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The role of guidelines in asthma treatment: From past to date

The role of guidelines in asthma treatment: From past to date. Prof Dr Füsun Yıldız Kocaeli University School of Medicine Chest Diseases Department Turkish Thoracic Society 10th Annual Congress 25-29 April 2007. Lecture plan.

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The role of guidelines in asthma treatment: From past to date

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  1. The role of guidelines in asthma treatment: From past to date Prof Dr Füsun Yıldız Kocaeli University School of Medicine Chest Diseases Department Turkish Thoracic Society 10th Annual Congress 25-29 April 2007

  2. Lecture plan 1-Definition of guideline, why and how should the guidelines be prepared? 2-Why do we need asthma guidelines? 3-The history of asthma guidelines from past to date 4-Are patients and physicians compliant to prepared guidelines?

  3. Definition of a guideline • The systematically developed definitions which help the physicians and their patients to select the most suitable health services on certain clinical circumstances

  4. The types of guidelines • Specialists consensus based • Evidence based • Conclusion based (metaanalysis, cost efectiveness, decision analysis) • Preference based (evidence based+ patient preference)

  5. Why and how should the guidelines be prepared? • The development of a guideline should be based on critical analysis of the diagnostic and/or therapeutic options available for a particular problem • Ideally the risks and benefits of the diagnostic and/or theurapeutic alternatives should be tested and their efficacy demonstrated • The information required to utilize a guideline should be easily acquired without unusual cost or risk to patient Campbell JA Clin Med and Research 2004;2:145-146

  6. Why and how should the guidelines be prepared? • Guidelines should be developed for a specific group of users • Those that are appropiate for the clinician may not be suitable for the patient • Guidelines may give general recommendations and should not be interpreted as standarts of care • Guidelines should be concise and be based on readily available clinical information • Guidelines need constant updating in order to follow the scientific evidence Campbell JA Clin Med and Research 2004;2:145-146

  7. Lecture plan 1-Definition of guideline, why and how should the guidelines be prepared? 2-Why do we need asthma guidelines? 3-The history of asthma guidelines from past to date 4-Are patients and physicians compliant to prepared guidelines

  8. Why do we need asthma guidelines? • Asthma is a common disease in developed countries (5-12% of population), and increasing in prevalence in the developing world • Random-dialing telephone surveys show that burden of asthma is great, that patients are rarely assessed by objective measures, and that effective treatments are under-prescribed and under-used • In the U.S. 5,000 deaths from asthma occur each year; most are preventable • In Europe and North America, 70% of patients with asthma seek care from a primary care physician, not from a specialist

  9. There are 300 million asthma patients all over the world 100 million is expected increase in 2025 >10.1 7.6 – 10.0 5.1 – 7.5 2.5 – 5.0 0 – 2.5 No standart results

  10. Asthma may cause deaths • 180 000 deaths related to asthma in 2000 WHOFactsheet 206 January 2000 • 255 000 asthma related deaths in 2005 World Health Organisation. The World Health report • Among 250 deaths 1 related to asthma all around the world Masoli M, et al. Allergy 2004

  11. Economic burden of asthma Expense per patient (ABD$) 1,315 $ 1,400 1,200 1,000 800 640 $ 522 $ 600 326 $ 400 200 0 England USA Sweden Austria Total expenses 457 million $ 1.79 billion $ 6.4 billion $ 348.3 billion $ GINA, 1995

  12. 40 30 20 10 0 36,33 6,16 PL Inhaled Steroid Asthma expenses decrease with appropiate treatment 86 asthmatic children, treatment with inhaled corticosteroid (mean duration~6 months) Mean expense per month (£) Perera BJC. Arch Dis Child 1995; 72: 312-316.

