Pediatrics.
`v, 128. no. 6 (Dec. 2011)
`General Collection
`W1 PE191
`201201—18 09:08:58
`
`MERICAN ACADEMY OF PEDIATRICS
`
`1 LUEATRICS
`
`DECEMBER 2011 ' VOLUME 128 ' NUMBER 6
`
`wwwpediairlcsorg
`
`Exclusive Breastfeeding in the US J. H, Jones at u/
`Paternal and Child Mental Health Problems
`M. Weitzmnn et a/
`1 12B
`
`‘. 117
`
`Antipsychotic Medication Use in Children
`8. E, Andrade et a/ 1155
`
`Effects of a Night—Team System on Sleep and Work Hours
`K.-P. Chua eta/ 1142
`
`Weight and Crash-Related Injury M. R. Zanfrii/D of a/ 1148
`Delayed Acyclovir and Mortality in Neonatal HSV
`S. S. Shah et ai 1155
`Outcomes of Children With Eczema Herpeticum
`P. L. Aranson at at 1151
`
`Role of Reputation in Pediatric Specialties Ranking
`R. A. Bush eta/ 1168
`
`CASE REPORTS—www.pediatri03mg
`Stress Hyperglycemia in Children and Familial Diabetes
`T. Oron et a/ 1208
`Paracetamol and FDA Constriction 0. Hammerman eta! 1208
`Myocardial Infarction, Synthetic Cannabis K2 A. Mir et a/
`1208
`
`Intravenous Lipid Emulsion for TCA Overdose in a Toddler
`D. Hendron et ai 1208
`Treatment of Kimura Disease With IVIC
`V. HomandezBaut/sta er a/ 1209
`Clinical and Biochemical Characterization of cblF Disease
`0, Oiadipa et a/ 1209
`
`1215
`
`FROM THE AMERICAN ACADEMY OF PEDIATRICS
`Meningococcal Conjugate Vaccine Booster Dose
`Recommendations Committee an Infectious Diseases
`Health Care for Youth in the Juvenile Justice System
`P. K, Braverman 1219
`Positional Skull Deformities in Infants 1/ Laugh/in,
`T. G. Luerssen, M. S. Dias, the Committee on Practice and
`Ambu/atvry Media/he, and Section on Neuro/ogica/ Surgery
`1256
`
`
`elines for Cardiovascular
`
`Health and Risk Reduction in Children and Adolescents:
`Summary Report RAE. W. Kavey, D. G. Simons—Marton,
`and J. M. (16 Jesus, Supplement Editors S215
`
`Antibiotic Prescribing in Ambulatory Pediatrics
`A. L. Hersh et ai 1053
`
`Pediatric Antimicrobial Stewardship M. C. Di Pentima et a/
`1082
`
`Infant Varicella in the US St S Chaves et (7/ 1071
`Adolescent Vaccination-Coverage Levels in the US: 2006—2009
`S. Stokley et at 1078
`Financial Impact to Providers Using Combination Vaccines
`A. K Shcn el HI 1087
`Pediatricians’ Views on Alternative Immunization
`Schedules A. Wightman at a/ 1094
`Infant Sleep Following Immunization: An R01 L. Franck et a/
`1100
`
`Welfare and Childhood Vaccination MW. Sohn at ul 1109
`
`i_ PEDIATRICS PERSPECTIVES
`Limits of Viability in the United States 8. H. Arzuaga et ai
`1047
`
`IlI
`
`STATE OF THE ART REVIEW ARTICLE
`
`Recent Advances in HAE N. Santana and 7. J Craig 1175
`
`SPECIAL ARTICLES
`
`Acetaminophen and Asthma J T. McBride 1181
`
`Contemporary Ethical Issues in Human Milk Banking
`0, .1. Miracle at a/
`1 186
`
`COMMENTARY
`
`Reflections on U.S. Immunization Challenges E. K. Marcuse
`I 192
`
`Abstracts appear on pages 1195—1210
`
`
`
`/. Rappupart et a] 1207
`Medication Recgnciliation D.
