Mary Ann Moon

African Americans with parkinsonism have more severe symptoms, more disability, and poorer symptom management than whites, according to a report published online Dec. 13 in the Archives of Neurology.

These disparities cannot be attributed to differences between the races in age, cognitive function, or disease duration since these factors were comparable between blacks and whites in this single-center study. It appears that the racial disparities "may be explained by delayed diagnosis, referral patterns, access to care, economic factors, or a combination of all of these," wrote Dr. J. Patrick Hemming and his associates at the University of Maryland, Baltimore (Arch. Neurol. 2010 Dec. 13 [doi:10.1001/archneurol.2010.326]).

Independently of race, both lower socioeconomic status and lower education level also were associated with more severe signs and symptoms, greater disability, and poorer management of parkinsonism in this study, which the investigators described as "the first to show health disparities in disease severity and disability in parkinsonism."

"Studies in different patient populations and geographic locations are necessary to confirm these findings," they noted.

In their study, Dr. Hemming and his colleagues evaluated 1,090 patients with parkinsonism who were participating in a quality of life assessment at the university’s movement disorders center between 2003 and 2008. A total of 66 patients were African-American and the rest were white; the researchers were unable to assess patients of other racial or ethnic backgrounds.

African Americans scored an average of 10 points higher on the Unified Parkinson’s Disease Rating Scale than did whites (53 vs. 42.8). The investigators called this finding a "striking difference that may influence mortality" because a previous study found that a one-point increase on the UPDRS scale was associated with a relative risk ratio of 1.1 for death within 7 years.

African Americans also had worse scores than did whites on a modified version of the Older Americans Resource and Services (OARS) disability subscale, which measures the level of difficulty in performing 14 daily activities.

Significantly fewer African Americans were prescribed antiparkinson medications than were whites (62% vs. 78%), and fewer African Americans also were receiving new dopaminergic agents (21% vs. 41%). In contrast, significantly more black patients used antipsychotic medications than did whites (13% vs. 6%).

When the data were analyzed by income and education level after controlling for race, UPDRS and OARS scores were significantly higher among patients who earned less than $30,000 per year than among those who earned more than $70,000 per year.

Similarly, low-income patients used newer dopaminergic agents significantly less often than did high-income patients (30% vs. 47%). Low-income patients, however, were more likely to be prescribed antidepressants, antipsychotics, and antidementia agents.

Newer dopamine agonists were prescribed significantly less often for patients with less than a college education (35%) than for those with a college education (43%). In contrast, antipsychotics were approximately twice as likely to be prescribed for patients without a college education (8.4%) as they were for those with a college education (4.7%).

These findings reinforce the conclusion that racial disparities in the management of parkinsonism are not solely due to differences in income or education level, but that race itself is a significant independent factor, Dr. Hemming and his associates said.

"The results of this study suggest we need to better understand the cause of parkinsonism and to find remedies for disparate outcomes among patients with parkinsonian disease who are of different backgrounds and means," they noted.

It is possible that African Americans or their physicians have a higher threshold for seeking specialized treatment for parkinsonian signs and symptoms. "Studies have shown that African Americans and other minorities may perceive common medical conditions as natural processes that do not require medical intervention," the investigators wrote.

In addition, they suggested that "physicians may be influenced by unconfirmed reports that Parkinson’s disease is less common in African American populations."

Future studies should examine patient and physician attitudes and beliefs about symptoms of and therapies for parkinsonism, Dr. Hemming and his associates added.

Dr. Hemming’s associates reported ties to numerous manufacturers of drugs for Parkinson’s disease.

African Americans with parkinsonism have more severe symptoms, more disability, and poorer symptom management than whites, according to a report published online Dec. 13 in the Archives of Neurology.

These disparities cannot be attributed to differences between the races in age, cognitive function, or disease duration since these factors were comparable between blacks and whites in this single-center study. It appears that the racial disparities "may be explained by delayed diagnosis, referral patterns, access to care, economic factors, or a combination of all of these," wrote Dr. J. Patrick Hemming and his associates at the University of Maryland, Baltimore (Arch. Neurol. 2010 Dec. 13 [doi:10.1001/archneurol.2010.326]).

Independently of race, both lower socioeconomic status and lower education level also were associated with more severe signs and symptoms, greater disability, and poorer management of parkinsonism in this study, which the investigators described as "the first to show health disparities in disease severity and disability in parkinsonism."

"Studies in different patient populations and geographic locations are necessary to confirm these findings," they noted.

In their study, Dr. Hemming and his colleagues evaluated 1,090 patients with parkinsonism who were participating in a quality of life assessment at the university’s movement disorders center between 2003 and 2008. A total of 66 patients were African-American and the rest were white; the researchers were unable to assess patients of other racial or ethnic backgrounds.

African Americans scored an average of 10 points higher on the Unified Parkinson’s Disease Rating Scale than did whites (53 vs. 42.8). The investigators called this finding a "striking difference that may influence mortality" because a previous study found that a one-point increase on the UPDRS scale was associated with a relative risk ratio of 1.1 for death within 7 years.

African Americans also had worse scores than did whites on a modified version of the Older Americans Resource and Services (OARS) disability subscale, which measures the level of difficulty in performing 14 daily activities.

Significantly fewer African Americans were prescribed antiparkinson medications than were whites (62% vs. 78%), and fewer African Americans also were receiving new dopaminergic agents (21% vs. 41%). In contrast, significantly more black patients used antipsychotic medications than did whites (13% vs. 6%).

When the data were analyzed by income and education level after controlling for race, UPDRS and OARS scores were significantly higher among patients who earned less than $30,000 per year than among those who earned more than $70,000 per year.

Similarly, low-income patients used newer dopaminergic agents significantly less often than did high-income patients (30% vs. 47%). Low-income patients, however, were more likely to be prescribed antidepressants, antipsychotics, and antidementia agents.

Newer dopamine agonists were prescribed significantly less often for patients with less than a college education (35%) than for those with a college education (43%). In contrast, antipsychotics were approximately twice as likely to be prescribed for patients without a college education (8.4%) as they were for those with a college education (4.7%).

These findings reinforce the conclusion that racial disparities in the management of parkinsonism are not solely due to differences in income or education level, but that race itself is a significant independent factor, Dr. Hemming and his associates said.

"The results of this study suggest we need to better understand the cause of parkinsonism and to find remedies for disparate outcomes among patients with parkinsonian disease who are of different backgrounds and means," they noted.

It is possible that African Americans or their physicians have a higher threshold for seeking specialized treatment for parkinsonian signs and symptoms. "Studies have shown that African Americans and other minorities may perceive common medical conditions as natural processes that do not require medical intervention," the investigators wrote.

In addition, they suggested that "physicians may be influenced by unconfirmed reports that Parkinson’s disease is less common in African American populations."

Future studies should examine patient and physician attitudes and beliefs about symptoms of and therapies for parkinsonism, Dr. Hemming and his associates added.

Dr. Hemming’s associates reported ties to numerous manufacturers of drugs for Parkinson’s disease.

African Americans with parkinsonism have more severe symptoms, more disability, and poorer symptom management than whites, according to a report published online Dec. 13 in the Archives of Neurology.

These disparities cannot be attributed to differences between the races in age, cognitive function, or disease duration since these factors were comparable between blacks and whites in this single-center study. It appears that the racial disparities "may be explained by delayed diagnosis, referral patterns, access to care, economic factors, or a combination of all of these," wrote Dr. J. Patrick Hemming and his associates at the University of Maryland, Baltimore (Arch. Neurol. 2010 Dec. 13 [doi:10.1001/archneurol.2010.326]).

Independently of race, both lower socioeconomic status and lower education level also were associated with more severe signs and symptoms, greater disability, and poorer management of parkinsonism in this study, which the investigators described as "the first to show health disparities in disease severity and disability in parkinsonism."

"Studies in different patient populations and geographic locations are necessary to confirm these findings," they noted.

In their study, Dr. Hemming and his colleagues evaluated 1,090 patients with parkinsonism who were participating in a quality of life assessment at the university’s movement disorders center between 2003 and 2008. A total of 66 patients were African-American and the rest were white; the researchers were unable to assess patients of other racial or ethnic backgrounds.

African Americans scored an average of 10 points higher on the Unified Parkinson’s Disease Rating Scale than did whites (53 vs. 42.8). The investigators called this finding a "striking difference that may influence mortality" because a previous study found that a one-point increase on the UPDRS scale was associated with a relative risk ratio of 1.1 for death within 7 years.

African Americans also had worse scores than did whites on a modified version of the Older Americans Resource and Services (OARS) disability subscale, which measures the level of difficulty in performing 14 daily activities.

Significantly fewer African Americans were prescribed antiparkinson medications than were whites (62% vs. 78%), and fewer African Americans also were receiving new dopaminergic agents (21% vs. 41%). In contrast, significantly more black patients used antipsychotic medications than did whites (13% vs. 6%).

When the data were analyzed by income and education level after controlling for race, UPDRS and OARS scores were significantly higher among patients who earned less than $30,000 per year than among those who earned more than $70,000 per year.

Similarly, low-income patients used newer dopaminergic agents significantly less often than did high-income patients (30% vs. 47%). Low-income patients, however, were more likely to be prescribed antidepressants, antipsychotics, and antidementia agents.

Newer dopamine agonists were prescribed significantly less often for patients with less than a college education (35%) than for those with a college education (43%). In contrast, antipsychotics were approximately twice as likely to be prescribed for patients without a college education (8.4%) as they were for those with a college education (4.7%).

These findings reinforce the conclusion that racial disparities in the management of parkinsonism are not solely due to differences in income or education level, but that race itself is a significant independent factor, Dr. Hemming and his associates said.

"The results of this study suggest we need to better understand the cause of parkinsonism and to find remedies for disparate outcomes among patients with parkinsonian disease who are of different backgrounds and means," they noted.

It is possible that African Americans or their physicians have a higher threshold for seeking specialized treatment for parkinsonian signs and symptoms. "Studies have shown that African Americans and other minorities may perceive common medical conditions as natural processes that do not require medical intervention," the investigators wrote.

