Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.

Atomoxetine for ADHD Reduces Symptoms, But Impairment Persists

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Atomoxetine for ADHD Reduces Symptoms, But Impairment Persists

Atomoxetine was generally well tolerated and resulted in reduced core ADHD symptoms in a study of 101 5- and 6-year-old children in a randomized, placebo-controlled trial, but those reductions did not necessarily translate to overall clinical and functional improvement.

After 8 weeks, mean total scores on the ADHD-IV Rating Scale were reduced significantly more in the treatment vs. placebo groups, based on both parent reports (–13.2 vs. –5.8 points) and teacher reports (–12.5 vs. –5.0 points). However, the difference between the treatment and placebo groups in regard to the number of patients who were much or very much improved, based on Clinical Global Impressions–Improvement (CGI-I) scale scores after adjustment for age and study center, did not differ significantly, with 40% vs. 22% of treatment and placebo patients, respectively, being much or very much improved, Dr. Christopher J. Kratochvil of the University of Nebraska, Omaha, and his colleagues reported online in Pediatrics.

Furthermore, 62% of 44 participants in the treatment group and 77% of 49 in the placebo group remained moderately, markedly, or severely ill at the completion of the study, based on the Clinical Global Impressions–Severity (CGI-S) scale, the investigators said (Pediatrics 2011 March 21 [doi:10.1542/peds.2010-0825]).

Study participants were children aged 5 and 6 years (mean, 6.1 years) who met the criteria for any subtype of ADHD based on the DISC (Diagnostic Interview Schedule for Children), a clinical interview, and review by a clinical consensus conference of the three academic research sites participating in the trial. Most of the children (68%) were male, and most (86%) were white.

The study drug was initiated at 0.5 mg/kg per day, with flexible titration to 0.8, 1.2, 1.4, and a maximum of 1.8 mg/kg per day (average, 1.4 mg/kg per day) at four weekly and one biweekly visit, based on response, tolerability and a pharmacotherapist’s clinical judgment. At each visit, a pharmacotherapist provided psychoeducation about ADHD and behavioral-management strategies to the parents.

Treatment was generally well tolerated. Those in the treatment group were significantly more likely to experience decreased appetite, gastrointestinal upset, and sedation. However, those effects were mild or moderate in severity.

The findings provide useful information because – despite limited data – practitioners commonly treat ADHD in preschoolers with stimulant and nonstimulant agents, including atomoxetine, the investigators said.

Based on findings from a prior study showing that effect sizes with another treatment (immediate-release methylphenidate) varied in preschool- and school-age children, investigators in the current study thought that it was important to determine whether such variations in efficacy and tolerability also exist for atomoxetine, they said. Several studies have provided evidence of safety and efficacy for children aged 6 years and older, but Dr. Kratochvil and his colleagues wrote that their study was first to provide randomized, controlled data on use of the drug in children as young as age 5 years.

The findings of the current study suggest that efficacy and tolerability of atomoxetine for 5- and 6-year-old children seem similar to that seen in older children. However, even with doses averaging at the maximum approved dose of 1.4 mg/kg per day combined with a psychoeducational intervention, only 40% of treated subjects were rated as "much" or "very much" improved at study end, they said.

Also, although the change in ADHD Rating Scale scores was statistically significantly improved, the mean final total score was still more than 1 standard deviation above norms.

"Thus, although effective, clinically significant symptoms remained for the majority of children treated with atomoxetine," they said, concluding that future research should include longer treatment and follow-up to help elucidate whether treatment benefits increase or are sustained over time, and to assess for long-term adverse effects.

The study is well designed, and provides useful information about the safety and efficacy of atomoxetine in young children, but the interpretation of the findings is ultimately limited by the size of the sample and the relatively brief duration of treatment, agreed Dr. David Fassler of the department of psychiatry at the University of Vermont, Burlington.

"In reality, most young children with ADHD are treated over an extended period of time," he said in an interview. "Accordingly, I would concur with the authors’ recommendation that future research should include longer treatment studies, as well as trials [in which atomoxetine is compared with] the stimulant medications typically used in the treatment of ADHD."

Dr. Kratochvil disclosed that he received grant support from Eli Lilly, McNeil, Shire, Abbott, Somerset, and Cephalon, and was a consultant for Eli Lilly, AstraZeneca, Abbott, Theravance, and Pfizer. He is the editor of the Brown University Child and Adolescent Psychopharmacology Update, receives royalties from a book with Oxford, is a member of the REACH Institute Primary Pediatric Psychopharmacology Steering Committee and the board of directors of the American Professional Society for ADHD and Related Disorders, and receives study drugs for a National Institute of Mental Health–funded study from Eli Lilly and Abbott. The study was supported by a National Institute of Mental Health grant, and contracts between Eli Lilly and Duke University Medical Center and Columbia University/New York State Psychiatric Institute. The study drug was provided by Eli Lilly. Dr. Fassler said that he had no conflicts of interest to disclose.

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Atomoxetine was generally well tolerated and resulted in reduced core ADHD symptoms in a study of 101 5- and 6-year-old children in a randomized, placebo-controlled trial, but those reductions did not necessarily translate to overall clinical and functional improvement.

After 8 weeks, mean total scores on the ADHD-IV Rating Scale were reduced significantly more in the treatment vs. placebo groups, based on both parent reports (–13.2 vs. –5.8 points) and teacher reports (–12.5 vs. –5.0 points). However, the difference between the treatment and placebo groups in regard to the number of patients who were much or very much improved, based on Clinical Global Impressions–Improvement (CGI-I) scale scores after adjustment for age and study center, did not differ significantly, with 40% vs. 22% of treatment and placebo patients, respectively, being much or very much improved, Dr. Christopher J. Kratochvil of the University of Nebraska, Omaha, and his colleagues reported online in Pediatrics.

Furthermore, 62% of 44 participants in the treatment group and 77% of 49 in the placebo group remained moderately, markedly, or severely ill at the completion of the study, based on the Clinical Global Impressions–Severity (CGI-S) scale, the investigators said (Pediatrics 2011 March 21 [doi:10.1542/peds.2010-0825]).

Study participants were children aged 5 and 6 years (mean, 6.1 years) who met the criteria for any subtype of ADHD based on the DISC (Diagnostic Interview Schedule for Children), a clinical interview, and review by a clinical consensus conference of the three academic research sites participating in the trial. Most of the children (68%) were male, and most (86%) were white.

The study drug was initiated at 0.5 mg/kg per day, with flexible titration to 0.8, 1.2, 1.4, and a maximum of 1.8 mg/kg per day (average, 1.4 mg/kg per day) at four weekly and one biweekly visit, based on response, tolerability and a pharmacotherapist’s clinical judgment. At each visit, a pharmacotherapist provided psychoeducation about ADHD and behavioral-management strategies to the parents.

Treatment was generally well tolerated. Those in the treatment group were significantly more likely to experience decreased appetite, gastrointestinal upset, and sedation. However, those effects were mild or moderate in severity.

The findings provide useful information because – despite limited data – practitioners commonly treat ADHD in preschoolers with stimulant and nonstimulant agents, including atomoxetine, the investigators said.

Based on findings from a prior study showing that effect sizes with another treatment (immediate-release methylphenidate) varied in preschool- and school-age children, investigators in the current study thought that it was important to determine whether such variations in efficacy and tolerability also exist for atomoxetine, they said. Several studies have provided evidence of safety and efficacy for children aged 6 years and older, but Dr. Kratochvil and his colleagues wrote that their study was first to provide randomized, controlled data on use of the drug in children as young as age 5 years.

The findings of the current study suggest that efficacy and tolerability of atomoxetine for 5- and 6-year-old children seem similar to that seen in older children. However, even with doses averaging at the maximum approved dose of 1.4 mg/kg per day combined with a psychoeducational intervention, only 40% of treated subjects were rated as "much" or "very much" improved at study end, they said.

Also, although the change in ADHD Rating Scale scores was statistically significantly improved, the mean final total score was still more than 1 standard deviation above norms.

"Thus, although effective, clinically significant symptoms remained for the majority of children treated with atomoxetine," they said, concluding that future research should include longer treatment and follow-up to help elucidate whether treatment benefits increase or are sustained over time, and to assess for long-term adverse effects.

