Heidi Splete

A new guideline issued by the Endocrine Society offers evidence-based recommendations that clinicians can use to combat the growing problem of childhood obesity in the United States.

The guideline is currently available online at http://jcem.endojournals.org

This is the first time the Endocrine Society has issued a clinical practice guideline for pediatric obesity, Dr. A. Jay Cohen, medical director of the Endocrine Clinic, P.C., in Memphis, Tenn., said in an interview.

The guideline will make it easier for clinicians to treat pediatric patients who are at risk for obesity, explained Dr. Cohen. “It will give direction to pediatricians, family practice physicians, and endocrinologists as to what to evaluate, how, and when. It will also give direction to insurance companies as to standards of care.” The guideline recommends that clinicians define overweight as a body mass index greater than the 85th percentile and obesity as a BMI greater than the 95th percentile.

The most important elements of the guideline that clinicians can use immediately are the recommendations for changes in daily exercise patterns and dramatic adjustments in food behaviors, Dr. Cohen said.

The guideline recommends breastfeeding of infants for at least 6 months as part of a strategy to prevent obesity. And as a first-line treatment for obesity in children and adolescents, the guideline emphasizes intensive lifestyle changes in diet, exercise, and behavior. To help with lifestyle modification, the guideline encourages clinicians to advocate for 60 minutes of moderate to vigorous exercise each day for all school-aged children in all grades.

While pharmacotherapy is included in the guideline, it should be considered for children only after lifestyle modification has failed, or if severe comorbidities such as nonalcoholic fatty liver disease persist despite lifestyle modification. And medication should be given only by clinicians who have experience in using antiobesity drugs and who understand the possible side effects and adverse reactions.

In addition, the guideline recommends evaluating children with a BMI above the 85th percentile for comorbidities and complications associated with obesity. This process would help identify children who might benefit from specialized treatment such as bariatric surgery.

Bariatric surgery may be an option for some children, but the guideline states that it should be considered only for adolescents with a BMI greater than 50, or in those with a BMI greater than 40 who have severe comorbidities or who have failed to manage weight with intensive lifestyle modification, pharmacotherapy, or both.

Implementation of this guideline into clinical practice poses many challenges, including the amount of time needed on a consistent basis to educate, support, and give follow-up care to young patients at risk for obesity, Dr. Cohen said, adding that reimbursement for care remains an issue. “Insurance companies must start covering for nutritionists and counseling.”

Additional research is needed to continue to support the guidelines or revise them if necessary, noted Dr. Cohen.

“Data will be needed to show the evolution of these patients into adulthood and the risks of diabetes, cardiac problems, and accelerated complications. The roles of medication and bariatric surgery are important issues to address in the near future,” he said.

A new guideline issued by the Endocrine Society offers evidence-based recommendations that clinicians can use to combat the growing problem of childhood obesity in the United States.

The guideline is currently available online at http://jcem.endojournals.org

This is the first time the Endocrine Society has issued a clinical practice guideline for pediatric obesity, Dr. A. Jay Cohen, medical director of the Endocrine Clinic, P.C., in Memphis, Tenn., said in an interview.

The guideline will make it easier for clinicians to treat pediatric patients who are at risk for obesity, explained Dr. Cohen. “It will give direction to pediatricians, family practice physicians, and endocrinologists as to what to evaluate, how, and when. It will also give direction to insurance companies as to standards of care.” The guideline recommends that clinicians define overweight as a body mass index greater than the 85th percentile and obesity as a BMI greater than the 95th percentile.

The most important elements of the guideline that clinicians can use immediately are the recommendations for changes in daily exercise patterns and dramatic adjustments in food behaviors, Dr. Cohen said.

The guideline recommends breastfeeding of infants for at least 6 months as part of a strategy to prevent obesity. And as a first-line treatment for obesity in children and adolescents, the guideline emphasizes intensive lifestyle changes in diet, exercise, and behavior. To help with lifestyle modification, the guideline encourages clinicians to advocate for 60 minutes of moderate to vigorous exercise each day for all school-aged children in all grades.

While pharmacotherapy is included in the guideline, it should be considered for children only after lifestyle modification has failed, or if severe comorbidities such as nonalcoholic fatty liver disease persist despite lifestyle modification. And medication should be given only by clinicians who have experience in using antiobesity drugs and who understand the possible side effects and adverse reactions.

In addition, the guideline recommends evaluating children with a BMI above the 85th percentile for comorbidities and complications associated with obesity. This process would help identify children who might benefit from specialized treatment such as bariatric surgery.

Bariatric surgery may be an option for some children, but the guideline states that it should be considered only for adolescents with a BMI greater than 50, or in those with a BMI greater than 40 who have severe comorbidities or who have failed to manage weight with intensive lifestyle modification, pharmacotherapy, or both.

Implementation of this guideline into clinical practice poses many challenges, including the amount of time needed on a consistent basis to educate, support, and give follow-up care to young patients at risk for obesity, Dr. Cohen said, adding that reimbursement for care remains an issue. “Insurance companies must start covering for nutritionists and counseling.”

Additional research is needed to continue to support the guidelines or revise them if necessary, noted Dr. Cohen.

“Data will be needed to show the evolution of these patients into adulthood and the risks of diabetes, cardiac problems, and accelerated complications. The roles of medication and bariatric surgery are important issues to address in the near future,” he said.

A new guideline issued by the Endocrine Society offers evidence-based recommendations that clinicians can use to combat the growing problem of childhood obesity in the United States.

The guideline is currently available online at http://jcem.endojournals.org

This is the first time the Endocrine Society has issued a clinical practice guideline for pediatric obesity, Dr. A. Jay Cohen, medical director of the Endocrine Clinic, P.C., in Memphis, Tenn., said in an interview.

The guideline will make it easier for clinicians to treat pediatric patients who are at risk for obesity, explained Dr. Cohen. “It will give direction to pediatricians, family practice physicians, and endocrinologists as to what to evaluate, how, and when. It will also give direction to insurance companies as to standards of care.” The guideline recommends that clinicians define overweight as a body mass index greater than the 85th percentile and obesity as a BMI greater than the 95th percentile.

The most important elements of the guideline that clinicians can use immediately are the recommendations for changes in daily exercise patterns and dramatic adjustments in food behaviors, Dr. Cohen said.

The guideline recommends breastfeeding of infants for at least 6 months as part of a strategy to prevent obesity. And as a first-line treatment for obesity in children and adolescents, the guideline emphasizes intensive lifestyle changes in diet, exercise, and behavior. To help with lifestyle modification, the guideline encourages clinicians to advocate for 60 minutes of moderate to vigorous exercise each day for all school-aged children in all grades.

While pharmacotherapy is included in the guideline, it should be considered for children only after lifestyle modification has failed, or if severe comorbidities such as nonalcoholic fatty liver disease persist despite lifestyle modification. And medication should be given only by clinicians who have experience in using antiobesity drugs and who understand the possible side effects and adverse reactions.

In addition, the guideline recommends evaluating children with a BMI above the 85th percentile for comorbidities and complications associated with obesity. This process would help identify children who might benefit from specialized treatment such as bariatric surgery.

Bariatric surgery may be an option for some children, but the guideline states that it should be considered only for adolescents with a BMI greater than 50, or in those with a BMI greater than 40 who have severe comorbidities or who have failed to manage weight with intensive lifestyle modification, pharmacotherapy, or both.

Implementation of this guideline into clinical practice poses many challenges, including the amount of time needed on a consistent basis to educate, support, and give follow-up care to young patients at risk for obesity, Dr. Cohen said, adding that reimbursement for care remains an issue. “Insurance companies must start covering for nutritionists and counseling.”

Additional research is needed to continue to support the guidelines or revise them if necessary, noted Dr. Cohen.

“Data will be needed to show the evolution of these patients into adulthood and the risks of diabetes, cardiac problems, and accelerated complications. The roles of medication and bariatric surgery are important issues to address in the near future,” he said.

WASHINGTON — Women who had hypertension during pregnancy are at increased risk for hypertension and stroke after 40 years of age.

Follow-up data from more than 4,000 women suggest providers should ask patients about a history of hypertension in pregnancy and note the increased risk of hypertension and stroke in those with such a history, said Dr. Vesna D. Garovic of the department of nephrology and hypertension at the Mayo Clinic in Rochester, Minn.

The current findings support previous research, but earlier studies have been small and registry-based, with limited follow-up, Dr. Garovic said at the annual congress of the International Society for the Study of Hypertension in Pregnancy.

