PMID- 19438584 OWN - NLM STAT- MEDLINE DCOM- 20091117 LR - 20131121 IS - 1365-2222 (Electronic) IS - 0954-7894 (Linking) VI - 39 IP - 9 DP - 2009 Sep TI - 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. PG - 1338-47 LID - 10.1111/j.1365-2222.2009.03257.x [doi] AB - 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. FAU - Kuna, P AU - Kuna P AD - Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Lodz, Poland. pkuna@barlicki.internetdsl.pl FAU - Bachert, C AU - Bachert C FAU - Nowacki, Z AU - Nowacki Z FAU - van Cauwenberge, P AU - van Cauwenberge P FAU - Agache, I AU - Agache I FAU - Fouquert, L AU - Fouquert L FAU - Roger, A AU - Roger A FAU - Sologuren, A AU - Sologuren A FAU - Valiente, R AU - Valiente R CN - Bilastine International Working Group LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20090504 PL - England TA - Clin Exp Allergy JT - Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology JID - 8906443 RN - 0 (Benzimidazoles) RN - 0 (Histamine H1 Antagonists, Non-Sedating) RN - 0 (Piperidines) RN - 0 (Receptors, Histamine H1) RN - PA1123N395 (bilastine) RN - YO7261ME24 (Cetirizine) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Benzimidazoles/*administration & dosage/adverse effects MH - Cetirizine/*administration & dosage/adverse effects MH - Child MH - Double-Blind Method MH - Female MH - Histamine H1 Antagonists, Non-Sedating/*administration & dosage/adverse effects MH - Humans MH - Male MH - Middle Aged MH - Piperidines/*administration & dosage/adverse effects MH - Receptors, Histamine H1/metabolism MH - Rhinitis, Allergic, Seasonal/*drug therapy/metabolism MH - Time Factors FIR - Clement, Peter IR - Clement P FIR - van Dist, Veerle IR - van Dist V FIR - Van Hoecke, Helen IR - Van Hoecke H FIR - Schmelzer, Albert A IR - Schmelzer AA FIR - Vandenbulcke, Lisbet IR - Vandenbulcke L FIR - Vidts, Godelieve IR - Vidts G FIR - Vlaminck, Stephan IR - Vlaminck S FIR - Spicakova, Marie IR - Spicakova M FIR - Fousek, Petr IR - Fousek P FIR - Hojka, Ivo IR - Hojka I FIR - Kolouchova, Elena IR - Kolouchova E FIR - Medonosova, Hana IR - Medonosova H FIR - Paukova, Hana IR - Paukova H FIR - Stenclova, Hana IR - Stenclova H FIR - Struplova, Vlastimila IR - Struplova V FIR - Svobodova, Liliana IR - Svobodova L FIR - Trnkova, Barbara IR - Trnkova B FIR - Agell-Perello, Montserrat IR - Agell-Perello M FIR - Bugnas, Bernard IR - Bugnas B FIR - Haddad, Ghassan IR - Haddad G FIR - Huet, Sylvie IR - Huet S FIR - Lebeaupin, Bruno IR - Lebeaupin B FIR - Le Sellin, James IR - Le Sellin J FIR - Ortolan, Dominique IR - Ortolan D FIR - Pigearias, Bernard IR - Pigearias B FIR - Sanquer, Francoise IR - Sanquer F FIR - Adolph, Jutta IR - Adolph J FIR - Botzen, Ulrich IR - Botzen U FIR - Decot, Elke IR - Decot E FIR - Jecker, Peter IR - Jecker P FIR - Nguyen, Thi Phuong Trinh IR - Nguyen TP FIR - Pasch, Nobert IR - Pasch N FIR - Ramoser, Horst IR - Ramoser H FIR - Reinhardt, Jorg IR - Reinhardt J FIR - Adamek-Guzik, Teresa IR - Adamek-Guzik T FIR - Guzik, Tomasz IR - Guzik T FIR - Iwko, Jacek IR - Iwko J FIR - Janiak, Radoslaw IR - Janiak R FIR - Kowalski, Marek IR - Kowalski M FIR - Malolepszy, Jozef IR - Malolepszy J FIR - Czerwinsk, Grazyna Mysik IR - Czerwinsk GM FIR - Nalepa, Piotr IR - Nalepa P FIR - Nowakowski, Marek IR - Nowakowski M FIR - Pavor, Adam IR - Pavor A FIR - Panaszek, Bernard IR - Panaszek B FIR - Skucha, Wojciech IR - Skucha W FIR - Agachi, Luminita IR - Agachi L FIR - Berghea, Elena C IR - Berghea EC FIR - Bumbacea, Roxana S IR - Bumbacea RS FIR - Burlan, Leonarda IR - Burlan L FIR - Carbune, Lucia IR - Carbune L FIR - Duca, Liliana IR - Duca L FIR - Gheonea, Cristian IR - Gheonea C FIR - Iacob, Irina IR - Iacob I FIR - Iacomi, Adriana IR - Iacomi A FIR - Iamandescu, Ioan B IR - Iamandescu IB FIR - Lungu, Marcel C IR - Lungu MC FIR - Neagoe, Daniela IR - Neagoe D FIR - Nechifor, Claudia E IR - Nechifor CE FIR - Negrila, Mihaela IR - Negrila M FIR - Samuila, Silvia IR - Samuila S FIR - Popa-Velea, Ovidiu IR - Popa-Velea O FIR - Voiculescu, Mihaela IR - Voiculescu M FIR - Almero, Ramon IR - Almero R FIR - Aragon, Rafael IR - Aragon R FIR - Armasen, Margarita IR - Armasen M FIR - Audicana, Teresa IR - Audicana T FIR - Basomba, Antonio IR - Basomba A FIR - Campos, Angel IR - Campos A FIR - Carretero, Pedro IR - Carretero P FIR - Dordal, M Teresa IR - Dordal MT FIR - Echenagusia, Miguel A IR - Echenagusia MA FIR - Fernandez, Eduardo IR - Fernandez E FIR - Garcia, Fernando IR - Garcia F FIR - Garcia, Inmaculada IR - Garcia I FIR - Gastaminza, Gabriel IR - Gastaminza G FIR - Hernandez, Elena IR - Hernandez E FIR - Juste, Sonsoles IR - Juste S FIR - Madero, Mauro IR - Madero M FIR - Mesa, Margarita IR - Mesa M FIR - Molina, Montserrat IR - Molina M FIR - Munoz, Daniel IR - Munoz D FIR - Perez, Reyes IR - Perez R FIR - Pinto, Ester IR - Pinto E FIR - Prados, Manuel IR - Prados M FIR - Reinares, Carmen IR - Reinares C FIR - Rivas, Pilar IR - Rivas P FIR - Rodriguez, Virginia IR - Rodriguez V FIR - Sastre, Joaquin IR - Sastre J FIR - Uriel, Olga IR - Uriel O FIR - Vidal, Carmen IR - Vidal C EDAT- 2009/05/15 09:00 MHDA- 2009/11/18 06:00 CRDT- 2009/05/15 09:00 PHST- 2009/05/15 09:00 [entrez] PHST- 2009/05/15 09:00 [pubmed] PHST- 2009/11/18 06:00 [medline] AID - CEA3257 [pii] AID - 10.1111/j.1365-2222.2009.03257.x [doi] PST - ppublish SO - Clin Exp Allergy. 2009 Sep;39(9):1338-47. doi: 10.1111/j.1365-2222.2009.03257.x. Epub 2009 May 4.