  13. Lecture plan 1-Definition of guideline, why and how should the guidelines be prepared? 2-Why do we need asthma guidelines? 3-The history of asthma guidelines from past to date 4-Are patients and physicians compliant to prepared guidelines

  14. Evolution of concepts for the asthma treatment Bousquet J etal Allergy 2007;62.102-112

  15. Guidelines?

  16. Development of guidelines Opinion-based Implementation of guidelines by adequate trials and surveillance studies 1985-1998 Guidelines 1998- Evidence-based

  17. Development of asthma guidelines • Guidelines prepared in Australia and New Zeland were among the first guidelines probably because of the asthma death epidemic of 1980s Sears MR etal Arch Dis Child 1986;61:6-10 • These guidelines were based on the opinion of experts and their goal was to reduce asthma deaths and morbidity Woolcock A etal Med J Austr 1989;151:650-652 • It is interesting to note that they were also published in nurse journals Old Nurse 1990;9:19-20

  18. Guidelines? TTS NATIONAL NHBLI GINA 2000 1991 1997 r 2002 r 2007 1995 2002 r 2004 r 2006

  19. Development of asthma guidelines: From opinion-based to evidence-based guidelines • In U.S., National Asthma Education and Prevention Program initiated by Office of Prevention and Education, Division of Lung Disease, NHLBI • Early recognition of need for Consensus Guidelines for Diagnosis and Management of Asthma • National Asthma Expert Panel appointed in 1990, with representatives from Pulmonary and Allergy Societies, Emergency Medicine Society, Association of Respiratory CareMembers included Primary Care Physicians, but not as official representatives of Primary Care Societies

  20. Expert Panel Report 1 • The report in 1991 focused on the role of the patient education and use of objective measures of lung function including home PEF monitoring • It also recognised the role of inflammation in the pathogenesis of asthma and recommended anti-inflammatory medications for patients with moderate-severe asthma • 1991 Guidelines organized around four topics -Assessment and Monitoring - Identification and control of factors contributing to severity - Pharmacology - Patient Education

  21. Classify Severity of Asthma Symptoms Nighttime Symptoms Lung Function Continual symptoms Frequent FEV1 or PEF ≤60% Limited physical activity PEF variability >30% Frequent exacerbations Symptoms on most days >2 time a week FEV1 60%-80% predicted Use of inhaled PEF variability >30% short-acting beta2-agonist on most days Exacerbations affect activity Exacerbations ≥2 times a week;may last days Symptoms on <3 days/week <2 times/month FEV1 or PEF >80% PEF variability 20% - 30% Exacerbations brief, (from a few hours to a few days); intensity may affect activity. Asymptomatic and normal PEF between exacerbations Step 3 Severe Step 2 Moderate Step 1 Mild Reference: National Asthma Education and Prevention Program. Expert Panel Report 1: Guidelines for the Diagnosis and Management of Asthma. Bethesda, Md: National Heart, Lung, and Blood Institute, National Institutes of Health; April 1992.

  22. NHLBI Treatment Guidelines (EPR 1) • Step 1 - Mild Asthma -No daily medication • Step 3 - Moderate Asthma -ICS (preferred) -Or theophylline, cromolyn, or leukotriene antagonist • Step 4 - Severe Asthma -High dose ICS -+ oral corticosteroid NAEPP Expert Panel Report 1, NHLBI, NIH 1992

  23. Controversies about EPR 1 1-Place of Leukotriene receptor antagonists? -Many studies show LTRA’s to be less effective thanICS therapy 2-Concern over possible harm from chronic use of inhaled ß2-agonist? - NIH-funded study showed that in mild asthma, regularuse of albuterol is associated with neither benefitnor harm

  24. Controversies about EPR 1 3-Place of long-acting ß2-agonists? -Studies show greater benefit of addition of long- acting ß2-agonist to ICS vs doubling dose of ICS -NIH study shows monotherapy with LABA no betterthan placebo in preventing exacerbations 4-Increased awareness of some asthma progressing to severe, irreversible airflow obstruction? -Pathologic studies show evidence of “remodeling” in even mild asthma. Presumed to reflect consequence of inflammation

  25. Controversies about EPR 1 5-Reports of loss of benefit of ICS therapy if treatment is delayed? -Supported by retrospective studies; fit with concept that unregulated inflammation results in poorly reversible changes in airway structure 6-Skepticism over importance of PEF monitoring for action plan?

