Trends in prescribing montelukast in patients with asthma in real-life: Results from the Turkish adult asthma registry
Main Article Content
Keywords
asthma, asthma treatment, leukotriene receptor antagonists, montelukast
Abstract
Montelukast, a leukotriene receptor antagonist (LTRA) approved for the treatment of asthma and allergic rhinitis, is widely used, though real-world data on its application in asthma management remain limited. This registry-based study evaluated the use of montelukast in adult asthma patients, examining demographic and disease characteristics, asthma control status, asthma phenotypes, presence of atopy, and treatment regimens. Among 2053 patients analyzed, 61.76% (n = 1268; mean age: 46.2 ± 14.3 years), predominantly females (~76%), received montelukast. Montelukast users showed higher rates of allergic rhinitis (P < 0.001), hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) (P = 0.008), and chronic rhinosinusitis (P = 0.008). Montelukast group also had higher atopy and total IgE levels and tended to be more eosinophilic. Montelukast was commonly preferred in allergic, eosinophilic, NSAID-exacerbated respiratory disease, and severe asthma phenotypes (P < 0.001). Patients receiving Steps 4 and 5 treatments are more likely to be prescribed montelukast (P < 0.001). Montelukast usage was higher among patients with uncontrolled asthma [ACT< 20 (OR:1.29, 95%CI:1.052–1.582, P = 0.014)]. In addition, logistic regression analyses identified the main factors associated with increased montelukast use as; female gender (OR:1.33, 95%CI:1.041–1.713, P = 0.02), presence of atopy (OR:1.46, 95%CI:1.157–1.864, P = 0.002), comorbid allergic rhinitis (OR:2.12, 95%CI:1.679–2.293, P < 0.001), and severe asthma (OR:2.18, 95%CI:1.712–2.784, P < 0.001). These findings reveal that montelukast use is prevalent among asthma patients, particularly in females, middle-aged adults, and those with comorbid allergic rhinitis, uncontrolled asthma, or specific asthma phenotypes, underscoring the factors that influence its prescription in asthma management.
References
1 Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention; 2022.
2 Baccioglu A, Bavbek S, Damadoglu E, Ediger D, Erkekol FO, Gemicioglu B, et al. Astım Tanı ve Tedavi Rehberi. In: Celik GE, editor. Astımın Kronik Tedavisi Basamak Tedavisi 2022 Güncellemesi. Ankara: Türkiye Ulusal Allerji ve Klinik İmmünoloji Derneği; 2022.
3 Al-Moamary MS, Alhaider SA, Alangari AA, Idrees MM, Zeitouni MO, Al Ghobain MO, et al. The Saudi Initiative for Asthma—2021 update: Guidelines for the diagnosis and management of asthma in adults and children. Ann Thorac Med. 2021;16(1):4–56. 10.4103/atm.ATM_697_20
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5 Singh RK, Gupta S, Dastidar S, Ray A. Cysteinyl leukotrienes and their receptors: Molecular and functional characteristics. Pharmacology. 2010;85(6):336–49. 10.1159/000312669
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12 Trinh HKT, Lee SH, Cao TBT, Park HS. Asthma pharmacotherapy: An update on leukotriene treatments. Expert Rev Respir Med. 2019;13(12):1169–78. 10.1080/17476348.2019.1670640
