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Treatment of Sleep Associate disturbance in Allergy Diseases Timothy J. Craig Professor of Medicine and Pediatrics Distinguished Educator Penn State University.

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Presentation on theme: "Treatment of Sleep Associate disturbance in Allergy Diseases Timothy J. Craig Professor of Medicine and Pediatrics Distinguished Educator Penn State University."— Presentation transcript:

1 Treatment of Sleep Associate disturbance in Allergy Diseases Timothy J. Craig Professor of Medicine and Pediatrics Distinguished Educator Penn State University

2 Presentation Overview Allergic Rhinitis and Sleep Disturbance Mechanisms of Sleep Disturbance in Allergic Rhinitis Impact of AR-associated Sleep Disturbances Effects of Allergic Rhinitis Therapies on Sleep and Quality of Life

3 conflicts of interest with this presentation Merck- speaker, researcher, consultant Astra-Zeneca- speaker Teva- speaker GSK- researcher

4 Allergic Rhinitis Adversely Impacts Sleep in Adults and Children/Adolescents N=476 Adults/Adolescents/ Children with AR Patients with Moderate or Severe Impact (%) SleepDaily Activities School/ Work Performance Lifestyle OConnor and Punekar. J Allergy Clin Immunol. 2006;117:S322. Abstract 1244. Scadding and Punekar. EAACI Abstract Book. 2006;211. Abstract 741. N=221 Adolescents/ Children with AR Patients with Impact (%) School/ Work Performance Normal Activities Sleep

5 Allergic Rhinitis Symptoms are Associated with Sleep Complaints Leger et al. Arch Intern Med. 2006;166:1744. Subjects with complaint (%) Difficulty Falling Asleep Nocturnal Awakening Early Awakening Nonrestorative Sleep Feeling of Lack of Sleep SnoringESS score >10 Prevalence of Sleep Complaints in Patients with Allergic Rhinitis and Controls *P<0.001 vs controls. * * * * * * *

6 Allergic Rhinitis (AR) Symptoms are Associated with Sleep Disorders Leger et al. Arch Intern Med. 2006;166:1744. Prevalence of Sleep Disorders in Patients with Allergic Rhinitis and Controls *P0.003 vs controls. Subjects with disorder (%) InsomniaSevere Insomnia Sleep Apnea Syndrome Hypersomnia * * * * 7.6 fold increase of OSA in AR

7 Allergic Patients Experience More Apnea/Hypopnea than Non-allergic Controls P<0.001 Stuck et al. J Allergy Clin Immunol. 2004;113:663. Allergic patients had more apnea/hypopnea episodes than non-allergic controls AHI=apnea/hypopnea index, determined as the total number of apnea and hypopnea episodes (assessed by polysomnography) divided by hours of sleep.

8 Patients with rhinitis had 10 times more microarousals (average of 50) than controls (n=14) Lavie et al. Acta Otolaryngol. 1981;92;529. Allergic Rhinitis is Associated with Increased Microarousals

9 Lavie et al. Acta Otolaryngol. 1981;92;529. Microarousals Correlate with Impaired Breathing Microarousals in Allergic Rhinitis Correlate with Impaired Breathing

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12 Similarities between the two Obese man with severe OAS Increase in IL-1 Increase in TNF Increase in Il-6 Increase in T-helper 2 cytokines Decrease in T-helper 1 cytokines A young girl snoring and with rhinitis Increase in IL-1 Increase in TNF Increase in Il-6 Increase in T-helper 2 cytokines Decrease in T-helper 1 cytokines

13 What is the Mechanism of Sleep Disturbance in Allergic Rhinitis? 1.Inflammatory components of the allergic response 2.Symptoms of allergic rhinitis 3.Nasal congestion 4.All three Answer

14 Impact of Poor Sleep Delayed onset Sleep fragmentation Arousals/microarousals Sleep Disordered Breathing Snoring Obstructive Sleep Apnea Impaired Social Functioning: daytime fatigue/somnolence Impaired performance Impaired learning Emotional/behavioral impact Associated Diseases: Hypertension Cardiovascular disease Stroke Diabetes Psychological disorders

15 Treatment Options

16 Treatment Options: Snoring Children

17 The approach to the child with concerns for having OSA

18 The affect of OSA and benefits of T+A on asthma

19 The affect of OSA and benefits of T+A on poorly controlled asthma

20 Kheirandish-Gozal. Pediatrics 2008 Sleep apnea in children treated with topical budesonide nasal spray

21 Leukotrienes in tonsil tissue in children with sleep apnea (SA) and those with recurrent infection (RI) LTC-4 LTB-4

22 Adenoid reduction with 16 weeks of montelukast therapy

23 Montelukast affect on sleep in children with sleep apnea compared with those receiving no therapy

24 Treatment Options for Rhinitis Associated With Sleep disordered Breathing

25 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids Oral antihistamines Intranasal antihistamines Oral decongestants Intranasal decongestants Intranasal cromones Anticholinergics Antileukotrienes Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

