Bilastine for seasonal allergic rhinitis: a systematic review
Abstract
OBJECTIVE
Bilastine is a second-generation oral H1-antihistamine that has therapeutic value in patients with seasonal allergic rhinitis. It shows efficacy and safety for the reduction of symptoms of seasonal allergic rhinitis. Nevertheless, no systematic review compares the efficacy and safety of bilastine and other second-generation oral H1-antihistamines for the reduction of symptoms of seasonal allergic rhinitis.
METHODS
We conducted a retrospective cohort study using medical records of outpatients with the diagnosis of TB/HIV co- infection in Khon Kaen Hospital, Thailand between January 2007 and August 2017. We included the patients who started tuberculosis treatment and various times of starting ART with CD4 count less than 350 cells/mm3. We separated patients into 3 groups by the time of initiated ART starting within the first 4 weeks, 5 to 8 weeks, and 9 to12 weeks after starting tuberculosis treatment. We compared the risk of all-cause mortality within 1 year after start tuberculosis treatment among three groups as our primary outcome. Our secondary outcomes were sputum conversion at 2 months after starting tuberculosis treatment and rate of CD4 count increasing in 1 year after tuberculosis treatment.
RESULTS
Two RCTs were included in the meta-analysis with 1401 patients with seasonal allergic rhinitis; bilastine (n=460), other second-generation oral H1-antihistamines (n=470), and placebo (n=471). It showed that no statistically significant difference among bilastine and other second-generation oral H1-antihistamines regarding the change from baseline in TSS-AUC of 0-14 days for the intention-to-treat (ITT) population (mean difference (MD), 2.69; 95% confidence interval (CI), -2.94 to 8.22; I2=0%). It showed the change from baseline in TSS-AUC of 0-14 days for ITT population was a significantly greater reduction in those using bilastine than those using placebo (MD, -17.73; 95% CI, -30.46 to -5.00; I2=78%). Adverse events (AEs) reported over 2 weeks, bilastine had no statistically significant difference compared with other second-generation oral H1-antihistamines and placebo for incidence 2% or more AEs in any treatment group including headache,somnolence and fatigue (relative risk (RR), 1.11; 95% CI, 0.76 to 1.62; I2=0%, RR, 0.51; 95% CI, 0.12 to 2.20; I2=77%, RR, 0.48; 95% CI, 0.02 to 11.50; I2=85%), drug-related AEs (RR, 0.78; 95% CI, 0.45 to 1.37; I2 =78%) and withdrawals due to AEs (RR, 0.98; 95% CI, 0.14 to 6.64; I2=0%) but patients reporting 1 or more AE were found significantly lower in those using bilastine (RR, 0.77; 95% CI, 0.62 to 0.98; I2 =26%) and bilastine had no statistically significant difference compared with placebo for incidence 2% or more AEs in any treatment group including headache,somnolence and fatigue (RR, 0.91; 95% CI, 0.64 to 1.31; I2=0%; RR, 1.02; 95% CI, 0.48 to 2.18; I2=0%; RR, 0.47; 95% CI, 0.07 to 3.38; I2=65%), drug-related AEs (RR, 0.90; 95% CI, 0.64 to 1.26; I2 =34%) and withdrawals due to AEs (RR, 0.26; 95% CI, 0.06 to 1.23; I2=0%) but patients reporting 1 or more AE were found significantly lower in those using bilastine (RR, 0.97; 95% CI, 0.72 to 1.29; I2 =47%).
CONCLUSION
Our systematic review showed that the efficacy of bilastine and other second-generation oral H1- antihistamines in the reduction of symptoms of seasonal allergic rhinitis was similar in patients with seasonal allergic rhinitis and secondary outcome including incidence 2% or more AEs in any treatment group, drug-related AEs, and withdrawals due to AEs were similar in those using other second-generation oral H1-antihistamines but patients reporting 1 or more AEs were found significantly lower in those using bilastine of admission. Due to the limitation of the standard protocol for PAD treatment practice, for further studies, the practical application of the standard protocol for PAD treatment should be strongly reinforced. Also, the association between the adverse effects and type, dosage, and duration of the agents should be observed. the all-cause mortality within 90 days of admission as shown in Table 3.
SUBGROUP ANALYSIS
The patients were recategorized into three groups; confirmed PTB, probable PTB, and possible PTB, we found that the agents were not significantly associated with the all-cause mortality within 90 days of admission (AHR, 0.73; 95% CI, 0.10 to 5.43) (AHR, 1.08; 95%CI, 0.79 to 1.48) (AHR, 0.80; 95% CI, 0.44 to 1.46) (Table 4). Then, we analyzed the association between each type of the agents and the outcomes; all- cause mortality within 90 days on admission, cardiac arrest, and shock. We found that there were no significant differences for all of the outcomes regarding each type of agents (Figure 3).
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