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DDW: Menopausal hormone therapy increases major GI bleed risk
Menopausal hormone therapy is associated with an increased risk of major gastrointestinal bleeding, particularly in the lower gastrointestinal tract, that is associated with duration of use, a study has found.
Analysis of data from 73,863 women enrolled in the Nurses’ Health Study II in 1989 showed that current users of menopausal hormone therapy had a 46% increase in the risk of a major gastrointestinal bleed and a more than twofold increase in the risk of a lower GI bleed or ischemic colitis, compared with never users, said Dr. Prashant Singh of Massachusetts General Hospital, Boston.
Past users showed a much smaller increase risk of bleeding, while increasing duration of hormone therapy was significantly associated with increasing risk of major and low gastrointestinal bleeding.
“Although our findings show that menopausal hormone therapy may increase the risk of major GI bleeding, especially in the lower GI tract, it is important for these patients to know that this therapy is still an effective treatment; however, both clinician and patient should be more cautious in using this therapy in some cases, such as with patients who have a history of ischemic colitis,” Dr. Singh said at the annual Digestive Disease Week.
Dr. Singh does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services that he discussed during the presentation.
Menopausal hormone therapy is associated with an increased risk of major gastrointestinal bleeding, particularly in the lower gastrointestinal tract, that is associated with duration of use, a study has found.
Analysis of data from 73,863 women enrolled in the Nurses’ Health Study II in 1989 showed that current users of menopausal hormone therapy had a 46% increase in the risk of a major gastrointestinal bleed and a more than twofold increase in the risk of a lower GI bleed or ischemic colitis, compared with never users, said Dr. Prashant Singh of Massachusetts General Hospital, Boston.
Past users showed a much smaller increase risk of bleeding, while increasing duration of hormone therapy was significantly associated with increasing risk of major and low gastrointestinal bleeding.
“Although our findings show that menopausal hormone therapy may increase the risk of major GI bleeding, especially in the lower GI tract, it is important for these patients to know that this therapy is still an effective treatment; however, both clinician and patient should be more cautious in using this therapy in some cases, such as with patients who have a history of ischemic colitis,” Dr. Singh said at the annual Digestive Disease Week.
Dr. Singh does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services that he discussed during the presentation.
Menopausal hormone therapy is associated with an increased risk of major gastrointestinal bleeding, particularly in the lower gastrointestinal tract, that is associated with duration of use, a study has found.
Analysis of data from 73,863 women enrolled in the Nurses’ Health Study II in 1989 showed that current users of menopausal hormone therapy had a 46% increase in the risk of a major gastrointestinal bleed and a more than twofold increase in the risk of a lower GI bleed or ischemic colitis, compared with never users, said Dr. Prashant Singh of Massachusetts General Hospital, Boston.
Past users showed a much smaller increase risk of bleeding, while increasing duration of hormone therapy was significantly associated with increasing risk of major and low gastrointestinal bleeding.
“Although our findings show that menopausal hormone therapy may increase the risk of major GI bleeding, especially in the lower GI tract, it is important for these patients to know that this therapy is still an effective treatment; however, both clinician and patient should be more cautious in using this therapy in some cases, such as with patients who have a history of ischemic colitis,” Dr. Singh said at the annual Digestive Disease Week.
Dr. Singh does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services that he discussed during the presentation.
FROM DDW 2015
Key clinical point: Menopausal hormone therapy is associated with an increased risk of major gastrointestinal bleeding, particularly in the lower gastrointestinal tract.
Major finding: Current users of menopausal hormone therapy had a 46% increase in the risk of a major gastrointestinal bleed and a more than twofold increase in the risk of a lower GI bleed or ischemic colitis.
Data source: Analysis of data from 73,863 women enrolled in the Nurses’ Health Study II.
Disclosures: No conflicts of interest were disclosed.
Significant Worker Productivity Gains With Newer Hepatitis C Drugs
Achieving a cure in hepatitis C infection could result in significant economic gains, with a study estimating that the beneficial effects in terms of improved worker productivity could total around $3.23 billion per year for the United States alone.
Researchers used data on work productivity and activity scores from patients enrolled in clinical trials of the all-oral sofosbuvir and lepidasvir combo to estimate the impact of achieving sustained virologic response at 12 weeks (SVR-12) on workers’ productivity.
They calculated an average work productivity loss of $4,954 for each employed patient with chronic hepatitis C infection per year in the United States and $1,129 per year for the five European Union countries included in the mix.
“These new all-oral combinations such as lepidasvir and sofosbuvir have cure rates between 95% and 99% with minimum side effects, [so] treating patients with these combinations results in improved work productivity, improved quality of life, and patient-reported outcomes that can translate into economic benefit,” Dr. Zobair M. Younossi of the Inova Fairfax Medical Campus, Falls Church, Va., said at the annual Digestive Disease Week.
No conflicts of interest were disclosed.
Achieving a cure in hepatitis C infection could result in significant economic gains, with a study estimating that the beneficial effects in terms of improved worker productivity could total around $3.23 billion per year for the United States alone.
Researchers used data on work productivity and activity scores from patients enrolled in clinical trials of the all-oral sofosbuvir and lepidasvir combo to estimate the impact of achieving sustained virologic response at 12 weeks (SVR-12) on workers’ productivity.
They calculated an average work productivity loss of $4,954 for each employed patient with chronic hepatitis C infection per year in the United States and $1,129 per year for the five European Union countries included in the mix.
“These new all-oral combinations such as lepidasvir and sofosbuvir have cure rates between 95% and 99% with minimum side effects, [so] treating patients with these combinations results in improved work productivity, improved quality of life, and patient-reported outcomes that can translate into economic benefit,” Dr. Zobair M. Younossi of the Inova Fairfax Medical Campus, Falls Church, Va., said at the annual Digestive Disease Week.
No conflicts of interest were disclosed.
Achieving a cure in hepatitis C infection could result in significant economic gains, with a study estimating that the beneficial effects in terms of improved worker productivity could total around $3.23 billion per year for the United States alone.
Researchers used data on work productivity and activity scores from patients enrolled in clinical trials of the all-oral sofosbuvir and lepidasvir combo to estimate the impact of achieving sustained virologic response at 12 weeks (SVR-12) on workers’ productivity.
They calculated an average work productivity loss of $4,954 for each employed patient with chronic hepatitis C infection per year in the United States and $1,129 per year for the five European Union countries included in the mix.
“These new all-oral combinations such as lepidasvir and sofosbuvir have cure rates between 95% and 99% with minimum side effects, [so] treating patients with these combinations results in improved work productivity, improved quality of life, and patient-reported outcomes that can translate into economic benefit,” Dr. Zobair M. Younossi of the Inova Fairfax Medical Campus, Falls Church, Va., said at the annual Digestive Disease Week.
No conflicts of interest were disclosed.
FROM DDW 2015
DDW: Significant worker productivity gains with newer hepatitis C drugs
Achieving a cure in hepatitis C infection could result in significant economic gains, with a study estimating that the beneficial effects in terms of improved worker productivity could total around $3.23 billion per year for the United States alone.
