Improving SAR symptoms with levocetirizine: evaluating active and placebo effects in pollen challenge vs. natural exposure studies.
ABSTRACT Despite a plethora of published data on levocetirizine, no meta-analyses exist on the effect of study design, and covariates like age, gender, and baseline symptom severity on treatment response. The objective of this study was the efficacy of levocetirizine 5 mg tablets and matching placebo at reducing allergy symptoms in adult subjects with seasonal allergic rhinitis under various pollen exposure study conditions and by age, gender and baseline symptom severity.
This was a meta-analysis of original reports from randomized, double-blind, placebo-controlled studies. Clinical studies without detailed reports, open-label, non-randomized and non-controlled studies, or paediatric studies, were excluded. Study subjects were divided into an environmental exposure (EE) group or a natural exposure (NE) group.
Data from 3640 subjects were analysed (n = 2174 for levocetirizine, n = 1466 for placebo). The overall results confirmed the efficacy of levocetirizine 5 mg, with an approximately 40% symptom score improvement from baseline, in both the EE and NE groups. While levocetirizine showed no gender- or age-related differences in efficacy, female subjects responded better to placebo in the EE, but not in the NE group; younger subjects (<30 years of age) responded less favourably to placebo compared with older subjects (≥ 50 years of age). Levocetirizine was consistently superior to placebo regardless of baseline symptom score levels. The highest significance levels between the active and placebo groups were observed in subjects sensitized to animal dander and grass.
Differences between an oral antihistamine and placebo in clinical studies of allergic rhinitis might be due to a different response to placebo rather than to the active drug. Levocetirizine seems to have consistent efficacy regardless of age, gender, and baseline scores.
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ABSTRACT: INTRODUCTION: There have recently been guidelines developed for the diagnosis and treatment of rhinitis and urticaria. For both conditions, second-generation antihistamines remain as the first-line therapy. AREAS COVERED: The article presents the current pharmacology, chemical properties, pharmacokinetics and metabolism of levocetirizine. The article also reviews the clinical efficacy of levocetirizine for seasonal allergic and perennial rhinitis, as well as chronic urticaria. The article is formed through the review of all the published literature in English retrieved from the PubMed/MEDLINE database between 1966 and March 2011 using the search terms: levocetirizine, allergic rhinitis, chronic urticaria and antihistamine. Furthermore, the article also reviews data provided by the manufacturer in addition to reports from governmental agencies. EXPERT OPINION: Levocetirizine has several pharmacokinetic properties that are desirable for an antihistamine providing a combination of both potency and safety. Its clinical advantages are derived from its rapid and extensive absorption, limited distribution and its very low degree of metabolism. Furthermore, levocetirizine scores very highly in terms of clinical efficacy as well as in patient/physician satisfaction studies. Given the lack of large multi-center studies that compare the treatment options for urticaria, clinicians must rely on potency studies when choosing treatment and levocetirizine does score very highly. However, other potent skin antihistamines, such as desloratadine or fexofenadine, should be preferred for patients who have a strict contraindication to the sedative effects of the drug.Expert Opinion on Drug Metabolism & Toxicology 06/2011; 7(8):1035-47. DOI:10.1517/17425255.2011.590131 · 2.93 Impact Factor
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ABSTRACT: This randomized, double-blind, placebo-controlled crossover study compared inhibition by one 5 mg dose of levocetirizine with two 60 mg doses of fexofenadine separated by 12 h of histamine-induced wheal and flare responses in 9 Caucasian and 9 Japanese healthy male volunteers. Levocetirizine was more inhibitory than fexofenadine on wheal, flare and pruritus (p < 0.005). Variability, evaluated from the standard deviation of inhibition, ranged from 14% to 23.2% for levocetirizine and 65.4% to 112.4% for fexofenadine. Levocetirizine had a faster onset of action (30-90 min versus 2 h), shorter time to maximum effect (3-4 versus 3-6 h) and longer duration of action (at least 24 h versus ~12 h) than fexofenadine. The plasma levels of levocetirizine rose more quickly, reached higher levels, were more consistent and decreased slower than those of fexofenadine. There were no clinically significant ethnic differences in responsiveness to the drugs.Acta Dermato-Venereologica 11/2012; 93(3). DOI:10.2340/00015555-1490 · 4.24 Impact Factor