In addition, they suggested that "physicians may be influenced by unconfirmed reports that Parkinson’s disease is less common in African American populations."

Future studies should examine patient and physician attitudes and beliefs about symptoms of and therapies for parkinsonism, Dr. Hemming and his associates added.

Dr. Hemming’s associates reported ties to numerous manufacturers of drugs for Parkinson’s disease.

Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Dec. 13/27 issue of the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study "support the safety of [NSAIDs] compared with other analgesics," said Dr. Daniel H. Solomon and his associates in the rheumatology and pharmacoepidemiology divisions at Brigham and Women’s Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). "Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies," Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78).

"Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses," they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse events leading to hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. In particular, the rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years in the opioid group, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group.

Even though a link between opioids and fractures has been reported previously, "the strength of the association we observed is larger than in previous reports," Dr. Solomon and his associates said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That "unexpected" finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, while NSAID users experienced the fewest. In addition, "opioid users experienced moderate risk early in treatment," the investigators noted, while the other groups did not.

Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, Dr. Solomon and his colleagues said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Dec. 13/27 issue of the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study "support the safety of [NSAIDs] compared with other analgesics," said Dr. Daniel H. Solomon and his associates in the rheumatology and pharmacoepidemiology divisions at Brigham and Women’s Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). "Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies," Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78).

"Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses," they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse events leading to hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. In particular, the rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years in the opioid group, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group.

Even though a link between opioids and fractures has been reported previously, "the strength of the association we observed is larger than in previous reports," Dr. Solomon and his associates said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That "unexpected" finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, while NSAID users experienced the fewest. In addition, "opioid users experienced moderate risk early in treatment," the investigators noted, while the other groups did not.

Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, Dr. Solomon and his colleagues said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Dec. 13/27 issue of the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study "support the safety of [NSAIDs] compared with other analgesics," said Dr. Daniel H. Solomon and his associates in the rheumatology and pharmacoepidemiology divisions at Brigham and Women’s Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). "Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies," Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78).

"Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses," they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse events leading to hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. In particular, the rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years in the opioid group, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group.

Even though a link between opioids and fractures has been reported previously, "the strength of the association we observed is larger than in previous reports," Dr. Solomon and his associates said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That "unexpected" finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, while NSAID users experienced the fewest. In addition, "opioid users experienced moderate risk early in treatment," the investigators noted, while the other groups did not.

Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, Dr. Solomon and his colleagues said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Dec. 13/27 issue of the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study "support the safety of [NSAIDs] compared with other analgesics," said Dr. Daniel H. Solomon and his associates in the rheumatology and pharmacoepidemiology divisions at Brigham and Women’s Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). "Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies," Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78).

"Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses," they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse events leading to hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. In particular, the rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years in the opioid group, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group.

Even though a link between opioids and fractures has been reported previously, "the strength of the association we observed is larger than in previous reports," Dr. Solomon and his associates said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That "unexpected" finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, while NSAID users experienced the fewest. In addition, "opioid users experienced moderate risk early in treatment," the investigators noted, while the other groups did not.

Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, Dr. Solomon and his colleagues said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Dec. 13/27 issue of the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study "support the safety of [NSAIDs] compared with other analgesics," said Dr. Daniel H. Solomon and his associates in the rheumatology and pharmacoepidemiology divisions at Brigham and Women’s Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). "Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies," Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78).

"Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses," they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse events leading to hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. In particular, the rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years in the opioid group, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group.

Even though a link between opioids and fractures has been reported previously, "the strength of the association we observed is larger than in previous reports," Dr. Solomon and his associates said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That "unexpected" finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, while NSAID users experienced the fewest. In addition, "opioid users experienced moderate risk early in treatment," the investigators noted, while the other groups did not.

Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, Dr. Solomon and his colleagues said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Dec. 13/27 issue of the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study "support the safety of [NSAIDs] compared with other analgesics," said Dr. Daniel H. Solomon and his associates in the rheumatology and pharmacoepidemiology divisions at Brigham and Women’s Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). "Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies," Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78).

"Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses," they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse events leading to hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. In particular, the rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years in the opioid group, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group.

Even though a link between opioids and fractures has been reported previously, "the strength of the association we observed is larger than in previous reports," Dr. Solomon and his associates said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That "unexpected" finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, while NSAID users experienced the fewest. In addition, "opioid users experienced moderate risk early in treatment," the investigators noted, while the other groups did not.

Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, Dr. Solomon and his colleagues said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

For symptomatic patients who undergo cardiac computed tomography angiography to evaluate suspected coronary artery disease, a finding of no CAD conveys an excellent prognosis, according to a report published online Dec. 9 in the Journal of the American College of Cardiology.

A meta-analysis of 18 studies of diagnostic cardiac computed tomography angiography (CCTA) clearly showed that the low (0.16%) annualized event rate that follows such negative test results is comparable to the background event rate among healthy, low-risk individuals in the general population. It is also comparable to the event rates observed after risk-stratification modalities such as stress echocardiography and myocardial perfusion scanning, said Dr. Edward A. Hulten of the cardiology service at Walter Reed Army Medical Center, Washington, and his associates.

The diagnostic accuracy of CCTA has been reported in more than 50 studies, but the technology’s prognostic value has been less well established, the investigators observed. This meta-analysis shows that "the concept that CCTA offers anatomic but not prognostic value compared with widely used functional stress testing is no longer accurate," they wrote.

Dr. Hulten and his colleagues performed a meta-analysis of prospective and retrospective observational studies in which 9,592 patients suspected of having CAD were evaluated using CCTA and followed for a median of 20 months. Seventeen of these studies were rated as good quality.

For the patients whose CCTA results indicated no CAD, the annualized rate of major adverse cardiovascular events (MACE) was 0.16%. There were no coronary revascularizations, myocardial infarctions, or admissions for unstable angina; the only events were from all-cause mortality.

"Considered in concert with the wealth of data regarding the high anatomic accuracy for CCTA, these results are convincing for CCTA to effectively diagnose CAD and convey risk strata for future adverse cardiovascular events," the investigators said (J. Am. Coll. Cardiol. 2010;57[doi:10.1016/jacc.2010.10.011]).

Positive results on CCTA correlated with major adverse cardiovascular events. The average annualized MACE rate for a finding of CAD was 8.8% per year (vs. 0.17% per year for negative findings). Revascularization procedures accounted for most of these events; the annualized rate of death or MI was 3.2% vs. 0.15 for positive vs. negative scans. Moreover, the rate of adverse events increased as the severity of coronary artery disease on CCTA exam increased.

Although a negative CCTA scan can be considered strongly predictive of an excellent outcome, the reverse is not true: A positive CCTA scan cannot be considered strongly predictive of future adverse events. With the annualized MACE rate at only 8.8%, the great majority of patients found on CCTA to have coronary disease also have good outcomes in the 20 months’ follow-up, Dr. Hulten and his associates pointed out.

They also noted that many of the authors of studies included in the meta-analysis "reported prognosis based on a relatively simple classification of CAD luminal stenosis, specifically, no CAD, nonobstructive CAD, or potentially obstructive CAD (greater than 50% stenosis)." With studies defining "normal" CCTA in slightly different ways, it was not possible to have stratification details that would be clinically informative, the authors wrote. They also noted that their research included data from "different generations of CT scanning technology" the newer of which are known to have improved image quality and accuracy.

As in many other many studies of noninvasive coronary risk stratification tests, the investigators wrote, a limitation of their study is verification bias: "The observed increase in MACE is driven in part by coronary revascularization, demonstrating evidence of a work-up or verification bias. That is, patients with CCTA evidence of a greater than 50% stenosis are more likely to undergo catheterization and subsequent revascularization."

For symptomatic patients who undergo cardiac computed tomography angiography to evaluate suspected coronary artery disease, a finding of no CAD conveys an excellent prognosis, according to a report published online Dec. 9 in the Journal of the American College of Cardiology.

A meta-analysis of 18 studies of diagnostic cardiac computed tomography angiography (CCTA) clearly showed that the low (0.16%) annualized event rate that follows such negative test results is comparable to the background event rate among healthy, low-risk individuals in the general population. It is also comparable to the event rates observed after risk-stratification modalities such as stress echocardiography and myocardial perfusion scanning, said Dr. Edward A. Hulten of the cardiology service at Walter Reed Army Medical Center, Washington, and his associates.

The diagnostic accuracy of CCTA has been reported in more than 50 studies, but the technology’s prognostic value has been less well established, the investigators observed. This meta-analysis shows that "the concept that CCTA offers anatomic but not prognostic value compared with widely used functional stress testing is no longer accurate," they wrote.

Dr. Hulten and his colleagues performed a meta-analysis of prospective and retrospective observational studies in which 9,592 patients suspected of having CAD were evaluated using CCTA and followed for a median of 20 months. Seventeen of these studies were rated as good quality.

For the patients whose CCTA results indicated no CAD, the annualized rate of major adverse cardiovascular events (MACE) was 0.16%. There were no coronary revascularizations, myocardial infarctions, or admissions for unstable angina; the only events were from all-cause mortality.

"Considered in concert with the wealth of data regarding the high anatomic accuracy for CCTA, these results are convincing for CCTA to effectively diagnose CAD and convey risk strata for future adverse cardiovascular events," the investigators said (J. Am. Coll. Cardiol. 2010;57[doi:10.1016/jacc.2010.10.011]).

Positive results on CCTA correlated with major adverse cardiovascular events. The average annualized MACE rate for a finding of CAD was 8.8% per year (vs. 0.17% per year for negative findings). Revascularization procedures accounted for most of these events; the annualized rate of death or MI was 3.2% vs. 0.15 for positive vs. negative scans. Moreover, the rate of adverse events increased as the severity of coronary artery disease on CCTA exam increased.

Although a negative CCTA scan can be considered strongly predictive of an excellent outcome, the reverse is not true: A positive CCTA scan cannot be considered strongly predictive of future adverse events. With the annualized MACE rate at only 8.8%, the great majority of patients found on CCTA to have coronary disease also have good outcomes in the 20 months’ follow-up, Dr. Hulten and his associates pointed out.