Researchers used data on work productivity and activity scores from patients enrolled in clinical trials of the all-oral sofosbuvir and lepidasvir combo to estimate the impact of achieving sustained virologic response at 12 weeks (SVR-12) on workers’ productivity.
They calculated an average work productivity loss of $4,954 for each employed patient with chronic hepatitis C infection per year in the United States and $1,129 per year for the five European Union countries included in the mix.
“These new all-oral combinations such as lepidasvir and sofosbuvir have cure rates between 95% and 99% with minimum side effects, [so] treating patients with these combinations results in improved work productivity, improved quality of life, and patient-reported outcomes that can translate into economic benefit,” Dr. Zobair M. Younossi of the Inova Fairfax Medical Campus, Falls Church, Va., said at the annual Digestive Disease Week.
No conflicts of interest were disclosed.
Achieving a cure in hepatitis C infection could result in significant economic gains, with a study estimating that the beneficial effects in terms of improved worker productivity could total around $3.23 billion per year for the United States alone.
Researchers used data on work productivity and activity scores from patients enrolled in clinical trials of the all-oral sofosbuvir and lepidasvir combo to estimate the impact of achieving sustained virologic response at 12 weeks (SVR-12) on workers’ productivity.
They calculated an average work productivity loss of $4,954 for each employed patient with chronic hepatitis C infection per year in the United States and $1,129 per year for the five European Union countries included in the mix.
“These new all-oral combinations such as lepidasvir and sofosbuvir have cure rates between 95% and 99% with minimum side effects, [so] treating patients with these combinations results in improved work productivity, improved quality of life, and patient-reported outcomes that can translate into economic benefit,” Dr. Zobair M. Younossi of the Inova Fairfax Medical Campus, Falls Church, Va., said at the annual Digestive Disease Week.
No conflicts of interest were disclosed.
Achieving a cure in hepatitis C infection could result in significant economic gains, with a study estimating that the beneficial effects in terms of improved worker productivity could total around $3.23 billion per year for the United States alone.
Researchers used data on work productivity and activity scores from patients enrolled in clinical trials of the all-oral sofosbuvir and lepidasvir combo to estimate the impact of achieving sustained virologic response at 12 weeks (SVR-12) on workers’ productivity.
They calculated an average work productivity loss of $4,954 for each employed patient with chronic hepatitis C infection per year in the United States and $1,129 per year for the five European Union countries included in the mix.
“These new all-oral combinations such as lepidasvir and sofosbuvir have cure rates between 95% and 99% with minimum side effects, [so] treating patients with these combinations results in improved work productivity, improved quality of life, and patient-reported outcomes that can translate into economic benefit,” Dr. Zobair M. Younossi of the Inova Fairfax Medical Campus, Falls Church, Va., said at the annual Digestive Disease Week.
No conflicts of interest were disclosed.
FROM DDW 2015
Key clinical point: Achieving a cure in hepatitis C infection could result in significant economic gains from improved worker productivity.
Major finding: The beneficial effects in terms of improved worker productivity could total around $3.23 billion per year for the United States alone.
Data source: Economic model using data from hepatitis C clinical trials in the United States and Europe.
Disclosures: No conflicts of interest were disclosed.
ED Visits for Tramadol Misuse More Than Double Over 5 Years
Emergency department visits associated with the misuse or abuse of tramadol more than doubled from 2005 to 2011, while visits for adverse reactions to tramadol increased 1.5-fold, according to two reports from the Substance Abuse and Mental Health Services Administration.
The first report showed that while tramadol prescriptions rose 88% from 23.3 million in 2008 to 43.8 million in 2013, the number of emergency department visits related to the misuse or abuse of the opioid rose from 6,255 in 2005 to 21,649 in 2011 – a 250% increase.
Women made up a slight majority of these visits over the course of those 5 years, but the greatest increase was observed among patients aged 55 or older, with ED visits for abuse or misuse of tramadol increasing 481%, from 892 visits in 2005 to 5,181 visits in 2011.
“The current report illustrates that tramadol misuse or abuse may be contributing to the overall problem of narcotic pain reliever misuse or abuse among older adults,” wrote Donna M. Bush, Ph.D., of SAMHSA’s Center for Behavioral Health Statistics and Quality (CBHSQ). “Prevention efforts targeted to this population as well as their medical care providers may help reduce ED visits and subsequent hospitalizations, and should remain a public health priority.”
Meanwhile, the second report by the same author showed that about half of the 54,397 ED visits associated with tramadol in 2011 were related to adverse reactions.
Overall, the number of visits for adverse reactions increased 172%, from 10,091 visits in 2005 to 27,421 visits in 2011, with women accounting for about three-quarters of all visits and patients over 65 years accounting for one-third. Most of the tramadol-related visits to emergency departments involved other drugs, Dr. Bush reported.
When combined with other drugs such as benzodiazepines, other narcotic pain relievers, and alcohol, tramadol’s sedative effects can be enhanced. She urged physicians who are prescribing tramadol to warn patients about these dangers. Dr. Bush also advised the emergency department staff to be aware of the symptoms of serotonin syndrome, which can occur when tramadol is taken in combination with some other drugs, including common antidepressants.
CBHSQ, the government’s lead agency for behavioral health statistics, is part of SAMHSA.
Emergency department visits associated with the misuse or abuse of tramadol more than doubled from 2005 to 2011, while visits for adverse reactions to tramadol increased 1.5-fold, according to two reports from the Substance Abuse and Mental Health Services Administration.
The first report showed that while tramadol prescriptions rose 88% from 23.3 million in 2008 to 43.8 million in 2013, the number of emergency department visits related to the misuse or abuse of the opioid rose from 6,255 in 2005 to 21,649 in 2011 – a 250% increase.
Women made up a slight majority of these visits over the course of those 5 years, but the greatest increase was observed among patients aged 55 or older, with ED visits for abuse or misuse of tramadol increasing 481%, from 892 visits in 2005 to 5,181 visits in 2011.
“The current report illustrates that tramadol misuse or abuse may be contributing to the overall problem of narcotic pain reliever misuse or abuse among older adults,” wrote Donna M. Bush, Ph.D., of SAMHSA’s Center for Behavioral Health Statistics and Quality (CBHSQ). “Prevention efforts targeted to this population as well as their medical care providers may help reduce ED visits and subsequent hospitalizations, and should remain a public health priority.”
Meanwhile, the second report by the same author showed that about half of the 54,397 ED visits associated with tramadol in 2011 were related to adverse reactions.
Overall, the number of visits for adverse reactions increased 172%, from 10,091 visits in 2005 to 27,421 visits in 2011, with women accounting for about three-quarters of all visits and patients over 65 years accounting for one-third. Most of the tramadol-related visits to emergency departments involved other drugs, Dr. Bush reported.
When combined with other drugs such as benzodiazepines, other narcotic pain relievers, and alcohol, tramadol’s sedative effects can be enhanced. She urged physicians who are prescribing tramadol to warn patients about these dangers. Dr. Bush also advised the emergency department staff to be aware of the symptoms of serotonin syndrome, which can occur when tramadol is taken in combination with some other drugs, including common antidepressants.
CBHSQ, the government’s lead agency for behavioral health statistics, is part of SAMHSA.
