The use of controller medications in the management of pediatric bronchial asthma - Dynamic patterns of LTRA (montelukast) use

Dynamic patterns of LTRA (montelukast) use ISSN: 2394-0026 (P)Original Research Article ISSN: 2394-0034 (O) The use of controller medications in themanagement of pediatric bronchial asthma -Dynamic patterns of LTRA (montelukast) useAnna Todorova1*, Antoaneta Tsvetkova2, Silvia Mihaylova2 1Faculty of Pharmacy, Medical University of Varna, Bulgaria2Assistant Pharmacist, Education and Research Center, Medical College of Varna, Bulgaria*Corresponding author email: [email protected] to cite this article: Anna Todorova, Antoaneta Tsvetkova, Silvia Mihaylova. The use ofcontroller medications in the management of pediatric bronchial asthma - Dynamic patterns of LTRA(montelukast) use. IAIM, 2015; 2(3): 40-46.Available online at www.iaimjournal.comReceived on: 20-02-2015 Accepted on: 26-02-2015AbstractOver the last few years, bronchial asthma morbidity in pediatric patients has been constantly rising.Asthma is considered the most common disease in adolescents. Our survey was focused on two agegroups of pediatric patients: 6 to 12 years old and 13 to 16 years old. It encompassed the periodfrom 2008 to 2013. We examined the use patterns of LTRA (montelukast) and its substantial share ofthe overall use of asthma controller medications. The results revealed a distinctive upward trend inthe use of LTRA (montelukast) in both age groups. The mean absolute growth of montelukast (5 mg)in the group of 6 to 12 years old was 521.6 packs, and the mean growth rate was 333.9%. In the agegroup of 13 to 16 years old, the mean absolute growth of montelukast (5 mg and 10 mg) was 226.8packs, and the mean growth rate was 341.3%. Both the drug profile and physicians’ propensity toprescribe innovative medicines promote the use of LTRA (montelukast) as an asthma control drugfor childhood patients.Key wordsAsthma, Control, LTRA, Montelukast, Use.Introduction and asthma prevalence in children has been constantly rising [1, 2]. The main purpose ofOver the last several decades, and especially GINA (the Global Initiative for Asthma) is toover the last couple of years, asthma morbidity develop a global strategy for better long-termhas increased worldwide. According to data management of asthma and asthma preventionprovided by WHO, the number of people with [3, 4]. The contemporary trends in asthmaasthma in the world is as high as 300 million,International Archives of Integrated Medicine, Vol. 2, Issue 3, March, 2015. Page 40Copy right © 2015, IAIM, All Rights Reserved.

Dynamic patterns of LTRA (montelukast) use ISSN: 2394-0026 (P) ISSN: 2394-0034 (O)management reveal a shift from relievers to Material and methodscontroller medications [5, 6, 7, 8, 9]. The We performed an analysis of the medicines withpatterns in the use of controllers and montelukast active ingredient used for thebronchodilators, as well as the ratio between treatment of children with asthma. The analysisthese two drug groups, are reliable indicators for was based on an exhaustive retrospective studythe quality of asthma treatment and of prescriptions fully or partially reimbursed bypredetermine the therapeutic outcome [10]. the NHIF (National Health Insurance Fund).Researches focused on the use of asthma Drug use data were collected from acontroller medications show that leukotriene representative sample of 37 communityinhibitors, and in particular – montelukast, pharmacies in the town of Varna (out of 148constitute a considerable portion of all the pharmacies in 2013). The selected pharmaciesadministered controller medications [8, 9]. had a cost-reimbursement contract with the NHIF and were situated in town areas withAs an alternative to the treatment with inhaled younger population.corticosteroids (ICS), leukotriene receptorantagonist (LTRA) can be administered as a The analysis was based on the medicinesmonotherapy to patients with mild persistent prescribed to pediatric patients in two ageasthma. Respectively, they can be administered groups (6 to 12 years old and 13 to 16 years old)as an adjunctive therapy to pediatric patients for the period 2008-2013.with moderate or severe asthma. Theadministration of leukotriene receptor Results and Discussionantagonists facilitates the decrease of inhaled The findings of our survey indicated that the usecorticosteroids doses [11]. Leukotriene of asthma controller medications in Bulgaria hasinhibitors suppress asthmatic responses to been increasing in line with global trends. Theallergens, exercise, and cold dry air [12]. increase has affected the group of controller medications as a whole and the separateThe treatment of allergic rhinitis with members of the group alike.montelukast also shows a good therapeuticoutcome. Montelukast is often favoured as a The group of LTRA medicines, immediatelymonotherapy for patients with mild to followed by ICS, has experienced the mostmoderate-severe persistent asthma and allergic significant increase (total number of packs sold)rhinitis [12]. in the age group 6-12 years. There was a slight increase in the use of ICS/LABA combinationThe profile of montelukast makes this drug the drugs in the period 2008 - 2012, followed by amost favoured one for the treatment of decrease in 2013. There was a slight upwardrespiratory allergies in childhood. trend in the use of SABA medications as per Graph – 1.ObjectivesTo examine the major drug groups used for the The results received in the age group 13-16treatment of pediatric asthma and to track the years reveal a strong upward trend in the use ofupward trend in the dynamic patterns of LTRA medicines. The group of ICS experiences anmontelukast (LTRA) use. uneven upward trend, and the use of ICB/LABAInternational Archives of Integrated Medicine, Vol. 2, Issue 3, March, 2015. Page 41Copy right © 2015, IAIM, All Rights Reserved.