Dr. Garovic and her colleagues reviewed data from 4,782 women in the Family Blood Pressure Program, a multicenter genetic study of high blood pressure and related conditions, to assess the role of hypertension in pregnancy as a risk factor for subsequent stroke and coronary heart disease.

The women were divided into three categories: those with no history of a full-term pregnancy, those with no history of hypertension in pregnancy, and those with a history of hypertension in at least one pregnancy. The women were also asked about other risk factors, including a family history of hypertension and a history of smoking, she explained.

The investigators tracked hypertension and related conditions after the women reached age 40 years. Overall, those with a history of hypertension in pregnancy had a significantly increased risk for hypertension, coronary heart disease (CHD), and stroke, compared with those who were not hypertensive in pregnancy.

After controlling for cardiovascular factors including race, family history of CVD, diabetes, dyslipidemia, and smoking, only the risk for hypertension later in life was significantly higher (hazard ratio, 1.88). After controlling for risk factors for stroke, including subsequent hypertension, the stroke risk was significantly increased (HR 2.10), but the CHDrisk was not.

Women with a history of hypertension in pregnancy also developed hypertension at a younger age than did those who weren't hypertensive in pregnancy. Of 643 women with a history of hypertension in pregnancy, 50% were hypertensive by age 53 years.

“You can postulate that [they] have some underlying increased risk,” but hypertension in pregnancy may cause changes that contribute to an increased risk of future cardiovascular disease, she said, adding tha the study was limited by selection bias and the use of self-reports.

The mechanism of action that connects hypertension in pregnancy to subsequent disease risk remains unknown.

Dr. Garovic stated that she had no conflicts of interest to disclose.

WASHINGTON — Women who had hypertension during pregnancy are at increased risk for hypertension and stroke after 40 years of age.

Follow-up data from more than 4,000 women suggest providers should ask patients about a history of hypertension in pregnancy and note the increased risk of hypertension and stroke in those with such a history, said Dr. Vesna D. Garovic of the department of nephrology and hypertension at the Mayo Clinic in Rochester, Minn.

The current findings support previous research, but earlier studies have been small and registry-based, with limited follow-up, Dr. Garovic said at the annual congress of the International Society for the Study of Hypertension in Pregnancy.

Dr. Garovic and her colleagues reviewed data from 4,782 women in the Family Blood Pressure Program, a multicenter genetic study of high blood pressure and related conditions, to assess the role of hypertension in pregnancy as a risk factor for subsequent stroke and coronary heart disease.

The women were divided into three categories: those with no history of a full-term pregnancy, those with no history of hypertension in pregnancy, and those with a history of hypertension in at least one pregnancy. The women were also asked about other risk factors, including a family history of hypertension and a history of smoking, she explained.

The investigators tracked hypertension and related conditions after the women reached age 40 years. Overall, those with a history of hypertension in pregnancy had a significantly increased risk for hypertension, coronary heart disease (CHD), and stroke, compared with those who were not hypertensive in pregnancy.

After controlling for cardiovascular factors including race, family history of CVD, diabetes, dyslipidemia, and smoking, only the risk for hypertension later in life was significantly higher (hazard ratio, 1.88). After controlling for risk factors for stroke, including subsequent hypertension, the stroke risk was significantly increased (HR 2.10), but the CHDrisk was not.

Women with a history of hypertension in pregnancy also developed hypertension at a younger age than did those who weren't hypertensive in pregnancy. Of 643 women with a history of hypertension in pregnancy, 50% were hypertensive by age 53 years.

“You can postulate that [they] have some underlying increased risk,” but hypertension in pregnancy may cause changes that contribute to an increased risk of future cardiovascular disease, she said, adding tha the study was limited by selection bias and the use of self-reports.

The mechanism of action that connects hypertension in pregnancy to subsequent disease risk remains unknown.

Dr. Garovic stated that she had no conflicts of interest to disclose.

WASHINGTON — Women who had hypertension during pregnancy are at increased risk for hypertension and stroke after 40 years of age.

Follow-up data from more than 4,000 women suggest providers should ask patients about a history of hypertension in pregnancy and note the increased risk of hypertension and stroke in those with such a history, said Dr. Vesna D. Garovic of the department of nephrology and hypertension at the Mayo Clinic in Rochester, Minn.

The current findings support previous research, but earlier studies have been small and registry-based, with limited follow-up, Dr. Garovic said at the annual congress of the International Society for the Study of Hypertension in Pregnancy.

Dr. Garovic and her colleagues reviewed data from 4,782 women in the Family Blood Pressure Program, a multicenter genetic study of high blood pressure and related conditions, to assess the role of hypertension in pregnancy as a risk factor for subsequent stroke and coronary heart disease.

The women were divided into three categories: those with no history of a full-term pregnancy, those with no history of hypertension in pregnancy, and those with a history of hypertension in at least one pregnancy. The women were also asked about other risk factors, including a family history of hypertension and a history of smoking, she explained.

The investigators tracked hypertension and related conditions after the women reached age 40 years. Overall, those with a history of hypertension in pregnancy had a significantly increased risk for hypertension, coronary heart disease (CHD), and stroke, compared with those who were not hypertensive in pregnancy.

After controlling for cardiovascular factors including race, family history of CVD, diabetes, dyslipidemia, and smoking, only the risk for hypertension later in life was significantly higher (hazard ratio, 1.88). After controlling for risk factors for stroke, including subsequent hypertension, the stroke risk was significantly increased (HR 2.10), but the CHDrisk was not.

Women with a history of hypertension in pregnancy also developed hypertension at a younger age than did those who weren't hypertensive in pregnancy. Of 643 women with a history of hypertension in pregnancy, 50% were hypertensive by age 53 years.

“You can postulate that [they] have some underlying increased risk,” but hypertension in pregnancy may cause changes that contribute to an increased risk of future cardiovascular disease, she said, adding tha the study was limited by selection bias and the use of self-reports.

The mechanism of action that connects hypertension in pregnancy to subsequent disease risk remains unknown.

Dr. Garovic stated that she had no conflicts of interest to disclose.

WASHINGTON — A maternal history of preeclampsia may identify adults who are at increased risk for stroke.

Adults whose mothers had severe preeclampsia were almost twice as likely to have strokes, compared with adults whose mothers didn't have preeclampsia, based on data from more than 6,000 singleton pregnancies in Finland.

This study is one of the first to examine the long-term health risks of the offspring of women who had preeclampsia, Dr. Eero Kajantie said at the annual congress of the International Society for the Study of Hypertension in Pregnancy. “We know surprisingly little about which pregnancy conditions are associated with increased risk for coronary heart disease and stroke” among offspring.

Previous studies have shown that these women are at increased risk for coronary heart disease and stroke later in life. Also, their children are prone to high blood pressure during childhood, said Dr. Kajantie of the National Public Health Institute in Helsinki.

Dr. Kajantie and his colleagues based their conclusion on a review of data from 6,410 members of the Helsinki Birth Cohort, who were born as singletons between 1934 and 1944.

Overall, 284 pregnancies (4.4%) were complicated by preeclampsia and 1,592 (24.8%) met criteria for hypertension without proteinuria. Among the children of these pregnancies, 464 (7.2%) had a diagnosis of coronary heart disease and 272 (4.2%) had a diagnosis of stroke. Diagnoses of CHD and stroke were collected from national hospital discharge records and death registries.

The risk of stroke was almost twice as likely in the 164 adults whose mothers had severe preeclampsia (hazard ratio, 1.7), after the researchers controlled for sex, low birth weight, and gestational age.

The researchers also examined hypertension without proteinuria as an outcome. They found that hypertension was a significant predictor of stroke, but that it was not a significant predictor of CHD.

“People born from pregnancies complicated by preeclampsia are at increased risk of stroke and hypertension,” Dr. Kajantie said. “We were unable to shown any association with CHD, although we are unable to exclude a small increase.”

Dr. Kajantie had no financial conflicts to disclose.

WASHINGTON — A maternal history of preeclampsia may identify adults who are at increased risk for stroke.

Adults whose mothers had severe preeclampsia were almost twice as likely to have strokes, compared with adults whose mothers didn't have preeclampsia, based on data from more than 6,000 singleton pregnancies in Finland.

