheckMate057 was funded by Bristol-Myers Squibb, the company that markets nivolumab (Opdivo). Dr. Peters has been a consultant to Bristol-Myers Squibb and to several other drug companies.
[email protected]
On Twitter @mitchelzoler
VIENNA – The oncologic immunotherapy drug nivolumab works by binding PD-1 receptors, but PD-L1 ligand levels in lung cancers do not predict how responsive patients are to the drug.
“While enhanced clinical activity with nivolumab correlates with increasing tumor PD-L1 expression, nivolumab-treated patients with little or no PD-L1 expression have a comparable probability of response, more durable responses, comparable overall survival, and fewer treatment-related adverse events, compared with patients treated with docetaxel,” Solange Peters, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
But a more detailed assessment of the survival data by Dr. Peters showed an unexpected pattern of an early hazard among the nivolumab patients. During the first 3 months on randomized treatment, 15 more patients died in the nivolumab arm than in the docetaxel arm. This quickly reversed during months 4-6 on treatment, when nine more patients died on docetaxel than on nivolumab, Dr. Peters reported. By 12 months after the onset of treatment, overall survival was 51% in the nivolumab group and 39% among those randomized to docetaxel.
A post hoc analysis showed a trend to a higher risk for death during the first 3 months of nivolumab treatment among patients with poorer prognostic features, more aggressive disease, and low or no tumor expression of PD-L1, Dr. Peters said.
Although patients with tumors with high levels of PD-L1 expression had the best response rate to nivolumab, patients with no PD-L1 expression had a response to nivolumab that was roughly equivalent to the response to docetaxel among patients randomized to chemotherapy. “Deep and durable responses were seen to nivolumab irrespective of the level of PD-L1 expression,” she said. Among patients with tumors that had a less than 1% rate of PD-L1 expression, the objective response rate was 9% with nivolumab and 15% with docetaxel. Among patients with tumors that had a PD-L1 expression rate of 1% or greater, the objective responses rate was 31% with nivolumab and 12% with docetaxel.
In a landmark analysis that excluded patients who died during the first 3 months on treatment, the pattern of responses to nivolumab and its advantage over docetaxel were similar among patients with no or low PD-L1 expression and among all patients enrolled in the study. In this landmark analysis, the hazard ratio for death after 3 months was reduced with nivolumab treatment by 34% among patients with no or low PD-L1 expression and by 31% in the entire study population, Dr. Peters reported.
CheckMate057 was funded by Bristol-Myers Squibb, the company that markets nivolumab (Opdivo). Dr. Peters has been a consultant to Bristol-Myers Squibb and to several other drug companies.
[email protected]
On Twitter @mitchelzoler
AT WCLC 2016
Key clinical point:
Major finding: When tumors had at least 1% PD-L1 expression, objective response rates were 31% with nivolumab and 12% with docetaxel.
Data source: CheckMate057, a pivotal trial of nivolumab that enrolled 592 patients with advanced, nonsquamous non–small cell lung cancer.
Disclosures: CheckMate057 was funded by Bristol-Myers Squibb, the company that markets nivolumab (Opdivo). Dr. Peters has been a consultant to Bristol-Myers Squibb and to several other drug companies.
Vagus Nerve Stimulation Reduces Seizures and Improves Quality of Life
Patients with epilepsy who do not respond to drug therapy and who are not candidates for surgery sometimes respond to vagus nerve stimulation (VNS). Research suggests that VNS reduces the frequency of seizures, but a recent study now suggests it may also improve patients’ quality of life. Englot et al found that the therapy improves alertness, post-ictal state, cluster seizures, mood, verbal communication, school and professional achievements, and memory. Several factors predicted patients’ improvement, including a shorter time to implant, female gender, generalized seizure type, and being Caucasian.
Englot DJ, Hassnain KH, Rolston JD, et al. Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data. Epilepsy Behav. 2017;66:4-9.
Patients with epilepsy who do not respond to drug therapy and who are not candidates for surgery sometimes respond to vagus nerve stimulation (VNS). Research suggests that VNS reduces the frequency of seizures, but a recent study now suggests it may also improve patients’ quality of life. Englot et al found that the therapy improves alertness, post-ictal state, cluster seizures, mood, verbal communication, school and professional achievements, and memory. Several factors predicted patients’ improvement, including a shorter time to implant, female gender, generalized seizure type, and being Caucasian.
