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Zileuton for the Prophylaxis and Chronic Treatment of Asthma

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Zileuton for the Prophylaxis and Chronic Treatment of Asthma Asthma Zileuton for the Prophylaxis and Chronic Treatment of Asthma a report by Bradley E Chipps, MD, FAAP, FAAAAI, FCCP Capital Allergy and Respiratory Disease Center Zileuton is the only commercially available leukotriene synthesis inhibitor pulmonary function, and will be able to lead a normal life, carrying on all approved for the prophylaxis and treatment of chronic asthma in adults activities desired.1 Risk refers to the potential for negative outcomes, which and adolescents aged 12 years and above. According to the updated and include symptom exacerbations and associated urgent care (i.e. comprehensive 2007 Expert Panel Report 3 (EPR3): Guidelines for the unscheduled office visits, emergency department visits, hospitalizations), as Diagnosis and Management of Asthma, zileuton is an alternative well as any adverse events associated with treatment.1 therapeutic option to be added to inhaled corticosteroids (ICS) to enhance asthma control for patients who remain uncontrolled despite According to the EPR3, patients who have more than one exacerbation of using recommended therapy.1 This article will examine the role of symptoms a year requiring a short course of oral corticosteroids (OCS) are zileuton in asthma management in relation to asthma control as an considered not well controlled.1 Between May 2006 and May 2007 almost unmet patient need. 1.7 million asthma patients received at least one prescription for OCS. This represented the largest single reason for OCS use in the US.4 What should Uncontrolled Asthma Remains an Unmet Need the physician do when the patient’s asthma remains uncontrolled despite Despite almost 20 years of global and national guidelines for managing optimal therapy? The EPR3 presents a revised step-care approach to therapy, asthma, and despite scientific contributions to understanding its with six steps, each accounting for a progressive drop in asthma control. pathogenesis, the burden of this disease remains high.1 Asthma continues Figure 1 shows the medications recommended for use to increase asthma to be associated with mortality, morbidity, and substantial costs to the control when a step-up is needed.1 healthcare system, as well as to the patient. The asthma burden may be higher than estimated as patients, care-givers, and healthcare professionals According to the updated step-care regimen, zileuton is recommended as have been found to overestimate asthma control. The result is that many an add-on therapy to ICS in both steps 3 and 4: in step 3 it is added to low- patients are undertreated, increasing their risk for unwanted symptoms and dose ICS, the combination providing an alternative to medium-dose ICS; in use of healthcare services, and lowering their ability to participate fully in step 4 it is added to medium-dose ICS, with the combination providing an daily activities.2 alternative to medium-dose ICS plus long-acting bronchodilator.1 It was estimated in 2005 that 32.6 million persons—representing more Uncontrolled asthma is not unusual even when patients are using than 11% of the US population—had been diagnosed with asthma during recommended therapy. An analysis of a web-based survey administered to their lifetime. Of those, 22.2 million or almost 8% of the US population patients with asthma for at least one year who were using multiple had a current diagnosis of asthma, and approximately 55% (12.2 million) controller medications showed that 55% of the 1,812 respondents had suffered an asthma exacerbation during that year. According to national uncontrolled asthma as defined by the Asthma Control Test, a self- statistics, asthma accounts for 1.8 million emergency department visits administered questionnaire.5 annually and almost 500,000 hospitalizations. Eleven people die from asthma every day.3 The reasons for uncontrolled asthma are varied and may reflect genetic heterogeneity and/or different underlying physiological mechanisms that The comprehensive update to the National Heart, Lung, and Blood Institute affect how the disease is expressed and how the individual patient (NHLBI) Guidelines for Diagnosing and Managing Asthma, the EPR3, responds to specific classes of medication. The variable response of some released in 2007, places the primary goal for treating asthma on control. patients to ICS is well documented, although not clearly understood.6–9 β This is in contrast to earlier Guidelines that focused on reducing asthma Additionally, recent evidence suggests that polymorphisms on the 2- severity.1 In the EPR3, asthma control is defined according to reductions in adrenergic receptor are associated with diminished responses to both β 10 two domains: impairment and risk (see Table 