Evidence for clinical safety, efficacy, and parent and physician perceptions of levocetirizine for the treatment of children with allergic disease

International Archives of Allergy and Immunology

Volumn 155, Issue 4, 2011, Pages 367-378

  Pampura, A N ^a   Papadopoulos, N G ^b   Spicak V ^c   Kurzawa, R ^d  

^a PIROGOV RUSSIAN NATIONAL RESEARCH MEDICAL UNIVERSITY   (Russian Federation)

^b UNIVERSITY OF ATHENS   (Greece)

^c UNIVERSITY HOSPITAL BULOVKA   (Czech Republic)

^d National Research Institute for Tuberculosis and Lung Diseases   (Poland)

Author keywords

Allergic rhinitis; Antihistamines; Levocetirizine; Paediatric population; Pharmacodynamics; Pharmacokinetics; Quality of life; Real life study; Total symptoms score; Urticaria

Indexed keywords

AZELASTINE; CETIRIZINE; CHLORPHENIRAMINE; CYPROHEPTADINE; DESLORATADINE; FEXOFENADINE; HISTAMINE H1 RECEPTOR; HISTAMINE H1 RECEPTOR ANTAGONIST; HYDROXYZINE; LEVOCETIRIZINE; LORATADINE; PROMETHAZINE; STEROID;

ADRENAL SUPPRESSION; AGE DISTRIBUTION; ALLERGIC DISEASE; ALLERGIC RHINITIS; ARTICLE; CHILDHOOD DISEASE; CHRONIC URTICARIA; COGNITIVE DEFECT; CONSTIPATION; DAILY LIFE ACTIVITY; DIARRHEA; DROWSINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EYE DISEASE; FATIGUE; GASTROINTESTINAL SYMPTOM; GROWTH RETARDATION; HUMAN; INSOMNIA; LEARNING DISORDER; NERVOUSNESS; PARENT; PHYSICIAN; PRIORITY JOURNAL; REM SLEEP DEPRIVATION; RESTLESSNESS; SEDATION; SEIZURE; SIDE EFFECT; SLEEP DISORDER; SLEEP PARAMETERS; SOMNOLENCE;

ADULT; ANTI-ALLERGIC AGENTS; ATTITUDE OF HEALTH PERSONNEL; CETIRIZINE; CHILD; CHILD, PRESCHOOL; CHRONIC DISEASE; HISTAMINE H1 ANTAGONISTS, NON-SEDATING; HUMANS; INFANT; PARENTS; PHYSICIANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RHINITIS, ALLERGIC, PERENNIAL; RHINITIS, ALLERGIC, SEASONAL; TREATMENT OUTCOME; URTICARIA;

EID: 79951855434     PISSN: 10182438     EISSN: 14230097     Source Type: Journal    
DOI: 10.1159/000321181     Document Type: Article

References (74)

1. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE: Developmental pharmacology - drug disposition, action, and therapy in infants and children. N Engl J Med 2003; 349: 1157-1167. (Pubitemid 37122329)
2. McKinney RE: Congress, the FDA, and the fair development of new medications for children. Pediatrics 2003; 112: 669-670.
3. Roberts R, Rodriguez W, Murphy D, Crescenzi T: Pediatric drug labeling: Improving the safety and efficacy of pediatric therapies. J Am Med Assoc 2003; 290: 905-911. (Pubitemid 37430462)
4. ICH (International Conference on Harmonization): ICH harmonised tripartite guideline: Clinical investigation of medicinal products in the pediatric population E11. Current step 4 version dated 20 July 2000. http://www. ich.org/LOB/media/MEDIA487.pdf (accessed 5th May 2010).
5. Blaiss M: Current concepts and therapeutic strategies for allergic rhinitis in school-age children. Clin Therap 2004; 26: 1876-1889. (Pubitemid 40089500)
6. Mennella JA, Beauchamp GK: Optimizing oral medications for children. Clin Ther 2008; 30: 2120-2132.
7. Vanchieri C, Stith Butler A, Knutsen A: Addressing the barriers to pediatric drug development - workshop summary. Forum on Drug Discovery, Development, and Translation. Institute of Medicine of the Nation - al Academies. Washington D.C., National Academies Press, 2008. www.nap.edu (accessed 5th May 2010).
8. European Medicines Agency: Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population. 2006. http://www.ema.europa. eu/pdfs/human/ewp/14701304en.pdf (accessed 5th May 2010).
9. Durmowicz E: Pediatric drug development - CDER forum for international drug regulatory authorities. 2009. http://www.fda.gov/ downloads/Drugs/ NewsEvents/UCM 182540.pdf (accessed 5th May 2010).
10. Dunne J: The European regulation on medicines for paediatric use. Paediatr Respir Rev 2007; 8: 177-183. (Pubitemid 46888355)
11. Mösges R, Klimek L: Today's allergic rhinitis patients are different: New factors that may play a role. Allergy 2007: 62: 969-975. (Pubitemid 47220973)
12. Barnes C, Dinakar C, Reddy M, Portnoy J: Frequency of fungi in homes of pediatric allergy patients. Allergy Clin Immunol Int: J World Allergy Org 2006; 18: 197-202. (Pubitemid 44741084)
13. Mudarri D, Fisk WJ: Public health and economic impact of dampness and mold. Indoor Air 2007; 17: 226-235. (Pubitemid 46836586)
14. Bernard A, Nickmilder M, Voisin C, Sardella A: Impact of chlorinated swimming pool attendance on the respiratory health of adolescents. Pediatrics 2009; 124: 1110-1118.
15. Ellwood P, Asher MI, Björkstén B, Burr M, Pearce N, Robertson CF: Diet and asthma, allergic rhinoconjunctivitis and atopic eczema symptom prevalence: An ecological analysis of the International Study of Asthma and Allergies in Childhood (ISAAC) data. ISAAC Phase One Study Group. Eur Respir J 2001; 17: 436-443. (Pubitemid 32600612)
16. Njå F, Nystad W, Lødrup Carlsen KC, Hetlevik O, Carlsen KH: Effects of early intake of fruit or vegetables in relation to later asthma and allergic sensitization in school-age children. Acta Paediatr 2005; 94: 147-154. (Pubitemid 40343687)
17. Marshall GD: Internal and external environmental influences in allergic diseases. J Am Osteopath Assoc 2004; 104(suppl 5):S2-S6.
18. Long A, McFadden C, DeVine D, Chew P, Kupelnick B, Lau J: Management of Allergic and Nonallergic Rhinitis (Evidence Report/ Technology Assessment No. 54 (Prepared by New England Medical Center Evidence- Based Practice Center under Contract No. 290-97-0019). AHRQ Pub. No. 02-E024.
19. Rockville, MD, Agency for Healthcare Research and Quality, 2002.
20. Bousquet J, Khaltaev N, Cruz AA, et al.: Allergic rhinitis and its impact on asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA 2 LEN and AllerGen). Allergy 2008; 63(suppl 86):8-160. (Pubitemid 351357811)
21. Bauchau V, Durham SR: Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J 2004; 24: 758-764. (Pubitemid 39504428)
22. Bachert C, van Cauwenberge P, Olbrecht J, van Schoor J: Prevalence, classification and perception of allergic and nonallergic rhinitis in Belgium. Allergy 2006; 61: 693-698. (Pubitemid 43801402)
23. The diagnosis and management of rhinitis: An updated practice parameter. Joint Task Force on Practice Parameters. J Allergy Clin Immunol 2008; 122:S1-S84.
24. Ceuppens J: Western lifestyle, local defenses and the rising incidence of allergic rhinitis. Acta Otorhinolaryngol Belg 2000; 54: 391-395.
25. Asher MI, Montefort S, Björkstén B, Lai CK, Strachan DP, Weiland SK, Williams H, ISAAC Phase Three Study Group: Worldwide time trends in the prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and eczema in childhood: ISAAC Phases One and Three repeat multicountry crosssectional surveys. Lancet 2006; 368: 733-743. (Pubitemid 44279052)