Englot DJ, Hassnain KH, Rolston JD, et al. Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data. Epilepsy Behav. 2017;66:4-9.
Patients with epilepsy who do not respond to drug therapy and who are not candidates for surgery sometimes respond to vagus nerve stimulation (VNS). Research suggests that VNS reduces the frequency of seizures, but a recent study now suggests it may also improve patients’ quality of life. Englot et al found that the therapy improves alertness, post-ictal state, cluster seizures, mood, verbal communication, school and professional achievements, and memory. Several factors predicted patients’ improvement, including a shorter time to implant, female gender, generalized seizure type, and being Caucasian.
Englot DJ, Hassnain KH, Rolston JD, et al. Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data. Epilepsy Behav. 2017;66:4-9.
Auditory Auras May Signal Poor Surgical Outcomes
Patients with temporal lobe epilepsy are more likely to fare poorly after surgery if they experience auditory auras. When Ali A. Asadi-Pooya and associates performed a retrospective analysis of 1186 drug-resistant patients who had had a temporal resection, they found that those with auditory auras were more likely to relapse after surgery, when compared to those who did not experience the auras (P=.03). The side of the head in which the procedure was performed did not affect postoperative prognosis.
Asadi-Pooya AA, Wyeth D, Nei M, et al. Postsurgical outcome in patients with auditory auras and drug-resistant epilepsy. Epilepsy Behav. 2017;66:49-52.
Patients with temporal lobe epilepsy are more likely to fare poorly after surgery if they experience auditory auras. When Ali A. Asadi-Pooya and associates performed a retrospective analysis of 1186 drug-resistant patients who had had a temporal resection, they found that those with auditory auras were more likely to relapse after surgery, when compared to those who did not experience the auras (P=.03). The side of the head in which the procedure was performed did not affect postoperative prognosis.
Asadi-Pooya AA, Wyeth D, Nei M, et al. Postsurgical outcome in patients with auditory auras and drug-resistant epilepsy. Epilepsy Behav. 2017;66:49-52.
Patients with temporal lobe epilepsy are more likely to fare poorly after surgery if they experience auditory auras. When Ali A. Asadi-Pooya and associates performed a retrospective analysis of 1186 drug-resistant patients who had had a temporal resection, they found that those with auditory auras were more likely to relapse after surgery, when compared to those who did not experience the auras (P=.03). The side of the head in which the procedure was performed did not affect postoperative prognosis.
Asadi-Pooya AA, Wyeth D, Nei M, et al. Postsurgical outcome in patients with auditory auras and drug-resistant epilepsy. Epilepsy Behav. 2017;66:49-52.
Older, Poorer Patients With Epilepsy Less Likely to Take their Medication
Approximately one-third of older adults with epilepsy do not adhere very well to their antiepileptic drug regimen, with older minority patients even less compliant. That’s the conclusion reached by researchers who analyzed Medicare claims from 2008 to 2010, using a 5% random sample of beneficiaries and augmenting it with minority patients. Piper et al looked at 36,912 cases of epilepsy and found 31.8% were nonadherent; that included 24.1% of whites and 34.3% of African Americans. They also found that Medicare beneficiaries who lived in high poverty areas were more likely to be noncompliant.
Piper K, Richman J, Faught E, at al. Adherence to antiepileptic drugs among diverse older Americans on Part D Medicare. Epilepsy Behav. 2017;66:68-73.
Approximately one-third of older adults with epilepsy do not adhere very well to their antiepileptic drug regimen, with older minority patients even less compliant. That’s the conclusion reached by researchers who analyzed Medicare claims from 2008 to 2010, using a 5% random sample of beneficiaries and augmenting it with minority patients. Piper et al looked at 36,912 cases of epilepsy and found 31.8% were nonadherent; that included 24.1% of whites and 34.3% of African Americans. They also found that Medicare beneficiaries who lived in high poverty areas were more likely to be noncompliant.
Piper K, Richman J, Faught E, at al. Adherence to antiepileptic drugs among diverse older Americans on Part D Medicare. Epilepsy Behav. 2017;66:68-73.
Approximately one-third of older adults with epilepsy do not adhere very well to their antiepileptic drug regimen, with older minority patients even less compliant. That’s the conclusion reached by researchers who analyzed Medicare claims from 2008 to 2010, using a 5% random sample of beneficiaries and augmenting it with minority patients. Piper et al looked at 36,912 cases of epilepsy and found 31.8% were nonadherent; that included 24.1% of whites and 34.3% of African Americans. They also found that Medicare beneficiaries who lived in high poverty areas were more likely to be noncompliant.
