title: Comparison of efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine in patients of allergic rhinitis: A randomized, double-blind clinical trial.
abstract: OBJECTIVE
  Allergic rhinitis (AR) is a global health problem. Almost 10%-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, and intranasal corticosteroids are the pillars in the management of AR. The combination therapy of montelukast with antihistaminic provides enhancing and complimentary effects, thereby reducing the symptoms effectively, but there are scanty data regarding the comparisons of combinations. Therefore, we aimed to compare the efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine combination in patients of AR.
  
  
  METHODS
  Seventy patients with AR participated in a prospective, randomized, double-blind, parallel, active-controlled, comparative 4-week trial. The patients between the age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent AR were included in the study. The study inclusion criteria required the patients with total nasal symptom score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetirizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter.
  
  
  RESULTS
  Evaluation of TNSS revealed significant difference (P< 0.05) when compared from baseline to 4thweek in both groups. The mean change of TNSS, i.e., 9.46 was significant (P< 0.05) in montelukast-fexofenadine group. The cost-effectiveness ratio was less in montelukast-levocetirizine group than in montelukast-fexofenadine group.
  
  
  CONCLUSIONS
  The decrease in TNSS was more in montelukast-fexofenadine group, but the cost-effectiveness is more with montelukast-levocetirizine combination.
authors.affiliation: Department of Pharmacology, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India.
authors.forename: Mohini Sachin
authors.initials: MS
authors.lastname: Mahatme
authors.affiliation: Department of Pharmacology, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India.
authors.forename: Ganesh Natthuji
authors.initials: GN
authors.lastname: Dakhale
authors.affiliation: Department of ENT, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India.
authors.forename: Kanchan
authors.initials: K
authors.lastname: Tadke
authors.affiliation: Department of Pharmacology, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India.
authors.forename: Sachin Keshaorao
authors.initials: SK
authors.lastname: Hiware
authors.affiliation: Department of Pharmacology, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India.
authors.forename: S D
authors.initials: SD
authors.lastname: Dudhgaonkar
authors.affiliation: Department of Pharmacology, Indira Gandhi Government Medical College, Nagpur, Maharashtra, India.
authors.forename: Sumit
authors.initials: S
authors.lastname: Wankhede
mesh_terms: D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D017332:Cetirizine / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D003362:Cost-Benefit Analysis / Q000379:methods*; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D065631:Rhinitis, Allergic / Q000175:diagnosis* / Q000188:drug therapy* / Q000191:economics; D013440:Sulfides; D016593:Terfenadine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000191:economics; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C472067:levocetirizine; D016593:Terfenadine; C093230:fexofenadine; C093875:montelukast; D017332:Cetirizine
keywords: Allergic rhinitis; cost-effectiveness; fexofenadine; levocetirizine; montelukast