Heidi Splete

A new clinical practice guideline from the Endocrine Society provides strategies for keeping type 2 diabetes and cardiovascular disease at bay in adults with metabolic syndrome.

“This guideline focuses on [those] with the components of the metabolic syndrome who do not yet have diagnosed cardiovascular disease or type 2 diabetes mellitus, and on the steps that can be taken to prevent these two diseases,” the guideline authors said in an introductory statement.

Health care providers are urged to make metabolic risk reduction part of their regular practice by measuring waist circumference, blood pressure, fasting lipid profiles, and fasting glucose as part of every routine clinical visit. (See table.)

If patients approach or fall into the at-risk category for any of these measures, they should be counseled on how to reduce their disease risk with lifestyle management, including a healthy diet, adequate exercise, and weight loss if needed.

The guideline appeared in print in the Journal of Clinical Endocrinology and Metabolism and is now available online at www.endojournals.org

It defines metabolic risk as the risk for CVD and type 2 diabetes based on several elements, including elevated triglycerides, reduced HDL cholesterol, increased plasma glucose levels, hypertension, enlarged waist circumference, a prothrombotic state, and a proinflammatory state.

It also recommends a global risk assessment for signs on cardiovascular and coronary heart disease every 10 years for patients meeting the criteria for metabolic risk. The LDL cholesterol measure should be used to target lipoprotein-lowering therapy if lifestyle modification has been insufficient.

Patients meeting criteria for prediabetes based on measurements from a routine visit should be screened for diabetes at 1- to 2-year intervals using a fasting plasma glucose test or a 2-hour oral glucose tolerance test.

The society suggests that physicians screen for metabolic risk factors using the American Heart Association/National Heart, Lung, and Blood Institute definition at each clinical visit. “The finding of three or more components especially should alert the clinician to a patient at metabolic risk,” the guideline states.

The guideline should not be considered inclusive or exclusive of other approaches to care, the authors noted.

Dr. James L. Rosenzweig of Boston University, chair of the task force that developed the guidelines, stated that he had no financial conflicts to disclose. Other members of the task force had no financial interests to disclose, but they have served on speakers bureaus for multiple pharmaceutical companies including Novartis, Pfizer Inc., Merck & Co., and GlaxoSmithKline.

Elsevier Global Medical News

A new clinical practice guideline from the Endocrine Society provides strategies for keeping type 2 diabetes and cardiovascular disease at bay in adults with metabolic syndrome.

“This guideline focuses on [those] with the components of the metabolic syndrome who do not yet have diagnosed cardiovascular disease or type 2 diabetes mellitus, and on the steps that can be taken to prevent these two diseases,” the guideline authors said in an introductory statement.

Health care providers are urged to make metabolic risk reduction part of their regular practice by measuring waist circumference, blood pressure, fasting lipid profiles, and fasting glucose as part of every routine clinical visit. (See table.)

If patients approach or fall into the at-risk category for any of these measures, they should be counseled on how to reduce their disease risk with lifestyle management, including a healthy diet, adequate exercise, and weight loss if needed.

The guideline appeared in print in the Journal of Clinical Endocrinology and Metabolism and is now available online at www.endojournals.org

It defines metabolic risk as the risk for CVD and type 2 diabetes based on several elements, including elevated triglycerides, reduced HDL cholesterol, increased plasma glucose levels, hypertension, enlarged waist circumference, a prothrombotic state, and a proinflammatory state.

It also recommends a global risk assessment for signs on cardiovascular and coronary heart disease every 10 years for patients meeting the criteria for metabolic risk. The LDL cholesterol measure should be used to target lipoprotein-lowering therapy if lifestyle modification has been insufficient.

Patients meeting criteria for prediabetes based on measurements from a routine visit should be screened for diabetes at 1- to 2-year intervals using a fasting plasma glucose test or a 2-hour oral glucose tolerance test.

The society suggests that physicians screen for metabolic risk factors using the American Heart Association/National Heart, Lung, and Blood Institute definition at each clinical visit. “The finding of three or more components especially should alert the clinician to a patient at metabolic risk,” the guideline states.

The guideline should not be considered inclusive or exclusive of other approaches to care, the authors noted.

Dr. James L. Rosenzweig of Boston University, chair of the task force that developed the guidelines, stated that he had no financial conflicts to disclose. Other members of the task force had no financial interests to disclose, but they have served on speakers bureaus for multiple pharmaceutical companies including Novartis, Pfizer Inc., Merck & Co., and GlaxoSmithKline.

Elsevier Global Medical News

A new clinical practice guideline from the Endocrine Society provides strategies for keeping type 2 diabetes and cardiovascular disease at bay in adults with metabolic syndrome.

“This guideline focuses on [those] with the components of the metabolic syndrome who do not yet have diagnosed cardiovascular disease or type 2 diabetes mellitus, and on the steps that can be taken to prevent these two diseases,” the guideline authors said in an introductory statement.

Health care providers are urged to make metabolic risk reduction part of their regular practice by measuring waist circumference, blood pressure, fasting lipid profiles, and fasting glucose as part of every routine clinical visit. (See table.)

If patients approach or fall into the at-risk category for any of these measures, they should be counseled on how to reduce their disease risk with lifestyle management, including a healthy diet, adequate exercise, and weight loss if needed.

The guideline appeared in print in the Journal of Clinical Endocrinology and Metabolism and is now available online at www.endojournals.org

It defines metabolic risk as the risk for CVD and type 2 diabetes based on several elements, including elevated triglycerides, reduced HDL cholesterol, increased plasma glucose levels, hypertension, enlarged waist circumference, a prothrombotic state, and a proinflammatory state.

