Lack of effects between rupatadine 10 mg and placebo on actual driving performance of healthy volunteers.
BACKGROUND
Rupatadine fumarate is a potent, selective, histamine H(1)-receptor antagonist and PAF inhibitor with demonstrated efficacy for the relief of allergic rhinitis. Rupatadine does not easily cross the blood-brain barrier and is believed to be non-sedating at therapeutic doses. Consequently, rupatadine should show no impairment on car driving.


OBJECTIVE
This study compared the acute effects of rupatadine, relative to placebo and hydroxyzine (as an active control), on healthy subjects' driving performance.


METHODS
Twenty subjects received a single dose of rupatadine 10 mg, hydroxyzine 50 mg, or placebo in each period of this randomized, double-blind, three-way crossover study. Two hours postdosing, subjects operated a specially instrumented vehicle in tests designed to measure their driving ability. Before and after the driving tests ratings of sedation were recorded.


RESULTS
There was no significant difference between rupatadine and placebo in the primary outcome variable: standard deviation of lateral position (SDLP); however, hydroxyzine treatment significantly increased SDLP (p < 0.001 for both comparisons). Objective (Stanford sleepiness scale) and subjective sedation ratings (Visual Analogue Scales) showed similar results: subjects reported negative effects after hydroxyzine but not after rupatadine.


CONCLUSIONS
Rupatadine 10 mg is not sedating and does not impair driving performance.
Vuurman
Eric
E
Brain and Behaviour Institute, Faculty of Medicine, Maastricht University, The Netherlands. e.vuurman@np.unimaas.nl
Theunissen
Eef
E
van Oers
Anita
A
van Leeuwen
Cees
C
Jolles
Jelle
J
D000328:Adult; D001334:Automobile Driving; D018592:Cross-Over Studies; D003533:Cyproheptadine / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects*; D006801:Humans; D006919:Hydroxyzine / Q000009:adverse effects; D008297:Male; D008875:Middle Aged
D006634:Histamine H1 Antagonists; C103639:rupatadine; D003533:Cyproheptadine; D006919:Hydroxyzine