Piper K, Richman J, Faught E, at al. Adherence to antiepileptic drugs among diverse older Americans on Part D Medicare. Epilepsy Behav. 2017;66:68-73.
Senate takes first step toward repealing ACA
With a Jan. 12 early morning procedural passed on party lines, the Senate has set the stage for the repeal of the revenue aspects of the Affordable Care Act.
Republican Senators will be using the budget reconciliation process, which will allow them to move forward with repealing certain provisions of the health care reform law without any Democratic support, although passage of any replacement will require some bipartisan support as Republicans do not have the required 60 votes to guarantee passage.
The budget resolution contains no details about what could be repealed or whether there will be a replacement, but it does direct the key committees to write draft legislation by Jan. 27.
Senate Republicans “plan to rescue those trapped in a failing system, to replace that system with a functional market, or markets, and then repeal Obamacare for good,” he said.
Sen. Alexander said the process will come in three parts. The first will protect the 11 million people who have purchased health insurance through the exchanges so that they don’t lose coverage.
“Second, we will build better systems providing Americans with more choices that cost less,” he said. “Note I say systems, not one system. If anyone is expecting [Senate Majority Leader Mitch] McConnell [R-Ky.] to roll a wheelbarrow on the Senate floor with a comprehensive Republican health care plan, they’re going to be waiting a long time because we don’t believe in that. We don’t want to replace a failed Obamacare federal system with another failed federal system.”
The last part will be to repeal what remains of the law after the new plan is in place.
Sen. Alexander reiterated that any future bill will keep the ban on coverage denials for preexisting conditions and the allowance of coverage of children up to the age of 26 who are on their parents’ plans.
He stated that this reform effort will not address Medicare reform, which will be the subject of separate legislative action.
The AGA opposes repealing the ACA unless a viable, equitable replacement is in place. Patients who have received coverage through the ACA should be able to maintain coverage without interruption, and any replacement package must ensure patient access and coverage of specialty care, provide for preventive screenings without cost-sharing, not discriminate on the basis of a pre-existing condition or gender, cover children until they are age 26, and ban annual and lifetime caps on coverage.
With a Jan. 12 early morning procedural passed on party lines, the Senate has set the stage for the repeal of the revenue aspects of the Affordable Care Act.
Republican Senators will be using the budget reconciliation process, which will allow them to move forward with repealing certain provisions of the health care reform law without any Democratic support, although passage of any replacement will require some bipartisan support as Republicans do not have the required 60 votes to guarantee passage.
The budget resolution contains no details about what could be repealed or whether there will be a replacement, but it does direct the key committees to write draft legislation by Jan. 27.
Senate Republicans “plan to rescue those trapped in a failing system, to replace that system with a functional market, or markets, and then repeal Obamacare for good,” he said.
Sen. Alexander said the process will come in three parts. The first will protect the 11 million people who have purchased health insurance through the exchanges so that they don’t lose coverage.
“Second, we will build better systems providing Americans with more choices that cost less,” he said. “Note I say systems, not one system. If anyone is expecting [Senate Majority Leader Mitch] McConnell [R-Ky.] to roll a wheelbarrow on the Senate floor with a comprehensive Republican health care plan, they’re going to be waiting a long time because we don’t believe in that. We don’t want to replace a failed Obamacare federal system with another failed federal system.”
The last part will be to repeal what remains of the law after the new plan is in place.
Sen. Alexander reiterated that any future bill will keep the ban on coverage denials for preexisting conditions and the allowance of coverage of children up to the age of 26 who are on their parents’ plans.
He stated that this reform effort will not address Medicare reform, which will be the subject of separate legislative action.
The AGA opposes repealing the ACA unless a viable, equitable replacement is in place. Patients who have received coverage through the ACA should be able to maintain coverage without interruption, and any replacement package must ensure patient access and coverage of specialty care, provide for preventive screenings without cost-sharing, not discriminate on the basis of a pre-existing condition or gender, cover children until they are age 26, and ban annual and lifetime caps on coverage.
With a Jan. 12 early morning procedural passed on party lines, the Senate has set the stage for the repeal of the revenue aspects of the Affordable Care Act.