Emergency department visits associated with the misuse or abuse of tramadol more than doubled from 2005 to 2011, while visits for adverse reactions to tramadol increased 1.5-fold, according to two reports from the Substance Abuse and Mental Health Services Administration.
The first report showed that while tramadol prescriptions rose 88% from 23.3 million in 2008 to 43.8 million in 2013, the number of emergency department visits related to the misuse or abuse of the opioid rose from 6,255 in 2005 to 21,649 in 2011 – a 250% increase.
Women made up a slight majority of these visits over the course of those 5 years, but the greatest increase was observed among patients aged 55 or older, with ED visits for abuse or misuse of tramadol increasing 481%, from 892 visits in 2005 to 5,181 visits in 2011.
“The current report illustrates that tramadol misuse or abuse may be contributing to the overall problem of narcotic pain reliever misuse or abuse among older adults,” wrote Donna M. Bush, Ph.D., of SAMHSA’s Center for Behavioral Health Statistics and Quality (CBHSQ). “Prevention efforts targeted to this population as well as their medical care providers may help reduce ED visits and subsequent hospitalizations, and should remain a public health priority.”
Meanwhile, the second report by the same author showed that about half of the 54,397 ED visits associated with tramadol in 2011 were related to adverse reactions.
Overall, the number of visits for adverse reactions increased 172%, from 10,091 visits in 2005 to 27,421 visits in 2011, with women accounting for about three-quarters of all visits and patients over 65 years accounting for one-third. Most of the tramadol-related visits to emergency departments involved other drugs, Dr. Bush reported.
When combined with other drugs such as benzodiazepines, other narcotic pain relievers, and alcohol, tramadol’s sedative effects can be enhanced. She urged physicians who are prescribing tramadol to warn patients about these dangers. Dr. Bush also advised the emergency department staff to be aware of the symptoms of serotonin syndrome, which can occur when tramadol is taken in combination with some other drugs, including common antidepressants.
CBHSQ, the government’s lead agency for behavioral health statistics, is part of SAMHSA.
ED visits for tramadol misuse more than double over 5 years
Emergency department visits associated with the misuse or abuse of tramadol more than doubled from 2005 to 2011, while visits for adverse reactions to tramadol increased 1.5-fold, according to two reports from the Substance Abuse and Mental Health Services Administration.
The first report showed that while tramadol prescriptions rose 88% from 23.3 million in 2008 to 43.8 million in 2013, the number of emergency department visits related to the misuse or abuse of the opioid rose from 6,255 in 2005 to 21,649 in 2011 – a 250% increase.
Women made up a slight majority of these visits over the course of those 5 years, but the greatest increase was observed among patients aged 55 or older, with ED visits for abuse or misuse of tramadol increasing 481%, from 892 visits in 2005 to 5,181 visits in 2011.
“The current report illustrates that tramadol misuse or abuse may be contributing to the overall problem of narcotic pain reliever misuse or abuse among older adults,” wrote Donna M. Bush, Ph.D., of SAMHSA’s Center for Behavioral Health Statistics and Quality (CBHSQ). “Prevention efforts targeted to this population as well as their medical care providers may help reduce ED visits and subsequent hospitalizations, and should remain a public health priority.”
Meanwhile, the second report by the same author showed that about half of the 54,397 ED visits associated with tramadol in 2011 were related to adverse reactions.
Overall, the number of visits for adverse reactions increased 172%, from 10,091 visits in 2005 to 27,421 visits in 2011, with women accounting for about three-quarters of all visits and patients over 65 years accounting for one-third. Most of the tramadol-related visits to emergency departments involved other drugs, Dr. Bush reported.
When combined with other drugs such as benzodiazepines, other narcotic pain relievers, and alcohol, tramadol’s sedative effects can be enhanced. She urged physicians who are prescribing tramadol to warn patients about these dangers. Dr. Bush also advised the emergency department staff to be aware of the symptoms of serotonin syndrome, which can occur when tramadol is taken in combination with some other drugs, including common antidepressants.
CBHSQ, the government’s lead agency for behavioral health statistics, is part of SAMHSA.
Emergency department visits associated with the misuse or abuse of tramadol more than doubled from 2005 to 2011, while visits for adverse reactions to tramadol increased 1.5-fold, according to two reports from the Substance Abuse and Mental Health Services Administration.
The first report showed that while tramadol prescriptions rose 88% from 23.3 million in 2008 to 43.8 million in 2013, the number of emergency department visits related to the misuse or abuse of the opioid rose from 6,255 in 2005 to 21,649 in 2011 – a 250% increase.
Women made up a slight majority of these visits over the course of those 5 years, but the greatest increase was observed among patients aged 55 or older, with ED visits for abuse or misuse of tramadol increasing 481%, from 892 visits in 2005 to 5,181 visits in 2011.
“The current report illustrates that tramadol misuse or abuse may be contributing to the overall problem of narcotic pain reliever misuse or abuse among older adults,” wrote Donna M. Bush, Ph.D., of SAMHSA’s Center for Behavioral Health Statistics and Quality (CBHSQ). “Prevention efforts targeted to this population as well as their medical care providers may help reduce ED visits and subsequent hospitalizations, and should remain a public health priority.”
Meanwhile, the second report by the same author showed that about half of the 54,397 ED visits associated with tramadol in 2011 were related to adverse reactions.
Overall, the number of visits for adverse reactions increased 172%, from 10,091 visits in 2005 to 27,421 visits in 2011, with women accounting for about three-quarters of all visits and patients over 65 years accounting for one-third. Most of the tramadol-related visits to emergency departments involved other drugs, Dr. Bush reported.
When combined with other drugs such as benzodiazepines, other narcotic pain relievers, and alcohol, tramadol’s sedative effects can be enhanced. She urged physicians who are prescribing tramadol to warn patients about these dangers. Dr. Bush also advised the emergency department staff to be aware of the symptoms of serotonin syndrome, which can occur when tramadol is taken in combination with some other drugs, including common antidepressants.
CBHSQ, the government’s lead agency for behavioral health statistics, is part of SAMHSA.
Emergency department visits associated with the misuse or abuse of tramadol more than doubled from 2005 to 2011, while visits for adverse reactions to tramadol increased 1.5-fold, according to two reports from the Substance Abuse and Mental Health Services Administration.
The first report showed that while tramadol prescriptions rose 88% from 23.3 million in 2008 to 43.8 million in 2013, the number of emergency department visits related to the misuse or abuse of the opioid rose from 6,255 in 2005 to 21,649 in 2011 – a 250% increase.
Women made up a slight majority of these visits over the course of those 5 years, but the greatest increase was observed among patients aged 55 or older, with ED visits for abuse or misuse of tramadol increasing 481%, from 892 visits in 2005 to 5,181 visits in 2011.
“The current report illustrates that tramadol misuse or abuse may be contributing to the overall problem of narcotic pain reliever misuse or abuse among older adults,” wrote Donna M. Bush, Ph.D., of SAMHSA’s Center for Behavioral Health Statistics and Quality (CBHSQ). “Prevention efforts targeted to this population as well as their medical care providers may help reduce ED visits and subsequent hospitalizations, and should remain a public health priority.”