26 Intranasal Steroid Therapy in Patients with PAR Improves Sleep* Change in Symptom Severity vs Baseline *Improvement in scores vs baseline was determined using the 0 (none) to 4 (greatly) scoring system in patient questionnaires. P0.05 vs placebo. Hughes et al. Allergy. 2003;58:380. CongestionSleep Problems Daytime Sleepiness Daytime Fatigue

27 Intranasal Steroid Therapy in Patients with PAR Improves Sleep Symptom Score *Congestion scores were rated on the scale from 0=none to 4=severe. Improvement in sleep, daytime sleepiness, and daily fatigue scores vs baseline was determined using the 0 (none) to 4 (greatly) scoring system in patient questionnaires. Craig et al. Allergy Asthma Proc. 2003;24:53. Congestion*Improved Sleep Improved Daytime Sleepiness Improved Daytime Fatigue P=0.04 vs placebo.

28 Intranasal Steroid Therapy in Patients with PAR Improves Congestion and Sleep* Improvement in symptoms per daily diary over 8 weeks *Improvement in congestion and sleep vs baseline was determined using the 0 (none) to 4 (greatly) scoring system in patient questionnaires. P<0.05 vs placebo. Craig et al. J Allergy Clin Immunol. 1998;101:633.

29 Intranasal Steroid Therapy Improves Symptoms, Sleep, and Quality of Life in Children with Allergic Rhinitis Mansfield et al. Ann Allergy Asthma Immunol. 2004;92:240.

30 Intranasal Steroid Therapy Reduces Respiratory Disturbances in Children with Allergic Rhinitis Mansfield et al. Ann Allergy Asthma Immunol. 2004;92:240.

31 Improvement of Epworth Sleepiness Scale: Budesonide vs Placebo Epworth Sleepiness Scale Difference=–3.85; P=0.02; SD=1.45.

32 Mixed/obstructive apnea/hypopnea index decreased from 10.7 ± 2.6 to 5.8 ± 2.2 (SE) in fluticasone group but increased from 10.9 ± 2.3 to 13.1 ± 3.6 in placebo group; P=0.4. AHI=apnea-hypopnea index. Brouillette RT, et al. J Pediatr. 2001;138:838-844. Efficacy of Fluticasone Nasal Spray Compared With Placebo on AHI (Number Per Hour) 15 10 5 0 PretreatmentPosttreatment Mixed/obstructive apnea/ hypopnea index (number per hour) Fluticasone Placebo

33 MFNS-4 Pooled Phase III Trials in SAR*: Change in Ocular Symptoms Data on file, Schering Corporation, Kenilworth, NJ. Protocol No. C93-013, C93-184, C94-145, I94-001. Submitted for AAAAI 2007 and publication. *C93013, C93184, C94145, I94001 TOSS=total ocular symptom scores. Mean Change in Daily rTOSS Days MFNS 200 µg OD (n=490) Placebo (n=492) Mean Change in daily rTOSS from Baseline P<0.001 Days Mean Change in daily rTNSS from Baseline P=0.002 MFNS 200 µg OD (n=298) Placebo (n=307) All Patients Patients with Moderate to Severe Ocular Symptoms at Baseline (TOSS4) 1-15

34 Fluticasone Propionate: Ocular Effects in Analysis of Pooled Trials in SAR DeWester et al. Allergy Asthma Proc. 2003;24:331. Mean change from baseline (points) TOSS Itching Tearing Puffing Redness Physician-Rated Ocular Symptoms at 14 Days* *Each of the 4 ocular symptoms was rated on a 1-100 visual analog scale (VAS). P<0.001 vs placebo.

35 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids+++ ++/+++++++ Oral antihistamines Intranasal antihistamines Oral decongestants Intranasal decongestants Intranasal cromones Anticholinergics Antileukotrienes Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

36 Oral Antihistamines Do Not Improve Sleep Latency and REM Sleep Duration *P0.05 vs placebo and fexofenadine. N=18 healthy Japanese volunteers. Boyle et al. Curr Med Res Opin. 2006;22:1343. Sleep Latency Immediately After Treatment Sleep Onset Latency (min) Placebo Fexo Chlor * Time (min) REM Latency and Duration * *

37 Desloratadine: Effect on Ocular Symptoms in Patients with SAR Desloratadine 5 mg OD (n=172) Placebo (n=174) AM/PM Reflective Ocular Symptom Scores (2-Week Average) *P<0.05 vs placebo. Meltzer et al. Clin Drug Invest. 2001;21:25. Data on File, Schering Corporation. Itching/ Burning Eyes Tearing/ Watery Eyes Redness of Eyes Mean change from baseline * * *

38 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids+++ ++/+++++++ Oral antihistamines++++++/+++ Intranasal antihistamines Oral decongestants Intranasal decongestants Intranasal cromones Anticholinergics Antileukotrienes Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