This study is one of the first to examine the long-term health risks of the offspring of women who had preeclampsia, Dr. Eero Kajantie said at the annual congress of the International Society for the Study of Hypertension in Pregnancy. “We know surprisingly little about which pregnancy conditions are associated with increased risk for coronary heart disease and stroke” among offspring.

Previous studies have shown that these women are at increased risk for coronary heart disease and stroke later in life. Also, their children are prone to high blood pressure during childhood, said Dr. Kajantie of the National Public Health Institute in Helsinki.

Dr. Kajantie and his colleagues based their conclusion on a review of data from 6,410 members of the Helsinki Birth Cohort, who were born as singletons between 1934 and 1944.

Overall, 284 pregnancies (4.4%) were complicated by preeclampsia and 1,592 (24.8%) met criteria for hypertension without proteinuria. Among the children of these pregnancies, 464 (7.2%) had a diagnosis of coronary heart disease and 272 (4.2%) had a diagnosis of stroke. Diagnoses of CHD and stroke were collected from national hospital discharge records and death registries.

The risk of stroke was almost twice as likely in the 164 adults whose mothers had severe preeclampsia (hazard ratio, 1.7), after the researchers controlled for sex, low birth weight, and gestational age.

The researchers also examined hypertension without proteinuria as an outcome. They found that hypertension was a significant predictor of stroke, but that it was not a significant predictor of CHD.

“People born from pregnancies complicated by preeclampsia are at increased risk of stroke and hypertension,” Dr. Kajantie said. “We were unable to shown any association with CHD, although we are unable to exclude a small increase.”

Dr. Kajantie had no financial conflicts to disclose.

WASHINGTON — A maternal history of preeclampsia may identify adults who are at increased risk for stroke.

Adults whose mothers had severe preeclampsia were almost twice as likely to have strokes, compared with adults whose mothers didn't have preeclampsia, based on data from more than 6,000 singleton pregnancies in Finland.

This study is one of the first to examine the long-term health risks of the offspring of women who had preeclampsia, Dr. Eero Kajantie said at the annual congress of the International Society for the Study of Hypertension in Pregnancy. “We know surprisingly little about which pregnancy conditions are associated with increased risk for coronary heart disease and stroke” among offspring.

Previous studies have shown that these women are at increased risk for coronary heart disease and stroke later in life. Also, their children are prone to high blood pressure during childhood, said Dr. Kajantie of the National Public Health Institute in Helsinki.

Dr. Kajantie and his colleagues based their conclusion on a review of data from 6,410 members of the Helsinki Birth Cohort, who were born as singletons between 1934 and 1944.

Overall, 284 pregnancies (4.4%) were complicated by preeclampsia and 1,592 (24.8%) met criteria for hypertension without proteinuria. Among the children of these pregnancies, 464 (7.2%) had a diagnosis of coronary heart disease and 272 (4.2%) had a diagnosis of stroke. Diagnoses of CHD and stroke were collected from national hospital discharge records and death registries.

The risk of stroke was almost twice as likely in the 164 adults whose mothers had severe preeclampsia (hazard ratio, 1.7), after the researchers controlled for sex, low birth weight, and gestational age.

The researchers also examined hypertension without proteinuria as an outcome. They found that hypertension was a significant predictor of stroke, but that it was not a significant predictor of CHD.

“People born from pregnancies complicated by preeclampsia are at increased risk of stroke and hypertension,” Dr. Kajantie said. “We were unable to shown any association with CHD, although we are unable to exclude a small increase.”

Dr. Kajantie had no financial conflicts to disclose.

ARLINGTON, VA. — Despite the lack of evidence that over-the-counter medicines cure the common cold, nearly two-thirds of American adults choose them to treat symptoms, according to survey results from 1,005 individuals aged 18 and older.

Evidence from previous studies has shown that OTC cold medicines are not effective for either preventing or treating the common cold, especially among children.

The findings suggest physicians should continue to educate patients about the limits of OTC medications and natural remedies for cold prevention and treatment, wrote Dr. Mark Moyad and colleagues in a poster presented at the annual meeting of the American College of Nutrition.

However, Americans appear to be getting the message about hand hygiene. Overall, 72% of the survey respondents reported frequent handwashing as a first line of defense against cold prevention. Other prevention methods included taking multivitamins (48%), getting plenty of rest (41%), and taking vitamin C supplements (36%).

Once they had a cold, 79% of the respondents reported drinking lots of fluids, 71% reported getting plenty of rest, and 68% reported using OTC medications.

Some gender differences emerged in the survey results. Significantly more women than men reported frequent hand washing (38% vs. 28%) and disinfecting their surroundings (38% vs. 28%) to prevent colds.

Data for this study were culled from a nationwide sample of respondents to an online survey conducted as part of a larger project that was commissioned by U.S. Nutrition and conducted by Booth Research Services Inc., of Atlanta. Dr. Moyad, codirector of the men's health program at the University of Michigan, Ann Arbor, is on the advisory board of Zila Pharmaceuticals, the manufacturer of the vitamin C supplement Ester-C.

ARLINGTON, VA. — Despite the lack of evidence that over-the-counter medicines cure the common cold, nearly two-thirds of American adults choose them to treat symptoms, according to survey results from 1,005 individuals aged 18 and older.

Evidence from previous studies has shown that OTC cold medicines are not effective for either preventing or treating the common cold, especially among children.

The findings suggest physicians should continue to educate patients about the limits of OTC medications and natural remedies for cold prevention and treatment, wrote Dr. Mark Moyad and colleagues in a poster presented at the annual meeting of the American College of Nutrition.

However, Americans appear to be getting the message about hand hygiene. Overall, 72% of the survey respondents reported frequent handwashing as a first line of defense against cold prevention. Other prevention methods included taking multivitamins (48%), getting plenty of rest (41%), and taking vitamin C supplements (36%).

Once they had a cold, 79% of the respondents reported drinking lots of fluids, 71% reported getting plenty of rest, and 68% reported using OTC medications.

Some gender differences emerged in the survey results. Significantly more women than men reported frequent hand washing (38% vs. 28%) and disinfecting their surroundings (38% vs. 28%) to prevent colds.

Data for this study were culled from a nationwide sample of respondents to an online survey conducted as part of a larger project that was commissioned by U.S. Nutrition and conducted by Booth Research Services Inc., of Atlanta. Dr. Moyad, codirector of the men's health program at the University of Michigan, Ann Arbor, is on the advisory board of Zila Pharmaceuticals, the manufacturer of the vitamin C supplement Ester-C.

ARLINGTON, VA. — Despite the lack of evidence that over-the-counter medicines cure the common cold, nearly two-thirds of American adults choose them to treat symptoms, according to survey results from 1,005 individuals aged 18 and older.

Evidence from previous studies has shown that OTC cold medicines are not effective for either preventing or treating the common cold, especially among children.

The findings suggest physicians should continue to educate patients about the limits of OTC medications and natural remedies for cold prevention and treatment, wrote Dr. Mark Moyad and colleagues in a poster presented at the annual meeting of the American College of Nutrition.

However, Americans appear to be getting the message about hand hygiene. Overall, 72% of the survey respondents reported frequent handwashing as a first line of defense against cold prevention. Other prevention methods included taking multivitamins (48%), getting plenty of rest (41%), and taking vitamin C supplements (36%).

Once they had a cold, 79% of the respondents reported drinking lots of fluids, 71% reported getting plenty of rest, and 68% reported using OTC medications.

Some gender differences emerged in the survey results. Significantly more women than men reported frequent hand washing (38% vs. 28%) and disinfecting their surroundings (38% vs. 28%) to prevent colds.

Data for this study were culled from a nationwide sample of respondents to an online survey conducted as part of a larger project that was commissioned by U.S. Nutrition and conducted by Booth Research Services Inc., of Atlanta. Dr. Moyad, codirector of the men's health program at the University of Michigan, Ann Arbor, is on the advisory board of Zila Pharmaceuticals, the manufacturer of the vitamin C supplement Ester-C.

WASHINGTON — Digoxin Immune Fab (DIF), a polyclonal fragmented antibody marketed for the treatment of digoxin toxicity, appears to improve renal function in women with severe preeclampsia, based on results of the first known study to show pharmacologic benefit for a drug that protects end-organ function in preeclamptic patients.

And DIF appeared to have no ill effects on the newborn, Dr. Garrett Lam said at the annual congress of the International Society for the Study of Hypertension in Pregnancy.

