Prescribing of long-acting beta-2-agonists/inhaled corticosteroids after the SMART trial

BMC Pulmonary Medicine

Sven Schmiedl¹  Joerg Hasford⁸  Petra Thürmann¹  Martin Tauscher⁷  Roman Gerlach⁷  Justyna Amelio⁵  Robert Reynolds⁶  Joan Fortuny³  Luisa Ibáñez²  Rainald Fischer⁴  Marietta Rottenkolber⁸ 

[1] Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany;Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Barcelona, Spain;Novartis Farmaceutica SA, Barcelona, Spain;Pneumologische Praxis Muenchen – Pasing, Munich, Germany;Amgen Ltd, Uxbridge, UK;Pfizer Research & Development, New York, USA;National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany;Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet, Marchioninistr. 15, Munich, D-81377, Germany

关键词: Drug regulatory actions;    SMART trial;    Drug utilisation study;    ACOS;    COPD;    Asthma;    Inhaled corticosteroids;    Long-acting adrenergic beta-2-receptor agonists;   

Others  :  1182382
DOI  :  10.1186/s12890-015-0051-x

 received in 2014-09-11, accepted in 2015-04-22,  发布年份 2015

【 摘 要 】

Background

After the SMART trial evaluating the safety of salmeterol (long-acting beta-2-agonist (LABA)) in asthma patients, regulatory actions were taken to promote a guideline-adherent prescribing of LABA only to patients receiving inhaled corticosteroids (ICS). We aim to analyse LABA- and ICS-related prescription patterns after the SMART trial in Germany.

Methods

Patients documented in the Bavarian Association of Statutory Health Insurance Physicians database (approximately 10.5 million people) were included if they had a diagnosis of asthma and at least one prescription of LABA and/or ICS between 2004 and 2008. Annual period prevalence rates (PPRs) were estimated and Cochrane Armitage tests were used for time trend analyses.

Results

Highest annual PPRs were found for budesonide and the fixed combination of salmeterol/fluticasone. The proportion of “concomitant LABA and ICS users” increased from 52.0 to 57.6% within the study period, whereas for “LABA users without ICS” a slight decrease from 6.5 to 5.4% was found. In 2008, the proportion of patients with at least one quarter with a LABA prescription without concomitant ICS was highest in elderly, male patients (≈20%). In the majority of these patients, a concomitant diagnosis of COPD (i.e. asthma-COPD overlap syndrome [ACOS]) was present.

Conclusions

Between 2004 and 2008, we found a moderate increase in guideline-adherent LABA prescribing in a representative German population. Elderly men received a significant number of LABA prescriptions without concomitant ICS probably due to ACOS.