They also noted that many of the authors of studies included in the meta-analysis "reported prognosis based on a relatively simple classification of CAD luminal stenosis, specifically, no CAD, nonobstructive CAD, or potentially obstructive CAD (greater than 50% stenosis)." With studies defining "normal" CCTA in slightly different ways, it was not possible to have stratification details that would be clinically informative, the authors wrote. They also noted that their research included data from "different generations of CT scanning technology" the newer of which are known to have improved image quality and accuracy.

As in many other many studies of noninvasive coronary risk stratification tests, the investigators wrote, a limitation of their study is verification bias: "The observed increase in MACE is driven in part by coronary revascularization, demonstrating evidence of a work-up or verification bias. That is, patients with CCTA evidence of a greater than 50% stenosis are more likely to undergo catheterization and subsequent revascularization."

For symptomatic patients who undergo cardiac computed tomography angiography to evaluate suspected coronary artery disease, a finding of no CAD conveys an excellent prognosis, according to a report published online Dec. 9 in the Journal of the American College of Cardiology.

A meta-analysis of 18 studies of diagnostic cardiac computed tomography angiography (CCTA) clearly showed that the low (0.16%) annualized event rate that follows such negative test results is comparable to the background event rate among healthy, low-risk individuals in the general population. It is also comparable to the event rates observed after risk-stratification modalities such as stress echocardiography and myocardial perfusion scanning, said Dr. Edward A. Hulten of the cardiology service at Walter Reed Army Medical Center, Washington, and his associates.

The diagnostic accuracy of CCTA has been reported in more than 50 studies, but the technology’s prognostic value has been less well established, the investigators observed. This meta-analysis shows that "the concept that CCTA offers anatomic but not prognostic value compared with widely used functional stress testing is no longer accurate," they wrote.

Dr. Hulten and his colleagues performed a meta-analysis of prospective and retrospective observational studies in which 9,592 patients suspected of having CAD were evaluated using CCTA and followed for a median of 20 months. Seventeen of these studies were rated as good quality.

For the patients whose CCTA results indicated no CAD, the annualized rate of major adverse cardiovascular events (MACE) was 0.16%. There were no coronary revascularizations, myocardial infarctions, or admissions for unstable angina; the only events were from all-cause mortality.

"Considered in concert with the wealth of data regarding the high anatomic accuracy for CCTA, these results are convincing for CCTA to effectively diagnose CAD and convey risk strata for future adverse cardiovascular events," the investigators said (J. Am. Coll. Cardiol. 2010;57[doi:10.1016/jacc.2010.10.011]).

Positive results on CCTA correlated with major adverse cardiovascular events. The average annualized MACE rate for a finding of CAD was 8.8% per year (vs. 0.17% per year for negative findings). Revascularization procedures accounted for most of these events; the annualized rate of death or MI was 3.2% vs. 0.15 for positive vs. negative scans. Moreover, the rate of adverse events increased as the severity of coronary artery disease on CCTA exam increased.

Although a negative CCTA scan can be considered strongly predictive of an excellent outcome, the reverse is not true: A positive CCTA scan cannot be considered strongly predictive of future adverse events. With the annualized MACE rate at only 8.8%, the great majority of patients found on CCTA to have coronary disease also have good outcomes in the 20 months’ follow-up, Dr. Hulten and his associates pointed out.

They also noted that many of the authors of studies included in the meta-analysis "reported prognosis based on a relatively simple classification of CAD luminal stenosis, specifically, no CAD, nonobstructive CAD, or potentially obstructive CAD (greater than 50% stenosis)." With studies defining "normal" CCTA in slightly different ways, it was not possible to have stratification details that would be clinically informative, the authors wrote. They also noted that their research included data from "different generations of CT scanning technology" the newer of which are known to have improved image quality and accuracy.

As in many other many studies of noninvasive coronary risk stratification tests, the investigators wrote, a limitation of their study is verification bias: "The observed increase in MACE is driven in part by coronary revascularization, demonstrating evidence of a work-up or verification bias. That is, patients with CCTA evidence of a greater than 50% stenosis are more likely to undergo catheterization and subsequent revascularization."

For symptomatic patients who undergo cardiac computed tomography angiography to evaluate suspected coronary artery disease, a finding of no CAD conveys an excellent prognosis, according to a report published online Dec. 9 in the Journal of the American College of Cardiology.

A meta-analysis of 18 studies of diagnostic cardiac computed tomography angiography (CCTA) clearly showed that the low (0.16%) annualized event rate that follows such negative test results is comparable to the background event rate among healthy, low-risk individuals in the general population. It is also comparable to the event rates observed after risk-stratification modalities such as stress echocardiography and myocardial perfusion scanning, said Dr. Edward A. Hulten of the cardiology service at Walter Reed Army Medical Center, Washington, and his associates.

The diagnostic accuracy of CCTA has been reported in more than 50 studies, but the technology’s prognostic value has been less well established, the investigators observed. This meta-analysis shows that "the concept that CCTA offers anatomic but not prognostic value compared with widely used functional stress testing is no longer accurate," they wrote.

Dr. Hulten and his colleagues performed a meta-analysis of prospective and retrospective observational studies in which 9,592 patients suspected of having CAD were evaluated using CCTA and followed for a median of 20 months. Seventeen of these studies were rated as good quality.

For the patients whose CCTA results indicated no CAD, the annualized rate of major adverse cardiovascular events (MACE) was 0.16%. There were no coronary revascularizations, myocardial infarctions, or admissions for unstable angina; the only events were from all-cause mortality.

"Considered in concert with the wealth of data regarding the high anatomic accuracy for CCTA, these results are convincing for CCTA to effectively diagnose CAD and convey risk strata for future adverse cardiovascular events," the investigators said (J. Am. Coll. Cardiol. 2010;57[doi:10.1016/jacc.2010.10.011]).

Positive results on CCTA correlated with major adverse cardiovascular events. The average annualized MACE rate for a finding of CAD was 8.8% per year (vs. 0.17% per year for negative findings). Revascularization procedures accounted for most of these events; the annualized rate of death or MI was 3.2% vs. 0.15 for positive vs. negative scans. Moreover, the rate of adverse events increased as the severity of coronary artery disease on CCTA exam increased.

Although a negative CCTA scan can be considered strongly predictive of an excellent outcome, the reverse is not true: A positive CCTA scan cannot be considered strongly predictive of future adverse events. With the annualized MACE rate at only 8.8%, the great majority of patients found on CCTA to have coronary disease also have good outcomes in the 20 months’ follow-up, Dr. Hulten and his associates pointed out.

They also noted that many of the authors of studies included in the meta-analysis "reported prognosis based on a relatively simple classification of CAD luminal stenosis, specifically, no CAD, nonobstructive CAD, or potentially obstructive CAD (greater than 50% stenosis)." With studies defining "normal" CCTA in slightly different ways, it was not possible to have stratification details that would be clinically informative, the authors wrote. They also noted that their research included data from "different generations of CT scanning technology" the newer of which are known to have improved image quality and accuracy.

As in many other many studies of noninvasive coronary risk stratification tests, the investigators wrote, a limitation of their study is verification bias: "The observed increase in MACE is driven in part by coronary revascularization, demonstrating evidence of a work-up or verification bias. That is, patients with CCTA evidence of a greater than 50% stenosis are more likely to undergo catheterization and subsequent revascularization."

For symptomatic patients who undergo cardiac computed tomography angiography to evaluate suspected coronary artery disease, a finding of no CAD conveys an excellent prognosis, according to a report published online Dec. 9 in the Journal of the American College of Cardiology.

A meta-analysis of 18 studies of diagnostic cardiac computed tomography angiography (CCTA) clearly showed that the low (0.16%) annualized event rate that follows such negative test results is comparable to the background event rate among healthy, low-risk individuals in the general population. It is also comparable to the event rates observed after risk-stratification modalities such as stress echocardiography and myocardial perfusion scanning, said Dr. Edward A. Hulten of the cardiology service at Walter Reed Army Medical Center, Washington, and his associates.

The diagnostic accuracy of CCTA has been reported in more than 50 studies, but the technology’s prognostic value has been less well established, the investigators observed. This meta-analysis shows that "the concept that CCTA offers anatomic but not prognostic value compared with widely used functional stress testing is no longer accurate," they wrote.

Dr. Hulten and his colleagues performed a meta-analysis of prospective and retrospective observational studies in which 9,592 patients suspected of having CAD were evaluated using CCTA and followed for a median of 20 months. Seventeen of these studies were rated as good quality.

For the patients whose CCTA results indicated no CAD, the annualized rate of major adverse cardiovascular events (MACE) was 0.16%. There were no coronary revascularizations, myocardial infarctions, or admissions for unstable angina; the only events were from all-cause mortality.

"Considered in concert with the wealth of data regarding the high anatomic accuracy for CCTA, these results are convincing for CCTA to effectively diagnose CAD and convey risk strata for future adverse cardiovascular events," the investigators said (J. Am. Coll. Cardiol. 2010;57[doi:10.1016/jacc.2010.10.011]).

Positive results on CCTA correlated with major adverse cardiovascular events. The average annualized MACE rate for a finding of CAD was 8.8% per year (vs. 0.17% per year for negative findings). Revascularization procedures accounted for most of these events; the annualized rate of death or MI was 3.2% vs. 0.15 for positive vs. negative scans. Moreover, the rate of adverse events increased as the severity of coronary artery disease on CCTA exam increased.

Although a negative CCTA scan can be considered strongly predictive of an excellent outcome, the reverse is not true: A positive CCTA scan cannot be considered strongly predictive of future adverse events. With the annualized MACE rate at only 8.8%, the great majority of patients found on CCTA to have coronary disease also have good outcomes in the 20 months’ follow-up, Dr. Hulten and his associates pointed out.

