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Pediatric Asthma:

Pediatric Asthma:. Navigating Through Guidelines and Black Boxes 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:

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Pediatric Asthma:

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  1. Pediatric Asthma: Navigating Through Guidelines and Black Boxes Vinit K. Mahesh, M.D.

  2. “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 the Speakers Bureau for Astra Zenca and Schering Plough. However, I acknowledge that today’s activity is certified for CME credit and thus cannot be promotional. I will give a balanced presentation using the best available evidence to support my conclusions and recommendations.” “I intend to discuss unapproved/investigative use of a commercial product/device in this presentation” Discussion of an unapproved/investigative use of a commercial product/device is based on the fact that there is no ICS approved under 1 years of age and no MDI ICS approved under 4 years of age.

  3. How Are These Images Relevant?

  4. Ranking of Evidence(randomly controlled trials) • Category A Rich body of RCT • Category B Limited body of data (RCT) • Category C NRUT, observations • Category D Panel consensus

  5. Classification of Asthma2003 • Mild Intermittent • Mild Persistent • Moderate Persistent • Severe Persistent

  6. Classification(changes) • Eliminate mild from mild intermittent • Severity/frequency of symptoms • Impairment vs risk • Meds needed to achieve control • Classification is almost retroactive

  7. Intermittent Asthma • Symptoms up to twice/week • Brief Exacerbations • Asymptomatic between episodes • Nocturnal symptoms up to twice a month • FEV1/PEFR > 80% predicted

  8. Intermittent Treatment • Short-acting beta agonist as needed • If twice a week or more, change classification • Severe exacerbations may require maintenance therapy

  9. Goals of Treatment • Reducing Impairment • Reducing Risk • Normalization of PFT’s • Limited SABA rescue (< 2X/wk) • Nocturnal symptoms (< 2X/month)

  10. Treatment Steps • Start with ICS and push to 400-500 mcg/day • If not controlled, equal weight to double ICS vs add LABA in > 12 years old • In younger, double ICS to 800-1000 mcg/day preferred • Leukotriene modifiers may also be added

  11. Mild Persistent • Low dose ICS (up to 400-500 mcg/day) • Use of LTM irrelevant for classification

  12. Moderate Persistent • High dose ICS or low dose ICS plus LABA • > 12 yo, equal preference • < 12 yo, high dose ICS preferred

  13. Severe Persistent • High dose ICS plus LABA • Xolair (Omalizumab) may be considered if not controlled with above

  14. How Much Really Gets In? • 400 mcg/day X 365 days = 146 mg • At best, one-third stays in body • 146/3 = < 50 mg/yr • Single dose of 1-2 mg/kg may full year of ICS

  15. Simplified Treatment • Most will benefit from ICS • Reassess and titrate up or down

  16. Black Box Warning(What a Blackhole?) • SMART Study • Inner city, impoverished, adolescent, African American males • Continue to purchase and use ICS • LABA added as part of study

  17. What Went Wrong? • Adolescent males • Was ICS continued • Over use of B-agonist

  18. Does This Change Plans? • Except for extreme cases, would start with monotherapy and push ICS • Should see some response, even if not complete • Close follow up • Liability

  19. Reassessment • Frequency of exacerbations • Frequency of exertional/nocturnal symptoms • Frequency of rescue • Systemic steroid use • Frequency of ER/hospitalization • Peak flow monitoring

  20. Obstacles to Asthma Care • GERD • Sinusitis • Environment • Behavior

  21. Compliance • 76% of prescriptions filled once • 43% refilled once • 36% refilled twice

  22. WHO IS RESPONSIBLE???

  23. Cost Effective Medicines • Most costs are ER/hospital related • Most cost effective plan is the one the works!!

  24. Medicaid Survival • MDI ICS Flovent; QVAR • Nebulized ICS *Pulmicort Respule (for children 5 and under) • LTM All • DPI ICS Asmanex • LABA/ICS combo Advair, Symbicort • LABA Foradil, Serevent

  25. Medicaid Survival (Rescue) • MDI SABA All • Nebulized SABA Albuterol

  26. Answers: • 3,500 people died on September 11, 2001 • 140 people were on Flight 1549 • 714 career home runs

  27. Can We Do Better? 4,200 asthma deaths in U.S. 484,000 hospital discharges 1.9 million ER visits (1/3 pediatric) $16.1 billion health care costs

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