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Биластин – новый антигистаминный препарат II поколения
Дворянкова Е.В. Биластин – новый антигистаминный препарат II поколения. Дерматология (Прил. к журн. Consilium Medicum). 2019; 2: 10–12. DOI: 10.26442/24143537.2019.2.190371
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Dvoriankova E.V. Bilastine – a new second generation H1-antihistamine drug. Dermatology (Suppl. Consilium Medicum). 2019; 2: 10–12. DOI: 10.26442/24143537.2019.2.190371
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Аннотация
Биластин – новый антигистаминный препарат II поколения, который является результатом эволюции в исследованиях антигистаминных лекарственных средств, касающихся эффективности и безопасности. В ходе проведения ряда клинических исследований была продемонстрирована эффективность биластина в терапии аллергического ринита и идиопатической крапивницы, а также улучшения качества жизни больных на фоне приема данного препарата. Профиль безопасности биластина схож с аналогичным показателем в группах пациентов, получавших плацебо. Баланс эффективности и безопасности биластина сохраняется при повышении стандартной дозировки в 4 раза.
Ключевые слова: антигистаминные препараты, биластин, аллергический ринит, хроническая крапивница, эффективность, безопасность.
Ключевые слова: антигистаминные препараты, биластин, аллергический ринит, хроническая крапивница, эффективность, безопасность.
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Bilastine is a new second generation H1-antihistamine drug which epitomizes the evolution of research on antihistamines concerning both efficacy and safety. A number of clinical studies demonstrated bilastine efficacy for the treatment of allergic rhinitis and idiopathic urticaria as well as improvement of patients' quality of life while taking this drug. The safety profile of bilastine was similar to that in the groups of patients who received placebo. The balance of efficacy and safety of bilastine is maintained with an increase in the standard dosage of 4 times.
Key words: antihistamines, bilastine, allergic rhinitis, chronic urticaria, efficacy, safety.
Полный текст
Список литературы
1. Maintz L, Novak N. Histamine and histamine intolerance. Am J Clin Nutr 2007; 85: 1185–6.
2. Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin Exp Allergy 2002; p. 32489–98.
3. Hill SJ, Ganelin CR, Timmerman H et al. International Union of Pharmacology. XIII. Classification of histamine receptors. Pharmacol Rev 1997; 49: 253–78.
4. Bovet D, Staub AM. Action protective de ethers phenoliques au cours de l’ntoxication histaminique. Compt Rend Soc Biol 1937; 124: 547–9.
5. Milligan G, Bond RA, Lee M. Inverse agonism: pharmacological curiosity or potential therapeutic strategy? Trends Pharmacol Sci 1995; 16: 10–3.
6. Bakker RA, Schoonus SB, Smit MJ et al. Histamine H(1)-receptor activation of nuclear factor-kappa B: roles for G beta gamma- and G alpha(q/11)-subunits in constitutive and agonistmediated signaling. Mol Pharmacol 2001; 60: 1133–42.
7. Corcóstegui R, Labeaga L, Innerárity A et al. Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist: receptor selectivity and in vitro antihistaminic activity. Drugs R D 2005; 6 (6): 371–84.
8. Corcóstegui R, Labeaga L, Innerárity A et al. In vivo pharmacological characterisation of bilastine, a potent and selective histamine H1 receptor antagonist. Drugs R D 2006; 7 (4): 219–31.
9. Alvarez-Mon M, San Antonio E, Lucero M et al. Bilastine, a novel antihistamine that preferentially inhibits histamine and interleukin-4 release from human mast cells and granulocytes. Allergy 2009; 64 (Suppl. 90): 555.
10. Jauregizar N, de la Fuente L, Lucero ML et al. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet 2009; 48 (8): 543–54.
11. Lucero ML, Gonzalo A, Ganza A et al. Interactions of bilastine, a new oral H (1) antihistamine, with human transporter systems. Drug Chem Toxicol 2012; 35 (Suppl. 1): 8–17.
12. Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010; 59 (5): 391–8.
13. 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: 158–65.
14. 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, parallelgroup study. Clin Exp Allergy 2009; 39: 1338–47.
15. Zuberbier T, Oanta A, Bogacka E et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 2010; 65 (4): 516–28.
16. Farré M, Pérez-Mañá C, Papaseit E et al. Bilastine vs. hydroxyzine: occupation of brain histamine H1-receptors evaluated by positron emission tomography in healthy volunteers. Br J Clin Pharmacol 2014; 78 (5): 970–80.
17. Tyl B, Kabbaj M, Azzam S et al. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol 2012; 52 (6): 893–903.
18. García-Gea C, Martínez J, Ballester MR et al. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials. Hum Psychopharmacol 2014; 29 (2): 120–32.
19. Graff C, Struijk JJ, Kanters JK et al. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig 2012; 32 (5): 339–51.
2. Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin Exp Allergy 2002; p. 32489–98.
3. Hill SJ, Ganelin CR, Timmerman H et al. International Union of Pharmacology. XIII. Classification of histamine receptors. Pharmacol Rev 1997; 49: 253–78.
4. Bovet D, Staub AM. Action protective de ethers phenoliques au cours de l’ntoxication histaminique. Compt Rend Soc Biol 1937; 124: 547–9.
5. Milligan G, Bond RA, Lee M. Inverse agonism: pharmacological curiosity or potential therapeutic strategy? Trends Pharmacol Sci 1995; 16: 10–3.