It also recommends a global risk assessment for signs on cardiovascular and coronary heart disease every 10 years for patients meeting the criteria for metabolic risk. The LDL cholesterol measure should be used to target lipoprotein-lowering therapy if lifestyle modification has been insufficient.

Patients meeting criteria for prediabetes based on measurements from a routine visit should be screened for diabetes at 1- to 2-year intervals using a fasting plasma glucose test or a 2-hour oral glucose tolerance test.

The society suggests that physicians screen for metabolic risk factors using the American Heart Association/National Heart, Lung, and Blood Institute definition at each clinical visit. “The finding of three or more components especially should alert the clinician to a patient at metabolic risk,” the guideline states.

The guideline should not be considered inclusive or exclusive of other approaches to care, the authors noted.

Dr. James L. Rosenzweig of Boston University, chair of the task force that developed the guidelines, stated that he had no financial conflicts to disclose. Other members of the task force had no financial interests to disclose, but they have served on speakers bureaus for multiple pharmaceutical companies including Novartis, Pfizer Inc., Merck & Co., and GlaxoSmithKline.

Elsevier Global Medical News

WASHINGTON—Perinatal outcomes were slightly, but not significantly, better in renal transplant recipients who were immunosuppressed with cyclosporine, compared with those given azathioprine, according to findings from a study involving 59 pregnant women at a single research center.

“There are no described rates of maternal mortality for women with renal transplants,” noted Dr. Vicenç Cararach, who presented study results at the annual meeting of the International Society of Obstetric Medicine.

Dr. Cararach and colleagues at the University of Barcelona compared 27 patients who were treated with azathioprine and prednisone (1973–1991) and 32 patients who were treated with cyclosporine and prednisone (1992–2007).

Overall, 3 patients (11%) in the azathioprine group and 2 patients (6%) in the cyclosporine group delivered at less than 32 weeks' gestation. An average of 13 infants in each group had birth weights below 2500 grams.

There were no maternal deaths in either group, and the three reported perinatal deaths all occurred in the azathioprine group.

More cases of premature rupture of membranes occurred in the azathioprine group, while more cases of preeclampsia and intrauterine growth restriction were found in the cyclosporine group.

Although these differences were not significant because of the limited number of cases, “it does not mean that they were not clinically important,” Dr. Cararach noted.

Creatinine levels during pregnancy were similar between the two groups, he said. However, 3 years after pregnancy, creatinine levels were higher in the cyclosporine group, which raises some concerns about renal function with long-term cyclosporine use, Dr. Cararach added.

The results support those from previous studies demonstrating that perinatal outcomes are generally positive among renal transplant recipients, he said.

However, the elevated risk of premature birth remains a concern. And there are long-term risks for hypertension and infection that deserve further study, he noted.

Dr. Cararach stated that he had no financial conflicts of interest.

WASHINGTON—Perinatal outcomes were slightly, but not significantly, better in renal transplant recipients who were immunosuppressed with cyclosporine, compared with those given azathioprine, according to findings from a study involving 59 pregnant women at a single research center.

“There are no described rates of maternal mortality for women with renal transplants,” noted Dr. Vicenç Cararach, who presented study results at the annual meeting of the International Society of Obstetric Medicine.

Dr. Cararach and colleagues at the University of Barcelona compared 27 patients who were treated with azathioprine and prednisone (1973–1991) and 32 patients who were treated with cyclosporine and prednisone (1992–2007).

Overall, 3 patients (11%) in the azathioprine group and 2 patients (6%) in the cyclosporine group delivered at less than 32 weeks' gestation. An average of 13 infants in each group had birth weights below 2500 grams.

There were no maternal deaths in either group, and the three reported perinatal deaths all occurred in the azathioprine group.

More cases of premature rupture of membranes occurred in the azathioprine group, while more cases of preeclampsia and intrauterine growth restriction were found in the cyclosporine group.

Although these differences were not significant because of the limited number of cases, “it does not mean that they were not clinically important,” Dr. Cararach noted.

Creatinine levels during pregnancy were similar between the two groups, he said. However, 3 years after pregnancy, creatinine levels were higher in the cyclosporine group, which raises some concerns about renal function with long-term cyclosporine use, Dr. Cararach added.

The results support those from previous studies demonstrating that perinatal outcomes are generally positive among renal transplant recipients, he said.

However, the elevated risk of premature birth remains a concern. And there are long-term risks for hypertension and infection that deserve further study, he noted.

Dr. Cararach stated that he had no financial conflicts of interest.

WASHINGTON—Perinatal outcomes were slightly, but not significantly, better in renal transplant recipients who were immunosuppressed with cyclosporine, compared with those given azathioprine, according to findings from a study involving 59 pregnant women at a single research center.

“There are no described rates of maternal mortality for women with renal transplants,” noted Dr. Vicenç Cararach, who presented study results at the annual meeting of the International Society of Obstetric Medicine.

Dr. Cararach and colleagues at the University of Barcelona compared 27 patients who were treated with azathioprine and prednisone (1973–1991) and 32 patients who were treated with cyclosporine and prednisone (1992–2007).

Overall, 3 patients (11%) in the azathioprine group and 2 patients (6%) in the cyclosporine group delivered at less than 32 weeks' gestation. An average of 13 infants in each group had birth weights below 2500 grams.

There were no maternal deaths in either group, and the three reported perinatal deaths all occurred in the azathioprine group.

More cases of premature rupture of membranes occurred in the azathioprine group, while more cases of preeclampsia and intrauterine growth restriction were found in the cyclosporine group.

Although these differences were not significant because of the limited number of cases, “it does not mean that they were not clinically important,” Dr. Cararach noted.