Dynamic patterns of LTRA (montelukast) use ISSN: 2394-0026 (P) ISSN: 2394-0034 (O)combination drugs exceeded the use of ICS after controller medications are used for the2012. There was a constant upward trend in the management of asthma control [4].use of SABA medications. Still, they are the leastprescribed medicines among the surveyed There was a distinctive upward trend in the usemedicines as per Graph – 2. of LTRA – montelukast. We inferred that the increase of LTRA use is determined by its profile.The increase in the use of SABA drugs registered Montelukast can be used both at the initial stagein both age groups implies poor asthma control, of a persistent asthma monotherapy (instead ofmore pronounced in the group 13-16 years. ICS), or as an adjunctive therapy to the treatment with ICS in cases of poor asthmaSurveys in the United States, Australia and control [4].Europe indicated a change in the medicationsused to prevent asthma in childhood, with an The convenience of the oral-route drugincrease in leukotriene receptor antagonists, administration probably underpins the frequentinhaled corticosteroids, and long-acting β- use of leukotriene antagonists because patientsagonists [5, 8, 9]. often fail to acquire and maintain adequate inhaler technique as an essential element of theAccording to the findings of our survey, inhaler therapy.controller medications constitute the greatestportion of drugs administered for outpatient The sales patterns of montelukast (the producttreatment in both survey groups. Short-acting β- with the most clear-cut trend of increase) inagonist (SABA) hold the modest share in the both age groups were as per Table – 1 and Tablesales of asthma drugs - 6.06% in the age group - 2.6-12 years, and 9.21% in the age group 13-16years. The percentage distribution of drugs most In 2013, the absolute growth of montelukast 5frequently used for pediatric asthma treatment mg in the age group 6-12 years is 806 packages.as per Graph – 3 and Graph - 4. There had been a steady upward trend in the use of montelukast 5 mg over the period 2008-According to the findings of our survey, the most 2013. The mean absolute growth was 521.6frequently used asthma drug was montelukast – packs, and the mean growth rate was 339.3%.46.01% in the age group 6-12 years, and 50.76%in the age group 13-16 years. The second most- The use of montelukast 5 mg and 10 mg in theused drugs were the inhaled corticosteroids – age group 13-16 years had been constantly39.74% in the age group 6-12 years, and 21.73% increasing over the survey period. Its absolutein the age group 13-16 years. The third most- growth for 2013 was 324 packages. The meanused group of drugs was the group of combined absolute growth was 226.8 packs, and the meanICS – respectively 8.19% and 18.3%. growth rate was 341.3%.The results showed that in general, the Undoubtedly the increased use of montelukastprescription patterns follow GINA’s had been underpinned by the implementedrecommendations and therapeutic guidelines. government policy on the generic drug use.The use of short-acting β agonist is confined only When the brand-name product faced a patentto symptom relief when necessary, whereas expiration in 2009, alternative generic medicines with competitive prices entered the market.International Archives of Integrated Medicine, Vol. 2, Issue 3, March, 2015. Page 42Copy right © 2015, IAIM, All Rights Reserved.