6. Bakker RA, Schoonus SB, Smit MJ et al. Histamine H(1)-receptor activation of nuclear factor-kappa B: roles for G beta gamma- and G alpha(q/11)-subunits in constitutive and agonistmediated signaling. Mol Pharmacol 2001; 60: 1133–42.
7. Corcóstegui R, Labeaga L, Innerárity A et al. Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist: receptor selectivity and in vitro antihistaminic activity. Drugs R D 2005; 6 (6): 371–84.
8. Corcóstegui R, Labeaga L, Innerárity A et al. In vivo pharmacological characterisation of bilastine, a potent and selective histamine H1 receptor antagonist. Drugs R D 2006; 7 (4): 219–31.
9. Alvarez-Mon M, San Antonio E, Lucero M et al. Bilastine, a novel antihistamine that preferentially inhibits histamine and interleukin-4 release from human mast cells and granulocytes. Allergy 2009; 64 (Suppl. 90): 555.
10. Jauregizar N, de la Fuente L, Lucero ML et al. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet 2009; 48 (8): 543–54.
11. Lucero ML, Gonzalo A, Ganza A et al. Interactions of bilastine, a new oral H (1) antihistamine, with human transporter systems. Drug Chem Toxicol 2012; 35 (Suppl. 1): 8–17.
12. Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010; 59 (5): 391–8.
13. 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: 158–65.
14. 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, parallelgroup study. Clin Exp Allergy 2009; 39: 1338–47.
15. Zuberbier T, Oanta A, Bogacka E et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 2010; 65 (4): 516–28.
16. Farré M, Pérez-Mañá C, Papaseit E et al. Bilastine vs. hydroxyzine: occupation of brain histamine H1-receptors evaluated by positron emission tomography in healthy volunteers. Br J Clin Pharmacol 2014; 78 (5): 970–80.
17. Tyl B, Kabbaj M, Azzam S et al. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol 2012; 52 (6): 893–903.
18. García-Gea C, Martínez J, Ballester MR et al. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials. Hum Psychopharmacol 2014; 29 (2): 120–32.
19. Graff C, Struijk JJ, Kanters JK et al. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig 2012; 32 (5): 339–51.
________________________________________________
1. Maintz L, Novak N. Histamine and histamine intolerance. Am J Clin Nutr 2007; 85: 1185–6.
2. Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin Exp Allergy 2002; p. 32489–98.
3. Hill SJ, Ganelin CR, Timmerman H et al. International Union of Pharmacology. XIII. Classification of histamine receptors. Pharmacol Rev 1997; 49: 253–78.
4. Bovet D, Staub AM. Action protective de ethers phenoliques au cours de l’ntoxication histaminique. Compt Rend Soc Biol 1937; 124: 547–9.
5. Milligan G, Bond RA, Lee M. Inverse agonism: pharmacological curiosity or potential therapeutic strategy? Trends Pharmacol Sci 1995; 16: 10–3.
6. Bakker RA, Schoonus SB, Smit MJ et al. Histamine H(1)-receptor activation of nuclear factor-kappa B: roles for G beta gamma- and G alpha(q/11)-subunits in constitutive and agonistmediated signaling. Mol Pharmacol 2001; 60: 1133–42.
7. Corcóstegui R, Labeaga L, Innerárity A et al. Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist: receptor selectivity and in vitro antihistaminic activity. Drugs R D 2005; 6 (6): 371–84.
8. Corcóstegui R, Labeaga L, Innerárity A et al. In vivo pharmacological characterisation of bilastine, a potent and selective histamine H1 receptor antagonist. Drugs R D 2006; 7 (4): 219–31.
9. Alvarez-Mon M, San Antonio E, Lucero M et al. Bilastine, a novel antihistamine that preferentially inhibits histamine and interleukin-4 release from human mast cells and granulocytes. Allergy 2009; 64 (Suppl. 90): 555.
10. Jauregizar N, de la Fuente L, Lucero ML et al. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet 2009; 48 (8): 543–54.
11. Lucero ML, Gonzalo A, Ganza A et al. Interactions of bilastine, a new oral H (1) antihistamine, with human transporter systems. Drug Chem Toxicol 2012; 35 (Suppl. 1): 8–17.
12. Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010; 59 (5): 391–8.
13. 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: 158–65.
14. 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, parallelgroup study. Clin Exp Allergy 2009; 39: 1338–47.
15. Zuberbier T, Oanta A, Bogacka E et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 2010; 65 (4): 516–28.
16. Farré M, Pérez-Mañá C, Papaseit E et al. Bilastine vs. hydroxyzine: occupation of brain histamine H1-receptors evaluated by positron emission tomography in healthy volunteers. Br J Clin Pharmacol 2014; 78 (5): 970–80.
17. Tyl B, Kabbaj M, Azzam S et al. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol 2012; 52 (6): 893–903.
18. García-Gea C, Martínez J, Ballester MR et al. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials. Hum Psychopharmacol 2014; 29 (2): 120–32.
19. Graff C, Struijk JJ, Kanters JK et al. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig 2012; 32 (5): 339–51.
Авторы
Е.В. Дворянкова*
ФГБУН «Центр теоретических проблем физико-химической фармакологии» РАН, Москва, Россия
*dvoriankova@mail.ru
ФГБУН «Центр теоретических проблем физико-химической фармакологии» РАН, Москва, Россия
*dvoriankova@mail.ru
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E.V. Dvoriankova*
Center for Theoretical Problems of Physicochemical Pharmacology of the Russian Academy of Sciences, Moscow, Russia
*dvoriankova@mail.ru
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