Creatinine levels during pregnancy were similar between the two groups, he said. However, 3 years after pregnancy, creatinine levels were higher in the cyclosporine group, which raises some concerns about renal function with long-term cyclosporine use, Dr. Cararach added.

The results support those from previous studies demonstrating that perinatal outcomes are generally positive among renal transplant recipients, he said.

However, the elevated risk of premature birth remains a concern. And there are long-term risks for hypertension and infection that deserve further study, he noted.

Dr. Cararach stated that he had no financial conflicts of interest.

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 as were adults whose mothers did not 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 found that hypertension was a significant predictor of stroke, but was not a significant predictor of CHD.

Dr. Kajantie stated that he 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 as were adults whose mothers did not 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 found that hypertension was a significant predictor of stroke, but was not a significant predictor of CHD.

Dr. Kajantie stated that he 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 as were adults whose mothers did not 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 found that hypertension was a significant predictor of stroke, but was not a significant predictor of CHD.

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

WASHINGTON — An updated pneumococcal conjugate vaccine containing 13 different bacterial strains appears to be safe and immunogenic, based on pilot data from four European studies including several hundred infants and toddlers.

The data were presented in a poster session at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the annual meeting of the Infectious Diseases Society of America (IDSA).

“Globally, the pneumococcus has been estimated to account for around 1 million deaths annually in children less than 5 years old,” stated Dr. Dorothee Kieninger of Johannes Gutenberg University in Mainz, Germany, and colleagues.

Data from the Centers for Disease Control and Prevention in Atlanta have shown a significant decrease in pneumococcal disease in U.S. children thanks to the 7-valent pneumococcal conjugate vaccine (PCV7). But outbreaks of disease in recent years have been linked to bacterial strains not included in this vaccine, particularly serotype 19A, according to the CDC.

The studies presented at the meeting showed that the new vaccine appeared to generate an immune response with few adverse effects, but it must earn approval from the Food and Drug Administration before it can be licensed and distributed.

In Dr. Kieninger's study, 604 healthy 2-month-old infants in Germany were randomized to receive PCV7 (303 infants) or the new vaccine PCV13 (301 infants). The children received the pneumococcal vaccines in addition to a combined diphtheria, tetanus, and acellular pertussis (DTaP) vaccine, inactivated polio vaccine (IPV), Haemophilus influenzae type b polysaccharide PRP (Hib), and hepatitis B surface antigen (HBsAg) (GlaxoSmithKline's Infanrix hexa). They received the vaccinations at 2, 3, and 4 months, and again at 11–12 months. Blood samples were taken after the infant series at 5 months, and again after the toddler vaccination at 12–13 months.

The researchers compared adverse events and assessed immune responses to the seven serotypes in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F) and the six additional strains in PCV13 (1, 3, 5, 6A, 7F, and 19A).

Overall, antibody responses to the PCV7 serotypes were similar in both groups. But for the six additional serotypes in PCV13, the functional antibodies were 10–100 times higher in the PCV13 group, compared with the PCV7 group.

The positive antibody response of 19A is of particular interest, given the increased incidence of pneumococcal disease caused by this serotype, Dr. Christine Juergens of Wyeth Research in Muenster, Germany, said in an interview.

The primary measure of immunogenicity in this study and the other PCV13 studies presented at the meeting was the proportion of children who achieved an antipolysaccharide IgG binding concentration of at least 0.35 mcg/mL. For 19A, this percentage was 99% in the PCV13 group.

The lack of interference from concomitant vaccines in the safety and effectiveness of PCV13 also is important, said Dr. Juergens, a coinvestigator for the study.

No clinically meaningful differences in safety or tolerability were observed between the two groups, the researchers said, and no severe adverse events were reported in either group in response to the infant dose. One incidence of febrile convulsion occurred in one toddler in the PCV7 group.

But there were some significant differences in local reactions between the PCV13 and PCV7 groups. Patients who received PCV13 compared with PCV7 reported significantly more induration (28% vs. 21%) but significantly less erythema (28% vs. 36%) after the first dose, and significantly less induration (27% vs. 35%) and erythema (34% vs. 47%) after the second dose. In addition, there was a significantly greater incidence of mild fever after the third dose in the PCV13 group, compared with the PCV7 group (46% vs. 37%) but there was a significantly lower incidence of sleepiness after the second dose in the PCV13 group, compared with the PCV7 group (54% vs. 67%).

Data from another study of a three-dose infant vaccination series showed similar safety and immunogenicity results for PCV7 and PCV13 when each vaccine was given along with a DTaP, IPV, and Hib vaccine (Sanofi Pasteur's Pentavac). This study was conducted in France by Dr. Emmanuel Grimprel of the Armand Trousseau Hospital in Paris, and colleagues.

Overall, the immune responses to the concomitant antigens for a three-dose infant series were similar between a group of 266 healthy 2-month-olds who were randomized to receive PCV13 and 263 who received PCV7. The infants were vaccinated at 2, 3, and 4 months of age, and blood samples were taken at 5 months to measure immune response.

After dose 3 of the infant series, the pneumococcal immune response rate in the PCV13 group was at least 72% for all serotypes and 98% for 19A. Antibody response rates to the concomitant vaccine ranged from 59% to 100% in the PCV13 group and 63% to 100% in the PCV7 group.

In this study, as in other studies, the incidence of adverse events including injection site tenderness, erythema, and induration were not significantly different between the two groups.

The results from the French study were mirrored in a similar study conducted by Dr. Chaamala Klinger of the University of Oxford (England), and colleagues. This study included data from 135 infants aged 6–14 weeks who were randomized to receive PCV13 and 132 infants who received PCV7. Infants in both groups received the meningococcal serotype C vaccine at 2 and 4 months of age, and the pneumococcal conjugate vaccine, plus a DTaP, IPV, and Hib vaccine at age 2, 3, and 4 months.

