Ebastine: A Review of its Pharmacological Properties and Clinical Efficacy in the Treatment of Allergic Disorders

Drugs

Volumn 51, Issue 2, 1996, Pages 260-277

  Wiseman, Lynda R ^a   Faulds, Diana ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIALLERGIC AGENT; ANTIHISTAMINIC AGENT; ASTEMIZOLE; CETIRIZINE; CHLORPHENIRAMINE; CIMETIDINE; EBASTINE; ERYTHROMYCIN; HISTAMINE H1 RECEPTOR; HISTAMINE H1 RECEPTOR ANTAGONIST; KETOCONAZOLE; KETOTIFEN; LORATADINE; MEQUITAZINE; TERFENADINE; WARFARIN; BUTYROPHENONE DERIVATIVE; PIPERIDINE DERIVATIVE;

AGITATION; ALLERGIC DISEASE; ALLERGIC RHINITIS; ASTHENIA; ASTHMA; BRONCHOSPASM; CARDIOVASCULAR FUNCTION; CENTRAL NERVOUS SYSTEM; CHRONIC URTICARIA; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DROWSINESS; DRUG EFFICACY; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; NAUSEA; ORAL DRUG ADMINISTRATION; PHARMACODYNAMICS; QT INTERVAL; REVIEW; SYMPTOM; TACHYCARDIA; VOMITING; XEROSTOMIA; ANIMAL; HYPERSENSITIVITY;

ANIMALS; BUTYROPHENONES; HISTAMINE H1 ANTAGONISTS; HUMANS; HYPERSENSITIVITY; PIPERIDINES;

EID: 0030074361     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-199651020-00006     Document Type: Review

References (90)

1. 1-recepior antagonists in the management of allergic rhinitis: a comparative review. Clin Immunother 1994 Nov; 2: 352-75
2. Krause HF. Pharmacotherapy of perennial and seasonal allergic rhinitis. Clin Immunother 1995; 3: 308-24
3. 1-receptor antagonist therapy. Clin Pharmacokinet 1991 Nov; 21: 372-93
4. Kukita A, Kawashima M, HaradaS, et al. Clinicopharmacological study of LAS-90: inhibitory effect on wheal and erythema induced by intradermal injection of histamine [in Japanese]. Rinsho Iyaku 1994; 10 Suppl. 1: 103-11
5. Buchmeier A, Nelson HS, Bucher B, et al. Dose-response of prick skin lest (PST) suppression by ebastine [abstract]. J Allergy Clin Immunol 1994 Jan; 92: 163
6. Simons FER, Watson WTA, Simons KJ. Pharmacokinetics and pharmacodynamics of ebastine in children. J Pediatr 1993 Apr; 122: 641-6
7. Almeda E, Dazu JC, Reyes L, et al. A comparative study of ebastine and cetirizine effect on in vivo test on children who are sensitive to olea pollen [abstract]. Allergy 1992; 47 (12) Suppl.: 99
8. Almeda E, Daza JC, Reyes L, et al. A comparative study of ebastine and loratadine effect on in vivo test of children sensitive to olea pollen [abstract]. Allergy Clin Immunol News 1994 Suppl. 2: 389
9. de la Cuadra J, Teruel M, Teixido P, et al. Assessment of the wheal size and skin blood flow of the erythema induced by histamine and its modification with cetirizine and ebastine: a crossover, double-blind study. Dermatology 1994; 188: 131-4
10. Rivest J, Despontin K, Ghys L. Pharmacological modulation by cetirizine and ebastine of the cutaneous reactivity to histamine. Dermatologica 1991; 183 (3): 208-11
11. Torrent Farnells J, Segura J. Study of the antihistamine effect of LAS W090 (INN ebastine) in healthy volunteers. Single oral administration of LAS W-090 (10mg) in human volunteers and a pharmacokinetic study of its acid metabolite. Rhône-Poulenc Rorer (Collegeville), 1984. Report no. Clin 1/5 and Bio 3/2. (Data on file)