26. Galassi C, De Sario M, Biggeri A, Bisanti L, Chellini E, Ciccone G, Petronio MG, Piffer S, Sestini P, Rusconi F, Viegi G, Forastiere F: Changes in prevalence of asthma and allergies among children and adolescents in Italy: 1994-2002. Pediatrics 2006; 117: 34-42. (Pubitemid 46050517)
27. Liao MF, Liao MN, Lin SN, Chen JY, Huang JL: Prevalence of allergic diseases of schoolchildren in central Taiwan. From ISAAC surveys 5 years apart. J Asthma 2009; 46: 541-545.
28. Sánchez-Lerma B, Morales-Chirivella FJ, Peñuelas I, Blanco Guerra C, Mesa Lugo F, Aguinaga-Ontoso I, Guillén-Grima F: High prevalence of asthma and allergic diseases in children aged 6 and 7 years from the Canary Islands: The International Study of Asthma and Allergies in Childhood. J Investig Allergol Clin Immunol 2009; 19: 383-390.
29. Björkstén B, Clayton T, Ellwood P, Stewart A, Strachan D; ISAAC Phase III Study Group: Worldwide time trends for symptoms of rhinitis and conjunctivitis: Phase III of the International Study of Asthma and Allergies in Childhood. Pediatr Allergy Immunol 2008; 19: 110-124. (Pubitemid 351197288)
30. Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC: A survey of the burden of allergic rhinitis in Europe. Allergy 2007; 62(suppl)85: 17-25. (Pubitemid 47561569)
31. Schatz M: A survey of the burden of allergic rhinitis in the USA. Allergy 2007; 62(suppl 85):9-16. (Pubitemid 47561568)
32. Nathan RA: The burden of allergic rhinitis. Allergy Asthma Proc 2007; 28: 3-9.
33. Reed SD, Lee TA, McCrory DC: The economic burden of allergic rhinitis. Pharmacoeconomics 2004; 22: 345-361.
34. Blaiss MS: Pediatric allergic rhinitis: Physical and mental complications. Allergy Asthma Proc 2007; 29: 1-6.
35. Meltzer EO, Blaiss MS, Derebery MJ, Mahr TA, Gordon BR, Sheth KK, Simmons AL, Wingertzahn MA, Boyle JM: Burden of allergic rhinitis: Results from the Pediatric Allergies in America survey. J Allergy Clin Immunol 2009; 124(suppl 3): S43-S70.
36. Scadding GK: Allergic rhinitis in children. Paed Child Health 2008; 18: 323-328. (Pubitemid 351885352)
37. Röder E, Berger MY, de Groot H, van Wijk RG: Immunotherapy in children and adolescents with allergic rhinoconjunctivitis: A systematic review. Pediatr Allergy Immunol 2008; 19: 197-207. (Pubitemid 351499173)
38. Bousquet PJ, Cox LS, Durham SR, et al.: Sublingual immunotherapy: World Allergy Organization Position Paper 2009. Allergy 2009; 64(suppl 91):1-59.
39. Schad CA, Skoner DP: Antihistamines in the pediatric population: Achieving optimal outcomes when treating seasonal allergic rhinitis and chronic urticaria. Allergy Asthma Proc 2008; 29: 7-13.
40. Meltzer LJ, Mindell JA, Owens JA, Byars KC: Use of sleep medications in hospitalized pediatric patients. Pediatrics 2007; 119: 1047-1055. (Pubitemid 46871257)
41. Owens JA, Rosen CL, Mindell JA: Medication use in the treatment of pediatric insomnia: Results of a survey of community-based pediatricians. Pediatrics 2003; 111:e628-e635.
42. Vernacchio L, Kelly JP, Kaufman DW, Mitchell AA: Cough and cold medication use by US children, 1999-2006: Results from the Slone survey. Pediatrics 2008; 122:e323-e329.
43. Chang AB, Peake J, McElrea MS: Antihis tamines for prolonged non-specific cough in children. Cochrane Database Syst Rev 2008; 2:CD005604. DOI: 10.1002/14651858. CD005604.pub3.
44. de Benedictis FM, de Benedictis D, Canonica GW: New oral H1-antihistaminesin children: Facts and unmet needs. Allergy 2008; 63: 1395-1404.
45. Lee HW, Lee HW, Park DJ, Moon SO, Ahn JH, Kim MJ, Kim SD, Kim JE, Yoon YR: The effects of fexofenadine at steady-state on sleep architecture: A study using polysomnography in healthy Korean volunteers. Expert Opin Pharmacother 2008; 9: 1655-1665.
46. Boyle J, Eriksson M, Stanley N, Fujita T, Kumagi Y: Allergy medication in Japanese volunteers: Treatment effect of single doses on nocturnal sleep architecture and next day residual effects. Curr Med Res Opin 2006; 22: 1343-1351. (Pubitemid 44085586)
47. Risberg AM, Risberg J, Ingvar DH: Effects of promethazine on nocturnal sleep in normal man. Psychopharmacologia 1975; 43: 279-284.
48. Sharfstein JM, North M, Serwint JR: Over the counter but no longer under the radar - pediatric cough and cold medications. N Engl J Med 2007; 357:2321-2324. (Pubitemid 350223385)
49. FDA: Using over-the-counter cough and cold products in children. http://www.fda.gov/downloads/ForConsumers/Consumer Updates/ucm048524.pdf (accessed 5th May 2010).
50. Church MK, Maurer M, Simons FE, Bindslev- Jensen C, van Cauwenberge P, Bousquet J, Holgate ST, Zuberbier T: Risk of first-generation H 1 -antihistamines: A GA 2 LEN position paper. Allergy 2010;65: 459-466.