Republican Senators will be using the budget reconciliation process, which will allow them to move forward with repealing certain provisions of the health care reform law without any Democratic support, although passage of any replacement will require some bipartisan support as Republicans do not have the required 60 votes to guarantee passage.
The budget resolution contains no details about what could be repealed or whether there will be a replacement, but it does direct the key committees to write draft legislation by Jan. 27.
Senate Republicans “plan to rescue those trapped in a failing system, to replace that system with a functional market, or markets, and then repeal Obamacare for good,” he said.
Sen. Alexander said the process will come in three parts. The first will protect the 11 million people who have purchased health insurance through the exchanges so that they don’t lose coverage.
“Second, we will build better systems providing Americans with more choices that cost less,” he said. “Note I say systems, not one system. If anyone is expecting [Senate Majority Leader Mitch] McConnell [R-Ky.] to roll a wheelbarrow on the Senate floor with a comprehensive Republican health care plan, they’re going to be waiting a long time because we don’t believe in that. We don’t want to replace a failed Obamacare federal system with another failed federal system.”
The last part will be to repeal what remains of the law after the new plan is in place.
Sen. Alexander reiterated that any future bill will keep the ban on coverage denials for preexisting conditions and the allowance of coverage of children up to the age of 26 who are on their parents’ plans.
He stated that this reform effort will not address Medicare reform, which will be the subject of separate legislative action.
The AGA opposes repealing the ACA unless a viable, equitable replacement is in place. Patients who have received coverage through the ACA should be able to maintain coverage without interruption, and any replacement package must ensure patient access and coverage of specialty care, provide for preventive screenings without cost-sharing, not discriminate on the basis of a pre-existing condition or gender, cover children until they are age 26, and ban annual and lifetime caps on coverage.
CMS nixes Part B drug payment demonstration
A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services. The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.
The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”
The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.
Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.
One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.
“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”
An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
The AGA expressed concern that many of the drugs that gastroenterologists administer would be included in this proposed new payment model and that the model would affect the patients treated for the most complex conditions, such as Crohn’s disease and ulcerative colitis. Ultimately, this payment model would limit patient access to specialist care. The AGA urged CMS to include all stakeholders in the development of approaches to control Part B costs.
A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services. The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.
The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”
The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.
Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.
One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.
“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”
An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
The AGA expressed concern that many of the drugs that gastroenterologists administer would be included in this proposed new payment model and that the model would affect the patients treated for the most complex conditions, such as Crohn’s disease and ulcerative colitis. Ultimately, this payment model would limit patient access to specialist care. The AGA urged CMS to include all stakeholders in the development of approaches to control Part B costs.
A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services. The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.
The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”
The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.
Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.
One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.
“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”
An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
The AGA expressed concern that many of the drugs that gastroenterologists administer would be included in this proposed new payment model and that the model would affect the patients treated for the most complex conditions, such as Crohn’s disease and ulcerative colitis. Ultimately, this payment model would limit patient access to specialist care. The AGA urged CMS to include all stakeholders in the development of approaches to control Part B costs.
Continuous glucose monitoring benefits patients with type 1 diabetes
, according to two separate randomized trials reported online Jan. 24 in JAMA.
Compared with usual care, continuous glucose monitoring decreased mean HbA1c levels by 0.6% in a multicenter open-label U.S. study involving 158 participants and by 0.4% in a multicenter open-label crossover trial in Sweden. Both research groups noted that lengthier trials are needed to assess longer-term effectiveness of continuous glucose monitoring in this patient population, the possible adverse effects of long-term use, and whether the reduction in HbA1c levels translates into improved clinical outcomes.
The first trial, which was conducted at 24 U.S. endocrinology practices, involved patients aged 25 and older (mean age, 48 years) who had had type 1 diabetes for a median of 19 years and whose baseline HbA1c levels ranged from 7.5% to 10%. A total of 105 of these participants were randomly assigned to use continuous glucose monitoring (CGM group) and 53 to receive usual care (control group) for 24 weeks, said Roy W. Beck, MD, PhD, of the Jaeb Center for Health Research, Tampa, and his associates.
The CGM group was instructed to wear the device on at least 85% of days and to calibrate it at least twice per day, and they were to verify their glucose level by doing blood glucose meter testing at least three times daily before injecting insulin. The control group was instructed to do blood glucose meter testing at least four times per day.