Overall, 79%–96% of the children who received PCV13 met the criteria for protection against the six serotypes not included in PCV7, and 95% met the criteria for protection against 19A. “PCV13 was immunogenic and well tolerated when given as part of the UK infant vaccine course,” the researchers wrote.

Local reactions including tenderness, induration, and erythema were similar between the two groups, as were systemic reactions.

A study of the safety and immunogenicity of PCV13 when it was produced on a manufacturing scale supported the results from the three pilot studies.

In this study, conducted by Dr. Janusz Gadzinowski of the Poznan (Poland) University of Medical Sciences, and colleagues, 134 healthy 2-month-olds were randomized to receive the PCV13 pilot vaccine and 135 received the PCV13 manufacturing scale vaccine.

The infants in each group received the PCV13 along with a DTaP, IPV, Hib vaccine, and a hepatitis B vaccine. The infants were vaccinated at 2, 3, and 4 months of age, and the researchers took blood samples at 5 months to test for immune response.

Overall, the proportions of responders who met the criteria for immunogenicity and geometric mean concentration were similar in both groups. For serotype 19A, both groups achieved identical response rates of 99%.

Adverse events were mostly mild or moderate and the investigators considered them unrelated to vaccine. Only one serious adverse event (a case of inconsolable crying) was considered vaccine related, they said. All four studies were supported by Wyeth, a manufacturer of PCV13.

S. pneumoniae Serotype 19A Tied To Necrotizing Pneumonia in Kids

Serotype 19A of Streptococcus pneumoniae is the culprit behind some complicated cases of necrotizing pneumonia in young children, based on findings from four cases that occurred between Sept. 7, 2007, and March 30, 2008, at a single hospital.

“Severe necrotizing pneumonia caused by this serotype had not previously been reported in children,” said Dr. Susan Wootton of the University of Texas, Houston, who presented the cases with her associates in a poster at the jointly held annual meeting of ICAAC and IDSA.

The 19A strain is one of several that are not included in the current pneumococcal conjugate vaccine, PCV7. Data from the Centers for Disease Control and Prevention that also were presented at the meeting showed an increase in invasive pneumococcal disease from nonvaccine serotypes in all age groups.

The patients ranged in age from 3 to 4 years (mean age, 3.4 years). Three were previously healthy and one had asthma. All four had been vaccinated with PCV7. S. pneumoniae was isolated from pleural fluid in three cases and from blood in three cases.

Chest radiographs revealed multilobar infiltrates in four children, empyema in three, and pneumatoceles in two. Three children were admitted to the intensive care unit and intubated 5–22 days. Three children had abscesses that required surgical drainage. The hospital stays ranged from 11 to 28 days.

Serotype 19A has not previously been reported as a cause of complicated pneumonia in children, but these cases suggest that it should now be considered in the differential diagnosis, Dr. Wootton and her associates noted. The results support the need for an expanded pneumococcal vaccine, they said.

Dr. Wootton had no financial conflicts to disclose.

WASHINGTON — An updated pneumococcal conjugate vaccine containing 13 different bacterial strains appears to be safe and immunogenic, based on pilot data from four European studies including several hundred infants and toddlers.

The data were presented in a poster session at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the annual meeting of the Infectious Diseases Society of America (IDSA).

“Globally, the pneumococcus has been estimated to account for around 1 million deaths annually in children less than 5 years old,” stated Dr. Dorothee Kieninger of Johannes Gutenberg University in Mainz, Germany, and colleagues.

Data from the Centers for Disease Control and Prevention in Atlanta have shown a significant decrease in pneumococcal disease in U.S. children thanks to the 7-valent pneumococcal conjugate vaccine (PCV7). But outbreaks of disease in recent years have been linked to bacterial strains not included in this vaccine, particularly serotype 19A, according to the CDC.

The studies presented at the meeting showed that the new vaccine appeared to generate an immune response with few adverse effects, but it must earn approval from the Food and Drug Administration before it can be licensed and distributed.

In Dr. Kieninger's study, 604 healthy 2-month-old infants in Germany were randomized to receive PCV7 (303 infants) or the new vaccine PCV13 (301 infants). The children received the pneumococcal vaccines in addition to a combined diphtheria, tetanus, and acellular pertussis (DTaP) vaccine, inactivated polio vaccine (IPV), Haemophilus influenzae type b polysaccharide PRP (Hib), and hepatitis B surface antigen (HBsAg) (GlaxoSmithKline's Infanrix hexa). They received the vaccinations at 2, 3, and 4 months, and again at 11–12 months. Blood samples were taken after the infant series at 5 months, and again after the toddler vaccination at 12–13 months.

The researchers compared adverse events and assessed immune responses to the seven serotypes in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F) and the six additional strains in PCV13 (1, 3, 5, 6A, 7F, and 19A).

Overall, antibody responses to the PCV7 serotypes were similar in both groups. But for the six additional serotypes in PCV13, the functional antibodies were 10–100 times higher in the PCV13 group, compared with the PCV7 group.

The positive antibody response of 19A is of particular interest, given the increased incidence of pneumococcal disease caused by this serotype, Dr. Christine Juergens of Wyeth Research in Muenster, Germany, said in an interview.

The primary measure of immunogenicity in this study and the other PCV13 studies presented at the meeting was the proportion of children who achieved an antipolysaccharide IgG binding concentration of at least 0.35 mcg/mL. For 19A, this percentage was 99% in the PCV13 group.

The lack of interference from concomitant vaccines in the safety and effectiveness of PCV13 also is important, said Dr. Juergens, a coinvestigator for the study.

