Montelukast Sodium. -A new class of seasonal allergic rhinitis therapy

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1 Montelukast Sodium -A new class of seasonal allergic rhinitis therapy

2 Symptoms of Seasonal Allergic Rhinitis Nasal itch Sneezing Rhinorrhoea Nasal stuffiness

3 Pathogenesis of Allergic Rhinitis Mast cells, Basophils, Eosinophils Histamine Cysteinyl leukotrienes Effects the nasal vasculature Nasal Itching, Sneezing Vascular permeability Vasodilation Mucosal swelling Congestion/stuffiness

4 Leukotriene production is important in the pathophysiology of rhinitis symptoms

5 Nasal allergen challenge studies LTC 4 is approximately 10 times as potent as histamine LTD 4 was shown to be 5000 times as potent as histamine in increasing nasal airway resistance Ann Pharmacother 2001;35:1274-7

6 It is thus reasonable to consider that cysteinyl leukotriene receptor blockade may reduce the symptoms of allergic rhinitis

7 Montelukast LTD 4 LTD 4 Leukotriene Receptor (CysLT 1 ) LTD 4 Airway cell (eosinophil, smooth muscle cell, etc.) Montelukast is a selective leukotriene receptor that blocks LTD4, a substance correlated with the pathophysiology of allergic rhinitis which are associated with the inflammatory process

8 Clinical benefits of Montelukast in SAR Objective: Method: Outcomes: To evaluate the clinical benefit of montelukast administered once daily for treating seasonal allergic rhinitis Multicenter, randomized, double-blind, placebo controlled study in which patients were randomly assigned to treatment with montelukast 10 mg (n=522) or placebo (n=171) once daily at bedtime for 2 weeks. Daytime nasal symptom score (mean score of congestion, rhinorrhea, pruritus and sneezing) Nighttime symptoms (mean score of difficulty in going to sleep, nighttime awakenings, nasal congestion on awakening) Daytime eye symptom score (mean score for tearing, pruritus, redness and puffiness) Peripheral blood Eosinophil count Ann Allergy Asthma Immunol 2003;90:

9 LS Mean Change from Baseline Daytime nasal p<0.05 compared with placebo Daytime Nasal Symptom Scores Congestion Rhinorrhea Pruritus Sneezing Placebo Montelukast

10 Nighttime Nighttime Symptom Scores 0 0 Nasal Congestion Difficulty Sleeping Nocturnal Awakenings LS Mean Change from Baseline p<0.05 compared with placebo Placebo Montelukast

11 Conclusions Therapy with montelukast significantly improves assessments of symptom severity as well as quality of life parameters for patients with seasonal allergic rhinitis

12 Objective: Design: Clinical benefits of Montelukast/Antihistamine Combination for SAR To evaluate the effectiveness and tolerability of montelukast, loratadine and combination therapy with montelukast and loratadine for treating patients with SAR. Multicenter, randomized, double-blind, parallel group, placebo-controlled trial. Treatments: Montelukast 10 mg once daily (n=155) Loratadine 10 mg once daily (n=301) Montelukast 10 mg + Loratadine 10 mg once daily (n=302) Placebo (n=149) Ann Allergy Asthma Immunol 2002;88:

13 Contd.. Parameters: Daytime nasal symptoms (nasal congestion, rhinorrhea, nasal pruritis, sneezing) Nighttime symptoms (difficulty in going to sleep, nighttime a awakenings, nasal congestion on awakening) Daily composite symptom score Peripheral blood eosinophil level

14 Daytime Nasal Symptoms Nighttime Symptoms Daily Composite (Daytime Nasal & Nighttime) Change from baseline (0.3 Scale; LS Mean + SE) Placebo Montelukast Loratadine Montelukast/Loratadine Significant change compared with placebo (p<0.003)

15 0 Placebo Montelukast Loratadine Montelukast / Loratadine Change from baseline (0.6 Scale; LS Mean + SE) Significant change compared with placebo (p<0.02) Significant change compared with placebo (p<0.001)

16 Conclusion Montelukast alone or in combination with loratadine is well tolerated and provides clinical and quality of life benefits for patients with seasonal allergic rhinitis.

17 Indications Montelukast sodium is used for the treatment of the symptoms of seasonal allergic rhinitis in adults and children above 2 years

18 Dosage and Administration Adolescents and adults 15 years of age and above One 10 mg-tablet daily to be taken in the evening Pediatric patients 6 to 14 years of age One 5-mg chewable tablet daily to be taken in the evening Pediatric patients 2 to 5 years of age One 4-mg chewable tablet daily to be taken in evening

19 Highlights Helps to relieve a broad range of seasonal allergy symptoms for a full 24 hours It is the only seasonal allergy medicine that specifically blocks leukotrienes, an underlying cause of allergy symptoms Once a day tablet US FDA approved for SAR in adults & children as young as 2 years and PAR as young as 6 months.

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