51. Holgate ST, Canonica GW, Simons FER, Taglialatela M, Tharp M, Timmerman H, Yanai K: Consensus Group on New Generation Antihistamines (CONGA): Present status and recommendations. Clin Exp Allergy 2003; 33: 1305-1324. (Pubitemid 37108537)
52. Scadding G: Pediatric allergy medications: Review of currently available formulations. Curr Med Res Opin 2009; 25: 2069-2079.
53. Klimek L, Wrede H, Schuti BC, Hansen I: Patients' perception of the value of levocetirizine in allergic diseases - a multicentre observational study in Germany. Clin Drug Invest 2005; 25: 609-614. (Pubitemid 41379851)
54. ETAC Study Group: Allergic factors associated with the development od asthma and the influence of cetirizine in a doubleblind, randomised, placebo-controlled trial: First results of ETAC. Pediatr Allergy Immunol 1998; 9: 116-124.
55. Simons FER: Prospective, long-term safety evaluation of the H 1 -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: 433-440. (Pubitemid 29420443)
56. Simons FER, 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: 535-542. (Pubitemid 47206747)
57. Grimfeld A, Holgate ST, Canonica GW, Bonini S, Borres MP, Adam D, Canseco Gonzalez C, Lobaton P, Patel P, Szczeklik A, Danzig MR, Roman I, Bismut H, Czarlewski W: Prophylactic management of children at risk for recurrent upper respiratory infections: The Preventia I Study. Clin Exp Allergy 2004; 34: 1665-1672. (Pubitemid 39551517)
58. Cranswick N, Turzikova J, Hulhoven R: Levocetirizine in one-to two-year-old children: Pharmacokinetic and pharmacokinetic profile. Int J Clin Pharmacol Therap 2005; 43: 172-177. (Pubitemid 40542378)
59. Hussein Z, Pitsiu M, Majid O, Aarons L, de Longueville M, Stockis A: Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC study. Br J Pharmacol 2005; 59: 28-37. (Pubitemid 40040093)
60. Simons FER: Population pharmacokinetics of levocetirizine in very young children: The pediatricians' perspective. Pediatr Allergy Immunol 2005; 16: 97-103.
61. del Cuvillo A, Sastre J, Montoro J, Jáuregui I, Ferre M, Dávila A, Bartra J, Mullol J, Valero A: Use of antihistamines in pediatrics. J Investig Allergol Clin Immunol 2007; 17(suppl 2):28-40. (Pubitemid 351252753)
62. Gupta S, Khalilieh S, Kantesaria B, Banfield C: Pharmacokinetics of desloratadine in children between 2 and 11 years of age. Br J Clin Pharmacol 2007; 63: 534-540. (Pubitemid 46632574)
63. Gupta S, Kantesaria B, Banfield C, Wang Z: Desloratadine dose selection in children aged 6 months to 2 years: Comparison of population pharmacokinetics between children and adults. Br J Clin Pharmacol 2007; 64: 174-184. (Pubitemid 47063240)
64. Hampel F, Ratner P, Haeusler JMC: Safety and tolerability of levocetirizine dihydrochloride in infants and children with allergic rhinitis or chronic urticaria. Allergy Asthma Proc 2010; 31; 290-295.
65. Billard E, Dubreil Y, Pujazon MC, Lévy J, Wessel F: Safety, acceptability and efficacy of levocetirizine in 2-6 year old children with allergic rhinitis. Abstract presented at ACAAI-HSACI Joint Allergy Symposium, Athens, 2006.
66. Simons FER: H 1 -antihistamine treatment in young atopic children: Effect on urticaria. Ann Allergy Asthma Immunol 2007; 99: 261-266. (Pubitemid 47417228)
67. Simons FER, Simons KJ: Levocetirizine: Pharmacokinetics and pharmacokinetics in children age 6 to 11 years. J Allergy Clin Immunol 2005; 116: 355-361. (Pubitemid 41096543)
68. Simons KJ, Strolin Benedetti M, Simons FER, Gillard M, Baltes E: Relevancy of H 1 - receptor occupancy to H 1 -antihistamine dosing in children. J Allergy Clin Immunol 2007; 119: 1551-1554. (Pubitemid 46855868)
69. de Blic J, Wahn U, Billard E, Alt R, Pujazon MC: Levocetirizine in children: Evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial. Pediatr Allergy Immunol 2005; 16: 267-275. (Pubitemid 40638057)
70. 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: 175-180. (Pubitemid 41170179)
71. Ferrer M, Morais-Almeida M, Guizova M, Khanferyan R: Evaluation of treatment satisfaction in children with allergic disease treated with an antihistamine. Clin Drug Invest 2010; 30: 15-34.
72. FDAAA: Title IV: Pediatric Research Equity Act of 2007. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Development-Resources/ ucm049867.htm (accessed 5th May 2010).
73. Baltes E, Coupez R, Giezek H, Voss G, Meyerhoff C, Strolin Benedetti M: Absorption and disposition of levocetirizine, the eutomer of cetirizine, administered alone or as cetirizine to healthy volunteers. Fundam Clin Pharmacol 2001;15: 269-277. (Pubitemid 32939496)
74. Molimard M, Diquet B, Strolin Benedetti M: Comparison of pharmacokinetics and metabolism of desloratadine, fexofenadine, levocetirizine and mizolastine in humans. Fundam Clin Pharmacol 2004; 18: 399-411. (Pubitemid 39215352)