Pediatric Asthma:Pediatric Asthma:
Navigating Through Guidelines Navigating Through Guidelines and and
Black BoxesBlack Boxes
Vinit K. Mahesh, M.D.Vinit K. Mahesh, M.D.
“I have the following financial relationships with the manufacturers(s) of any commercial products(s) and/or provider
of commercial services discussed in this CME activity:”
Research Support from: Speakers’ Bureau: Astra Zenca and Schering-Plough
It is my obligation to disclose to you (the audience) that I am on It is my obligation to disclose to you (the audience) that I am on the Speakers Bureau for Astra Zenca and the Speakers Bureau for Astra Zenca and Schering Plough.
However, I acknowledge that today’s activity is certified for CME However, I acknowledge that today’s activity is certified for CME credit and thus cannot be promotional. I will give a balanced credit and thus cannot be promotional. I will give a balanced presentation using the best available evidence to support my presentation using the best available evidence to support my
conclusions and recommendations.”conclusions and recommendations.”
““I intend to discuss unapproved/investigative use of a I intend to discuss unapproved/investigative use of a commercial product/device in this presentation”commercial product/device in this presentation”
Discussion of an unapproved/investigative use of a commercial Discussion of an unapproved/investigative use of a commercial product/device is based on the fact that there is no ICS product/device is based on the fact that there is no ICS approved under 1 years of age and no MDI ICS approved under approved under 1 years of age and no MDI ICS approved under 4 years of age.4 years of age.
How Are These Images How Are These Images Relevant? Relevant?
Ranking of EvidenceRanking of Evidence(randomly controlled trials)(randomly controlled trials)
►Category ACategory A Rich body of RCTRich body of RCT►Category BCategory B Limited body of data Limited body of data
(RCT)(RCT)►Category CCategory C NRUT, observationsNRUT, observations►Category DCategory D Panel consensusPanel consensus
Classification of AsthmaClassification of Asthma20032003
►Mild IntermittentMild Intermittent►Mild PersistentMild Persistent►Moderate PersistentModerate Persistent►Severe PersistentSevere Persistent
ClassificationClassification(changes)(changes)
►Eliminate mild from mild intermittentEliminate mild from mild intermittent►Severity/frequency of symptomsSeverity/frequency of symptoms► Impairment vs riskImpairment vs risk►Meds needed to achieve controlMeds needed to achieve control►Classification is almost retroactiveClassification is almost retroactive
Intermittent AsthmaIntermittent Asthma
►Symptoms up to twice/weekSymptoms up to twice/week►Brief ExacerbationsBrief Exacerbations►Asymptomatic between episodesAsymptomatic between episodes►Nocturnal symptoms up to twice a Nocturnal symptoms up to twice a
monthmonth►FEVFEV11/PEFR > 80% predicted/PEFR > 80% predicted
Intermittent TreatmentIntermittent Treatment
►Short-acting beta agonist as neededShort-acting beta agonist as needed► If twice a week or more, change If twice a week or more, change
classificationclassification►Severe exacerbations may require Severe exacerbations may require
maintenance therapymaintenance therapy
Goals of TreatmentGoals of Treatment
►Reducing ImpairmentReducing Impairment►Reducing RiskReducing Risk►Normalization of PFT’sNormalization of PFT’s►Limited SABA rescue (< 2X/wk)Limited SABA rescue (< 2X/wk)►Nocturnal symptoms (< 2X/month)Nocturnal symptoms (< 2X/month)
Treatment StepsTreatment Steps
►Start with ICS and push to 400-500 Start with ICS and push to 400-500 mcg/daymcg/day
► If not controlled, equal weight to double If not controlled, equal weight to double ICS vs add LABA in > 12 years oldICS vs add LABA in > 12 years old
► In younger, double ICS to 800-1000 In younger, double ICS to 800-1000 mcg/day preferredmcg/day preferred
►Leukotriene modifiers may also be Leukotriene modifiers may also be addedadded
Mild PersistentMild Persistent
►Low dose ICS (up to 400-500 mcg/day)Low dose ICS (up to 400-500 mcg/day)►Use of LTM irrelevant for classificationUse of LTM irrelevant for classification
Moderate Persistent Moderate Persistent
►High dose ICS or low dose ICS plus High dose ICS or low dose ICS plus LABALABA
►> 12 yo, equal preference> 12 yo, equal preference►< 12 yo, high dose ICS preferred< 12 yo, high dose ICS preferred
Severe PersistentSevere Persistent
►High dose ICS plus LABAHigh dose ICS plus LABA►Xolair (Omalizumab) may be Xolair (Omalizumab) may be
considered if not controlled with aboveconsidered if not controlled with above
How Much Really Gets In?How Much Really Gets In?
