The efficacy and safety of fexofenadine allergic rhinitis Review article
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Published:
Dec 31, 2016
Keywords:
fexofenadine, allergic rhinitis, efficacy, safety
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Abstract
Antihistaminic therapy is essential for the prevention and management of various allergic disorders. Antihistaminic are a class of drugs commonly recommended as first-line treatment for allergic rhinitis due to their influence on relieving four main symptoms: rhinorrhea, itching, sneezing, and nasal obstruction. Fexofenadine is second-generation H1-antihistamines, which is devoid of anticholinergic, sedative and cardiotoxic effects. Fexofenadine exerts action by inhibition and stabilization of H1 receptor and also by H1-receptor independent anti-inflammatory actions, which plays a crucial role in late-phase allergic reactions. Multicenter clinical trials have shown that fexofenadine has the good safety profile, is well tolerated and highly effective in reducing allergic rhinitis symptoms, whether given alone or in combination.
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Wyleżoł, P., Solarska, M., & Postuła , M. (2016). The efficacy and safety of fexofenadine allergic rhinitis. Medycyna Faktow (J EBM), 9(4(33), 293-299. Retrieved from https://journalsmededu.pl/index.php/jebm/article/view/2201
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References
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9. European Allergy White Paper, UCB Institute of Allergy, 1997.
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11. Camelo-Nunes I.C.: New antihistamines: a critical review. J. Pediatr. 2006; 82: 173-180.
12. Tashiro M., Sakurada Y., Iwabuchi K. et al.: Central effects of fexofenadine and cetirizine: measurement of psychomotor performance, subjective sleepiness, and brain histamine H1-receptor occupancy using 11C-doxepin positron emission tomography. J. Clin. Pharmacol. 2004; 44: 890-900.
13. Weiler J.M., Bloomfield J.R., Woodworth G.G. et al.: Effects of fexofenadine, diphenhydramine, and alcohol on driving performance: a randomized, placebo-controlled trial in the Iowa driving simulator. Ann. Intern. Med. 2000; 132: 354-363.
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15. Layton D., Wilton L., Boshier A. et al.: Comparison of the risk of drowsiness and sedation between levocetirizine and desloratadine: a prescription- event monitoring study in England. Drug Saf. 2006; 29: 897-909.
16. Leurs R., Church M.K., Taglialatela M.: H1 antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin. Exp. Allergy 2002; 32: 489-498.
17. DaBuske L., Kowal K.: Update on prescription and over-the-counter histamine inverse agonists in rhinitis therapy. Curr. Allergy Asthma Rep. 2009; 9: 140-148.
18. Ciprandi G., Tosca M.A., Cosentino C. et al.: Effects of fexofenadine and other antihistamines on components of the allergic response: adhesion molecules. J. Allergy Clin. Immunol. 2003; 112: 78-82.
19. Triggiani M., Gentile M., Secondo A. et al.: Histamine induces exocytosis and IL-6 production from human lung macrophages through interaction with H1 receptors. J. Immunol. 2001; 166: 4083-4091.
20. Asano K., Kanai K., Suzaki H.: Suppressive activity of fexofenadine hydrochloride on the production of eosinophil chemoattractants from human nasal fibroblasts in vitro. Arzneimittel-Forschung 2004; 54: 436-443.
21. Juergens U.R., Gillissen A., Uen S. et al.: New evidence of H1-receptor independent COX-2 inhibition by fexofenadine HCl in vitro. Pharmacology 2006; 78: 129-135.
22. Smith S.M., Gums J.G.: Fexofenadine: biochemical, pharmacokinetic and pharmacodynamic properties and its unique role in allergic disorders. Expert Opin. Drug Metab. Toxicol. 2009; 5(7): 813-822.
23. Charakterystyka produktu leczniczego Telfexo.
24. Russell T., Stoltz M., Weir S.: Pharmacokinetics, pharmacodynamics and tolerance of single and multiple dose fexofenadine hydrochloride in healthy human volunteers. Clin. Phramacol. Ther. 1998; 64: 612-621.
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27. van Cauwenberge P., Juniper E.F.; Star Study Investigating Group: Comparison of the efficacy, safety, and quality of life provided by fexofenadine 120 mg, loratadine 10 mg, and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin. Exp. Allergy 2000; 30: 891-899.
