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 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.” 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 ARich body of RCT ► Category BLimited body of data (RCT) ► Category CNRUT, observations ► Category DPanel consensus

5. Classification of Asthma 2003 ► Mild Intermittent ► Mild Persistent ► Moderate Persistent ► Severe Persistent

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

8. Intermittent Asthma ► Symptoms up to twice/week ► Brief Exacerbations ► Asymptomatic between episodes ► Nocturnal symptoms up to twice a month ► FEV 1 /PEFR > 80% predicted

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

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

11. 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

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

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

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

15. 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

16. Simplified Treatment ► Most will benefit from ICS ► Reassess and titrate up or down

17. 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

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

19. 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

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

21. Obstacles to Asthma Care ► GERD ► Sinusitis ► Environment ► Behavior

22. Compliance ► 76% of prescriptions filled once ► 43% refilled once ► 36% refilled twice

23. WHO IS RESPONSIBLE???

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

25. Medicaid Survival ► MDI ICSFlovent; QVAR ► Nebulized ICS*Pulmicort Respule (for children 5 and under) ► LTMAll ► DPI ICSAsmanex ► LABA/ICS comboAdvair, Symbicort ► LABAForadil, Serevent

26. Medicaid Survival (Rescue) ► MDI SABAAll ► Nebulized SABAAlbuterol

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

28. 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