13 Wermuth HR, Badri T, Takov V. Montelukast. StatPearls. Treasure Island (FL) ineligible companies. 2023.
14 Miligkos M, Bannuru RR, Alkofide H, Kher SR, Schmid CH, Balk EM. Leukotriene-receptor antagonists versus placebo in the treatment of asthma in adults and adolescents: A systematic review and meta-analysis. Ann Intern Med. 2015;163(10):756–67. 10.7326/M15-1059
15 Marcello C, Carlo L. Asthma phenotypes: The intriguing selective intervention with Montelukast. Asthma Res Pract. 2016;2:11. 10.1186/s40733-016-0026-6
16 Paggiaro P, Bacci E. Montelukast in asthma: A review of its efficacy and place in therapy. Ther Adv Chronic Dis. 2011;2(1):47–58. 10.1177/2040622310383343
17 Celik GE, Aydin O, Gokmen D, Koycu Buhari G, Celebi Sozener Z, Gemicioglu B, et al. Picturing asthma in Turkey: Results from the Turkish adult asthma registry. J Asthma. 2023:1–14. 10.1080/02770903.2023.2206902
18 Seo MS, Hillen J, Kang DY, Pratt N, Shin JY. Prescription patterns of asthma preventers among children and adolescents between Australia and South Korea. Front Pharmacol. 2022;13:834116. 10.3389/fphar.2022.834116
19 Lee HY, Sim DW, Lee Y, Park S-Y, Lee S-K, Lee H, et al. Characteristics of severe asthma in the elderly: Observations from the Korean Severe Asthma Registry (KoSAR). Allergy Asthma Immunol Res. 2024;16(3):267–78. 10.4168/aair.2024.16.3.267
20 Hansen S, von Bulow A, Sandin P, Ernstsson O, Janson C, Lehtimaki L, et al. Prevalence and management of severe asthma in the Nordic countries: Findings from the NORDSTAR cohort. ERJ Open Res. 2023;9(2):687-2022. 10.1183/23120541.00687-2022
21 Henriksen DP, Davidsen JR, Laursen CB, Christiansen A, Damkier P, Hallas J, et al. Montelukast use-a 19-year nationwide drug utilisation study. Eur J Clin Pharmacol. 2017;73(10):1297–304. 10.1007/s00228-017-2286-3
22 James DR, Lyttle MD. British guideline on the management of asthma: SIGN Clinical Guideline 141, 2014. Arch Dis Child Educ Pract Ed. 2016;101(6):319–22. 10.1136/archdischild-2015-310145
23 NICE. 2021 exceptional surveillance of asthma: Diagnosis, monitoring and chronic asthma management (NICE guideline NG80). London; 2021.
24 Price D, Musgrave SD, Shepstone L, Hillyer EV, Sims EJ, Gilbert RF, et al. Leukotriene antagonists as first-line or add-on asthma-controller therapy. N Engl J Med. 2011;364(18):1695–707. 10.1056/NEJMoa1010846
25 Wu AC, Li L, Fung V, Kharbanda EO, Larkin EK, Vollmer WM, et al. Use of leukotriene receptor antagonists are associated with a similar risk of asthma exacerbations as inhaled corticosteroids. J Allergy Clin Immunol Pract. 2014;2(5):607–13. 10.1016/j.jaip.2014.05.009
26 Kowalski ML, Agache I, Bavbek S, Bakirtas A, Blanca M, Bochenek G, et al. Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper. Allergy. 2019;74(1):28–39. 10.1111/all.13599
27 Dahlen SE, Malmstrom K, Nizankowska E, Dahlen B, Kuna P, Kowalski M, et al. Improvement of aspirin-intolerant asthma by montelukast, a leukotriene antagonist: A randomized, double-blind, placebo-controlled trial. Am J Respir Crit Care Med. 2002;165(1):9–14. 10.1164/ajrccm.165.1.2010080
28 Mastalerz L, Nizankowska E, Sanak M, Mejza F, Pierzchalska M, Bazan-Socha S, et al. Clinical and genetic features underlying the response of patients with bronchial asthma to treatment with a leukotriene receptor antagonist. Eur J Clin Invest. 2002;32(12):949–55. 10.1046/j.1365-2362.2002.01088.x
29 Chowdhury NU, Guntur VP, Newcomb DC, Wechsler ME. Sex and gender in asthma. Eur Respir Rev. 2021;30(162):210067. 10.1183/16000617.0067-2021
30 Disease GBD, Injury I, Prevalence C. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1211–59. 10.1016/S0140-6736(17)32154-2
31 Schatz M, Camargo CA, Jr. The relationship of sex to asthma prevalence, health care utilization, and medications in a large managed care organization. Ann Allergy Asthma Immunol. 2003;91(6):553–8. 10.1016/S1081-1206(10)61533-5