【 授权许可】

   
2015 Rottenkolber et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006; 129(1):15-26.
• [2]Global Initiative for Asthma (GINA) Global strategy for asthma management and prevention 2003 [www.ginasthma.org] [Accessed 22 March 2015]
• [3]Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention 2014 [www.ginasthma.org] [Accessed 22 March 2015]
• [4]U. [http://www.fda.gov] webciteS. Food and Drug Administration (FDA). FDA talk paper, 14 Aug 2003 [Available from URL: , cited in WHO Pharmaceuticals Newsletter 2003, No. 04 (http://apps.who.int/medicinedocs/es/d/Js4947e/1.8.html webcite)] [Accessed 22 March 2015]
• [5]GlaxoSmithKline Inc. [http://www.hc-sc.gc.ca] webcite ‘Dear Healthcare Professional’ letter from GlaxoSmithKline Inc, 15 Aug 2003 [URL: , cited in WHO Pharmaceuticals Newsletter 2003, No. 05 (http://apps.who.int/medicinedocs/es/d/Js4948e/2.6.html#Js4948e.2.6 webcite)] [Accessed 22 March 2015]
• [6]GlaxoSmithKline Inc. [http://www.hc-sc.gc.ca] webcite Public advisory from GlaxoSmithKline Inc, 4 Sep 2003 [URL: , cited in WHO Pharmaceuticals Newsletter 2003, No. 05 (http://apps.who.int/medicinedocs/es/d/Js4948e/2.6.html#Js4948e.2.6 webcite)] [Accessed 22 March 2015]
• [7]Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. Lancet. 2005; 366(9493):1261-2.
• [8]U.S. Food and Drug Administration (FDA). Long-Acting Beta Agonist (LABA) Information. Information for healthcare professionals - Salmeterol xinafoate (marketed as Serevent Diskus). 11/2005. [http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm162673.htm ] [Accessed 22 March 2015]
• [9]U.S. Food and Drug Administration (FDA). Long-Acting Beta Agonist (LABA) Information. Information for healthcare professionals - fluticasone propionate; salmeterol xinafoate (marketed as Advair Diskus). 11/2005. [http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm162675.htm ] [Accessed 22 March 2015]
• [10]U.S. Food and Drug Administration (FDA). Information. Information for healthcare professionals - formoterol fumarate (marketed as Foradil). 11/2005. [http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm162677.htm ] [Accessed 22 March 2015]
• [11]U.S. Food and Drug Administration (FDA). Long-Acting Beta Agonist (LABA) Information. Public health advisory: update on Serevent Diskus (salmeterol xinafoate inhalation powder), Advair Diskus (fluticasone propionate & salmeterol inhalation powder), Foradil Aerolizer (formoterol fumarate inhalation powder). 05/2006. [http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm162678.htm] [Accessed 22 March 2015]
• [12]Sears MR. The FDA-mandated trial of safety of long-acting beta-agonists in asthma: finality or futility? Thorax. 2013; 68(2):195-8.
• [13]Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Anwendungshinweise für Salmeterol in der Asthmatherapie. 2003. [http://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RI/2003/RI-asi-salmeterol-asthmatherapie-anwendungshinweise.html] [Accessed 22 March 2015]
• [14]Arzneimittelkommission der deutschen Ärzteschaft. Empfehlungen zur Therapie des Asthma bronchiale im Erwachsenenalter. AVP-Sonderheft Therapieempfehlungen. September 2001.
• [15]Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Langwirksame Beta-Mimetika (Formoterol, Salmeterol) zur Asthmatherapie: Sicherheitsbewertung hinsichtlich respiratorischer Nebenwirkungen, Änderungen der Produktinformationen. 2006. [http://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RI/2006/RI-beta-mimetika1-aenderung-produktinfo.html] [Accessed 22 March 2015]
• [16]Chowdhury BA, Dal PG. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med. 2010; 362(13):1169-71.
• [17]Patel M, Shirtcliffe P, Beasley R. The beta-2 agonist debate: is there still a problem? Curr Opin Allergy Clin Immunol. 2013; 13(1):58-62.
• [18]British Thoracic Society Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma. Thorax 2008, 63 Suppl 4:iv1-121.
• [19]Cazzola M, Segreti A, Bettoncelli G, Calzetta L, Cricelli C, Pasqua F et al.. Change in asthma and COPD prescribing by Italian general practitioners between 2006 and 2008. Prim Care Respir J. 2011; 20(3):291-8.
