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Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study.
Clin Exp Allergy. 2009 Sep; 39(9):1338-47.CE

Abstract

BACKGROUND

Bilastine is a new non-sedative H(1) receptor antagonist, indicated for the treatment of allergic rhinitis (AR) (seasonal and perennial).

OBJECTIVE

To assess and compare the efficacy and safety of bilastine 20 mg vs. cetirizine 10 mg and placebo in relieving the symptoms of seasonal allergic rhinitis (SAR).

METHODS

Overall, 683 SAR patients, aged 12-70 years, were randomized to a double-blind treatment with bilastine 20 mg, cetirizine 10 mg or placebo, once daily for 14 days, in 61 centres across Europe. Patients recorded reflective (over the past 12 h) and instantaneous nasal (obstruction, rhinorrhoea, itching and sneezing) and non-nasal (ocular tearing, redness and itching) symptom scores (NSS and NNSS, respectively) twice daily, according to a pre-determined severity scale to provide reflective and instantaneous total symptom scores (TSS). The primary efficacy measure was the area under curve (AUC) of reflective TSS over 14 days of treatment (TSS-AUC(0-14 days)). Secondary efficacy measures included mean change from baseline in TSS, NSS and NNSS; discomfort caused by AR; and investigator's clinical global impression of the treatment. Safety was assessed according to adverse events (AEs), laboratory tests and electrocardiograms.

RESULTS

The mean TSS-AUC(0-14 days) (score x day) was reduced in bilastine- and cetirizine-treated groups to a similar and significantly greater extent, compared with placebo (76.5, 72.3 and 100.6, respectively; P<0.001). Similarly, bilastine and cetirizine were comparable and significantly superior to placebo for all secondary outcomes. While all treatments were well tolerated and the AE profiles of bilastine and placebo were similar, significantly fewer patients in the bilastine-treated group experienced somnolence (1.8%; P<0.001) and fatigue (0.4%; P=0.02) than patients in the cetirizine-treated group (7.5% and 4.8%, respectively).

CONCLUSIONS

Bilastine 20 mg once daily was significantly superior to placebo and comparable to cetirizine 10 mg in relieving symptoms of SAR, although it demonstrated a significantly better AE profile than cetirizine.

Authors+Show Affiliations

Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Lódz, Poland. pkuna@barlicki.internetdsl.plNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19438584

Citation

Kuna, P, et al. "Efficacy and Safety of Bilastine 20 Mg Compared With Cetirizine 10 Mg and Placebo for the Symptomatic Treatment of Seasonal Allergic Rhinitis: a Randomized, Double-blind, Parallel-group Study." Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology, vol. 39, no. 9, 2009, pp. 1338-47.
Kuna P, Bachert C, Nowacki Z, et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clin Exp Allergy. 2009;39(9):1338-47.
Kuna, P., Bachert, C., Nowacki, Z., van Cauwenberge, P., Agache, I., Fouquert, L., Roger, A., Sologuren, A., & Valiente, R. (2009). Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology, 39(9), 1338-47. https://doi.org/10.1111/j.1365-2222.2009.03257.x
Kuna P, et al. Efficacy and Safety of Bilastine 20 Mg Compared With Cetirizine 10 Mg and Placebo for the Symptomatic Treatment of Seasonal Allergic Rhinitis: a Randomized, Double-blind, Parallel-group Study. Clin Exp Allergy. 2009;39(9):1338-47. PubMed PMID: 19438584.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. AU - Kuna,P, AU - Bachert,C, AU - Nowacki,Z, AU - van Cauwenberge,P, AU - Agache,I, AU - Fouquert,L, AU - Roger,A, AU - Sologuren,A, AU - Valiente,R, AU - ,, Y1 - 2009/05/04/ PY - 2009/5/15/entrez PY - 2009/5/15/pubmed PY - 2009/11/18/medline SP - 1338 EP - 47 JF - Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology JO - Clin Exp Allergy VL - 39 IS - 9 N2 - BACKGROUND: Bilastine is a new non-sedative H(1) receptor antagonist, indicated for the treatment of allergic rhinitis (AR) (seasonal and perennial). OBJECTIVE: To assess and compare the efficacy and safety of bilastine 20 mg vs. cetirizine 10 mg and placebo in relieving the symptoms of seasonal allergic rhinitis (SAR). METHODS: Overall, 683 SAR patients, aged 12-70 years, were randomized to a double-blind treatment with bilastine 20 mg, cetirizine 10 mg or placebo, once daily for 14 days, in 61 centres across Europe. Patients recorded reflective (over the past 12 h) and instantaneous nasal (obstruction, rhinorrhoea, itching and sneezing) and non-nasal (ocular tearing, redness and itching) symptom scores (NSS and NNSS, respectively) twice daily, according to a pre-determined severity scale to provide reflective and instantaneous total symptom scores (TSS). The primary efficacy measure was the area under curve (AUC) of reflective TSS over 14 days of treatment (TSS-AUC(0-14 days)). Secondary efficacy measures included mean change from baseline in TSS, NSS and NNSS; discomfort caused by AR; and investigator's clinical global impression of the treatment. Safety was assessed according to adverse events (AEs), laboratory tests and electrocardiograms. RESULTS: The mean TSS-AUC(0-14 days) (score x day) was reduced in bilastine- and cetirizine-treated groups to a similar and significantly greater extent, compared with placebo (76.5, 72.3 and 100.6, respectively; P<0.001). Similarly, bilastine and cetirizine were comparable and significantly superior to placebo for all secondary outcomes. While all treatments were well tolerated and the AE profiles of bilastine and placebo were similar, significantly fewer patients in the bilastine-treated group experienced somnolence (1.8%; P<0.001) and fatigue (0.4%; P=0.02) than patients in the cetirizine-treated group (7.5% and 4.8%, respectively). CONCLUSIONS: Bilastine 20 mg once daily was significantly superior to placebo and comparable to cetirizine 10 mg in relieving symptoms of SAR, although it demonstrated a significantly better AE profile than cetirizine. SN - 1365-2222 UR - https://www.unboundmedicine.com/medline/citation/19438584/Efficacy_and_safety_of_bilastine_20_mg_compared_with_cetirizine_10_mg_and_placebo_for_the_symptomatic_treatment_of_seasonal_allergic_rhinitis:_a_randomized_double_blind_parallel_group_study_ DB - PRIME DP - Unbound Medicine ER -