28. Meeves S.G., Appajosyula S.: Efficacy and safety profile of fexofenadine HCl: A unique therapeutic option in H1-receptor antagonist treatment. J. Allergy Clin. Immunol. 2003; 112: 69-77.
29. Howarth P., Stern M., Roi L. et al.: Double-blind, placebo controlled study comparing the efficacy and safety of fexofenadine hydrochloride (120 and 180 mg once daily) and cetirizine in seasonal allergic rhinitis. J. Allergy Clin. Immunol. 1999; 104: 927-933.
30. Hampel F.C., Kittner B., van Bavel J.H.: Safety and tolerability of fexofenadine hydrochloride, 15 and 30 mg, twice daily in children aged 6 months to 2 years with allergic rhinitis. Ann. Allergy Asthma Immunol. 2007; 99: 549-554.
31. Hindmarch I., Johnson S., Meadows R. et al.: The Acute and sub-chronic effects of levocetirizine, cetirizine, loratadine, promethazine and placebo on cognitive function, psychomotor performance, and weal and flare. Curr. Med. Res. Opin. 2001; 17: 241-255.
32. Shamsi Z., Hindmarch I.: Sedation and antihistamines: a review of inter-drug differences using proportional impairment ratios. Hum. Psychopharmacol. Clin. Exp. 2000; 15(supl. 1): 3-30.
33. Casale T.B., Blaiss M.S., Gelfand E. et al.: First do no harm: managing antihistamine impairment in patients with allergic rhinitis. J. Allergy Clin. Immunol. 2003; 111: 835-842.
34. Estelle F., Simon R., Simons K.J.: H1 Antihistamines: Current Status and Future Directions. World Allergy Organ J. 2008; 1(9): 145-155.
35. Hansen J., Klimek L., Hormann K.: Pharmacological management of allergic rhinitis in the elderly: safety issues with oral antihistamines. Drugs Aging 2005; 22: 289-296.
36. Coggins M.D.: Antihistamine Risks. Aging Well. 2013; 6(2): 6.
37. Magen E., Yosefy C., Viskoper R.J. et al.: Treatment of allergic rhinitis can improve blood pressure control. J. Hum. Hypertens. 2006; 20: 888-893.
38. Kony S., Zureik M., Neukirch C. et al.: Rhinitis is associated with increased systolic blood pressure in men: a population-based study. Am. J. Respir. Crit. Care Med. 2003; 167: 538-543.
39. Peppard P.E., Young T.: Nose and blood pressure. Am. J. Respir. Crit. Care Med. 2004; 169: 318.
40. Dahl M., Tybjaerg-Hansen A., Nordestgaard B.G. et al.: Nose and blood pressure. Am. J. Respir. Crit. Care Med. 2004; 169: 318.
41. Woosley R.L., Chen Y., Freiman J.P. et al.: Mechanism of the cardiotoxic actions of erfenadine. JAMA 1993; 269: 1532-1536.
42. Zareba W.: Drug induced QT prolongation. Cardiol. J. 2007; 14: 523-533.
43. Crumb W.: Rate and concentration-dependent blockade of HERG by loratadine. Allergy 2000; 55(supl. 63): 264.
44. Simons F.E.: Advances in H1-antihistamines. N. Engl. J. Med. 2004; 351: 2203-2217.
45. Simons F.E., Akdis C.A.: Histamine and antihistamines. W: Adkinson N.F. Jr., Yunginger J.W., Busse W.W. et al. (red.): Middleton’s allergy principles and practice. 7th ed. Mosby, Inc. St. Louis 2008: 1517-1547.
46. Warner J.O.: A double-blind, randomized, placebo-controlled trial of cetirizine in preventing the onset of asthma in children with atopic dermatitis: 18 months’ treatment and 18 months’ post-treatment follow-up. J. Allergy Clin. Immunol. 2001; 108: 929-937.
2. Long A., McFadden C., DeVine D. et al.: Management of allergic and nonallergic rhinitis. W: Agency for Healthcare Research and Quality. Evidence Report/Technology Assessment Number 54. Rockville 1998-2005.
3. Bousquet J., van Cauwenberge P., Khaltaev N.; Aria Workshop Group; World Health Organization: Allergic rhinitis and its impact on asthma. J. Allergy Clin. Immunol. 2001; 108(supl. 5): 147-334.
