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

Summary Background Bilastine is a new non‐sedative H1 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...

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Veröffentlicht in:Clinical and experimental allergy 2009-09, Vol.39 (9), p.1338-1347
Hauptverfasser: Kuna, P., Bachert, C., Nowacki, Z., Van Cauwenberge, P., Agache, I., Fouquert, L., Roger, A., Sologuren, A., Valiente, R.
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container_end_page 1347
container_issue 9
container_start_page 1338
container_title Clinical and experimental allergy
container_volume 39
creator Kuna, P.
Bachert, C.
Nowacki, Z.
Van Cauwenberge, P.
Agache, I.
Fouquert, L.
Roger, A.
Sologuren, A.
Valiente, R.
description Summary Background Bilastine is a new non‐sedative H1 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‐AUC0−14 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‐AUC0−14 days (score × 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
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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‐AUC0−14 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‐AUC0−14 days (score × 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&lt;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&lt;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.</description><identifier>ISSN: 0954-7894</identifier><identifier>EISSN: 1365-2222</identifier><identifier>DOI: 10.1111/j.1365-2222.2009.03257.x</identifier><identifier>PMID: 19438584</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Benzimidazoles - administration &amp; dosage ; Benzimidazoles - adverse effects ; bilastine ; Biological and medical sciences ; cetirizine ; Cetirizine - administration &amp; dosage ; Cetirizine - adverse effects ; Child ; Double-Blind Method ; Female ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; H1 antihistamine ; Histamine H1 Antagonists, Non-Sedating - administration &amp; dosage ; Histamine H1 Antagonists, Non-Sedating - adverse effects ; Humans ; Male ; Medical sciences ; Middle Aged ; nasal symptoms score ; Non tumoral diseases ; non-nasal symptoms score ; Otorhinolaryngology. Stomatology ; Piperidines - administration &amp; dosage ; Piperidines - adverse effects ; Receptors, Histamine H1 - metabolism ; Rhinitis, Allergic, Seasonal - drug therapy ; Rhinitis, Allergic, Seasonal - metabolism ; seasonal allergic rhinitis ; Time Factors ; total symptom score ; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology</subject><ispartof>Clinical and experimental allergy, 2009-09, Vol.39 (9), p.1338-1347</ispartof><rights>2009 Blackwell Publishing Ltd</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4667-3ab0cd1e3b85e0ac094791b84792ab621fe93f6df0484c14c8d2a30da424cbc83</citedby><cites>FETCH-LOGICAL-c4667-3ab0cd1e3b85e0ac094791b84792ab621fe93f6df0484c14c8d2a30da424cbc83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2222.2009.03257.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2222.2009.03257.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,27926,27927,45576,45577</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=21816161$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19438584$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kuna, P.</creatorcontrib><creatorcontrib>Bachert, C.</creatorcontrib><creatorcontrib>Nowacki, Z.</creatorcontrib><creatorcontrib>Van Cauwenberge, P.</creatorcontrib><creatorcontrib>Agache, I.</creatorcontrib><creatorcontrib>Fouquert, L.</creatorcontrib><creatorcontrib>Roger, A.</creatorcontrib><creatorcontrib>Sologuren, A.</creatorcontrib><creatorcontrib>Valiente, R.</creatorcontrib><creatorcontrib>Bilastine International Working Group</creatorcontrib><creatorcontrib>The Bilastine International Working Group</creatorcontrib><title>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</title><title>Clinical and experimental allergy</title><addtitle>Clin Exp Allergy</addtitle><description>Summary Background Bilastine is a new non‐sedative H1 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‐AUC0−14 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‐AUC0−14 days (score × 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&lt;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&lt;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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Benzimidazoles - administration &amp; dosage</subject><subject>Benzimidazoles - adverse effects</subject><subject>bilastine</subject><subject>Biological and medical sciences</subject><subject>cetirizine</subject><subject>Cetirizine - administration &amp; dosage</subject><subject>Cetirizine - adverse effects</subject><subject>Child</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Fundamental immunology</subject><subject>H1 antihistamine</subject><subject>Histamine H1 Antagonists, Non-Sedating - administration &amp; dosage</subject><subject>Histamine H1 Antagonists, Non-Sedating - adverse effects</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>nasal symptoms score</subject><subject>Non tumoral diseases</subject><subject>non-nasal symptoms score</subject><subject>Otorhinolaryngology. Stomatology</subject><subject>Piperidines - administration &amp; dosage</subject><subject>Piperidines - adverse effects</subject><subject>Receptors, Histamine H1 - metabolism</subject><subject>Rhinitis, Allergic, Seasonal - drug therapy</subject><subject>Rhinitis, Allergic, Seasonal - metabolism</subject><subject>seasonal allergic rhinitis</subject><subject>Time Factors</subject><subject>total symptom