Meanwhile, the second report by the same author showed that about half of the 54,397 ED visits associated with tramadol in 2011 were related to adverse reactions.
Overall, the number of visits for adverse reactions increased 172%, from 10,091 visits in 2005 to 27,421 visits in 2011, with women accounting for about three-quarters of all visits and patients over 65 years accounting for one-third. Most of the tramadol-related visits to emergency departments involved other drugs, Dr. Bush reported.
When combined with other drugs such as benzodiazepines, other narcotic pain relievers, and alcohol, tramadol’s sedative effects can be enhanced. She urged physicians who are prescribing tramadol to warn patients about these dangers. Dr. Bush also advised the emergency department staff to be aware of the symptoms of serotonin syndrome, which can occur when tramadol is taken in combination with some other drugs, including common antidepressants.
CBHSQ, the government’s lead agency for behavioral health statistics, is part of SAMHSA.
Key clinical point: Emergency department visits associated with the misuse or abuse of tramadol more than doubled from 2005 to 2011.
Major finding: The number of emergency department visits related to the misuse or abuse of tramadol rose from 6,255 in 2005 to 21,649 in 2011 – a 250% increase.
Data source: An analysis of data by the Center for Behavioral Health Statistics and Quality from the Drug Abuse Warning Network.
Disclosures: CBHSQ, the government’s lead agency for behavioral health statistics, is part of the Substance Abuse and Mental Health Services Administration.
Asymptomatic carotid stenosis and central sleep apnea linked
More than two-thirds of patients with asymptomatic carotid stenosis are likely have sleep apnea, according to an observational study.
The polysomnography results of 96 patients with asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea. Obstructive sleep apnea was present in 42% of patients and central sleep apnea in 27%.
Stenosis severity was significantly associated with central sleep apnea, but not with obstructive sleep apnea. Researchers found that central sleep apnea, but not obstructive sleep apnea, was associated with arterial hypertension and diabetes mellitus in those patients with asymptomatic carotid stenosis (CHEST 2015;147:1029-1036 [doi:10.1378/chest.14-1655]).
The patients ranged in age from 39 to 86 years (mean age, 70 years); 64 were men. Of the 96 patients, 21 had mild/moderate stenosis and 75 had severe carotid stenosis. Patients with severe stenosis were older, average age 67 years, than were those with mild/moderate stenosis, average age 61 years. The frequency of arterial hypertension and diabetes mellitus was higher in the severe stenosis group than in the mild/moderate stenosis group.
The prevalence of sleep apnea was 76% in patients with severe stenosis compared with 29% in those with mild/moderate carotid stenosis. Total apnea-hypopnea index was higher in the severe stenosis group compared with the mild/moderate stenosis group (P less than or equal to .009). Increase in sleep apnea severity was based on an increase in central apnea-hypopnea index (P less than or equal to .001) but not in obstructive apnea-hypopnea index, reflecting an augmentation of central sleep apnea and not of obstructive sleep apnea in patients with severe compared with mild/moderate carotid stenosis.
“This vascular risk constellation seems to be more strongly connected with CSA [central sleep apnea] than with OSA [obstructive sleep apnea], possibly attributable to carotid chemoreceptor dysfunction,” wrote Dr. Jens Ehrhardt and colleagues at Jena University Hospital, Germany.
No conflicts of interest were declared.
More than two-thirds of patients with asymptomatic carotid stenosis are likely have sleep apnea, according to an observational study.
The polysomnography results of 96 patients with asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea. Obstructive sleep apnea was present in 42% of patients and central sleep apnea in 27%.
Stenosis severity was significantly associated with central sleep apnea, but not with obstructive sleep apnea. Researchers found that central sleep apnea, but not obstructive sleep apnea, was associated with arterial hypertension and diabetes mellitus in those patients with asymptomatic carotid stenosis (CHEST 2015;147:1029-1036 [doi:10.1378/chest.14-1655]).
The patients ranged in age from 39 to 86 years (mean age, 70 years); 64 were men. Of the 96 patients, 21 had mild/moderate stenosis and 75 had severe carotid stenosis. Patients with severe stenosis were older, average age 67 years, than were those with mild/moderate stenosis, average age 61 years. The frequency of arterial hypertension and diabetes mellitus was higher in the severe stenosis group than in the mild/moderate stenosis group.
The prevalence of sleep apnea was 76% in patients with severe stenosis compared with 29% in those with mild/moderate carotid stenosis. Total apnea-hypopnea index was higher in the severe stenosis group compared with the mild/moderate stenosis group (P less than or equal to .009). Increase in sleep apnea severity was based on an increase in central apnea-hypopnea index (P less than or equal to .001) but not in obstructive apnea-hypopnea index, reflecting an augmentation of central sleep apnea and not of obstructive sleep apnea in patients with severe compared with mild/moderate carotid stenosis.
“This vascular risk constellation seems to be more strongly connected with CSA [central sleep apnea] than with OSA [obstructive sleep apnea], possibly attributable to carotid chemoreceptor dysfunction,” wrote Dr. Jens Ehrhardt and colleagues at Jena University Hospital, Germany.
No conflicts of interest were declared.
More than two-thirds of patients with asymptomatic carotid stenosis are likely have sleep apnea, according to an observational study.
The polysomnography results of 96 patients with asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea. Obstructive sleep apnea was present in 42% of patients and central sleep apnea in 27%.
Stenosis severity was significantly associated with central sleep apnea, but not with obstructive sleep apnea. Researchers found that central sleep apnea, but not obstructive sleep apnea, was associated with arterial hypertension and diabetes mellitus in those patients with asymptomatic carotid stenosis (CHEST 2015;147:1029-1036 [doi:10.1378/chest.14-1655]).
The patients ranged in age from 39 to 86 years (mean age, 70 years); 64 were men. Of the 96 patients, 21 had mild/moderate stenosis and 75 had severe carotid stenosis. Patients with severe stenosis were older, average age 67 years, than were those with mild/moderate stenosis, average age 61 years. The frequency of arterial hypertension and diabetes mellitus was higher in the severe stenosis group than in the mild/moderate stenosis group.
The prevalence of sleep apnea was 76% in patients with severe stenosis compared with 29% in those with mild/moderate carotid stenosis. Total apnea-hypopnea index was higher in the severe stenosis group compared with the mild/moderate stenosis group (P less than or equal to .009). Increase in sleep apnea severity was based on an increase in central apnea-hypopnea index (P less than or equal to .001) but not in obstructive apnea-hypopnea index, reflecting an augmentation of central sleep apnea and not of obstructive sleep apnea in patients with severe compared with mild/moderate carotid stenosis.
“This vascular risk constellation seems to be more strongly connected with CSA [central sleep apnea] than with OSA [obstructive sleep apnea], possibly attributable to carotid chemoreceptor dysfunction,” wrote Dr. Jens Ehrhardt and colleagues at Jena University Hospital, Germany.
No conflicts of interest were declared.
FROM CHEST
Key clinical point: More than two-thirds of patients with asymptomatic carotid stenosis are likely to have sleep apnea.
