Robert Finn

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration and the manufacturer, referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society. And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately. The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women. The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls. The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators, disclosed that they had no conflicts of interest related to their presentation.

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration and the manufacturer, referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society. And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately. The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women. The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls. The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators, disclosed that they had no conflicts of interest related to their presentation.

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration and the manufacturer, referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society. And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately. The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women. The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls. The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators, disclosed that they had no conflicts of interest related to their presentation.

HONOLULU — Children who perceive the world in hostile ways are significantly more likely to have hypertension, according to a study of almost 900 children.

A style of interaction marked by hostility has long been known to be a risk factor for hypertension in adults, but with this study Dr. Désirée Seeyave of the University of Michigan, Ann Arbor, and her colleagues extended that observation to children as young as 9 years old.

Among 873 children, those who scored in the highest tertile of hostility were 13.5 times more likely to have a diastolic blood pressure at or above the 90th percentile than were children in the lowest tertile, after the investigators controlled for race, gender, maternal education, and body mass index z score, Dr. Seeyave reported at the annual meeting of the Pediatric Academic Societies.

The children were enrolled in the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development. When they were in the third, fourth, and fifth grades, investigators administered the Intent Attributions and Feelings of Distress Scale, Hostile Intent Instrumental Provocation Score.

This instrument assesses to what extent a child ascribes hostile intent to ambiguous situations. For example, the child is asked to imagine a scenario in which he or she lets another child play with a radio that then gets broken. The interviewer will ask why the other child broke the toy and whether he or she was trying to be mean. The child will score high on hostile attribution if he or she assumes that the other child broke the toy intentionally in an effort to be mean.

A year later, when the children were in the fourth, fifth, and sixth grades, investigators measured blood pressure by standard protocols. In the multivariate analysis, the investigators found no significant associations between high blood pressure and gender, race, or mother's education. Children whose BMIs were above average for their age were 3.8 times more likely to have diastolic blood pressure in the 90th percentile or above than were children whose BMIs were normal for their age.

These findings have implications for prevention of cardiovascular disease risk factors such as hostility and obesity beginning in childhood, the investigators wrote.

Dr. Seeyave stated that she had no conflicts of interest related to her presentation.

HONOLULU — Children who perceive the world in hostile ways are significantly more likely to have hypertension, according to a study of almost 900 children.

A style of interaction marked by hostility has long been known to be a risk factor for hypertension in adults, but with this study Dr. Désirée Seeyave of the University of Michigan, Ann Arbor, and her colleagues extended that observation to children as young as 9 years old.

Among 873 children, those who scored in the highest tertile of hostility were 13.5 times more likely to have a diastolic blood pressure at or above the 90th percentile than were children in the lowest tertile, after the investigators controlled for race, gender, maternal education, and body mass index z score, Dr. Seeyave reported at the annual meeting of the Pediatric Academic Societies.

The children were enrolled in the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development. When they were in the third, fourth, and fifth grades, investigators administered the Intent Attributions and Feelings of Distress Scale, Hostile Intent Instrumental Provocation Score.

This instrument assesses to what extent a child ascribes hostile intent to ambiguous situations. For example, the child is asked to imagine a scenario in which he or she lets another child play with a radio that then gets broken. The interviewer will ask why the other child broke the toy and whether he or she was trying to be mean. The child will score high on hostile attribution if he or she assumes that the other child broke the toy intentionally in an effort to be mean.

A year later, when the children were in the fourth, fifth, and sixth grades, investigators measured blood pressure by standard protocols. In the multivariate analysis, the investigators found no significant associations between high blood pressure and gender, race, or mother's education. Children whose BMIs were above average for their age were 3.8 times more likely to have diastolic blood pressure in the 90th percentile or above than were children whose BMIs were normal for their age.

These findings have implications for prevention of cardiovascular disease risk factors such as hostility and obesity beginning in childhood, the investigators wrote.

Dr. Seeyave stated that she had no conflicts of interest related to her presentation.

HONOLULU — Children who perceive the world in hostile ways are significantly more likely to have hypertension, according to a study of almost 900 children.

A style of interaction marked by hostility has long been known to be a risk factor for hypertension in adults, but with this study Dr. Désirée Seeyave of the University of Michigan, Ann Arbor, and her colleagues extended that observation to children as young as 9 years old.

Among 873 children, those who scored in the highest tertile of hostility were 13.5 times more likely to have a diastolic blood pressure at or above the 90th percentile than were children in the lowest tertile, after the investigators controlled for race, gender, maternal education, and body mass index z score, Dr. Seeyave reported at the annual meeting of the Pediatric Academic Societies.

The children were enrolled in the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development. When they were in the third, fourth, and fifth grades, investigators administered the Intent Attributions and Feelings of Distress Scale, Hostile Intent Instrumental Provocation Score.

This instrument assesses to what extent a child ascribes hostile intent to ambiguous situations. For example, the child is asked to imagine a scenario in which he or she lets another child play with a radio that then gets broken. The interviewer will ask why the other child broke the toy and whether he or she was trying to be mean. The child will score high on hostile attribution if he or she assumes that the other child broke the toy intentionally in an effort to be mean.

A year later, when the children were in the fourth, fifth, and sixth grades, investigators measured blood pressure by standard protocols. In the multivariate analysis, the investigators found no significant associations between high blood pressure and gender, race, or mother's education. Children whose BMIs were above average for their age were 3.8 times more likely to have diastolic blood pressure in the 90th percentile or above than were children whose BMIs were normal for their age.

These findings have implications for prevention of cardiovascular disease risk factors such as hostility and obesity beginning in childhood, the investigators wrote.

Dr. Seeyave stated that she had no conflicts of interest related to her presentation.

BEVERLY HILLS, CALIF. — The jury may still be out on whether probiotics are beneficial, but at least they do no harm and can be safely recommended to patients, right? Not so, said Dr. David R. Mack at the International Probiotics Association World Congress. Several recent studies have uncovered some risks associated with probiotic use, in both children and adults. “We [physicians] are always looking for new things, but we're a conservative, skeptical lot, and safety is a primary concern.”

One of the most concerning studies is also one of the newest, noted Dr. Mack of the University of Ottawa (Ont.). Investigators randomized 298 patients with predicted acute pancreatitis to receive probiotic prophylaxis or placebo. The probiotic preparation consisted of six live bacterial species: Lactobacillus acidophilus, L. casei, L. salivarius, Lactococcus lactis, Bifidobacterium bifidum, and B. lactis.

Not only did the probiotic preparation fail to reduce the risk of infectious complications, but the mortality rate was 2.5 times higher among the patients receiving probiotics than among those receiving placebo. Twenty-four (16%) of the patients in the probiotics group died, compared with nine (6%) in the placebo group.

Furthermore, nine of the patients in the probiotics group developed bowel ischemia (eight with fatal outcomes), compared with none in the placebo group. The other deaths involved multiorgan failure (Lancet 2008;371:651-9).