He and his colleagues collaborated on a randomized controlled trial of DIF vs. placebo that examined two primary end points—change in creatinine clearance and the use of antihypertensive medication. The study, known as the Digibind Efficacy Evaluation in Preeclampsia (DEEP) study, was supported in part by Protherics PLC, whose DIF product (marketed in the United States as Digifab) is an alternative to the GlaxoSmithKline's (marketed in the United States as Digibind).

In all, 51 women who met criteria for severe preeclampsia were randomized to receive either DIF or placebo intravenously every 6 hours for 48 hours. Candidates were selected based on the American College of Obstetricians and Gynecologists' criteria for severe preeclampsia, or by the presence of preeclampsia so severe that delivery was expected within 72 hours of admission. The gestational ages ranged from 23 weeks and 5 days to 34 weeks, and no patient had a family history of chronic hypertension, autoimmune disease, liver disease, or renal disease.

Overall, creatinine clearance was essentially preserved in the DIF-treated group, while the placebo group showed a statistically significant change. By the end of the 48-hour treatment phase, the placebo group had a drop in creatinine clearance of 34 mL/min from baseline vs. a change of only 3 mL/min from baseline in the DIF group. Once DIF was stopped, the creatinine clearance of the treatment group began to drop. “When DIF is discontinued, renal function deteriorates,” said Dr. Lam, who is in private practice in Phoenix.

While there is strong evidence for DIF's beneficial effect, Dr. Lam emphasized that larger studies are needed, both to assess the clinical implications of treating preeclamptic women with DIF and to evaluate neonatal outcomes.

Fewer patients in the DIF group needed antihypertensive medication vs. the placebo group, although this difference was not significant (46% vs. 52%). However, the study did not dictate a protocol for when antihypertensives were initiated or increased, which may have contributed to the null result for this end point, Dr. Lam said. Adverse events were reported in 8% of the DIF group and in 22% of the placebo group, but none of these was determined to be related to the study drug, he said.

The researchers also examined DIF's impact on newborns weighing 1,250 grams or less as a secondary outcome. They found fewer instances of both intraventricular hemorrhage and necrotizing enterocolitis (trending toward a significant difference) among low-birth-weight babies in the DIF group than among their same-sized counterparts in the placebo group. “The interpretation can be made that DIF has a possible protective effect in these very low-birth-weight infants,” Dr. Lam said.

Previous studies have shown increased levels of endogenous digoxinlike factors (EDLFs) in patients with preeclampsia, Dr. Lam said. EDLFs impair sodium/potassium ATPase pump activity, which is crucial in transporting calcium and in maintaining the action potential across cell membranes. The impairment of calcium clearance thus can cause contraction of vascular smooth muscle, resulting in hypertension. Three other presentations at the meeting showed evidence of the direct influence of DIF on the sodium/potassium ATPase pump. DIF binds EDLF, and it may improve outcomes in preeclamptic patients, he said.

Dr. Lam stated that he had no financial conflicts to disclose.

WASHINGTON — Digoxin Immune Fab (DIF), a polyclonal fragmented antibody marketed for the treatment of digoxin toxicity, appears to improve renal function in women with severe preeclampsia, based on results of the first known study to show pharmacologic benefit for a drug that protects end-organ function in preeclamptic patients.

And DIF appeared to have no ill effects on the newborn, Dr. Garrett Lam said at the annual congress of the International Society for the Study of Hypertension in Pregnancy.

He and his colleagues collaborated on a randomized controlled trial of DIF vs. placebo that examined two primary end points—change in creatinine clearance and the use of antihypertensive medication. The study, known as the Digibind Efficacy Evaluation in Preeclampsia (DEEP) study, was supported in part by Protherics PLC, whose DIF product (marketed in the United States as Digifab) is an alternative to the GlaxoSmithKline's (marketed in the United States as Digibind).

In all, 51 women who met criteria for severe preeclampsia were randomized to receive either DIF or placebo intravenously every 6 hours for 48 hours. Candidates were selected based on the American College of Obstetricians and Gynecologists' criteria for severe preeclampsia, or by the presence of preeclampsia so severe that delivery was expected within 72 hours of admission. The gestational ages ranged from 23 weeks and 5 days to 34 weeks, and no patient had a family history of chronic hypertension, autoimmune disease, liver disease, or renal disease.

Overall, creatinine clearance was essentially preserved in the DIF-treated group, while the placebo group showed a statistically significant change. By the end of the 48-hour treatment phase, the placebo group had a drop in creatinine clearance of 34 mL/min from baseline vs. a change of only 3 mL/min from baseline in the DIF group. Once DIF was stopped, the creatinine clearance of the treatment group began to drop. “When DIF is discontinued, renal function deteriorates,” said Dr. Lam, who is in private practice in Phoenix.

While there is strong evidence for DIF's beneficial effect, Dr. Lam emphasized that larger studies are needed, both to assess the clinical implications of treating preeclamptic women with DIF and to evaluate neonatal outcomes.

Fewer patients in the DIF group needed antihypertensive medication vs. the placebo group, although this difference was not significant (46% vs. 52%). However, the study did not dictate a protocol for when antihypertensives were initiated or increased, which may have contributed to the null result for this end point, Dr. Lam said. Adverse events were reported in 8% of the DIF group and in 22% of the placebo group, but none of these was determined to be related to the study drug, he said.

The researchers also examined DIF's impact on newborns weighing 1,250 grams or less as a secondary outcome. They found fewer instances of both intraventricular hemorrhage and necrotizing enterocolitis (trending toward a significant difference) among low-birth-weight babies in the DIF group than among their same-sized counterparts in the placebo group. “The interpretation can be made that DIF has a possible protective effect in these very low-birth-weight infants,” Dr. Lam said.

Previous studies have shown increased levels of endogenous digoxinlike factors (EDLFs) in patients with preeclampsia, Dr. Lam said. EDLFs impair sodium/potassium ATPase pump activity, which is crucial in transporting calcium and in maintaining the action potential across cell membranes. The impairment of calcium clearance thus can cause contraction of vascular smooth muscle, resulting in hypertension. Three other presentations at the meeting showed evidence of the direct influence of DIF on the sodium/potassium ATPase pump. DIF binds EDLF, and it may improve outcomes in preeclamptic patients, he said.

Dr. Lam stated that he had no financial conflicts to disclose.

WASHINGTON — Digoxin Immune Fab (DIF), a polyclonal fragmented antibody marketed for the treatment of digoxin toxicity, appears to improve renal function in women with severe preeclampsia, based on results of the first known study to show pharmacologic benefit for a drug that protects end-organ function in preeclamptic patients.

And DIF appeared to have no ill effects on the newborn, Dr. Garrett Lam said at the annual congress of the International Society for the Study of Hypertension in Pregnancy.

He and his colleagues collaborated on a randomized controlled trial of DIF vs. placebo that examined two primary end points—change in creatinine clearance and the use of antihypertensive medication. The study, known as the Digibind Efficacy Evaluation in Preeclampsia (DEEP) study, was supported in part by Protherics PLC, whose DIF product (marketed in the United States as Digifab) is an alternative to the GlaxoSmithKline's (marketed in the United States as Digibind).

In all, 51 women who met criteria for severe preeclampsia were randomized to receive either DIF or placebo intravenously every 6 hours for 48 hours. Candidates were selected based on the American College of Obstetricians and Gynecologists' criteria for severe preeclampsia, or by the presence of preeclampsia so severe that delivery was expected within 72 hours of admission. The gestational ages ranged from 23 weeks and 5 days to 34 weeks, and no patient had a family history of chronic hypertension, autoimmune disease, liver disease, or renal disease.

Overall, creatinine clearance was essentially preserved in the DIF-treated group, while the placebo group showed a statistically significant change. By the end of the 48-hour treatment phase, the placebo group had a drop in creatinine clearance of 34 mL/min from baseline vs. a change of only 3 mL/min from baseline in the DIF group. Once DIF was stopped, the creatinine clearance of the treatment group began to drop. “When DIF is discontinued, renal function deteriorates,” said Dr. Lam, who is in private practice in Phoenix.

While there is strong evidence for DIF's beneficial effect, Dr. Lam emphasized that larger studies are needed, both to assess the clinical implications of treating preeclamptic women with DIF and to evaluate neonatal outcomes.

Fewer patients in the DIF group needed antihypertensive medication vs. the placebo group, although this difference was not significant (46% vs. 52%). However, the study did not dictate a protocol for when antihypertensives were initiated or increased, which may have contributed to the null result for this end point, Dr. Lam said. Adverse events were reported in 8% of the DIF group and in 22% of the placebo group, but none of these was determined to be related to the study drug, he said.