4. Rosenwasser L.: New insights into the pathophysiology of allergic rhinitis. Allergy Asthma Proc. 2007; 28: 10-15.
5. Wilson S.J., Lau L., Howarth P.H.: Inflammatory mediators in naturally occurring rhinitis. Clin. Experiment. Allergy 1998; 28: 220-227.
6. Bousquet J., Bullinger M., Fayol C. et al.: Assessment of the quality of life in patients with perennial allergic rhinitis with the French version of the SF-36 Health Status Questionnaire. J. Allergy Clin. Immunol. 1994; 94: 182-188.
7. Juniper E.F., Guyatt G.H., Dolvich J.: Assessment of quality of life in adolescents with allergic rhinoconjunctivitis: development and testing of a questionnaire for clinical trials. J. Allergy Clin. Immunol. 1994; 93: 413-423.
8. Simons F.E.: Learning impairment and allergic rhinitis. Allergy Asthma Proc. 1996; 17: 185-189.
9. European Allergy White Paper, UCB Institute of Allergy, 1997.
10. Brozek J.L., Bousquet J., Baena-Cagnani C.E. et al.; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group: Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 Revision. J. Allergy Clin. Immunol. 2010; 126(3): 466-476.
11. Camelo-Nunes I.C.: New antihistamines: a critical review. J. Pediatr. 2006; 82: 173-180.
12. Tashiro M., Sakurada Y., Iwabuchi K. et al.: Central effects of fexofenadine and cetirizine: measurement of psychomotor performance, subjective sleepiness, and brain histamine H1-receptor occupancy using 11C-doxepin positron emission tomography. J. Clin. Pharmacol. 2004; 44: 890-900.
13. Weiler J.M., Bloomfield J.R., Woodworth G.G. et al.: Effects of fexofenadine, diphenhydramine, and alcohol on driving performance: a randomized, placebo-controlled trial in the Iowa driving simulator. Ann. Intern. Med. 2000; 132: 354-363.
14. Mann R.D., Pearce G.L., Dunn N. et al.: Sedation with “non-sedating” antihistamines: four prescription-event monitoring studies in general practice. BMJ 2000; 320(7243): 1184-1186.
15. Layton D., Wilton L., Boshier A. et al.: Comparison of the risk of drowsiness and sedation between levocetirizine and desloratadine: a prescription- event monitoring study in England. Drug Saf. 2006; 29: 897-909.
16. Leurs R., Church M.K., Taglialatela M.: H1 antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin. Exp. Allergy 2002; 32: 489-498.
17. DaBuske L., Kowal K.: Update on prescription and over-the-counter histamine inverse agonists in rhinitis therapy. Curr. Allergy Asthma Rep. 2009; 9: 140-148.
18. Ciprandi G., Tosca M.A., Cosentino C. et al.: Effects of fexofenadine and other antihistamines on components of the allergic response: adhesion molecules. J. Allergy Clin. Immunol. 2003; 112: 78-82.
19. Triggiani M., Gentile M., Secondo A. et al.: Histamine induces exocytosis and IL-6 production from human lung macrophages through interaction with H1 receptors. J. Immunol. 2001; 166: 4083-4091.
20. Asano K., Kanai K., Suzaki H.: Suppressive activity of fexofenadine hydrochloride on the production of eosinophil chemoattractants from human nasal fibroblasts in vitro. Arzneimittel-Forschung 2004; 54: 436-443.
21. Juergens U.R., Gillissen A., Uen S. et al.: New evidence of H1-receptor independent COX-2 inhibition by fexofenadine HCl in vitro. Pharmacology 2006; 78: 129-135.
22. Smith S.M., Gums J.G.: Fexofenadine: biochemical, pharmacokinetic and pharmacodynamic properties and its unique role in allergic disorders. Expert Opin. Drug Metab. Toxicol. 2009; 5(7): 813-822.
23. Charakterystyka produktu leczniczego Telfexo.
24. Russell T., Stoltz M., Weir S.: Pharmacokinetics, pharmacodynamics and tolerance of single and multiple dose fexofenadine hydrochloride in healthy human volunteers. Clin. Phramacol. Ther. 1998; 64: 612-621.