No clinically meaningful differences in safety or tolerability were observed between the two groups, the researchers said, and no severe adverse events were reported in either group in response to the infant dose. One incidence of febrile convulsion occurred in one toddler in the PCV7 group.

But there were some significant differences in local reactions between the PCV13 and PCV7 groups. Patients who received PCV13 compared with PCV7 reported significantly more induration (28% vs. 21%) but significantly less erythema (28% vs. 36%) after the first dose, and significantly less induration (27% vs. 35%) and erythema (34% vs. 47%) after the second dose. In addition, there was a significantly greater incidence of mild fever after the third dose in the PCV13 group, compared with the PCV7 group (46% vs. 37%) but there was a significantly lower incidence of sleepiness after the second dose in the PCV13 group, compared with the PCV7 group (54% vs. 67%).

Data from another study of a three-dose infant vaccination series showed similar safety and immunogenicity results for PCV7 and PCV13 when each vaccine was given along with a DTaP, IPV, and Hib vaccine (Sanofi Pasteur's Pentavac). This study was conducted in France by Dr. Emmanuel Grimprel of the Armand Trousseau Hospital in Paris, and colleagues.

Overall, the immune responses to the concomitant antigens for a three-dose infant series were similar between a group of 266 healthy 2-month-olds who were randomized to receive PCV13 and 263 who received PCV7. The infants were vaccinated at 2, 3, and 4 months of age, and blood samples were taken at 5 months to measure immune response.

After dose 3 of the infant series, the pneumococcal immune response rate in the PCV13 group was at least 72% for all serotypes and 98% for 19A. Antibody response rates to the concomitant vaccine ranged from 59% to 100% in the PCV13 group and 63% to 100% in the PCV7 group.

In this study, as in other studies, the incidence of adverse events including injection site tenderness, erythema, and induration were not significantly different between the two groups.

The results from the French study were mirrored in a similar study conducted by Dr. Chaamala Klinger of the University of Oxford (England), and colleagues. This study included data from 135 infants aged 6–14 weeks who were randomized to receive PCV13 and 132 infants who received PCV7. Infants in both groups received the meningococcal serotype C vaccine at 2 and 4 months of age, and the pneumococcal conjugate vaccine, plus a DTaP, IPV, and Hib vaccine at age 2, 3, and 4 months.

Overall, 79%–96% of the children who received PCV13 met the criteria for protection against the six serotypes not included in PCV7, and 95% met the criteria for protection against 19A. “PCV13 was immunogenic and well tolerated when given as part of the UK infant vaccine course,” the researchers wrote.

Local reactions including tenderness, induration, and erythema were similar between the two groups, as were systemic reactions.

A study of the safety and immunogenicity of PCV13 when it was produced on a manufacturing scale supported the results from the three pilot studies.

In this study, conducted by Dr. Janusz Gadzinowski of the Poznan (Poland) University of Medical Sciences, and colleagues, 134 healthy 2-month-olds were randomized to receive the PCV13 pilot vaccine and 135 received the PCV13 manufacturing scale vaccine.

The infants in each group received the PCV13 along with a DTaP, IPV, Hib vaccine, and a hepatitis B vaccine. The infants were vaccinated at 2, 3, and 4 months of age, and the researchers took blood samples at 5 months to test for immune response.

Overall, the proportions of responders who met the criteria for immunogenicity and geometric mean concentration were similar in both groups. For serotype 19A, both groups achieved identical response rates of 99%.

Adverse events were mostly mild or moderate and the investigators considered them unrelated to vaccine. Only one serious adverse event (a case of inconsolable crying) was considered vaccine related, they said. All four studies were supported by Wyeth, a manufacturer of PCV13.

S. pneumoniae Serotype 19A Tied To Necrotizing Pneumonia in Kids

Serotype 19A of Streptococcus pneumoniae is the culprit behind some complicated cases of necrotizing pneumonia in young children, based on findings from four cases that occurred between Sept. 7, 2007, and March 30, 2008, at a single hospital.

“Severe necrotizing pneumonia caused by this serotype had not previously been reported in children,” said Dr. Susan Wootton of the University of Texas, Houston, who presented the cases with her associates in a poster at the jointly held annual meeting of ICAAC and IDSA.

The 19A strain is one of several that are not included in the current pneumococcal conjugate vaccine, PCV7. Data from the Centers for Disease Control and Prevention that also were presented at the meeting showed an increase in invasive pneumococcal disease from nonvaccine serotypes in all age groups.

The patients ranged in age from 3 to 4 years (mean age, 3.4 years). Three were previously healthy and one had asthma. All four had been vaccinated with PCV7. S. pneumoniae was isolated from pleural fluid in three cases and from blood in three cases.

Chest radiographs revealed multilobar infiltrates in four children, empyema in three, and pneumatoceles in two. Three children were admitted to the intensive care unit and intubated 5–22 days. Three children had abscesses that required surgical drainage. The hospital stays ranged from 11 to 28 days.

Serotype 19A has not previously been reported as a cause of complicated pneumonia in children, but these cases suggest that it should now be considered in the differential diagnosis, Dr. Wootton and her associates noted. The results support the need for an expanded pneumococcal vaccine, they said.

Dr. Wootton had no financial conflicts to disclose.

WASHINGTON — An updated pneumococcal conjugate vaccine containing 13 different bacterial strains appears to be safe and immunogenic, based on pilot data from four European studies including several hundred infants and toddlers.

The data were presented in a poster session at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the annual meeting of the Infectious Diseases Society of America (IDSA).

“Globally, the pneumococcus has been estimated to account for around 1 million deaths annually in children less than 5 years old,” stated Dr. Dorothee Kieninger of Johannes Gutenberg University in Mainz, Germany, and colleagues.