According to some studies, probiotics are associated with increased asthma and wheezing in children. In one study, for example, children exposed to L. rhamnosus GG at birth had 3.4 times the risk of having asthma at age 7 years as a control group had (J. Allergy Clin. Immunol. 2007;119:1019-21). In another study involving the use of L. rhamnosus GG to prevent atopic dermatitis, 26% of the children in the probiotic group versus 9% in the control group developed wheezing bronchitis (Pediatrics 2008;121:e850-6 [Epub doi:10.1542/peds.2007-1492

And there is further evidence of possible allergic complications following probiotic use. One study in France demonstrated that two out of three common probiotic preparations contained cow's milk proteins (J. Allergy Clin. Immunol. 2007;119:746-7), and a separate case report described a child who developed anaphylaxis after taking a probiotic containing cow's milk proteins (Allergy 2006;61:507-8). Beyond these known adverse reactions, there are other reasons to be concerned about the possible long-term effects of probiotics in young children. When adults take probiotics, it's rare to see extended colonization by the probiotic bacterial species, but outcomes appear to be different in young children: Some probiotic species have been detected in stool samples years later.

BEVERLY HILLS, CALIF. — The jury may still be out on whether probiotics are beneficial, but at least they do no harm and can be safely recommended to patients, right? Not so, said Dr. David R. Mack at the International Probiotics Association World Congress. Several recent studies have uncovered some risks associated with probiotic use, in both children and adults. “We [physicians] are always looking for new things, but we're a conservative, skeptical lot, and safety is a primary concern.”

One of the most concerning studies is also one of the newest, noted Dr. Mack of the University of Ottawa (Ont.). Investigators randomized 298 patients with predicted acute pancreatitis to receive probiotic prophylaxis or placebo. The probiotic preparation consisted of six live bacterial species: Lactobacillus acidophilus, L. casei, L. salivarius, Lactococcus lactis, Bifidobacterium bifidum, and B. lactis.

Not only did the probiotic preparation fail to reduce the risk of infectious complications, but the mortality rate was 2.5 times higher among the patients receiving probiotics than among those receiving placebo. Twenty-four (16%) of the patients in the probiotics group died, compared with nine (6%) in the placebo group.

Furthermore, nine of the patients in the probiotics group developed bowel ischemia (eight with fatal outcomes), compared with none in the placebo group. The other deaths involved multiorgan failure (Lancet 2008;371:651-9).

According to some studies, probiotics are associated with increased asthma and wheezing in children. In one study, for example, children exposed to L. rhamnosus GG at birth had 3.4 times the risk of having asthma at age 7 years as a control group had (J. Allergy Clin. Immunol. 2007;119:1019-21). In another study involving the use of L. rhamnosus GG to prevent atopic dermatitis, 26% of the children in the probiotic group versus 9% in the control group developed wheezing bronchitis (Pediatrics 2008;121:e850-6 [Epub doi:10.1542/peds.2007-1492

And there is further evidence of possible allergic complications following probiotic use. One study in France demonstrated that two out of three common probiotic preparations contained cow's milk proteins (J. Allergy Clin. Immunol. 2007;119:746-7), and a separate case report described a child who developed anaphylaxis after taking a probiotic containing cow's milk proteins (Allergy 2006;61:507-8). Beyond these known adverse reactions, there are other reasons to be concerned about the possible long-term effects of probiotics in young children. When adults take probiotics, it's rare to see extended colonization by the probiotic bacterial species, but outcomes appear to be different in young children: Some probiotic species have been detected in stool samples years later.

BEVERLY HILLS, CALIF. — The jury may still be out on whether probiotics are beneficial, but at least they do no harm and can be safely recommended to patients, right? Not so, said Dr. David R. Mack at the International Probiotics Association World Congress. Several recent studies have uncovered some risks associated with probiotic use, in both children and adults. “We [physicians] are always looking for new things, but we're a conservative, skeptical lot, and safety is a primary concern.”

One of the most concerning studies is also one of the newest, noted Dr. Mack of the University of Ottawa (Ont.). Investigators randomized 298 patients with predicted acute pancreatitis to receive probiotic prophylaxis or placebo. The probiotic preparation consisted of six live bacterial species: Lactobacillus acidophilus, L. casei, L. salivarius, Lactococcus lactis, Bifidobacterium bifidum, and B. lactis.

Not only did the probiotic preparation fail to reduce the risk of infectious complications, but the mortality rate was 2.5 times higher among the patients receiving probiotics than among those receiving placebo. Twenty-four (16%) of the patients in the probiotics group died, compared with nine (6%) in the placebo group.

Furthermore, nine of the patients in the probiotics group developed bowel ischemia (eight with fatal outcomes), compared with none in the placebo group. The other deaths involved multiorgan failure (Lancet 2008;371:651-9).

According to some studies, probiotics are associated with increased asthma and wheezing in children. In one study, for example, children exposed to L. rhamnosus GG at birth had 3.4 times the risk of having asthma at age 7 years as a control group had (J. Allergy Clin. Immunol. 2007;119:1019-21). In another study involving the use of L. rhamnosus GG to prevent atopic dermatitis, 26% of the children in the probiotic group versus 9% in the control group developed wheezing bronchitis (Pediatrics 2008;121:e850-6 [Epub doi:10.1542/peds.2007-1492

And there is further evidence of possible allergic complications following probiotic use. One study in France demonstrated that two out of three common probiotic preparations contained cow's milk proteins (J. Allergy Clin. Immunol. 2007;119:746-7), and a separate case report described a child who developed anaphylaxis after taking a probiotic containing cow's milk proteins (Allergy 2006;61:507-8). Beyond these known adverse reactions, there are other reasons to be concerned about the possible long-term effects of probiotics in young children. When adults take probiotics, it's rare to see extended colonization by the probiotic bacterial species, but outcomes appear to be different in young children: Some probiotic species have been detected in stool samples years later.

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as between 1 month prior to pregnancy and the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use. Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

Dr. Lin disclosed no conflicts of interest associated with the study.

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as between 1 month prior to pregnancy and the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use. Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

Dr. Lin disclosed no conflicts of interest associated with the study.

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as between 1 month prior to pregnancy and the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use. Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

Dr. Lin disclosed no conflicts of interest associated with the study.

SAN FRANCISCO — Only about 40% of patients who were newly prescribed oral antidiabetes drugs received a fasting plasma glucose test, according to findings in a recent study.

In addition, only about half of patients received any hemoglobin A1c monitoring during the period beginning 90 days before the drug regimen started and lasting through the regimen's full course. And of the 50% whose HbA1c was monitored, 39% showed evidence of inadequate glycemic control, reported Shanthy Krishnarajah of Bristol-Myers Squibb at the annual scientific sessions of the American Diabetes Association.

