Generic placeholder image

Current Respiratory Medicine Reviews

Editor-in-Chief

ISSN (Print): 1573-398X
ISSN (Online): 1875-6387

Research Article

Local Adverse Drug Reactions in Ambulatory Asthma Patients Treated With Inhaled Corticosteroids: An Experience from a South Indian Teaching Hospital

Author(s): Ashwaghosha Parthasarathi*, Sachith Srinivas, Jayaraj Biligere Siddaiah and Padukudru Anand Mahesh

Volume 18, Issue 3, 2022

Published on: 05 July, 2022

Page: [217 - 227] Pages: 11

DOI: 10.2174/1573398X18666220501124708

Price: $65

conference banner
Abstract

Background: Inhaled corticosteroids (ICS) have an essential and established role in the treatment of asthma. Both systemic and local adverse effects may accompany the long-term use of ICS. Systemic adverse drug reactions (ADRs) of ICS are well established. However, there is a paucity of information on local ADRs, especially in the Indian population.

Objectives: This study aimed to determine the prevalence, severity, predictability, and preventability of local ADRs to ICS and their associated risk factors.

Methods: Patients with asthma who need ICS were enrolled. Study patients were interviewed with open-ended questions to assess local ADRs to ICS at baseline and each follow-up visit, once a month for three months. Causality (Naranjo’s algorithm and WHO scale), severity (Hartwig SC scale), predictability (based on the frequency of occurrence of ADR and history of drug exposure), and preventability (Schumock and Thornton criteria) of local ADRs were assessed. Bivariate analysis and subsequently multivariate logistic regression were used to identify the risk factors for local ADRs to ICS.

Results: A total of 243 patients (134 female) were included in the study. A total of 74 local ADRs were observed in 59 patients (a prevalence of 24.3%). The most common local ADRs included the feeling of thirst (14.8%), followed by cough during inhalation (8.6%) and taste disturbance (4.5%). All ADRs were predictable and mild in severity. Preventability assessment found 85.1% of local ADRs as ‘probably preventable’. Two out of five patients who had ADRs reduced or skipped doses because of the discomfort, despite their physician’s recommendation to continue their regular dose of ICS. Age >41 years, use of MDI without spacer, and use of budesonide were identified as the risk factors for developing ADRs to ICS.

Conclusion: Local ADRs to ICS were observed in approximately one in four patients with asthma. Two out of five patients who had ADRs reduced or skipped doses. Strategies to prevent local ADRs to ICS should focus on patients aged >41 years, receiving budesonide, and using MDI without a spacer. We need to establish standards on the best practices for preventing ADRs, such as identifying the most suited device or ICS that is best tolerated by the individual patient and identifying the least ICS dose that maintains ideal asthma control.

Keywords: Asthma, inhaled corticosteroids, ICS, drug safety, adverse drug reactions, local ADRs, ICS therapy.