32 Wang E, Wechsler ME, Tran TN, Heaney LG, Jones RC, Menzies-Gow AN, et al. Characterization of severe asthma worldwide: Data from the International Severe Asthma Registry. Chest. 2020;157(4):790–804. 10.1016/j.chest.2019.10.053
33 El-Husseini ZW, Gosens R, Dekker F, Koppelman GH. The genetics of asthma and the promise of genomics-guided drug target discovery. Lancet Respir Med. 2020;8(10):1045–56. 10.1016/S2213-2600(20)30363-5
34 Han YY, Forno E, Celedon JC. Sex steroid hormones and asthma in a nationwide study of US adults. Am J Respir Crit Care Med. 2020;201(2):158–66. 10.1164/rccm.201905-0996OC
35 Gomez JL. Epigenetics in asthma. Curr Allergy Asthma Rep. 2019;19(12):56. 10.1007/s11882-019-0886-y
36 Makhinova T, Barner JC, Richards KM, Rascati KL. Asthma controller medication adherence, risk of exacerbation, and use of rescue agents among Texas medicaid patients with persistent asthma. J Manag Care Spec Pharm. 2015;21(12):1124–32. 10.18553/jmcp.2015.21.12.1124
37 Williams LK PM, Xi H, Peterson EL, Joseph C, Lafata JE, Ownby DR, Johnson CC. Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J Allergy Clin Immunol. 2004;114(6):1288–93. 10.1016/j.jaci.2004.09.028
38 Hong SH, Kang HR, Nam JH, Park SK, Kim TB, Lee EK. A comparison of leukotriene receptor antagonists to low-dose inhaled corticosteroids in the elderly with mild asthma. J Allergy Clin Immunol Pract. 2019;7(8):2642–52 e3. 10.1016/j.jaip.2019.05.006
39 Federman AD, Wolf MS, Sofianou A, Martynenko M, O’Connor R, Halm EA, et al. Self-management behaviors in older adults with asthma: Associations with health literacy. J Am Geriatr Soc. 2014;62(5):872–9. 10.1111/jgs.12797
40 Baig S, Khan RA, Khan K, Rizvi N. Effectiveness and quality of life with montelukast in asthma—A double-blind randomized control trial. Pak J Med Sci. 2019;35(3):731–6. 10.12669/pjms.35.3.42
41 Chauhan BF, Jeyaraman MM, Singh Mann A, Lys J, Abou-Setta AM, Zarychanski R, et al. Addition of anti-leukotriene agents to inhaled corticosteroids for adults and adolescents with persistent asthma. Cochrane Database Syst Rev. 2017;3(3):CD010347. 10.12669/pjms.35.3.42
2 Baccioglu A, Bavbek S, Damadoglu E, Ediger D, Erkekol FO, Gemicioglu B, et al. Astım Tanı ve Tedavi Rehberi. In: Celik GE, editor. Astımın Kronik Tedavisi Basamak Tedavisi 2022 Güncellemesi. Ankara: Türkiye Ulusal Allerji ve Klinik İmmünoloji Derneği; 2022.
3 Al-Moamary MS, Alhaider SA, Alangari AA, Idrees MM, Zeitouni MO, Al Ghobain MO, et al. The Saudi Initiative for Asthma—2021 update: Guidelines for the diagnosis and management of asthma in adults and children. Ann Thorac Med. 2021;16(1):4–56. 10.4103/atm.ATM_697_20
4 Cuzzo B, Lappin SL. Physiology, leukotrienes. StatPearls. Treasure Island (FL) ineligible companies. Disclosure: Sarah Lappin declares no relevant financial relationships with ineligible companies. 2023.
5 Singh RK, Gupta S, Dastidar S, Ray A. Cysteinyl leukotrienes and their receptors: Molecular and functional characteristics. Pharmacology. 2010;85(6):336–49. 10.1159/000312669
6 Mendez-Enriquez E, Hallgren J. Mast cells and their progenitors in allergic asthma. Front Immunol. 2019;10:821. 10.3389/fimmu.2019.00821
7 Hallstrand TS, Henderson WR, Jr. An update on the role of leukotrienes in asthma. Curr Opin Allergy Clin Immunol. 2010;10(1):60–6. 10.1097/ACI.0b013e32833489c3
8 Yokomizo T, Nakamura M, Shimizu T. Leukotriene receptors as potential therapeutic targets. J Clin Invest. 2018;128(7):2691–701. 10.1172/JCI97946
9 Lee YJ, Kim CK. Montelukast use over the past 20 years: Monitoring of its effects and safety issues. Clin Exp Pediatr. 2020;63(10):376–81. 10.3345/cep.2019.00325
10 New NHLBI guidelines for the diagnosis and management of asthma. National Heart, Lung and Blood Institute. Lippincott Health Promot Lett. 1997;2(7):1, 8–9.
11 Choi J, Azmat CE. Leukotriene Receptor Antagonists. StatPearls. Treasure Island (FL) ineligible companies. Disclosure: Chaudhary Ehtsham Azmat declares no relevant financial relationships with ineligible companies. 2023.