12. Carrenca FJ, Farnells JT, Pulido II, et al. Study of safety, pharmacokinetics and antihistamine effects of LAS W-090 at repeated doses in healthy volunteers. Rhône-Poulenc Rorer (Collegeville), 1986. Report No. Clin 1/7. (Data on file)
13. Aparicio S, Granel C, Randazzo L, et al. Studies of nonsedative antihistamines. M. Assessment of its antihistaminic potency. Allergol Immunopathol Madr 1992 Sep-Oct; 20: 207-10
14. 1-histamine antagonist, ebastine, against histamine and methacholine-induced bronchoconstriction in patients with asthma. Agents Actions 1990 Apr; 30: 284-6
15. Fernández L, Fernández del Cotero JN, Rodríguez F, et al. Protective effect of ebastine on the conjunctival provocation test with histamine [abstract no. P-0300]. Allergy 1995; 50 Suppl.: 182
16. 1-receptor antagonist. Drugs Today 1992; 28 Suppl. B: 11-21
17. Chanal I, Maudino G, Campbell AM, et al. Efficacy of ebastine assessed by nasal challenge in a double-blind placebo-controlled study [abstract]. J Allergy Clin Immunol 1994 Jan; 93: 272
18. Campbell AM, Crampelte L, Lebel B, et al. In Vitro inhibition of PGD2 and LTC4 release from human nasal polyp cells by ebastine and carebastine [abstract no. P-0335]. Allergy 1995; 26 Suppl.: 194
19. Puigdemont A, Queralt M, Llenas J. Suppressive effect of ebastine on histamine. PAF and allergen induced wheals in hypersensitive dogs [abstract no. P-0352]. Allergy 1995; 5 Suppl. 26: 199
20. Berga P, Puig J, Fernández AG. et al. Preclinical safety studies with ebastine. I. Pharmacological effects on the central nervous system. Drugs Today 1992; 28 Suppl. B: 23-7
21. Aoki Y, Funabashi H, Terada Y, et al. Reproductive and developmental toxicity studies of ebastine (2): teratogenicity study in rats [in Japanese). Yakuri to Chiryo 1994 Mar; 22: 1193-215
22. Nakashima M, Uematsu T, Kanamaru M. Phase I study of LAS-90 (1st report): single oral administration in healthy volunteers [in Japanese]. Rinsho Iyaku 1994; 10 Suppl. 1: 3-21
23. Hopes H, Meuret G-H, Ungethüm W, et al. Placebo controlled comparison of acute effects of ebastine and clemastine on performance and EEC. Eur J Clin Pharmacol 1992 Jan; 42: 55-9
24. Vincent J, Sumner DJ, Reid JL. Ebastine: the effect of a new antihistamine on psychomotor performance and autonomic responses in healthy subjects. Br J Clin Pharmacol 1988 Nov; 26: 503-8
25. Mattila MJ, Kuitunen T, Plétan Y. Lack of pharmacodynamic and pharmacokinetic interactions of the antihistamine ebastine with ethanol in healthy subjects. Eur J Clin Pharmacol 1992 Aug; 43: 179-84
26. Barbanoj MJ, Torrent J, Azcona O, et al. Psychomotor performance after different single oral doses of a new non-sedating H1 antihistamine in healthy subjects. Rhône-Poulenc Rorer (Collegeville). (Data on file)
27. 1-histamine receptor antagonist ebastine in 10, 20 and 30 mg dose, and triprolidine 10 mg on car driving performance. Br J Clin Pharmacol 1993 Ju;; 36: 67-70
28. Azcona O, Barbanoj MJ, Gich I, et al. Evaluation of CNS effects of repeated doses of ebastine and their interaction with ethanol in healthy subjects [abstract no. 100]. J Psychopharmacol 1992 Suppl.: A25
29. Manila MJ, Aranko K, Kuitunen T. Diazepam effects on the performance of healthy subjects are not enhanced by treatment with the antihistamine ebastine. Br J Clin Pharmacol 1993 Mar; 35: 272-7
