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ISSN 1405-1699 (Print)
Órgano Oficial del Colegio Mexicano de Alergia, Asma e Inmunología Pediátrica y de la Asociación Latinoamericana de Pediatría

2000, Number 3

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Alerg Asma Inmunol Pediatr 2000; 9 (3)

Open, aleatory, controlled study to evaluate the security and clinical effectiveness of epinastine 10mg syrup versus loratadine 10mg syrup, once a day, during three weeks, in patient pediatric of 6 to 12 years of age with diagnosis of allergic rhinit

Sienra MJJL, López PG, Flores NA, Cortés BP, Linares ZFJ, Ramírez SE, Domínguez HR, Fuente JJ, Rosas VMÁ, Reyes RNI, Río NB

Language: Spanish
References: 32
Page: 86-95
PDF size: 595.02 Kb.


ABSTRACT

Objective: To determine the security and effectiveness of the epinastine 10 mg syrup versus loratadine 10 mg syrup, once A day during three weeks, in patient with allergic rhinitis of 6 to 12 years of age. Material and methods: One study multicentric, open, aleatory, longitudinal, experimental was designed. To the patients included with allergic rhinitis they were divided aleatorily in two groups. After a week of laundry, they were administered during 3: epinastine (E) or loratadine (L), in syrup 10 mg a day in unique dose. According to the sintomatology, to the entrance of the patients the graveness of the rhinitis was classified in absent, light, moderate and severe. The evaluations were every week and one week after having finished the study where they were qualified their improvement according to the investigator and the patient’s perception and they registered the adverse events. The analysis statistical employment measures of central tendency and dispersion and tests of Mantel-Hanzel, paired t, McNemar and exact of Fisher. Results: 81 patients were entered, 44 masculine, 37 feminine, of 6.01 to 12.11 years of age. Significant difference didn’t exist in the qualification of the perennial allergic rhinitis for the investigator for the group E and for the group L (p = 0.147). The qualification for the patient neither had significant difference between both groups. During the three weeks of the period of treatment the global qualification of signs for the investigator showed statistical difference with regard to the basal one (E p = 0.0001 and L p = 0.0001 respectively), but not for intergroup (p = 809). The global qualification of symptoms for the patient presented a similar behavior. The effectiveness evaluated by the investigator didn’t have difference statistical intergroups (p = 0.330), the same evaluation made by the patient showed the same behavior (p = 0.358). The security didn’t show difference significant intergroups (p = 0.50). The events adverse totals were 25 in both groups, qualified as light. The adverse events related with medications were 6 significant difference didn’t exist groups between both (p = 0.1797).


REFERENCES

  1. Sheehan C. Clinical Immunology, Principles and Laboratory Diagnosis. J.B. Lippincott Company 1990, 298-304.

  2. Roitt L et al. Inmunología. 2ª ed., Salvat, 1991, 19.1-19.15

  3. Parker C. Clinical Immunology. Saunders Company 1980, 1375-1431.

  4. Warren BC, Pearlman DS. Allergic Diseases from Infancy to Adulthood, Second Edition, W.B. Saunders Company. Harcourt Brace Jovanovich, Inc. 1988.

  5. Vurman EF. Seasonal Allergic Rhinitis and antihistamine effects on children’s learning. Ann Allergy 1993; 71: 121-6.

  6. Rijntjes E, Ghys I, Rihoux J-P. Astemizole and cetirizine in the treatment of seasonal allergic rhinitis-A comparative double blind multicenter study. J Int Med Res 1990; 18: 219-224.

  7. Storms WW, Bodman SF, Nathan A. SCH434: A new antihistamine/decongestant for seasonal allergic rhinitis. J Allergy Clin Immunol 1989; 83: 1083-1090.

  8. Adamus WS, Oldigs-Kerber J, Lohmann HF. Antihistamine Activity and Central Effects of WAL801CL in man. Eur J Clin Pharmacol 1987; 33:381-85.

  9. Corey JP. Advances in the pharmacotherapy of Allergic Rhinitis: second generation H1-receptor antagonists. Otolaryngol Head Neck Surg 1993; 109: 589-92.

  10. Walther G. New Tetracyclic Guanidine Derivatives with H1-Antihistaminic Properties. Chemistry of Epinastine. Arzneim-Forsch/Drug Res 1990; 40: 44046.

  11. Tasaka K. Effect of Epinastine, A new Antiallergic Agent, on the Central Nervous System. Oyo Yakuri/Pharmacometrics 1989; 38: 53-62.

