Table 1.

Summary of efficacy and safety of fexofenadine from various clinical studies

Reference	Study population	Treatment arm	Efficacy data	Safety data
Howarth PH et al. 199949	Seasonal AR	Fexofenadine HCl 120 mg QD; n = 211 Fexofenadine HCl 180 mg QD; n = 202 Cetirizine 10 mg QD; n = 207 Placebo; n = 201	•The total symptom score was considerably reduced by all active treatments as compared to placebo (p ≤ 0.0001) •In the placebo, fexofenadine 120 mg, fexofenadine 180 mg, and cetirizine 10 mg groups, the mean reduction was −1.9, −3.0, −3.3, and −3.3, respectively •No differences were observed in efficacy between the 2 doses of fexofenadine and cetirizine	•There were no major side effects •Cetirizine showed a greater incidence of drowsiness or fatigue (9%) compared with placebo (4%) (P = 0.07) or fexofenadine (4%) (P = 0.02)
Ellis AK et al. 202151	Seasonal AR	Fexofenadine HCl 180 mg; n = 126 Placebo; n = 125	•Least squares mean difference (95% CI) for Log AUC2−12 of the total nasal symptom score between fexofenadine versus placebo was −0.24 (−0.425 to −0.047; p = 0.0148) •A single dose of fexofenadine 180 mg significantly decreased the symptoms compared with placebo •Seasonal AR symptoms induced by ragweed were aggravated by diesel exhaust particles	•The proportion of patients reporting a TEAE was higher in the placebo group (15.1%), compared with the fexofenadine group (12.6%)
Casale TB et al. 199952	Seasonal AR	Fexofenadine HCl 120 mg QD; n = 287 Fexofenadine 180 mg QD; n = 282 Placebo; n = 292	•Compared to placebo, both fexofenadine doses significantly reduced total symptom score from the baseline over the 2-week treatment period (p = 0.05 and p ≤ 0.002)	•The frequency of reported adverse events was similar between fexofenadine (30.2%) and placebo groups (30.0%)
Nathan RA et al. 199953	Healthy volunteers	6-month study Fexofenadine 60 mg BID; n = 217 Placebo; n = 211 12-month study Fexofenadine 240 mg QD; n = 234 Placebo; n = 235	NA (Safety studies)	•In the 6-month and 12-month studies, one or more adverse events were reported in 74.2% and 92.8% of the fexofenadine group and 79.6% and 87.6% of the placebo group, respectively. •No statistically significant difference in the frequency of adverse events were reported between fexofenadine and placebo

AR, allergic rhinitis; AUC_2-12, area under the curve from baseline to 12h; BID, twice daily; CI, confidence interval; HCl, hydrochloride; n, number of subjects; NA,: not applicable; QD, once a day; TEAE, treatment-emergent adverse event.