The study is well designed, and provides useful information about the safety and efficacy of atomoxetine in young children, but the interpretation of the findings is ultimately limited by the size of the sample and the relatively brief duration of treatment, agreed Dr. David Fassler of the department of psychiatry at the University of Vermont, Burlington.

"In reality, most young children with ADHD are treated over an extended period of time," he said in an interview. "Accordingly, I would concur with the authors’ recommendation that future research should include longer treatment studies, as well as trials [in which atomoxetine is compared with] the stimulant medications typically used in the treatment of ADHD."

Dr. Kratochvil disclosed that he received grant support from Eli Lilly, McNeil, Shire, Abbott, Somerset, and Cephalon, and was a consultant for Eli Lilly, AstraZeneca, Abbott, Theravance, and Pfizer. He is the editor of the Brown University Child and Adolescent Psychopharmacology Update, receives royalties from a book with Oxford, is a member of the REACH Institute Primary Pediatric Psychopharmacology Steering Committee and the board of directors of the American Professional Society for ADHD and Related Disorders, and receives study drugs for a National Institute of Mental Health–funded study from Eli Lilly and Abbott. The study was supported by a National Institute of Mental Health grant, and contracts between Eli Lilly and Duke University Medical Center and Columbia University/New York State Psychiatric Institute. The study drug was provided by Eli Lilly. Dr. Fassler said that he had no conflicts of interest to disclose.

Atomoxetine was generally well tolerated and resulted in reduced core ADHD symptoms in a study of 101 5- and 6-year-old children in a randomized, placebo-controlled trial, but those reductions did not necessarily translate to overall clinical and functional improvement.

After 8 weeks, mean total scores on the ADHD-IV Rating Scale were reduced significantly more in the treatment vs. placebo groups, based on both parent reports (–13.2 vs. –5.8 points) and teacher reports (–12.5 vs. –5.0 points). However, the difference between the treatment and placebo groups in regard to the number of patients who were much or very much improved, based on Clinical Global Impressions–Improvement (CGI-I) scale scores after adjustment for age and study center, did not differ significantly, with 40% vs. 22% of treatment and placebo patients, respectively, being much or very much improved, Dr. Christopher J. Kratochvil of the University of Nebraska, Omaha, and his colleagues reported online in Pediatrics.

Furthermore, 62% of 44 participants in the treatment group and 77% of 49 in the placebo group remained moderately, markedly, or severely ill at the completion of the study, based on the Clinical Global Impressions–Severity (CGI-S) scale, the investigators said (Pediatrics 2011 March 21 [doi:10.1542/peds.2010-0825]).

Study participants were children aged 5 and 6 years (mean, 6.1 years) who met the criteria for any subtype of ADHD based on the DISC (Diagnostic Interview Schedule for Children), a clinical interview, and review by a clinical consensus conference of the three academic research sites participating in the trial. Most of the children (68%) were male, and most (86%) were white.

The study drug was initiated at 0.5 mg/kg per day, with flexible titration to 0.8, 1.2, 1.4, and a maximum of 1.8 mg/kg per day (average, 1.4 mg/kg per day) at four weekly and one biweekly visit, based on response, tolerability and a pharmacotherapist’s clinical judgment. At each visit, a pharmacotherapist provided psychoeducation about ADHD and behavioral-management strategies to the parents.

Treatment was generally well tolerated. Those in the treatment group were significantly more likely to experience decreased appetite, gastrointestinal upset, and sedation. However, those effects were mild or moderate in severity.

The findings provide useful information because – despite limited data – practitioners commonly treat ADHD in preschoolers with stimulant and nonstimulant agents, including atomoxetine, the investigators said.

Based on findings from a prior study showing that effect sizes with another treatment (immediate-release methylphenidate) varied in preschool- and school-age children, investigators in the current study thought that it was important to determine whether such variations in efficacy and tolerability also exist for atomoxetine, they said. Several studies have provided evidence of safety and efficacy for children aged 6 years and older, but Dr. Kratochvil and his colleagues wrote that their study was first to provide randomized, controlled data on use of the drug in children as young as age 5 years.

The findings of the current study suggest that efficacy and tolerability of atomoxetine for 5- and 6-year-old children seem similar to that seen in older children. However, even with doses averaging at the maximum approved dose of 1.4 mg/kg per day combined with a psychoeducational intervention, only 40% of treated subjects were rated as "much" or "very much" improved at study end, they said.

Also, although the change in ADHD Rating Scale scores was statistically significantly improved, the mean final total score was still more than 1 standard deviation above norms.

"Thus, although effective, clinically significant symptoms remained for the majority of children treated with atomoxetine," they said, concluding that future research should include longer treatment and follow-up to help elucidate whether treatment benefits increase or are sustained over time, and to assess for long-term adverse effects.

The study is well designed, and provides useful information about the safety and efficacy of atomoxetine in young children, but the interpretation of the findings is ultimately limited by the size of the sample and the relatively brief duration of treatment, agreed Dr. David Fassler of the department of psychiatry at the University of Vermont, Burlington.

"In reality, most young children with ADHD are treated over an extended period of time," he said in an interview. "Accordingly, I would concur with the authors’ recommendation that future research should include longer treatment studies, as well as trials [in which atomoxetine is compared with] the stimulant medications typically used in the treatment of ADHD."

Dr. Kratochvil disclosed that he received grant support from Eli Lilly, McNeil, Shire, Abbott, Somerset, and Cephalon, and was a consultant for Eli Lilly, AstraZeneca, Abbott, Theravance, and Pfizer. He is the editor of the Brown University Child and Adolescent Psychopharmacology Update, receives royalties from a book with Oxford, is a member of the REACH Institute Primary Pediatric Psychopharmacology Steering Committee and the board of directors of the American Professional Society for ADHD and Related Disorders, and receives study drugs for a National Institute of Mental Health–funded study from Eli Lilly and Abbott. The study was supported by a National Institute of Mental Health grant, and contracts between Eli Lilly and Duke University Medical Center and Columbia University/New York State Psychiatric Institute. The study drug was provided by Eli Lilly. Dr. Fassler said that he had no conflicts of interest to disclose.

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Atomoxetine for ADHD Reduces Symptoms, But Impairment Persists
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Major Finding: ADHD-IV Rating Scale scores were reduced significantly more in the treatment vs. placebo groups, based on both parent reports (–13.2 vs. –5.8 points) and teacher reports (–12.5 vs. –5.0 points), but no significant difference was found between the treatment and placebo groups in the number of patients who were much or very much improved. .

Data Source: A double-blind, placebo-controlled study of atomoxetine in young children with ADHD.

Disclosures: Dr. Kratochvil disclosed that he received grant support from Eli Lilly, McNeil, Shire, Abbott, Somerset, and Cephalon, and was a consultant for Eli Lilly, AstraZeneca, Abbott, Theravance, and Pfizer. He is the editor of the Brown University Child and Adolescent Psychopharmacology Update, receives royalties from a book with Oxford, is a member of the REACH Institute Primary Pediatric Psychopharmacology Steering Committee and the board of directors of the American Professional Society for ADHD and Related Disorders, and receives study drugs for a National Institute of Mental Health–funded study from Eli Lilly and Abbott. The study was supported by a National Institute of Mental Health grant, and contracts between Eli Lilly and Duke University Medical Center and Columbia University/New York State Psychiatric Institute. The study drug was provided by Eli Lilly.

Atomoxetine for ADHD Reduces Symptoms, But Impairment Persists

Article Type
Changed
Display Headline
Atomoxetine for ADHD Reduces Symptoms, But Impairment Persists

Atomoxetine was generally well tolerated and resulted in reduced core ADHD symptoms in a study of 101 5- and 6-year-old children in a randomized, placebo-controlled trial, but those reductions did not necessarily translate to overall clinical and functional improvement.