The researchers also examined DIF's impact on newborns weighing 1,250 grams or less as a secondary outcome. They found fewer instances of both intraventricular hemorrhage and necrotizing enterocolitis (trending toward a significant difference) among low-birth-weight babies in the DIF group than among their same-sized counterparts in the placebo group. “The interpretation can be made that DIF has a possible protective effect in these very low-birth-weight infants,” Dr. Lam said.

Previous studies have shown increased levels of endogenous digoxinlike factors (EDLFs) in patients with preeclampsia, Dr. Lam said. EDLFs impair sodium/potassium ATPase pump activity, which is crucial in transporting calcium and in maintaining the action potential across cell membranes. The impairment of calcium clearance thus can cause contraction of vascular smooth muscle, resulting in hypertension. Three other presentations at the meeting showed evidence of the direct influence of DIF on the sodium/potassium ATPase pump. DIF binds EDLF, and it may improve outcomes in preeclamptic patients, he said.

Dr. Lam stated that he had no financial conflicts to disclose.

WASHINGTON — More than 70% of women with access to dietary iodine may remain at risk for unrecognized iodine deficiency during pregnancy, based on results from an observational study conducted in 53 pregnant women in Canada.

The average urinary iodine concentration (UIC) was 111.3 mcg/L (range, 21.2–373.0 mcg/L) in this group of women. This average was below the range of 150–249 mcg/L that the World Health Organization recommends for pregnant women, said Dr. Pamela Katz, who presented the findings at the annual meeting of the International Society of Obstetric Medicine.

“Iodine receives little attention in North America,” said Dr. Katz. Adequate iodine intake is not considered a problem in North America, but this assumption may be inaccurate, she said.

It is recommended that pregnant women consume 200–300 mcg of dietary iodine daily. Dietary intake of iodized salt is the most common source of iodine for pregnant women in North America, although many prenatal vitamins contain iodine.

To determine whether women living in areas considered iodine sufficient were consuming adequate iodine, Dr. Katz and her colleagues at the University of Toronto and Mount Sinai Hospital, also in Toronto, measured the UIC of 53 women with an average age of 33 years during standard prenatal visits to the hospital. The average gestational age was 26 weeks.

With a UIC range of 21.2–373.0 mcg/L, only 21% of the women had a UIC within the recommended range of 150–249 mcg/L, while 71% were below the range and 8% were above it.

The study was limited by its lack of information on maternal diet and fetal outcomes, and the results may not be generalizable to other regions.

The reason for the reduced UIC remains unclear, but the results are consistent with data from larger studies, and it may be that women in some iodine-sufficient areas are consuming less salt as part of their diets, Dr. Katz said.

The findings suggest a greater need for increased awareness of the importance of iodine for a healthy pregnancy, and the iodine content of prenatal supplements should be standardized to meet the increased requirements of pregnancy, she emphasized.

Physiological changes associated with pregnancy, including increased renal clearance of iodine and the iodine requirements of the fetus, require additional iodine intake. Maternal iodine deficiency has been associated with an increased risk of complications including stillbirth and spontaneous abortion, as well as developmental problems in children, including developmental delay and mental retardation, Dr. Katz noted.

WASHINGTON — More than 70% of women with access to dietary iodine may remain at risk for unrecognized iodine deficiency during pregnancy, based on results from an observational study conducted in 53 pregnant women in Canada.

The average urinary iodine concentration (UIC) was 111.3 mcg/L (range, 21.2–373.0 mcg/L) in this group of women. This average was below the range of 150–249 mcg/L that the World Health Organization recommends for pregnant women, said Dr. Pamela Katz, who presented the findings at the annual meeting of the International Society of Obstetric Medicine.

“Iodine receives little attention in North America,” said Dr. Katz. Adequate iodine intake is not considered a problem in North America, but this assumption may be inaccurate, she said.

It is recommended that pregnant women consume 200–300 mcg of dietary iodine daily. Dietary intake of iodized salt is the most common source of iodine for pregnant women in North America, although many prenatal vitamins contain iodine.

To determine whether women living in areas considered iodine sufficient were consuming adequate iodine, Dr. Katz and her colleagues at the University of Toronto and Mount Sinai Hospital, also in Toronto, measured the UIC of 53 women with an average age of 33 years during standard prenatal visits to the hospital. The average gestational age was 26 weeks.

With a UIC range of 21.2–373.0 mcg/L, only 21% of the women had a UIC within the recommended range of 150–249 mcg/L, while 71% were below the range and 8% were above it.

The study was limited by its lack of information on maternal diet and fetal outcomes, and the results may not be generalizable to other regions.

The reason for the reduced UIC remains unclear, but the results are consistent with data from larger studies, and it may be that women in some iodine-sufficient areas are consuming less salt as part of their diets, Dr. Katz said.

The findings suggest a greater need for increased awareness of the importance of iodine for a healthy pregnancy, and the iodine content of prenatal supplements should be standardized to meet the increased requirements of pregnancy, she emphasized.

Physiological changes associated with pregnancy, including increased renal clearance of iodine and the iodine requirements of the fetus, require additional iodine intake. Maternal iodine deficiency has been associated with an increased risk of complications including stillbirth and spontaneous abortion, as well as developmental problems in children, including developmental delay and mental retardation, Dr. Katz noted.

WASHINGTON — More than 70% of women with access to dietary iodine may remain at risk for unrecognized iodine deficiency during pregnancy, based on results from an observational study conducted in 53 pregnant women in Canada.

The average urinary iodine concentration (UIC) was 111.3 mcg/L (range, 21.2–373.0 mcg/L) in this group of women. This average was below the range of 150–249 mcg/L that the World Health Organization recommends for pregnant women, said Dr. Pamela Katz, who presented the findings at the annual meeting of the International Society of Obstetric Medicine.

“Iodine receives little attention in North America,” said Dr. Katz. Adequate iodine intake is not considered a problem in North America, but this assumption may be inaccurate, she said.

It is recommended that pregnant women consume 200–300 mcg of dietary iodine daily. Dietary intake of iodized salt is the most common source of iodine for pregnant women in North America, although many prenatal vitamins contain iodine.

To determine whether women living in areas considered iodine sufficient were consuming adequate iodine, Dr. Katz and her colleagues at the University of Toronto and Mount Sinai Hospital, also in Toronto, measured the UIC of 53 women with an average age of 33 years during standard prenatal visits to the hospital. The average gestational age was 26 weeks.

With a UIC range of 21.2–373.0 mcg/L, only 21% of the women had a UIC within the recommended range of 150–249 mcg/L, while 71% were below the range and 8% were above it.

The study was limited by its lack of information on maternal diet and fetal outcomes, and the results may not be generalizable to other regions.

The reason for the reduced UIC remains unclear, but the results are consistent with data from larger studies, and it may be that women in some iodine-sufficient areas are consuming less salt as part of their diets, Dr. Katz said.

The findings suggest a greater need for increased awareness of the importance of iodine for a healthy pregnancy, and the iodine content of prenatal supplements should be standardized to meet the increased requirements of pregnancy, she emphasized.

Physiological changes associated with pregnancy, including increased renal clearance of iodine and the iodine requirements of the fetus, require additional iodine intake. Maternal iodine deficiency has been associated with an increased risk of complications including stillbirth and spontaneous abortion, as well as developmental problems in children, including developmental delay and mental retardation, Dr. Katz noted.

Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a questionnaire-based study.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11–12 years and young women aged 13–26 years. HPV has been identified as a leading cause of cervical cancer.

Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.

To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11–17 years who were visitors to a university-based primary care clinic.

The study included complete results from 153 mothers of various ethnicities (average age, 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).

Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.

None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.

Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.

There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.

“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.

The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.

But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.

Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.

The study was funded by grants from Merck & Co. and the National Institutes of Health.

Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a questionnaire-based study.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11–12 years and young women aged 13–26 years. HPV has been identified as a leading cause of cervical cancer.

Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.

To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11–17 years who were visitors to a university-based primary care clinic.

The study included complete results from 153 mothers of various ethnicities (average age, 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).

Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.

None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.

Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.

There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.

“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.

The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.

But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.

Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.

The study was funded by grants from Merck & Co. and the National Institutes of Health.