They also noted that many of the authors of studies included in the meta-analysis "reported prognosis based on a relatively simple classification of CAD luminal stenosis, specifically, no CAD, nonobstructive CAD, or potentially obstructive CAD (greater than 50% stenosis)." With studies defining "normal" CCTA in slightly different ways, it was not possible to have stratification details that would be clinically informative, the authors wrote. They also noted that their research included data from "different generations of CT scanning technology" the newer of which are known to have improved image quality and accuracy.

As in many other many studies of noninvasive coronary risk stratification tests, the investigators wrote, a limitation of their study is verification bias: "The observed increase in MACE is driven in part by coronary revascularization, demonstrating evidence of a work-up or verification bias. That is, patients with CCTA evidence of a greater than 50% stenosis are more likely to undergo catheterization and subsequent revascularization."

For symptomatic patients who undergo cardiac computed tomography angiography to evaluate suspected coronary artery disease, a finding of no CAD conveys an excellent prognosis, according to a report published online Dec. 9 in the Journal of the American College of Cardiology.

A meta-analysis of 18 studies of diagnostic cardiac computed tomography angiography (CCTA) clearly showed that the low (0.16%) annualized event rate that follows such negative test results is comparable to the background event rate among healthy, low-risk individuals in the general population. It is also comparable to the event rates observed after risk-stratification modalities such as stress echocardiography and myocardial perfusion scanning, said Dr. Edward A. Hulten of the cardiology service at Walter Reed Army Medical Center, Washington, and his associates.

The diagnostic accuracy of CCTA has been reported in more than 50 studies, but the technology’s prognostic value has been less well established, the investigators observed. This meta-analysis shows that "the concept that CCTA offers anatomic but not prognostic value compared with widely used functional stress testing is no longer accurate," they wrote.

Dr. Hulten and his colleagues performed a meta-analysis of prospective and retrospective observational studies in which 9,592 patients suspected of having CAD were evaluated using CCTA and followed for a median of 20 months. Seventeen of these studies were rated as good quality.

For the patients whose CCTA results indicated no CAD, the annualized rate of major adverse cardiovascular events (MACE) was 0.16%. There were no coronary revascularizations, myocardial infarctions, or admissions for unstable angina; the only events were from all-cause mortality.

"Considered in concert with the wealth of data regarding the high anatomic accuracy for CCTA, these results are convincing for CCTA to effectively diagnose CAD and convey risk strata for future adverse cardiovascular events," the investigators said (J. Am. Coll. Cardiol. 2010;57[doi:10.1016/jacc.2010.10.011]).

Positive results on CCTA correlated with major adverse cardiovascular events. The average annualized MACE rate for a finding of CAD was 8.8% per year (vs. 0.17% per year for negative findings). Revascularization procedures accounted for most of these events; the annualized rate of death or MI was 3.2% vs. 0.15 for positive vs. negative scans. Moreover, the rate of adverse events increased as the severity of coronary artery disease on CCTA exam increased.

Although a negative CCTA scan can be considered strongly predictive of an excellent outcome, the reverse is not true: A positive CCTA scan cannot be considered strongly predictive of future adverse events. With the annualized MACE rate at only 8.8%, the great majority of patients found on CCTA to have coronary disease also have good outcomes in the 20 months’ follow-up, Dr. Hulten and his associates pointed out.

They also noted that many of the authors of studies included in the meta-analysis "reported prognosis based on a relatively simple classification of CAD luminal stenosis, specifically, no CAD, nonobstructive CAD, or potentially obstructive CAD (greater than 50% stenosis)." With studies defining "normal" CCTA in slightly different ways, it was not possible to have stratification details that would be clinically informative, the authors wrote. They also noted that their research included data from "different generations of CT scanning technology" the newer of which are known to have improved image quality and accuracy.

As in many other many studies of noninvasive coronary risk stratification tests, the investigators wrote, a limitation of their study is verification bias: "The observed increase in MACE is driven in part by coronary revascularization, demonstrating evidence of a work-up or verification bias. That is, patients with CCTA evidence of a greater than 50% stenosis are more likely to undergo catheterization and subsequent revascularization."

For opioid-dependent women who are pregnant, buprenorphine appears to offer an effective, safe first-line alternative to methadone, according to a report in the Dec. 9 issue of the New England Journal of Medicine.

In a randomized clinical trial comparing pregnancy outcomes among women seeking treatment for opioid dependence, infants exposed in utero to buprenorphine developed significantly less severe neonatal abstinence syndrome than did infants exposed in utero to methadone, said Hendrée E. Jones, Ph.D., of the department of psychiatry and behavioral sciences and the department of obstetrics and gynecology at Johns Hopkins University, Baltimore, and her associates.

The study involved 175 women aged 18-41 years who were at 6-30 weeks’ gestation when they entered treatment for opioid dependence at eight sites in the United States, Austria, and Canada. Eighty-six were randomly assigned to receive oral buprenorphine and 89 to receive oral methadone in a double-blind fashion.

After delivery, their neonates were assessed for signs and symptoms of neonatal abstinence syndrome (NAS) twice a day for at least 10 days.

There were five primary neonatal outcomes. Three of these – percentage of neonates requiring NAS treatment, peak NAS scores, and head circumference – did not differ between the two study groups. However, two of the five primary outcomes – amount of morphine required to treat NAS and length of hospital stay – favored the infants in the buprenorphine group. On average, infants exposed to buprenorphine required 89% less morphine and spent 43% less time in the hospital (10 days vs. 17.5 days) than infants exposed to methadone.

"The benefits of buprenorphine in reducing the severity of NAS among neonates with this complication suggest that it should be considered a first-line treatment option in pregnancy," Dr. Jones and her colleagues said (N. Engl. J. Med. 2010;363:2320-31).

Neonates of mothers who received buprenorphine also required a significantly shorter period of treatment for NAS (4.1 days) than did neonates of mothers who received methadone, who required 9.9 days of treatment for NAS, they reported.

There were no differences in any maternal outcomes between women who took buprenorphine and those who took methadone.

Despite the comparable or even superior efficacy and safety of buprenorphine, there was one important drawback with the therapy: Women were more likely to discontinue treatment for opioid dependency with buprenorphine (33%) than with methadone (18%). Most (71%) of the women in the buprenorphine group who discontinued treatment cited "dissatisfaction" with the drug as their reason, while only 13% of those in the methadone group did so.

The benefits of buprenorphine therapy "must be considered in light of the markedly different rates of attrition," Dr. Jones and her associates said. Future research should focus on reducing this "dissatisfaction" as well as on identifying "subpopulations of pregnant patients who are more likely to have a response to one medication than to the other," they added.

This study was funded by grants from the National Institute on Drug Abuse. Buprenorphine tablets and the associated placebo were supplied by Reckitt Benckiser. Dr. Jones had no financial conflicts to disclose. One of Dr. Jones’ associates reported ties to a number of drug companies, and others had or were seeking federal grants.

For opioid-dependent women who are pregnant, buprenorphine appears to offer an effective, safe first-line alternative to methadone, according to a report in the Dec. 9 issue of the New England Journal of Medicine.

In a randomized clinical trial comparing pregnancy outcomes among women seeking treatment for opioid dependence, infants exposed in utero to buprenorphine developed significantly less severe neonatal abstinence syndrome than did infants exposed in utero to methadone, said Hendrée E. Jones, Ph.D., of the department of psychiatry and behavioral sciences and the department of obstetrics and gynecology at Johns Hopkins University, Baltimore, and her associates.

The study involved 175 women aged 18-41 years who were at 6-30 weeks’ gestation when they entered treatment for opioid dependence at eight sites in the United States, Austria, and Canada. Eighty-six were randomly assigned to receive oral buprenorphine and 89 to receive oral methadone in a double-blind fashion.

After delivery, their neonates were assessed for signs and symptoms of neonatal abstinence syndrome (NAS) twice a day for at least 10 days.

There were five primary neonatal outcomes. Three of these – percentage of neonates requiring NAS treatment, peak NAS scores, and head circumference – did not differ between the two study groups. However, two of the five primary outcomes – amount of morphine required to treat NAS and length of hospital stay – favored the infants in the buprenorphine group. On average, infants exposed to buprenorphine required 89% less morphine and spent 43% less time in the hospital (10 days vs. 17.5 days) than infants exposed to methadone.

"The benefits of buprenorphine in reducing the severity of NAS among neonates with this complication suggest that it should be considered a first-line treatment option in pregnancy," Dr. Jones and her colleagues said (N. Engl. J. Med. 2010;363:2320-31).

Neonates of mothers who received buprenorphine also required a significantly shorter period of treatment for NAS (4.1 days) than did neonates of mothers who received methadone, who required 9.9 days of treatment for NAS, they reported.

There were no differences in any maternal outcomes between women who took buprenorphine and those who took methadone.

Despite the comparable or even superior efficacy and safety of buprenorphine, there was one important drawback with the therapy: Women were more likely to discontinue treatment for opioid dependency with buprenorphine (33%) than with methadone (18%). Most (71%) of the women in the buprenorphine group who discontinued treatment cited "dissatisfaction" with the drug as their reason, while only 13% of those in the methadone group did so.

The benefits of buprenorphine therapy "must be considered in light of the markedly different rates of attrition," Dr. Jones and her associates said. Future research should focus on reducing this "dissatisfaction" as well as on identifying "subpopulations of pregnant patients who are more likely to have a response to one medication than to the other," they added.

This study was funded by grants from the National Institute on Drug Abuse. Buprenorphine tablets and the associated placebo were supplied by Reckitt Benckiser. Dr. Jones had no financial conflicts to disclose. One of Dr. Jones’ associates reported ties to a number of drug companies, and others had or were seeking federal grants.

For opioid-dependent women who are pregnant, buprenorphine appears to offer an effective, safe first-line alternative to methadone, according to a report in the Dec. 9 issue of the New England Journal of Medicine.

In a randomized clinical trial comparing pregnancy outcomes among women seeking treatment for opioid dependence, infants exposed in utero to buprenorphine developed significantly less severe neonatal abstinence syndrome than did infants exposed in utero to methadone, said Hendrée E. Jones, Ph.D., of the department of psychiatry and behavioral sciences and the department of obstetrics and gynecology at Johns Hopkins University, Baltimore, and her associates.