After 8 weeks, mean total scores on the ADHD-IV Rating Scale were reduced significantly more in the treatment vs. placebo groups, based on both parent reports (–13.2 vs. –5.8 points) and teacher reports (–12.5 vs. –5.0 points). However, the difference between the treatment and placebo groups in regard to the number of patients who were much or very much improved, based on Clinical Global Impressions–Improvement (CGI-I) scale scores after adjustment for age and study center, did not differ significantly, with 40% vs. 22% of treatment and placebo patients, respectively, being much or very much improved, Dr. Christopher J. Kratochvil of the University of Nebraska, Omaha, and his colleagues reported online in Pediatrics.

Furthermore, 62% of 44 participants in the treatment group and 77% of 49 in the placebo group remained moderately, markedly, or severely ill at the completion of the study, based on the Clinical Global Impressions–Severity (CGI-S) scale, the investigators said (Pediatrics 2011 March 21 [doi:10.1542/peds.2010-0825]).

Study participants were children aged 5 and 6 years (mean, 6.1 years) who met the criteria for any subtype of ADHD based on the DISC (Diagnostic Interview Schedule for Children), a clinical interview, and review by a clinical consensus conference of the three academic research sites participating in the trial. Most of the children (68%) were male, and most (86%) were white.

The study drug was initiated at 0.5 mg/kg per day, with flexible titration to 0.8, 1.2, 1.4, and a maximum of 1.8 mg/kg per day (average, 1.4 mg/kg per day) at four weekly and one biweekly visit, based on response, tolerability and a pharmacotherapist’s clinical judgment. At each visit, a pharmacotherapist provided psychoeducation about ADHD and behavioral-management strategies to the parents.

Treatment was generally well tolerated. Those in the treatment group were significantly more likely to experience decreased appetite, gastrointestinal upset, and sedation. However, those effects were mild or moderate in severity.

The findings provide useful information because – despite limited data – practitioners commonly treat ADHD in preschoolers with stimulant and nonstimulant agents, including atomoxetine, the investigators said.

Based on findings from a prior study showing that effect sizes with another treatment (immediate-release methylphenidate) varied in preschool- and school-age children, investigators in the current study thought that it was important to determine whether such variations in efficacy and tolerability also exist for atomoxetine, they said. Several studies have provided evidence of safety and efficacy for children aged 6 years and older, but Dr. Kratochvil and his colleagues wrote that their study was first to provide randomized, controlled data on use of the drug in children as young as age 5 years.

The findings of the current study suggest that efficacy and tolerability of atomoxetine for 5- and 6-year-old children seem similar to that seen in older children. However, even with doses averaging at the maximum approved dose of 1.4 mg/kg per day combined with a psychoeducational intervention, only 40% of treated subjects were rated as "much" or "very much" improved at study end, they said.

Also, although the change in ADHD Rating Scale scores was statistically significantly improved, the mean final total score was still more than 1 standard deviation above norms.

"Thus, although effective, clinically significant symptoms remained for the majority of children treated with atomoxetine," they said, concluding that future research should include longer treatment and follow-up to help elucidate whether treatment benefits increase or are sustained over time, and to assess for long-term adverse effects.

The study is well designed, and provides useful information about the safety and efficacy of atomoxetine in young children, but the interpretation of the findings is ultimately limited by the size of the sample and the relatively brief duration of treatment, agreed Dr. David Fassler of the department of psychiatry at the University of Vermont, Burlington.

"In reality, most young children with ADHD are treated over an extended period of time," he said in an interview. "Accordingly, I would concur with the authors’ recommendation that future research should include longer treatment studies, as well as trials [in which atomoxetine is compared with] the stimulant medications typically used in the treatment of ADHD."

Dr. Kratochvil disclosed that he received grant support from Eli Lilly, McNeil, Shire, Abbott, Somerset, and Cephalon, and was a consultant for Eli Lilly, AstraZeneca, Abbott, Theravance, and Pfizer. He is the editor of the Brown University Child and Adolescent Psychopharmacology Update, receives royalties from a book with Oxford, is a member of the REACH Institute Primary Pediatric Psychopharmacology Steering Committee and the board of directors of the American Professional Society for ADHD and Related Disorders, and receives study drugs for a National Institute of Mental Health–funded study from Eli Lilly and Abbott. The study was supported by a National Institute of Mental Health grant, and contracts between Eli Lilly and Duke University Medical Center and Columbia University/New York State Psychiatric Institute. The study drug was provided by Eli Lilly. Dr. Fassler said that he had no conflicts of interest to disclose.

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Atomoxetine was generally well tolerated and resulted in reduced core ADHD symptoms in a study of 101 5- and 6-year-old children in a randomized, placebo-controlled trial, but those reductions did not necessarily translate to overall clinical and functional improvement.

After 8 weeks, mean total scores on the ADHD-IV Rating Scale were reduced significantly more in the treatment vs. placebo groups, based on both parent reports (–13.2 vs. –5.8 points) and teacher reports (–12.5 vs. –5.0 points). However, the difference between the treatment and placebo groups in regard to the number of patients who were much or very much improved, based on Clinical Global Impressions–Improvement (CGI-I) scale scores after adjustment for age and study center, did not differ significantly, with 40% vs. 22% of treatment and placebo patients, respectively, being much or very much improved, Dr. Christopher J. Kratochvil of the University of Nebraska, Omaha, and his colleagues reported online in Pediatrics.

Furthermore, 62% of 44 participants in the treatment group and 77% of 49 in the placebo group remained moderately, markedly, or severely ill at the completion of the study, based on the Clinical Global Impressions–Severity (CGI-S) scale, the investigators said (Pediatrics 2011 March 21 [doi:10.1542/peds.2010-0825]).

Study participants were children aged 5 and 6 years (mean, 6.1 years) who met the criteria for any subtype of ADHD based on the DISC (Diagnostic Interview Schedule for Children), a clinical interview, and review by a clinical consensus conference of the three academic research sites participating in the trial. Most of the children (68%) were male, and most (86%) were white.

The study drug was initiated at 0.5 mg/kg per day, with flexible titration to 0.8, 1.2, 1.4, and a maximum of 1.8 mg/kg per day (average, 1.4 mg/kg per day) at four weekly and one biweekly visit, based on response, tolerability and a pharmacotherapist’s clinical judgment. At each visit, a pharmacotherapist provided psychoeducation about ADHD and behavioral-management strategies to the parents.

Treatment was generally well tolerated. Those in the treatment group were significantly more likely to experience decreased appetite, gastrointestinal upset, and sedation. However, those effects were mild or moderate in severity.

The findings provide useful information because – despite limited data – practitioners commonly treat ADHD in preschoolers with stimulant and nonstimulant agents, including atomoxetine, the investigators said.

Based on findings from a prior study showing that effect sizes with another treatment (immediate-release methylphenidate) varied in preschool- and school-age children, investigators in the current study thought that it was important to determine whether such variations in efficacy and tolerability also exist for atomoxetine, they said. Several studies have provided evidence of safety and efficacy for children aged 6 years and older, but Dr. Kratochvil and his colleagues wrote that their study was first to provide randomized, controlled data on use of the drug in children as young as age 5 years.

The findings of the current study suggest that efficacy and tolerability of atomoxetine for 5- and 6-year-old children seem similar to that seen in older children. However, even with doses averaging at the maximum approved dose of 1.4 mg/kg per day combined with a psychoeducational intervention, only 40% of treated subjects were rated as "much" or "very much" improved at study end, they said.

Also, although the change in ADHD Rating Scale scores was statistically significantly improved, the mean final total score was still more than 1 standard deviation above norms.

"Thus, although effective, clinically significant symptoms remained for the majority of children treated with atomoxetine," they said, concluding that future research should include longer treatment and follow-up to help elucidate whether treatment benefits increase or are sustained over time, and to assess for long-term adverse effects.

The study is well designed, and provides useful information about the safety and efficacy of atomoxetine in young children, but the interpretation of the findings is ultimately limited by the size of the sample and the relatively brief duration of treatment, agreed Dr. David Fassler of the department of psychiatry at the University of Vermont, Burlington.

"In reality, most young children with ADHD are treated over an extended period of time," he said in an interview. "Accordingly, I would concur with the authors’ recommendation that future research should include longer treatment studies, as well as trials [in which atomoxetine is compared with] the stimulant medications typically used in the treatment of ADHD."

