2018
DOI: 10.2500/aap.2018.39.4136
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Open-label safety assessment of bilastine in elderly patients with allergic rhinoconjunctivitis and/or urticaria

Abstract: Bilastine 20 mg showed a favorable safety profile with a low incidence of TEAEs in patients aged ≥65 years. The results were in accordance with the known safety profile of bilastine 20 mg and incidence of AEs reported in previous studies and described in the approved summary of product characteristics.

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Cited by 14 publications
(12 citation statements)
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“…Overall, this study showed that bilastine 20 mg once daily had a favourable safety profile, with a low incidence of TEAEs, in elderly patients with allergic rhinoconjunctivitis and/or urticaria. Moreover, the safety profile in elderly patients was not different from that in placebocontrolled clinical trials in which adverse event rates reported for bilastine were similar to those for placebo 75 .…”
Section: Elderly Patientsmentioning
confidence: 69%
See 1 more Smart Citation
“…Overall, this study showed that bilastine 20 mg once daily had a favourable safety profile, with a low incidence of TEAEs, in elderly patients with allergic rhinoconjunctivitis and/or urticaria. Moreover, the safety profile in elderly patients was not different from that in placebocontrolled clinical trials in which adverse event rates reported for bilastine were similar to those for placebo 75 .…”
Section: Elderly Patientsmentioning
confidence: 69%
“…In clinical trials performed as part of the European development programme for bilastine, only 69 patients were aged 65 years, of whom 34 received bilastine 75 . Consequently, a prospective observational study in a real-world practice setting was undertaken to evaluate the safety profile in 146 patients aged 65 years with allergic rhinoconjunctivitis and/or urticaria who were prescribed bilastine 20 mg once daily and followed up for 3 months 75 . The mean ± SD age of participants was 74.8 ± 6.6 years; 74% had allergic rhinoconjunctivitis, 19% had urticaria and 7% had both disorders.…”
Section: Elderly Patientsmentioning
confidence: 99%
“…18,26,48 In a prospective study, bilastine 20 mg was well tolerated by patients with 65 years or more age. 49 No environmental concerns exist from bilastine use in patients with urticaria. 19…”
Section: Tolerability and Adverse Events With Bilastinementioning
confidence: 99%
“…In the wheal and flare test on healthy volunteers, bilastine onset of action occurred within 1 h and reduction of itching sensation was better than that of desloratadine (p < 0.05) and for rupatadine (p < 0.01) [16 ]. No dosage adjustments are needed in patients with mild, moderate, or severe renal impairment, with hepatic impairment, and in elderly subjects, overall endorsing a good tolerability profile [17, 18 ]. Bilastine has a high affinity for the P‐gP efflux pump, and this effect restricts transit across the blood–brain barrier and limits the potential for sedation [14, 15 ].…”
Section: Main Textmentioning
confidence: 99%