12 Trinh HKT, Lee SH, Cao TBT, Park HS. Asthma pharmacotherapy: An update on leukotriene treatments. Expert Rev Respir Med. 2019;13(12):1169–78. 10.1080/17476348.2019.1670640
13 Wermuth HR, Badri T, Takov V. Montelukast. StatPearls. Treasure Island (FL) ineligible companies. 2023.
14 Miligkos M, Bannuru RR, Alkofide H, Kher SR, Schmid CH, Balk EM. Leukotriene-receptor antagonists versus placebo in the treatment of asthma in adults and adolescents: A systematic review and meta-analysis. Ann Intern Med. 2015;163(10):756–67. 10.7326/M15-1059
15 Marcello C, Carlo L. Asthma phenotypes: The intriguing selective intervention with Montelukast. Asthma Res Pract. 2016;2:11. 10.1186/s40733-016-0026-6
16 Paggiaro P, Bacci E. Montelukast in asthma: A review of its efficacy and place in therapy. Ther Adv Chronic Dis. 2011;2(1):47–58. 10.1177/2040622310383343
17 Celik GE, Aydin O, Gokmen D, Koycu Buhari G, Celebi Sozener Z, Gemicioglu B, et al. Picturing asthma in Turkey: Results from the Turkish adult asthma registry. J Asthma. 2023:1–14. 10.1080/02770903.2023.2206902
18 Seo MS, Hillen J, Kang DY, Pratt N, Shin JY. Prescription patterns of asthma preventers among children and adolescents between Australia and South Korea. Front Pharmacol. 2022;13:834116. 10.3389/fphar.2022.834116
19 Lee HY, Sim DW, Lee Y, Park S-Y, Lee S-K, Lee H, et al. Characteristics of severe asthma in the elderly: Observations from the Korean Severe Asthma Registry (KoSAR). Allergy Asthma Immunol Res. 2024;16(3):267–78. 10.4168/aair.2024.16.3.267
20 Hansen S, von Bulow A, Sandin P, Ernstsson O, Janson C, Lehtimaki L, et al. Prevalence and management of severe asthma in the Nordic countries: Findings from the NORDSTAR cohort. ERJ Open Res. 2023;9(2):687-2022. 10.1183/23120541.00687-2022
21 Henriksen DP, Davidsen JR, Laursen CB, Christiansen A, Damkier P, Hallas J, et al. Montelukast use-a 19-year nationwide drug utilisation study. Eur J Clin Pharmacol. 2017;73(10):1297–304. 10.1007/s00228-017-2286-3
22 James DR, Lyttle MD. British guideline on the management of asthma: SIGN Clinical Guideline 141, 2014. Arch Dis Child Educ Pract Ed. 2016;101(6):319–22. 10.1136/archdischild-2015-310145
23 NICE. 2021 exceptional surveillance of asthma: Diagnosis, monitoring and chronic asthma management (NICE guideline NG80). London; 2021.
24 Price D, Musgrave SD, Shepstone L, Hillyer EV, Sims EJ, Gilbert RF, et al. Leukotriene antagonists as first-line or add-on asthma-controller therapy. N Engl J Med. 2011;364(18):1695–707. 10.1056/NEJMoa1010846
25 Wu AC, Li L, Fung V, Kharbanda EO, Larkin EK, Vollmer WM, et al. Use of leukotriene receptor antagonists are associated with a similar risk of asthma exacerbations as inhaled corticosteroids. J Allergy Clin Immunol Pract. 2014;2(5):607–13. 10.1016/j.jaip.2014.05.009
26 Kowalski ML, Agache I, Bavbek S, Bakirtas A, Blanca M, Bochenek G, et al. Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper. Allergy. 2019;74(1):28–39. 10.1111/all.13599
27 Dahlen SE, Malmstrom K, Nizankowska E, Dahlen B, Kuna P, Kowalski M, et al. Improvement of aspirin-intolerant asthma by montelukast, a leukotriene antagonist: A randomized, double-blind, placebo-controlled trial. Am J Respir Crit Care Med. 2002;165(1):9–14. 10.1164/ajrccm.165.1.2010080
28 Mastalerz L, Nizankowska E, Sanak M, Mejza F, Pierzchalska M, Bazan-Socha S, et al. Clinical and genetic features underlying the response of patients with bronchial asthma to treatment with a leukotriene receptor antagonist. Eur J Clin Invest. 2002;32(12):949–55. 10.1046/j.1365-2362.2002.01088.x
29 Chowdhury NU, Guntur VP, Newcomb DC, Wechsler ME. Sex and gender in asthma. Eur Respir Rev. 2021;30(162):210067. 10.1183/16000617.0067-2021