Dr. Kratochvil disclosed that he received grant support from Eli Lilly, McNeil, Shire, Abbott, Somerset, and Cephalon, and was a consultant for Eli Lilly, AstraZeneca, Abbott, Theravance, and Pfizer. He is the editor of the Brown University Child and Adolescent Psychopharmacology Update, receives royalties from a book with Oxford, is a member of the REACH Institute Primary Pediatric Psychopharmacology Steering Committee and the board of directors of the American Professional Society for ADHD and Related Disorders, and receives study drugs for a National Institute of Mental Health–funded study from Eli Lilly and Abbott. The study was supported by a National Institute of Mental Health grant, and contracts between Eli Lilly and Duke University Medical Center and Columbia University/New York State Psychiatric Institute. The study drug was provided by Eli Lilly. Dr. Fassler said that he had no conflicts of interest to disclose.

Atomoxetine was generally well tolerated and resulted in reduced core ADHD symptoms in a study of 101 5- and 6-year-old children in a randomized, placebo-controlled trial, but those reductions did not necessarily translate to overall clinical and functional improvement.

After 8 weeks, mean total scores on the ADHD-IV Rating Scale were reduced significantly more in the treatment vs. placebo groups, based on both parent reports (–13.2 vs. –5.8 points) and teacher reports (–12.5 vs. –5.0 points). However, the difference between the treatment and placebo groups in regard to the number of patients who were much or very much improved, based on Clinical Global Impressions–Improvement (CGI-I) scale scores after adjustment for age and study center, did not differ significantly, with 40% vs. 22% of treatment and placebo patients, respectively, being much or very much improved, Dr. Christopher J. Kratochvil of the University of Nebraska, Omaha, and his colleagues reported online in Pediatrics.

Furthermore, 62% of 44 participants in the treatment group and 77% of 49 in the placebo group remained moderately, markedly, or severely ill at the completion of the study, based on the Clinical Global Impressions–Severity (CGI-S) scale, the investigators said (Pediatrics 2011 March 21 [doi:10.1542/peds.2010-0825]).

Study participants were children aged 5 and 6 years (mean, 6.1 years) who met the criteria for any subtype of ADHD based on the DISC (Diagnostic Interview Schedule for Children), a clinical interview, and review by a clinical consensus conference of the three academic research sites participating in the trial. Most of the children (68%) were male, and most (86%) were white.

The study drug was initiated at 0.5 mg/kg per day, with flexible titration to 0.8, 1.2, 1.4, and a maximum of 1.8 mg/kg per day (average, 1.4 mg/kg per day) at four weekly and one biweekly visit, based on response, tolerability and a pharmacotherapist’s clinical judgment. At each visit, a pharmacotherapist provided psychoeducation about ADHD and behavioral-management strategies to the parents.

Treatment was generally well tolerated. Those in the treatment group were significantly more likely to experience decreased appetite, gastrointestinal upset, and sedation. However, those effects were mild or moderate in severity.

The findings provide useful information because – despite limited data – practitioners commonly treat ADHD in preschoolers with stimulant and nonstimulant agents, including atomoxetine, the investigators said.

Based on findings from a prior study showing that effect sizes with another treatment (immediate-release methylphenidate) varied in preschool- and school-age children, investigators in the current study thought that it was important to determine whether such variations in efficacy and tolerability also exist for atomoxetine, they said. Several studies have provided evidence of safety and efficacy for children aged 6 years and older, but Dr. Kratochvil and his colleagues wrote that their study was first to provide randomized, controlled data on use of the drug in children as young as age 5 years.

The findings of the current study suggest that efficacy and tolerability of atomoxetine for 5- and 6-year-old children seem similar to that seen in older children. However, even with doses averaging at the maximum approved dose of 1.4 mg/kg per day combined with a psychoeducational intervention, only 40% of treated subjects were rated as "much" or "very much" improved at study end, they said.

Also, although the change in ADHD Rating Scale scores was statistically significantly improved, the mean final total score was still more than 1 standard deviation above norms.

"Thus, although effective, clinically significant symptoms remained for the majority of children treated with atomoxetine," they said, concluding that future research should include longer treatment and follow-up to help elucidate whether treatment benefits increase or are sustained over time, and to assess for long-term adverse effects.

The study is well designed, and provides useful information about the safety and efficacy of atomoxetine in young children, but the interpretation of the findings is ultimately limited by the size of the sample and the relatively brief duration of treatment, agreed Dr. David Fassler of the department of psychiatry at the University of Vermont, Burlington.

"In reality, most young children with ADHD are treated over an extended period of time," he said in an interview. "Accordingly, I would concur with the authors’ recommendation that future research should include longer treatment studies, as well as trials [in which atomoxetine is compared with] the stimulant medications typically used in the treatment of ADHD."

Dr. Kratochvil disclosed that he received grant support from Eli Lilly, McNeil, Shire, Abbott, Somerset, and Cephalon, and was a consultant for Eli Lilly, AstraZeneca, Abbott, Theravance, and Pfizer. He is the editor of the Brown University Child and Adolescent Psychopharmacology Update, receives royalties from a book with Oxford, is a member of the REACH Institute Primary Pediatric Psychopharmacology Steering Committee and the board of directors of the American Professional Society for ADHD and Related Disorders, and receives study drugs for a National Institute of Mental Health–funded study from Eli Lilly and Abbott. The study was supported by a National Institute of Mental Health grant, and contracts between Eli Lilly and Duke University Medical Center and Columbia University/New York State Psychiatric Institute. The study drug was provided by Eli Lilly. Dr. Fassler said that he had no conflicts of interest to disclose.

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Major Finding: ADHD-IV Rating Scale scores were reduced significantly more in the treatment vs. placebo groups, based on both parent reports (–13.2 vs. –5.8 points) and teacher reports (–12.5 vs. –5.0 points), but no significant difference was found between the treatment and placebo groups in the number of patients who were much or very much improved. .

Data Source: A double-blind, placebo-controlled study of atomoxetine in young children with ADHD.

Disclosures: Dr. Kratochvil disclosed that he received grant support from Eli Lilly, McNeil, Shire, Abbott, Somerset, and Cephalon, and was a consultant for Eli Lilly, AstraZeneca, Abbott, Theravance, and Pfizer. He is the editor of the Brown University Child and Adolescent Psychopharmacology Update, receives royalties from a book with Oxford, is a member of the REACH Institute Primary Pediatric Psychopharmacology Steering Committee and the board of directors of the American Professional Society for ADHD and Related Disorders, and receives study drugs for a National Institute of Mental Health–funded study from Eli Lilly and Abbott. The study was supported by a National Institute of Mental Health grant, and contracts between Eli Lilly and Duke University Medical Center and Columbia University/New York State Psychiatric Institute. The study drug was provided by Eli Lilly.

Gastric Bypass Surgery Linked to Bone Loss in Teens

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Gastric Bypass Surgery Linked to Bone Loss in Teens

Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

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Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

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Major Finding: Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 adolescent patients who underwent Roux-en Y gastric bypass. Predicted bone mineral content decreased by 7.4% in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1.

Data Source: A retrospective case review of 61 adolescents who underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008.

Disclosures: The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

Gastric Bypass Surgery Linked to Bone Loss in Teens

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Display Headline
Gastric Bypass Surgery Linked to Bone Loss in Teens

Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

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Gastric bypass surgery, adolescence, teens, obesity, bone loss, bone density, Roux-en Y gastric bypass, Cincinnati Children’s Hospital, Dr. Anne-Marie D. Kaulfers, Pediatrics, weight loss
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Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

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Reduced Rabies Postexposure Prophylaxis Endorsed by AAP

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The American Academy of Pediatrics has officially endorsed a 2010 recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices that reduces by one the number of vaccine doses required for postexposure rabies prophylaxis.

The recommendation calls for a reduction in the number of postexposure doses of human diploid cell vaccine (HDCV) or purified chick embryo cell vaccine (PCECV) from five to four doses, with the first dose of 1 mL to be given intramuscularly as soon as possible after exposure (day 0) and subsequent doses to be given on days 3, 7, and 14 after the first dose except in people with immune suppression, who should continue to receive the five-dose regimen with the fifth dose given on day 28.