`Improving Reporting of Outpatient Medical Errors
`0 i7, Neuspiel et a/ 1207
`
`American Academy of Pediatrics
`
`DEDICATED TO THE HEALTH OF ALL CHILDREN"
`
`Page 1 of 17
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`The content oflhe iour‘nal is
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`PEDIATRICS, January l91l8
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`Editor
`Lewrs R. Eirst, Burlington, VT
`Deputy Editor
`Virginia A, Moyer, Houston, TX
`Editor Emeritus
`Jerald F Lucey, Burlington, VT
`Associate Editors
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`Jeffrey D. Harbor, Burlington, VT
`J. Jeffrey Malatack, Wilmington, DE
`William V, Raszka, Burlington, VT
`Gordon rschutze, Houston, TX
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`Assistant Editors
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`Claudia Kozinetz, Houston, TX
`Diane Duvall Marshall, Chapel Hill, NC
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`Barbara Cromcr, Cleveland, OH
`Eric Eichenwald, Houston, TX
`Gary Freed, Ann Arbor, MI
`Lydia Furman, Cleveland, OH
`Stephen J. Harris, San lose, CA
`Helen Lauro, Brooklyn, NY
`Alex Levrrr, Philadelphia, PA
`Donald E. Lighter, Knoxville, TN
`Reuoen rVIatann, Galveston, TX
`Rebecka Meyers, Salttake City, UT
`Thomas Newman, San Franc/5cm, CA
`Richard I
`rsaphir, New York, NY
`Joann Schultc,Atlanta, GA
`Gary Smith, Columbus, OH
`Tina Tan, Chicago, IL
`Robert Vorgt, Houston, TX
`Steven Zeichner, Bethesda, MD
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`Ex Officio
`0. Marion Burton, President
`Errol R, Alden, Executive Director
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`Pubfisher
`American Academy of Pediatrics
`Robert Perelman, Director, Department of Education
`Michael Held, Director, Division ofScholar/y Journals
`and Professional Periodicals
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`PED AIRICSIISSNOO31 4005) is owned and controlled by the American Academy of Pediatrics. It is published monthly
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`PEDIATRIC?
`
`DECEMBER 2011- VOLUME 128 - NUMBER 6
`
`
`Most of the articles in PEDIATRICS have more
`
`content available online at www.pedlatrics.org
`
`
`= data file available online
`
`@Ebe
`
`= podcast available online
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`= video available online
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`= free access online
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`= funded by NIH
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`General Information
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`
`PEDIATRICS PERSPECTIVES
` limits of Human Viability in the llnited States: A
`Medicolegal Review Bonnie Hope Arzuaga, Ben Hakew Lee
`
`
`ARTICLES
`
`
`
`Antibiotic Prescribing in Ambulatory Pediatrics in the
`United States Adam L, Hersh, Daniel J. Shapiro,
`Andrew T. Pavia, Samir Si Shah
`
`Benefits of a Pediatric Antimicrobial Stewardship
`Program at a Children’s Hospital M. Cecilia Di Pentima,
`Shannon Chan, Jobayer Hossain
`
`@ Varicella in Infants After implementation of the [IS
`Varlcella Vaccination Program Sandra 5‘, Chm/es,
`Adriana S, Lopez, Tureka L Watson, Rachel Given,
`Barbara Watson, Laurene Masaola) Jana F. Seward
`
`® Adolescent Vaccination-Coverage Levels in the United
`States: 2006-2009 Shannon Stok/ey, Amanda Conn,
`Christina Dare/l, Susan Hariri, Dav/a Yankey,
`Nancy Messannier, Pascale M. Wort/52y
`
`Financial Impact to Providers Uslng Pediatric
`Combination Vaccines Angela K. Sheri, Elizabeth Sabczyk,
`Lane Simonsen, Farid Khan, Allahna Esber,
`Margie G, Andreae
`
`Washington State Pediatricians’ Attitudes Toward
`Alternative Childhood Immunization Schedules
`Aaron Wightman, Douglas J Opel, EdgarK. Marcusel
`James A. Taylor
`
`Infant Sleep After Immunization: Randomized Controlled
`Trial of Prophylactic Acetaminophen Linda Franck,
`Caryl L Gay, Mary Lynch, Kathryn A. Lee
`
`1062
`
`1071
`
`1078
`
`1087
`
`1094
`
`1 100
`
`
`
`American Academy of Pediatrics
`DEDICA'I'EI) TU 'I'HI'L HEALTH OF ALI. CHILDREN"
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`PEDIATRICS!”