The primary outcome, reduction in HbA1c level, was 1.1% at 12 weeks and 1% at 24 weeks with CGM, compared with 0.5% at 12 weeks and 0.4% at 24 weeks with usual care. At the end of the treatment period, the mean difference between the two study groups in HbA1c reduction was 0.6%.
Secondary outcomes also favored CGM, including the time spent with glucose levels within the target range of 70-180 mg/dL, duration of hypoglycemia, duration of hyperglycemia, and glycemic variability. In addition, patients reported a high level of satisfaction with CGM, Dr. Beck and his associates said (JAMA. 2017 Jan 24. doi: 10.1001/jama.2016.19975).
The second trial was conducted at 15 medical centers in Sweden and involved 161 adults aged 18 and older (mean age, 44 years) whose baseline HbA1c levels were 7.5% or higher. The participants served as their own controls, randomly assigned to use either CGM or usual care for 26 weeks and then to crossover to the other group for 26 weeks, said Marcus Lind, MD, PhD, of the diabetes outpatient clinic, Uddevalla (Sweden) Hospital, and his associates.
The primary outcome, reduction in HbA1c level, was lower by 0.4% with CGM than with usual care. In addition, secondary outcomes also favored CGM, including treatment satisfaction, patient concern about having a hypoglycemic episode, overall well-being, and mean glucose levels. However, in this study, patients measured their blood glucose levels less often with CGM (2.7 measurements per day) than with usual care (3.7 measurements per day).
One patient developed an allergic reaction to the device’s internal sensor and had it removed, according to Dr. Lind and his associates (JAMA. 2017 Jan 24. doi: 10.1001/jama.2016.19976).
Dr. Beck’s study was sponsored by Dexcom, maker of the CGM device, which also participated in designing the study, writing the protocol, reviewing and approving the manuscripts, and interpreting the data. Dr. Beck reported financial relationships with Dexcom and Abbott Diabetes Care, and his associates reported ties to numerous industry sources. Dr. Lind’s study was sponsored by the NU Hospital Group and Dexcom. Dr. Lind reported financial relationships with AstraZeneca, Dexcom, Eli Lilly, Medtronic, Novo Nordisk, and Rubin Medical, and his associates reported ties to numerous industry sources.
Both of these studies show a clear benefit with continuous glucose monitoring in patients with type 1 diabetes, but there are a few concerns.
First, CGM is expensive, and insurers may be reluctant to pay for this device in light of the relatively modest benefits reported by Beck et al. and Lind et al. Second, CGM is invasive and still requires patients to monitor their blood glucose with needle sticks several times per day – two factors that may limit its acceptability to many patients.
Third, the clinicians in these trials were experienced with using CGM and instructing patients in its use. Most clinicians who are not endocrinologists, and even some endocrinologists, would not have the time to manage the volume of data generated by the device and to guide patients’ lifestyle and insulin dosage changes accordingly, given the current time constraints in managing diabetes care.
Mayer B. Davidson, MD, is at Charles R. Drew University of Medicine and Science, Los Angeles. He reported having no relevant financial disclosures. Dr. Davidson made these remarks in an editorial accompanying the two reports (JAMA. 2017;317:363-4).
Both of these studies show a clear benefit with continuous glucose monitoring in patients with type 1 diabetes, but there are a few concerns.
First, CGM is expensive, and insurers may be reluctant to pay for this device in light of the relatively modest benefits reported by Beck et al. and Lind et al. Second, CGM is invasive and still requires patients to monitor their blood glucose with needle sticks several times per day – two factors that may limit its acceptability to many patients.
Third, the clinicians in these trials were experienced with using CGM and instructing patients in its use. Most clinicians who are not endocrinologists, and even some endocrinologists, would not have the time to manage the volume of data generated by the device and to guide patients’ lifestyle and insulin dosage changes accordingly, given the current time constraints in managing diabetes care.
Mayer B. Davidson, MD, is at Charles R. Drew University of Medicine and Science, Los Angeles. He reported having no relevant financial disclosures. Dr. Davidson made these remarks in an editorial accompanying the two reports (JAMA. 2017;317:363-4).
Both of these studies show a clear benefit with continuous glucose monitoring in patients with type 1 diabetes, but there are a few concerns.
First, CGM is expensive, and insurers may be reluctant to pay for this device in light of the relatively modest benefits reported by Beck et al. and Lind et al. Second, CGM is invasive and still requires patients to monitor their blood glucose with needle sticks several times per day – two factors that may limit its acceptability to many patients.