Photo credit: © astridb05/Fotolia.com
Despite the rarity of cases of  human rabies infection, potential exposure due to animal bites is common.    

The recommendation is the result of a review beginning in 2007 during a time when human rabies vaccine was in limited supply. The Advisory Committee on Immunization Practices (ACIP) formed a work group to review rabies vaccine options, and found that four doses were adequate for inducing rabies-neutralizing antibody, according to an AAP Policy Statement published March 28 in Pediatrics, which announces the AAP’s endorsement of the recommendation (Pediatrics 2011 March 28 [doi: 10.1542/peds.2011-0095]).

A detailed review by the ACIP rabies work group of the evidence in support of the reduced dosing schedule showed that in all of approximately 1,000 patients, an adequate immune response to vaccination was achieved by day 14 (when the fourth dose of cell-derived rabies vaccine was given). In addition, observational studies of people with likely rabies exposure showed that no cases of rabies have been attributed to the lack of a fifth dose.

Furthermore, animal models demonstrated that the number of vaccine doses did not contribute to significant differences in survival rate, and, theoretically, a reduced dosing schedule would result in similar or reduced rates of adverse reactions, which already are uncommon in children even when five doses are given.

Finally, the ACIP recommendation, which was published in 2010 (MMWR 2010;59:1-9), showed that reducing the dosing schedule to four doses would result in an estimated $16.6 million cost savings to the U.S. health care system.

Approximately 20,000-30,000 people receive rabies postexposure prophylaxis (PEP) in the United States each year, and one to three cases of human rabies occur each year, according to the AAP Policy Statement. Since the 1970s, with the introduction of modern cell-derived vaccines, no PEP failures have occurred.

Effective PEP has been attributed to prompt washing of the wound with copious amounts of soap and water, infiltration of human rabies immunoglobulin (HRIG) into and around the wound, and an appropriate dose schedule of intramuscular vaccine, which is now considered to be four doses in most patients, according to the Policy Statement. All other rabies PEP recommendations remain the same.

It is important that pediatricians be up to date on the new recommendations for rabies PEP, Dr. Mary Ann Jackson said in an interview.

"Despite the rarity of human rabies infection in the United States, questions for the pediatrician arising from potential animal exposures are surprisingly frequent, as animal bites and even bat exposures occur not uncommonly in the pediatric population," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals & Clinics, Kansas City, Mo.

Pediatricians also need to know that the decision to embark on rabies PEP should be urgently but not emergently handled, she added, explaining that most exposures relate to domestic animal encounters (often strays) or incidents in which bats are found in the family home.

"Careful attention to information gathering related to the exposure is key (see our form at www.childrensmercy.org/rabiesform), and practitioners should utilize their health department and local infectious disease specialists for input in situations where PEP is considered," she said.

Dr. Jackson, who also is a professor of pediatrics at the University of Missouri–Kansas City, advised that in any instance where PEP is being considered, it is important to keep in mind that wound cleansing is essential and the child’s tetanus vaccine history should be confirmed, with vaccine provided in appropriate cases. Rabies immune globulin must be concurrently given in the wound site in addition to rabies vaccine in an alternative site in every case where PEP is being provided for the first time in an otherwise healthy child.

In the instance where a bat is discovered in the room of a sleeping child, the PEP decision is certainly straightforward if the animal is available for rabies testing, and results can be ascertained promptly. In an otherwise healthy domestic pet exposure, a 10-day observation period should be ensured, utilizing the assistance of the local animal control and public health officials and in low-risk situations, which may obviate the need for PEP, said Dr. Jackson, who is a member of the AAP Committee on Infectious Diseases that wrote the new AAP Policy Statement.

 

 

All authors have filed conflict of interest statements with the AAP. Any conflicts have been resolved through a process approved by the AAP Board of Directors, according to Pediatrics.




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The American Academy of Pediatrics has officially endorsed a 2010 recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices that reduces by one the number of vaccine doses required for postexposure rabies prophylaxis.

The recommendation calls for a reduction in the number of postexposure doses of human diploid cell vaccine (HDCV) or purified chick embryo cell vaccine (PCECV) from five to four doses, with the first dose of 1 mL to be given intramuscularly as soon as possible after exposure (day 0) and subsequent doses to be given on days 3, 7, and 14 after the first dose except in people with immune suppression, who should continue to receive the five-dose regimen with the fifth dose given on day 28.

Photo credit: © astridb05/Fotolia.com
Despite the rarity of cases of  human rabies infection, potential exposure due to animal bites is common.    

The recommendation is the result of a review beginning in 2007 during a time when human rabies vaccine was in limited supply. The Advisory Committee on Immunization Practices (ACIP) formed a work group to review rabies vaccine options, and found that four doses were adequate for inducing rabies-neutralizing antibody, according to an AAP Policy Statement published March 28 in Pediatrics, which announces the AAP’s endorsement of the recommendation (Pediatrics 2011 March 28 [doi: 10.1542/peds.2011-0095]).

A detailed review by the ACIP rabies work group of the evidence in support of the reduced dosing schedule showed that in all of approximately 1,000 patients, an adequate immune response to vaccination was achieved by day 14 (when the fourth dose of cell-derived rabies vaccine was given). In addition, observational studies of people with likely rabies exposure showed that no cases of rabies have been attributed to the lack of a fifth dose.

Furthermore, animal models demonstrated that the number of vaccine doses did not contribute to significant differences in survival rate, and, theoretically, a reduced dosing schedule would result in similar or reduced rates of adverse reactions, which already are uncommon in children even when five doses are given.

Finally, the ACIP recommendation, which was published in 2010 (MMWR 2010;59:1-9), showed that reducing the dosing schedule to four doses would result in an estimated $16.6 million cost savings to the U.S. health care system.

Approximately 20,000-30,000 people receive rabies postexposure prophylaxis (PEP) in the United States each year, and one to three cases of human rabies occur each year, according to the AAP Policy Statement. Since the 1970s, with the introduction of modern cell-derived vaccines, no PEP failures have occurred.

Effective PEP has been attributed to prompt washing of the wound with copious amounts of soap and water, infiltration of human rabies immunoglobulin (HRIG) into and around the wound, and an appropriate dose schedule of intramuscular vaccine, which is now considered to be four doses in most patients, according to the Policy Statement. All other rabies PEP recommendations remain the same.

It is important that pediatricians be up to date on the new recommendations for rabies PEP, Dr. Mary Ann Jackson said in an interview.

"Despite the rarity of human rabies infection in the United States, questions for the pediatrician arising from potential animal exposures are surprisingly frequent, as animal bites and even bat exposures occur not uncommonly in the pediatric population," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals & Clinics, Kansas City, Mo.

Pediatricians also need to know that the decision to embark on rabies PEP should be urgently but not emergently handled, she added, explaining that most exposures relate to domestic animal encounters (often strays) or incidents in which bats are found in the family home.

"Careful attention to information gathering related to the exposure is key (see our form at www.childrensmercy.org/rabiesform), and practitioners should utilize their health department and local infectious disease specialists for input in situations where PEP is considered," she said.

Dr. Jackson, who also is a professor of pediatrics at the University of Missouri–Kansas City, advised that in any instance where PEP is being considered, it is important to keep in mind that wound cleansing is essential and the child’s tetanus vaccine history should be confirmed, with vaccine provided in appropriate cases. Rabies immune globulin must be concurrently given in the wound site in addition to rabies vaccine in an alternative site in every case where PEP is being provided for the first time in an otherwise healthy child.

In the instance where a bat is discovered in the room of a sleeping child, the PEP decision is certainly straightforward if the animal is available for rabies testing, and results can be ascertained promptly. In an otherwise healthy domestic pet exposure, a 10-day observation period should be ensured, utilizing the assistance of the local animal control and public health officials and in low-risk situations, which may obviate the need for PEP, said Dr. Jackson, who is a member of the AAP Committee on Infectious Diseases that wrote the new AAP Policy Statement.

 

 

All authors have filed conflict of interest statements with the AAP. Any conflicts have been resolved through a process approved by the AAP Board of Directors, according to Pediatrics.




The American Academy of Pediatrics has officially endorsed a 2010 recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices that reduces by one the number of vaccine doses required for postexposure rabies prophylaxis.