Major finding: The prevalence of sleep apnea was 76% in patients with severe stenosis compared with 29% in those with mild/moderate carotid stenosis.
Data source: Study of 96 patients with asymptomatic extracranial carotid stenosis.
Disclosures: No conflicts of interest were declared.
Obesity increases risk of bleeding on warfarin
Obese patients on warfarin may be at greater risk of bleeding than those of normal weight, according to a study presented at the American Heart Association’s Arteriosclerosis, Thrombosis, and Vascular Biology/Peripheral Vascular Disease Scientific Sessions 2015.
Researchers followed 863 patients attending an anticoagulation clinic for 1 year and found that obesity (body mass index greater than 30 kg/m2) was associated with a statistically significant 84% increase in the risk of major bleeds, such as gastrointestinal, intracerebral, and retroperitoneal hemorrhage.
The study also showed that increasing obesity increased bleeding risk; there was a 30% increase in bleeding risk for patients with class I obesity but a 93% increase in patients with class III obesity.
“This result suggests that BMI plays a role in bleeding events in patients on warfarin [and] future studies are needed to understand the mechanism by which obesity increases bleeding risk for patients on warfarin, and whether similar risk exists for the novel oral anticoagulants,” said Dr. Adedotun A. Ogunsua of the University of Massachusetts, Worcester, and coauthors.
There were no conflicts of interest disclosed.
Obese patients on warfarin may be at greater risk of bleeding than those of normal weight, according to a study presented at the American Heart Association’s Arteriosclerosis, Thrombosis, and Vascular Biology/Peripheral Vascular Disease Scientific Sessions 2015.
Researchers followed 863 patients attending an anticoagulation clinic for 1 year and found that obesity (body mass index greater than 30 kg/m2) was associated with a statistically significant 84% increase in the risk of major bleeds, such as gastrointestinal, intracerebral, and retroperitoneal hemorrhage.
The study also showed that increasing obesity increased bleeding risk; there was a 30% increase in bleeding risk for patients with class I obesity but a 93% increase in patients with class III obesity.
“This result suggests that BMI plays a role in bleeding events in patients on warfarin [and] future studies are needed to understand the mechanism by which obesity increases bleeding risk for patients on warfarin, and whether similar risk exists for the novel oral anticoagulants,” said Dr. Adedotun A. Ogunsua of the University of Massachusetts, Worcester, and coauthors.
There were no conflicts of interest disclosed.
Obese patients on warfarin may be at greater risk of bleeding than those of normal weight, according to a study presented at the American Heart Association’s Arteriosclerosis, Thrombosis, and Vascular Biology/Peripheral Vascular Disease Scientific Sessions 2015.
Researchers followed 863 patients attending an anticoagulation clinic for 1 year and found that obesity (body mass index greater than 30 kg/m2) was associated with a statistically significant 84% increase in the risk of major bleeds, such as gastrointestinal, intracerebral, and retroperitoneal hemorrhage.
The study also showed that increasing obesity increased bleeding risk; there was a 30% increase in bleeding risk for patients with class I obesity but a 93% increase in patients with class III obesity.
“This result suggests that BMI plays a role in bleeding events in patients on warfarin [and] future studies are needed to understand the mechanism by which obesity increases bleeding risk for patients on warfarin, and whether similar risk exists for the novel oral anticoagulants,” said Dr. Adedotun A. Ogunsua of the University of Massachusetts, Worcester, and coauthors.
There were no conflicts of interest disclosed.
FROM ATVB/PVD 2015
Key clinical point: Obesity is associated with an increased risk of major bleeding in patients taking warfarin.
Major finding: Obese patients on warfarin had an 84% increased incidence of major bleeding.
Data source: Observational study of 863 patients attending an anticoagulation clinic.
Disclosures: No conflicts of interest were disclosed.
Interferon-free antiviral regimens achieve high response rates in HCV
A 12-week course of oral daclatasvir, asunaprevir, and beclabuvir, with or without ribavirin, achieved a sustained virologic response (SVR) in patients with hepatitis C, judging from the findings of two studies.
In the first open-label study (UNITY-1), 312 treatment-naive and 103 treatment-experienced cirrhosis-free patients with chronic infection with hepatitis C virus (HCV) genotype 1 were treated with an oral fixed-dose regimen of daclatasvir, asunaprevir, and beclabuvir for 12 weeks, reported Dr. Andrew J. Muir of Duke Clinical Research Institute, Durham, N.C., and his associates.
Overall, 91.3% of patients achieved an SVR at 12 weeks (HCV-RNA < 25 IU/mL) after treatment cessation, with a slightly greater response among treatment-naive patients, compared with treatment-experienced patients (92% vs. 89.3%), according to a paper published May 5 in JAMA.
HCV treatment regimens are evolving rapidly away from interferon-based regimens toward all-oral antiviral regimens, such as the one used in this study, according to the investigators.
Daclatasvir inhibits the HCV NS5A protein, asunaprevir is an NS3 protease inhibitor with activity against genotypes 1 and 4.5, and beclabuvir is a nonnucleoside NS5B inhibitor.
Patients with genotype 1b showed higher response rates than those with genotype 1a in both the treatment-experienced and treatment-naive cohorts (JAMA 2015;313:1728-35 [doi:10.1001/jama.2015.3860]).
The second study (UNITY-2) involved 112 treatment-naive and 90 treatment-experienced patients with HCV and compensated cirrhosis, also treated with daclatasvir, asunaprevir, and beclabuvir.
However in this study, published in the same edition of JAMA, the patients were also randomized to double-blinded, weight-based ribavirin (1000-1200 mg/day) or placebo (JAMA 2015;313:1736-44 [doi:10.1001/jama.2015.3868]).
Among the treatment-naive group, 98% of patients also treated with ribavirin achieved an SVR at 12 weeks, while the response rate for treatment alone was 93%.
The response rate was 93% among treatment-experienced patients also given ribavirin and 87% among those given treatment alone.
The authors of the UNITY-2 study said patients with cirrhosis often experienced problems with peginterferon-based treatment regimens because of reduced response rates and more frequent and severe adverse events, hence the interest in interferon-free treatment options.
Both studies observed treatment-emergent alanine aminotransferase elevations – two cases in UNITY-1 and four cases in UNITY-2 – but only UNITY-2 recorded treatment-related adverse events, including anemia, aminotransferase and bilirubin elevations, and ribavirin overdose.
The UNITY-2 study also recorded grade 3 or 4 hemoglobin abnormalities in 5% of patients taking ribavirin but none in the treatment-only group.
Researchers on UNITY-1 said the response rates they observed in their study group were comparable to those seen in other phase III studies of all-oral direct-acting antiviral regimens, such as the fixed-dose combinations of sofosbuvir and ledipasvir and ABT-450/ritonavir, ombitasvir, dasabuvir, and ribavirin.
“Furthermore, SVR12 rates in this study were consistently high across baseline subgroups of patients, including sex, age, HCV-RNA level, and IL28B genotype, suggesting that this regimen has the potential to be broadly effective across genotype 1 patient populations,” wrote Dr. Fred Poordad of the University of Texas Health Science Center at San Antonio and his associates in the UNITY-1 study.
