Abstract
Allergic rhinitis (AR) is a chronic disease with an increasing trend in most of the Western Countries. It may significantly impair the individual quality of life (QoL) and also represents a social burden for its economic costs. Levocetirizine (XYZAL; UCB Pharma) as a second generation, nonsedating H1-antihistamine, has been shown to be clinically effective in patients with AR in different randomized controlled trials. The XPERT (XYZAL in Persistent Rhinitis Trial) is the first large, long-term clinical study involving patients with persistent rhinitis as defined by ARIA (Allergic Rhinitis and its Impact on Asthma). The XPERT was a 6-month double-blind, placebo-controlled, multicenter, multinational trial in 551 subjects. Adults with persistent rhinitis sensitized to both grass pollen and house dust mites were randomized to receive levocetirizine 5 mg/d or placebo. Two primary objectives were considered: comparison of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score and Total 5 Symptoms Score (rhinorrhea, sneezing, nasal congestion, and nasal and ocular pruritus) (T5SS) between active and control group over a period of 4 weeks. As secondary endpoints, similar evaluations at 1 week and 3, 4, 5, and 6 months, summary scores for a general health status questionnaire (Medical Outcomes Survey Short Form 36), comorbidities, pharmacoeconomic and safety evaluations. Levocetirizine significantly improved both the RQLQ overall score and the T5SS from week 1 to 6 months (P <.001). Medical Outcomes Survey Short Form 36 summary scores were also improved in the group treated with levocetirizine with respect to placebo. Treatment cessation because of lack of efficacy, comorbidities, and overall costs of disease, and comorbidities per working patient per month (160.27 vs 108.18) were lower in the levocetirizine group. In conclusion, levocetirizine resulted to improve the quality of life and the symptoms related to AR and also to reduce the overall costs of the disease after 6 months treatment.
Highlights
Allergic rhinitis (AR) is a chronic disease with an increasing trend in most of the Western Countries
S32 shown that allergic rhinitis has an economically remarkable impact caused by work days loss, absenteeism, and poor task performance, with a global reduction in productivity
It is fundamental to remember the ARIA document published in 20011 where allergic rhinitis is divided into 4 categories: mild intermittent, moderate/severe intermittent, mild persistent, and moderate/severe persistent
Summary
The present survey provided a relevant analysis of pharmacoeconomic data about the treatment of PER It is a large multicenter, randomized, placebo-controlled, doubleblind, parallel group trial, involving more than 500 patients from 63 centers in 5 European countries (Belgium, France, Germany, Italy, and Spain); in addition, it is the first longterm (6-month) trial carried out with an oral H1-antihistamine in PER, with important consequential implications on guidelines criteria use and clinical practice. All the patients enrolled were 18 years old at least and presented symptoms related to PER (defined as allergic rhinitis symptoms lasting 4 days or more per week for 4 consecutive weeks or more per year). All the patients could use nasal or ocular cromoglycate and, in case of unbearable impairment of the allergic rhinitis symptoms, after a minimum of 4 weeks of treatment, were permitted a maximum of 20 mg of oral prednisolone once daily for 5 days, for a maximum of 2 prednisolone courses during the whole study. Direct costs consisted of the use of medical resources: hospitalization, physician visits, S33
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