Data from the Centers for Disease Control and Prevention in Atlanta have shown a significant decrease in pneumococcal disease in U.S. children thanks to the 7-valent pneumococcal conjugate vaccine (PCV7). But outbreaks of disease in recent years have been linked to bacterial strains not included in this vaccine, particularly serotype 19A, according to the CDC.

The studies presented at the meeting showed that the new vaccine appeared to generate an immune response with few adverse effects, but it must earn approval from the Food and Drug Administration before it can be licensed and distributed.

In Dr. Kieninger's study, 604 healthy 2-month-old infants in Germany were randomized to receive PCV7 (303 infants) or the new vaccine PCV13 (301 infants). The children received the pneumococcal vaccines in addition to a combined diphtheria, tetanus, and acellular pertussis (DTaP) vaccine, inactivated polio vaccine (IPV), Haemophilus influenzae type b polysaccharide PRP (Hib), and hepatitis B surface antigen (HBsAg) (GlaxoSmithKline's Infanrix hexa). They received the vaccinations at 2, 3, and 4 months, and again at 11–12 months. Blood samples were taken after the infant series at 5 months, and again after the toddler vaccination at 12–13 months.

The researchers compared adverse events and assessed immune responses to the seven serotypes in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F) and the six additional strains in PCV13 (1, 3, 5, 6A, 7F, and 19A).

Overall, antibody responses to the PCV7 serotypes were similar in both groups. But for the six additional serotypes in PCV13, the functional antibodies were 10–100 times higher in the PCV13 group, compared with the PCV7 group.

The positive antibody response of 19A is of particular interest, given the increased incidence of pneumococcal disease caused by this serotype, Dr. Christine Juergens of Wyeth Research in Muenster, Germany, said in an interview.

The primary measure of immunogenicity in this study and the other PCV13 studies presented at the meeting was the proportion of children who achieved an antipolysaccharide IgG binding concentration of at least 0.35 mcg/mL. For 19A, this percentage was 99% in the PCV13 group.

The lack of interference from concomitant vaccines in the safety and effectiveness of PCV13 also is important, said Dr. Juergens, a coinvestigator for the study.

No clinically meaningful differences in safety or tolerability were observed between the two groups, the researchers said, and no severe adverse events were reported in either group in response to the infant dose. One incidence of febrile convulsion occurred in one toddler in the PCV7 group.

But there were some significant differences in local reactions between the PCV13 and PCV7 groups. Patients who received PCV13 compared with PCV7 reported significantly more induration (28% vs. 21%) but significantly less erythema (28% vs. 36%) after the first dose, and significantly less induration (27% vs. 35%) and erythema (34% vs. 47%) after the second dose. In addition, there was a significantly greater incidence of mild fever after the third dose in the PCV13 group, compared with the PCV7 group (46% vs. 37%) but there was a significantly lower incidence of sleepiness after the second dose in the PCV13 group, compared with the PCV7 group (54% vs. 67%).

Data from another study of a three-dose infant vaccination series showed similar safety and immunogenicity results for PCV7 and PCV13 when each vaccine was given along with a DTaP, IPV, and Hib vaccine (Sanofi Pasteur's Pentavac). This study was conducted in France by Dr. Emmanuel Grimprel of the Armand Trousseau Hospital in Paris, and colleagues.

Overall, the immune responses to the concomitant antigens for a three-dose infant series were similar between a group of 266 healthy 2-month-olds who were randomized to receive PCV13 and 263 who received PCV7. The infants were vaccinated at 2, 3, and 4 months of age, and blood samples were taken at 5 months to measure immune response.

After dose 3 of the infant series, the pneumococcal immune response rate in the PCV13 group was at least 72% for all serotypes and 98% for 19A. Antibody response rates to the concomitant vaccine ranged from 59% to 100% in the PCV13 group and 63% to 100% in the PCV7 group.

In this study, as in other studies, the incidence of adverse events including injection site tenderness, erythema, and induration were not significantly different between the two groups.

The results from the French study were mirrored in a similar study conducted by Dr. Chaamala Klinger of the University of Oxford (England), and colleagues. This study included data from 135 infants aged 6–14 weeks who were randomized to receive PCV13 and 132 infants who received PCV7. Infants in both groups received the meningococcal serotype C vaccine at 2 and 4 months of age, and the pneumococcal conjugate vaccine, plus a DTaP, IPV, and Hib vaccine at age 2, 3, and 4 months.

Overall, 79%–96% of the children who received PCV13 met the criteria for protection against the six serotypes not included in PCV7, and 95% met the criteria for protection against 19A. “PCV13 was immunogenic and well tolerated when given as part of the UK infant vaccine course,” the researchers wrote.

Local reactions including tenderness, induration, and erythema were similar between the two groups, as were systemic reactions.

A study of the safety and immunogenicity of PCV13 when it was produced on a manufacturing scale supported the results from the three pilot studies.

In this study, conducted by Dr. Janusz Gadzinowski of the Poznan (Poland) University of Medical Sciences, and colleagues, 134 healthy 2-month-olds were randomized to receive the PCV13 pilot vaccine and 135 received the PCV13 manufacturing scale vaccine.

The infants in each group received the PCV13 along with a DTaP, IPV, Hib vaccine, and a hepatitis B vaccine. The infants were vaccinated at 2, 3, and 4 months of age, and the researchers took blood samples at 5 months to test for immune response.

Overall, the proportions of responders who met the criteria for immunogenicity and geometric mean concentration were similar in both groups. For serotype 19A, both groups achieved identical response rates of 99%.

Adverse events were mostly mild or moderate and the investigators considered them unrelated to vaccine. Only one serious adverse event (a case of inconsolable crying) was considered vaccine related, they said. All four studies were supported by Wyeth, a manufacturer of PCV13.