  26. EPR-2 Reclassification of Asthma Severity Symptoms Nighttime Symptoms Lung Function Continual symptoms Frequent FEV1 or PEF ≤60% Limited physical activity PEF variability >30% Frequent exacerbations Daily symptoms >1 time a week FEV1 60%-80% predicted Daily use of inhaled PEF 60%-80% predicted short-acting beta2-agonist Exacerbations affect activity PEF variability >30% Exacerbations ≥2 times a week;may last days Symptoms >2 times a week but ≥2 times a month FEV1 or PEF >80%<1 time a day Exacerbations affect activity PEF variability 20% - 30% Symptoms ≤2 times a week <2 times a month FEV1 or PEF ≥80% Asymptomatic and normal PEF PEF variability 20% - 30%between exacerbations Exacerbations brief (from a fewhours to a few days); intensity may vary Step 4 Severe Persistent Step 3 Moderate Persistent Step 2 Mild Persistent Step 1 Mild Intermittent Reference: National Asthma Education and Prevention Program. Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. Bethesda, Md: National Heart, Lung, and Blood Institute, National Institutes of Health; April 1997. NIH publication 97-4051.

  27. Expert Panel Report 2 (EPR 2): Treatment Revision • Step 1 - Mild Intermittent Asthma • No daily medication • Step 2 - Mild Persistent Asthma • Low dose ICSor Cromolyn/nedocromil • (or Leukotriene antagonist or theophylline) • Step 3 - Moderate Persistent Asthma • Medium dose ICS or • Low-medium dose ICS + long-acting bronchodilator: long-acting inhaled ß2-agonist • (or theophylline or oral long-acting ß2-agonist) • Step 4 - Severe Persistent Asthma • High dose ICS + long-acting bronchodilator: long-acting inhaled ß2-agonist • (or theophylline or oral long-acting ß2-agonist) • + oral corticosteroid NAEPP Expert Panel Report 2, NHLBI, NIH 1997

  28. Controversies about EPR-2 1-Does addition of another long term control agent improve outcomes who are receiving IKS over 5 who have moderate or severe persistent asthma? -Combination therapy that is adding long-acting ß2 agonists to IKS is more effective than simply increasing the dose of IKS for patients over 5 who have moderate or severe persistent asthma 2-Are long term use of IKS in children effect vertical growth, bone mineral density, ocular toxicity and supression of HPA? - Studies includes 6 years of observation low-to-medium doses of IKS have no adverse effect on growth velocity, bone mineral density, ocular toxicity and supression of HPA

  29. Controversies about EPR-2 3-Does adding antibiotics to standart care improve outcomes of treatment for acute exacerbations of asthma? -Antibiotics are not recommended for the treatment of acute asthma exacerbations except as needed for comorbid conditions 4-Does early intervention with long term therapy prevent progression of asthma as indicated by changes in lung function and severity of symptoms? -Evidence is insufficient to permit conclusions on the benefits of early treatment of asthma in preventing the progression of disease

  30. Revision of Expert Panel Report 2 (up 2002) • The guidelines that were first published in 1991, revised in 1997, were revised in 2002 in the way that reflected the latest scientific advances • The update stressed that IKS are preferred for controling and preventing asthma symptoms and for improving lung function and quality of life • New data provide reassuring evidence on the safety of IKS use at appropriate doses in children NAEPP Expert Panel Report 2, NHLBI, NIH 2002(update)

  31. Asthma Guidelines: Recent discussions 1-Distinction between “Severity” and “Control” 2-Concern over possible harm from chronic use of inhaled ß2-agonist in subgroups (by genotype, race, or some unknown interacting feature) 3-Alternatives to addition of long-acting ß2-agonists to ICS treatment (LTRA, theophylline) 4-Variations among asthmatic patients in responsiveness to different treatments 5-Challenge to central role of eosinophil in pathogenesis of remodeling 6-Place of expensive, anti-IgE monoclonal antibody treatment

  32. No daytime symptoms No nocturnal symptoms Morning PEF ≥ 80% Normal daily activities No exacerbation No emergency visit Lowest drug dose with minimum adverse effect GINA 1995-2005 : Goals of therapy

  33. GINA 2005: Stepwise Treatment End-point: asthma control End-point: possible best point 4thSevere persistent 3rd stp Moderate persistent • High dose IKS + LABA • + If needed • Anti-IgE • Lökotrieneantagonist • Oral 2-agonist • Oral corticosteroid • theophylline-SR 2nd Step Mild persistent Low-moderate dose IKS +LABA (theophylline, lökotrieneantagonist,oral 2-agonist) 1st step Intermittant Low dose IKS (theophylline, lökotrieneantagonist, chromoline) No treatment IKS = inhaled corticosteroid; LABA = long actingβ2-agonist GINA Workshop Report 2005.