score</subject><subject>Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology</subject><issn>0954-7894</issn><issn>1365-2222</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkd-K1DAUxoso7rj6CpIbvbKzSdO_ghfLMO4uLAqirHfhND2dyZg2NUnZ6V4JPppv4pOYOsN46wnkD_l9Xw75oogwumShLnZLxvMsTkItE0qrJeVJViz3j6LF6eJxtKBVlsZFWaVn0TPndpRSnlXl0-iMVSkvszJdRL_WbaskyIlA3xAHLfqJmJbUSoPzqkeS0N8_fnYbIk03gMWG3Cu_JRK9suphBtgRmA0GDRJrQ1pjid8icVM3eNOBV5J4i-A77P3s7xCc6UET0BrtJlzbreqVV-4tAWKDl-nUAzZvSGPGWmNca9WHU2hhVuh4Y804EOfHZnoePWlBO3xxXM-jL-_Xn1fX8e3Hq5vV5W0s0zwvYg41lQ1DXpcZUpC0SouK1WWYE6jzhLVY8TZvWpqWqWSpLJsEOG0gTVJZy5KfR68PvoM130d0XnTKSdQaejSjEwktaBLgAJYHUFrjnMVWDFZ1YCfBqJgDFDsx5yTmnMQcoPgboNgH6cvjG2PdYfNPeEwsAK-OADgJug1fJZU7cQkrWR5G4N4duHulcfrvBsRqfTnvgj4-6JXzuD_pwX4TecGLTNx9uBJfC86ui08rccf_AKNayx8</recordid><startdate>200909</startdate><enddate>200909</enddate><creator>Kuna, P.</creator><creator>Bachert, C.</creator><creator>Nowacki, Z.</creator><creator>Van Cauwenberge, P.</creator><creator>Agache, I.</creator><creator>Fouquert, L.</creator><creator>Roger, A.</creator><creator>Sologuren, A.</creator><creator>Valiente, R.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>200909</creationdate><title>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</title><author>Kuna, P. ; Bachert, C. ; Nowacki, Z. ; Van Cauwenberge, P. ; Agache, I. ; Fouquert, L. ; Roger, A. ; Sologuren, A. ; Valiente, R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4667-3ab0cd1e3b85e0ac094791b84792ab621fe93f6df0484c14c8d2a30da424cbc83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Benzimidazoles - administration &amp; dosage</topic><topic>Benzimidazoles - adverse effects</topic><topic>bilastine</topic><topic>Biological and medical sciences</topic><topic>cetirizine</topic><topic>Cetirizine - administration &amp; dosage</topic><topic>Cetirizine - adverse effects</topic><topic>Child</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Fundamental immunology</topic><topic>H1 antihistamine</topic><topic>Histamine H1 Antagonists, Non-Sedating - administration &amp; dosage</topic><topic>Histamine H1 Antagonists, Non-Sedating - adverse effects</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>nasal symptoms score</topic><topic>Non tumoral diseases</topic><topic>non-nasal symptoms score</topic><topic>Otorhinolaryngology. Stomatology</topic><topic>Piperidines - administration &amp; dosage</topic><topic>Piperidines - adverse effects</topic><topic>Receptors, Histamine H1 - metabolism</topic><topic>Rhinitis, Allergic, Seasonal - drug therapy</topic><topic>Rhinitis, Allergic, Seasonal - metabolism</topic><topic>seasonal allergic rhinitis</topic><topic>Time Factors</topic><topic>total symptom score</topic><topic>Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kuna, P.</creatorcontrib><creatorcontrib>Bachert, C.</creatorcontrib><creatorcontrib>Nowacki, Z.</creatorcontrib><creatorcontrib>Van Cauwenberge, P.</creatorcontrib><creatorcontrib>Agache, I.</creatorcontrib><creatorcontrib>Fouquert, L.</creatorcontrib><creatorcontrib>Roger, A.</creatorcontrib><creatorcontrib>Sologuren, A.</creatorcontrib><creatorcontrib>Valiente, R.</creatorcontrib><creatorcontrib>Bilastine International Working Group</creatorcontrib><creatorcontrib>The Bilastine International Working Group</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Clinical and experimental allergy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kuna, P.</au><au>Bachert, C.</au><au>Nowacki, Z.</au><au>Van Cauwenberge, P.</au><au>Agache, I.</au><au>Fouquert, L.</au><au>Roger, A.</au><au>Sologuren, A.</au><au>Valiente, R.</au><aucorp>Bilastine International Working Group</aucorp><aucorp>The Bilastine International Working Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Clinical and experimental allergy</jtitle><addtitle>Clin Exp Allergy</addtitle><date>2009-09</date><risdate>2009</risdate><volume>39</volume><issue>9</issue><spage>1338</spage><epage>1347</epage><pages>1338-1347</pages><issn>0954-7894</issn><eissn>1365-2222</eissn><abstract>Summary Background Bilastine is a new non‐sedative H1 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‐AUC0−14 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‐AUC0−14 days (score × 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&lt;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&lt;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.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>19438584</pmid><doi>10.1111/j.1365-2222.2009.03257.x</doi><tpages>10</tpages></addata></record>
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subjects Adolescent
Adult
Aged
Benzimidazoles - administration & dosage
Benzimidazoles - adverse effects
bilastine
Biological and medical sciences
cetirizine
Cetirizine - administration & dosage
Cetirizine - adverse effects
Child
Double-Blind Method
Female
Fundamental and applied biological sciences. Psychology
Fundamental immunology
H1 antihistamine
Histamine H1 Antagonists, Non-Sedating - administration & dosage
Histamine H1 Antagonists, Non-Sedating - adverse effects
Humans
Male
Medical sciences
Middle Aged
nasal symptoms score
Non tumoral diseases
non-nasal symptoms score
Otorhinolaryngology. Stomatology
Piperidines - administration & dosage
Piperidines - adverse effects
Receptors, Histamine H1 - metabolism
Rhinitis, Allergic, Seasonal - drug therapy
Rhinitis, Allergic, Seasonal - metabolism
seasonal allergic rhinitis
Time Factors
total symptom score
Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology
title 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
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