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• W1565136502 abstract "Is montelukast an effective treatment for patients with chronic rhinosinusitis? Cysteinyl leukotrienes (CysLT) are a class of inflammatory mediators synthesized by eosinophils and mast cells through the breakdown of arachidonic acid. They are known to play a key role in the molecular pathophysiology of asthma and chronic rhinosinusitis (CRS), promoting bronchoconstriction, mucus production, edema, and chemotaxis of neutrophils and eosinophils. Indeed, upregulation of CysLT receptors and overproduction of CysLTs has been demonstrated in asthma, allergic rhinitis, and CRS with nasal polyposis (CRSwNP), particularly in patients with Samter's triad, and reversal of this upregulation has been observed following aspirin salicylic acid (ASA) desensitization. Several CysLT inhibitors have been developed within the past 20 years, and due to their “corticosteroid sparing” effects are commonly prescribed adjunctive therapeutics for asthma, allergic rhinitis, and exercise-induced bronchoconstriction. Montelukast (Singulair, Merck; Whitehouse Station, NJ), zafirlukast (Accolate, Vanticon, Accoleit; Sellect Chemicals LLC, Houston, TX, and AstraZeneca; Wilmington, DE) and pranlukast (Ultair, Cayman Chemical; Ann Arbor, MI) act as competitive antagonists at the CysLT1 receptor. Notably, upregulation of a separate CysLT receptor (CysLT2) has been observed in nasal mucosa of patients with CRSwNP; however, Montelukast, Pranlukast, and Zafirlukast all lack antagonist action at this receptor. Zileuton (Zyflo CR, Cary, NC, Cornerstone Therapeutics) is a selective 5-lipoxygenase enzyme inhibitor, preventing CysLT synthesis. A recent discovery of another class of antileukotrienes, termed 5-lipoxygenase activating protein (FLAP) inhibitors, may allow for potential future drug development. Although they are commonly utilized as adjunctive treatments, there is a paucity of evidence regarding efficacy of CysLT inhibitor treatment for CRSwNP. Therefore, we asked the question: Is Montelukast indicated for treatment of CRSwNP? Only a few English language studies have been published evaluating the utility of antileukotriene treatment for CRSwNP, including two studies evaluating efficacy of antileukotrienes versus topical and/or oral steroid therapy. In a rigorous prospective, randomized controlled study, Schäper et al.1 describe their work evaluating the effects of treatment with montelukast in patients with both CRSwNP and asthma. All patients had previously undergone endoscopic sinus surgery (ESS) with total ethmoidectomy. They treated 24 patients in a blinded, placebo-controlled fashion using 10 mg montelukast daily for 6 weeks, with a 4-week placebo phase randomly assigned before or after treatment. Outcomes were measured in various fashions and compared to placebo, including the use of nonstandardized, nonvalidated symptom and 4-point rhinoscopy scores, measurement of various inflammatory mediators in nasal lavage fluid, eosinophil counts in nasal smears and peripheral blood smears, rhinomanometry, and olfactometry. Significant improvements were noted in all measured outcomes following montelukast treatment, including significant decrease in mean concentration of CysLTs, substance-P, eosinophil cationic protein, and neurokinin A in nasal lavage fluid, as well as significant decrease in peripheral blood and nasal smear eosinophil counts. Unfortunately, little information is provided regarding rhinoscopy technique (likely not endoscopic), and validated questionnaires and grading systems were not utilized. Vuralkan et al.2 compared the efficacy of montelukast versus mometasone furoate nasal spray for treatment of CRSwNP following ESS. 50 patients were prospectively randomized into either group and treated for 6 months following ESS. Outcomes were measured using Sino-Nasal Outcome test (SNOT)−22 scores, polyp grades, Lund-Mackay computed tomography (CT) scores and eosinophil counts in polyp tissue and peripheral blood smears. Both groups exhibited significant improvement in SNOT-22 scores following treatment. There was a significantly higher rate of polyp recurrence in the montelukast treatment group (48%) compared to the mometasone group (20%). Eosinophil counts were not significantly improved following either treatment, and higher eosinophil counts were noted to be a risk factor for polyp recurrence. In another comparison study, Stewart et al.3 performed a randomized, prospective controlled trial evaluating montelukast therapy plus oral and topical nasal steroid therapy versus oral and topical nasal steroid therapy alone in 38 patients