The study population was derived from the Integrated Health Care Information Services National Managed Care Benchmark Database, a compilation of data from 40 million people enrolled in health plans in the United States.

Ms. Krishnarajah and her colleagues identified 53,772 patients, aged 18 years and older, with type 2 diabetes who received their first prescription for an oral antidiabetes drug between 2000 and 2006. Patients with any prior experience with oral antidiabetes drugs and those who weren't continuously enrolled in their health plans during treatment were excluded.

The patients were followed beginning 90 days before their initial prescription through any change in that initial drug regimen, which took place about 1 year after starting therapy.

ADA guidelines state that patients with type 2 diabetes have their glycemic control monitored at least twice a year, and as often as four times yearly if their glucose levels are not well controlled. Despite that, about 50% of the patients in this cohort did not have their HbA1c measured even once. “Fewer than 3% are getting their A1c tested [at the quarterly visit],” she said.

In patients whose glycemic control was measured, the average declines in HbA1c ranged from 0.91% for patients on sulfonylureas to 1.69% for those on thiazolidinediones. In those who had HbA1c levels recorded, however, 39% never demonstrated glycemic control during the oral antidiabetes drug regimen.

In a multivariate logistic regression analysis that controlled for all relevant variables, the only factors independently associated with a greater likelihood of HbA1c testing were female gender, membership in a point-of-service health plan, and total health care utilization. A lower likelihood of HbA1c testing was associated with Medicaid or Medicare patients and those aged 65 years or older.

Ms. Krishnarajah acknowledged the data set didn't capture self-monitoring of blood glucose or tests done in practices and that some newer classes were excluded.

SAN FRANCISCO — Only about 40% of patients who were newly prescribed oral antidiabetes drugs received a fasting plasma glucose test, according to findings in a recent study.

In addition, only about half of patients received any hemoglobin A1c monitoring during the period beginning 90 days before the drug regimen started and lasting through the regimen's full course. And of the 50% whose HbA1c was monitored, 39% showed evidence of inadequate glycemic control, reported Shanthy Krishnarajah of Bristol-Myers Squibb at the annual scientific sessions of the American Diabetes Association.

The study population was derived from the Integrated Health Care Information Services National Managed Care Benchmark Database, a compilation of data from 40 million people enrolled in health plans in the United States.

Ms. Krishnarajah and her colleagues identified 53,772 patients, aged 18 years and older, with type 2 diabetes who received their first prescription for an oral antidiabetes drug between 2000 and 2006. Patients with any prior experience with oral antidiabetes drugs and those who weren't continuously enrolled in their health plans during treatment were excluded.

The patients were followed beginning 90 days before their initial prescription through any change in that initial drug regimen, which took place about 1 year after starting therapy.

ADA guidelines state that patients with type 2 diabetes have their glycemic control monitored at least twice a year, and as often as four times yearly if their glucose levels are not well controlled. Despite that, about 50% of the patients in this cohort did not have their HbA1c measured even once. “Fewer than 3% are getting their A1c tested [at the quarterly visit],” she said.

In patients whose glycemic control was measured, the average declines in HbA1c ranged from 0.91% for patients on sulfonylureas to 1.69% for those on thiazolidinediones. In those who had HbA1c levels recorded, however, 39% never demonstrated glycemic control during the oral antidiabetes drug regimen.

In a multivariate logistic regression analysis that controlled for all relevant variables, the only factors independently associated with a greater likelihood of HbA1c testing were female gender, membership in a point-of-service health plan, and total health care utilization. A lower likelihood of HbA1c testing was associated with Medicaid or Medicare patients and those aged 65 years or older.

Ms. Krishnarajah acknowledged the data set didn't capture self-monitoring of blood glucose or tests done in practices and that some newer classes were excluded.

SAN FRANCISCO — Only about 40% of patients who were newly prescribed oral antidiabetes drugs received a fasting plasma glucose test, according to findings in a recent study.

In addition, only about half of patients received any hemoglobin A1c monitoring during the period beginning 90 days before the drug regimen started and lasting through the regimen's full course. And of the 50% whose HbA1c was monitored, 39% showed evidence of inadequate glycemic control, reported Shanthy Krishnarajah of Bristol-Myers Squibb at the annual scientific sessions of the American Diabetes Association.

The study population was derived from the Integrated Health Care Information Services National Managed Care Benchmark Database, a compilation of data from 40 million people enrolled in health plans in the United States.

Ms. Krishnarajah and her colleagues identified 53,772 patients, aged 18 years and older, with type 2 diabetes who received their first prescription for an oral antidiabetes drug between 2000 and 2006. Patients with any prior experience with oral antidiabetes drugs and those who weren't continuously enrolled in their health plans during treatment were excluded.

The patients were followed beginning 90 days before their initial prescription through any change in that initial drug regimen, which took place about 1 year after starting therapy.

ADA guidelines state that patients with type 2 diabetes have their glycemic control monitored at least twice a year, and as often as four times yearly if their glucose levels are not well controlled. Despite that, about 50% of the patients in this cohort did not have their HbA1c measured even once. “Fewer than 3% are getting their A1c tested [at the quarterly visit],” she said.

In patients whose glycemic control was measured, the average declines in HbA1c ranged from 0.91% for patients on sulfonylureas to 1.69% for those on thiazolidinediones. In those who had HbA1c levels recorded, however, 39% never demonstrated glycemic control during the oral antidiabetes drug regimen.

In a multivariate logistic regression analysis that controlled for all relevant variables, the only factors independently associated with a greater likelihood of HbA1c testing were female gender, membership in a point-of-service health plan, and total health care utilization. A lower likelihood of HbA1c testing was associated with Medicaid or Medicare patients and those aged 65 years or older.

Ms. Krishnarajah acknowledged the data set didn't capture self-monitoring of blood glucose or tests done in practices and that some newer classes were excluded.

SAN FRANCISCO — All statins may not be created equal as far as diabetes patients are concerned, according to a recent study.

In patients with diabetes initiating statin therapy for the first time, those who took atorvastatin experienced 12% fewer cardiovascular events than those who took simvastatin, said Joshua Benner, Pharm.D., Sc.D., of IMS Health Care, Falls Church, Va. He spoke at the annual scientific sessions of the American Diabetes Association in place of the study's first author, Dr. Joanne M. Foody of Harvard Medical School, Boston.

The observational, comparative-effectiveness study used a large managed-care database including patient information from 92 health care plans in the United States, In all, the investigators identified 12,304 patients with diabetes initiating statin therapy with simvastatin and 33,772 initiating statin therapy with atorvastatin.

The researchers included only adult patients who were continuously enrolled in their health plan for 1 year prior to their first statin prescription and for at least 30 days after. Patients had to be taking either 10 mg or 20 mg of atorvastatin or 20 mg or 40 mg of simvastatin. The simvastatin group was followed for a mean of 591 days, and the atorvastatin group was followed for a mean of 556 days.

