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Table 4 Summary of the studies investigating the efficacy of fexofenadine HCl in pediatric and adult populations

From: Insights into urticaria in pediatric and adult populations and its management with fexofenadine hydrochloride

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
  1. BID twice daily, DLQI Dermatology Life Quality Index, SE standard error, QD once daily, QoL quality of life, TSS total symptom scores
  2. a ≥ 12 years old