They qualified this by pointing out that the study included relatively few patients of black race – as did UNITY-2 – although the response rates were still high among this group.
Both studies were funded by Bristol-Myers Squibb. Many authors reported personal fees, grants, and speaking engagements from the pharmaceutical industry, including Bristol-Myers Squibb, and several authors were employees of Bristol-Myers Squibb.
These two studies add to the armamentarium of all-oral IFN-free regimens that have revolutionized the management of hepatitis C virus infection, not only for patients who are treatment naive with no significant liver disease but also for those who are treatment experienced and those with cirrhosis.
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Dr. Hari Conjeevaram |
However questions still remain about the response rate based on race, access to, and affordability of these therapies, improvements in quality of life, cost-effectiveness, and their use in difficult-to-treat situations such as patients with end-stage liver disease or those undergoing hemodialysis.
Hepatitis C is a global disease and although substantial progress has been made in HCV eradication, the success of such progress will be defined not just by the SVR rates but by accessibility and affordability of these medications.
Dr. Hari Conjeevaram is from the division of gastroenterology at the University of Michigan. These comments are taken from an accompanying editorial (JAMA 2015 May 5 [doi:10.1001/jama.2015.4368]. No conflicts of interest were declared.
These two studies add to the armamentarium of all-oral IFN-free regimens that have revolutionized the management of hepatitis C virus infection, not only for patients who are treatment naive with no significant liver disease but also for those who are treatment experienced and those with cirrhosis.
|
|
Dr. Hari Conjeevaram |
However questions still remain about the response rate based on race, access to, and affordability of these therapies, improvements in quality of life, cost-effectiveness, and their use in difficult-to-treat situations such as patients with end-stage liver disease or those undergoing hemodialysis.
Hepatitis C is a global disease and although substantial progress has been made in HCV eradication, the success of such progress will be defined not just by the SVR rates but by accessibility and affordability of these medications.
Dr. Hari Conjeevaram is from the division of gastroenterology at the University of Michigan. These comments are taken from an accompanying editorial (JAMA 2015 May 5 [doi:10.1001/jama.2015.4368]. No conflicts of interest were declared.
These two studies add to the armamentarium of all-oral IFN-free regimens that have revolutionized the management of hepatitis C virus infection, not only for patients who are treatment naive with no significant liver disease but also for those who are treatment experienced and those with cirrhosis.
|
|
Dr. Hari Conjeevaram |
However questions still remain about the response rate based on race, access to, and affordability of these therapies, improvements in quality of life, cost-effectiveness, and their use in difficult-to-treat situations such as patients with end-stage liver disease or those undergoing hemodialysis.
Hepatitis C is a global disease and although substantial progress has been made in HCV eradication, the success of such progress will be defined not just by the SVR rates but by accessibility and affordability of these medications.
Dr. Hari Conjeevaram is from the division of gastroenterology at the University of Michigan. These comments are taken from an accompanying editorial (JAMA 2015 May 5 [doi:10.1001/jama.2015.4368]. No conflicts of interest were declared.
A 12-week course of oral daclatasvir, asunaprevir, and beclabuvir, with or without ribavirin, achieved a sustained virologic response (SVR) in patients with hepatitis C, judging from the findings of two studies.
In the first open-label study (UNITY-1), 312 treatment-naive and 103 treatment-experienced cirrhosis-free patients with chronic infection with hepatitis C virus (HCV) genotype 1 were treated with an oral fixed-dose regimen of daclatasvir, asunaprevir, and beclabuvir for 12 weeks, reported Dr. Andrew J. Muir of Duke Clinical Research Institute, Durham, N.C., and his associates.
Overall, 91.3% of patients achieved an SVR at 12 weeks (HCV-RNA < 25 IU/mL) after treatment cessation, with a slightly greater response among treatment-naive patients, compared with treatment-experienced patients (92% vs. 89.3%), according to a paper published May 5 in JAMA.
HCV treatment regimens are evolving rapidly away from interferon-based regimens toward all-oral antiviral regimens, such as the one used in this study, according to the investigators.
Daclatasvir inhibits the HCV NS5A protein, asunaprevir is an NS3 protease inhibitor with activity against genotypes 1 and 4.5, and beclabuvir is a nonnucleoside NS5B inhibitor.
Patients with genotype 1b showed higher response rates than those with genotype 1a in both the treatment-experienced and treatment-naive cohorts (JAMA 2015;313:1728-35 [doi:10.1001/jama.2015.3860]).
The second study (UNITY-2) involved 112 treatment-naive and 90 treatment-experienced patients with HCV and compensated cirrhosis, also treated with daclatasvir, asunaprevir, and beclabuvir.
However in this study, published in the same edition of JAMA, the patients were also randomized to double-blinded, weight-based ribavirin (1000-1200 mg/day) or placebo (JAMA 2015;313:1736-44 [doi:10.1001/jama.2015.3868]).
Among the treatment-naive group, 98% of patients also treated with ribavirin achieved an SVR at 12 weeks, while the response rate for treatment alone was 93%.
The response rate was 93% among treatment-experienced patients also given ribavirin and 87% among those given treatment alone.
The authors of the UNITY-2 study said patients with cirrhosis often experienced problems with peginterferon-based treatment regimens because of reduced response rates and more frequent and severe adverse events, hence the interest in interferon-free treatment options.
Both studies observed treatment-emergent alanine aminotransferase elevations – two cases in UNITY-1 and four cases in UNITY-2 – but only UNITY-2 recorded treatment-related adverse events, including anemia, aminotransferase and bilirubin elevations, and ribavirin overdose.
The UNITY-2 study also recorded grade 3 or 4 hemoglobin abnormalities in 5% of patients taking ribavirin but none in the treatment-only group.
Researchers on UNITY-1 said the response rates they observed in their study group were comparable to those seen in other phase III studies of all-oral direct-acting antiviral regimens, such as the fixed-dose combinations of sofosbuvir and ledipasvir and ABT-450/ritonavir, ombitasvir, dasabuvir, and ribavirin.
“Furthermore, SVR12 rates in this study were consistently high across baseline subgroups of patients, including sex, age, HCV-RNA level, and IL28B genotype, suggesting that this regimen has the potential to be broadly effective across genotype 1 patient populations,” wrote Dr. Fred Poordad of the University of Texas Health Science Center at San Antonio and his associates in the UNITY-1 study.
They qualified this by pointing out that the study included relatively few patients of black race – as did UNITY-2 – although the response rates were still high among this group.
Both studies were funded by Bristol-Myers Squibb. Many authors reported personal fees, grants, and speaking engagements from the pharmaceutical industry, including Bristol-Myers Squibb, and several authors were employees of Bristol-Myers Squibb.
A 12-week course of oral daclatasvir, asunaprevir, and beclabuvir, with or without ribavirin, achieved a sustained virologic response (SVR) in patients with hepatitis C, judging from the findings of two studies.