Among patients taking atorvastatin, the unadjusted rate of cardiovascular events requiring hospitalization was 3.35 per 100 person-years, significantly lower than the rate for simvastatin, which was 4.45 per 100 person-years.

After adjustment for age, gender, type of health plan, payer type, geographic region, calendar year of statin initiation, physician specialty, comorbidities, concomitant therapies, and prior health care cost, the hazard ratio for atorvastatin was 0.88 relative to simvastatin, indicating a 12% reduction in cardiovascular risk.

Atorvastatin and simvastatin were the two most commonly prescribed statins in the United States during the study period, which ran from January 2003 to September 2005, said Dr. Benner. “The comparison between these two statins is especially important given the recent trends in their utilization, where simvastatin recently became generic and is now preferred by many payers in the United States.”

Patients taking atorvastatin persisted with that prescription for a mean of 219 days, significantly longer than the 153 days for the patients taking simvastatin. Although the investigators did not compile data on adverse events, Dr. Benner said that this difference in persistence times suggests that there were fewer dose-limiting or a treatment-limiting side effects among those taking atorvastatin.

Future studies are needed to determine whether differences in “persistence, achieved LDL levels, or other factors may have contributed to the improved outcomes in diabetes patients taking atorvastatin,” he said.

The researchers have not yet concluded that atorvastatin's greater efficacy justifies its higher cost. “That's where a number of analyses are headed, because this raises the important policy question of what is the clinical and economic value of a marginal increase in effectiveness.”

Dr. Benner said the IMS Health Group conducts research and consulting projects supported by manufacturers of numerous lipid-lowering drugs.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — All statins may not be created equal as far as diabetes patients are concerned, according to a recent study.

In patients with diabetes initiating statin therapy for the first time, those who took atorvastatin experienced 12% fewer cardiovascular events than those who took simvastatin, said Joshua Benner, Pharm.D., Sc.D., of IMS Health Care, Falls Church, Va. He spoke at the annual scientific sessions of the American Diabetes Association in place of the study's first author, Dr. Joanne M. Foody of Harvard Medical School, Boston.

The observational, comparative-effectiveness study used a large managed-care database including patient information from 92 health care plans in the United States, In all, the investigators identified 12,304 patients with diabetes initiating statin therapy with simvastatin and 33,772 initiating statin therapy with atorvastatin.

The researchers included only adult patients who were continuously enrolled in their health plan for 1 year prior to their first statin prescription and for at least 30 days after. Patients had to be taking either 10 mg or 20 mg of atorvastatin or 20 mg or 40 mg of simvastatin. The simvastatin group was followed for a mean of 591 days, and the atorvastatin group was followed for a mean of 556 days.

Among patients taking atorvastatin, the unadjusted rate of cardiovascular events requiring hospitalization was 3.35 per 100 person-years, significantly lower than the rate for simvastatin, which was 4.45 per 100 person-years.

After adjustment for age, gender, type of health plan, payer type, geographic region, calendar year of statin initiation, physician specialty, comorbidities, concomitant therapies, and prior health care cost, the hazard ratio for atorvastatin was 0.88 relative to simvastatin, indicating a 12% reduction in cardiovascular risk.

Atorvastatin and simvastatin were the two most commonly prescribed statins in the United States during the study period, which ran from January 2003 to September 2005, said Dr. Benner. “The comparison between these two statins is especially important given the recent trends in their utilization, where simvastatin recently became generic and is now preferred by many payers in the United States.”

Patients taking atorvastatin persisted with that prescription for a mean of 219 days, significantly longer than the 153 days for the patients taking simvastatin. Although the investigators did not compile data on adverse events, Dr. Benner said that this difference in persistence times suggests that there were fewer dose-limiting or a treatment-limiting side effects among those taking atorvastatin.

Future studies are needed to determine whether differences in “persistence, achieved LDL levels, or other factors may have contributed to the improved outcomes in diabetes patients taking atorvastatin,” he said.

The researchers have not yet concluded that atorvastatin's greater efficacy justifies its higher cost. “That's where a number of analyses are headed, because this raises the important policy question of what is the clinical and economic value of a marginal increase in effectiveness.”

Dr. Benner said the IMS Health Group conducts research and consulting projects supported by manufacturers of numerous lipid-lowering drugs.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — All statins may not be created equal as far as diabetes patients are concerned, according to a recent study.

In patients with diabetes initiating statin therapy for the first time, those who took atorvastatin experienced 12% fewer cardiovascular events than those who took simvastatin, said Joshua Benner, Pharm.D., Sc.D., of IMS Health Care, Falls Church, Va. He spoke at the annual scientific sessions of the American Diabetes Association in place of the study's first author, Dr. Joanne M. Foody of Harvard Medical School, Boston.

The observational, comparative-effectiveness study used a large managed-care database including patient information from 92 health care plans in the United States, In all, the investigators identified 12,304 patients with diabetes initiating statin therapy with simvastatin and 33,772 initiating statin therapy with atorvastatin.

The researchers included only adult patients who were continuously enrolled in their health plan for 1 year prior to their first statin prescription and for at least 30 days after. Patients had to be taking either 10 mg or 20 mg of atorvastatin or 20 mg or 40 mg of simvastatin. The simvastatin group was followed for a mean of 591 days, and the atorvastatin group was followed for a mean of 556 days.

Among patients taking atorvastatin, the unadjusted rate of cardiovascular events requiring hospitalization was 3.35 per 100 person-years, significantly lower than the rate for simvastatin, which was 4.45 per 100 person-years.

After adjustment for age, gender, type of health plan, payer type, geographic region, calendar year of statin initiation, physician specialty, comorbidities, concomitant therapies, and prior health care cost, the hazard ratio for atorvastatin was 0.88 relative to simvastatin, indicating a 12% reduction in cardiovascular risk.

Atorvastatin and simvastatin were the two most commonly prescribed statins in the United States during the study period, which ran from January 2003 to September 2005, said Dr. Benner. “The comparison between these two statins is especially important given the recent trends in their utilization, where simvastatin recently became generic and is now preferred by many payers in the United States.”

Patients taking atorvastatin persisted with that prescription for a mean of 219 days, significantly longer than the 153 days for the patients taking simvastatin. Although the investigators did not compile data on adverse events, Dr. Benner said that this difference in persistence times suggests that there were fewer dose-limiting or a treatment-limiting side effects among those taking atorvastatin.

Future studies are needed to determine whether differences in “persistence, achieved LDL levels, or other factors may have contributed to the improved outcomes in diabetes patients taking atorvastatin,” he said.

The researchers have not yet concluded that atorvastatin's greater efficacy justifies its higher cost. “That's where a number of analyses are headed, because this raises the important policy question of what is the clinical and economic value of a marginal increase in effectiveness.”

Dr. Benner said the IMS Health Group conducts research and consulting projects supported by manufacturers of numerous lipid-lowering drugs.