S. pneumoniae Serotype 19A Tied To Necrotizing Pneumonia in Kids

Serotype 19A of Streptococcus pneumoniae is the culprit behind some complicated cases of necrotizing pneumonia in young children, based on findings from four cases that occurred between Sept. 7, 2007, and March 30, 2008, at a single hospital.

“Severe necrotizing pneumonia caused by this serotype had not previously been reported in children,” said Dr. Susan Wootton of the University of Texas, Houston, who presented the cases with her associates in a poster at the jointly held annual meeting of ICAAC and IDSA.

The 19A strain is one of several that are not included in the current pneumococcal conjugate vaccine, PCV7. Data from the Centers for Disease Control and Prevention that also were presented at the meeting showed an increase in invasive pneumococcal disease from nonvaccine serotypes in all age groups.

The patients ranged in age from 3 to 4 years (mean age, 3.4 years). Three were previously healthy and one had asthma. All four had been vaccinated with PCV7. S. pneumoniae was isolated from pleural fluid in three cases and from blood in three cases.

Chest radiographs revealed multilobar infiltrates in four children, empyema in three, and pneumatoceles in two. Three children were admitted to the intensive care unit and intubated 5–22 days. Three children had abscesses that required surgical drainage. The hospital stays ranged from 11 to 28 days.

Serotype 19A has not previously been reported as a cause of complicated pneumonia in children, but these cases suggest that it should now be considered in the differential diagnosis, Dr. Wootton and her associates noted. The results support the need for an expanded pneumococcal vaccine, they said.

Dr. Wootton had no financial conflicts to disclose.

WASHINGTON — Despite recent mumps outbreaks in vaccinated populations, a two-dose vaccination strategy appears effective, according to findings from an analysis of the 2006 mumps outbreak in the United States.

That said, a third dose may be warranted during an outbreak, Dr. Jane Seward suggested during a presentation at the joint annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America.

“A resurgence of mumps in countries using mumps vaccine programs should be kept in the perspective of the tremendous gains from the entire program,” said Dr. Seward, deputy director of the division of viral diseases at the National Center for Infectious Diseases, a division of the Centers for Disease Control and Prevention.

Findings from previous studies demonstrate that the effectiveness of one dose of mumps vaccine is approximately 80%, and the effectiveness of two doses is about 90%. Outbreaks have been reported in several countries in populations that have received a single dose of vaccine.

After vaccination was introduced in the United States in 1977, the number of mumps cases underwent a “sharp and sustained decline,” Dr. Seward said.

Nevertheless, two recent outbreaks in populations that were highly vaccinated with two doses of mumps vaccine raise concerns that the vaccine's effectiveness might be waning, she said.

The 2006 mumps outbreak in the United States involved 6,584 people. The outbreak was heavily centered on college campuses in the Midwest. Most cases occurred in individuals aged 18–24 years, and the vaccine coverage rate among the cases was more than 95%.

Most people in the United States who had received two doses of vaccine didn't get mumps, Dr. Seward emphasized. Before the 2006 outbreak, fewer than 300 cases had been reported annually for several years.

In addition to waning vaccine effectiveness, possible factors associated with the 2006 outbreak also include a lack of exposure to the wild mumps virus, the high-transmission environment of university settings, and transmission of the mumps virus from subclinical infections, Dr. Seward said.

Data from studies conducted during the outbreak showed that infection was most common among college freshman and that infection was more likely among individuals who had received their second dose of vaccine more than 10 years before the outbreak.

An analysis of blood samples from students at an unaffected campus indicated that mumps antibody levels were significantly higher in those who had received their second dose of vaccine less than 5 years earlier, compared with those who had received it more than 15 years earlier.

During a similar outbreak in the Czech Republic, 6,000 cases of mumps were reported over an 18-month period in 2006–2007. The median age of the patients during this outbreak was 16 years. The incidence was 230/100,000 in 15- to 19-year-olds, compared with the national incidence of 39/100,000. About 70% of those infected had received two doses, and the median age of the two-dose recipients was 15 years, Dr. Seward said.

“We are starting a project to understand the immune response to a third dose, and we will follow those patients,” Dr. Seward said at a press conference. The cause of mumps outbreaks in vaccinated populations remains unknown, and more research is needed to determine whether a third dose of vaccine given routinely or in cases of outbreaks would be beneficial, she noted.

“If we see outbreaks [as] we saw in 2006, especially on college campuses where there is a lot of transmission, we would consider offering a third dose during an outbreak.”

Adolescents and adults without evidence of immunity should receive two doses of the mumps vaccine. Mumps vaccination has had a dramatic impact on morbidity and mortality in the United States, and has reduced the rates of serious complications including meningitis and deafness. “There were probably 2 million cases of mumps per year before the vaccine came into use,” Dr. Seward said.

Dr. Seward stated that she had no financial conflicts to disclose.

WASHINGTON — Despite recent mumps outbreaks in vaccinated populations, a two-dose vaccination strategy appears effective, according to findings from an analysis of the 2006 mumps outbreak in the United States.

That said, a third dose may be warranted during an outbreak, Dr. Jane Seward suggested during a presentation at the joint annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America.

“A resurgence of mumps in countries using mumps vaccine programs should be kept in the perspective of the tremendous gains from the entire program,” said Dr. Seward, deputy director of the division of viral diseases at the National Center for Infectious Diseases, a division of the Centers for Disease Control and Prevention.

Findings from previous studies demonstrate that the effectiveness of one dose of mumps vaccine is approximately 80%, and the effectiveness of two doses is about 90%. Outbreaks have been reported in several countries in populations that have received a single dose of vaccine.