Safety, not sexuality, was a key factor in the reluctance of mothers to have their teenage daughters vaccinated against human papillomavirus, according to results from a questionnaire-based study.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends a three-dose vaccine against the human papillomavirus (HPV) for all girls aged 11–12 years and young women aged 13–26 years. HPV has been identified as a leading cause of cervical cancer.

Previous studies have shown that parents were in favor of vaccination for adolescents but hesitant to vaccinate younger girls. But data from these studies have shown that in most cases, this resistance was not brought on by concerns that the vaccination might make teenage girls more likely to engage in risky sexual activities.

To examine the factors that influence parents' acceptance of the HPV vaccine, Susan L. Rosenthal, Ph.D., of the University of Texas Medical Branch in Galveston and her colleagues interviewed mothers with daughters aged 11–17 years who were visitors to a university-based primary care clinic.

The study included complete results from 153 mothers of various ethnicities (average age, 41 years) who completed a questionnaire. The questionnaire included ratings of seven health beliefs including perceptions of HPV disease severity and barriers to vaccination, such as cost. The questionnaire also addressed aspects of the parent/child relationship, including how closely the girls' activities were monitored by parents and whether the parents had discussed topics such as birth control, dating, and making decisions about sex (J. Adolesc. Health 2008;43:239-45).

Overall, 18% (27) of the mothers had been offered the HPV vaccination for their daughters but had not chosen it, and did not plan to vaccinate their daughters within the next year, while 34% (52) had not been offered the vaccination and did not plan to vaccinate their daughters within the next year. Another 22% (34) had not been offered the vaccine but were aware of it and planned to vaccinate their daughters within the next year, and 26% (40) of the mothers reported that their daughters had started or completed the vaccination series.

None of the mothers whose daughters had been vaccinated said they viewed the vaccine as unsafe, but objections to the vaccine were focused mostly on the lack of safety data because of the newness of the vaccine. Mothers who were offered the vaccine but did not plan to vaccinate their daughters within the year often cited a lack information about the vaccine, and some cited a lack of urgency based on their perceptions of their daughters' likely exposure to HPV.

Significant predictors of HPV vaccination after a multivariate analysis were mothers who had less than a high school education, had a history of sexually transmitted infections, had monitored their daughters' activities with peers, and had thought their daughters would not mind getting the shots.

There was no significant association between HPV vaccine acceptance and the ages and ethnicities of the mothers and daughters, the daughters' dating status, mothers' history of HPV, mother/daughter discussion of sex topics, or the general family environment.

“Although the study was not designed to examine the process of and impact of physician counseling, it appeared that those who had been counseled had more positive attitudes toward the vaccine and understood better the reasons for vaccinating their daughters prior to initiation of sexual activity,” the researchers noted.

The study was limited by the relatively small sample and by the university setting, which might have provided more education to parents and daughters than would other settings.

But the results suggest that even those parents and daughters who were counseled about the HPV vaccine wanted more information, and further studies are needed to determine the most effective ways to provide more education, the researchers wrote.

Many mothers who were not planning to vaccinate their daughters within the next year planned to vaccinate them eventually, they added.

The study was funded by grants from Merck & Co. and the National Institutes of Health.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births published online in the American Journal of Obstetrics and Gynecology.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted. “We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” they wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births published online in the American Journal of Obstetrics and Gynecology.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted. “We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” they wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

Women who are diagnosed with diabetes prior to pregnancy are three to four times more likely to have a child with birth defects, compared with women who don't have diabetes prior to pregnancy, based on results from a study of more than 15,000 live births published online in the American Journal of Obstetrics and Gynecology.

Although previous studies have established pregestational diabetes mellitus (PGDM) as a risk factor for several types of birth defects, the prevalence of maternal diabetes in cases of birth defects has not been well quantified, said Dr. Adolfo Correa, an epidemiologist at the Centers for Disease Control and Prevention.

Dr. Correa and his colleagues reviewed data from 13,030 cases of infants with birth defects and 4,895 control infants. The data came from the National Birth Defects Prevention Study, an ongoing population-based study that includes birth defect surveillance at 10 locations in the United States (Am. J. Obstet. Gynecol. 2008 [doi:10.1016/j.ajog.2008.06.028).

The overall prevalence of PGDM was 2.2% in cases of infants with birth defects (283 cases/13,030 births), compared with 0.5% for the control infants (24 cases/4,895 births). In the birth defects group, 138 mothers had type 1 diabetes and 145 had type 2 diabetes. In the control group, 10 mothers had type 1 diabetes and 14 had type 2 diabetes.

Overall, 70% of the cases of isolated birth defects and 90% of cases of multiple birth defects in infants whose mothers had PGDM might be attributed to the mother's diabetes, the researchers noted. The prevalence of both types of diabetes was highest among mothers of infants with multiple defects.

The researchers found significant associations between PGDM and several types of heart defects including aortic stenosis and atrial ventricular septal defects. They also found significant associations between PGDM and other types of birth defects including hydrocephalus, cleft lip (with and without cleft palate), anorectal atresia, and longitudinal limb deficiencies. The associations between PGDM and these defects were seen in isolated cases, but the association was even stronger in cases of multiple defects.

“Our findings of moderate to strong odds ratios for PGDM and a wide range of birth defects are consistent with and expand on previous reports that examined all birth defects as a group or broad categories of birth defects,” the researchers said.

The study population included women with known diabetes status prior to pregnancy and delivery dates between Oct. 1, 1997, and Dec. 31, 2003. The researchers excluded cases of birth defects that were linked to a known cause, such as a genetic disorder.

In addition, the prevalence of gestational diabetes mellitus (GDM) was 3.7% among control mothers vs. 5.1% among mothers whose infants had birth defects. But some women who are diagnosed with gestational diabetes may in fact have had undiagnosed type 2 diabetes prior to pregnancy, the researchers noted. “We were able to identify overweight and obese women with GDM as a subgroup who may be at increased risk of having offspring with birth defects and in need of closer follow-up examination and evaluation,” they wrote.

The study was limited by the use of maternal self-reports of diagnosed diabetes and by a lack of data on how many pregnancies complicated by PGDM were terminated in the study population.

More research is needed to determine how maternal hyperglycemia affects the developing fetus, the researchers noted. But the range and severity of the defects suggest that diabetes affects the developing embryo in complex and nonspecific ways, they added.

Dr. Correa stated that he had no financial conflicts to disclose.

Culturally based type 2 diabetes education programs improved patients' glycemic control for at least 6 months, based on results from a meta-analysis of 11 studies involving more than 1,000 patients.

“In some cases, cultural and communication barriers increase the problems minority ethnic communities experience in accessing good quality diabetes health education, a vital aspect contributing towards patient understanding, use of services, empowerment, and behaviour change towards healthier lifestyles,” the reviewers wrote in a report by the Cochrane Collaboration published online.

Overall, findings from the studies showed significant improvement in glycemic control (as measured by hemoglobin A_1c levels) at 3- and 6-month follow-ups among patients who received culturally appropriate health education interventions, compared with control patients who received standard health education (described as “usual care”). This finding is clinically important if the improvement can be sustained, the reviewers noted, but the improvement in glycemic control was not significantly different between the groups at 12 months after the intervention.

In addition, patients in the intervention group showed significantly improved knowledge about diabetes and healthy lifestyles, compared with the control group at 3, 6, and 12 months after the intervention.

The report consisted of data from 11 trials including 1,603 individuals at least 16 years old who had type 2 diabetes. The patients were members of ethnic-minority groups in upper-middle-income or high-income countries. Previous studies have suggested that ethnic minorities in these countries have higher rates of type 2 diabetes, compared with the majority populations, and the investigators who conducted the studies theorized that culturally appropriate education would improve diabetes management in ethnic-minority patients. The primary outcome measure was glycemic control.

The studies included in the review took place in Europe, the United States, Canada, South Africa, New Zealand, and Australia. In most of the studies, the intervention was repeated several times for periods lasting from 6 to 12 weeks. None of the studies followed patients for more than 12 months from the start of the intervention (Cochrane Database Syst. Rev. 2008 [doi: 10.1002/14651858.CD006424.pub2]).

Culturally appropriate health education intervention was defined as “education that is tailored to the cultural or religious beliefs and linguistic skills of the community being approached, taking into account likely literacy skills,” the researchers wrote. The intervention strategies varied among the studies and included using community-based health advocates, providing education to same-gender groups, and adapting dietary advice to fit a community's available food options.