ELSEVIER GLOBAL MEDICAL NEWS

SAN DIEGO — Interim results from a randomized, controlled trial suggest that radiofrequency ablation is more effective than frequent surveillance for Barrett's esophagus.

The study compared 84 patients who underwent ablation with 43 who underwent a sham operation. All of the patients received high-dose acid suppression (40 mg esomeprazole twice daily). The ablation patients with high-grade dysplasia underwent endoscopic biopsies at 3, 6, 9, and 12 months, whereas those with low-grade dysplasia underwent endoscopic biopsies at 6 and 12 months, Dr. Nicholas Shaheen said at the annual Digestive Disease Week.

At the end of that time, 80% of the ablation patients with high-grade dysplasia and 90% of those with low-grade dysplasia experienced a complete response, defined as having all biopsies free of any histologic evidence of dysplasia, said Dr. Shaheen of the University of North Carolina, Chapel Hill.

In contrast, 26% of the control patients experienced a complete response. The difference between the ablation and control patients was statistically significant in the intent-to-treat analysis.

Of the patients who underwent ablation, 77% experienced a complete response for intestinal metaplasia, compared with none of the control patients. This difference also was statistically significant.

There was also a significant difference in the rate of histologic progression from low-grade dysplasia to high-grade dysplasia, and from high-grade dysplasia to cancer. Of those receiving a sham operation, 19% experienced progression of the disease, compared with 5% of the ablated patients.

Adverse events were relatively minor. Of the ablated patients, 6% experienced strictures, but all resolved after a mean of two dilations. There were three serious adverse events in the ablated patients and none in those who received a sham operation. One patient experienced an upper GI bleed, and two others experienced chest pain and were admitted overnight for observation.

“Patients often do have chest pain after the procedure,” Dr. Shaheen said in an interview. “This pain is usually mild to moderate, and was managed successfully in 295 of the 297 procedures performed in the trial with oral pain medications or no medications. Two patients had to be admitted for chest pain.”

The study, which is ongoing, is being conducted at 19 medical centers in the United States. It was funded by BÂRRX Medical Inc., which manufactures the radiofrequency ablation system used in the study. Dr. Shaheen said she received “other financial benefits” from that company, as well as consulting fees, speaking fees, research support, and/or other financial benefits from AstraZeneca Pharmaceuticals LP, TAP Pharmaceutical Products Inc., Procter & Gamble Co., Eisai Co., Merck & Co., and Ethicon Endo-Surgery Inc.

Endoscopic view of a Barrett's esophagus patient after radiofrequency ablation. Courtesy Dr. Nicholas Shaheen

SAN DIEGO — Interim results from a randomized, controlled trial suggest that radiofrequency ablation is more effective than frequent surveillance for Barrett's esophagus.

The study compared 84 patients who underwent ablation with 43 who underwent a sham operation. All of the patients received high-dose acid suppression (40 mg esomeprazole twice daily). The ablation patients with high-grade dysplasia underwent endoscopic biopsies at 3, 6, 9, and 12 months, whereas those with low-grade dysplasia underwent endoscopic biopsies at 6 and 12 months, Dr. Nicholas Shaheen said at the annual Digestive Disease Week.

At the end of that time, 80% of the ablation patients with high-grade dysplasia and 90% of those with low-grade dysplasia experienced a complete response, defined as having all biopsies free of any histologic evidence of dysplasia, said Dr. Shaheen of the University of North Carolina, Chapel Hill.

In contrast, 26% of the control patients experienced a complete response. The difference between the ablation and control patients was statistically significant in the intent-to-treat analysis.

Of the patients who underwent ablation, 77% experienced a complete response for intestinal metaplasia, compared with none of the control patients. This difference also was statistically significant.

There was also a significant difference in the rate of histologic progression from low-grade dysplasia to high-grade dysplasia, and from high-grade dysplasia to cancer. Of those receiving a sham operation, 19% experienced progression of the disease, compared with 5% of the ablated patients.

Adverse events were relatively minor. Of the ablated patients, 6% experienced strictures, but all resolved after a mean of two dilations. There were three serious adverse events in the ablated patients and none in those who received a sham operation. One patient experienced an upper GI bleed, and two others experienced chest pain and were admitted overnight for observation.

“Patients often do have chest pain after the procedure,” Dr. Shaheen said in an interview. “This pain is usually mild to moderate, and was managed successfully in 295 of the 297 procedures performed in the trial with oral pain medications or no medications. Two patients had to be admitted for chest pain.”

The study, which is ongoing, is being conducted at 19 medical centers in the United States. It was funded by BÂRRX Medical Inc., which manufactures the radiofrequency ablation system used in the study. Dr. Shaheen said she received “other financial benefits” from that company, as well as consulting fees, speaking fees, research support, and/or other financial benefits from AstraZeneca Pharmaceuticals LP, TAP Pharmaceutical Products Inc., Procter & Gamble Co., Eisai Co., Merck & Co., and Ethicon Endo-Surgery Inc.

Endoscopic view of a Barrett's esophagus patient after radiofrequency ablation. Courtesy Dr. Nicholas Shaheen

SAN DIEGO — Interim results from a randomized, controlled trial suggest that radiofrequency ablation is more effective than frequent surveillance for Barrett's esophagus.

The study compared 84 patients who underwent ablation with 43 who underwent a sham operation. All of the patients received high-dose acid suppression (40 mg esomeprazole twice daily). The ablation patients with high-grade dysplasia underwent endoscopic biopsies at 3, 6, 9, and 12 months, whereas those with low-grade dysplasia underwent endoscopic biopsies at 6 and 12 months, Dr. Nicholas Shaheen said at the annual Digestive Disease Week.

At the end of that time, 80% of the ablation patients with high-grade dysplasia and 90% of those with low-grade dysplasia experienced a complete response, defined as having all biopsies free of any histologic evidence of dysplasia, said Dr. Shaheen of the University of North Carolina, Chapel Hill.

In contrast, 26% of the control patients experienced a complete response. The difference between the ablation and control patients was statistically significant in the intent-to-treat analysis.

Of the patients who underwent ablation, 77% experienced a complete response for intestinal metaplasia, compared with none of the control patients. This difference also was statistically significant.

There was also a significant difference in the rate of histologic progression from low-grade dysplasia to high-grade dysplasia, and from high-grade dysplasia to cancer. Of those receiving a sham operation, 19% experienced progression of the disease, compared with 5% of the ablated patients.

Adverse events were relatively minor. Of the ablated patients, 6% experienced strictures, but all resolved after a mean of two dilations. There were three serious adverse events in the ablated patients and none in those who received a sham operation. One patient experienced an upper GI bleed, and two others experienced chest pain and were admitted overnight for observation.

“Patients often do have chest pain after the procedure,” Dr. Shaheen said in an interview. “This pain is usually mild to moderate, and was managed successfully in 295 of the 297 procedures performed in the trial with oral pain medications or no medications. Two patients had to be admitted for chest pain.”

