The clinical evidence of second-generation H1-antihistamines in the treatment of allergic rhinitis and urticaria in children over 2 years with a special focus on rupatadine

References

• de Benedictis FM, de Benedictis D, Canonica GW. New oral H1 antihistamines in children: facts and unmet needs. Allergy. 2008;63(10):1395–1404.
   PubMed Web of Science ®Google Scholar
• Fitzsimons R, van der Poel LA, Thornhill W, et al. Antihistamine use in children. Arch Dis Child Educ Pract Ed. 2015 Jun;100(3):122–131.
   PubMed Web of Science ®Google Scholar
• Tomasi PA, Egger GF, Pallidis C, et al. Enabling development of paediatric medicines in Europe: 10 years of the EU paediatric regulation. Paediatr Drugs. 2017 Dec;19(6):505–513.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Khaltaev N, Cruz AA, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaborationwith the World Health Organization, GA2LEN and AllerGen). Allergy. 2008;63(Suppl 86):8–160.
   PubMed Web of Science ®Google Scholar
• Mullol J, Valero A, Alobid I, et al. Allergic Rhinitis and its Impact on Asthma update (ARIA 2008). The perspective from Spain. J Invest Allergol Clin Immunol. 2008;18(5):327–334.
   PubMed Web of Science ®Google Scholar
• Jáuregui I, Dávila I, Sastre J, et al. Validation of ARIA (Allergic Rhinitis and its Impact on Asthma) classification in a pediatric population: the PEDRIAL study. Pediatr Allergy Immunol. 2011;22(4):388–392.
   PubMed Web of Science ®Google Scholar
• Montoro J, Del Cuvillo A, Mullol J, et al. Validation of the modified allergic rhinitis and its impact on asthma (ARIA) severity classification in allergic rhinitis children: the PEDRIAL study. Allergy. 2012;67(11):1437–1442.
   PubMed Web of Science ®Google Scholar
• Asher MI, Montefort S, Björkstén B, et al. Worldwide time trends in the prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and eczema in childhood: ISAAC Phases One and Three repeat multicountry cross-sectional surveys. Lancet. 2006;368(9537):733–743.
   PubMed Web of Science ®Google Scholar
• Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018 Jul;73(7):1393–1414.
   PubMed Web of Science ®Google Scholar
• Caffarelli C, Cuomo B, Cardinale F, et al. Aetiological factors associated with chronic urticaria in children: a systematic review. Acta Derm Venereol. 2013 May;93(3):268–272.
   PubMed Web of Science ®Google Scholar
• Balp MM, Weller K, Carboni V, et al. Prevalence and clinical characteristics of chronic spontaneous urticaria in pediatric patients. Pediatr Allergy Immunol. 2018 Sep;29(6):630–636.
   PubMedGoogle Scholar
• Muñoz-Cano R, Ainsua-Enrich E, Torres-Atencio I, et al. Effects of rupatadine on platelet activating factor-induced human mast cell degranulation compared with desloratadine and levocetirizine (The MASPAF Study). J Invest Allergol Clin Immunol. 2017;27(3):161–168.
   PubMed Web of Science ®Google Scholar
• Mullol J, Bousquet J, Bachert C, et al. Rupatadine in allergic rhinitis and chronic urticaria. Allergy. 2008 Apr;63(Suppl 87):5–28.
   PubMed Web of Science ®Google Scholar
• Giménez-Arnau A, Pujol RM, Ianosi S, et al. Rupatadine in the treatment of chronic idiopathic urticaria: a double-blind,randomized, placebo-controlled multicentre study. Allergy. 2007;62(5):539–546.
   PubMed Web of Science ®Google Scholar
• Shamizadeh S, Brockow K, Ring J. Rupatadine: efficacy and safety of a non-sedating antihistamine with PAF-antagonist effects. Allergo J Int. 2014;23(3):87–95.
   PubMedGoogle Scholar
• Izquierdo I, Merlos M, García-Rafanell J. Rupatadine: a new selective histamine H1 receptor and platelet-activating factor (PAF) antagonist. A review of pharmacological profile and clinical management of allergic rhinitis. Drugs Today (Barc). 2003 Jun;39(6):451–468.
   PubMed Web of Science ®Google Scholar
• Mullol J, Bousquet J, Bachert C, et al. Update on rupatadine in the management of allergic disorders. Allergy. 2015 Jan;70(Suppl 100):1–24.
   PubMed Web of Science ®Google Scholar
• Muñoz-Cano R, Valero A, Roca-Ferrer J, et al. Platelet-activating factor nasal challenge induces nasal congestion and reduces nasal volume in both healthy volunteers and allergic rhinitis patients. Am J Rhinol Allergy. 2013 Mar-Apr;27(2):e48–52.