`
`DECEMBER 2011 - VOLUME 128 ' NUMBER 8
`
`
`Welfare, Maternal Work, and Dn-Time Childhood
`Vaccination Rates Mln-Woong Soh/L Joan Yon, Elissa H1 0h,
`Laura E. Amsden, Jane A. Holl
`
`@ Factors Associated With Exclusive Breastfeeding in the
`United States Jessica R. Jones, Michael D, Kogun,
`Gapa/ K, Singh, Deborah L, Dee, Laurence M. Grumrner—Strawn
`
`® Paternal Depressive Symptoms and Child Behavioral
`or Emotional Problems in the United States
`Michael Weitzman, David G Rosenthal, Ying-Haa liu
`
`Antipsychotic Medication Use Among Children and
`Risk of Diabetes Mellitus Susan E Andrade, Joan 0. Lo,
`Douglas Rab/in, Hassan Foaayzi, Daniel F. Connor,
`Robert B. Peale/d, Mali/7i Chandra, George Reed,
`Jerryl-l Gurwitz
`
`Effects of a Night-Team System on Resident Sleep and
`Work Hours KaarP/ng Chaa, Mary Beth Gordon,
`Theodore Sect/sh, Christopher P. Landrigan
`Association Between Weight and Risk of Crash-Related
`Injuries for Children in Child Restraints Mark R, Zonir/llo,
`Michael R. Elliott, Carol A. Flannagan, Dennis R. Doro/n
`
`Delayed Acyclovir Therapy and Death Among Neonates
`With Herpes simplex Virus Infection Sam/r S. Shah,
`Paul l. Aronson, Zeinab Mohamed, Scott/1. Loroh
`
`Delayed Acyclovir and Outcomes oi Children
`Hospitalized With Eczema Herpeticum Paul L Aronsan,
`Albert a Yon, Mann} K. Mittal Zeinab Mohamad, Sam/"r 8, Shah
`
`1109
`
`1 1 17
`
`1 126
`
`1 155
`
`1 42
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`1 48
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`1 55
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`1 51
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`
`
`Role of Reputation in Top Pediatric Specialties Rankings 1 68
`Hath A, Bush, Edward J Oaigley, Lyman Fox, lvan Garcia-Bassets
`
`REVIEW ARTICLES
`
`
`
`
`e~review articles—www.pediatricsorg
`Management of Children With Sickle Cell Disease:
`1205
`A Comprehensive Review of the literature
`Pair/Clot. Kavanagh, Philippa G. Sprlnzi Samuel H. I/inci,
`Ho ward Baachner, L‘. Jason Wang
`
`@ The Safety of Pediatric Acupuncture: A Systematic
`Review Denise Adams, Florence Chang, Hsing Jou,
`Steven Aang, Yataka Yasai, Sunita Vohra
`Efficacy of Porcine Versus Bovine Surfactants for
`Preterm Newborns With Respiratory Distress
`Syndrome: Systematic Review and Meta-analysis
`Neetu Singh, Kristyl Haw/ey, Kristin Viswanathan
`
`1208
`
`1206
`
`“-
`
`Page 4 of 17
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`atthe NLM and may be
`Ban] 2 :t Us Copyright Laws
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`American Academy of Pediatrics
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`DEDICA'I‘I‘ZD TO THE HEALTH 0|" ALL CHILDRRN‘
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`

`PEDIATRICS”
`
`DECEMBER 20H - VOLUME 128 ‘ NUMBER 6
`
`
`
`The Association of Acetaminophen and Asthma
`Prevalence and Severity John T. McBride
`
`1181
`
`
`
`STATE-0 F-THE-ART REVIEW ARTICLE
`
`Recent Advances in Management and Treatment of
`1175
`Hereditary Angioedema Niti Saraana, Timothy/J, Craig
`
`SPECIAL ARTICLES
`
`
`
`1185
`
`® Contemporary Ethical Issues in Human Milk-Banking in
`the United States Donna J. Miracle, KingaA. Szucs,
`Alexia M. Torke, Paul H. He/ft
`
`
`
` COMMENTARIES
`
`Reflections on IIS Immunilation Challenges: lady
`Montague, Where Are You? Edgar K. Marcuse
`
`
`
`
`e-commentaries—www.pediatrics.org
`Safely Doing less: A Missing Component of the Patient
`Safety Dialogue Alan R. Schroeder, Stephen J. Harris,
`Thomas B. Newman
`
`Early Detection of Biliary Atresia Raises Questions
`About Etiology and Screening Ezequiel Neimark,
`Neal 8. ieleiko
`
`1207
`
`1207
`
`Pediatrics digest available online at
`www.pediatrics.org
`
`Emergency Department laboratory Evaluations of Fever
`Without Source in Children Aged 3 to 58 Months
`Alan E Simon, Susan L. Lukacs, Pauline Mendoia
`
`® National Trends in Exposure to and Experiences of
`Violence on the Internet Among Children
`Michele L Ybarra, Kimberlyd. Mitchell,
`Josephine D. Korchmaros
`
`Immunogeniclty and Safety of MMRV and PCV-7
`Administered Concomitantly in Healthy Children
`Michael ieonarai, Kenneth Bromberg, Roger Baxter,
`Julie L, Gardner, Stephanie Klopfer, Ouzama Nicholson,
`Michael Brock/9y, James Trammei, Vickyieamy,
`Wendy Williams, Barbara Kuter, Florian Schb‘dei
`
`
`
`I 195
`
`1195
`
`1195
`
`A6
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`Page 5 of 17
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`American Academy of Pediatrics "3‘
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`DEDICATED TO THE HEALTH 01" ALI. CHILDREN" \
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`PEDIATRICS/L"
`
`,i‘
`w
`.