►400 mcg/day X 365 days = 146 mg400 mcg/day X 365 days = 146 mg►At best, one-third stays in bodyAt best, one-third stays in body►146/3 = < 50 mg/yr146/3 = < 50 mg/yr►Single dose of 1-2 mg/kg may full year Single dose of 1-2 mg/kg may full year
of ICSof ICS
Simplified TreatmentSimplified Treatment
►Most will benefit from ICSMost will benefit from ICS►Reassess and titrate up or downReassess and titrate up or down
Black Box WarningBlack Box Warning(What a Blackhole?)(What a Blackhole?)
►SMART StudySMART Study► Inner city, impoverished, adolescent, Inner city, impoverished, adolescent,
African American malesAfrican American males►Continue to purchase and use ICSContinue to purchase and use ICS►LABA added as part of studyLABA added as part of study
What Went Wrong?What Went Wrong?
►Adolescent malesAdolescent males►Was ICS continuedWas ICS continued►Over use of Over use of BB-agonist-agonist
Does This Change Plans?Does This Change Plans?
►Except for extreme cases, would start Except for extreme cases, would start with monotherapy and push ICS with monotherapy and push ICS
►Should see some response, even if not Should see some response, even if not completecomplete
►Close follow upClose follow up►LiabilityLiability
ReassessmentReassessment
►Frequency of exacerbationsFrequency of exacerbations►Frequency of exertional/nocturnal Frequency of exertional/nocturnal
symptomssymptoms►Frequency of rescueFrequency of rescue►Systemic steroid useSystemic steroid use►Frequency of ER/hospitalizationFrequency of ER/hospitalization►Peak flow monitoringPeak flow monitoring
Obstacles to Asthma CareObstacles to Asthma Care
►GERDGERD►SinusitisSinusitis►EnvironmentEnvironment►BehaviorBehavior
ComplianceCompliance
►76% of prescriptions filled once76% of prescriptions filled once►43% refilled once43% refilled once►36% refilled twice36% refilled twice
WHO IS RESPONSIBLE???WHO IS RESPONSIBLE???
Cost Effective MedicinesCost Effective Medicines
►Most costs are ER/hospital relatedMost costs are ER/hospital related►Most cost effective plan is the one the Most cost effective plan is the one the
works!!works!!
Medicaid SurvivalMedicaid Survival
►MDI ICSMDI ICS Flovent; QVARFlovent; QVAR►Nebulized ICSNebulized ICS *Pulmicort Respule *Pulmicort Respule
(for (for children 5 and children 5 and under)under)
►LTMLTM AllAll►DPI ICSDPI ICS AsmanexAsmanex►LABA/ICS comboLABA/ICS combo Advair, SymbicortAdvair, Symbicort►LABALABA Foradil, SereventForadil, Serevent
Medicaid Survival (Rescue)Medicaid Survival (Rescue)
►MDI SABAMDI SABA AllAll►Nebulized SABANebulized SABA AlbuterolAlbuterol
Answers:Answers:
►3,500 people died on September 11, 3,500 people died on September 11, 20012001
►140 people were on Flight 1549140 people were on Flight 1549►714 career home runs714 career home runs
Can We Do Better?Can We Do Better?
►4,200 asthma deaths in U.S. 4,200 asthma deaths in U.S. ►484,000 hospital discharges484,000 hospital discharges►1.9 million ER visits (1/3 pediatric)1.9 million ER visits (1/3 pediatric)►$16.1 billion health care costs$16.1 billion health care costs