Efficacy and safety profile of fexofenadine HCL

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Presentation transcript:

Efficacy and safety profile of fexofenadine HCL Suzanne G Meeves, PharmD, MBA, Sireesh Appajosyula, PharmD Journal of Allergy and Clinical Immunology Volume 112, Issue 4, Pages S69-S77 (October 2003) DOI: 10.1016/S0091-6749(03)01879-7

FIG 1 Fexofenadine HCl 120 mg once a day vs loratadine 10 mg once a day: 24-hour reflective individual symptom scores. P values indicate active drug vs placebo. ns, Not significant. ∗P ≤ .05; †P ≤ .01; ‡P ≤ .005; §P < .001; ∥P ≤ .0001. Fexofenadine vs loratadine ¶P ≤ .05. Reproduced with permission from Blackwell Publishing. van Cauwenberge et al. Clin Exp Allergy 2000;30:891-9.10 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)

FIG 2 Fexofenadine HCl 180 mg once a day: 12-hour reflective nasal congestion symptom scores. ∗P = .021; †P = .0004. Reproduced with permission from Meeves et al. Abstract presented at AAAAI annual meeting, 2000.15 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)

FIG 3 Fexofenadine HCl 120 mg once a day vs loratadine 10 mg once a day: Overall RQLQ scores. ∗P < .005 vs placebo; †P ≤ .03 fexofenadine vs loratadine; ‡Baseline score, ∼3.0. Reproduced with permission from Blackwell Publishing. van Cauwenberge et al. Clin Exp Allergy 2000;30:891-9.10 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)

FIG 4 Fexofenadine HCl 120 mg once a day vs cetirizine 10 mg once a day: Incidence of drowsiness and fatigue. ∗P = .018 cetirizine vs fexofenadine. Produced with permission from Mosby, Inc. Data from Howarth et al. J Allergy Clin Immunol 1999;104:927-33.11 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)

FIG 5 11C-doxepin binding to H1-receptors in the living human brain: Effects of fexofenadine and cetirizine. Brain images demonstrating differences in central H1-receptor binding with fexofenadine (FEX) and cetirizine (CET). Fexofenadine binding is equivalent to that of placebo, as demonstrated by the similar amount of 11C-doxepin binding (visualized as white areas on the scans). Cetirizine, however, has blocked 11C-doxepin binding, as demonstrated by the “dimming” of the white areas compared with placebo in both the transaxial (top) and sagittal (bottom) slices. Reprinted with permission from Elsevier. Tashiro M, Mochizuki H, Iwabuchi K, et al. Roles of histamine in regulation of arousal and cognition: functional neuroimaging of histamine H1 receptors in human brain. Life Sciences 2002;72:409-14.24 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)

FIG 6 Fexofenadine driving performance study: Change in SDLP. Day 1 of treatment. SDLP, Standard deviation of lateral position (a measure of “weaving”). ∗P = .0006 vs placebo. Adapted with permission from Mosby. J Allergy Clin Immunol 1998;101:306-11.28 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)

FIG 7 Fexofenadine driving performance study: Primary efficacy measure—coherence.∗ ∗Correlation between the speed and following distance from the lead vehicle. BAC, Blood alcohol concentration. †Not significant vs placebo; ‡P < .05 vs placebo. Data from Weiler et al. Ann Intern Med 2000;132:354-63.29 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)

FIG 8 Fexofenadine driving performance study: Drowsiness. ‡Baseline, ∼40 for each treatment; §Before driving, ∼2.5 hours after fexofenadine, diphenhydramine, or placebo; ∼1 hour after alcohol. Confidence limits before drive: ∗5 to 27 points vs placebo; †5 to 27 points vs fexofenadine. Confidence limits after drive: ∗15 to 41 points vs placebo; †9 to 35 points vs fexofenadine. Reprinted with permission from Mosby/Elsevier. Weiler et al. Ann Intern Med 2000;132:354-63.29 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)

Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10 Journal of Allergy and Clinical Immunology 2003 112, S69-S77DOI: (10.1016/S0091-6749(03)01879-7)