   PubMed Web of Science ®Google Scholar
• Muñoz-Cano RM, Casas-Saucedo R, Valero Santiago A, et al. Platelet-Activating Factor (PAF) in allergic rhinitis: clinical and therapeutic implications. J Clin Med. 2019 Aug 29;8(9):1338.
   PubMed Web of Science ®Google Scholar
• Izquierdo-Domínguez A, Valero AL, Mullol J. Comparative analysis of allergic rhinitis in children and adults. Curr Allergy Asthma Rep. 2013;13(2):142–151.
   PubMed Web of Science ®Google Scholar
• Brozek JL, Bousquet J, Agache I, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol. 2017 Oct;140(4):950–958.
   PubMed Web of Science ®Google Scholar
• Roberts G, Xatzipsalti M, Borrego LM, et al. Paediatric rhinitis: position paper of the European academy of allergy and clinical immunology. Allergy. 2013;68(9):1102–1116.
   PubMed Web of Science ®Google Scholar
• Mullol J. Positioning of antihistamines in the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines. Clin Exp Allergy Rev. 2012;12:17–26.
   Google Scholar
• Church MK, Maurer M, Simons FE, et al. Risk of first-generation H (1)-antihistamines: a GA(2)LEN position paper. Allergy. 2010;65(4):459–466.
   PubMed Web of Science ®Google Scholar
• Santamaría E, Estévez JA, Riba J, et al. Population pharmacokinetic modelling of rupatadine solution in 6–11-yearolds and optimisation of the experimental design in younger children. PLoS One. 2017 Apr 18;12(4):e0176091.
   PubMed Web of Science ®Google Scholar
• Muñoz-Cano R, Valero A, Izquierdo I, et al. Evaluation of nasal symptoms induced by platelet activating factor, after nasal challenge in both healthy and allergic rhinitis subjects pretreated with rupatadine, levocetirizine or placebo in a cross-over study design. Allergy Asthma Clin Immunol. 2013 Nov 1;9(1):43.
   PubMedGoogle Scholar
• Pearlman DS, Lumry WR, Winder JA, et al. Once-daily cetirizine effective in the treatment of seasonal allergic rhinitis in children aged 6 to 11 years: a randomized, double-blind, placebo-controlled study. Clin Pediatr (Phila). 1997;36(4):209–215.
   PubMed Web of Science ®Google Scholar
• Jobst S, van den Wijngaart W, Schubert A. van de Venne H. Assessment of the efficacy and safety of three dose levels of cetirizine given once daily in children with perennial allergic rhinitis. Allergy. 1994;49(8):598–604.
   PubMed Web of Science ®Google Scholar
• Chen ST, Lu KH, Sun HL, et al. Randomized placebo-controlled trial comparing montelukast and cetirizine for treating perennial allergic rhinitis in children aged 2–6 yr. Pediatr Allergy Immunol. 2006;17(1):49–54.
   PubMed Web of Science ®Google Scholar
• de Blic J, Wahn U, Billard E, et al. Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial. Pediatr Allergy Immunol. 2005;16(3):267–275.
   PubMed Web of Science ®Google Scholar
• Paediatric Levocetirizine Study Group, Potter PC. Efficacy and safety of levocetirizine on symptoms and health-related quality of life of children with perennial allergic rhinitis: a double-blind, placebo-controlled randomized clinical trial. Ann Allergy Asthma Immunol. 2005;95(2):175–180.
   PubMed Web of Science ®Google Scholar
• Santamaría E, Izquierdo I, Valle M, et al. Rupatadine oral solution for 2–5-year-old children with allergic rhinitis: a safety, open-label, prospective study. J Asthma Allergy. 2018 Sep 4;11:225–231.
   PubMed Web of Science ®Google Scholar
• Potter P, Maspero JF, Vermeulen J, et al. Rupatadine oral solution in children with persistent allergic rhinitis: A randomized, double-blind, placebo-controlled study. Pediatr Allergy Immunol. 2013;24(2):144–150.
   PubMed Web of Science ®Google Scholar
• Cornillier H, Giraudeau B, Munck S, et al. Chronic spontaneous urticaria in children - a systematic review on interventions and comorbidities. Pediatr Allergy Immunol. 2018 May;29(3):303–310.
   Google Scholar
• Wang EA, Chan SK. Chronic Urticaria in Children: an update on diagnosis and treatment. Curr Allergy Asthma Rep. 2020 Jun 6;20(8):31.
