Comparison of the Risk of Drowsiness and Sedation between Levocetirizine and Desloratadine
- PDF / 141,061 Bytes
- 13 Pages / 505 x 720 pts Page_size
- 76 Downloads / 146 Views
ORIGINAL RESEARCH ARTICLE
© 2006 Adis Data Information BV. All rights reserved.
Comparison of the Risk of Drowsiness and Sedation between Levocetirizine and Desloratadine A Prescription-Event Monitoring Study in England Deborah Layton,1,2 Lynda Wilton,1,2 Andrew Boshier,1,2 Victoria Cornelius,1 Scott Harris3 and Saad A.W. Shakir1,2 1 2 3
Drug Safety Research Unit, Southampton, UK University of Portsmouth, Portsmouth, UK Southampton University Hospital Trust, Southampton, UK
Abstract
Background and objectives: Desloratadine and levocetirizine are histamine H1 receptor antagonists (antihistamines) that were launched in the UK in 2001. Our objective was to compare the frequency with which drowsiness and sedation were reported for desloratadine and levocetirizine within the first 30 days of observation, as monitored using the observational cohort technique of prescription-event monitoring (PEM). Methods: Exposure data were derived from dispensed prescriptions written by primary care physicians and outcome data were derived from questionnaires that were posted to prescribers at least 6 months after the date of the first prescription for each patient. The odds ratio (OR) was calculated using unconditional logistic regression modelling. The effect of age, sex, reported prescribing indication (allergic rhinitis with asthma/wheezing, allergic rhinitis without asthma/wheezing, ‘other’), pattern of use and reported previous antihistamine use on the OR was examined. A time-to-event analysis was performed. Results: The cohorts comprised >24 000 patients in total. Cohort demographics were similar (both cohorts: median age 37 years; 60% women); the most frequently reported prescribing indication for both drugs was allergic rhinitis without asthma/wheezing (54%). The incidence of first reports of drowsiness/sedation for levocetirizine or desloratadine was low (46 [0.37%] and 9 [0.08%], respectively) and statistically different (p < 0.0001). These events tended to occur earlier for desloratadine than levocetirizine (50% at 7 or 14 days of observation, respectively; p = 0.6487), but the cumulative time to event differed, with more events observed for levocetirizine than expected (p < 0.0001; 46 vs 28.09). The final estimates of risk were the sex-adjusted ORs for each prescribing indication category: allergic rhinitis with asthma/wheezing (3.51; 95% CI 0.71, 17.43; n = 3357), allergic rhinitis without asthma/wheezing (6.75; 95% CI 2.37, 19.22; n = 12 627) and ‘other’ (3.11; 95% CI 0.86, 11.31; n = 6725). Discussion: Although the reporting rates of drowsiness and sedation are low for both drugs, patients prescribed levocetirizine are more likely to experience
898
Layton et al.
drowsiness and sedation in the first month of observation (after starting treatment) than patients prescribed desloratadine. For patients with allergic rhinitis without asthma/wheezing, the sex-adjusted odds of drowsiness/sedation were over six times greater in patients using levocetirizine than desloratadine in the first month of observation, with the
Data Loading...