30 Disease GBD, Injury I, Prevalence C. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1211–59. 10.1016/S0140-6736(17)32154-2
31 Schatz M, Camargo CA, Jr. The relationship of sex to asthma prevalence, health care utilization, and medications in a large managed care organization. Ann Allergy Asthma Immunol. 2003;91(6):553–8. 10.1016/S1081-1206(10)61533-5
32 Wang E, Wechsler ME, Tran TN, Heaney LG, Jones RC, Menzies-Gow AN, et al. Characterization of severe asthma worldwide: Data from the International Severe Asthma Registry. Chest. 2020;157(4):790–804. 10.1016/j.chest.2019.10.053
33 El-Husseini ZW, Gosens R, Dekker F, Koppelman GH. The genetics of asthma and the promise of genomics-guided drug target discovery. Lancet Respir Med. 2020;8(10):1045–56. 10.1016/S2213-2600(20)30363-5
34 Han YY, Forno E, Celedon JC. Sex steroid hormones and asthma in a nationwide study of US adults. Am J Respir Crit Care Med. 2020;201(2):158–66. 10.1164/rccm.201905-0996OC
35 Gomez JL. Epigenetics in asthma. Curr Allergy Asthma Rep. 2019;19(12):56. 10.1007/s11882-019-0886-y
36 Makhinova T, Barner JC, Richards KM, Rascati KL. Asthma controller medication adherence, risk of exacerbation, and use of rescue agents among Texas medicaid patients with persistent asthma. J Manag Care Spec Pharm. 2015;21(12):1124–32. 10.18553/jmcp.2015.21.12.1124
37 Williams LK PM, Xi H, Peterson EL, Joseph C, Lafata JE, Ownby DR, Johnson CC. Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J Allergy Clin Immunol. 2004;114(6):1288–93. 10.1016/j.jaci.2004.09.028
38 Hong SH, Kang HR, Nam JH, Park SK, Kim TB, Lee EK. A comparison of leukotriene receptor antagonists to low-dose inhaled corticosteroids in the elderly with mild asthma. J Allergy Clin Immunol Pract. 2019;7(8):2642–52 e3. 10.1016/j.jaip.2019.05.006
39 Federman AD, Wolf MS, Sofianou A, Martynenko M, O’Connor R, Halm EA, et al. Self-management behaviors in older adults with asthma: Associations with health literacy. J Am Geriatr Soc. 2014;62(5):872–9. 10.1111/jgs.12797
40 Baig S, Khan RA, Khan K, Rizvi N. Effectiveness and quality of life with montelukast in asthma—A double-blind randomized control trial. Pak J Med Sci. 2019;35(3):731–6. 10.12669/pjms.35.3.42
41 Chauhan BF, Jeyaraman MM, Singh Mann A, Lys J, Abou-Setta AM, Zarychanski R, et al. Addition of anti-leukotriene agents to inhaled corticosteroids for adults and adolescents with persistent asthma. Cochrane Database Syst Rev. 2017;3(3):CD010347. 10.12669/pjms.35.3.42
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Jan 1, 2025
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Beyaz, Şengül, Erdinç, M., Hayme, S., Feyza Aslan, A., Aydın, Ömür, Gökmen, D., Köycü Buhari, G., Çelebi Sözener, Z., Gemicioğlu, B., Bulut, İsmet, Örçen, C., Kepil Özdemir, S., Keren, M., Damadoğlu, E., Yakut, T., Füsun Kalpaklıoğlu, A., Baccıoğlu, A., Alan Yalım, S., Yılmaz, İnsu, … Elif Çelik, G. (2025). Trends in prescribing montelukast in patients with asthma in real-life: Results from the Turkish adult asthma registry. Allergologia Et Immunopathologia, 53(1), 12-25. https://doi.org/10.15586/aei.v53i1.1183
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Beyaz, Şengül, Erdinç, M., Hayme, S., Feyza Aslan, A., Aydın, Ömür, Gökmen, D., Köycü Buhari, G., Çelebi Sözener, Z., Gemicioğlu, B., Bulut, İsmet, Örçen, C., Kepil Özdemir, S., Keren, M., Damadoğlu, E., Yakut, T., Füsun Kalpaklıoğlu, A., Baccıoğlu, A., Alan Yalım, S., Yılmaz, İnsu, … Elif Çelik, G. (2025). Trends in prescribing montelukast in patients with asthma in real-life: Results from the Turkish adult asthma registry. Allergologia Et Immunopathologia, 53(1), 12-25. https://doi.org/10.15586/aei.v53i1.1183