   PubMed Web of Science ®Google Scholar
• La Rosa M, Leonardi S, Marchese G, et al. Double-blind multicenter study on the efficacy and tolerability of cetirizine compared with oxatomide in chronic idiopathic urticaria in preschool children. Ann Allergy Asthma Immunol. 2001;87(1):48–53.
   PubMed Web of Science ®Google Scholar
• Potter P, Mitha E, Barkai L, et al. Rupatadine is effective in the treatment of chronic spontaneous urticaria in children aged 2–11 years. Pediatr Allergy Immunol. 2016;27(1):55–61.
   PubMed Web of Science ®Google Scholar
• Simons FE. Prospective, long-term safety evaluation of the H1-receptor antagonist cetirizine in very young children with atopic dermatitis. ETAC study group. Early treatment of the atopic child. J Allergy Clin Immunol. 1999;104(2 Pt 1):433–440.
   PubMed Web of Science ®Google Scholar
• Simons FE. Early Prevention of Asthma in Atopic Children (EPAAC) study group. Safety of levocetirizine treatment in young atopic children: an 18-month study. Pediatr Allergy Immunol. 2007;18(6):535–542.
   PubMed Web of Science ®Google Scholar
• Lutsky B, Lorber R, Bloom M Safety of desloratadine syrup in children 6 months to <24 months of age: a randomized placebo-controlled study. American College of Allergy, Asthma & Immunology (ACAAI); 2003 Nov 7–12; New Orleans, USA.
   Google Scholar
• Bloom M, Staudinger H, Herron J. Safety of desloratadine syrup in children. Curr Med Res Opin. 2004;20(12):1959–1965.
   PubMed Web of Science ®Google Scholar
• Segall N, Grubbe RE, Levy AL, et al. Pharmacokinetics, safety and tolerability of an oral suspension of fexofenadine for children with allergic rhinitis. Allergy Asthma Proc. 2008;29(4):380–385.
   PubMed Web of Science ®Google Scholar
• Milgrom H, Kittner B, Lanier R, et al. Safety and tolerability of fexofenadine for the treatment of allergic rhinitis in children 2 to 5 years old. Ann Allergy Asthma Immunol. 2007;99(4):358–363.
   PubMed Web of Science ®Google Scholar
• González-Núñez V, Bachert C, Mullol J, et al. Rupatadine: global safety evaluation in allergic rhinitis and urticaria. Expert Opin Drug Saf. 2016;15(10):1439–1448.
   PubMed Web of Science ®Google Scholar
• Bachert C, Kuna P, Sanquer F, et al. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009;64(1):158–165.
   PubMed Web of Science ®Google Scholar
• Kuna P, Bachert C, Nowacki Z, et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clin Exp Allergy. 2009;39(9):1338–1347.
   PubMed Web of Science ®Google Scholar
• Sastre J, Mullol J, Valero A, et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo in the treatment of perennial allergic rhinitis. Curr Med Res Opin. 2012;28(1):121–130.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Gaudaño EM, Palma Carlos AG. Staudinger H.A 12-week, placebo-controlled study of the efficacy and safety of ebastine, 10 and 20 mg once daily, in the treatment of perennial allergic rhinitis. RMulticentre study group. Allergy. 1999;54(6):562–568.
   PubMed Web of Science ®Google Scholar
• de Molina M, Cadahia A, Cano L, et al. Efficacy and tolerability of ebastine at two dose levels in the treatment of seasonal allergic rhinitis. Drug Invest. 1989;1(1):40–46.
   Google Scholar
• Novák Z, Yáñez A, Kiss I, et al. Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases. Pediatr Allergy Immunol. 2016;27(5):493–498.
   PubMed Web of Science ®Google Scholar
• Izquierdo I, Potter P, Maspero J, et al. Rupatadine oral solution improves rhino-conjunctive symptoms control in children with 6–11 years weighing ≥25 kg with persistent allergic rhinitis. Clin Trans Allergy. 2013;3(Suppl 2):P33.
   PubMedGoogle Scholar
• Potter P, Maspero J, Vermeulen J, et al. Subanalysis of quality of life in children with 6–11 years weighing ≥25 kg with persistent allergic rhinitis: rupatadine results [abstract no. 686]. Allergy. 2013;68(Suppl.97):275.
   Google Scholar
• Cataldi M, Maurer M, Taglialatela M, et al. Cardiac safety of second-generation H1 -antihistamines when updosed in chronic spontaneous urticaria. Clin Exp Allergy. 2019;49(12):1615–1623.
   PubMed Web of Science ®Google Scholar
• Ridolo E, Montagni M, Fassio F, et al. Rupatadine for the treatment of allergic rhinitis and urticaria: a look at the clinical data. Clin Invest. 2014;4(5):453–461.