No significant improvements were found in most of the other clinical outcomes measured in the studies (including triglycerides, blood pressure, or weight) between patients who received culturally appropriate education intervention and those who received usual care. Total cholesterol was the exception—the intervention patients showed improvement in total cholesterol at 12 months, but not at 3 months or 6 months, compared with the control patients, based on data from the three studies that addressed this outcome.

No significant differences in quality of life were reported between patients who received culturally appropriate diabetes education and those who received standard education, according to findings from the three studies that addressed quality of life.

Despite the short duration of improvement, the findings suggest that culturally appropriate education programs can make a significant difference in diabetes control and are worth developing, the reviewers said.

“It has been known for some time that diabetes health education improves knowledge about diabetes as well as blood glucose control, but this review has shown that culturally appropriate health education is better than 'normal' practice for minority communities,” they wrote. “The results strengthen the belief, based on educational theory, that health education should be couched in a learner-centered manner that respects their religious, social, and cultural values in order to have the most impact.”

The lead review author, Dr. Kamila Hawthorne of Cardiff (Wales) University, was the author of one of the studies included in the review. The other reviewers had no conflicts of interest to disclose.

Culturally based type 2 diabetes education programs improved patients' glycemic control for at least 6 months, based on results from a meta-analysis of 11 studies involving more than 1,000 patients.

“In some cases, cultural and communication barriers increase the problems minority ethnic communities experience in accessing good quality diabetes health education, a vital aspect contributing towards patient understanding, use of services, empowerment, and behaviour change towards healthier lifestyles,” the reviewers wrote in a report by the Cochrane Collaboration published online.

Overall, findings from the studies showed significant improvement in glycemic control (as measured by hemoglobin A_1c levels) at 3- and 6-month follow-ups among patients who received culturally appropriate health education interventions, compared with control patients who received standard health education (described as “usual care”). This finding is clinically important if the improvement can be sustained, the reviewers noted, but the improvement in glycemic control was not significantly different between the groups at 12 months after the intervention.

In addition, patients in the intervention group showed significantly improved knowledge about diabetes and healthy lifestyles, compared with the control group at 3, 6, and 12 months after the intervention.

The report consisted of data from 11 trials including 1,603 individuals at least 16 years old who had type 2 diabetes. The patients were members of ethnic-minority groups in upper-middle-income or high-income countries. Previous studies have suggested that ethnic minorities in these countries have higher rates of type 2 diabetes, compared with the majority populations, and the investigators who conducted the studies theorized that culturally appropriate education would improve diabetes management in ethnic-minority patients. The primary outcome measure was glycemic control.

The studies included in the review took place in Europe, the United States, Canada, South Africa, New Zealand, and Australia. In most of the studies, the intervention was repeated several times for periods lasting from 6 to 12 weeks. None of the studies followed patients for more than 12 months from the start of the intervention (Cochrane Database Syst. Rev. 2008 [doi: 10.1002/14651858.CD006424.pub2]).

Culturally appropriate health education intervention was defined as “education that is tailored to the cultural or religious beliefs and linguistic skills of the community being approached, taking into account likely literacy skills,” the researchers wrote. The intervention strategies varied among the studies and included using community-based health advocates, providing education to same-gender groups, and adapting dietary advice to fit a community's available food options.

No significant improvements were found in most of the other clinical outcomes measured in the studies (including triglycerides, blood pressure, or weight) between patients who received culturally appropriate education intervention and those who received usual care. Total cholesterol was the exception—the intervention patients showed improvement in total cholesterol at 12 months, but not at 3 months or 6 months, compared with the control patients, based on data from the three studies that addressed this outcome.

No significant differences in quality of life were reported between patients who received culturally appropriate diabetes education and those who received standard education, according to findings from the three studies that addressed quality of life.

Despite the short duration of improvement, the findings suggest that culturally appropriate education programs can make a significant difference in diabetes control and are worth developing, the reviewers said.

“It has been known for some time that diabetes health education improves knowledge about diabetes as well as blood glucose control, but this review has shown that culturally appropriate health education is better than 'normal' practice for minority communities,” they wrote. “The results strengthen the belief, based on educational theory, that health education should be couched in a learner-centered manner that respects their religious, social, and cultural values in order to have the most impact.”

The lead review author, Dr. Kamila Hawthorne of Cardiff (Wales) University, was the author of one of the studies included in the review. The other reviewers had no conflicts of interest to disclose.

Culturally based type 2 diabetes education programs improved patients' glycemic control for at least 6 months, based on results from a meta-analysis of 11 studies involving more than 1,000 patients.

“In some cases, cultural and communication barriers increase the problems minority ethnic communities experience in accessing good quality diabetes health education, a vital aspect contributing towards patient understanding, use of services, empowerment, and behaviour change towards healthier lifestyles,” the reviewers wrote in a report by the Cochrane Collaboration published online.

Overall, findings from the studies showed significant improvement in glycemic control (as measured by hemoglobin A_1c levels) at 3- and 6-month follow-ups among patients who received culturally appropriate health education interventions, compared with control patients who received standard health education (described as “usual care”). This finding is clinically important if the improvement can be sustained, the reviewers noted, but the improvement in glycemic control was not significantly different between the groups at 12 months after the intervention.

In addition, patients in the intervention group showed significantly improved knowledge about diabetes and healthy lifestyles, compared with the control group at 3, 6, and 12 months after the intervention.

The report consisted of data from 11 trials including 1,603 individuals at least 16 years old who had type 2 diabetes. The patients were members of ethnic-minority groups in upper-middle-income or high-income countries. Previous studies have suggested that ethnic minorities in these countries have higher rates of type 2 diabetes, compared with the majority populations, and the investigators who conducted the studies theorized that culturally appropriate education would improve diabetes management in ethnic-minority patients. The primary outcome measure was glycemic control.

The studies included in the review took place in Europe, the United States, Canada, South Africa, New Zealand, and Australia. In most of the studies, the intervention was repeated several times for periods lasting from 6 to 12 weeks. None of the studies followed patients for more than 12 months from the start of the intervention (Cochrane Database Syst. Rev. 2008 [doi: 10.1002/14651858.CD006424.pub2]).

Culturally appropriate health education intervention was defined as “education that is tailored to the cultural or religious beliefs and linguistic skills of the community being approached, taking into account likely literacy skills,” the researchers wrote. The intervention strategies varied among the studies and included using community-based health advocates, providing education to same-gender groups, and adapting dietary advice to fit a community's available food options.

No significant improvements were found in most of the other clinical outcomes measured in the studies (including triglycerides, blood pressure, or weight) between patients who received culturally appropriate education intervention and those who received usual care. Total cholesterol was the exception—the intervention patients showed improvement in total cholesterol at 12 months, but not at 3 months or 6 months, compared with the control patients, based on data from the three studies that addressed this outcome.

No significant differences in quality of life were reported between patients who received culturally appropriate diabetes education and those who received standard education, according to findings from the three studies that addressed quality of life.

Despite the short duration of improvement, the findings suggest that culturally appropriate education programs can make a significant difference in diabetes control and are worth developing, the reviewers said.

“It has been known for some time that diabetes health education improves knowledge about diabetes as well as blood glucose control, but this review has shown that culturally appropriate health education is better than 'normal' practice for minority communities,” they wrote. “The results strengthen the belief, based on educational theory, that health education should be couched in a learner-centered manner that respects their religious, social, and cultural values in order to have the most impact.”

The lead review author, Dr. Kamila Hawthorne of Cardiff (Wales) University, was the author of one of the studies included in the review. The other reviewers had no conflicts of interest to disclose.

Ondansetron therapy effectively reduced vomiting and other emetic complications—including hospital admissions—in children with acute gastroenteritis, based on results from a meta-analysis.

Current practice guidelines for treating children with gastroenteritis recommend oral rehydration therapy, but the guidelines don't recommend a drug treatment for vomiting, wrote Dr. Lisa Ross DeCamp and her colleagues at the University of North Carolina at Chapel Hill.

Vomiting may undermine oral rehydration therapy, and it is stressful for the children and their families (Arch. Pediatr. Adolesc. Med. 2008;?162:858-65).

To determine the value of antiemetics in relieving vomiting, the investigators reviewed findings from 11 studies on this topic. Several studies involved more than one drug.

The antiemetics included ondansetron (six studies), domperidone (two studies), trimethobenzamide (two studies), pyrilamine-pentobarbital (two studies), metoclopramide (two studies), dexamethasone (one study), and promethazine (one study).