Dynamic patterns of LTRA (montelukast) use ISSN: 2394-0026 (P) ISSN: 2394-0034 (O)Generic drugs are “therapeutically equivalent”, asthma. Drugs Today (Barc), 2008; 44(11):hence assumed to provide therapeutic results 845-55.equivalent to those of the original product [13]. 2. http://www.who.int/inf-fs/en/fact206.html. World Health Organization. BronchialCheaper analogues have been NHIF’s favoured asthma. WHO Fact Sheet # 206.choice for reimbursement after the entry of 3. Peroni DG, Piacentini GL, Ress M, Bodini A,generic drugs. Thus, the treatment costs have Loiacono A, Aralla R, Boner AL. Time efficacybeen reduced and savings have been allocated of a single dose of montelukast on exercise-for alternative projects. The comparison induced asthma in children., Pediatr. Allergybetween the reimbursement patterns of the Immunol., 2002; 13(6): 434-7.brand name product and the montelukast 4. http://www.ginasthma.org.GINA. Globalgeneric analogues was as per Graph - 5. Strategy for Asthma Management and Prevention, 2012.We can summarize the factors underpinning the 5. Brian K. Kit, Alan E. Simon, Cynthia L. Ogden,increased use of montelukast sodium in Bulgaria Lara J. Akinbami. Trends in Preventiveas follows: Asthma Medication Use Among Children• The drug profile and physicians’ and Adolescents 1988 -2008. Pediatrics,propensity to innovative medical 2012; 129: 1–8.products. 6. Davidsen JR. Drug utilization and asthma• Patent expiration of the brand name control among young Danish adults withproduct in 2009, followed by the entry asthma. Analyses of trends andof generic products. determinants. Dan Med J., 2012; 59(8):• The increased number of consumers as B4501.a result from the reduced financial 7. Janson C., R. de Marco, S. Accordini, E.pressure on the health insurance funds, Almar, M. Bugiani, A. Carolei, et al. Changesand the improved access to medicines in the use of anti-asthmatic medication in anafter 2009. international cohort. Eur Respir J, 2005; 26: 1047–1055.Conclusion 8. Miller G. E., Sarpong E. M. Trends in the Pharmaceutical Treatment of Children’sThe survey of asthma drugs administered to Asthma, 1997 to 2008. Research Findingspediatric patients found that asthma No. 31. September 2011. Agencyformanagement complies with the therapeutic Healthcare Research and Quality, Rockville,guidelines and GINA’s recommendations. The MD.implemented government policy on generic http://meps.ahrq.gov/mepsweb/data_files/drugs and the generic drugs entry in the publications/rf31/rf.pdf.pharmaceutical market improve the access tomedical products and facilitate the effective 9. Phillips C, McDonald T. Trends in medicationmanagement and prevention of asthma. use for asthma among children. Allergy Clin Immunol., 2008; 8(3): 232-7.References 10. Shelley M, Croft P, Chapman S, Pantin C. Is the quality of asthma prescribing, as1. Benedictis FM, Vaccher S, de Benedictis D. measured by the general practice ratio of Montelukast sodium for exercise-induced corticosteroid to bronchodilator, associatedInternational Archives of Integrated Medicine, Vol. 2, Issue 3, March, 2015. Page 43Copy right © 2015, IAIM, All Rights Reserved.

Dynamic patterns of LTRA (montelukast) use ISSN: 2394-0026 (P) ISSN: 2394-0034 (O)with asthma morbidity? J ClinEpidemiol., 13. http://www.hospital.bg/news-6738-2000; 53(12): 1217–1221. hadzhidontchev-da-se-vuvedat-bezplatni-11. National consensus on diagnosis, prevention terapevtitchni-paketi-s-generitsi.html.and treatment of bronchial asthma inchildhood, Sofia 2003.12. Currie G., Devereux G., Lee D., et al. Recentdevelopments in asthma management.British Medical Journal, 2005; 330: 585-589.Source of support: Nil Conflict of interest: None declared.Graph – 1: Trends in the use of asthma drugs (number of packs) for the period 2008-2013 in the agegroup 6-12 years.1200 ICS1000 ICS/LABA LTRA 800 β-agonist 600 400 200 0 2008 2009 2010 2011 2012 2013Graph – 2: Trends in the use of asthma drugs (number of packs) for the period 2008-2013 in the agegroup 13-16 years.450 ICS400 ICS/ LABA350 LTRA (montelukast)300 β 2 agonist (Salbutamol)250200 2009 2010 2011 2012 2013150100 50 0 2008International Archives of Integrated Medicine, Vol. 2, Issue 3, March, 2015. Page 44Copy right © 2015, IAIM, All Rights Reserved.

Dynamic patterns of LTRA (montelukast) use ISSN: 2394-0026 (P) ISSN: 2394-0034 (O)Graph – 3: Percentage distribution of drug groups used for asthma treatment in the age group 6-12years (number of packs). β 2 agonist 6% ICS 40%LTRA46% ICS/LABA 8%Graph – 4: Percentage distribution of drug groups used for asthma treatment in the age group 13-16years (number of packs). β 2 agonist ICS (Salbutamol) 22% 9% LTRA ICS/ LABA(montelukast) 18% 51%International Archives of Integrated Medicine, Vol. 2, Issue 3, March, 2015. Page 45Copy right © 2015, IAIM, All Rights Reserved.

Dynamic patterns of LTRA (montelukast) use ISSN: 2394-0026 (P) ISSN: 2394-0034 (O)Graph – 5: Dynamic patterns of reimbursement – brand name montelukast and genericmontelukast. Reimbursement dinamic patterns100%80%60%40%20%00% 2010 2011 2012 2013 2009 Brand name montelukast Generic montelukastTable – 1: Dynamic patterns montelukast (5 mg) use, age group 6-12 years.Montelukast Total number Absolute growth Growth rate5 mg of packs2008 218 58 126.6%2009 276 403 284.9%2010 621 592 371.6%2011 810 749 443.6%2012 967 806 469.7%2013 1024Table – 2: Dynamic patterns montelukast (5 mg/ 10 mg) use, age group 13-16 years.Montelukast Total number of Absolute growth Growth rate5 mg /10 mg packs2008 94 204,3%2009 192 98 261,7%2010 246 152 361,7%2011 340 246 434,0%2012 408 314 444,7%2013 418 324International Archives of Integrated Medicine, Vol. 2, Issue 3, March, 2015. Page 46Copy right © 2015, IAIM, All Rights Reserved.