Third, the clinicians in these trials were experienced with using CGM and instructing patients in its use. Most clinicians who are not endocrinologists, and even some endocrinologists, would not have the time to manage the volume of data generated by the device and to guide patients’ lifestyle and insulin dosage changes accordingly, given the current time constraints in managing diabetes care.
Mayer B. Davidson, MD, is at Charles R. Drew University of Medicine and Science, Los Angeles. He reported having no relevant financial disclosures. Dr. Davidson made these remarks in an editorial accompanying the two reports (JAMA. 2017;317:363-4).
, according to two separate randomized trials reported online Jan. 24 in JAMA.
Compared with usual care, continuous glucose monitoring decreased mean HbA1c levels by 0.6% in a multicenter open-label U.S. study involving 158 participants and by 0.4% in a multicenter open-label crossover trial in Sweden. Both research groups noted that lengthier trials are needed to assess longer-term effectiveness of continuous glucose monitoring in this patient population, the possible adverse effects of long-term use, and whether the reduction in HbA1c levels translates into improved clinical outcomes.
The first trial, which was conducted at 24 U.S. endocrinology practices, involved patients aged 25 and older (mean age, 48 years) who had had type 1 diabetes for a median of 19 years and whose baseline HbA1c levels ranged from 7.5% to 10%. A total of 105 of these participants were randomly assigned to use continuous glucose monitoring (CGM group) and 53 to receive usual care (control group) for 24 weeks, said Roy W. Beck, MD, PhD, of the Jaeb Center for Health Research, Tampa, and his associates.
The CGM group was instructed to wear the device on at least 85% of days and to calibrate it at least twice per day, and they were to verify their glucose level by doing blood glucose meter testing at least three times daily before injecting insulin. The control group was instructed to do blood glucose meter testing at least four times per day.
The primary outcome, reduction in HbA1c level, was 1.1% at 12 weeks and 1% at 24 weeks with CGM, compared with 0.5% at 12 weeks and 0.4% at 24 weeks with usual care. At the end of the treatment period, the mean difference between the two study groups in HbA1c reduction was 0.6%.
Secondary outcomes also favored CGM, including the time spent with glucose levels within the target range of 70-180 mg/dL, duration of hypoglycemia, duration of hyperglycemia, and glycemic variability. In addition, patients reported a high level of satisfaction with CGM, Dr. Beck and his associates said (JAMA. 2017 Jan 24. doi: 10.1001/jama.2016.19975).
The second trial was conducted at 15 medical centers in Sweden and involved 161 adults aged 18 and older (mean age, 44 years) whose baseline HbA1c levels were 7.5% or higher. The participants served as their own controls, randomly assigned to use either CGM or usual care for 26 weeks and then to crossover to the other group for 26 weeks, said Marcus Lind, MD, PhD, of the diabetes outpatient clinic, Uddevalla (Sweden) Hospital, and his associates.
The primary outcome, reduction in HbA1c level, was lower by 0.4% with CGM than with usual care. In addition, secondary outcomes also favored CGM, including treatment satisfaction, patient concern about having a hypoglycemic episode, overall well-being, and mean glucose levels. However, in this study, patients measured their blood glucose levels less often with CGM (2.7 measurements per day) than with usual care (3.7 measurements per day).
One patient developed an allergic reaction to the device’s internal sensor and had it removed, according to Dr. Lind and his associates (JAMA. 2017 Jan 24. doi: 10.1001/jama.2016.19976).
Dr. Beck’s study was sponsored by Dexcom, maker of the CGM device, which also participated in designing the study, writing the protocol, reviewing and approving the manuscripts, and interpreting the data. Dr. Beck reported financial relationships with Dexcom and Abbott Diabetes Care, and his associates reported ties to numerous industry sources. Dr. Lind’s study was sponsored by the NU Hospital Group and Dexcom. Dr. Lind reported financial relationships with AstraZeneca, Dexcom, Eli Lilly, Medtronic, Novo Nordisk, and Rubin Medical, and his associates reported ties to numerous industry sources.
, according to two separate randomized trials reported online Jan. 24 in JAMA.
