Table 4 Summary of the studies investigating the efficacy of fexofenadine HCl in pediatric and adult populations
Study | Treatment and dosage | Patient population, N | Fexofenadine HCl outcomes |
|---|---|---|---|
Maciel-Guerra et al. 2018 [65] | Dexchlorpheniramine 2 mg, hydroxyzine 25 mg, levocetirizine 5 mg, fexofenadine HCl 180 mg, cetirizine 10 mg, loratadine 10 mg, ebastine 10 mg, desloratadine 5 mg, epinastine 20 mg, rupatadine 10 mg | Adults (healthy), N = 10 | • All antihistamines suppressed wheal (p < 0.02) and flares, except for rupatadine (p = 0.70) in histamine test |
Meltzer et al. 2007 [66] | Fexofenadine HCl, 180 mg, desloratadine, 5 mg or placebo | Adolescents a and adults (healthy), N = 54 | • Fexofenadine HCl was significantly superior to desloratadine in the suppression of wheal (at 2–6 h, p ≤ 0.005) in histamine test. Fexofenadine was also superior to in suppression of flares 3 h (83% vs 18%, respectively), 4 h (79% vs 3%, respectively), 5 h (75% vs 27%, respectively) and 6 h (85% vs 36%, respectively) post-treatment (p < 0.05) in histamine test |
Tanizaki et al. 2012 [67] | Bepotastine besilate 10 mg; fexofenadine HCl 60 mg; or placebo | Adults (healthy), N = 10 | • Fexofenadine HCl suppressed wheal and flare 3 h after histamine test (p < 0.05), and itch within 30 min (p < 0.05) |
Purohit et al. 2004 [68] | Fexofenadine HCl, 180 mg; or cetirizine 10 mg | Adults (healthy), N = 42 | • Frequency of 95% or greater wheal inhibition occurred with fexofenadine at 1.5–2.5 h compared with 3–4 h with cetirizine, but this difference was not statistically significant |
Paul et al. 1998 [69] | Fexofenadine HCl 60, 120, 180, 240 mg QD; or placebo | Adults (urticaria), N = 222 | • Significant reduction of mean daily TSS in the combined fexofenadine HCl group compared with placebo (73–81% vs 54%, respectively, p = 0.0019) • The response was dose-dependent (p = 0.001) |
Fouad et al. 2017[71] | Fexofenadine HCl (details not available) | Adults (urticaria), N = 498 | • At the end of the study 74.9% and 81.1% of patients had pruritus and hives cured, respectively (p < 0.001, both) |
Kaplan et al. 2005 [70] | Fexofenadine HCl, 180 mg QD; or placebo | Adolescents a and adults (urticaria), N = 255 | • Reduction of mean daily wheal score (fexofenadine HCl, − 0.78; placebo, − 0.40) and mean daily pruritus score (fexofenadine HCl, − 1.04; placebo, − 0.57); p < 0.001 both |
Nelson et al. 2000 [75] | Fexofenadine HCl 20, 60, 120, 240 mg BID; or placebo | Adolescents a and adults (urticaria), N = 418 | • Mean (SE) change in pruritus score at week 4 was: − 0.68 (0.10); − 1.12 (0.09); − 0.87 (0.10); − 1.15 (0.10) for fexofenadine HCl 20, 60, 120 and 240 mg, respectively (p = 0.0019) • All doses were superior in reducing interference with sleep (p ≤ 0.0011) and daily activities than placebo (p ≤ 0.0014) |
Finn et al. 1999 [76] | Fexofenadine HCl 20, 60, 120, or 240 mg BID; or placebo | Adults (urticaria), N = 439 | • Mean (SE) change in pruritus score at week 4 was: − 1.17 (0.08); − 1.15(0.08); − 1.13(0.08); − 1.29(0.08) for fexofenadine HCl 20, 60, 120 and 240 mg, respectively (p = 0.0001) • All doses reduced the mean number of wheals score compared with placebo (p ≤ 0.0238); improvement was dose-related (p = 0.0001) |
Thompson et al. 2000 [73] | Fexofenadine HCl 60 mg BID; placebo | Adolescents a and adults (urticaria), N = 325 | • Fexofenadine improved DLQI score from baseline compared with placebo (10.0−10.6 vs 11.0–12.1, respectively; p ≤ 0.0002) • Improved overall productivity at work (9.5–7.0% higher than placebo; p ≤ 0.152), in the classroom productivity (not significant), and in regular activities (10.2–10.0% higher than placebo; p ≤ 0.0002) |
Spector et al. 2007 [74] | Fexofenadine HCl 180 mg QD, or placebo | Adults (urticaria), N = 254 | • Improvements in mean total DLQI score (p = 0.0219) compared with placebo • Less impairment in work productivity, overall work, and activity |