The recommendation calls for a reduction in the number of postexposure doses of human diploid cell vaccine (HDCV) or purified chick embryo cell vaccine (PCECV) from five to four doses, with the first dose of 1 mL to be given intramuscularly as soon as possible after exposure (day 0) and subsequent doses to be given on days 3, 7, and 14 after the first dose except in people with immune suppression, who should continue to receive the five-dose regimen with the fifth dose given on day 28.

Photo credit: © astridb05/Fotolia.com
Despite the rarity of cases of  human rabies infection, potential exposure due to animal bites is common.    

The recommendation is the result of a review beginning in 2007 during a time when human rabies vaccine was in limited supply. The Advisory Committee on Immunization Practices (ACIP) formed a work group to review rabies vaccine options, and found that four doses were adequate for inducing rabies-neutralizing antibody, according to an AAP Policy Statement published March 28 in Pediatrics, which announces the AAP’s endorsement of the recommendation (Pediatrics 2011 March 28 [doi: 10.1542/peds.2011-0095]).

A detailed review by the ACIP rabies work group of the evidence in support of the reduced dosing schedule showed that in all of approximately 1,000 patients, an adequate immune response to vaccination was achieved by day 14 (when the fourth dose of cell-derived rabies vaccine was given). In addition, observational studies of people with likely rabies exposure showed that no cases of rabies have been attributed to the lack of a fifth dose.

Furthermore, animal models demonstrated that the number of vaccine doses did not contribute to significant differences in survival rate, and, theoretically, a reduced dosing schedule would result in similar or reduced rates of adverse reactions, which already are uncommon in children even when five doses are given.

Finally, the ACIP recommendation, which was published in 2010 (MMWR 2010;59:1-9), showed that reducing the dosing schedule to four doses would result in an estimated $16.6 million cost savings to the U.S. health care system.

Approximately 20,000-30,000 people receive rabies postexposure prophylaxis (PEP) in the United States each year, and one to three cases of human rabies occur each year, according to the AAP Policy Statement. Since the 1970s, with the introduction of modern cell-derived vaccines, no PEP failures have occurred.

Effective PEP has been attributed to prompt washing of the wound with copious amounts of soap and water, infiltration of human rabies immunoglobulin (HRIG) into and around the wound, and an appropriate dose schedule of intramuscular vaccine, which is now considered to be four doses in most patients, according to the Policy Statement. All other rabies PEP recommendations remain the same.

It is important that pediatricians be up to date on the new recommendations for rabies PEP, Dr. Mary Ann Jackson said in an interview.

"Despite the rarity of human rabies infection in the United States, questions for the pediatrician arising from potential animal exposures are surprisingly frequent, as animal bites and even bat exposures occur not uncommonly in the pediatric population," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals & Clinics, Kansas City, Mo.

Pediatricians also need to know that the decision to embark on rabies PEP should be urgently but not emergently handled, she added, explaining that most exposures relate to domestic animal encounters (often strays) or incidents in which bats are found in the family home.

"Careful attention to information gathering related to the exposure is key (see our form at www.childrensmercy.org/rabiesform), and practitioners should utilize their health department and local infectious disease specialists for input in situations where PEP is considered," she said.

Dr. Jackson, who also is a professor of pediatrics at the University of Missouri–Kansas City, advised that in any instance where PEP is being considered, it is important to keep in mind that wound cleansing is essential and the child’s tetanus vaccine history should be confirmed, with vaccine provided in appropriate cases. Rabies immune globulin must be concurrently given in the wound site in addition to rabies vaccine in an alternative site in every case where PEP is being provided for the first time in an otherwise healthy child.

In the instance where a bat is discovered in the room of a sleeping child, the PEP decision is certainly straightforward if the animal is available for rabies testing, and results can be ascertained promptly. In an otherwise healthy domestic pet exposure, a 10-day observation period should be ensured, utilizing the assistance of the local animal control and public health officials and in low-risk situations, which may obviate the need for PEP, said Dr. Jackson, who is a member of the AAP Committee on Infectious Diseases that wrote the new AAP Policy Statement.

 

 

All authors have filed conflict of interest statements with the AAP. Any conflicts have been resolved through a process approved by the AAP Board of Directors, according to Pediatrics.




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Gastric Bypass Surgery Linked to Bone Loss in Teens

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Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

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Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

Gastric bypass surgery during adolescence was associated with significant bone loss in 61 patients in a retrospective study, but participants’ predicted bone density at 2 years following the procedure did not fall below the expected value for gender and age.

Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 patients, all of whom underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008. Predicted bone mineral content decreased by 7.4% (from 2,692 g to 2,494 g) in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1, Dr. Anne-Marie D. Kaulfers and her colleagues from Cincinnati Children’s Hospital Medical Center reported online in the March 28 issue of Pediatrics.

However, the z score remained above average for age and gender throughout the 2-year follow-up period, they said (Pediatrics 2011 March 28 [doi:10.1542/peds.2010-0785]).

In the first year following surgery, reductions in weight correlated significantly with reductions in bone mineral content, and weight loss was shown to account for only 14% of the decrease in bone mineral content, they noted.

Concern about possible bone loss among adolescents undergoing gastric bypass surgery is particularly relevant given that more than 18% of adolescents in the United States are obese and that the number of adolescents who elect to undergo gastric bypass surgery continues to rise; from 2000 to 2003 the number increased threefold from 222 to 771, the investigator said.

Furthermore, adolescents who undergo Roux-en Y gastric bypass tend to experience dramatic weight loss of up to 73% of their excess weight by 1 year, and in adult studies, the extent of bone loss has been shown to be related to the amount of weight loss.

"Loss of bone mineral at the age when adolescents should be approaching peak bone mass (estimated at age 20) could potentially compromise their future bone health," the investigators noted.

Though limited by sample size, retrospective study design, and relatively short follow-up, among other factors, the findings of this study, which included teens with an average age of 17.3 years, a body mass index of greater than 35 (mean of 54.4), and at least 1 obesity-related comorbid illness, showed that bone loss did not fall below expected values at 2 years following surgery. It is likely that this finding is a consequence of high bone mineral content and density prior to surgery in this extremely obese population, the investigators said.

If bone loss continues in this population, however, the risk of fractures later in life might be increased.

"These adolescents need to be followed over the long-term to determine if the decrease in BMD z score continues and increases their risk for future fractures," they said, adding that the effects of bariatric surgery on bone mass and the clinical consequences of this need to be better understood.

This is especially important for primary care physicians who will be providing routine care for these patients.

The primary care physician should be aware of the possibility of low bone mass in adolescents after bariatric surgery so that it can be monitored and managed appropriately, they concluded.

The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

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Major Finding: Whole body bone mineral content, bone mineral density z score, and weight each decreased significantly over time in the 61 adolescent patients who underwent Roux-en Y gastric bypass. Predicted bone mineral content decreased by 7.4% in the first 2 years after surgery, and the predicted age- and gender-specific bone mineral density z score decreased from 1.5 to 0.1.

Data Source: A retrospective case review of 61 adolescents who underwent Roux-en Y gastric bypass at Cincinnati Children’s Hospital during 2001-2008.

Disclosures: The authors reported having no relevant financial disclosures. This study was funded by the National Institutes of Health.

Reduced Rabies Postexposure Prophylaxis Endorsed by AAP

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The American Academy of Pediatrics has officially endorsed a 2010 recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices that reduces by one the number of vaccine doses required for postexposure rabies prophylaxis.

The recommendation calls for a reduction in the number of postexposure doses of human diploid cell vaccine (HDCV) or purified chick embryo cell vaccine (PCECV) from five to four doses, with the first dose of 1 mL to be given intramuscularly as soon as possible after exposure (day 0) and subsequent doses to be given on days 3, 7, and 14 after the first dose except in people with immune suppression, who should continue to receive the five-dose regimen with the fifth dose given on day 28.

Photo credit: © astridb05/Fotolia.com
Despite the rarity of cases of  human rabies infection, potential exposure due to animal bites is common.    

