levocetirizine and bilastine

The year 2012 has seen relevant changes in Polish pharmaceutical legislation and drug reimbursement, among others limiting the reimbursement solely to indications stated in the Summaries of Product Characteristics (SPCs). A discrepancy with expert recommendations became apparent. The aim of this study was to analyze discordances between up-to-date expert recommendations, the SPCs in force, and the evidence for the effectiveness of recommended drugs in urticaria. Guidelines for the treatment of urticaria issued by Polish and international expert bodies were analyzed, along with the SPCs. A systematic review of clinical trials of recommended drugs was carried out. Of drugs recommended by the experts, 203 were authorized in Poland for urticaria treatment, including 167 oral preparations of second-generation antihistamines (SGAH, 8 active substances), 29 oral preparations of first-generation antihistamines (6 substances), 4 preparations of systemic glucocorticosteroids (2), 2 topical glucocorticosteroid preparations (2) and one combined preparation of human immunoglobulin with histamine. Among products both recommended by experts and licensed for the treatment of urticaria in Poland, high or moderate-level of evidence of effectiveness was available for 7 active substances (bilastine, cetirizine, desloratadine, fexofenadine, loratadine, levocetirizine, rupatadine). Nevertheless, 39% of SGAH available in Poland (66 preparations of cetirizine, emedastine, levocetirizine, loratadine or fexofenadine) were registered exclusively for "chronic idiopathic urticaria" - a diagnosis inconsistent with the current state of medical knowledge. We conclude that there exist considerable discrepancies between expert recommendations for the pharmacotherapy of urticaria, the licensed use of drugs as defined in Summaries of Product Characteristics and scientific evidence for their effectiveness.

Topics: Administration, Oral; Administration, Topical; Anti-Allergic Agents; Benzimidazoles; Cetirizine; Glucocorticoids; Histamine Antagonists; Histamine H1 Antagonists, Non-Sedating; Humans; Loratadine; Piperidines; Poland; Practice Guidelines as Topic; Terfenadine; Treatment Outcome; Urticaria

Bilastine is an orally administered, second-generation antihistamine used in the symptomatic treatment of seasonal or perennial allergic rhinoconjunctivitis and urticaria. In two well designed phase III trials, 14 days' treatment with bilastine was associated with a significantly lower area under the effect curve (AUEC) for the reflective total symptom score (TSS) than placebo in patients with symptomatic seasonal allergic rhinitis. Additionally, reflective nasal symptom scores were significantly lower in bilastine than placebo recipients in patients with a history of seasonal allergic rhinitis who were challenged with grass pollen allergen in a single-centre, phase II study. Neither bilastine nor cetirizine was effective in the treatment of perennial allergic rhinitis with regard to the mean AUEC for reflective TSS in another well designed phase III trial. However, results may have been altered by differences in some baseline characteristics and placebo responses between study countries. In another well designed phase III trial, compared with placebo, bilastine was associated with a significantly greater change from baseline to day 28 in the mean reflective daily urticaria symptom score in patients with chronic urticaria. There were no significant differences in primary endpoint results between bilastine and any of the active comparators used in these trials (i.e. cetirizine, levocetirizine and desloratadine). Bilastine was generally well tolerated, with a tolerability profile that was generally similar to that of the other second-generation antihistamines included in phase III clinical trials.

Topics: Area Under Curve; Benzimidazoles; Cetirizine; Histamine H1 Antagonists, Non-Sedating; Humans; Loratadine; Piperidines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Perennial; Urticaria

Chronic spontaneous urticaria (CSU) is a debilitating condition, adversely affecting the patient's quality of life. Bilastine is a recently introduced, non-sedative H1-antihistamine for its treatment. We wanted to compare the effectiveness, safety, and tolerability of bilastine 20 mg vs levocetirizine 5 mg in moderate-to-severe CSU. We conducted a double-blind, randomized controlled trial with two groups: bilastine 20 mg (n = 31) and levocetirizine 5 mg (n = 27), once daily for 42 days. We included patients (18-65 years), with moderate-to-severe CSU. UAS7, VAS, and DLQI were used to assess severity of urticaria, global urticaria-induced discomfort and quality of life, respectively. DLQI was assessed at baseline (D0) and end-of-treatment (D42), while UAS7 and VAS were noted at baseline and all follow-up visits. Assessment of UAS7 alteration was our primary objective, while changes in DLQI and VAS were the secondary outcomes. Safety was assessed by recording drug-related adverse events, biochemical investigations, and electrocardiogram, along with tolerability and compliance. Both drugs significantly improved UAS7, DLQI, and VAS at end-of-treatment (D42) compared with baseline (intra-group). At the end-of-treatment, all parameters showed greater improvement with bilastine, but only UAS7 reduction was significant (bilastine > levocetirizine, P = .03). In both the groups, UAS7 and VAS improved significantly D14 onwards, and was maintained throughout the study. Sedation was significantly less with bilastine (P = .04), while neither drug showed any serious adverse-effect. Tolerability of both drugs was similar. Therefore, bilastine was found to be a more effective and less-sedative novel therapy for CSU compared to levocetirizine, with similar effect on quality of life.

Topics: Benzimidazoles; Cetirizine; Chronic Disease; Chronic Urticaria; Double-Blind Method; Histamine H1 Antagonists, Non-Sedating; Humans; Piperidines; Quality of Life; Treatment Outcome; Urticaria

Bilastine is a novel nonsedative H(1)-receptor antagonist, which may be used for the symptomatic treatment of chronic idiopathic urticaria (CU). The aim of this study was to compare the clinical efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg and placebo in CU patients with moderate-to-severe symptoms.. Overall 525 male and female subjects aged 18-70 years were randomized to receive bilastine 20 mg, levocetirizine 5 mg or placebo, once daily for 28 days, in double-blind manner, in 46 centres across Europe and Argentina. Patients rated symptoms of pruritus, number of wheals, and maximum size of wheals (on predefined scales) as reflective (over past 12 h) symptoms twice daily, for assessment of change from baseline in the total symptoms scores (TSS) over 28 days as the primary efficacy measure. Changes in reflective and instantaneous symptoms scores, Dermatology Life Quality Index (DLQI), and CU-associated discomfort and sleep disturbance were assessed as secondary outcomes. Safety was assessed according to adverse events, laboratory tests and electrocardiograms.. Bilastine reduced patients' mean reflective and instantaneous TSS from baseline to a significantly greater degree than placebo (P < 0.001); from day 2 onwards of treatment. The DLQI, general discomfort, and sleep disruption were also improved significantly in bilastine-treated patients as compared with placebo-treated patients (P < 0.001 for all parameters). Comparison with levocetirizine indicated both treatments to be equally efficacious as well as equally safe and well tolerated as compared with placebo.. Bilastine 20 mg is a novel effective and safe treatment option for the management of CU.

Topics: Adolescent; Adult; Aged; Area Under Curve; Benzimidazoles; Cetirizine; Chronic Disease; Double-Blind Method; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Male; Middle Aged; Piperidines; Quality of Life; Urticaria; Young Adult

Topics: Benzimidazoles; Cetirizine; Chronic Disease; Chronic Urticaria; Humans; India; Piperidines; Urticaria