The study, which is ongoing, is being conducted at 19 medical centers in the United States. It was funded by BÂRRX Medical Inc., which manufactures the radiofrequency ablation system used in the study. Dr. Shaheen said she received “other financial benefits” from that company, as well as consulting fees, speaking fees, research support, and/or other financial benefits from AstraZeneca Pharmaceuticals LP, TAP Pharmaceutical Products Inc., Procter & Gamble Co., Eisai Co., Merck & Co., and Ethicon Endo-Surgery Inc.

Endoscopic view of a Barrett's esophagus patient after radiofrequency ablation. Courtesy Dr. Nicholas Shaheen

HONOLULU — Consider influenza testing in children hospitalized for asthma because children with both conditions have almost five times the chance of intubation or death, compared with asthmatic children without a comorbid condition, according to a poster at the annual meeting of the Pediatric Academic Societies.

Dr. Alan S. Weller and Dr. Kitaw Demissie of the Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed a nationally representative sample of 641,354 children, aged 2–17 years, who were included in the National Hospital Discharge Survey for 2001–2005. All were hospitalized primarily for asthma.

Of the 2,505 children with influenza in that group, 2% experienced an adverse outcome (intubation or death) with an adjusted odds ratio of 4.79 in the multivariate analysis, which corrected for age, race, gender, insurance, region, and comorbid conditions.

Influenza was the only comorbid condition that predicted adverse outcome. Children with sinusitis had a 63% lower chance of an adverse outcome, and those with upper respiratory infections had an 88% lower chance of an adverse outcome.

The investigators concluded that further studies would be required to characterize the role of these predictors and to formulate appropriate interventions for those in high-risk groups.

Dr. Weller disclosed no conflicts of interest related to this study.

HONOLULU — Consider influenza testing in children hospitalized for asthma because children with both conditions have almost five times the chance of intubation or death, compared with asthmatic children without a comorbid condition, according to a poster at the annual meeting of the Pediatric Academic Societies.

Dr. Alan S. Weller and Dr. Kitaw Demissie of the Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed a nationally representative sample of 641,354 children, aged 2–17 years, who were included in the National Hospital Discharge Survey for 2001–2005. All were hospitalized primarily for asthma.

Of the 2,505 children with influenza in that group, 2% experienced an adverse outcome (intubation or death) with an adjusted odds ratio of 4.79 in the multivariate analysis, which corrected for age, race, gender, insurance, region, and comorbid conditions.

Influenza was the only comorbid condition that predicted adverse outcome. Children with sinusitis had a 63% lower chance of an adverse outcome, and those with upper respiratory infections had an 88% lower chance of an adverse outcome.

The investigators concluded that further studies would be required to characterize the role of these predictors and to formulate appropriate interventions for those in high-risk groups.

Dr. Weller disclosed no conflicts of interest related to this study.

HONOLULU — Consider influenza testing in children hospitalized for asthma because children with both conditions have almost five times the chance of intubation or death, compared with asthmatic children without a comorbid condition, according to a poster at the annual meeting of the Pediatric Academic Societies.

Dr. Alan S. Weller and Dr. Kitaw Demissie of the Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed a nationally representative sample of 641,354 children, aged 2–17 years, who were included in the National Hospital Discharge Survey for 2001–2005. All were hospitalized primarily for asthma.

Of the 2,505 children with influenza in that group, 2% experienced an adverse outcome (intubation or death) with an adjusted odds ratio of 4.79 in the multivariate analysis, which corrected for age, race, gender, insurance, region, and comorbid conditions.

Influenza was the only comorbid condition that predicted adverse outcome. Children with sinusitis had a 63% lower chance of an adverse outcome, and those with upper respiratory infections had an 88% lower chance of an adverse outcome.

The investigators concluded that further studies would be required to characterize the role of these predictors and to formulate appropriate interventions for those in high-risk groups.

Dr. Weller disclosed no conflicts of interest related to this study.

SAN FRANCISCO — A population-based screening program for type 2 diabetes does not decrease all-cause, cardiovascular, or cancer-related mortality over a 5-year period, according to a large randomized controlled trial presented at the annual scientific sessions of the American Diabetes Association.

Moreover, screened patients offered intensive diabetes treatment did no better in terms of mortality than did screened patients offered routine diabetes treatment, said Dr. Justin Basile Echouffo-Tcheugui of the University of Cambridge (England).

The results call into question the value of large-scale screening for type 2 diabetes and of intensive diabetes management. And they conflict with mathematical models that predicted such screening would result in a 26%–40% reduction in diabetes-specific mortality, he said.

The 79,085 people who participated in the study were patients at 32 primary care practices in England. Using data from medical records, researchers calculated patients' Cambridge Risk Score (CRS), which reflects an individual's risk of developing diabetes. Of the original cohort, 19,881 people with CRS scores above 0.17 were included in the study. According to an earlier study, using a CRS score of 0.17 as a cut-off point results in a 70% sensitivity and a 64% specificity in identifying patients at high risk of type 2 diabetes (Diabetes Care 2002;25:984-8).

In five of the practices, having a total of 4,137 high-risk patients, no further screening was done. These patients constituted the control group. In the remaining 27 practices, patients were offered stepwise screening for type 2 diabetes.

In the first step, they were tested for capillary blood glucose and hemoglobin A_1c. Those with suspicious results went to the second step: capillary fasting blood glucose. Those with suspicious results from that test underwent a glucose tolerance test for a definitive diagnosis of diabetes.

In 13 practices, with 7,462 high-risk patients, those with diabetes were offered routine diabetes treatment. In 14 of the practices, with 8,282 high-risk patients, those with diabetes were offered intensive treatment. In all, 78% of the high-risk patients in the routine care and intensive care practices attended the stepwise screening, and 407 received a diagnosis of diabetes. During 104,218 person-years of observation (a mean of 5.5 years of follow-up per patient) there were 743 deaths in the screening practices and 192 deaths in the control practices.

After adjusting for the practice, age, gender, and steroid and antihypertensive drugs, the researchers found no significant differences between patients in screening practices and those in control practices in overall mortality, cardiovascular mortality, or cancer mortality. There were also no significant differences between the intensive care and routine care patients in overall, cardiovascular, or cancer mortality.

There were two positive results in the trial. In screening practices, high-risk patients who agreed to be screened had 27% lower overall mortality than did those in the control practices. Those who were offered but declined screening had an 86% higher overall mortality than did controls. But these positive results are less persuasive than the others because the researchers don't know if there were important differences between patients who chose to be screened and those who chose not to be screened.

In response to a question, Dr. Echouffo- Tcheugui acknowledged that one would not expect many deaths in 5.5 years of follow-up in newly diagnosed diabetics. He said he and his colleagues would continue to follow the patients. Dr. Echouffo-Tcheugui said he had no conflicts of interest related to his presentation.