30. Roll LN. Important drug warning. Marion Merrell Dow Inc. 1990, Aug 6.
31. Monahan BP, Ferguson CL, Killeavy ES, et al. Torsades de pointes occurring in association with terfenadine use. JAMA 1990; 264: 2788-90
32. 1-Receptor antagonists: comparative tolerability and safety. Drug Saf 1994; 10: 350-80
33. Spatzenegger M, Jaeger W. Clinical importance of hepatic cytochrome P450 in drug metabolism. Drug Metab Rev 1995; 27: 397-417
34. 1-receptor antagonists. Clin Exp Allergy 1994; 24: 707-23
35. Llenas J, Bou J, Massingham R. Preclinical safety studies with ebastine. II. Pharmacological effects on the cardiovascular system. Drugs Today 1992; 28 Suppl. B: 29-34
36. Llenas J, Cardelus I, Gristwood RW. Terfenadine, but not ebastine, increases the force of contraction of guinea pig ventricular strips by an action on histamine receptors [abstract no. 120]. Br J Pharmacol 1985; 87: 91P
37. Investigator's Brochure. Rhône-Poulenc Rorer (Collegeville), 1995. (Data on file)
38. Geary III WJ, Garcia JD, Dockhorn RJ. Electrocardiographs safety of 10mg of ebastine in healthy elderly and young adult volunteers [abstract no. P-0351]. Allergy 1995; 50(26) Suppl.: 199
39. Wilson J, Huang M-Y, Garcia J, et al. AN open-label interaction study between a single dose of ebastine and multiple doses of ketoconazole on the cardiac function and pharmacokinetic profile in healthy adult male volunteers. Rhône-Poulenc Rorer (Collegeville), 1994. Report No. EBA 127. (Data on file)
40. Wilson J, Huang M-Y, Garcia J, et al. An open-label interaction study between a single dose of ebastine and a multiple dose of erythromycin stearate on the cardiac function and pharmacokinetic profile in healthy adult male volunteers. Rhône-Poulenc Rorer (Collegeville), 1994. Report no. EBA 130. (Data on file)
41. Martínez-Tobed A, Tarrús E, Segura J, et al. Pharmacokinetic studies of ebastine in rats, dogs and man. Drugs Today 1992; 28 Suppl. B: 57-67
42. Vincent J, Liminana R, Meredith PA, et al. The pharmacokinetics, antihistamine and concentration-effect relationship of ebastine in healthy subjects. Br J Clin Pharmacol 1988 Nov; 26: 497-502
43. 1-receplor antagonist ebastine and its active metabolite carebastine in healthy subjects. Arzneimittel Forschung 1994 Jan; 44: 59-64
44. Nakamura T, Mizorogi Y, Matsuda M, et al. Pharmacokinetics of ebastine in the elderly. Rinsho Iyaku 1994; 10 (9): 47-54
45. Huang M-Y, Wilson J, Argenti D, et al. Comparative pharmacokinetics of ebastine/carebastine in liver cirrhosis and healthy volunteers following administration of a 10mg ebastine tablet. Pharm Res 1993; 10 (10 Suppl.): S-390
46. Huang M-Y, Argenti D, Wilson J, et al. Single dose and steady-state pharmacokinetics of carebastine following administration of 10mg ebastine tablets once daily in healthy elderly and young adults. Pharm Res 1993; 10 (10 Suppl.): S-391
47. Dorr MB, Huang M-Y, Heald D, et al. Effect of food on the bioavailability of carebastine in healthy male volunteers. Pharm Res 1993; 10 (10 Suppl.): S-306
48. Fujii T, Matsumoto S, Amejima H, et al. Absorption, distribution, metabolism and excretion of [14C] ebastine after a single administration in rats. Arzneimittel Forschung 1994 Apr; 44: 527-38
49. 1-receptor antagonist ebastine to its active metabolite carebastine. Br J Clin Pharmacol 1993 Jun; 35: 661-3
50. Moreland TA, Pears JS, Mills MJ, et al. The effect of ebastine on warfarin kinetics and dynamics. 5th World Conference on Clinical Pharmacology & Therapeutics: 1992 Jul 26-31; Yokohama, Japan
51. Kukita A, Harada S, Yoshida H, et al. Clinical study of LAS-90 on eczema/dermatitis, prurigo and pruritus cutaneous [in Japanese], Rinsho Iyaku 1994; 10 Suppl. 1: 73-88