   Google Scholar
• Compalati E, Canonica GW. Efficacy and safety of rupatadine for allergic rhino-conjunctivitis: a systematic review of randomized, double-blind, placebo-controlled studies with meta-analysis. Curr Med Res Opin. 2013;29(11):1539–1551.
   PubMed Web of Science ®Google Scholar
• Donado E, Izquierdo I, Pérez I, et al. No cardiac effects of therapeutic and supratherapeutic doses of rupatadine: results from a ‘thorough QT/QTc study’ performed according to ICH guidelines. Br J Clin Pharmacol. 2010;69(4):401–410.
   PubMed Web of Science ®Google Scholar
• Solans A, Izquierdo I, Donado E, et al. Pharmacokinetic and safety profile of rupatadine when coadministered with azithromycin at steady-state levels: a randomized, open-label, two-way, crossover, Phase I study. ClinTher. 2008 Sep;30(9):1639–1650.
   Google Scholar
• Picado C. Rupatadine: pharmacological profile and its use in the treatment of allergic disorders. Expert Opin Pharmacother. 2006;7(14):1989–2001.
   PubMed Web of Science ®Google Scholar
• García-Gea C, Ballester MR, Martínez J, et al. Rupatadine does not potentiate the CNS depressant effects of lorazepam: randomized, double-blind, crossover, repeated dose, placebo-controlled study. Br J Clin Pharmacol. 2010;69(6):663–674.
   PubMed Web of Science ®Google Scholar
• Barbanoj MJ, García-Gea C, Antonijoan R, et al. Evaluation of the cognitive, psychomotor and pharmacokinetic profiles of rupatadine, hydroxyzine and cetirizine, in combination with alcohol, in healthy volunteers. Hum Psychopharmacol. 2006;21(1):13–26.
   PubMed Web of Science ®Google Scholar
• Vuurman E, Theunissen E, van Oers A, et al. Lack of effects between rupatadine 10 mg and placebo on actual driving performance of healthy volunteers. Hum Psychopharmacol. 2007;22(5):289–297.
   PubMed Web of Science ®Google Scholar
• Marcucci F, Sensi LG, Abate P, et al. Anti-inflammatory activity and clinical efficacy of a 3-month levocetirizine therapy in mite-allergic children. Inflamm Allergy Drug Targets. 2011;10(1):32–38.
   PubMedGoogle Scholar
• Dizdar EA, Sekerel BE, Keskin O, et al. The effect of regular versus on-demand desloratadine treatment in children with allergic rhinitis. Int J Pediatr Otorhinolaryngol. 2007;71(6):843–849.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Bachert C, Canonica GW, et al. Efficacy of desloratadine in intermittent allergic rhinitis: a GA2LEN study. Allergy. 2009;64(10):1516–1523.
   PubMed Web of Science ®Google Scholar
• Graft DF, Bernstein DI, Goldsobel A, et al. Safety of fexofenadine in children treated for seasonal allergic rhinitis.Ann. Allergy Asthma Immunol. 2001;87(1):22–26.
   PubMed Web of Science ®Google Scholar
• Wahn U, Meltzer EO, Finn AF Jr, et al. Fexofenadine is efficacious and safe in children (aged 6–11 years) with seasonal allergic rhinitis. J Allergy Clin Immunol. 2003;111(4):763–769.
   PubMed Web of Science ®Google Scholar
• Meltzer EO, Scheinmann P, Rosado Pinto JE, et al. Safety and efficacy of oral fexofenadine in children with seasonal allergic rhinitis--a pooled analysis of three studies. Pediatr Allergy Immunol. 2004;15(3):253–260.
   PubMed Web of Science ®Google Scholar
• Ngamphaiboon J, Direkwattanachai C, Visitsunthorn N, et al. The efficacy and safety of 30 mg fexofenadine HCl bid in pediatric patients with allergic rhinitis. Asian Pac J Allergy Immunol. 2005;23(4):169–174.
   PubMed Web of Science ®Google Scholar
• Izquierdo I, Cranswick N, McCreanor J, et al. Rupatadine in children aged 6–11 years with allergic rhinitis: A proof of concept evaluation by a 4 weeks treatment follow-up study. Pediatr Allergy Immunol. 2009;20(Suppl 20):2.
   Google Scholar
• Valero A, de la Torre F, Castillo JA, et al. Safety of rupatadine administered over a period of 1 year in the treatment of persistent allergic rhinitis: a multicentre, open-label study in Spain. Drug Saf. 2009;32(1):33–42.
   PubMed Web of Science ®Google Scholar