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Asthma and Pregnancy

Asthma and Pregnancy. Michael Schatz, MD, MS Chief, Department of Allergy Kaiser-Permanente Medical Center San Diego, CA. Disclosures. Investigator-initiated Research Support Aerocrine Genentech GlaxoSmithKline Merck Research Consultant Amgen GlaxoSmithKline Merck.

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Asthma and Pregnancy

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  1. Asthma and Pregnancy Michael Schatz, MD, MS Chief, Department of Allergy Kaiser-Permanente Medical Center San Diego, CA

  2. Disclosures • Investigator-initiated Research Support • Aerocrine • Genentech • GlaxoSmithKline • Merck • Research Consultant • Amgen • GlaxoSmithKline • Merck

  3. Asthma and Pregnancy • Most common potentially serious medical problem to complicate pregnancy • May increase the risk of perinatal complications • The risks of uncontrolled asthma appear to be greater than the risks of asthma medications • Aggressive asthma management similar to non-pregnant patients is recommended

  4. Asthma and Pregnancy: Clinically Relevant Questions • Does asthma control make a difference? • Are asthma medications safe during pregnancy? • What are the barriers to asthma control during pregnancy? • What is the role of exhaled nitric oxide in asthma management during pregnancy?

  5. Relationship to Asthma Control • Case reports—severe exacerbations associated with • Maternal and/or fetal deaths • Severe infant neurologic disease • Studies • Parameters of asthma control • Symptoms • FEV1 • Exacerbations • Outcomes affected • Low birth weight/SGA • Preterm birth • Congenital malformations (one study) .

  6. Relationship Between FEV1 During Pregnancy and Prematurity Schatz.. Am J Obstet Gynecol 2006; 194:120

  7. The Relationship of Asthma Exacerbations During Pregnancy to Infant Low Birth Weight Murphy. Thorax 2006; 61:169

  8. Asthma Severity/Control and Congenital Malformations • Canadian administrative database study • 4344 pregnancies of asthmatic women • Incidence of malformations • 9.2 % total • 6.0 % major • Odd Ratio (95 % CI) for patients with first trimester exacerbations • Total 1.48 (1.04-2.09) • Major 1.32 (0.86-2.04) Blais. J Allergy Clin Immunol 2008; 121:1379

  9. Conclusions Regarding Asthma Control • Better control (based on symptoms, pulmonary function, exacerbations) associated with improved outcomes • LBW • Preterm • SGA • Congenital malformations • Relationship can’t be proven by RCTs (random assignment to controlled versus not controlled)

  10. Asthma and Pregnancy: Clinically Relevant Questions • Does asthma control make a difference? • Are asthma medications safe during pregnancy? • What are the barriers to asthma control during pregnancy? • What is the role of exhaled nitric oxide in asthma management?

  11. Asthma Medications and Prematurity/Fetal Growth *No increased risk

  12. Congenital Malformations • Total malformations • Background risk of 3-5 % • Increased risk of specific malformations • Drugs are generally associated with an increased risk of specific, rather than total malformations • Most studies have inadequate power for specific malformations • Confounding by control/severity still possible

  13. Specific Congenital Malformations and Bronchodilators • Albuterol or bronchodilators (primarily albuterol) • Cardiac • Gastroschisis • Cleft lip/palate • LABA • Cardiac Kallen, 2007; Lin, 2008; Lin, 2009; Munsie, 2011; Eltonsy, 2011

  14. Congenital Malformations and Corticosteroids • Inhaled • No significant increase in Swedish Medical Birth Registry study • 11,487 total • 10,013 budesonide • Increased total malformations in high dose users versus other users in one database study • Oral • Increased oral clefts in case control studies • Not confirmed in recent cohort study Kallen, 2007; Blais, 2009; Park-Wylie, 2000 ; Hvid, 2011

  15. Asthma Medications: Conclusions • Asthma medications (other than prednisone) not likely to be the cause of prematurity or reduced fetal growth • Bronchodilators, oral corticosteroids, and possibly high dose inhaled corticosteroids have been associated with certain birth defects • Confounding by indication (more severe disease and exacerbations) may explain these associations

  16. Asthma and Pregnancy: Clinically Relevant Questions • Does asthma control make a difference? • Are asthma medications safe during pregnancy? • What are the barriers to asthma control during pregnancy? • What is the role of exhaled nitric oxide in asthma management?

  17. Barriers to Asthma Control • Smoking • Associated with increased exacerbations • Clinician undertreatment • Documented in ED • Adherence • Substantial proportion of women reduce medications • Common cause of exacerbations • Viral infections • Most common cause of exacerbations Murphy, 2010; Cydulka, 1999; McCallister, 2011; Enriquez, 2006; Murphy, 2005

  18. Asthma and Pregnancy: Clinically Relevant Questions • Does asthma control make a difference? • Are asthma medications safe during pregnancy? • What are the barriers to asthma control during pregnancy? • What is the role of exhaled nitric oxide in asthma management?

  19. Exhaled Nitric Oxide (eNO) and Pregnancy • Mean levels of eNO were not different in asthmatic pregnant versus non-pregnant women • Mean ACT scores were not different in asthmatic pregnant versus non-pregnant women • Levels of eNO were modestly (r = 0.30) but significantly (p = 0.02) correlated with ACT scores in pregnant asthmatic women Tamasi. J Asthma 2009; 46:786

  20. Managing Asthma in Pregnancy (MAP) Study • Double blind parallel group RCT • 220 pregnant asthmatic women • Algorithm based on eNO and ACQ • Inhaled corticosteroid increased with inadequate control and high eNO • Formoterol increased with inadequate control and low eNO • Inhaled corticosteroid decreased with adequate control and low eNO Powell. Lancet 2011; 378:983

  21. 75 Control group: rate = 0.615 FENO group: rate = 0.288 IRR = 0.499 SE = 0.107 p = 0.001 50 Exacerbations 25 0 0 5 10 15 20 25 Time (weeks) Incidence of Exacerbations Over Time

  22. Comparison of Treatment Profiles

  23. Comparison of ICS Doses Control group 900 FENO group 800 p=0.043 Mean ICS Dose (ug/day) 700 600 500 4 1 2 3 5 6 Visit

  24. Conclusions • Asthma control during pregnancy makes a difference • Asthma medications appear to have few risks during pregnancy, and those risks that have been identified may be due to confounding • There are barriers that need to be addressed to improve asthma control during pregnancy • eNO may allow more targeted and more effective management of asthma during pregnancy

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