In the first open-label study (UNITY-1), 312 treatment-naive and 103 treatment-experienced cirrhosis-free patients with chronic infection with hepatitis C virus (HCV) genotype 1 were treated with an oral fixed-dose regimen of daclatasvir, asunaprevir, and beclabuvir for 12 weeks, reported Dr. Andrew J. Muir of Duke Clinical Research Institute, Durham, N.C., and his associates.
Overall, 91.3% of patients achieved an SVR at 12 weeks (HCV-RNA < 25 IU/mL) after treatment cessation, with a slightly greater response among treatment-naive patients, compared with treatment-experienced patients (92% vs. 89.3%), according to a paper published May 5 in JAMA.
HCV treatment regimens are evolving rapidly away from interferon-based regimens toward all-oral antiviral regimens, such as the one used in this study, according to the investigators.
Daclatasvir inhibits the HCV NS5A protein, asunaprevir is an NS3 protease inhibitor with activity against genotypes 1 and 4.5, and beclabuvir is a nonnucleoside NS5B inhibitor.
Patients with genotype 1b showed higher response rates than those with genotype 1a in both the treatment-experienced and treatment-naive cohorts (JAMA 2015;313:1728-35 [doi:10.1001/jama.2015.3860]).
The second study (UNITY-2) involved 112 treatment-naive and 90 treatment-experienced patients with HCV and compensated cirrhosis, also treated with daclatasvir, asunaprevir, and beclabuvir.
However in this study, published in the same edition of JAMA, the patients were also randomized to double-blinded, weight-based ribavirin (1000-1200 mg/day) or placebo (JAMA 2015;313:1736-44 [doi:10.1001/jama.2015.3868]).
Among the treatment-naive group, 98% of patients also treated with ribavirin achieved an SVR at 12 weeks, while the response rate for treatment alone was 93%.
The response rate was 93% among treatment-experienced patients also given ribavirin and 87% among those given treatment alone.
The authors of the UNITY-2 study said patients with cirrhosis often experienced problems with peginterferon-based treatment regimens because of reduced response rates and more frequent and severe adverse events, hence the interest in interferon-free treatment options.
Both studies observed treatment-emergent alanine aminotransferase elevations – two cases in UNITY-1 and four cases in UNITY-2 – but only UNITY-2 recorded treatment-related adverse events, including anemia, aminotransferase and bilirubin elevations, and ribavirin overdose.
The UNITY-2 study also recorded grade 3 or 4 hemoglobin abnormalities in 5% of patients taking ribavirin but none in the treatment-only group.
Researchers on UNITY-1 said the response rates they observed in their study group were comparable to those seen in other phase III studies of all-oral direct-acting antiviral regimens, such as the fixed-dose combinations of sofosbuvir and ledipasvir and ABT-450/ritonavir, ombitasvir, dasabuvir, and ribavirin.
“Furthermore, SVR12 rates in this study were consistently high across baseline subgroups of patients, including sex, age, HCV-RNA level, and IL28B genotype, suggesting that this regimen has the potential to be broadly effective across genotype 1 patient populations,” wrote Dr. Fred Poordad of the University of Texas Health Science Center at San Antonio and his associates in the UNITY-1 study.
They qualified this by pointing out that the study included relatively few patients of black race – as did UNITY-2 – although the response rates were still high among this group.
Both studies were funded by Bristol-Myers Squibb. Many authors reported personal fees, grants, and speaking engagements from the pharmaceutical industry, including Bristol-Myers Squibb, and several authors were employees of Bristol-Myers Squibb.
FROM JAMA
Key clinical point: A 12-week course of oral daclatasvir, asunaprevir, and beclabuvir, with or without ribavirin achieves a high response rate in patients with hepatitis C.
Major finding: More than nine out of ten treatment-naive or treatment-experienced patients achieved a sustained virologic response at 12 weeks.
Data source: Two prospective, open-label, nonrandomized studies, the first in 415 cirrhosis-free patients with HCV, and the second in 202 patients with cirrhosis and HCV.
Disclosures: Both studies were funded by Bristol-Myers Squibb. Many authors reported personal fees, grants, and speaking engagements from the pharmaceutical industry, including Bristol-Myers Squibb, and several authors were employees of Bristol-Myers Squibb.
Nontoxigenic C. difficile colonization reduces recurrence rates
Treatment with the spores of nontoxigenic Clostridium difficile is well tolerated, and successful colonization of the gastrointestinal tract is associated with a significant reduction in C. difficile infection, according to a phase 2 study published May 5 in JAMA.
The randomized, double-blind, placebo-controlled study involving 173 patients with C. difficile infection showed that the lowest rate of recurrence (5%) was among the 43 patients who received the higher dose of 107 spores/day for 7 days, compared with 15% recurrence in those who received 107 spores/day for 14 days or 104 spores/day for 7 days, and 30% in the placebo group, reported Dr. Dale N. Gerding of Edward Hines, Jr. VA Hospital, Hines, Ill. and his associates.
The multicenter study, which involved patients who had all successfully completed treatment with metronidazole, oral vancomycin, or both, showed that fecal colonization occurred in 71% of patients who received the higher spore dose for 7 days and 63% of those who received the lower dose (JAMA 2015;313:1719-27 [doi:10.1001/jama.2015.3725]).
“The most likely hypothesized mechanism of action of NTCD-M3 [nontoxigenic C. difficile strain M3] is that it occupies the same metabolic or adherence niche in the gastrointestinal tract as does toxigenic C. difficile and, once established, is able to outcompete resident or newly ingested toxigenic strains,” Dr. Gerding and his associates wrote.
The study was sponsored by ViroPharma Incorporated. One author declared patents for the prevention of C. difficile infection, licensed to ViroPharma/Shire, and two authors were employees of ViroPharma/Shire during the study. Other authors reported personal fees, board positions, clinical trial participation, and consultancies with pharmaceutical companies, including the study sponsor.
Treatment with the spores of nontoxigenic Clostridium difficile is well tolerated, and successful colonization of the gastrointestinal tract is associated with a significant reduction in C. difficile infection, according to a phase 2 study published May 5 in JAMA.
The randomized, double-blind, placebo-controlled study involving 173 patients with C. difficile infection showed that the lowest rate of recurrence (5%) was among the 43 patients who received the higher dose of 107 spores/day for 7 days, compared with 15% recurrence in those who received 107 spores/day for 14 days or 104 spores/day for 7 days, and 30% in the placebo group, reported Dr. Dale N. Gerding of Edward Hines, Jr. VA Hospital, Hines, Ill. and his associates.
The multicenter study, which involved patients who had all successfully completed treatment with metronidazole, oral vancomycin, or both, showed that fecal colonization occurred in 71% of patients who received the higher spore dose for 7 days and 63% of those who received the lower dose (JAMA 2015;313:1719-27 [doi:10.1001/jama.2015.3725]).
“The most likely hypothesized mechanism of action of NTCD-M3 [nontoxigenic C. difficile strain M3] is that it occupies the same metabolic or adherence niche in the gastrointestinal tract as does toxigenic C. difficile and, once established, is able to outcompete resident or newly ingested toxigenic strains,” Dr. Gerding and his associates wrote.