The recommendation is the result of a review beginning in 2007 during a time when human rabies vaccine was in limited supply. The Advisory Committee on Immunization Practices (ACIP) formed a work group to review rabies vaccine options, and found that four doses were adequate for inducing rabies-neutralizing antibody, according to an AAP Policy Statement published March 28 in Pediatrics, which announces the AAP’s endorsement of the recommendation (Pediatrics 2011 March 28 [doi: 10.1542/peds.2011-0095]).

A detailed review by the ACIP rabies work group of the evidence in support of the reduced dosing schedule showed that in all of approximately 1,000 patients, an adequate immune response to vaccination was achieved by day 14 (when the fourth dose of cell-derived rabies vaccine was given). In addition, observational studies of people with likely rabies exposure showed that no cases of rabies have been attributed to the lack of a fifth dose.

Furthermore, animal models demonstrated that the number of vaccine doses did not contribute to significant differences in survival rate, and, theoretically, a reduced dosing schedule would result in similar or reduced rates of adverse reactions, which already are uncommon in children even when five doses are given.

Finally, the ACIP recommendation, which was published in 2010 (MMWR 2010;59:1-9), showed that reducing the dosing schedule to four doses would result in an estimated $16.6 million cost savings to the U.S. health care system.

Approximately 20,000-30,000 people receive rabies postexposure prophylaxis (PEP) in the United States each year, and one to three cases of human rabies occur each year, according to the AAP Policy Statement. Since the 1970s, with the introduction of modern cell-derived vaccines, no PEP failures have occurred.

Effective PEP has been attributed to prompt washing of the wound with copious amounts of soap and water, infiltration of human rabies immunoglobulin (HRIG) into and around the wound, and an appropriate dose schedule of intramuscular vaccine, which is now considered to be four doses in most patients, according to the Policy Statement. All other rabies PEP recommendations remain the same.

It is important that pediatricians be up to date on the new recommendations for rabies PEP, Dr. Mary Ann Jackson said in an interview.

"Despite the rarity of human rabies infection in the United States, questions for the pediatrician arising from potential animal exposures are surprisingly frequent, as animal bites and even bat exposures occur not uncommonly in the pediatric population," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals & Clinics, Kansas City, Mo.

Pediatricians also need to know that the decision to embark on rabies PEP should be urgently but not emergently handled, she added, explaining that most exposures relate to domestic animal encounters (often strays) or incidents in which bats are found in the family home.

"Careful attention to information gathering related to the exposure is key (see our form at www.childrensmercy.org/rabiesform), and practitioners should utilize their health department and local infectious disease specialists for input in situations where PEP is considered," she said.

Dr. Jackson, who also is a professor of pediatrics at the University of Missouri–Kansas City, advised that in any instance where PEP is being considered, it is important to keep in mind that wound cleansing is essential and the child’s tetanus vaccine history should be confirmed, with vaccine provided in appropriate cases. Rabies immune globulin must be concurrently given in the wound site in addition to rabies vaccine in an alternative site in every case where PEP is being provided for the first time in an otherwise healthy child.

In the instance where a bat is discovered in the room of a sleeping child, the PEP decision is certainly straightforward if the animal is available for rabies testing, and results can be ascertained promptly. In an otherwise healthy domestic pet exposure, a 10-day observation period should be ensured, utilizing the assistance of the local animal control and public health officials and in low-risk situations, which may obviate the need for PEP, said Dr. Jackson, who is a member of the AAP Committee on Infectious Diseases that wrote the new AAP Policy Statement.

 

 

All authors have filed conflict of interest statements with the AAP. Any conflicts have been resolved through a process approved by the AAP Board of Directors, according to Pediatrics.




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The American Academy of Pediatrics has officially endorsed a 2010 recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices that reduces by one the number of vaccine doses required for postexposure rabies prophylaxis.

The recommendation calls for a reduction in the number of postexposure doses of human diploid cell vaccine (HDCV) or purified chick embryo cell vaccine (PCECV) from five to four doses, with the first dose of 1 mL to be given intramuscularly as soon as possible after exposure (day 0) and subsequent doses to be given on days 3, 7, and 14 after the first dose except in people with immune suppression, who should continue to receive the five-dose regimen with the fifth dose given on day 28.

Photo credit: © astridb05/Fotolia.com
Despite the rarity of cases of  human rabies infection, potential exposure due to animal bites is common.    

The recommendation is the result of a review beginning in 2007 during a time when human rabies vaccine was in limited supply. The Advisory Committee on Immunization Practices (ACIP) formed a work group to review rabies vaccine options, and found that four doses were adequate for inducing rabies-neutralizing antibody, according to an AAP Policy Statement published March 28 in Pediatrics, which announces the AAP’s endorsement of the recommendation (Pediatrics 2011 March 28 [doi: 10.1542/peds.2011-0095]).

A detailed review by the ACIP rabies work group of the evidence in support of the reduced dosing schedule showed that in all of approximately 1,000 patients, an adequate immune response to vaccination was achieved by day 14 (when the fourth dose of cell-derived rabies vaccine was given). In addition, observational studies of people with likely rabies exposure showed that no cases of rabies have been attributed to the lack of a fifth dose.

Furthermore, animal models demonstrated that the number of vaccine doses did not contribute to significant differences in survival rate, and, theoretically, a reduced dosing schedule would result in similar or reduced rates of adverse reactions, which already are uncommon in children even when five doses are given.

Finally, the ACIP recommendation, which was published in 2010 (MMWR 2010;59:1-9), showed that reducing the dosing schedule to four doses would result in an estimated $16.6 million cost savings to the U.S. health care system.

Approximately 20,000-30,000 people receive rabies postexposure prophylaxis (PEP) in the United States each year, and one to three cases of human rabies occur each year, according to the AAP Policy Statement. Since the 1970s, with the introduction of modern cell-derived vaccines, no PEP failures have occurred.

Effective PEP has been attributed to prompt washing of the wound with copious amounts of soap and water, infiltration of human rabies immunoglobulin (HRIG) into and around the wound, and an appropriate dose schedule of intramuscular vaccine, which is now considered to be four doses in most patients, according to the Policy Statement. All other rabies PEP recommendations remain the same.

It is important that pediatricians be up to date on the new recommendations for rabies PEP, Dr. Mary Ann Jackson said in an interview.

"Despite the rarity of human rabies infection in the United States, questions for the pediatrician arising from potential animal exposures are surprisingly frequent, as animal bites and even bat exposures occur not uncommonly in the pediatric population," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals & Clinics, Kansas City, Mo.

Pediatricians also need to know that the decision to embark on rabies PEP should be urgently but not emergently handled, she added, explaining that most exposures relate to domestic animal encounters (often strays) or incidents in which bats are found in the family home.

"Careful attention to information gathering related to the exposure is key (see our form at www.childrensmercy.org/rabiesform), and practitioners should utilize their health department and local infectious disease specialists for input in situations where PEP is considered," she said.

Dr. Jackson, who also is a professor of pediatrics at the University of Missouri–Kansas City, advised that in any instance where PEP is being considered, it is important to keep in mind that wound cleansing is essential and the child’s tetanus vaccine history should be confirmed, with vaccine provided in appropriate cases. Rabies immune globulin must be concurrently given in the wound site in addition to rabies vaccine in an alternative site in every case where PEP is being provided for the first time in an otherwise healthy child.

In the instance where a bat is discovered in the room of a sleeping child, the PEP decision is certainly straightforward if the animal is available for rabies testing, and results can be ascertained promptly. In an otherwise healthy domestic pet exposure, a 10-day observation period should be ensured, utilizing the assistance of the local animal control and public health officials and in low-risk situations, which may obviate the need for PEP, said Dr. Jackson, who is a member of the AAP Committee on Infectious Diseases that wrote the new AAP Policy Statement.

 

 

All authors have filed conflict of interest statements with the AAP. Any conflicts have been resolved through a process approved by the AAP Board of Directors, according to Pediatrics.




The American Academy of Pediatrics has officially endorsed a 2010 recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices that reduces by one the number of vaccine doses required for postexposure rabies prophylaxis.

The recommendation calls for a reduction in the number of postexposure doses of human diploid cell vaccine (HDCV) or purified chick embryo cell vaccine (PCECV) from five to four doses, with the first dose of 1 mL to be given intramuscularly as soon as possible after exposure (day 0) and subsequent doses to be given on days 3, 7, and 14 after the first dose except in people with immune suppression, who should continue to receive the five-dose regimen with the fifth dose given on day 28.