52. Czarny D, Gillis D, Katelaris C, et al. A double-blind randomized controlled multicentre phase III efficacy and safely trial to assess the effect of ebastine (RP 64305) 10mg (o.d.) versus terfenadine 60mg (b.i.d.) and placebo given for a period of three weeks in the treatment of adult patients with seasonal allergic rhinitis. Rhône-Poulenc Rorer (Collegeville). Report No. 59 (Pt IV.B.1), (Data on file)
53. Ankier SI, Warrington SJ. A double-blind placebo-controlled study of the efficacy and tolerability of ebastine against hay-fever in general practice patients. J Intern Med 1989 Dec; 226: 453-8
54. Ankier SI, Fay L, Warrington SJ. Report on a placebo-controlled study in general practice to compare the efficacy and tolerability of ebastine and astemizole 10mg against the symptoms of hay fever. Rhône-Poulenc Rorer (Collegeville). Report No. 61 (Pt IV.B.1). (Data on file)
55. Luria X, Robert M, Antepara I, et al. A double-blind placebo controlled study of the efficacy and tolerability of ebastine and loratidine in seasonal allergic rhinitis patients [abstract no. P-0350]. Allergy 1995; 50: 199
56. Antépara I, Basomba, Castillo, et al. Double-blind randomised parallel clinical trial to compare the efficacy and tolerability of ebastine 20mg once daily with loratidine 10mg once daily and placebo in the treatment of seasonal allergic rhinitis. Rhône-Poulenc Rorer (Collegeville). Report No. 72 (Pt IV.B.2). (Data on file)
57. Castro E, Molina E, Prieto L, et al. A comparative study of the efficacy and tolerability of ebastine (LAS W 0-90) and terfenadine in the treatment of seasonal allergic rhinitis. Rhône-Poulenc Rorer (Collegeville). Report No. 60 (Pt IV.B.1). (Data on file)
58. de Molina M, Cadahia L, 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): 40-6
59. Gehannol P, Brémard-Oury C, Zeisser P. A double-blind multicenter randomized study comparing once daily oral administration of ebastine 20mg, ebastine 10mg, and cetirizine 10mg for the treatment of seasonal allergic rhinitis in adults. Rhône-Poulenc Rorer (Collegeville). (Data on file)
60. Banov CH, Chervinsky P, Munk ZM, et al. Multicenter double-blind parallel-group randomized comparisons of ebastine and placebo in patients with seasonal allergic rhinitis. Rhône-Poulenc Rorer (Collegeville), 1992. Report no. EBA 124. (Data on file)
61. Teran-Ortiz L, Flores-Sandoval G, Orea-Solano M, et al. Ebastine vs terfenadine in allergic rhinitis [in Spanish]. Rev Alerg 1993 Jul-Aug; 40: 82-5
62. Morris RJ, Garcia JD, Tobey RE Multicenter trial of ebastine for seasonal allergic rhinitis [abstract]. Ann Allergy 1994 Jan; 72: 58
63. Luria X, Raga E, Molina M, et al. Resultados del ensayo clínico de la prevención de aparición de síntomas de rinitis alérgica estacional de ebastina vs astemizol [abstract no. 116]. Rev Espanola Alergol Immunol Clin 1992; 7 Suppl. 2: 86
64. Nevot S, Sierra JI, Marco MT, et al. Resultados del ensayo clinico de ebastina en niños de 2 a 5 años de edad (abstract). Rev Espanola Alergol Immunol Clin 1992; 7 Suppl. 2: 57
65. Teran-Ortiz L, Sandoval GF, Solano MO, et al. Ebastina vs terfenadina en la rinitis alérgica. Rev Alergica Mexico 1993; 40 (4): 82-5
66. Picado Valles C, Cadahia Garcia A, Cistero Bahima A, et al. Ebastine in perennial allergic rhinitis. Ann Allergy 1991 Dec; 67: 615-8
67. Baba S, Ito H, Takagi I, et al. Early phase II study of LAS-90 on perennial allergic rhinitis [in Japanese]. Rinsho Iyaku 1994; 10 Suppl. 1: 113-24
68. Baba S, Takagi I, Saito Y, et al. Clinical evaluation of LAS-90 on Japanese cedar pollinosis [in Japanese]. Rinsho Iyaku 1994; 10 Suppl. 1: 147-61
69. Baba S, Takagi I, Okuda M, et al. Phase II study of LAS-90 on perennial allergic rhinitis: optimal dose finding study by double-blind technique [in Japanese]. Rinsho Iyaku 1994; 10 Suppl. 1: 125-45
70. Baba S, Mamiya S, Sakakura Y, et al. Clinical trial of LAS-90 on perennial allergic rhinitis: a double blind study in comparison with ketotifen fumarate [in Japanese]. Rinsho Iyaku 1994; 10 (5): 1143-62