39 Intranasal Antihistamines: Effect on Congestion and Sleep *Improvement was determined using the 0 (none) to 4 (greatly) scoring system in patient questionnaires. N=24 patients with perennial allergic rhinitis. P=0.041 Golden et al. Ann Allergy Asthma Immunol. 2000;85:53. Improvement vs baseline over 8 weeks (score)*

40 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids+++ ++/+++++++ Oral antihistamines++++++/+++ Intranasal antihistamines+++++/++tiredness Oral decongestants Intranasal decongestants Intranasal cromones Anticholinergics Antileukotrienes Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

41 Oral decongestants compared to placebo and benefit on sleep and rhinitis

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43 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids+++ ++/+++++++ Oral antihistamines++++++/+++ Intranasal antihistamines+++++/++tried Oral decongestants++--/-0 Intranasal decongestants Intranasal cromones Anticholinergics Antileukotrienes Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

44 Nasal Decongestant: Effect on Apnea- Hypopnea Index in Snorers Braver and Block. Sleep. 1994;17:516. N=20 asymptomatic male snorers. *P0.03 vs control. Apnea-Hypopnea Index ControlNasal Decongestant Best PositionNasal Decongestant + Best Position * *

45 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids+++ ++/+++++++ Oral antihistamines++++++/+++ Intranasal antihistamines+++++/++tried Oral decongestants++--/-0 Intranasal decongestants++++--+ Intranasal cromones Anticholinergics Antileukotrienes Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

46 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids+++ ++/+++++++ Oral antihistamines++++++/+++ Intranasal antihistamines+++++/++tried Oral decongestants++--/-0 Intranasal decongestants++++--+ Intranasal cromones+++/+- Anticholinergics Antileukotrienes Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

47 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids+++ ++/+++++++ Oral antihistamines++++++/+++ Intranasal antihistamines+++++/++tried Oral decongestants++--/-0 Intranasal decongestants++++--+ Intranasal cromones+++/+- Anticholinergics-++-/-- Antileukotrienes Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

48 Leukotriene Receptor Antagonists: Effect on Congestion and Sleep in Patients with SAR Improvement in Total and Individual Nighttime Symptoms Over Placebo * * Philip et al. Clin Exp Allergy. 2002;32:1020. *P0.003 vs placebo. All symptoms were scored on a scale from 0 (best) to 3 (worst). Improvement over Placebo Difficulty going to sleep Nighttime awakenings Congestion on awakening Total nighttime symptoms Loratadine 10 mg (n=602) Montelukast 10 mg (n=348) Percentage improvements over placebo were modest for both total and individual nighttime symptoms

49 Leukotriene Receptor Antagonists: Ocular Effects in Patients with SAR Improvement in Total and Individual Daytime Eye Symptoms Over Placebo * * Philip et al. Clin Exp Allergy. 2002;32:1020. *P0.001 vs placebo. All symptoms were scored on a scale from 0 (best) to 3 (worst). Improvement over Placebo Tearing Pruritus Redness Total daytime eye symptoms Loratadine 10 mg (n=602) Montelukast 10 mg (n=348) Percentage improvements over placebo for both total and individual daytime eye symptoms were greater with loratadine

50 Montelukast for sleep disturbance associated with rhinitis Santos et al. Allergy and Asthma Proceedings

51 Treatment Considerations in Allergic Rhinitis: ARIA Guidelines CongestionRhinorrhea Itching/ Sneezing Sleep Intranasal steroids+++ ++/+++++++ Oral antihistamines++++++/+++ Intranasal antihistamines+++++/++tried Oral decongestants++--/-0 Intranasal decongestants++++--+ Intranasal cromones+++/+- Anticholinergics-++-/-- Antileukotrienes+++-/-++ Bousquet et al. Allergy. 2003;58:192. Bousquet et al. Allergy. 2002;57:841. Van Cauwenberge et al. Allergy. 2000;55:116.

52 Effect of Therapies for Allergic Rhinitis on Sleep and Quality of Life: Summary Intranasal steroids provide significant relief of congestion and ocular symptoms and improve sleep in patients with allergic rhinitis Non-sedating antihistamines and leukotriene receptor antagonists provide modest improvements in congestion, ocular, and nighttime symptoms Decongestants effectively reduce congestion, but have minimal affect on sleep-disordered breathing

53 Adverse Impact of Allergic Rhinitis on the Patient Quality of Life-Focus on Sleep: Conclusions Allergic rhinitis is associated with impaired sleep Sleep impairment in allergic rhinitis can be caused by – Inflammatory mediators – Nasal symptoms, primarily congestion and rhinorrhea – Ocular symptoms Impaired sleep adversely affects performance, productivity and social functioning, and increases the risk of associated diseases Intranasal steroids effectively target inflammation and relieve symptoms to provide improved sleep

54 Thank you Stephanie Teets Stan Golden Josh Berlin Sujani Kukumanu Katherine Hughs Casey Glass Joel Torretti Faina Gurevich Wenxin Wei Jeff McCann Chris Hanks Carah Santos Niti Sardana

55 Questions Have a great day.


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