`DECEMBER 2011-V01UME128‘NUMBEP7
`
`1 196
`
`1196
`
`1197
`
`1 197
`
`1 '98
`
`“98
`
`1 W9
`
`CDto
`
`-
`on: Values Among Children and Adolescents Presenting
`to the Emergency Department Charlotte 8. l/an Darn,’ ‘ n
`Jonathan N Johnson, Nathaniel W iaggart, £013 Thar“ 5" '
`MichaelJ Ackern'ian
`
`.
`.
`Symptomatic Neonatal Arterial lschemic Stroke. The
`International Pediatric Stroke Study Adam Kirtoni
`Jennifer Armstronngells, Taaun Chang, Gabriel/e deVeDei'.
`Michael J, li’ivkln, Marta Hernandez, Jessica Carpenter,
`Jerome Y. Yager, John K. Lynch, Donna M. Ferrioro, for the
`International Pediatric Stroke Study Investigators
`
`Changes in Body Mass During Elementary and Middle
`School in a National Cohort of Kindergarteners
`Ash/csha Datar, Victoria Shier, Roland Storm
`
`llndernutrition, Poor Feeding Practices, and
`Low Coverage of Key Nutrition Interventions
`Chessa K. Latter, Bernadette M. E G, [Jae/mans,
`Mercedes de Unis, Monika T, Kothari, Marie T. Ruel,
`Mary Arimond, Megan Dalton/er, Kathryn G. Dewey,
`Monika Blossner, Elaine Borghi
`
`Patients With Biliary Atresia Have Elevated Direct!
`Conjugated Bilirubin Levels Shortly After Birth
`Sanjiv Harpavat, Milton J. Finegold, Saul J. Karpen
`
`Attitudes Toward Newborn Screening for
`Cytomegalovirus Infection Erica 8. Din, Cedric J. Brown.
`Scott D. Grosso, Chengbin Wang, Stephanie R. Elia/ek,
`Danielle S. Ross, Miohaeld. Cannon
`
`Pediatric Paradoxical Vocal-Fold Motion: Presentation
`and Natural History Stephen Maturo, Courtney Hill,
`Glenn Hunting, Cathy Ba/ifif Jyoti Ramakrishna,
`Christina Scirica, Shannon Fracohia, Abigail Donovan,
`Christopher Hariniok
`
`Critically Ill Children During the 2009—2010 Influenza
`Pandemic in the United States Adrienne G. Randolph,
`Frances Vaughn, Ryan Sullivan, Lewis Robinson,
`8. Taylor Thompson, Grace Yoon, Elizabeth Smoot
`Todd W Rice, Laura L. Loft/s, Mark Helfacr, Allan Doctor,
`Matthew Paden, Heidi Flori, Christopher Babbitt,
`Ana Lia Graciana, Rainer Gedeir, Ronald C Sanders,
`John S. Giuliano, Jerry Zimmerman. Timothy M. Uyeki, and
`the Pediatric Acute Lung injury and Sepsis investigator's
`Network and the National Heart, Lung, and Blood Institute
`AHDS Clinical Trials Network
`
`Antipsychotic Treatment Among Youth in Foster Care
`Susan dosRe/S, Yese/ Yoon, David M. Rubin, Mark/l. Riddle,
`Elizabeth Noll, Aileen Rothbard
`
`1200
`
`A8
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`Page 6 of 17
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`This material was copied
`
`American Academy of Pediatrics
`
`DIEDICA'l'ltli 'I'O 'I'Hli HEALTH 0! i\1.I,(lHlI.I)RliN"‘
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`Page 6 of 17
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`

`PEDIATRICSw
`
`DECEMBER 2011' VOLUMF 198 - NUMBER 6
`
`Development of a Risk-Stratification Tool for Medical
`Child Abuse in Failure to Thrive Constance Mash,
`Thomas Frazier, Amy Nowocki, Sarah Wor/cy,
`Johanna Goidfarb
`
`leveraging State Immunization Information Systems to
`Measure the Effectiveness of Rotavirus Vaccine
`Margaret M, Cortese, Julie LeB/anc, Karen E. White,
`Robert G. Jerris, Patricia Stinchfielci, Kcnan L. Preston,
`James Meek, Lynda 0aofin, Saadia Khizer, Claudia A. Miller,
`Vicki Buttery, Slavica Mijatovic Rustempasio, Jamie Lewis,
`Umesh D, Parashar, Lil/y Chang lmmergluck
`Medical-legal Partnership: Impact on Patients With
`Sickle Cell Disease Robert Pettlgnano, Sylvia B. Caley
`Lisa R. Bliss
`
`Parental Knowledge Regarding Lifelong Congenital
`Cardiac Care Susan M Fernaiicles, Amy Verstappen,
`Kathy Aakerman, Elizabeth E. Adams, Cheryl Barton,
`Petar Brei‘tinger, Stephen Crumb, Kirsten Bummer,
`Kano Harada, Paul Khairy, Michael J. Landzberg,