• [20]Elkout H, Helms PJ, Simpson CR, McLay JS. Changes in primary care prescribing patterns for paediatric asthma: a prescribing database analysis. Arch Dis Child. 2012; 97(6):521-5.
• [21]The Bavarian association of statutory health insurance physicians (Kassenärztliche Vereinigung Bayerns) [http://www.kvb.de/] [Accessed 22 March 2015]
• [22]WHO. Anatomical Therapeutic Chemical (ATC) classification index. Geneva: WHO Collaborating Centre for Drug Statistics Methodology; 1992.
• [23]Graubner B. ICD-10-GM Internationale statistische Klassifikation der Krankheiten und verwandter Gesundheitsprobleme, 10. Revision, German Modification, Version 2009. Köln, Deutscher Ärzte-Verlag; 2008.
• [24]Statistics on the memebers of the German statutory health insurances [http://www.bmg.bund.de/krankenversicherung/zahlen-und-fakten-zur-krankenversicherung.html] [Accessed 22 March 2015]
• [25]Higashi A, Zhu S, Stafford RS, Alexander GC. National trends in ambulatory asthma treatment, 1997–2009. J Gen Intern Med. 2011; 26(12):1465-70.
• [26]Price D, Virchow C. Trends in prescribing of inhaled corticosteroids alone and in combinaton with long-acting beta2-agonists in Europe in 2004–2009. In: World allergy congress. UAE, Dubai; 2010.
• [27]Lim HS, Choi SM, Lee J, Park YS, Lee SM, Yim JJ et al.. Responsiveness to inhaled corticosteroid treatment in patients with asthma-chronic obstructive pulmonary disease overlap syndrome. Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology. 2014; 113(6):652-7.
• [28]Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane Effective Practice and Organization of Care Review Group. BMJ. 1998; 317(7156):465-8.
• [29]Boaz A, Baeza J, Fraser A. Effective implementation of research into practice: an overview of systematic reviews of the health literature. BMC Res Notes. 2011; 4:212. BioMed Central Full Text
• [30]Licskai C, Sands T, Ong M, Paolatto L, Nicoletti I. Using a knowledge translation framework to implement asthma clinical practice guidelines in primary care. Int J Qual Health Care. 2012; 24(5):538-46.
• [31]Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013; 11:CD010013.
• [32]Minard JP, Dostaler SM, Taite AK, Olajos-Clow JG, Sands TW, Licskai CJ et al.. Development and implementation of an electronic asthma record for primary care: integrating guidelines into practice. J Asthma. 2014; 51(1):58-68.
• [33]Mehring M, Donnachie E, Mutschler R, Hofmann F, Keller M, Schneider A. Disease management programs for patients with asthma in Germany: a longitudinal population-based study. Respir Care. 2013; 58(7):1170-7.
• [34]Piening S, Haaijer-Ruskamp FM, de Vries JT, van der Elst ME, de Graeff PA, Straus SM et al.. Impact of safety-related regulatory action on clinical practice: a systematic review. Drug Saf. 2012; 35(5):373-85.
• [35]Schachtele S, Tumena T, Gassmann KG, Fromm MF, Maas R. Implementation of warnings from Dear Doctor Letters (Rote-Hand-Briefe): an analysis of medication data from a large cohort of elderly patients. Dtsch Arztebl Int. 2014; 111(15):255-63.
• [36]Lemmer B. Bronchospasmolytika und Antiasthmatika. Arzneiverordnungs-Report 2009. Schwabe U, Paffrath D, editors. Springer Medizin Verlag, Heidelberg; 2009.
• [37]Lemmer B. Bronchospasmolytika und Antiasthmatika. Arzneiverordnungs-Report 2014. Schwabe U, Paffrath D, editors. Springer-Verlag Berlin, Heidelberg; 2014.
• [38]Arnlind MH, Wettermark B, Nokela M, Hjemdahl P, Rehnberg C, Jonsson EW. Regional variation and adherence to guidelines for drug treatment of asthma. Eur J Clin Pharmacol. 2010; 66(2):187-98.
• [39]Bianchi M, Clavenna A, Bonati M. Inter-country variations in anti-asthmatic drug prescriptions for children. Systematic review of studies published during the 2000–2009 period. Eur J Clin Pharmacol. 2010; 66(9):929-36.
• [40]Lemmer B. Bronchospasmolytika und Antiasthmatika. Arzneiverordnungs-Report 2005. Schwabe U, Paffrath D, editors. Springer Medizin Verlag, Heidelberg; 2006.
• [41]Andersen M. Is it possible to measure prescribing quality using only prescription data? Basic Clin Pharmacol Toxicol. 2006; 98(3):314-9.
• [42]Tinkelman DG, Price DB, Nordyke RJ, Halbert RJ. Misdiagnosis of COPD and asthma in primary care patients 40 years of age and over. J Asthma. 2006; 43(1):75-80.