The study was sponsored by ViroPharma Incorporated. One author declared patents for the prevention of C. difficile infection, licensed to ViroPharma/Shire, and two authors were employees of ViroPharma/Shire during the study. Other authors reported personal fees, board positions, clinical trial participation, and consultancies with pharmaceutical companies, including the study sponsor.
Treatment with the spores of nontoxigenic Clostridium difficile is well tolerated, and successful colonization of the gastrointestinal tract is associated with a significant reduction in C. difficile infection, according to a phase 2 study published May 5 in JAMA.
The randomized, double-blind, placebo-controlled study involving 173 patients with C. difficile infection showed that the lowest rate of recurrence (5%) was among the 43 patients who received the higher dose of 107 spores/day for 7 days, compared with 15% recurrence in those who received 107 spores/day for 14 days or 104 spores/day for 7 days, and 30% in the placebo group, reported Dr. Dale N. Gerding of Edward Hines, Jr. VA Hospital, Hines, Ill. and his associates.
The multicenter study, which involved patients who had all successfully completed treatment with metronidazole, oral vancomycin, or both, showed that fecal colonization occurred in 71% of patients who received the higher spore dose for 7 days and 63% of those who received the lower dose (JAMA 2015;313:1719-27 [doi:10.1001/jama.2015.3725]).
“The most likely hypothesized mechanism of action of NTCD-M3 [nontoxigenic C. difficile strain M3] is that it occupies the same metabolic or adherence niche in the gastrointestinal tract as does toxigenic C. difficile and, once established, is able to outcompete resident or newly ingested toxigenic strains,” Dr. Gerding and his associates wrote.
The study was sponsored by ViroPharma Incorporated. One author declared patents for the prevention of C. difficile infection, licensed to ViroPharma/Shire, and two authors were employees of ViroPharma/Shire during the study. Other authors reported personal fees, board positions, clinical trial participation, and consultancies with pharmaceutical companies, including the study sponsor.
FROM JAMA
Key clinical point: Successful colonization of the gastrointestinal tract with nontoxigenic C. difficile is associated with a significant reduction in infection recurrence.
Major finding: The lowest rate of recurrence (5%) was among the 43 patients who received the higher dose of 107 spores/day for 7 days, compared with 15% recurrence in those who received 107 spores/day for 14 days or 104 spores/day for 7 days and with 30% in the placebo group.
Data source: Double-blind, placebo-controlled phase 2 study in 173 patients who received a 7-day course of nontoxigenic C. difficile spores.
Disclosures: The study was sponsored by ViroPharma Incorporated. One author declared patents for the prevention of C. difficile infection licensed to ViroPharma/Shire and two authors were employees of ViroPharma/Shire during the study. Other authors reported personal fees, board positions, clinical trial participation, and consultancies with pharmaceutical companies, including the study sponsor.
Cesarean intervention reduces rates in low-risk pregnancies
An intervention involving audits of indications for cesarean delivery, feedback for health professionals, and implementation of best practices has resulted in a small but significant reduction in the rate of cesarean deliveries without negatively impacting maternal or neonatal outcomes.
A cluster-randomized controlled trial in 32 Quebec hospitals showed introduction of the 1.5-year intervention – involving 52,265 women – was associated with a 10% reduction in cesarean delivery rates (which went from 22.5% to 21.8%, for an adjusted odds ratio of 0.90, P = 0.04) in the year after introduction of the intervention, compared with the year before, according to the study (N. Eng. J. Med. 2015;372:1710-21).
The reduction in the rate of cesarean deliveries was even greater among low-risk pregnancies (adjusted OR, 0.80; P = .03), but was not significant among high-risk pregnancies, with the only impact on complications being a significant increase in maternal blood transfusion rates. Also, there was a significant reduction in minor and major neonatal morbidity in the intervention group.
“The QUARISMA program was designed to allow health professionals to assess care relative to operational standards (algorithms), to detect cases in which care could have been improved and an unnecessary cesarean delivery avoided, and to standardize clinical practice,” wrote Dr. Nils Chaillet of the Centre Hospitalier Universitaire de Sherbrooke (Que.) and his associates.
The study was supported by the Canadian Institutes of Health Research. No conflicts of interest were disclosed.
An intervention involving audits of indications for cesarean delivery, feedback for health professionals, and implementation of best practices has resulted in a small but significant reduction in the rate of cesarean deliveries without negatively impacting maternal or neonatal outcomes.
A cluster-randomized controlled trial in 32 Quebec hospitals showed introduction of the 1.5-year intervention – involving 52,265 women – was associated with a 10% reduction in cesarean delivery rates (which went from 22.5% to 21.8%, for an adjusted odds ratio of 0.90, P = 0.04) in the year after introduction of the intervention, compared with the year before, according to the study (N. Eng. J. Med. 2015;372:1710-21).
The reduction in the rate of cesarean deliveries was even greater among low-risk pregnancies (adjusted OR, 0.80; P = .03), but was not significant among high-risk pregnancies, with the only impact on complications being a significant increase in maternal blood transfusion rates. Also, there was a significant reduction in minor and major neonatal morbidity in the intervention group.
“The QUARISMA program was designed to allow health professionals to assess care relative to operational standards (algorithms), to detect cases in which care could have been improved and an unnecessary cesarean delivery avoided, and to standardize clinical practice,” wrote Dr. Nils Chaillet of the Centre Hospitalier Universitaire de Sherbrooke (Que.) and his associates.
The study was supported by the Canadian Institutes of Health Research. No conflicts of interest were disclosed.
An intervention involving audits of indications for cesarean delivery, feedback for health professionals, and implementation of best practices has resulted in a small but significant reduction in the rate of cesarean deliveries without negatively impacting maternal or neonatal outcomes.
A cluster-randomized controlled trial in 32 Quebec hospitals showed introduction of the 1.5-year intervention – involving 52,265 women – was associated with a 10% reduction in cesarean delivery rates (which went from 22.5% to 21.8%, for an adjusted odds ratio of 0.90, P = 0.04) in the year after introduction of the intervention, compared with the year before, according to the study (N. Eng. J. Med. 2015;372:1710-21).
The reduction in the rate of cesarean deliveries was even greater among low-risk pregnancies (adjusted OR, 0.80; P = .03), but was not significant among high-risk pregnancies, with the only impact on complications being a significant increase in maternal blood transfusion rates. Also, there was a significant reduction in minor and major neonatal morbidity in the intervention group.
“The QUARISMA program was designed to allow health professionals to assess care relative to operational standards (algorithms), to detect cases in which care could have been improved and an unnecessary cesarean delivery avoided, and to standardize clinical practice,” wrote Dr. Nils Chaillet of the Centre Hospitalier Universitaire de Sherbrooke (Que.) and his associates.
The study was supported by the Canadian Institutes of Health Research. No conflicts of interest were disclosed.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Audits of indications for cesarean delivery and feedback for health professionals can reduce the rate of cesarean deliveries, especially in low-risk pregnancies.
Major finding: A multifaceted intervention resulted in an overall 10% reduction in the rate of cesarean deliveries.
Data source: A cluster-randomized controlled trial in 32 Quebec hospitals, involving a total of 184,952 women.
Disclosures: The study was supported by the Canadian Institutes of Health Research. No conflicts of interest were disclosed.