`Rachel Linstead-Goldsmith, Allison K. Meadows,
`Jo Ann Nieves, Arwa Saiai’, Masato Takahashi', Jing Zhou,
`Sonja Ziniel, Roberta Williams, on behalf of the Adult
`Congenital Heart Association the Adult Congenital Cardiac
`Care Associate Research Network
`
`Glarithromycin in Preventing Bronchopulmonary
`Dysplasia in llreaplusma urealyticum—Positive
`Preterm Infants Ramazan Dzaemir, Omer Eraeve,
`Evrim Aiyamac Dizaar, Serifo Suna Liguz, Nuraan Uras,
`Sibel Saygan, Erdem Karabu/ut, Ugur Dilmen
`Effect of Antihypotensive Treatment on Cerebral
`Oxygenation of Preterm Infants Without PDA
`Hilae J. C. Bonestroo, Petra M. A, Lemmers, Wim Baerts,
`Frank van Bel
`
`Ilse of a Visual Aid to Improve Counseling at the
`Threshold of Viability Venkatakrishna Kakki/aya,
`Lynn J. Graeme, Dacl P/att, Dalihor Kurepa, Arun Pi'amanik,
`Gloria Co/aita, Lesley Conrad, Joseph A. Bocohini Jr,
`Terry C. Davis
`
`Preterm Milk Oligosaccharides During the First
`Month of Lactation Grazia Gabrielli, Lucia Zampinl,
`Tiziana Galeozzi Lucio Fade/la, Lucia Santoro, Chiara Pei/a,
`Francesca Giuliani, Enrico Bertino, Claudio Fabris,
`Giovanni 1/. Coppa
`
`Psychiatric and Medical Gomorbldity and Quality of Life
`Outcomes in Childhood-Onset Epilepsy Christine H. flaca,
`Barbara G, Vickrey, Rochelle cap/an, Stefanie i). Vassar,
`Anne I Berg
`
`1201
`
`1201
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`1202
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`1202
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`1205
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`120.5
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`1204
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`1204
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`1204
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`A10
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`Page 7 of 17
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`American Academy of Pediatrics \
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`DEDICA’I'I'II) TO THE HliAH'H 0]" ALL CHILDREN"
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`

`

`PEDIATRICS”
`
`DECEMBER 2011' VDLUME128 ' NUMBER 8
`
`Parent Participation and Physician-Parent
`Communication During Informed Consent in Child
`Leukemia Melissa Cousma, Rebecaa llazen,
`Amy Yamakoski, Victoria Mil/or, Stephen Zyzanski,
`Dennis Drotan Eric Kodish, on behalf of the Mu/fIVS/Z‘G
`Intervention Study to improve Consent Research Team
`
`
`Implementing Medication Reconciliation in Outpatient
`Pediatrics Dawa l. Rappapart, Brian Collins, Alex Kaster,
`Arnel Mercado, day Greenspan, Steven Lawless,
`Jobayer Hossain, lman Sharif
`
`1205
`
`I207
`
`Improving Reporting of outpatient Pediatric Medical
`Errors Daniel R Neaspiel, Erin H. Stubbs, Lari liggin
`
`
`
`CASE REPORTS—www.pediatricsorg
`Stress Hyperglycemia: A Sign of Familial Diabetes in
`1208
`Children fa/ Oran, Gal/a (:‘atAYab/onski, tiara Lazar,
`Moshe Phillip, Yael Goa/an
`
`1207
`
`Ductal Closure With Paracetamol: A Surprising New
`Approach to Patent Ductus Arleriosus Treatment
`Cathy Hammerman, Alana Bin-Nun, Einat Markov/ton,
`Michael St Schimmel, Michael Kaplan, Daniel Fink
`Myocardial Infarction Associated With Use of the
`Synthetic Cannahinoid K2 Arshid Mir, Aaebisi Dbafemi,
`Amy Young, Colin Kane
`
`Tricyclic Antidepressant Overdose in a toddler Treated
`With Intravenous lipid Emulsion David Hendron,
`Gareth Menagh, than A Sand/lands, and Damian Scull/0n
`Treatment of Kimura Disease With Intravenous
`lmmunoglobulin Victor Hernandez—Bautista,
`Marco Antonio YamazakivNakashimada,
`Ruben Vazquez-Garcia, Danie/a Stamatelas Albarran
`Daniel DarrasaarDaza, Ana luisa Rodriguez-lozano
`
