Examining the utilization and tolerability of the non-sedating antihistamine levocetirizine in England using prescription-event monitoring data
| Autor: | Deborah Layton, Anna Gilchrist, Vicki Osborne, Saad A. W. Shakir |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male medicine.medical_specialty Histamine H1 Antagonists Non-Sedating Adolescent medicine.medical_treatment Symptomatic treatment Toxicology Levocetirizine Young Adult medicine Hypersensitivity Product Surveillance Postmarketing Humans Pharmacology (medical) Child health care economics and organizations Aged Pharmacology Aged 80 and over Desloratadine business.industry Middle Aged Dermatology Cetirizine Drug Utilization Tolerability England Prescription event monitoring Anesthesia Antihistamine Female Chronic idiopathic urticaria business medicine.drug |
| Zdroj: | Drug safety. 34(12) |
| ISSN: | 1179-1942 |
| Popis: | Levocetirizine was launched onto the UK market in September 2001. It is indicated for symptomatic treatment of allergic rhinitis (AR), including persistent AR and chronic idiopathic urticaria.The aim of the study was to monitor the safety of levocetirizine prescribed in the primary care setting in England, in the immediate postmarketing period.Exposure data were derived from dispensed prescriptions written by primary care physicians (general practitioners [GPs]) for levocetirizine (November 2001-November 2002): patient demographic, indication, pattern of use and outcome (event) data from enhanced prescription-event monitoring (PEM) questionnaires (with additional questions to gather further relevant information) returned by GPs. Incidence density observation rates (IDobs) [number of first reports/1000 patient-months] between months 1 and 2 (IDobs(m1/m2)) were compared for the whole cohort and by groups defined by indication and pattern of use.The cohort comprised 12 367 patients (median age 37 years [interquartile range 22-55]; 58% female). The most frequent indication was AR (67%; n = 8275). After 2 months, 35.7% (n = 2414) of patients were still taking levocetirizine. 'Condition improved' was the most common event and reason for stopping treatment. Headache/migraine was uncommon but associated with starting treatment (IDobs(m1/m2) 2.4 [95% CI 1.1, 6.0]), as was drowsiness/sedation (IDobs(m1/m2) 11.5 [95% CI 4.2, 43.9]). Cardiovascular events occurred rarely or very rarely, as did most central and peripheral nervous system events. No serious adverse drug reactions (ADRs) were reported. Events related to effectiveness were more frequent in month 1 than month 2 for all patient subgroups.This postmarketing surveillance study shows that levocetirizine is well tolerated when used in general practice in England. No previously unrecognized ADRs were detected. This study highlights how modifications to PEM, such as additional questions, are contributing to the evaluation of drug utilization factors in relation to risks. |
| Databáze: | OpenAIRE |
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