71. 1-antihistamine ebastine in the treatment of perennial allergic rhinitis. Laboratorios Almirall, Barcelona. (Data on file)
72. de Molina M, Garcia P. A study of the efficacy and tolerabilily of ebastine (LAS W-090) at two therapeutic dose levels in the treatment of perennial allergic rhinitis in adolescents. Rhône-Poulenc Rorer (Collegeville). 1988. Report no. CLIN 2/8. (Data on file)
73. Kukita A, Harada S, Yoshida H, et al. Early phase II study of LAS-90 on chronic urticaria [in Japanese]. Rinsho Iyaku 1994; 10 Suppl. 1: 43-53
74. Kukita A, Harada S, Yoshida H, et al. Late phase II study of LAS-90 on chronic urticaria: optimal dose finding study by double-blind technique [in Japanese]. Rinsho Iyaku 1994; 10 Suppl. 1: 55-72
75. Kalis B, Brémard-Oury C. A 3-month double-blind comparative study of ebastinc (10mg o.d.), terfenadine (60mg b.i.d.) and placebo in the treatment of chronic urticaria [abstract no. P-0895]. Allergy 1995; 50 Suppl.: 380
76. Peyri J, Vidal J, Marrón J, et al. Ebastine in chronic urticaria: a double-blind placebo-controlled study. J Dermatol Treat 1991; 2: 51-3
77. Kukita A, Harada S, Yoshida H, et al. Phase III study of LAS-90 on chronic urticaria: double blind comparative study with ketotifen fumarate [in Japanese]. Rinsho Iyaku 1994; 10(4): 895-912
78. Ledo A, Fonseca E, De Molina G, et al. A study of the efficacy and tolerability of two dose levels of ebastine (LAS W-090) and astemizole in the treatment of chronic urticaria over a four-week period. Rhône-Poulenc Rorer (Collegeville). (Data on file)
79. Kukita A, Harada S, Yoshida H, et al. Long-term treatment of LAS-90 on chronic urticaria [in Japanese]. Rinsho Iyaku 1994; 10 Suppl. 1: 89-102
80. Double blind randomised parallel clinical trial to determine the safety and tolerabilily over one month of ebastine 20mg once daily compared to placebo in patients with chronic urticaria. One year follow up of the ebastine 20mg group. Rhône-Poulenc Rorer (Collegeville). 1995. Report no. M-09020.21. (Data on file)
81. Thomas K. A long term (one year) safety and efficacy study of ebastine 10mg in the treatment of chronic urticaria in adult patients. Rhône-Poulenc Rorer (Collegeville). 1994. Report no. EBA 020. (Data on file)
82. Chico C, Domingo C, de Molina G, et al. A study of the efficacy and tolerability ot two therapeutic doses of ebastine compared with placebo in the treatment of perennial allergic rhinitis. Rhône-Poulenc Rorer (Collegeville), 1987. Report no. CLIN 2/7. (Data on file)
83. A double-blind placebo-controlled parallel group field study on the onset of action of ebastine 20mg in patients with seasonal allergic rhinitis. Rhône-Poulenc Rorer (Collegeville). 1994. Report no. EBA 133. (Data on file)
84. Beaucher WN, Grossman J, Morris RJ, et al. Multicenter double-blind parallel group randomized comparison of ebastine and placebo in patients with perennial allergic rhinitis. Rhône-Poulenc Rorer (Collegeville), 1992. Report no. EBA 109. (Data on file)
85. Luria X, Bakke OM. Ebastine (LAS W-090): overview of clinical trials. Drugs Today 1992; 28 Suppl. B: 69-79
86. Banov CH, Chervinsky P, Munk ZM, et al. Multicenter open-label long-term safety study of ebastine in patients with pollen induced allergic rhinitis. Rhône-Poulenc Rorer (Collegeville) 1995. Report no. EBA 124LT. (Data on file)
87. Weiss KB, Sullivan SD. Socio-economic burden of asthma, allergy, and other atopic illnesses. Pediatr Allergy Immunol 1994; 5 Suppl. 1: 7-12
88. McMenamin P. Costs of hay fever in the United States in 1990. Ann Allergy 1994; 73: 35-9
89. Krause HF. Antihistamines and decongestants. Otolaryngol Head Neck Surg 1992; 107: 835-40
90. Busse WW. Role of antihistamines in allergic disease. Ann Allergy 1994; 71: 371-5