The study involved 175 women aged 18-41 years who were at 6-30 weeks’ gestation when they entered treatment for opioid dependence at eight sites in the United States, Austria, and Canada. Eighty-six were randomly assigned to receive oral buprenorphine and 89 to receive oral methadone in a double-blind fashion.

After delivery, their neonates were assessed for signs and symptoms of neonatal abstinence syndrome (NAS) twice a day for at least 10 days.

There were five primary neonatal outcomes. Three of these – percentage of neonates requiring NAS treatment, peak NAS scores, and head circumference – did not differ between the two study groups. However, two of the five primary outcomes – amount of morphine required to treat NAS and length of hospital stay – favored the infants in the buprenorphine group. On average, infants exposed to buprenorphine required 89% less morphine and spent 43% less time in the hospital (10 days vs. 17.5 days) than infants exposed to methadone.

"The benefits of buprenorphine in reducing the severity of NAS among neonates with this complication suggest that it should be considered a first-line treatment option in pregnancy," Dr. Jones and her colleagues said (N. Engl. J. Med. 2010;363:2320-31).

Neonates of mothers who received buprenorphine also required a significantly shorter period of treatment for NAS (4.1 days) than did neonates of mothers who received methadone, who required 9.9 days of treatment for NAS, they reported.

There were no differences in any maternal outcomes between women who took buprenorphine and those who took methadone.

Despite the comparable or even superior efficacy and safety of buprenorphine, there was one important drawback with the therapy: Women were more likely to discontinue treatment for opioid dependency with buprenorphine (33%) than with methadone (18%). Most (71%) of the women in the buprenorphine group who discontinued treatment cited "dissatisfaction" with the drug as their reason, while only 13% of those in the methadone group did so.

The benefits of buprenorphine therapy "must be considered in light of the markedly different rates of attrition," Dr. Jones and her associates said. Future research should focus on reducing this "dissatisfaction" as well as on identifying "subpopulations of pregnant patients who are more likely to have a response to one medication than to the other," they added.

This study was funded by grants from the National Institute on Drug Abuse. Buprenorphine tablets and the associated placebo were supplied by Reckitt Benckiser. Dr. Jones had no financial conflicts to disclose. One of Dr. Jones’ associates reported ties to a number of drug companies, and others had or were seeking federal grants.

The new, highly sensitive cardiac troponin T assay finds detectable levels of the biomarker in 25% of adults in the general population who would not be identified by the standard troponin T assay, and that result often correlates with cardiac structural abnormalities, according to large cohort study reported in the Dec. 8 issue of JAMA.

In addition, elevated cardiac troponin T levels identified with the highly sensitive assay also correlate with all-cause and cardiovascular mortality, independently of other risk factors and even in people thought to be at low cardiovascular risk, said Dr. James A. de Lemos of the University of Texas Southwestern Medical Center, Dallas, and his associates.

The highly sensitive assay detects levels of cardiac troponin T that are approximately one-tenth of the levels detectable with the standard assay. Dr. de Lemos and his colleagues examined the results of this assay in a general population cohort of adults aged 30-65 years participating in the Dallas Heart Study. The 3,546 subjects in this random probability sample had detailed cardiovascular profiles, including MRI and electron-beam CT imaging of the heart and aorta, and their mortality was tracked for a median of 6 years.

The prevalence of detectable cardiac troponin T by this highly sensitive assay was 25% in this multiethnic cohort that included a high proportion of blacks and women. In contrast, the standard assay found detectable levels in only 0.7%.

Higher levels of the biomarker on the highly sensitive assay were associated with cardiac structural abnormalities including left ventricular hypertrophy (both wall thickening and dilation) and left ventricular systolic dysfunction, even in subjects who were asymptomatic, had no known CVD, and were classified as low-risk by their Framingham Risk Scores.

"Moreover, higher cardiac troponin T levels demonstrate[d] a graded association with all-cause and cardiovascular mortality, independent of traditional risk factors, renal function, and levels of other biomarkers" such as high-sensitivity C-reactive protein and N-terminal prohormone brain natriuretic peptide, the investigators said (JAMA 2010;304:2503-12).

"Prior studies have described associations between increased troponin levels detected with standard assays and future risk for mortality. Here, we report that these associations extend to much lower troponin levels not detected with assays in current clinical use," they added.

More research is needed to determine whether routine use of the highly sensitive assay would aid in cardiovascular risk assessment in the general population.

In the meantime, the findings have important implications for the use of this assay for diagnosing acute MI in the hospital setting. Given that one-fourth of the general population have "elevated" troponin T on this test, false-positive diagnoses will increase. "It is possible that widespread application of highly sensitive assays without integrating new approaches to discriminate acute injury will expose some patients to unnecessary risk and expense," Dr. de Lemos and his associates noted.

The Dallas Heart Study was supported by the Donald W. Reynolds Foundation and the National Institutes of Health. Assays were provided by Roche Diagnostics. Dr. de Lemos and his associates reported ties to numerous pharmaceutical and device manufacturers.

The new, highly sensitive cardiac troponin T assay finds detectable levels of the biomarker in 25% of adults in the general population who would not be identified by the standard troponin T assay, and that result often correlates with cardiac structural abnormalities, according to large cohort study reported in the Dec. 8 issue of JAMA.

In addition, elevated cardiac troponin T levels identified with the highly sensitive assay also correlate with all-cause and cardiovascular mortality, independently of other risk factors and even in people thought to be at low cardiovascular risk, said Dr. James A. de Lemos of the University of Texas Southwestern Medical Center, Dallas, and his associates.

The highly sensitive assay detects levels of cardiac troponin T that are approximately one-tenth of the levels detectable with the standard assay. Dr. de Lemos and his colleagues examined the results of this assay in a general population cohort of adults aged 30-65 years participating in the Dallas Heart Study. The 3,546 subjects in this random probability sample had detailed cardiovascular profiles, including MRI and electron-beam CT imaging of the heart and aorta, and their mortality was tracked for a median of 6 years.

The prevalence of detectable cardiac troponin T by this highly sensitive assay was 25% in this multiethnic cohort that included a high proportion of blacks and women. In contrast, the standard assay found detectable levels in only 0.7%.

Higher levels of the biomarker on the highly sensitive assay were associated with cardiac structural abnormalities including left ventricular hypertrophy (both wall thickening and dilation) and left ventricular systolic dysfunction, even in subjects who were asymptomatic, had no known CVD, and were classified as low-risk by their Framingham Risk Scores.

"Moreover, higher cardiac troponin T levels demonstrate[d] a graded association with all-cause and cardiovascular mortality, independent of traditional risk factors, renal function, and levels of other biomarkers" such as high-sensitivity C-reactive protein and N-terminal prohormone brain natriuretic peptide, the investigators said (JAMA 2010;304:2503-12).

"Prior studies have described associations between increased troponin levels detected with standard assays and future risk for mortality. Here, we report that these associations extend to much lower troponin levels not detected with assays in current clinical use," they added.

More research is needed to determine whether routine use of the highly sensitive assay would aid in cardiovascular risk assessment in the general population.

In the meantime, the findings have important implications for the use of this assay for diagnosing acute MI in the hospital setting. Given that one-fourth of the general population have "elevated" troponin T on this test, false-positive diagnoses will increase. "It is possible that widespread application of highly sensitive assays without integrating new approaches to discriminate acute injury will expose some patients to unnecessary risk and expense," Dr. de Lemos and his associates noted.

The Dallas Heart Study was supported by the Donald W. Reynolds Foundation and the National Institutes of Health. Assays were provided by Roche Diagnostics. Dr. de Lemos and his associates reported ties to numerous pharmaceutical and device manufacturers.

The new, highly sensitive cardiac troponin T assay finds detectable levels of the biomarker in 25% of adults in the general population who would not be identified by the standard troponin T assay, and that result often correlates with cardiac structural abnormalities, according to large cohort study reported in the Dec. 8 issue of JAMA.

In addition, elevated cardiac troponin T levels identified with the highly sensitive assay also correlate with all-cause and cardiovascular mortality, independently of other risk factors and even in people thought to be at low cardiovascular risk, said Dr. James A. de Lemos of the University of Texas Southwestern Medical Center, Dallas, and his associates.

The highly sensitive assay detects levels of cardiac troponin T that are approximately one-tenth of the levels detectable with the standard assay. Dr. de Lemos and his colleagues examined the results of this assay in a general population cohort of adults aged 30-65 years participating in the Dallas Heart Study. The 3,546 subjects in this random probability sample had detailed cardiovascular profiles, including MRI and electron-beam CT imaging of the heart and aorta, and their mortality was tracked for a median of 6 years.

The prevalence of detectable cardiac troponin T by this highly sensitive assay was 25% in this multiethnic cohort that included a high proportion of blacks and women. In contrast, the standard assay found detectable levels in only 0.7%.

Higher levels of the biomarker on the highly sensitive assay were associated with cardiac structural abnormalities including left ventricular hypertrophy (both wall thickening and dilation) and left ventricular systolic dysfunction, even in subjects who were asymptomatic, had no known CVD, and were classified as low-risk by their Framingham Risk Scores.

"Moreover, higher cardiac troponin T levels demonstrate[d] a graded association with all-cause and cardiovascular mortality, independent of traditional risk factors, renal function, and levels of other biomarkers" such as high-sensitivity C-reactive protein and N-terminal prohormone brain natriuretic peptide, the investigators said (JAMA 2010;304:2503-12).

"Prior studies have described associations between increased troponin levels detected with standard assays and future risk for mortality. Here, we report that these associations extend to much lower troponin levels not detected with assays in current clinical use," they added.

More research is needed to determine whether routine use of the highly sensitive assay would aid in cardiovascular risk assessment in the general population.

In the meantime, the findings have important implications for the use of this assay for diagnosing acute MI in the hospital setting. Given that one-fourth of the general population have "elevated" troponin T on this test, false-positive diagnoses will increase. "It is possible that widespread application of highly sensitive assays without integrating new approaches to discriminate acute injury will expose some patients to unnecessary risk and expense," Dr. de Lemos and his associates noted.

