Efficacy of Metered-Dose Inhalers and Dry Powder Inhalers of Salmeterol Xinafoate/Fluticasone Propionate on Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Retrospective Cohort Study from Real-World Data
Article Sidebar
Main Article Content
Abstract
Objective: To study the efficacy of two pharmaceutical inhaler dosage forms of salmeterol/fluticasone i.e., metered-dose inhalers (MDI) and dry powder inhalers (DPI), on acute exacerbation of chronic obstructive pulmonary disease (AECOPD) from real-world use in clinical practice. Methods: This was a retrospective cohort study, in which data were collected from medical records of patients diagnosed with chronic obstructive pulmonary disease (COPD) and receiving treatments at Watchan 80th Celebrations Hospital, Thailand, from Feb 12, 2008, to May 31, 2021. The outcome was AECOPD occurred after receiving salmeterol/fluticasone, which was further grouped into 1) incident AECOPD, 2) recurrent AECOPD episodes, and 3) frequency of AECOPDs throughout the study period and using MDI as a reference group. The data were then analyzed using the Cox proportional-hazards regression, recurrent event analysis, and negative binomial regression, respectively. The multivariable models were adjusted for age, sex, and propensity score of receiving DPI. Results: After a median follow-up time of 9.3 months amongst 110 COPD individuals receiving salmeterol/fluticasone, receiving DPI, compared to MDI, was associated with the increased incidence of AECOPD with adjusted hazard ratio (aHR) 3.88 (95%CI 1.29-11.65). However, receiving DPI was also associated with a decreased risk of recurrent AECOPD with aHR 0.78 (95%CI 0.60-0.99), compared to MDI. Additionally, there was no evidence of a difference in the frequency of AECOPDs between the two groups (adjusted incidence rate ratio 1.09 (95%CI 0.27-4.35). Notably, subgroup analyses revealed that the COPD severity might confound the observed association between receiving DPI and the increased incident AECOPD. Conclusion: Whilst DPI dosage form of salmeterol/fluticasone was associated with the increased risk of incident AECOPD, it might be related to the decreased recurrent episodes. Nonetheless, these two dosage forms did not differ in terms of reducing the frequency of AECOPD.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
References
World Health Organization. The top 10 causes of death [online]. 2020 [cited May 22, 2021]. Available from: www.who.int/news-room/fact-sheets/detail/the -top-10-causes-of-death
Ministry of Public Health. Information in response to COPD service plan [online]. 2021 [cited May 22, 2021]. Available from: hdcservice.moph.go.th/hdc/re ports/page.php?cat_id=67473ea582306d345ce1bb44b06ba2e9
Strategy and Planning Division, Ministry of Public Health. An approach to the operating of sustainable development goals [online]. [cited May 22, 2021]. Available from: bps.moph.go.th/new_bps/
Global Initative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, manage ment, and prevention of chronic obstructive pulmo nary disease 2021 report [online]. 2021 [cited Aug 10, 2021]. Available from: goldcopd.org/wp-content/ uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov 20_WMV.pdf
Sharafkhaneh A, Spiegelman AM, Main K, Tavakoli-Tabasi S, Lan C, Musher D. Mortality in patients admitted for concurrent COPD exacerbation and pneumonia. J Chronic Obstr Pulm Dis. 2017; 14: 23–9.
Silverman EK, Crapo JD, Make BJ. Chronic obstructive pulmonary disease. In: Jameson JL, Fauci AS, Kasper DL, Hauser SL, Longo DL, Loscalzo J, editors. Harrison’s principles of internal medicine. 20th ed. New York: McGraw-Hill Educa- tion; 2018. p. 1990–9.
Calverley PMA, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007 ; 356: 775–89.
Buddiga P. Use of metered dose inhalers, spacers, and nebulizers: practice essentials, overview, preparation [online]. 2020 [cited Aug 10, 2021]. Available from: emedicine.medscape.com/article/14 13366-overview#a2
Koser A, Westerman J, Sharma S, Emmett A, Crater GD, Misawa M. Safety and efficacy of flutica sone propionate/salmeterol hydrofluoroalkane 134a metered-dose-inhaler compared with fluticasone propionate/salmeterol diskus in patients with chronic obstructive pulmonary disease. Open Respir Med J. 2010; 4: 86–91.