`Cobalamin F Disease Detected by Newborn Screening
`and Follow-up on a MrYear-Dld Patient Ulay’amoke Uladipa,
`David S. Rosana/0th Davia Wat/(Ins, Isabelle Racine Miausse,
`laarie Sprietsma, Dennis .J. Dietzen, Marwan Shinawi
`
`120R
`
`1208
`
`1209
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`1209
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`1209
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`
`eLetters-www.pediatricsorg
`
`eletters appear on page 1211 and online at
`www.pediatrius.org
`
`Errata
`
`1 2 1 2
`
`A12
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`Page 8 of 17
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`Thismaterialwascapied
`atthe NLI'vI and may be
`in his n: US- Copyright Laws
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`I, CHILDREN"
`American Academy of Pediatrics \
`I)I'.I)[(IA’I'I’.I) 'l () ’I‘l'lli H l‘.:\I.'I‘l»I OI" Al
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`PEDIATRICSID
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`DECEMBER 2011 ' VOLUME 128 - NUMBER 8
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`FROM THE AMERICAN ACADEMY OF PEDIATRICS
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`Policy Statement
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`American Academy of Pediatrics
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`DEDICA'I'I‘ZI) TO THE. III-ZAI'I'H ()Ii ALI, (.‘IllI.I)l(I-,N"
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`STATE-OF-THE-ART REVIEW ARTICLES
`
`Recent Advances in Management and Treatment of
`Hereditary Angioedema
`
`AUTHORS: Niti Sardana, MD,“ and Timothyd. Craig, D0U
`"Department e/Pediatries, Weill Cornell Medical Center, New
`York Presbyterian Hospital, New York, New York; and “DIVISION of
`Pulmonary, Allergy and Critical Care, Penn State University
`Milton S. Hershey Medical Center, Hershey, Pennsylvania
`KEY WORDS
`hereditary angioedema, treatment, prophylaxis. C1 inhibitor,
`bradykinin
`ABBREVIATIONS
`HAErwhereditary angioedema
`C1rlNH——Cl inhibitor
`SDF‘fiselvent detergentetrcated plasma
`FFP——lr-esh-trn7en plasma
`TAitrariexamic doid
`ntCirlNH—vnanohltered Cl inhibitor
`pdCIrlNH plasma-derived C1 inhibitor
`rhCl lNHirecombiriant human C1 inhibitor
`FDAeFood and Drug Administration
`Drs Sardana and Craig developed and worked on the
`manuscript and meet the requirements for being authors on the
`heels of substantial contribution to design otthe study and the
`manuscript, drafting ottlie article and revising it as necessary,
`and approving the final version submitted, neither author is a
`government employee
`wwwpediatricsorg/cgi/doil10.1542lpeds2011-0546
`doi:10.1542/peds 201170b4b‘
`
`Accepted for publication Jun 8, 2011
`Address correspondence to l'imothyd. Craig DU,Div13ion of
`Pulmonary, Allergy and Critical Care, Penn State UniverSity, 500
`University Dr, HO41, Hershey, PA 17053. Email: tcraig@psu.edu
`PEDlATRICS (ISSN Numbers Print, 00314005; Online, 109874275).
`
`Copyright © 2011 by the American Academy of Pediatrics
`FINANCIAL DISCLOSURE: Dr Craig has performed research for
`051 Behring, Dyox, Flier/hing, Shire, Seiinuln, and VlroP/iurmo,
`Speaks for [)St Behring, Virol’narma, and Dyox, and consults lor
`CSL Behring and Dyax Dr Surdana has indicated she has no
`linunoio/ relationships relevant to this article to disclose
`
`CONTEXT: Hereditary angioedema (HAE) is a rare autosomaI-dominant
`disease characterized by recurrent self-limiting episodes of skin and
`mucosal edema. Morbidity and mortality are significant, and new and
`pendingtherapies are now available to reduce the risk associated with
`the disease.
`
`OBJECTIVE: To update the reader on new advances in HAE to improve
`patient care.