The Dallas Heart Study was supported by the Donald W. Reynolds Foundation and the National Institutes of Health. Assays were provided by Roche Diagnostics. Dr. de Lemos and his associates reported ties to numerous pharmaceutical and device manufacturers.

Low-dose aspirin therapy does not appear to compromise the results of immunochemical tests for fecal occult blood, as it may with other types of FOBTs, according to a report in the Dec. 8 issue of JAMA.

The sensitivity of two different immunochemical FOBTs for detecting colorectal neoplasms was actually higher among patients taking low-dose aspirin therapy than among those not taking aspirin, particularly in cases of advanced neoplasms, said Dr. Hermann Brenner and his associates in the division of clinical epidemiology and aging research, German Cancer Research Center, Heidelberg.

Concerns have been raised that low-dose aspirin therapy might cause bleeding from upper GI lesions or insignificant colonic lesions, which would produce false-positive FOBT results. Some physicians have even called for suspension of aspirin therapy before FOBT.

But immunochemical FOBTs (iFOBTs) react to globin, which is degraded as it passes through the gastrointestinal tract. They are less likely to produce false-positives from upper GI bleeds than are the guaiac-based FOBTs that react to the heme moiety of hemoglobin, which is more stable as it passes through the digestive system.

Dr. Brenner and his colleagues assessed the relationship between aspirin therapy and iFOBT results in a large sample of adults participating in a screening colonoscopy program at 20 GI practices across southern Germany. The 1,979 study subjects (mean age, 62 years) provided stool samples before undergoing bowel preparation for colonoscopy.

A total of 233 of these subjects (12%) were taking low-dose aspirin therapy for cardiovascular prophylaxis, while the remainder had never used low-dose aspirin. The prevalence of neoplasms found on colonoscopy was similar between the two groups.

The study also found that two different iFOBTs had substantially (about 30%) higher sensitivity in detecting any neoplasm in people using aspirin therapy than in nonusers. The difference in test sensitivity was greatest in people found to have advanced malignancies, with one of the iFOBTs achieving a sensitivity of 71% among those using aspirin therapy but only a sensitivity of 36% among nonusers (P = .001).

This enhanced sensitivity was consistent across various subgroups of patients and across a broad range of cut points for test positivity. The advantages of aspirin therapy were particularly marked in men: among men taking low-dose aspirin, the sensitivity of iFOBTs was up to 46 percentage points higher than it was in men not using aspirin therapy, the investigators said (JAMA 2010;304:2513-20).

In contrast, the specificity of iFOBTs was slightly (about 5%) lower in people using aspirin therapy than in nonusers.

These findings indicate that "there is no need to stop low-dose aspirin use prior to undergoing iFOBT," Dr. Brenner and his associates said.

"On the contrary, our results may even raise the provocative suggestion of whether temporary use of low-dose aspirin might be considered to enhance performance of iFOBTs," they said.

Given their findings, temporary use of low-dose aspirin might yield a sensitivity for detecting advanced neoplasms of 60%-70% at a specificity of approximately 90% – levels of sensitivity and specificity that exceed those of other established stool tests and that "might come close to the sensitivity of sigmoidoscopy," the researchers noted.

However, it would be premature to make such a recommendation before these findings are replicated in other populations "and followed up in further research, ideally including randomized trials and different types of FOBTs," they added.

This study was somewhat limited in that despite the large sample size, there were few advanced neoplasms, resulting in broad confidence intervals around some estimates of iFOBT performance, Dr. Brenner and his colleagues said.

The study was supported in part by the German Research Foundation and the German Federal Ministry of Education and Research. The test kits were provided free of charge by the manufacturer. Dr. Brenner reported that the German Cancer Research Center has received funding from Eiken Chemical to evaluate an iFOBT that was not included in this analysis. Also, a patent application was filed at the European Patent Office for the combination of low-dose aspirin use and iFOBTs in early detection of colorectal neoplasms.

Low-dose aspirin therapy does not appear to compromise the results of immunochemical tests for fecal occult blood, as it may with other types of FOBTs, according to a report in the Dec. 8 issue of JAMA.

The sensitivity of two different immunochemical FOBTs for detecting colorectal neoplasms was actually higher among patients taking low-dose aspirin therapy than among those not taking aspirin, particularly in cases of advanced neoplasms, said Dr. Hermann Brenner and his associates in the division of clinical epidemiology and aging research, German Cancer Research Center, Heidelberg.

Concerns have been raised that low-dose aspirin therapy might cause bleeding from upper GI lesions or insignificant colonic lesions, which would produce false-positive FOBT results. Some physicians have even called for suspension of aspirin therapy before FOBT.

But immunochemical FOBTs (iFOBTs) react to globin, which is degraded as it passes through the gastrointestinal tract. They are less likely to produce false-positives from upper GI bleeds than are the guaiac-based FOBTs that react to the heme moiety of hemoglobin, which is more stable as it passes through the digestive system.

Dr. Brenner and his colleagues assessed the relationship between aspirin therapy and iFOBT results in a large sample of adults participating in a screening colonoscopy program at 20 GI practices across southern Germany. The 1,979 study subjects (mean age, 62 years) provided stool samples before undergoing bowel preparation for colonoscopy.

A total of 233 of these subjects (12%) were taking low-dose aspirin therapy for cardiovascular prophylaxis, while the remainder had never used low-dose aspirin. The prevalence of neoplasms found on colonoscopy was similar between the two groups.

The study also found that two different iFOBTs had substantially (about 30%) higher sensitivity in detecting any neoplasm in people using aspirin therapy than in nonusers. The difference in test sensitivity was greatest in people found to have advanced malignancies, with one of the iFOBTs achieving a sensitivity of 71% among those using aspirin therapy but only a sensitivity of 36% among nonusers (P = .001).

This enhanced sensitivity was consistent across various subgroups of patients and across a broad range of cut points for test positivity. The advantages of aspirin therapy were particularly marked in men: among men taking low-dose aspirin, the sensitivity of iFOBTs was up to 46 percentage points higher than it was in men not using aspirin therapy, the investigators said (JAMA 2010;304:2513-20).

In contrast, the specificity of iFOBTs was slightly (about 5%) lower in people using aspirin therapy than in nonusers.

These findings indicate that "there is no need to stop low-dose aspirin use prior to undergoing iFOBT," Dr. Brenner and his associates said.

"On the contrary, our results may even raise the provocative suggestion of whether temporary use of low-dose aspirin might be considered to enhance performance of iFOBTs," they said.

Given their findings, temporary use of low-dose aspirin might yield a sensitivity for detecting advanced neoplasms of 60%-70% at a specificity of approximately 90% – levels of sensitivity and specificity that exceed those of other established stool tests and that "might come close to the sensitivity of sigmoidoscopy," the researchers noted.

However, it would be premature to make such a recommendation before these findings are replicated in other populations "and followed up in further research, ideally including randomized trials and different types of FOBTs," they added.

This study was somewhat limited in that despite the large sample size, there were few advanced neoplasms, resulting in broad confidence intervals around some estimates of iFOBT performance, Dr. Brenner and his colleagues said.

The study was supported in part by the German Research Foundation and the German Federal Ministry of Education and Research. The test kits were provided free of charge by the manufacturer. Dr. Brenner reported that the German Cancer Research Center has received funding from Eiken Chemical to evaluate an iFOBT that was not included in this analysis. Also, a patent application was filed at the European Patent Office for the combination of low-dose aspirin use and iFOBTs in early detection of colorectal neoplasms.

Low-dose aspirin therapy does not appear to compromise the results of immunochemical tests for fecal occult blood, as it may with other types of FOBTs, according to a report in the Dec. 8 issue of JAMA.

The sensitivity of two different immunochemical FOBTs for detecting colorectal neoplasms was actually higher among patients taking low-dose aspirin therapy than among those not taking aspirin, particularly in cases of advanced neoplasms, said Dr. Hermann Brenner and his associates in the division of clinical epidemiology and aging research, German Cancer Research Center, Heidelberg.

Concerns have been raised that low-dose aspirin therapy might cause bleeding from upper GI lesions or insignificant colonic lesions, which would produce false-positive FOBT results. Some physicians have even called for suspension of aspirin therapy before FOBT.

But immunochemical FOBTs (iFOBTs) react to globin, which is degraded as it passes through the gastrointestinal tract. They are less likely to produce false-positives from upper GI bleeds than are the guaiac-based FOBTs that react to the heme moiety of hemoglobin, which is more stable as it passes through the digestive system.

Dr. Brenner and his colleagues assessed the relationship between aspirin therapy and iFOBT results in a large sample of adults participating in a screening colonoscopy program at 20 GI practices across southern Germany. The 1,979 study subjects (mean age, 62 years) provided stool samples before undergoing bowel preparation for colonoscopy.

A total of 233 of these subjects (12%) were taking low-dose aspirin therapy for cardiovascular prophylaxis, while the remainder had never used low-dose aspirin. The prevalence of neoplasms found on colonoscopy was similar between the two groups.

The study also found that two different iFOBTs had substantially (about 30%) higher sensitivity in detecting any neoplasm in people using aspirin therapy than in nonusers. The difference in test sensitivity was greatest in people found to have advanced malignancies, with one of the iFOBTs achieving a sensitivity of 71% among those using aspirin therapy but only a sensitivity of 36% among nonusers (P = .001).

This enhanced sensitivity was consistent across various subgroups of patients and across a broad range of cut points for test positivity. The advantages of aspirin therapy were particularly marked in men: among men taking low-dose aspirin, the sensitivity of iFOBTs was up to 46 percentage points higher than it was in men not using aspirin therapy, the investigators said (JAMA 2010;304:2513-20).

In contrast, the specificity of iFOBTs was slightly (about 5%) lower in people using aspirin therapy than in nonusers.

These findings indicate that "there is no need to stop low-dose aspirin use prior to undergoing iFOBT," Dr. Brenner and his associates said.