Compared with usual care, continuous glucose monitoring decreased mean HbA1c levels by 0.6% in a multicenter open-label U.S. study involving 158 participants and by 0.4% in a multicenter open-label crossover trial in Sweden. Both research groups noted that lengthier trials are needed to assess longer-term effectiveness of continuous glucose monitoring in this patient population, the possible adverse effects of long-term use, and whether the reduction in HbA1c levels translates into improved clinical outcomes.
The first trial, which was conducted at 24 U.S. endocrinology practices, involved patients aged 25 and older (mean age, 48 years) who had had type 1 diabetes for a median of 19 years and whose baseline HbA1c levels ranged from 7.5% to 10%. A total of 105 of these participants were randomly assigned to use continuous glucose monitoring (CGM group) and 53 to receive usual care (control group) for 24 weeks, said Roy W. Beck, MD, PhD, of the Jaeb Center for Health Research, Tampa, and his associates.
The CGM group was instructed to wear the device on at least 85% of days and to calibrate it at least twice per day, and they were to verify their glucose level by doing blood glucose meter testing at least three times daily before injecting insulin. The control group was instructed to do blood glucose meter testing at least four times per day.
The primary outcome, reduction in HbA1c level, was 1.1% at 12 weeks and 1% at 24 weeks with CGM, compared with 0.5% at 12 weeks and 0.4% at 24 weeks with usual care. At the end of the treatment period, the mean difference between the two study groups in HbA1c reduction was 0.6%.
Secondary outcomes also favored CGM, including the time spent with glucose levels within the target range of 70-180 mg/dL, duration of hypoglycemia, duration of hyperglycemia, and glycemic variability. In addition, patients reported a high level of satisfaction with CGM, Dr. Beck and his associates said (JAMA. 2017 Jan 24. doi: 10.1001/jama.2016.19975).
The second trial was conducted at 15 medical centers in Sweden and involved 161 adults aged 18 and older (mean age, 44 years) whose baseline HbA1c levels were 7.5% or higher. The participants served as their own controls, randomly assigned to use either CGM or usual care for 26 weeks and then to crossover to the other group for 26 weeks, said Marcus Lind, MD, PhD, of the diabetes outpatient clinic, Uddevalla (Sweden) Hospital, and his associates.
The primary outcome, reduction in HbA1c level, was lower by 0.4% with CGM than with usual care. In addition, secondary outcomes also favored CGM, including treatment satisfaction, patient concern about having a hypoglycemic episode, overall well-being, and mean glucose levels. However, in this study, patients measured their blood glucose levels less often with CGM (2.7 measurements per day) than with usual care (3.7 measurements per day).
One patient developed an allergic reaction to the device’s internal sensor and had it removed, according to Dr. Lind and his associates (JAMA. 2017 Jan 24. doi: 10.1001/jama.2016.19976).
Dr. Beck’s study was sponsored by Dexcom, maker of the CGM device, which also participated in designing the study, writing the protocol, reviewing and approving the manuscripts, and interpreting the data. Dr. Beck reported financial relationships with Dexcom and Abbott Diabetes Care, and his associates reported ties to numerous industry sources. Dr. Lind’s study was sponsored by the NU Hospital Group and Dexcom. Dr. Lind reported financial relationships with AstraZeneca, Dexcom, Eli Lilly, Medtronic, Novo Nordisk, and Rubin Medical, and his associates reported ties to numerous industry sources.
FROM JAMA
Key clinical point: A 6-month course of continuous glucose monitoring modestly reduced HbA1c levels in patients with type 1 diabetes who used multiple daily insulin injections.
Major finding: Compared with usual care, continuous glucose monitoring decreased mean HbA1c by 0.6% in a multicenter open-label U.S. study involving 158 participants and by 0.4% in a multicenter open-label crossover trial in Sweden.
Data source: Two separate short-term randomized trials comparing the effect of continuous glucose monitoring against usual care in 319 adults with type 1 diabetes.
Disclosures: Dr. Beck’s study was sponsored by Dexcom, maker of the CGM device, which also participated in designing the study, writing the protocol, reviewing and approving the manuscripts, and interpreting the data. Dr. Beck reported financial relationships with Dexcom and Abbott Diabetes Care, and his associates reported ties to numerous industry sources. Dr. Lind’s study was sponsored by the NU Hospital Group and Dexcom. Dr. Lind reported financial relationships with AstraZeneca, Dexcom, Eli Lilly, Medtronic, Novo Nordisk, and Rubin Medical, and his associates reported ties to numerous industry sources.