Graphical Abstract

[1]
Hargreave FE, Nair P. The definition and diagnosis of asthma. Clin Exp Allergy 2009; 39(11): 1652-8.
[http://dx.doi.org/10.1111/j.1365-2222.2009.03321.x] [PMID: 19622089]
[2]
Poddighe D, Brambilla I, Licari A, Marseglia GL. Omalizumab in the therapy of pediatric asthma. Recent Pat Inflamm Allergy Drug Discov 2018; 12(2): 103-9.
[http://dx.doi.org/10.2174/1872213X12666180430161351] [PMID: 29714140]
[3]
Global initiative for asthma. Global strategy for asthma management and prevention 2021. Available from: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf (Accessed on Jul 8, 2021).
[4]
WHO. WHO Asthma factsheet 2020. Available from: https://www.who.int/news-room/fact-sheets/detail/asthma (Accessed on Nov 4, 2020).
[5]
Kuruvilla ME, Lee FE-H, Lee GB. Understanding asthma phenotypes, endotypes, and mechanisms of disease. Clin Rev Allergy Immunol 2019; 56(2): 219-33.
[http://dx.doi.org/10.1007/s12016-018-8712-1] [PMID: 30206782]
[6]
Braman SS. The global burden of asthma. Chest 2006; 130(1)(Suppl.): 4S-12S.
[http://dx.doi.org/10.1378/chest.130.1_suppl.4S] [PMID: 16840363]
[7]
Aggarwal AN, Chaudhry K, Chhabra SK, et al. Asthma Epidemiology Study Group. Prevalence and risk factors for bronchial asthma in Indian adults: A multicentre study. Indian J Chest Dis Allied Sci 2006; 48(1): 13-22.
[PMID: 16482947]
[8]
Barnes PJ, Pedersen S. Efficacy and safety of inhaled corticosteroids in asthma. Report of a workshop held in Eze, France, October 1992. Am Rev Respir Dis 1993; 148(4 Pt 2): S1-S26.
[http://dx.doi.org/10.1164/ajrccm/148.4_Pt_2.S1] [PMID: 8214958]
[9]
Bateman ED, Hurd SS, Barnes PJ, et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J 2008; 31(1): 143-78.
[http://dx.doi.org/10.1183/09031936.00138707] [PMID: 18166595]
[10]
National Asthma Education and Prevention Program. National asthma education and prevention program. expert panel report: Guidelines for the diagnosis and management of asthma update on selected topics-2002. J Allergy Clin Immunol 2002; 110(5): S141-219.
[PMID: 12542074]
[11]
Kelly HW, Nelson HS. Potential adverse effects of the inhaled corticosteroids. J Allergy Clin Immunol 2003; 112(3): 469-78.
[http://dx.doi.org/10.1016/S0091-6749(03)01870-0] [PMID: 13679801]
[12]
Roland NJ, Bhalla RK, Earis J. The local side effects of inhaled corticosteroids: Current understanding and review of the literature. Chest 2004; 126(1): 213-9.
[http://dx.doi.org/10.1378/chest.126.1.213] [PMID: 15249465]
[13]
Buhl R. Local oropharyngeal side effects of inhaled corticosteroids in patients with asthma. Allergy 2006; 61(5): 518-26.
[http://dx.doi.org/10.1111/j.1398-9995.2006.01090.x] [PMID: 16629778]
[14]
Williamson IJ, Matusiewicz SP, Brown PH, Greening AP, Crompton GK. Frequency of voice problems and cough in patients using pressurized aerosol inhaled steroid preparations. Eur Respir J 1995; 8(4): 590-2.
[PMID: 7664859]
[15]
Perera BJ. Efficacy and cost effectiveness of inhaled steroids in asthma in a developing country. Arch Dis Child 1995; 72(4): 312-5.
[http://dx.doi.org/10.1136/adc.72.4.312] [PMID: 7763062]
[16]
Masoli M, Fabian D, Holt S, Beasley R. Global Initiative for Asthma (GINA) program. The global burden of asthma: Executive summary of the GINA dissemination committee report. Allergy 2004; 59(5): 469-78.
[http://dx.doi.org/10.1111/j.1398-9995.2004.00526.x] [PMID: 15080825]
[17]
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986; 24(1): 67-74.
[http://dx.doi.org/10.1097/00005650-198601000-00007] [PMID: 3945130]
[18]
Meyboom RH, Hekster YA, Egberts AC, Gribnau FW, Edwards IR. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 1997; 17(6): 374-89.
[http://dx.doi.org/10.2165/00002018-199717060-00004] [PMID: 9429837]
[19]
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30(2): 239-45.
[http://dx.doi.org/10.1038/clpt.1981.154] [PMID: 7249508]
[20]
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49(9): 2229-32.
[http://dx.doi.org/10.1093/ajhp/49.9.2229] [PMID: 1524068]
[21]
Modayil RR, Harugeri A, Parthasarathi G, et al. Adverse drug reactions to antiretroviral therapy (ART): An experience of spontaneous reporting and intensive monitoring from ART centre in India. Pharmacoepidemiol Drug Saf 2010; 19(3): 247-55.
[http://dx.doi.org/10.1002/pds.1907] [PMID: 20066675]
[22]