After vaccination was introduced in the United States in 1977, the number of mumps cases underwent a “sharp and sustained decline,” Dr. Seward said.

Nevertheless, two recent outbreaks in populations that were highly vaccinated with two doses of mumps vaccine raise concerns that the vaccine's effectiveness might be waning, she said.

The 2006 mumps outbreak in the United States involved 6,584 people. The outbreak was heavily centered on college campuses in the Midwest. Most cases occurred in individuals aged 18–24 years, and the vaccine coverage rate among the cases was more than 95%.

Most people in the United States who had received two doses of vaccine didn't get mumps, Dr. Seward emphasized. Before the 2006 outbreak, fewer than 300 cases had been reported annually for several years.

In addition to waning vaccine effectiveness, possible factors associated with the 2006 outbreak also include a lack of exposure to the wild mumps virus, the high-transmission environment of university settings, and transmission of the mumps virus from subclinical infections, Dr. Seward said.

Data from studies conducted during the outbreak showed that infection was most common among college freshman and that infection was more likely among individuals who had received their second dose of vaccine more than 10 years before the outbreak.

An analysis of blood samples from students at an unaffected campus indicated that mumps antibody levels were significantly higher in those who had received their second dose of vaccine less than 5 years earlier, compared with those who had received it more than 15 years earlier.

During a similar outbreak in the Czech Republic, 6,000 cases of mumps were reported over an 18-month period in 2006–2007. The median age of the patients during this outbreak was 16 years. The incidence was 230/100,000 in 15- to 19-year-olds, compared with the national incidence of 39/100,000. About 70% of those infected had received two doses, and the median age of the two-dose recipients was 15 years, Dr. Seward said.

“We are starting a project to understand the immune response to a third dose, and we will follow those patients,” Dr. Seward said at a press conference. The cause of mumps outbreaks in vaccinated populations remains unknown, and more research is needed to determine whether a third dose of vaccine given routinely or in cases of outbreaks would be beneficial, she noted.

“If we see outbreaks [as] we saw in 2006, especially on college campuses where there is a lot of transmission, we would consider offering a third dose during an outbreak.”

Adolescents and adults without evidence of immunity should receive two doses of the mumps vaccine. Mumps vaccination has had a dramatic impact on morbidity and mortality in the United States, and has reduced the rates of serious complications including meningitis and deafness. “There were probably 2 million cases of mumps per year before the vaccine came into use,” Dr. Seward said.

Dr. Seward stated that she had no financial conflicts to disclose.

WASHINGTON — Despite recent mumps outbreaks in vaccinated populations, a two-dose vaccination strategy appears effective, according to findings from an analysis of the 2006 mumps outbreak in the United States.

That said, a third dose may be warranted during an outbreak, Dr. Jane Seward suggested during a presentation at the joint annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America.

“A resurgence of mumps in countries using mumps vaccine programs should be kept in the perspective of the tremendous gains from the entire program,” said Dr. Seward, deputy director of the division of viral diseases at the National Center for Infectious Diseases, a division of the Centers for Disease Control and Prevention.

Findings from previous studies demonstrate that the effectiveness of one dose of mumps vaccine is approximately 80%, and the effectiveness of two doses is about 90%. Outbreaks have been reported in several countries in populations that have received a single dose of vaccine.

After vaccination was introduced in the United States in 1977, the number of mumps cases underwent a “sharp and sustained decline,” Dr. Seward said.

Nevertheless, two recent outbreaks in populations that were highly vaccinated with two doses of mumps vaccine raise concerns that the vaccine's effectiveness might be waning, she said.

The 2006 mumps outbreak in the United States involved 6,584 people. The outbreak was heavily centered on college campuses in the Midwest. Most cases occurred in individuals aged 18–24 years, and the vaccine coverage rate among the cases was more than 95%.

Most people in the United States who had received two doses of vaccine didn't get mumps, Dr. Seward emphasized. Before the 2006 outbreak, fewer than 300 cases had been reported annually for several years.

In addition to waning vaccine effectiveness, possible factors associated with the 2006 outbreak also include a lack of exposure to the wild mumps virus, the high-transmission environment of university settings, and transmission of the mumps virus from subclinical infections, Dr. Seward said.

Data from studies conducted during the outbreak showed that infection was most common among college freshman and that infection was more likely among individuals who had received their second dose of vaccine more than 10 years before the outbreak.

An analysis of blood samples from students at an unaffected campus indicated that mumps antibody levels were significantly higher in those who had received their second dose of vaccine less than 5 years earlier, compared with those who had received it more than 15 years earlier.

During a similar outbreak in the Czech Republic, 6,000 cases of mumps were reported over an 18-month period in 2006–2007. The median age of the patients during this outbreak was 16 years. The incidence was 230/100,000 in 15- to 19-year-olds, compared with the national incidence of 39/100,000. About 70% of those infected had received two doses, and the median age of the two-dose recipients was 15 years, Dr. Seward said.

“We are starting a project to understand the immune response to a third dose, and we will follow those patients,” Dr. Seward said at a press conference. The cause of mumps outbreaks in vaccinated populations remains unknown, and more research is needed to determine whether a third dose of vaccine given routinely or in cases of outbreaks would be beneficial, she noted.

“If we see outbreaks [as] we saw in 2006, especially on college campuses where there is a lot of transmission, we would consider offering a third dose during an outbreak.”

Adolescents and adults without evidence of immunity should receive two doses of the mumps vaccine. Mumps vaccination has had a dramatic impact on morbidity and mortality in the United States, and has reduced the rates of serious complications including meningitis and deafness. “There were probably 2 million cases of mumps per year before the vaccine came into use,” Dr. Seward said.

Dr. Seward stated that she had no financial conflicts to disclose.

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.