Photo credit: © astridb05/Fotolia.com
Despite the rarity of cases of  human rabies infection, potential exposure due to animal bites is common.    

The recommendation is the result of a review beginning in 2007 during a time when human rabies vaccine was in limited supply. The Advisory Committee on Immunization Practices (ACIP) formed a work group to review rabies vaccine options, and found that four doses were adequate for inducing rabies-neutralizing antibody, according to an AAP Policy Statement published March 28 in Pediatrics, which announces the AAP’s endorsement of the recommendation (Pediatrics 2011 March 28 [doi: 10.1542/peds.2011-0095]).

A detailed review by the ACIP rabies work group of the evidence in support of the reduced dosing schedule showed that in all of approximately 1,000 patients, an adequate immune response to vaccination was achieved by day 14 (when the fourth dose of cell-derived rabies vaccine was given). In addition, observational studies of people with likely rabies exposure showed that no cases of rabies have been attributed to the lack of a fifth dose.

Furthermore, animal models demonstrated that the number of vaccine doses did not contribute to significant differences in survival rate, and, theoretically, a reduced dosing schedule would result in similar or reduced rates of adverse reactions, which already are uncommon in children even when five doses are given.

Finally, the ACIP recommendation, which was published in 2010 (MMWR 2010;59:1-9), showed that reducing the dosing schedule to four doses would result in an estimated $16.6 million cost savings to the U.S. health care system.

Approximately 20,000-30,000 people receive rabies postexposure prophylaxis (PEP) in the United States each year, and one to three cases of human rabies occur each year, according to the AAP Policy Statement. Since the 1970s, with the introduction of modern cell-derived vaccines, no PEP failures have occurred.

Effective PEP has been attributed to prompt washing of the wound with copious amounts of soap and water, infiltration of human rabies immunoglobulin (HRIG) into and around the wound, and an appropriate dose schedule of intramuscular vaccine, which is now considered to be four doses in most patients, according to the Policy Statement. All other rabies PEP recommendations remain the same.

It is important that pediatricians be up to date on the new recommendations for rabies PEP, Dr. Mary Ann Jackson said in an interview.

"Despite the rarity of human rabies infection in the United States, questions for the pediatrician arising from potential animal exposures are surprisingly frequent, as animal bites and even bat exposures occur not uncommonly in the pediatric population," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals & Clinics, Kansas City, Mo.

Pediatricians also need to know that the decision to embark on rabies PEP should be urgently but not emergently handled, she added, explaining that most exposures relate to domestic animal encounters (often strays) or incidents in which bats are found in the family home.

"Careful attention to information gathering related to the exposure is key (see our form at www.childrensmercy.org/rabiesform), and practitioners should utilize their health department and local infectious disease specialists for input in situations where PEP is considered," she said.

Dr. Jackson, who also is a professor of pediatrics at the University of Missouri–Kansas City, advised that in any instance where PEP is being considered, it is important to keep in mind that wound cleansing is essential and the child’s tetanus vaccine history should be confirmed, with vaccine provided in appropriate cases. Rabies immune globulin must be concurrently given in the wound site in addition to rabies vaccine in an alternative site in every case where PEP is being provided for the first time in an otherwise healthy child.

In the instance where a bat is discovered in the room of a sleeping child, the PEP decision is certainly straightforward if the animal is available for rabies testing, and results can be ascertained promptly. In an otherwise healthy domestic pet exposure, a 10-day observation period should be ensured, utilizing the assistance of the local animal control and public health officials and in low-risk situations, which may obviate the need for PEP, said Dr. Jackson, who is a member of the AAP Committee on Infectious Diseases that wrote the new AAP Policy Statement.

 

 

All authors have filed conflict of interest statements with the AAP. Any conflicts have been resolved through a process approved by the AAP Board of Directors, according to Pediatrics.




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Cephalexin a Viable Option for Children's MRSA Skin Infections

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Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

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Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

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Major Finding: Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin. By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively.

Data Source: A randomized trial comparing cephalexin and clindamycin for the treatment of uncomplicated pediatric skin and soft tissue infections in children.

Disclosures: Dr. Chen and associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

Cephalexin a Viable Option for Children's MRSA Skin Infections

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Cephalexin a Viable Option for Children's MRSA Skin Infections

Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

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Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

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Major Finding: Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin. By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively.

Data Source: A randomized trial comparing cephalexin and clindamycin for the treatment of uncomplicated pediatric skin and soft tissue infections in children.

Disclosures: Dr. Chen and associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

Cephalexin a Viable Option for Children's MRSA Skin Infections

Article Type
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Display Headline
Cephalexin a Viable Option for Children's MRSA Skin Infections

Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

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Cephalexin, clindamycin, pediatrics, skin infection, soft tissue infection, community-acquired methicillin-resistant Staphylococcus aureus, MRSA
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Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

Cephalexin and clindamycin have comparable effectiveness for the treatment of uncomplicated pediatric skin and soft tissue infections caused by community-acquired methicillin-resistant Staphylococcus aureus, findings from a randomized double-blind study of 200 patients suggest.

Clinical improvement occurred by 48-72 hours in 94% of 100 patients randomized to receive treatment with 40 mg/kg per day of cephalexin taken orally in divided doses administered 3 times per day – a traditional antistaphylococcal antibiotic without activity against methicillin-resistant S. aureus (MRSA), and in 97% of 100 patients randomized to receive treatment with 20 mg/kg per day of clindamycin taken orally in divided doses administered 3 times per day – an antibiotic with high clinical activity against community-acquired MRSA (CA-MRSA). By 7 days, all subjects in both groups were improved, with complete resolution in 97% and 94% of patients in the cephalexin and clindamycin groups, respectively, Dr. Aaron E. Chen of Johns Hopkins Medical Institutions, Baltimore, and his colleagues reported in the March issue of Pediatrics.

The response rates in the groups did not differ significantly, but fever and age of less than 1 year were significantly associated with a lower rate of resolution at 48-72 hours. Only fever at baseline was associated with a significantly lower rate of resolution at 7 days, the investigators wrote (Pediatrics 2011;127:e573-80).

Patients in the study were children aged 6 months to 18 years who presented from September 2006 through May 2009 with uncomplicated skin and soft tissue infections (SSTI) not requiring hospitalization. MRSA was cultured from wounds in 69% of participants, and the isolates had characteristics consistent with community-acquired infection, the investigators noted.

Neither demographic variables nor characteristics of infection at baseline differed significantly between the two groups.

Unless additional studies confirm previous reports that adjuvant antibiotics offer no benefit for the treatment of uncomplicated, purulent SSTIs in children, the current findings suggest that cephalexin is "a viable empiric antibiotic choice (even in areas with a high prevalence of CA-MRSA) in the context of management that already includes careful drainage of purulent collections, attention to wound care, and appropriate follow-up, especially in children of younger age and with fever," Dr. Chen and his associates wrote.

The findings are important because clindamycin is frequently used for the treatment of uncomplicated SSTIs. At Johns Hopkins, for instance, it has been standard practice since mid-2004 to use clindamycin for this purpose – a decision based on "reports of safety and efficacy in children with MRSA infections and the perceived importance of antibiotics in the management of SSTIs," the investigators wrote.

This has resulted in significantly increased use of clindamycin despite its numerous disadvantages over traditional antistaphylococcal antibiotics, including higher cost, poor palatability, greater concern regarding adverse effects, and development of antibiotic resistance, they added.

Dr. Chen and his associates reported having no relevant financial disclosures. This study was funded in part by the National Institutes of Health.

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Cephalexin a Viable Option for Children's MRSA Skin Infections
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Cephalexin a Viable Option for Children's MRSA Skin Infections
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Cephalexin, clindamycin, pediatrics, skin infection, soft tissue infection, community-acquired methicillin-resistant Staphylococcus aureus, MRSA
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Cephalexin, clindamycin, pediatrics, skin infection, soft tissue infection, community-acquired methicillin-resistant Staphylococcus aureus, MRSA
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