25. Gelfand E.W.: Inflammatory mediators in allergic rhinitis. J. Allergy Clin. Immunol. 2004; 114(5): 135-138.
26. Yanai K., Ryu J.H., Watanabe T. et al.: Histamine H1 receptor occupancy in human brains after single oral doses of histamine H1 antagonists measured by positron emission tomography. Br. J. Pharmacol. 1995; 116: 1649-1655.
27. van Cauwenberge P., Juniper E.F.; Star Study Investigating Group: Comparison of the efficacy, safety, and quality of life provided by fexofenadine 120 mg, loratadine 10 mg, and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin. Exp. Allergy 2000; 30: 891-899.
28. Meeves S.G., Appajosyula S.: Efficacy and safety profile of fexofenadine HCl: A unique therapeutic option in H1-receptor antagonist treatment. J. Allergy Clin. Immunol. 2003; 112: 69-77.
29. Howarth P., Stern M., Roi L. et al.: Double-blind, placebo controlled study comparing the efficacy and safety of fexofenadine hydrochloride (120 and 180 mg once daily) and cetirizine in seasonal allergic rhinitis. J. Allergy Clin. Immunol. 1999; 104: 927-933.
30. Hampel F.C., Kittner B., van Bavel J.H.: Safety and tolerability of fexofenadine hydrochloride, 15 and 30 mg, twice daily in children aged 6 months to 2 years with allergic rhinitis. Ann. Allergy Asthma Immunol. 2007; 99: 549-554.
31. Hindmarch I., Johnson S., Meadows R. et al.: The Acute and sub-chronic effects of levocetirizine, cetirizine, loratadine, promethazine and placebo on cognitive function, psychomotor performance, and weal and flare. Curr. Med. Res. Opin. 2001; 17: 241-255.
32. Shamsi Z., Hindmarch I.: Sedation and antihistamines: a review of inter-drug differences using proportional impairment ratios. Hum. Psychopharmacol. Clin. Exp. 2000; 15(supl. 1): 3-30.
33. Casale T.B., Blaiss M.S., Gelfand E. et al.: First do no harm: managing antihistamine impairment in patients with allergic rhinitis. J. Allergy Clin. Immunol. 2003; 111: 835-842.
34. Estelle F., Simon R., Simons K.J.: H1 Antihistamines: Current Status and Future Directions. World Allergy Organ J. 2008; 1(9): 145-155.
35. Hansen J., Klimek L., Hormann K.: Pharmacological management of allergic rhinitis in the elderly: safety issues with oral antihistamines. Drugs Aging 2005; 22: 289-296.
36. Coggins M.D.: Antihistamine Risks. Aging Well. 2013; 6(2): 6.
37. Magen E., Yosefy C., Viskoper R.J. et al.: Treatment of allergic rhinitis can improve blood pressure control. J. Hum. Hypertens. 2006; 20: 888-893.
38. Kony S., Zureik M., Neukirch C. et al.: Rhinitis is associated with increased systolic blood pressure in men: a population-based study. Am. J. Respir. Crit. Care Med. 2003; 167: 538-543.
39. Peppard P.E., Young T.: Nose and blood pressure. Am. J. Respir. Crit. Care Med. 2004; 169: 318.
40. Dahl M., Tybjaerg-Hansen A., Nordestgaard B.G. et al.: Nose and blood pressure. Am. J. Respir. Crit. Care Med. 2004; 169: 318.
41. Woosley R.L., Chen Y., Freiman J.P. et al.: Mechanism of the cardiotoxic actions of erfenadine. JAMA 1993; 269: 1532-1536.
42. Zareba W.: Drug induced QT prolongation. Cardiol. J. 2007; 14: 523-533.
43. Crumb W.: Rate and concentration-dependent blockade of HERG by loratadine. Allergy 2000; 55(supl. 63): 264.
44. Simons F.E.: Advances in H1-antihistamines. N. Engl. J. Med. 2004; 351: 2203-2217.
45. Simons F.E., Akdis C.A.: Histamine and antihistamines. W: Adkinson N.F. Jr., Yunginger J.W., Busse W.W. et al. (red.): Middleton’s allergy principles and practice. 7th ed. Mosby, Inc. St. Louis 2008: 1517-1547.
46. Warner J.O.: A double-blind, randomized, placebo-controlled trial of cetirizine in preventing the onset of asthma in children with atopic dermatitis: 18 months’ treatment and 18 months’ post-treatment follow-up. J. Allergy Clin. Immunol. 2001; 108: 929-937.