"On the contrary, our results may even raise the provocative suggestion of whether temporary use of low-dose aspirin might be considered to enhance performance of iFOBTs," they said.

Given their findings, temporary use of low-dose aspirin might yield a sensitivity for detecting advanced neoplasms of 60%-70% at a specificity of approximately 90% – levels of sensitivity and specificity that exceed those of other established stool tests and that "might come close to the sensitivity of sigmoidoscopy," the researchers noted.

However, it would be premature to make such a recommendation before these findings are replicated in other populations "and followed up in further research, ideally including randomized trials and different types of FOBTs," they added.

This study was somewhat limited in that despite the large sample size, there were few advanced neoplasms, resulting in broad confidence intervals around some estimates of iFOBT performance, Dr. Brenner and his colleagues said.

The study was supported in part by the German Research Foundation and the German Federal Ministry of Education and Research. The test kits were provided free of charge by the manufacturer. Dr. Brenner reported that the German Cancer Research Center has received funding from Eiken Chemical to evaluate an iFOBT that was not included in this analysis. Also, a patent application was filed at the European Patent Office for the combination of low-dose aspirin use and iFOBTs in early detection of colorectal neoplasms.

The new, highly sensitive cardiac troponin T assay finds detectable levels of the biomarker in 25% of adults in the general population who would not be identified by the standard troponin T assay, and that result often correlates with cardiac structural abnormalities, according to large cohort study reported in the Dec. 8 issue of JAMA.

In addition, elevated cardiac troponin T levels identified with the highly sensitive assay also correlate with all-cause and cardiovascular mortality, independently of other risk factors and even in people thought to be at low cardiovascular risk, said Dr. James A. de Lemos of the University of Texas Southwestern Medical Center, Dallas, and his associates.

The highly sensitive assay detects levels of cardiac troponin T that are approximately one-tenth of the levels detectable with the standard assay. Dr. de Lemos and his colleagues examined the results of this assay in a general population cohort of adults aged 30-65 years participating in the Dallas Heart Study. The 3,546 subjects in this random probability sample had detailed cardiovascular profiles, including MRI and electron-beam CT imaging of the heart and aorta, and their mortality was tracked for a median of 6 years.

The prevalence of detectable cardiac troponin T by this highly sensitive assay was 25% in this multiethnic cohort that included a high proportion of blacks and women. In contrast, the standard assay found detectable levels in only 0.7%.

Higher levels of the biomarker on the highly sensitive assay were associated with cardiac structural abnormalities including left ventricular hypertrophy (both wall thickening and dilation) and left ventricular systolic dysfunction, even in subjects who were asymptomatic, had no known CVD, and were classified as low-risk by their Framingham Risk Scores.

"Moreover, higher cardiac troponin T levels demonstrate[d] a graded association with all-cause and cardiovascular mortality, independent of traditional risk factors, renal function, and levels of other biomarkers" such as high-sensitivity C-reactive protein and N-terminal prohormone brain natriuretic peptide, the investigators said (JAMA 2010;304:2503-12).

"Prior studies have described associations between increased troponin levels detected with standard assays and future risk for mortality. Here, we report that these associations extend to much lower troponin levels not detected with assays in current clinical use," they added.

More research is needed to determine whether routine use of the highly sensitive assay would aid in cardiovascular risk assessment in the general population.

In the meantime, the findings have important implications for the use of this assay for diagnosing acute MI in the hospital setting. Given that one-fourth of the general population have "elevated" troponin T on this test, false-positive diagnoses will increase. "It is possible that widespread application of highly sensitive assays without integrating new approaches to discriminate acute injury will expose some patients to unnecessary risk and expense," Dr. de Lemos and his associates noted.

The Dallas Heart Study was supported by the Donald W. Reynolds Foundation and the National Institutes of Health. Assays were provided by Roche Diagnostics. Dr. de Lemos and his associates reported ties to numerous pharmaceutical and device manufacturers.

The new, highly sensitive cardiac troponin T assay finds detectable levels of the biomarker in 25% of adults in the general population who would not be identified by the standard troponin T assay, and that result often correlates with cardiac structural abnormalities, according to large cohort study reported in the Dec. 8 issue of JAMA.

In addition, elevated cardiac troponin T levels identified with the highly sensitive assay also correlate with all-cause and cardiovascular mortality, independently of other risk factors and even in people thought to be at low cardiovascular risk, said Dr. James A. de Lemos of the University of Texas Southwestern Medical Center, Dallas, and his associates.

The highly sensitive assay detects levels of cardiac troponin T that are approximately one-tenth of the levels detectable with the standard assay. Dr. de Lemos and his colleagues examined the results of this assay in a general population cohort of adults aged 30-65 years participating in the Dallas Heart Study. The 3,546 subjects in this random probability sample had detailed cardiovascular profiles, including MRI and electron-beam CT imaging of the heart and aorta, and their mortality was tracked for a median of 6 years.

The prevalence of detectable cardiac troponin T by this highly sensitive assay was 25% in this multiethnic cohort that included a high proportion of blacks and women. In contrast, the standard assay found detectable levels in only 0.7%.

Higher levels of the biomarker on the highly sensitive assay were associated with cardiac structural abnormalities including left ventricular hypertrophy (both wall thickening and dilation) and left ventricular systolic dysfunction, even in subjects who were asymptomatic, had no known CVD, and were classified as low-risk by their Framingham Risk Scores.

"Moreover, higher cardiac troponin T levels demonstrate[d] a graded association with all-cause and cardiovascular mortality, independent of traditional risk factors, renal function, and levels of other biomarkers" such as high-sensitivity C-reactive protein and N-terminal prohormone brain natriuretic peptide, the investigators said (JAMA 2010;304:2503-12).

"Prior studies have described associations between increased troponin levels detected with standard assays and future risk for mortality. Here, we report that these associations extend to much lower troponin levels not detected with assays in current clinical use," they added.

More research is needed to determine whether routine use of the highly sensitive assay would aid in cardiovascular risk assessment in the general population.

In the meantime, the findings have important implications for the use of this assay for diagnosing acute MI in the hospital setting. Given that one-fourth of the general population have "elevated" troponin T on this test, false-positive diagnoses will increase. "It is possible that widespread application of highly sensitive assays without integrating new approaches to discriminate acute injury will expose some patients to unnecessary risk and expense," Dr. de Lemos and his associates noted.

The Dallas Heart Study was supported by the Donald W. Reynolds Foundation and the National Institutes of Health. Assays were provided by Roche Diagnostics. Dr. de Lemos and his associates reported ties to numerous pharmaceutical and device manufacturers.

The new, highly sensitive cardiac troponin T assay finds detectable levels of the biomarker in 25% of adults in the general population who would not be identified by the standard troponin T assay, and that result often correlates with cardiac structural abnormalities, according to large cohort study reported in the Dec. 8 issue of JAMA.

In addition, elevated cardiac troponin T levels identified with the highly sensitive assay also correlate with all-cause and cardiovascular mortality, independently of other risk factors and even in people thought to be at low cardiovascular risk, said Dr. James A. de Lemos of the University of Texas Southwestern Medical Center, Dallas, and his associates.

The highly sensitive assay detects levels of cardiac troponin T that are approximately one-tenth of the levels detectable with the standard assay. Dr. de Lemos and his colleagues examined the results of this assay in a general population cohort of adults aged 30-65 years participating in the Dallas Heart Study. The 3,546 subjects in this random probability sample had detailed cardiovascular profiles, including MRI and electron-beam CT imaging of the heart and aorta, and their mortality was tracked for a median of 6 years.

The prevalence of detectable cardiac troponin T by this highly sensitive assay was 25% in this multiethnic cohort that included a high proportion of blacks and women. In contrast, the standard assay found detectable levels in only 0.7%.

Higher levels of the biomarker on the highly sensitive assay were associated with cardiac structural abnormalities including left ventricular hypertrophy (both wall thickening and dilation) and left ventricular systolic dysfunction, even in subjects who were asymptomatic, had no known CVD, and were classified as low-risk by their Framingham Risk Scores.

"Moreover, higher cardiac troponin T levels demonstrate[d] a graded association with all-cause and cardiovascular mortality, independent of traditional risk factors, renal function, and levels of other biomarkers" such as high-sensitivity C-reactive protein and N-terminal prohormone brain natriuretic peptide, the investigators said (JAMA 2010;304:2503-12).

"Prior studies have described associations between increased troponin levels detected with standard assays and future risk for mortality. Here, we report that these associations extend to much lower troponin levels not detected with assays in current clinical use," they added.

More research is needed to determine whether routine use of the highly sensitive assay would aid in cardiovascular risk assessment in the general population.

In the meantime, the findings have important implications for the use of this assay for diagnosing acute MI in the hospital setting. Given that one-fourth of the general population have "elevated" troponin T on this test, false-positive diagnoses will increase. "It is possible that widespread application of highly sensitive assays without integrating new approaches to discriminate acute injury will expose some patients to unnecessary risk and expense," Dr. de Lemos and his associates noted.

The Dallas Heart Study was supported by the Donald W. Reynolds Foundation and the National Institutes of Health. Assays were provided by Roche Diagnostics. Dr. de Lemos and his associates reported ties to numerous pharmaceutical and device manufacturers.

Low-dose aspirin therapy does not appear to compromise the results of immunochemical tests for fecal occult blood, as it may with other types of FOBTs, according to a report in the Dec. 8 issue of JAMA.

The sensitivity of two different immunochemical FOBTs for detecting colorectal neoplasms was actually higher among patients taking low-dose aspirin therapy than among those not taking aspirin, particularly in cases of advanced neoplasms, said Dr. Hermann Brenner and his associates in the division of clinical epidemiology and aging research, German Cancer Research Center, Heidelberg.

Concerns have been raised that low-dose aspirin therapy might cause bleeding from upper GI lesions or insignificant colonic lesions, which would produce false-positive FOBT results. Some physicians have even called for suspension of aspirin therapy before FOBT.

