Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study.
This randomised, double-blind, placebo-controlled, parallel-group, international, dose-ranging study investigated the effect of treatment with rupatadine 5, 10 and 20 mg once daily for 4 weeks on symptoms and interference with daily activities and sleep in 12-65 years-old patients with moderate-to-severe chronic idiopathic urticaria (CIU). Rupatadine 10 and 20 mg significantly reduced pruritus severity by 62.05% and 71.87% respectively, from baseline, over a period of 4 weeks compared to reduction with placebo by 46.59% (p < 0.05). Linear trends were noted for reductions in mean number of wheals and interference with daily activities and sleep with rupatadine 10 and 20 mg over the 4-week treatment period. The two most frequently reported AEs were somnolence (2.90% for placebo, 4.29% for 5 mg-, 5.41% for 10 mg- and 21.43% for 20 mg-rupatadine-treated group) and headache (4.35% for placebo, 2.86% for 5 mg-, 4.05% for 10 mg- and 4.29% for 20 mg-rupatadine-treated group). These findings suggest that rupatadine 10 and 20 mg is a fast-acting, efficacious and safe treatment for the management of patients with moderate-to-severe CIU. Rupatadine decreased pruritus severity, in a dose- and time-dependent manner.
Dubertret
Louis
L
Institute for Skin Research, University Paris VII, Hôpital Saint-Louis, Paris, France.
Zalupca
Lavinia
L
Cristodoulo
Tania
T
Benea
Vasile
V
Medina
Iris
I
Fantin
Sara
S
Lahfa
Morad
M
Pérez
Iñaki
I
Izquierdo
Iñaki
I
Arnaiz
Eva
E
D000284:Administration, Oral; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002908:Chronic Disease; D003533:Cyproheptadine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011537:Pruritus / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy*
D018926:Anti-Allergic Agents; D006634:Histamine H1 Antagonists; C103639:rupatadine; D003533:Cyproheptadine