with CRSwNP without a prior history of ESS. Subjects in the treatment group received a 2-week tapering course of oral steroids, as well as 8 weeks of daily montelukast and steroid nasal spray. Subjects in the control group received only oral steroids and steroid nasal spray. Outcomes were measured using both a validated general quality-of-life (QOL) questionnaire (SF-36) at 12 weeks following initiation of treatment, as well as a validated nasal symptom-specific questionnaire (International Classification of Sinus Disease, ICSD) at both 8 and 12 weeks. No differences were noted in general QOL at 12 weeks between treatment groups. Significant reductions in symptom-specific scores of headache, facial pain, and sneezing were noted in the montelukast treatment group at 8 weeks; however, no significant symptom-specific differences between treatment groups were noted at 12 weeks. Ragab et al.4 performed a nonrandomized, noncontrolled study evaluating the efficacy of montelukast as an add-on therapy to topical nasal steroids and inhaled oral steroids in patients with CRSwNP and asthma. A total of 44 patients, including 24 patients with ASA-sensitive disease, were treated with 3 months of montelukast, as well as a topical nasal steroid and an inhaled oral steroid. Objective measurements included acoustic rhinometry and nasal inspiratory peak flow, as well as nasal cavity nitric oxide levels. At the end of the treatment period, patients were assigned a subjective clinical score based on reported symptoms and exam findings, as well as peak expiratory flow rates. Of interest, subjective clinical improvement occurred in 50% of ASA-sensitive patients and 64% of ASA-tolerant patients. The authors observed greater improvement in nasal inspiratory peak flow in patients with improved polyp scores, and a trend toward increased nasal cavity nitric-oxide levels was also noted. This study is significantly limited by lack of a comparison group; because montelukast was evaluated as an add-on therapy to topical steroids, no significant conclusions may be drawn regarding the clinical efficacy of montelukast therapy alone in this study. DiCapite et al.5 performed an ex-vivo study using cultured mast cells derived from sinonasal mucosa of patients with CRSwNP. They were able to activate cultured mast cells using CysLTs, and this activation was blocked using montelukast. Of interest, they also demonstrated that combined treatment with both zileuton and montelukast resulted in near total prevention of mast cell activation following application of CysLTs. This raises the possibility of additive effect of treatment with both a CysLT1 receptor antagonist (montelukast) and a 5-lipoxygenase inhibitor (zileuton), although no conclusions can be drawn regarding a direct clinical effect due to study design. Upregulation of a separate CysLT receptor, CysLT2, has been observed in nasal mucosa of patients with CRSwNP; however, montelukast, pranlukast, and zafirlukast all lack antagonist action at this receptor. Other classes of antileukotrienes, however, have been recently developed or are currently under development. Zileuton (Zyflo CR, Cornerstone Therapeutics; Cary, NC) is a selective 5-lipoxygenase enzyme inhibitor, preventing CysLT synthesis. A recently described class of antileukotrienes, termed FLAP inhibitors, may allow for potential future drug development. There is moderate evidence suggesting that montelukast is an effective adjunctive therapy in CRSwNP when used in conjunction with topical and/or oral steroids. There are no studies evaluating montelukast treatment in patients with CRS without nasal polyposis. Montelukast alone may not be as effective at preventing polyp recurrence following ESS as compared to steroid nasal spray therapy. Further studies are required to determine the efficacy of zileuton for treatment of CRSwNP; however, an ex-vivo basic science study suggests that zileuton plus montelukast is more effective than montelukast alone in preventing mast cell activation in CRSwNP. There is no evidence at this time to suggest that antileukotrienes are more effective in ASA-sensitive versus ASA-tolerant CRSwNP. There are no studies evaluating efficacy of FLAP inhibitors for treatment of upper airway inflammatory disorders, although this may prove to be a promising future treatment option. Three level 1b studies, a level III study, and a level V study were evaluated in this review." @default.
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• W1565136502 title "Is montelukast indicated for treatment of chronic rhinosinusitis with polyposis?" @default.
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