`
`METHODS: We performed a literature search of Ovid, PubMed, and
`Google to develop this review. Articles that are necessary for the un-
`derstanding and use of the new therapeutic options for HAE were cho—
`sen, and studies of high quality were used to support the use either-
`apies, and in most cases, results from phase III studies were used,
`
`RESULTS: Until recently, therapy for HAE attacks in the United States
`consisted of symptom reliefwith narcotics, hydration, and fresh—frozen
`plasma, which contains active 01 inhibitor. Therapy to prevent HAE
`attacks has been confined to androgens and, occasionally, antifibrino-
`lytic agents; however, both drug groups have significant adverse ef-
`fects. The approval of C1vinhibitor concentrate for prevention and
`acute therapy has improved efficacy and safety. Ecallantide has also
`been approved for therapy of attacks, and icatibant is expected to be
`approved in the next few months for attacks Recombinant Cl inhibitor
`13 presently in phase lll studies and should be available for attacks in
`the near future.
`
`CONCLUSION: In this article we review the changing therapeutic OD-
`tions available for patients in 2011 and beyond. Pediatrics 2011:1282
`1175~1 180
`
`PEDIATRICS Volume 128, Number Ii, December 2011
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`This material was :Dpied
`attl'ie NLM and may the
`Subject US Copyright Laws
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`Page 10 of 17
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`The objective ofthis state-of-the-art re—
`View is to update the pediatric physi-
`cian on recent and pending advances
`in the prevention and treatment of he-
`reditary angioedema (HAE). We focus
`mainly on therapeutic changes that
`have occurred over the past 5 years
`and are expected to occur in the next 2
`years.
`
`OVERVIEW
`
`HAE is characterized by self-limited tis-
`sue swelling that most often affects
`the skin and upper respiratory and
`gastrointestinal tracts. The prevalence
`of HAE is estimated between i
`in 10 000
`
`in 150 000 worldwide, and the
`and i
`estimated population of people with
`HAE in the United States ranges from
`6000 to 10 000 people; however, we ex-
`pect that the number of patients with
`HAE is greater. Most data show no de-
`
`viation correlated to either gender or
`ethnicity. There is a significant age-
`related difference in frequency of HAE
`attacks (there is an increase at the
`
`time of puberty), but quality of life is
`affected significantly at all ages.“2
`
`The underlying cause of HAE is attrib
`uted to autosomal-dominant
`inheri—
`tance of mutations in the Cl inhibitor
`
`(CielNH) gene (SERP/NGI), which was
`mapped to chromosome ii
`(11qu-
`q13.i).Morethan 200 mutations ofthis
`gene have been linked to the clinical
`HAE manifestations} The majority of
`the HAE cases show a familial pattern
`of inheritance, whereas 25% are re,
`lated to spontaneous mutations.
`
`Two types of HAE account for the ma-
`jority ofcases. An estimated 85% of all
`patients have type i HAE, character-
`ized by low production of functionally
`active CHNH. The majority of patients
`with non—type ‘l HAE have type 2 HAE,
`characterized by normal or elevated
`levels of Cl~lNH but with functional im-
`
`pairment of the protein, Recently, a
`type 5 HAE (Mendelian Inheritance in
`Man No. 610618) was described. Type 5
`
`1174
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`SARDANA and CRAIG
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`Page 11 of 17
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`HAE has Similar clinical manifestations
`
`to the first 2 types but differs in that
`there are no abnormalities in C4 or Cl-
`lNH level or function. A mutation in co-
`
`agulation factor Xll protease (Hage-
`man factor) with dominant inheritance
`
`is suspected to occur in some case of
`type 3 HAE, but causation has not been
`documentedt7 Type 5 HAE will not be
`discussed further in this review.
`
`Almost half of all patients with HAE
`manifest the disease before puberty.
`The earliest onsets of HAE occur Within
`
`the first year of life, and in 55% the
`disease presents between puberty and
`20 years of age/"iv“ Another l5% develop
`their first episode later in young-adult
`life, and only ”44% of patients experi-
`ence their first attack after the age of
`408,“)
`
`The number of attacks also varies
`
`among patients. Evidence indicates
`that patients with onset of symptoms
`before the age of 5 have attacks more
`frequently than those who develop HAE
`after (5 years of age.” In a study of 226
`patients with HAE,
`the frequency of
`yearly attacks varied; 50% experienced
`£5 per year, whereas 50% had >12
`attacks per year.6 The diagnosis of HAE
`is commonly delayedThe averagetime
`from the beginning of symptoms to di-
`agnOSIs ranges between l5 and 2i
`years."H This delay results in signifi—
`cant morbidity and even mortality in
`affected patients. The knowledge of af—
`fected family members expedites rec-
`ognition ofthe disease.“
`
`Clinical presentation of HAE can in-
`volve any area of the skin, upper air—
`way, or abdomen. Almost all patients
`with HAE experience skin swelling. The
`disease commonly affects extremities
`but can target any body part and cause
`temporary debilitation and disfigure-
`ment that can last for up to 1 week.