Combined data from six randomized, double-blind, placebo-controlled trials including 745 children showed that ondansetron significantly reduced the risk of additional vomiting, the need for intravenous fluid (IVF), and the need for hospital admission, compared with a placebo.

Although the use of ondansetron was associated with increased diarrhea within 48 hours of administration in three studies, this effect did not appear to increase health care use and it did not persist beyond 48 hours.

No other serious adverse events were reported in connection with ondansetron use.

Overall, the numbers of children needed to treat with ondansetron to prevent hospital admission, IVF use, and further vomiting for 1 child were 14, 5, and 5 children, respectively.

Doses of ondansetron ranged from 2 mg to 8 mg when given orally using weight-based dosing and 1.6–4.0 mg when given orally using age-based dosing. The intravenous ondansetron dosage ranged from 0.3 mg/kg to 0.15 mg/kg.

“Studies of antiemetic agents other than ondansetron had small sample sizes, were of low methodological quality, and produced inconsistent results,” the researchers explained.

The results were limited by the fact that the ondansetron studies included in this review were supported by GlaxoSmithKline, a manufacturer of ondansetron (Zofran). But ondansetron is available in a generic form, and additional studies, including cost-effectiveness studies, should not require industry support, the researchers noted.

Most of the studies in this review focused on moderately ill children who were treated in an emergency department. These children are generally at greater risk for hospitalization or IVF treatment than are children who present to primary care offices, the researchers added.

“Given the costs associated with IVF or hospital admission and the relatively low [numbers needed to treat] demonstrated in the present study, ondansetron use in [emergency departments] is likely to be cost effective,” they wrote.

No known data exist on the use of ondansetron to treat pediatric vomiting in general office settings, and more studies are needed to evaluate outcomes after ondansetron use in these settings.

“There is not sufficient evidence to recommend the use of ondansetron for pediatric [gastroenteritis] in outpatient settings, or among children with mild disease,” Dr. Rachel C. Vreeman of Indiana University, Indianapolis, and her colleagues wrote in an accompanying editorial (Arch. Pediatr. Adolesc. Med. 2008;162:866-9).

Dr. DeCamp and her colleagues and Dr. Vreeman and her colleagues stated that they had no financial conflicts.

Ondansetron therapy effectively reduced vomiting and other emetic complications—including hospital admissions—in children with acute gastroenteritis, based on results from a meta-analysis.

Current practice guidelines for treating children with gastroenteritis recommend oral rehydration therapy, but the guidelines don't recommend a drug treatment for vomiting, wrote Dr. Lisa Ross DeCamp and her colleagues at the University of North Carolina at Chapel Hill.

Vomiting may undermine oral rehydration therapy, and it is stressful for the children and their families (Arch. Pediatr. Adolesc. Med. 2008;?162:858-65).

To determine the value of antiemetics in relieving vomiting, the investigators reviewed findings from 11 studies on this topic. Several studies involved more than one drug.

The antiemetics included ondansetron (six studies), domperidone (two studies), trimethobenzamide (two studies), pyrilamine-pentobarbital (two studies), metoclopramide (two studies), dexamethasone (one study), and promethazine (one study).

Combined data from six randomized, double-blind, placebo-controlled trials including 745 children showed that ondansetron significantly reduced the risk of additional vomiting, the need for intravenous fluid (IVF), and the need for hospital admission, compared with a placebo.

Although the use of ondansetron was associated with increased diarrhea within 48 hours of administration in three studies, this effect did not appear to increase health care use and it did not persist beyond 48 hours.

No other serious adverse events were reported in connection with ondansetron use.

Overall, the numbers of children needed to treat with ondansetron to prevent hospital admission, IVF use, and further vomiting for 1 child were 14, 5, and 5 children, respectively.

Doses of ondansetron ranged from 2 mg to 8 mg when given orally using weight-based dosing and 1.6–4.0 mg when given orally using age-based dosing. The intravenous ondansetron dosage ranged from 0.3 mg/kg to 0.15 mg/kg.

“Studies of antiemetic agents other than ondansetron had small sample sizes, were of low methodological quality, and produced inconsistent results,” the researchers explained.

The results were limited by the fact that the ondansetron studies included in this review were supported by GlaxoSmithKline, a manufacturer of ondansetron (Zofran). But ondansetron is available in a generic form, and additional studies, including cost-effectiveness studies, should not require industry support, the researchers noted.

Most of the studies in this review focused on moderately ill children who were treated in an emergency department. These children are generally at greater risk for hospitalization or IVF treatment than are children who present to primary care offices, the researchers added.

“Given the costs associated with IVF or hospital admission and the relatively low [numbers needed to treat] demonstrated in the present study, ondansetron use in [emergency departments] is likely to be cost effective,” they wrote.

No known data exist on the use of ondansetron to treat pediatric vomiting in general office settings, and more studies are needed to evaluate outcomes after ondansetron use in these settings.

“There is not sufficient evidence to recommend the use of ondansetron for pediatric [gastroenteritis] in outpatient settings, or among children with mild disease,” Dr. Rachel C. Vreeman of Indiana University, Indianapolis, and her colleagues wrote in an accompanying editorial (Arch. Pediatr. Adolesc. Med. 2008;162:866-9).

Dr. DeCamp and her colleagues and Dr. Vreeman and her colleagues stated that they had no financial conflicts.

Ondansetron therapy effectively reduced vomiting and other emetic complications—including hospital admissions—in children with acute gastroenteritis, based on results from a meta-analysis.

Current practice guidelines for treating children with gastroenteritis recommend oral rehydration therapy, but the guidelines don't recommend a drug treatment for vomiting, wrote Dr. Lisa Ross DeCamp and her colleagues at the University of North Carolina at Chapel Hill.

Vomiting may undermine oral rehydration therapy, and it is stressful for the children and their families (Arch. Pediatr. Adolesc. Med. 2008;?162:858-65).

To determine the value of antiemetics in relieving vomiting, the investigators reviewed findings from 11 studies on this topic. Several studies involved more than one drug.

The antiemetics included ondansetron (six studies), domperidone (two studies), trimethobenzamide (two studies), pyrilamine-pentobarbital (two studies), metoclopramide (two studies), dexamethasone (one study), and promethazine (one study).

Combined data from six randomized, double-blind, placebo-controlled trials including 745 children showed that ondansetron significantly reduced the risk of additional vomiting, the need for intravenous fluid (IVF), and the need for hospital admission, compared with a placebo.

Although the use of ondansetron was associated with increased diarrhea within 48 hours of administration in three studies, this effect did not appear to increase health care use and it did not persist beyond 48 hours.

No other serious adverse events were reported in connection with ondansetron use.

Overall, the numbers of children needed to treat with ondansetron to prevent hospital admission, IVF use, and further vomiting for 1 child were 14, 5, and 5 children, respectively.

Doses of ondansetron ranged from 2 mg to 8 mg when given orally using weight-based dosing and 1.6–4.0 mg when given orally using age-based dosing. The intravenous ondansetron dosage ranged from 0.3 mg/kg to 0.15 mg/kg.

“Studies of antiemetic agents other than ondansetron had small sample sizes, were of low methodological quality, and produced inconsistent results,” the researchers explained.

The results were limited by the fact that the ondansetron studies included in this review were supported by GlaxoSmithKline, a manufacturer of ondansetron (Zofran). But ondansetron is available in a generic form, and additional studies, including cost-effectiveness studies, should not require industry support, the researchers noted.

Most of the studies in this review focused on moderately ill children who were treated in an emergency department. These children are generally at greater risk for hospitalization or IVF treatment than are children who present to primary care offices, the researchers added.

“Given the costs associated with IVF or hospital admission and the relatively low [numbers needed to treat] demonstrated in the present study, ondansetron use in [emergency departments] is likely to be cost effective,” they wrote.

No known data exist on the use of ondansetron to treat pediatric vomiting in general office settings, and more studies are needed to evaluate outcomes after ondansetron use in these settings.

“There is not sufficient evidence to recommend the use of ondansetron for pediatric [gastroenteritis] in outpatient settings, or among children with mild disease,” Dr. Rachel C. Vreeman of Indiana University, Indianapolis, and her colleagues wrote in an accompanying editorial (Arch. Pediatr. Adolesc. Med. 2008;162:866-9).

Dr. DeCamp and her colleagues and Dr. Vreeman and her colleagues stated that they had no financial conflicts.