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992; 27(6): 538.
[PMID: 10118597]
[23]
Foster JM, van Sonderen E, Lee AJ, et al. A self-rating scale for patient-perceived side effects of inhaled corticosteroids. Respir Res 2006; 7(1): 131.
[http://dx.doi.org/10.1186/1465-9921-7-131] [PMID: 17062139]
[24]
Foster JM, Aucott L, van der Werf RHW, et al. Higher patient perceived side effects related to higher daily doses of inhaled corticosteroids in the community: A cross-sectional analysis. Respir Med 2006; 100(8): 1318-36.
[http://dx.doi.org/10.1016/j.rmed.2005.11.029] [PMID: 16442275]
[25]
Dubus JC, Marguet C, Deschildre A, et al. Réseau de Recherche Clinique en Pneumonologie Pédiatrique. Local side-effects of inhaled corticosteroids in asthmatic children: Influence of drug, dose, age, and device. Allergy 2001; 56(10): 944-8.
[http://dx.doi.org/10.1034/j.1398-9995.2001.00100.x] [PMID: 11576072]
[26]
Fitzgerald JM, Chan CK, Holroyde MC, Boulet L-P. The CASE survey: Patient and physician perceptions regarding asthma medication use and associated oropharyngeal symptoms. Can Respir J 2008; 15(1): 27-32.
[http://dx.doi.org/10.1155/2008/593723] [PMID: 18292850]
[27]
Ivanova JI, Birnbaum HG, Hsieh M, et al. Adherence to inhaled corticosteroid use and local adverse events in persistent asthma. Am J Manag Care 2008; 14(12): 801-9.
[PMID: 19067497]
[28]
Molimard M, Le Gros V, Robinson P, Bourdeix I. Prevalence and associated factors of oropharyngeal side effects in users of inhaled corticosteroids in a real-life setting. J Aerosol Med Pulm Drug Deliv 2010; 23(2): 91-5.
[http://dx.doi.org/10.1089/jamp.2009.0762] [PMID: 19778267]
[29]
Rachelefsky GS, Liao Y, Faruqi R. Impact of inhaled corticosteroid-induced oropharyngeal adverse events: Results from a meta-analysis. Ann Allergy Asthma Immunol 2007; 98(3): 225-38.
[http://dx.doi.org/10.1016/S1081-1206(10)60711-9] [PMID: 17378253]
[30]
Shim CS, Williams MH Jr. Cough and wheezing from beclomethasone dipropionate aerosol are absent after triamcinolone acetonide. Ann Intern Med 1987; 106(5): 700-3.
[http://dx.doi.org/10.7326/0003-4819-106-5-700] [PMID: 3565967]
[31]
Chang RYK, Kwok PCL, Ghassabian S, Brannan JD, Koskela HO, Chan HK. Cough as an adverse effect on inhalation pharmaceutical products. Br J Pharmacol 2020; 177(18): 4096-112.
[http://dx.doi.org/10.1111/bph.15197] [PMID: 32668011]
[32]
Dubus J-C, Mély L, Huiart L, Marguet C, Le Roux P. Réseau de Recherche Clinique en Pneumologie Pédiatrique. Cough after inhalation of corticosteroids delivered from spacer devices in children with asthma. Fundam Clin Pharmacol 2003; 17(5): 627-31.
[http://dx.doi.org/10.1046/j.1472-8206.2003.00191.x] [PMID: 14703724]
[33]
Williams AJ, Baghat MS, Stableforth DE, Cayton RM, Shenoi PM, Skinner C. Dysphonia caused by inhaled steroids: Recognition of a characteristic laryngeal abnormality. Thorax 1983; 38(11): 813-21.
[http://dx.doi.org/10.1136/thx.38.11.813] [PMID: 6648863]
[34]
Babu S, Samuel P. The effect of inhaled steroids on the upper respiratory tract. J Laryngol Otol 1988; 102(7): 592-4.
[http://dx.doi.org/10.1017/S0022215100105808] [PMID: 3411208]
[35]
Inhaler Devices for Asthma. Inhaler devices for asthma. Drug Ther Bull 2000; 38(2): 9-14.
[http://dx.doi.org/10.1136/dtb.2000.3829] [PMID: 10829349]
[36]
Fabbri L, Burge PS, Croonenborgh L, et al. International Study Group. Comparison of fluticasone propionate with beclomethasone dipropionate in moderate to severe asthma treated for one year. Thorax 1993; 48(8): 817-23.
[http://dx.doi.org/10.1136/thx.48.8.817] [PMID: 8211872]
[37]
Ayres JG, Bateman ED, Lundbäck B, Harris TA. International Study Group. High dose fluticasone propionate, 1 mg daily, versus fluticasone propionate, 2 mg daily, or budesonide, 1.6 mg daily, in patients with chronic severe asthma. Eur Respir J 1995; 8(4): 579-86.
[PMID: 7664857]
[38]
Selroos O, Backman R, Forsén K-O, et al. Local side-effects during 4-year treatment with inhaled corticosteroids--a comparison between pressurized metered-dose inhalers and Turbuhaler. Allergy 1994; 49(10): 888-90.
[http://dx.doi.org/10.1111/j.1398-9995.1994.tb00794.x] [PMID: 7710001]
[39]
Shaw NJ, Edmunds AT. Inhaled beclomethasone and oral candidiasis. Arch Dis Child 1986; 61(8): 788-90.
[http://dx.doi.org/10.1136/adc.61.8.788] [PMID: 3740927]