`Facial edema might occasionally prog—
`ress to laryngeal swelling, which can
`be
`life-threatening and cause pro
`longed intenswe respiratory care or
`
`This materialwas copied
`atthe NLM and may be
`Sub] EEt U5 Cup-fright Laws
`
`even death from asphyxia.” Laryngeal
`edema is most common in patients be-
`tween ll and 45 years of age.” Un-
`treated laryngeal edema usually pro—
`gresses for up to 8 to ‘2 hours and can
`last for up to 4 days. Patients with la—
`ryngeal edema might require urgent
`ventilator
`support
`and,
`therefore,
`should be observed in well-equippet
`facilities such as emergency depart
`ments or lCUs.
`
`
`
`Abdominal HAE represents a differen
`scope of medical and social problems
`for patients. Abdominal attacks car
`last for l to 8 days and often keep pa‘
`tients on bed rest with a loss of pro—
`ductive time, Children With abdomina
`
`attacks might require hospitalization.
`During abdominal attacks patients
`may experience significant pain,whicr
`might be misdiagnosed as a surgica
`abdominal
`emergency. Accordingly,
`more than oneethird of patients With
`HAE have had their appendix removet
`or carry a history of exploratory
`laparoscopies.“
`
`ADVANCES
`
`Treating Patients With HAE
`
`Treatment options for HAE vary in
`terms of treatment for acute attacks,
`chronic therapy for patients With fre
`quent attacks, and short-term prophyv
`lactic treatment before or during a
`known exposure to triggers such as in-
`fection,
`surgery, dental work,
`and
`trauma. According to the current 20H)
`international consensus algorithm for
`the diagnosis, therapy, and manage—
`ment of HAE, supportive therapy com
`bined with the specific therapies dis
`cussed below is the preferred therapy
`for HAE attacks)“ General measures
`
`for treating attacks involve hydration,
`pain relief, and treating as soon as
`possible with plasmaederived Cl-lNH
`(pdCl—INH) or ecallantide.
`It
`is antici—
`pated that icatibant (presently available
`in Europe) and recombinant human Cl?
`lNH (human protein derived from rab-
`
`Page 11 of 17
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`with attenuated androgens should be
`monitored closely.ml The major con
`cern in children is early closure ofthe
`epiphyseal plate leadingto decrease in
`growth and Viriiization. Because of
`these adverse effects, the use of an-
`drogens is often delayed until after pu<
`berty or when full height has been
`achieved; an exception is short—term
`use before procedures, in which case
`these risks are minimized and pre-
`ferred over the use of FFP.“J 7"
`
`Antifibrinolytic agents may be used
`when androgens are contraindicated
`(prepuberty,
`pregnancy,
`lactation,
`hepatitis) or poorly tolerated and
`when other treatments have failed.
`
`However, antifibrinclytic agents are
`generally less effective than andro-
`gens.1W Antifibrinolytic agents are of,
`ten recommended as a drug of choice
`for children With severe HAE; however,
`offalabel use of ()l-lNH is an alternative
`(its main limitation is cost). The thera-
`
`peutic effect of antifibrinolytic agents
`is thought to be a result of deactivation
`of plasminogen and subsequent
`de—
`creased consumption ofCllNH. in gen-
`eral, the adverse effects of antifibrinov
`lytic
`agents
`include
`hypotension,
`cardiac arrhythmias, rhabdomyolysis,
`and generation ofthrombi and associ-
`ated risk of emboli. e-Aminocaproic
`acid, although used for treatment of
`HAE in the past, has been replaced with
`tranexamic acid (TA) because of its
`fewer adverse effects and bettertoler—
`
`ability; however, TA is rarely used in
`the United States.H TA dosage is not
`standardized, and close monitoring
`(creatinine kinase levels, urinalysis,
`liver and renal function, ophthalmol—
`ogy examination) for adverse events is
`reddired.”
`
`Plasma-Derived GI-INH
`
`Cl—lNH concentrate derived from hu-
`
`man plasma has been used for the
`treatment ofacute HAE for >3 decades
`
`STATE-OF-TH E-ART REVIEW ARTICLES
`
`erlands) produces ClrlNH concentrate
`in Europe underthe trade name Cctor,
`and in the United States it is referred
`
`to as Cinryze (nfCl-INH) (ViroPharma,
`Exton, PA). nfCt—INH is a nanofiltered,
`pasteurized Cl—lNH concentrate for in-
`travenous use. it has been approved by
`the US Food and Drug Admin