title: Olopatadine versus levocetirizine in chronic urticaria: an observer-blind, randomized, controlled trial of effectiveness and safety.
abstract: OBJECTIVE
  Chronic urticaria (CU) is characterized by frequent appearance of wheals for ≥ 6 weeks. This study was undertaken to compare effectiveness and safety of olopatadine, a newer antihistamine with additional anti-inflammatory properties, in treating CU in comparison to the established second-generation antihistamine levocetirizine.
  
  
  METHODS
  A single center, assessor-blind, randomized (1:1), active-controlled, parallel group, Phase IV trial (CTRI/2011/08/001965) was conducted with 120 adult CU patients of either sex. Subjects received either olopatadine (5 mg b.i.d.) or levocetirizine (5 mg/day) for 9 weeks, continuously for first 4 weeks and then on demand basis for last 5 weeks. Primary outcome measures were urticaria activity score (UAS) and urticaria total severity score (TSS). Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety.
  
  
  RESULTS
  Data from 54 subjects on olopatadine and 51 on levocetirizine were analyzed for effectiveness. UAS and TSS values declined significantly with both drugs over the treatment period but the reduction was greater with olopatadine. Adverse event profiles were comparable with sedation being the commonest complaint.
  
  
  CONCLUSIONS
  Olopatadine is a safe and more effective alternative to levocetirizine in the treatment of CU.
authors.affiliation: Department of Pharmacology, Burdwan Medical College , Burdwan, West Bengal , India.
authors.forename: Amrita
authors.initials: A
authors.lastname: Sil
authors.forename: Santanu Kumar
authors.initials: SK
authors.lastname: Tripathi
authors.forename: Anita
authors.initials: A
authors.lastname: Chaudhuri
authors.forename: Nilay Kanti
authors.initials: NK
authors.lastname: Das
authors.forename: Avijit
authors.initials: A
authors.lastname: Hazra
authors.forename: Chiranjib
authors.initials: C
authors.lastname: Bagchi
authors.forename: Chowdhury Nazrul
authors.initials: CN
authors.lastname: Islam
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D017332:Cetirizine / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003990:Dibenzoxepins / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069605:Olopatadine Hydrochloride; D016037:Single-Blind Method; D014581:Urticaria / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D003990:Dibenzoxepins; D006634:Histamine H1 Antagonists; D039563:Histamine H1 Antagonists, Non-Sedating; D000069605:Olopatadine Hydrochloride; C472067:levocetirizine; D017332:Cetirizine