SAN FRANCISCO — A population-based screening program for type 2 diabetes does not decrease all-cause, cardiovascular, or cancer-related mortality over a 5-year period, according to a large randomized controlled trial presented at the annual scientific sessions of the American Diabetes Association.

Moreover, screened patients offered intensive diabetes treatment did no better in terms of mortality than did screened patients offered routine diabetes treatment, said Dr. Justin Basile Echouffo-Tcheugui of the University of Cambridge (England).

The results call into question the value of large-scale screening for type 2 diabetes and of intensive diabetes management. And they conflict with mathematical models that predicted such screening would result in a 26%–40% reduction in diabetes-specific mortality, he said.

The 79,085 people who participated in the study were patients at 32 primary care practices in England. Using data from medical records, researchers calculated patients' Cambridge Risk Score (CRS), which reflects an individual's risk of developing diabetes. Of the original cohort, 19,881 people with CRS scores above 0.17 were included in the study. According to an earlier study, using a CRS score of 0.17 as a cut-off point results in a 70% sensitivity and a 64% specificity in identifying patients at high risk of type 2 diabetes (Diabetes Care 2002;25:984-8).

In five of the practices, having a total of 4,137 high-risk patients, no further screening was done. These patients constituted the control group. In the remaining 27 practices, patients were offered stepwise screening for type 2 diabetes.

In the first step, they were tested for capillary blood glucose and hemoglobin A_1c. Those with suspicious results went to the second step: capillary fasting blood glucose. Those with suspicious results from that test underwent a glucose tolerance test for a definitive diagnosis of diabetes.

In 13 practices, with 7,462 high-risk patients, those with diabetes were offered routine diabetes treatment. In 14 of the practices, with 8,282 high-risk patients, those with diabetes were offered intensive treatment. In all, 78% of the high-risk patients in the routine care and intensive care practices attended the stepwise screening, and 407 received a diagnosis of diabetes. During 104,218 person-years of observation (a mean of 5.5 years of follow-up per patient) there were 743 deaths in the screening practices and 192 deaths in the control practices.

After adjusting for the practice, age, gender, and steroid and antihypertensive drugs, the researchers found no significant differences between patients in screening practices and those in control practices in overall mortality, cardiovascular mortality, or cancer mortality. There were also no significant differences between the intensive care and routine care patients in overall, cardiovascular, or cancer mortality.

There were two positive results in the trial. In screening practices, high-risk patients who agreed to be screened had 27% lower overall mortality than did those in the control practices. Those who were offered but declined screening had an 86% higher overall mortality than did controls. But these positive results are less persuasive than the others because the researchers don't know if there were important differences between patients who chose to be screened and those who chose not to be screened.

In response to a question, Dr. Echouffo- Tcheugui acknowledged that one would not expect many deaths in 5.5 years of follow-up in newly diagnosed diabetics. He said he and his colleagues would continue to follow the patients. Dr. Echouffo-Tcheugui said he had no conflicts of interest related to his presentation.

SAN FRANCISCO — A population-based screening program for type 2 diabetes does not decrease all-cause, cardiovascular, or cancer-related mortality over a 5-year period, according to a large randomized controlled trial presented at the annual scientific sessions of the American Diabetes Association.

Moreover, screened patients offered intensive diabetes treatment did no better in terms of mortality than did screened patients offered routine diabetes treatment, said Dr. Justin Basile Echouffo-Tcheugui of the University of Cambridge (England).

The results call into question the value of large-scale screening for type 2 diabetes and of intensive diabetes management. And they conflict with mathematical models that predicted such screening would result in a 26%–40% reduction in diabetes-specific mortality, he said.

The 79,085 people who participated in the study were patients at 32 primary care practices in England. Using data from medical records, researchers calculated patients' Cambridge Risk Score (CRS), which reflects an individual's risk of developing diabetes. Of the original cohort, 19,881 people with CRS scores above 0.17 were included in the study. According to an earlier study, using a CRS score of 0.17 as a cut-off point results in a 70% sensitivity and a 64% specificity in identifying patients at high risk of type 2 diabetes (Diabetes Care 2002;25:984-8).

In five of the practices, having a total of 4,137 high-risk patients, no further screening was done. These patients constituted the control group. In the remaining 27 practices, patients were offered stepwise screening for type 2 diabetes.

In the first step, they were tested for capillary blood glucose and hemoglobin A_1c. Those with suspicious results went to the second step: capillary fasting blood glucose. Those with suspicious results from that test underwent a glucose tolerance test for a definitive diagnosis of diabetes.

In 13 practices, with 7,462 high-risk patients, those with diabetes were offered routine diabetes treatment. In 14 of the practices, with 8,282 high-risk patients, those with diabetes were offered intensive treatment. In all, 78% of the high-risk patients in the routine care and intensive care practices attended the stepwise screening, and 407 received a diagnosis of diabetes. During 104,218 person-years of observation (a mean of 5.5 years of follow-up per patient) there were 743 deaths in the screening practices and 192 deaths in the control practices.

After adjusting for the practice, age, gender, and steroid and antihypertensive drugs, the researchers found no significant differences between patients in screening practices and those in control practices in overall mortality, cardiovascular mortality, or cancer mortality. There were also no significant differences between the intensive care and routine care patients in overall, cardiovascular, or cancer mortality.

There were two positive results in the trial. In screening practices, high-risk patients who agreed to be screened had 27% lower overall mortality than did those in the control practices. Those who were offered but declined screening had an 86% higher overall mortality than did controls. But these positive results are less persuasive than the others because the researchers don't know if there were important differences between patients who chose to be screened and those who chose not to be screened.

In response to a question, Dr. Echouffo- Tcheugui acknowledged that one would not expect many deaths in 5.5 years of follow-up in newly diagnosed diabetics. He said he and his colleagues would continue to follow the patients. Dr. Echouffo-Tcheugui said he had no conflicts of interest related to his presentation.

BEVERLY HILLS, CALIF. — The jury may still be out on whether probiotics are beneficial, but at least they do no harm and can be safely recommended to patients, right? Not so, said Dr. David R. Mack at the International Probiotics Association World Congress.

Several recent studies have uncovered some risks associated with probiotic use. “We [physicians] are always looking for new things, but we're a conservative, skeptical lot, and safety is a primary concern,” Dr. Mack said.

One of the most concerning studies is also one of the newest, noted Dr. Mack of the University of Ottawa (Ont.). Investigators randomized 298 patients with predicted acute pancreatitis to receive probiotic prophylaxis or placebo. The probiotic preparation consisted of six live bacterial species: Lactobacillus acidophilus, L. casei, L. salivarius, Lactococcus lactis, Bifidobacterium bifidum, and B. lactis.

Not only did the probiotic preparation fail to reduce the risk of infectious complications, but the mortality rate was 2.5 times higher among the patients receiving probiotics than among those receiving placebo. Twenty-four (16%) of the patients in the probiotics group died, compared with nine (6%) in the placebo group.

