Levocetirizine improves health-related quality of life and health status in persistent allergic rhinitis.

BACKGROUND: Allergic rhinitis is a chronic respiratory disorder with a detrimental impact on health-related quality of life (HRQOL) and health status. Enhancement and maintenance of patient function and well-being are therefore considered as essential. OBJECTIVE: To determine whether long-term treatment with levocetirizine 5mg improves HRQOL and health status in persistent allergic rhinitis (PER) patients assessed with RQLQ and SF-36 scales over a 6-month period. METHODS: The Xyzal in PER Trial (XPERT) was a multi-center, double-blind, parallel-group study. A total of 551 patients were randomized to receive levocetirizine 5mg or placebo once daily for 6 months and assessed for symptoms, HRQOL (Rhinoconjunctivitis Quality of Life Questionnaire: RQLQ) and health status (SF-36). Sensitivity of the RQLQ and SF-36 to disease severity was tested to ensure their suitability for use in PER patients. Treatment effect was assessed by means of repeated measures analyses. RESULTS: Over the 6-month treatment period, levocetirizine showed statistically significant improvements over placebo in HRQOL (P < 0.001 for all RQLQ domains and overall scores) and health status (P < or = 0.004 for SF-36 physical and mental summary scores; P < 0.05 for all SF-36 scales). The relative improvement of levocetirizine over placebo exceeded the predefined clinically meaningful threshold of 30% for all RQLQ scores and the improvement from baseline was 3 times the established MID for RQLQ. CONCLUSION: The RQLQ and SF-36 could be used to measure HRQOL and health status in PER patients. Long-term treatment with levocetirizine provides sustained improvement of HRQOL and reduces disease burden in PER patients.

Levocetirizine improves quality of life and reduces costs in long-term management of persistent allergic rhinitis.

BACKGROUND: Allergic Rhinitis and its Impact on Asthma in collaboration with the World Health Organization initiative reclassified allergic rhinitis, like asthma, by duration and severity. The Xyzal in Persistent Rhinitis Trial is the first large, long-term clinical trial studying patients with persistent rhinitis as defined by Allergic Rhinitis and its Impact on Asthma. OBJECTIVES: Two primary objectives were defined: comparison of the Rhinoconjunctivitis Quality of Life Questionnaire overall score and Total 5 Symptoms Score (rhinorrhea, sneezing, nasal congestion, and nasal and ocular pruritus) over a period of 4 weeks between levocetirizine 5 mg and placebo. Secondary endpoints included 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), a pharmacoeconomic assessment, comorbidities, and a safety evaluation. METHODS: The Xyzal in Persistent Rhinitis Trial was a 6-month double-blind, placebo-controlled, multicenter, multinational trial in 551 patients. Adults with persistent rhinitis sensitized to both grass pollen and house dust mite were randomized to receive levocetirizine 5 mg/d or placebo. RESULTS: A total of 421 patients completed the full study. Levocetirizine significantly improved both the Rhinoconjunctivitis Quality of Life Questionnaire overall score and the Total 5 Symptoms Score from week 1 to 6 months (all P values <.001). Medical Outcomes Survey Short Form 36 summary scores were also improved in the levocetirizine group compared with the placebo group. Treatment cessation because of lack of effect, comorbidities, and overall costs of disease, and comorbidities per working patient per month (160.27 vs 108.18) were lower in the levocetirizine group. CONCLUSION: Levocetirizine was shown to improve quality of life and symptoms and to decrease the overall costs of the disease over the 6-month treatment period.

Maintenance of improvement in health-related quality of life during long-term treatment with levetiracetam.

Health-related quality of life (HRQOL) of patients taking levetiracetam (LEV) was evaluated in long-term follow-up. Short-term assessments compared LEV and placebo add-on therapy in an 18-week clinical trial, with long-term follow-up for a mean of 4.1 years. The QOLIE-31 was expanded to assess distress associated with each domain, change, and priority of importance of each domain. Significant improvements were observed at short-term in patients starting with LEV (N=66), whereas patients initially randomized to placebo (N=35) were unchanged. Improvement observed in LEV starters remained stable long-term. Placebo starters reached the same level of improvement in HRQOL at long-term. Correlations between the QOLIE-31-P distress items and domain items indicated that distress was significantly lower when HRQOL was better (P<0.0001, all domains). At long-term, highest-priority QOLIE-31-P domains were Social Functioning, Cognitive Function, and Overall QOL. Thus, gains in HRQOL were maintained during long-term LEV treatment, whether LEV was initiated early or late. Patient distress and importance of domains are useful data in determining how treatments impact on HRQOL.