Jones R, Martin J, Thomas V, Skinner D, Marshall J, Stagno d’Alcontres M, et al. The comparative effectiveness of initiating fluticasone/salmeterol combination therapy via pMDI versus DPI in reducing exacerbations and treatment escalation in COPD: a UK database study. Int J COPD. 2017; 12: 2445–54.
Luedicke J. POWERSIM: Stata module for simulation-based power analysis for linear and generalized linear models [online]. 2013 [cited Aug 14, 2021]. Available from: ideas.repec.org/c/boc/bo code/s457691.html
Patumanont C. Clinical statistics: advanced regres- sion analysis. Bangkok: Amarin Printing; 2013
Brookhart MA, Schneeweiss S, Rothman KJ, Glynn RJ, Avorn J, Stürmer T. Variable selection for propensity score models. Am J Epidemiol 2006; 163: 1149–56.
Moons KGM, Altman DG, Reitsma JB, Ioannidis JPA, Macaskill P, Steyerberg EW, et al. Transpa rent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med. 2015; 162: W1–73.
Vatcheva KP, Lee M, McCormic JB, Rahbar MH. Multicollinearity in regression analyses conducted in epidemiologic studies. Epidemiology 2016; 6: 1–9.
Williamson E, Morley R, Lucas A, Carpenter J. Propensity scores: from naïve enthusiasm to intuitive understanding. Stat Methods Med Res. 2012; 21: 273–93.
Kostikas K, Mackay AJ, Vogelmeier CF, Frent SM, Gupta P, Banerji D, et al. Early clinically important improvement (ECII) and exacerbation outcomes in COPD patients. Int J COPD 2020; 15: 1831–8.
Puhan MA, Garcia-Aymerich J, Frey M, ter Riet G, Antó JM, Agustí AG, et al. Expansion of the prognostic assessment of patients with chronic obstructive pulmonary disease: the updated BODE index and the ADO index. Lancet. 2009; 374: 704–11.
Proschan MA, Waclawiw MA. Practical guidelines for multiplicity adjustment in clinical trials. Control Clin Trials. 2000; 21: 527–39.
Wittbrodt ET, Millette LA, Evans KA, Bonafede M, Tkacz J, Ferguson GT. Differences in health care outcomes between postdischarge COPD patients treated with inhaled corticosteroid/long-acting β2 -agonist via dry-powder inhalers and pressurized metered-dose inhalers. Int J COPD. 2019; 14: 101–14.
Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A, et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2003; 361: 449–56.
Azuero A. A note on the magnitude of hazard ratios. Cancer. 2016; 122: 1298–9.
Boonreung J, Suwanno J, Phonphet C, Petsirasan R, Thiamwong L. Predictors of chronic obstructive pulmonary disease severe acute exacerbation. Thai Journal of Cardio-Thoracic Nursing. 2017; 28:111–28.
Lavorini F, Magnan A, Christophe Dubus J, Voshaar T, Corbetta L, Broeders M, et al. Effect of incorrect use of dry powder inhalers on manage ment of patients with asthma and COPD. Respir Med. 2008; 102: 593–604.
Jansen EM, van de Hei SJ, Dierick BJH, Kerst- jens HAM, Kocks JWH, van Boven JFM. Global burden of medication non-adherence in chronic obstructive pulmonary disease (COPD) and asthma: a narrative review of the clinical and economic case for smart inhalers. J Thorac Dis. 2021; 13: 3846–64.
Roberts NJ, Ghiassi R, Partridge MR. Health literacy in COPD. Int J Chron Obstruct Pulmon Dis. 2008; 3: 499–507.
Stellefson M, Paige SR, Alber JM, Chaney BH, Chaney D, Apperson A, et al. Association between health literacy, electronic health literacy, disease-specific knowledge, and health-related quality of life among adults with chronic obstructive pulmonary disease: cross-sectional study. J Med Internet Res. 2019; 21: e12165.
Ramadan WH, Sarkis AT. Patterns of use of dry powder inhalers versus pressurized metered-dose inhalers devices in adult patients with chronic obstructive pulmonary disease or asthma: an observational comparative study. Chron Respir Dis. 2017; 14: 309–20.