Nine of the patients in the probiotics group developed bowel ischemia (eight with fatal outcomes), compared with none in the placebo group. The other deaths involved multiorgan failure (Lancet 2008;371:651–9).

According to some studies, probiotics are associated with increased asthma and wheezing in children. In one study, for example, children exposed to L. rhamnosus GG at birth had 3.4 times the risk of having asthma at age 7 years as a control group had (J. Allergy Clin. Immunol. 2007;119:1019–21). In another study involving the use of L. rhamnosus GG to prevent atopic dermatitis, 26% of the children in the probiotic group vs. 9% in the control group developed wheezing bronchitis (Pediatrics 2008;121:e850–6 [Epub doi:10.1542/peds.2007–1492]).

And there is further evidence of possible allergic complications following probiotic use. One study in France showed that two out of three common probiotic preparations contained cow's milk proteins (J. Allergy Clin. Immunol. 2007;119:746–7), and a separate case report described a child who developed anaphylaxis after taking a probiotic containing cow's milk proteins. Dr. Mack noted that one in five babies is allergic to cow's milk (Allergy 2006;61:507–8).

Beyond these known adverse reactions, there are other reasons to be concerned about the possible long-term effects of probiotics in young children. When adults take probiotics, it's rare to see extended colonization by the probiotic bacterial species, but outcomes appear to be different in young children: Some probiotic species have been detected in stool samples years later. The consequences of this extended exposure to probiotic organisms are unknown, he said.

Speaking of these studies as a group, he added, “These are a little warning shot across the bow,” and safety trials are needed.

BEVERLY HILLS, CALIF. — The jury may still be out on whether probiotics are beneficial, but at least they do no harm and can be safely recommended to patients, right? Not so, said Dr. David R. Mack at the International Probiotics Association World Congress.

Several recent studies have uncovered some risks associated with probiotic use. “We [physicians] are always looking for new things, but we're a conservative, skeptical lot, and safety is a primary concern,” Dr. Mack said.

One of the most concerning studies is also one of the newest, noted Dr. Mack of the University of Ottawa (Ont.). Investigators randomized 298 patients with predicted acute pancreatitis to receive probiotic prophylaxis or placebo. The probiotic preparation consisted of six live bacterial species: Lactobacillus acidophilus, L. casei, L. salivarius, Lactococcus lactis, Bifidobacterium bifidum, and B. lactis.

Not only did the probiotic preparation fail to reduce the risk of infectious complications, but the mortality rate was 2.5 times higher among the patients receiving probiotics than among those receiving placebo. Twenty-four (16%) of the patients in the probiotics group died, compared with nine (6%) in the placebo group.

Nine of the patients in the probiotics group developed bowel ischemia (eight with fatal outcomes), compared with none in the placebo group. The other deaths involved multiorgan failure (Lancet 2008;371:651–9).

According to some studies, probiotics are associated with increased asthma and wheezing in children. In one study, for example, children exposed to L. rhamnosus GG at birth had 3.4 times the risk of having asthma at age 7 years as a control group had (J. Allergy Clin. Immunol. 2007;119:1019–21). In another study involving the use of L. rhamnosus GG to prevent atopic dermatitis, 26% of the children in the probiotic group vs. 9% in the control group developed wheezing bronchitis (Pediatrics 2008;121:e850–6 [Epub doi:10.1542/peds.2007–1492]).

And there is further evidence of possible allergic complications following probiotic use. One study in France showed that two out of three common probiotic preparations contained cow's milk proteins (J. Allergy Clin. Immunol. 2007;119:746–7), and a separate case report described a child who developed anaphylaxis after taking a probiotic containing cow's milk proteins. Dr. Mack noted that one in five babies is allergic to cow's milk (Allergy 2006;61:507–8).

Beyond these known adverse reactions, there are other reasons to be concerned about the possible long-term effects of probiotics in young children. When adults take probiotics, it's rare to see extended colonization by the probiotic bacterial species, but outcomes appear to be different in young children: Some probiotic species have been detected in stool samples years later. The consequences of this extended exposure to probiotic organisms are unknown, he said.

Speaking of these studies as a group, he added, “These are a little warning shot across the bow,” and safety trials are needed.

BEVERLY HILLS, CALIF. — The jury may still be out on whether probiotics are beneficial, but at least they do no harm and can be safely recommended to patients, right? Not so, said Dr. David R. Mack at the International Probiotics Association World Congress.

Several recent studies have uncovered some risks associated with probiotic use. “We [physicians] are always looking for new things, but we're a conservative, skeptical lot, and safety is a primary concern,” Dr. Mack said.

One of the most concerning studies is also one of the newest, noted Dr. Mack of the University of Ottawa (Ont.). Investigators randomized 298 patients with predicted acute pancreatitis to receive probiotic prophylaxis or placebo. The probiotic preparation consisted of six live bacterial species: Lactobacillus acidophilus, L. casei, L. salivarius, Lactococcus lactis, Bifidobacterium bifidum, and B. lactis.

Not only did the probiotic preparation fail to reduce the risk of infectious complications, but the mortality rate was 2.5 times higher among the patients receiving probiotics than among those receiving placebo. Twenty-four (16%) of the patients in the probiotics group died, compared with nine (6%) in the placebo group.

Nine of the patients in the probiotics group developed bowel ischemia (eight with fatal outcomes), compared with none in the placebo group. The other deaths involved multiorgan failure (Lancet 2008;371:651–9).

According to some studies, probiotics are associated with increased asthma and wheezing in children. In one study, for example, children exposed to L. rhamnosus GG at birth had 3.4 times the risk of having asthma at age 7 years as a control group had (J. Allergy Clin. Immunol. 2007;119:1019–21). In another study involving the use of L. rhamnosus GG to prevent atopic dermatitis, 26% of the children in the probiotic group vs. 9% in the control group developed wheezing bronchitis (Pediatrics 2008;121:e850–6 [Epub doi:10.1542/peds.2007–1492]).

And there is further evidence of possible allergic complications following probiotic use. One study in France showed that two out of three common probiotic preparations contained cow's milk proteins (J. Allergy Clin. Immunol. 2007;119:746–7), and a separate case report described a child who developed anaphylaxis after taking a probiotic containing cow's milk proteins. Dr. Mack noted that one in five babies is allergic to cow's milk (Allergy 2006;61:507–8).

Beyond these known adverse reactions, there are other reasons to be concerned about the possible long-term effects of probiotics in young children. When adults take probiotics, it's rare to see extended colonization by the probiotic bacterial species, but outcomes appear to be different in young children: Some probiotic species have been detected in stool samples years later. The consequences of this extended exposure to probiotic organisms are unknown, he said.

Speaking of these studies as a group, he added, “These are a little warning shot across the bow,” and safety trials are needed.