  12. O’hara N. General Pharmacology of Epinastine Hydrochloride (WAL801CL), an Antiallergic Agent. Jpn Pharmacol Ther 1992; 20: 63-90.

  13. Epinastine Hydrochloride. Drugs of the Future 1987; 12: 1106-7.

  14. Epinastine Hydrochloride. Drugs of the Future 1988; 12: 1090.

  15. Epinastine Hydrochloride. Drugs of the Future 1990; 15: 1215-6.

  16. Fuegner A. Pharmacology of the Antihistamine WAL801CL. Department of Pharmacology Boehringer Ingelheim KG 1983.

  17. Okuda, M, Mogi G, Asakura K, Matsubara A, Baba K, Kiyomo J, Ishida T, Sakata J. Clinical evaluation of WAL801CL (epinastine) for perennial allergic rhinitis-Double blind controlled study using azelastine hydrochloride as a control drug. Otorhinolaringology 1992; 35 (Suppl 2): 61-79.

  18. Schilling JC, Adamus WS, Kuthan H. Antihistaminic activity and side effect profile of epinastine and terfenadine in healthy volunteers. Int J Clin Pharmacol Ther Toxicol 1990; 28: 493-497.

  19. Cortés-Borrego P, López-Pérez G, Sienra-Monge JJL. Estudio comparativo de la eficacia y seguridad de epinastina versus loratadina en el tratamiento de pacientes con rinitis alérgica. Alergia, Asma e Inmunología Pediátricas 1998: 7; 90-97.

  20. Taniguchi Y, Tarmura G, Sakai K, Honma M, Aizawa T. Effects of WAL801CL (epinastine) on allergen inhalation challenge and skin test sensitivity. By a double blind crossover method. J Clin Ther Med 1992; 8 (Suppl 1): 127-138.

  21. Gambardella R. A comparison of the Efficacy of Azelastin nasal spray and Loratadine tablets in the treatment of Seasonal Allergic Rhinitis. J It Med Res 1993; 21: 268-75.

  22. Carlsen KH. Loratadine and Terfenadine in Perennial Allergic Rhinitis. Treatment of non-responders to one drug with the other drug. Allergy 1993; 48: 431-6.

  23. Roman IJ, Dansig MR. Loratadine. A review of recent finding in pharmacology, pharmacokinetics, efficacy and safety with a look at its use in combination with pseudoephedrine. Clin Rev Allergy 1993; 11: 89-110.

  24. Jalowayski AA, Zeiger RS. Examination of nasal and conjunctival specimens. In: Lawlor GJ and Fischer TJ: Manual of allergy and immunology, diagnosis and therapy, 2 ed. Boston, Little Brown and Co. 1986.

  25. Takishima T, Miyamoto T, Shida T, Kishimoto S, Nagano H. Late phase II study of WAL801CL (epinastine) on adult bronchial asthma. Optimal dose finding study. J Clin Ther Med 1992; 8 (Suppl 1): 157-184.

  26. Takishima T, Tamura G, Yamauchi K, Miyamoto T, Shida T. Clinical study of WAL801CL (epinastine) on adult bronchial asthma. Multicenter double blind controlled study vs ketotifen fumarate. J Clin Ther Med 1992; 8 (Suppl 1): 169-197.

  27. Yoshida M, Ishibashi T, Hirose T, Aritomi T, Takihara H. Clinical study of WAL801CL (epinastine hydrochloride) on adult bronchial asthma in long-term treatment. J Clin Ther Med 1992; 8 (Suppl 1): 185-214.

  28. Adamus WS, Oldigs-Kerber J, Lohmann H. Pharmacodynamics of the new H1-antagonist 3-amino-9, 13b-dihydro-1H-dibenz (c, f) imidazol (1, 5-a) azepine hydrochloride in volunteers. Arzneimittelforschung 1987; 37: 569-572.

  29. Juniper EF, Guyatt GH, Dolovich 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: 413-23.

  30. Shelley J. Investigators Drug Brochure. Boehringer Ingelheim.

  31. Fuegner A et al. Pharmacology of the Antihistamine WAL801CL. Department of Pharmacology Boehringer Ingelheim KG 1983.

  32. Tasaka K et al. Antiallergic Effects of Epinastine: the elucidation of the mechanism. Oyo Yakuri/Pharmacometrics 1990; 39: 365-73.




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