But immunochemical FOBTs (iFOBTs) react to globin, which is degraded as it passes through the gastrointestinal tract. They are less likely to produce false-positives from upper GI bleeds than are the guaiac-based FOBTs that react to the heme moiety of hemoglobin, which is more stable as it passes through the digestive system.

Dr. Brenner and his colleagues assessed the relationship between aspirin therapy and iFOBT results in a large sample of adults participating in a screening colonoscopy program at 20 GI practices across southern Germany. The 1,979 study subjects (mean age, 62 years) provided stool samples before undergoing bowel preparation for colonoscopy.

A total of 233 of these subjects (12%) were taking low-dose aspirin therapy for cardiovascular prophylaxis, while the remainder had never used low-dose aspirin. The prevalence of neoplasms found on colonoscopy was similar between the two groups.

The study also found that two different iFOBTs had substantially (about 30%) higher sensitivity in detecting any neoplasm in people using aspirin therapy than in nonusers. The difference in test sensitivity was greatest in people found to have advanced malignancies, with one of the iFOBTs achieving a sensitivity of 71% among those using aspirin therapy but only a sensitivity of 36% among nonusers (P = .001).

This enhanced sensitivity was consistent across various subgroups of patients and across a broad range of cut points for test positivity. The advantages of aspirin therapy were particularly marked in men: among men taking low-dose aspirin, the sensitivity of iFOBTs was up to 46 percentage points higher than it was in men not using aspirin therapy, the investigators said (JAMA 2010;304:2513-20).

In contrast, the specificity of iFOBTs was slightly (about 5%) lower in people using aspirin therapy than in nonusers.

These findings indicate that "there is no need to stop low-dose aspirin use prior to undergoing iFOBT," Dr. Brenner and his associates said.

"On the contrary, our results may even raise the provocative suggestion of whether temporary use of low-dose aspirin might be considered to enhance performance of iFOBTs," they said.

Given their findings, temporary use of low-dose aspirin might yield a sensitivity for detecting advanced neoplasms of 60%-70% at a specificity of approximately 90% – levels of sensitivity and specificity that exceed those of other established stool tests and that "might come close to the sensitivity of sigmoidoscopy," the researchers noted.

However, it would be premature to make such a recommendation before these findings are replicated in other populations "and followed up in further research, ideally including randomized trials and different types of FOBTs," they added.

This study was somewhat limited in that despite the large sample size, there were few advanced neoplasms, resulting in broad confidence intervals around some estimates of iFOBT performance, Dr. Brenner and his colleagues said.

The study was supported in part by the German Research Foundation and the German Federal Ministry of Education and Research. The test kits were provided free of charge by the manufacturer. Dr. Brenner reported that the German Cancer Research Center has received funding from Eiken Chemical to evaluate an iFOBT that was not included in this analysis. Also, a patent application was filed at the European Patent Office for the combination of low-dose aspirin use and iFOBTs in early detection of colorectal neoplasms.

Low-dose aspirin therapy does not appear to compromise the results of immunochemical tests for fecal occult blood, as it may with other types of FOBTs, according to a report in the Dec. 8 issue of JAMA.

The sensitivity of two different immunochemical FOBTs for detecting colorectal neoplasms was actually higher among patients taking low-dose aspirin therapy than among those not taking aspirin, particularly in cases of advanced neoplasms, said Dr. Hermann Brenner and his associates in the division of clinical epidemiology and aging research, German Cancer Research Center, Heidelberg.

Concerns have been raised that low-dose aspirin therapy might cause bleeding from upper GI lesions or insignificant colonic lesions, which would produce false-positive FOBT results. Some physicians have even called for suspension of aspirin therapy before FOBT.

But immunochemical FOBTs (iFOBTs) react to globin, which is degraded as it passes through the gastrointestinal tract. They are less likely to produce false-positives from upper GI bleeds than are the guaiac-based FOBTs that react to the heme moiety of hemoglobin, which is more stable as it passes through the digestive system.

Dr. Brenner and his colleagues assessed the relationship between aspirin therapy and iFOBT results in a large sample of adults participating in a screening colonoscopy program at 20 GI practices across southern Germany. The 1,979 study subjects (mean age, 62 years) provided stool samples before undergoing bowel preparation for colonoscopy.

A total of 233 of these subjects (12%) were taking low-dose aspirin therapy for cardiovascular prophylaxis, while the remainder had never used low-dose aspirin. The prevalence of neoplasms found on colonoscopy was similar between the two groups.

The study also found that two different iFOBTs had substantially (about 30%) higher sensitivity in detecting any neoplasm in people using aspirin therapy than in nonusers. The difference in test sensitivity was greatest in people found to have advanced malignancies, with one of the iFOBTs achieving a sensitivity of 71% among those using aspirin therapy but only a sensitivity of 36% among nonusers (P = .001).

This enhanced sensitivity was consistent across various subgroups of patients and across a broad range of cut points for test positivity. The advantages of aspirin therapy were particularly marked in men: among men taking low-dose aspirin, the sensitivity of iFOBTs was up to 46 percentage points higher than it was in men not using aspirin therapy, the investigators said (JAMA 2010;304:2513-20).

In contrast, the specificity of iFOBTs was slightly (about 5%) lower in people using aspirin therapy than in nonusers.

These findings indicate that "there is no need to stop low-dose aspirin use prior to undergoing iFOBT," Dr. Brenner and his associates said.

"On the contrary, our results may even raise the provocative suggestion of whether temporary use of low-dose aspirin might be considered to enhance performance of iFOBTs," they said.

Given their findings, temporary use of low-dose aspirin might yield a sensitivity for detecting advanced neoplasms of 60%-70% at a specificity of approximately 90% – levels of sensitivity and specificity that exceed those of other established stool tests and that "might come close to the sensitivity of sigmoidoscopy," the researchers noted.

However, it would be premature to make such a recommendation before these findings are replicated in other populations "and followed up in further research, ideally including randomized trials and different types of FOBTs," they added.

This study was somewhat limited in that despite the large sample size, there were few advanced neoplasms, resulting in broad confidence intervals around some estimates of iFOBT performance, Dr. Brenner and his colleagues said.

The study was supported in part by the German Research Foundation and the German Federal Ministry of Education and Research. The test kits were provided free of charge by the manufacturer. Dr. Brenner reported that the German Cancer Research Center has received funding from Eiken Chemical to evaluate an iFOBT that was not included in this analysis. Also, a patent application was filed at the European Patent Office for the combination of low-dose aspirin use and iFOBTs in early detection of colorectal neoplasms.

Low-dose aspirin therapy does not appear to compromise the results of immunochemical tests for fecal occult blood, as it may with other types of FOBTs, according to a report in the Dec. 8 issue of JAMA.

The sensitivity of two different immunochemical FOBTs for detecting colorectal neoplasms was actually higher among patients taking low-dose aspirin therapy than among those not taking aspirin, particularly in cases of advanced neoplasms, said Dr. Hermann Brenner and his associates in the division of clinical epidemiology and aging research, German Cancer Research Center, Heidelberg.

Concerns have been raised that low-dose aspirin therapy might cause bleeding from upper GI lesions or insignificant colonic lesions, which would produce false-positive FOBT results. Some physicians have even called for suspension of aspirin therapy before FOBT.

But immunochemical FOBTs (iFOBTs) react to globin, which is degraded as it passes through the gastrointestinal tract. They are less likely to produce false-positives from upper GI bleeds than are the guaiac-based FOBTs that react to the heme moiety of hemoglobin, which is more stable as it passes through the digestive system.

Dr. Brenner and his colleagues assessed the relationship between aspirin therapy and iFOBT results in a large sample of adults participating in a screening colonoscopy program at 20 GI practices across southern Germany. The 1,979 study subjects (mean age, 62 years) provided stool samples before undergoing bowel preparation for colonoscopy.

A total of 233 of these subjects (12%) were taking low-dose aspirin therapy for cardiovascular prophylaxis, while the remainder had never used low-dose aspirin. The prevalence of neoplasms found on colonoscopy was similar between the two groups.

The study also found that two different iFOBTs had substantially (about 30%) higher sensitivity in detecting any neoplasm in people using aspirin therapy than in nonusers. The difference in test sensitivity was greatest in people found to have advanced malignancies, with one of the iFOBTs achieving a sensitivity of 71% among those using aspirin therapy but only a sensitivity of 36% among nonusers (P = .001).

This enhanced sensitivity was consistent across various subgroups of patients and across a broad range of cut points for test positivity. The advantages of aspirin therapy were particularly marked in men: among men taking low-dose aspirin, the sensitivity of iFOBTs was up to 46 percentage points higher than it was in men not using aspirin therapy, the investigators said (JAMA 2010;304:2513-20).

In contrast, the specificity of iFOBTs was slightly (about 5%) lower in people using aspirin therapy than in nonusers.

These findings indicate that "there is no need to stop low-dose aspirin use prior to undergoing iFOBT," Dr. Brenner and his associates said.

"On the contrary, our results may even raise the provocative suggestion of whether temporary use of low-dose aspirin might be considered to enhance performance of iFOBTs," they said.

Given their findings, temporary use of low-dose aspirin might yield a sensitivity for detecting advanced neoplasms of 60%-70% at a specificity of approximately 90% – levels of sensitivity and specificity that exceed those of other established stool tests and that "might come close to the sensitivity of sigmoidoscopy," the researchers noted.

However, it would be premature to make such a recommendation before these findings are replicated in other populations "and followed up in further research, ideally including randomized trials and different types of FOBTs," they added.

This study was somewhat limited in that despite the large sample size, there were few advanced neoplasms, resulting in broad confidence intervals around some estimates of iFOBT performance, Dr. Brenner and his colleagues said.

The study was supported in part by the German Research Foundation and the German Federal Ministry of Education and Research. The test kits were provided free of charge by the manufacturer. Dr. Brenner reported that the German Cancer Research Center has received funding from Eiken Chemical to evaluate an iFOBT that was not included in this analysis. Also, a patent application was filed at the European Patent Office for the combination of low-dose aspirin use and iFOBTs in early detection of colorectal neoplasms.