  34. Severity and Control Concepts 1991 2006 SEVERITY CONTROL The step of disease tells both severity and response to treatment If trere is response to treatment then you can control the disease Response to treatment Stoloff SW. et al. J Allergy Clin Immunol 2006; 117: 544-8

  35. Problems in assessing the severity • To assess the severity cause problem in patients who are still under treatment • The run of asthma is variable, it is difficult to assess the severity in one visit, the severity of disease may change over time • The symptoms are not parallel with the severity of disease all the time • Response to treatment changes, the response may not be like in all patients with same severity Li JT, JACI 2005; 116: S3-11

  36. GINA 2006Asthma Control Criteria

  37. GINA 2006:Treatment with control criteria decrease increase

  38. Lecture plan 1-Definition of guideline, why and how should the guidelines be prepared? 2-Why do we need asthma guidelines? 3-The history of asthma guidelines from past to date 4-Are patients and physicians compliant to prepared guidelines

  39. How is the compliance to the prepared guidelines? • Problems related to guidelines -Classification with severity -Ignorance of personal differences -Not suitable for daily practice -The discordance of reference studies with real life • Lack of concordance of physicians to the proposals of guidelines • Inconsistency of patients to prescribed treatments • Problems related with policy makers and regulatory authorities

  40. EPR-2 emphasized the role of inflammation in the pathogenesis of asthma • The report also presented basic recommendations for the diagnosis and management of asthma that will help the clinicans and patients make appropriate decisions about asthma care • Although the NHBLI asthma guidelines have been in existence for nearly a decade they have not been widely utilized by health care providers

  41. Asthma Guidelines: An assessment of physician understanding and practiceDoerschug KC et al Am J Respir Crit Care Med 1999;159:1735-1741 • Hypothesis: Not all components of the updated guidelines are well understood by the physicians who care for asthmatics • Material-methods: Based upon 1997 prepared NHLBI guideline, a multiple-choice test of asthma knowledge distributed to physicians at a University Hospital • 20 asthma specialists, 11 asthma speciality fellow, 11 General Medicine faculty, 5 Family medicine faculty, 51 Internal medicine residents and 5 Family medicine residents completed the questionnaires

  42. Results of questionnaire on asthma knowledge Doerschug KC et al Am J Respir Crit Care Med 1999;159:1735-1741

  43. The comparison of percentage of correct answers among all physicians Doerschug KC et al Am J Respir Crit Care Med 1999;159:1735-1741

  44. Performance of all physicians in the estimation of disease severity Doerschug KC et al Am J Respir Crit Care Med 1999;159:1735-1741

  45. Compliance with National Asthma Management guidelines • Asthmatics receiving care in different physicians noted that 72% of respondents with severe disease reported having a steroid inhaler whom 54% used it daily • In addition although 26 % of respondents reported having a peak flowmeter, only 16% used it on a daily basis Logoreta AP etal Arch Intern Med 1998;158:457-464

  46. ‘Asthma in America’ survey results: 2509 adult asthmatics or asthmatic children parents, 512 physicians were included in the study Rickard KA etal J Allergy Immmunol 1999;103:S171

  47. RESULT • There have been a significant role of guidelines that were prepared for diagnosis and treatment of asthma in the last 15 years • But recent studies have shown that there are still serious problems to achieve the control in asthmatic patients • Updated guidelines (GINA 2006, NHLBI/NIH 2007) suggest to use control criterias in place of disease severity in the adjustment of treatment • In order to evaluate the control, utilization of symptoms and physiologic parameters seems to be the most realistic way

  48. It would appear that further research is needed. What does the Cochrane review say?

  49. World Asthma Meeting 2007 (WAM) 22-25 June 2007 İstanbul We are looking forward to seeing you!

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