1). Impairment refers to the short- and long-acting 2-agonists. Finally, multiple asthmatic frequency and intensity of symptoms and how those symptoms influence phenotypes, such as smoking asthmatics, nocturnal asthma, occupational the patient’s daily life. The goal in reducing impairment thus focuses on asthma, and exercise-induced bronchospasm, along with a variety of reducing asthma symptoms and, ideally, preventing symptoms. Meeting comorbid conditions such as obesity and upper-airway inflammation, this goal also means that the patient will need little or no rescue influence the variable response to asthma medications.1 Therefore, medications (for breakthrough symptoms), will have no nocturnal or early targeting multiple inflammatory pathways therapeutically enhances morning awakenings due to symptoms, will demonstrate no deficit in asthma control for many patients. © TOUCH BRIEFINGS 2008 15 Asthma Table 1: Goals for Improving Asthma Control by Targeting the eosinophils, neutrophils, and macrophages, all of which have been implicated Domains of Risk and Impairment1 in asthma pathogenesis. Leukotrienes of interest in asthma include: Reduction in Impairment Reduction in Risk • the cysteinyl leukotrienes, LTC4/D4/E4, which are involved in Minimal (ideally no) troublesome symptoms Minimal (ideally no) symptom exacerbations bronchoconstriction, mucus secretion, vascular permeability, airway No rescue medications needed No urgent care (unscheduled office visits, smooth-muscle contraction, and eosinophil infiltration;5 No night-time awakenings due to symptoms emergency department visits, hospitalizations) •LTB, an extremely potent chemoattractant for inflammatory cells (e.g. (Near) normal pulmonary function Minimal (ideally no) adverse events 4 Normal daily activities from pharmacotherapy T-effector cells, eosinophils, neutrophils) and the major 5-lipoxygenase (5-LO) product of neutrophils, monocytes, and alveolar macrophages, Figure 1: Step Approach to Asthma Control1 which stimulates leukocyte chemotaxis, chemokinesis, and vascular endothelium adherence, delays neutrophil apoptosis, and prolongs 11,12 Persistent asthma: daily medication neutrophil survival; and Intermittent Consult with asthma specialist if step 4 care or higher is required asthma • 5-oxo-6,8,11,14-eicosatetraenoic acid (5-oxo-ETE), a chemoattractant Consider consultation at step 3 Step up for eosinophils that is over 30 times more potent than the cysteinyl if needed (first check leukotrienes; 5-oxo-ETE induces migration of eosinophils and prolongs Step 6 adherence, Preferred: their survival, activates neutrophils and stimulates neutrophil Step 5 environmental Step 3 high-dose Step 4 Preferred: control, and 13 Preferred: ICS + LABA degranulation, and induces potent basophil migratory responses. Preferred: high-dose comorbid medium-dose + oral medium-dose ICS + LABA conditions) Step 2 ICS or corticosteroid ICS + LABA and Preferred: low-dose and Leukotrienes Are Associated with Uncontrolled Asthma Alternative: Consider: Assess low-dose ICS ICS + LABA Consider: medium-dose omalizumbab Control Alternative: Alternative: omalizumab Leukotrienes are important mediators in asthma pathogenesis, and 5-LO ICS + for patients cromolyn, low-dose ICS for patients Step 1 LTRA, who have Step down products have been shown to be increased in all levels of asthma severity, nedocromil, + LTRA, who have Preferred: theophylline, allergies if possible LTRA, or theohylline, allergies 5,7,14–16 SABA prn or zileuton (and asthma despite treatment with ICS and OCS. Multiple studies have theophylline or zileuton is well- demonstrated increases in the 5-LO products 5-HETE, LTB , and the cysteinyl controlled 4 Patient education and environmental control at each step ≥3 months) leukotrienes, despite corticosteroid treatment; additionally, OCS have not been shown to reduce urinary LTE4 levels, thought to be a marker of whole- body leukotriene production.14–16 Figure 2: Targeting Leukotrienes in the 5-lipoxygenase Pathway5 There is a strong association between increased leukotriene levels and Membrane phospholipids asthma exacerbations, evidenced by heightened cysteinyl leukotriene 17,18 cPLA2 production and measurable increases in urinary LTE4 levels. Asthma is a heterogeneous disease, and interest exists in how differences in underlying Arachidonic acid 5-lipoxygenase • Eosinophil disease pathology might affect response to treatment. Data exist implicating Zileuton FLAP chemoattractant increased leukotriene levels (measured by urinary LTE4), an elevated 5-HPETE 5-HETE 5-oxo-ETE • Neutrophil monocyte migration neutrophil:eosinophil ratio, and decreased atopy in some patients who do 5-Lipoxygenase • Neutrophil activation not show optimal responses to corticosteroids.6,7 Leukotriene A4 LTC4 hydrolase LTC4 synthase Related to this, evidence suggests that neutrophilic
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