[40]
Agertoft L, Larsen FE, Pedersen S. Posterior subcapsular cataracts, bruises and hoarseness in children with asthma receiving long-term treatment with inhaled budesonide. Eur Respir J 1998; 12(1): 130-5.
[http://dx.doi.org/10.1183/09031936.98.12010130] [PMID: 9701427]
[41]
Adams N, Bestall J, Lasserson T, Jones P. Inhaled Fluticasone versus inhaled beclomethasone or inhaled budesonide for chronic asthma. In: Cochrane Database of Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd 2004; p. CD002310.
[http://dx.doi.org/10.1002/14651858.CD002310.pub2]
[42]
Ellepola AN, Samaranayake LP. Inhalational and topical steroids, and oral candidosis: A mini review. Oral Dis 2001; 7(4): 211-6.
[http://dx.doi.org/10.1034/j.1601-0825.2001.70402.x] [PMID: 11575870]
[43]
Knight L, Fletcher J. Growth of Candida albicans in saliva: Stimulation by glucose associated with antibiotics, corticosteroids, and diabetes mellitus. J Infect Dis 1971; 123(4): 371-7.
[http://dx.doi.org/10.1093/infdis/123.4.371] [PMID: 5110739]
[44]
Fidel PL Jr. Distinct protective host defenses against oral and vaginal candidiasis. Med Mycol 2002; 40(4): 359-75.
[http://dx.doi.org/10.1080/714031126] [PMID: 12230215]
[45]
Simon MR, Houser WL, Smith KA, Long PM. Esophageal candidiasis as a complication of inhaled corticosteroids. Ann Allergy Asthma Immunol 1997; 79(4): 333-8.
[http://dx.doi.org/10.1016/S1081-1206(10)63024-4] [PMID: 9357379]
[46]
Milne LJ, Crompton GK. Beclomethasone dipropionate and oropharyngeal candidiasis. BMJ 1974; 3(5934): 797-8.
[http://dx.doi.org/10.1136/bmj.3.5934.797] [PMID: 4606264]
[47]
Yokoyama H, Yamamura Y, Ozeki T, Iga T, Yamada Y. Influence of mouth washing procedures on the removal of drug residues following inhalation of corticosteroids. Biol Pharm Bull 2006; 29(9): 1923-5.
[http://dx.doi.org/10.1248/bpb.29.1923] [PMID: 16946510]
[48]
Nave R, Mueller H. From inhaler to lung: Clinical implications of the formulations of ciclesonide and other inhaled corticosteroids. Int J Gen Med 2013; 6: 99-107.
[http://dx.doi.org/10.2147/IJGM.S39134] [PMID: 23516175]
[49]
Dolovich M, Ruffin R, Corr D, Newhouse MT. Clinical evaluation of a simple demand inhalation MDI aerosol delivery device. Chest 1983; 84(1): 36-41.
[http://dx.doi.org/10.1378/chest.84.1.36] [PMID: 6861546]
[50]
Lipworth BJ. New perspectives on inhaled drug delivery and systemic bioactivity. Thorax 1995; 50(2): 105-10.
[http://dx.doi.org/10.1136/thx.50.2.105] [PMID: 7701444]
[51]
Crompton GK. Dry powder inhalers: Advantages and limitations. J Aerosol Med 1991; 4(3): 151-6.
[http://dx.doi.org/10.1089/jam.1991.4.151] [PMID: 10147676]
[52]
Islam N, Cleary MJ. Developing an efficient and reliable dry powder inhaler for pulmonary drug delivery-a review for multidisciplinary researchers. Med Eng Phys 2012; 34(4): 409-27.
[http://dx.doi.org/10.1016/j.medengphy.2011.12.025] [PMID: 22277307]
[53]
Dima AL, van Ganse E, Stadler G, de Bruin M. ASTRO-LAB group. Members of the ASTRO-LAB group were. Does adherence to inhaled corticosteroids predict asthma-related outcomes over time? A cohort study. Eur Respir J 2019; 54(6): 1900901.
[http://dx.doi.org/10.1183/13993003.00901-2019] [PMID: 31601714]
[54]
Clatworthy J, Price D, Ryan D, Haughney J, Horne R. The value of self-report assessment of adherence, rhinitis and smoking in relation to asthma control. Prim Care Respir J J Gen Pract Airw Group 2009; 18(4): 300-5.
[http://dx.doi.org/10.4104/pcrj.2009.00037] [PMID: 19562233]
[55]
Allegra L, Cremonesi G, Girbino G, et al. PRISMA (PRospectIve study on asthma control) study group. real-life prospective study on asthma control in italy: cross-sectional phase results. Respir Med 2012; 106(2): 205-14.
[http://dx.doi.org/10.1016/j.rmed.2011.10.001] [PMID: 22035853]
[56]
Komiyama EY, Ribeiro PM, Junqueira JC, Koga-Ito CY, Jorge AOC. Prevalence of yeasts in the oral cavity of children treated with inhaled corticosteroids. Braz Oral Res 2004; 18(3): 197-201.
[http://dx.doi.org/10.1590/S1806-83242004000300004] [PMID: 15619871]
[57]
Heffler E, Bagnasco D, Canonica GW. Strategies to reduce corticosteroid-related adverse events in asthma. Curr Opin Allergy Clin Immunol 2019; 19(1): 61-7.
[http://dx.doi.org/10.1097/ACI.0000000000000493] [PMID: 30407207]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy