Analysis of drug adverse events in elderly patients based on the Japanese Adverse Drug Event Report Database.
adverse drug event
database
direct-acting oral anticoagulants
elderly
hypnotics
sedatives
theophylline
Journal
Journal of clinical pharmacy and therapeutics
ISSN: 1365-2710
Titre abrégé: J Clin Pharm Ther
Pays: England
ID NLM: 8704308
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
revised:
19
03
2022
received:
19
02
2022
accepted:
30
03
2022
pubmed:
27
4
2022
medline:
25
8
2022
entrez:
26
4
2022
Statut:
ppublish
Résumé
Compared with the general adult population, pharmacokinetics and changes in drug responsiveness occur to a greater extent in the elderly. Interactions may occur between drugs used in combination to treat various diseases and may cause adverse events (AEs). We conducted a cross-sectional risk assessment of AEs in elderly patients based on information gathered from Japanese medical practices with the goal of obtaining information that will contribute to optimizing pharmacotherapy. The Japanese Adverse Drug Event Report database was used to determine the incidence of AEs in elderly patients (aged 80 years or older) compared with patients aged less than 80 years old by evaluating the reporting odds ratio using the data obtained from reports. Hypnotics and anxiolytics, as well as anticoagulants and theophylline, were identified as groups of drugs that warrant special attention in the elderly. Hypnotics and anxiolytics, especially those that are short-acting, tend to cause delirium and geriatric syndromes including falls and fractures. With respect to anticoagulants, no increase in the risk of bleeding was evident and the dose was believed to be properly adjusted; however, there was an increased risk of anemia. Theophylline toxicity tended to occur more frequently in the elderly, suggesting the need for drug monitoring. Based on these cross-sectional studies, the evaluation of the risk of AEs for drugs commonly used in the elderly based on near real-world information was achieved.
Substances chimiques
Anti-Anxiety Agents
0
Anticoagulants
0
Hypnotics and Sedatives
0
Theophylline
C137DTR5RG
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1264-1269Subventions
Organisme : Japan Agency for Medical Research and Development
ID : 20mk0101159h0002
Organisme : Japan Agency for Medical Research and Development
ID : 19mk0101159h0001
Informations de copyright
© 2022 John Wiley & Sons Ltd.
Références
Ministry of Health, Labour and Welfare. Guidance of Appropriate Medication for Elderly Patients (General), 2018. Available from: https://www.pmda.go.jp/files/000232249.pdf. Accessed May 1 2019.
Kojima T, Akishita M, Kameyama Y, et al. High risk of adverse drug reactions in elderly patients taking six or more drugs: analysis of inpatient database. Geriatr Gerontol Int. 2012;12:761-762.
Ritschel WA. Pharmacokinetic approach to drug dosing in the aged. J Am Geriatr Soc. 1976;24:344-354.
PMDA: Japanese Adverse Drug Event Report database (JADER). Available from: http://www.info.pmda.go.jp/fukusayoudb/CsvDownload.jsp. Accessed May 1 2019.
Ministry of Health, Labour and Welfare. Guidance of Appropriate Medication for Elderly Patients [Particular (by Recuperation Environment)]. 2019. Available from: https://www.mhlw.go.jp/stf/newpage_05217.html. (only in Japanese) Accessed May 1 2020.
The Japan Geriatrics Society. Guidelines for medical treatment and its safety in the elderly 2015. Medical View Co., Ltd.; 2015.
Dal Negro R, Pomari C, Turco P. Famotidine and theophylline pharmacokinetics. An unexpected cimetidine-like interaction in patients with chronic obstructive pulmonary disease. Clin Pharmacokinet. 1993;24:255-258.
Manfredi RL, Vesell ES. Inhibition of theophylline metabolism by long-term allopurinol administration. Clin Pharmacol Ther. 1981;29:224-229.
Sakai T. Role and applicability of spontaneous reporting databases in medical big data. Yakugaku Zasshi. 2021;141:165-168.
Negishi A, Oshima S, Horii N, et al. Categorisation of pharmaceutical adverse events using the japanese adverse drug event report database: characteristic adverse drug events of the elderly treated with polypharmacy. Drugs Real World Outcomes. 2021;8:49-61.
Bloch F, Thibaud M, Dugué B, Brèque C, Rigaud AS, Kemoun G. Episodes of falling among elderly people: a systematic review and meta-analysis of social and demographic pre-disposing characteristics. Clinics (Sao Paulo). 2010;65:895-903.
Seppala LJ, Wermelink AMAT, de Vries M, et al. Fall-risk-increasing drugs: a systematic review and meta-analysis: II psychotropics. J Am Med Dir Assoc. 2018;19:371.e11-371.e17.
Johnell K, Jonasdottir Bergman G, Fastbom J, Danielsson B, Borg N, Salmi P. Psychotropic drugs and the risk of fall injuries, hospitalisations and mortality among older adults. Int J Geriatr Psychiatry. 2017;32:414-420.
Andrade C. Sedative hypnotics and the risk of falls and fractures in the elderly. J Clin Psychiatry. 2018;79:18f12340.
Otani K. Cytochrome P450 3A4 and benzodiazepines. Seishin Shinkeigaku Zasshi. 2003;105:631-642.
Greenblatt DJ, Harmatz JS, Shapiro L, Engelhardt N, Gouthro TA, Shader RI. Sensitivity to triazolam in the elderly. N Engl J Med. 1991;324:1691-1698.
Psaty BM, Manolio TA, Kuller LH, et al. Incidence of and risk factors for atrial fibrillation in older adults. Circulation. 1997;96:2455-2461.
Chisaki Y, Aoji S, Yano Y. Analysis of adverse drug reaction risk in elderly patients using the Japanese Adverse Drug Event Report (JADER) database. Biol Pharm Bull. 2017;40:824-829.
Jusko WJ, Gardner MJ, Mangione A, Schentag JJ, Koup JR, Vance JW. Factors affecting theophylline clearances: age, tobacco, marijuana, cirrhosis, congestive heart failure, obesity, oral contraceptives, benzodiazepines, barbiturates, and ethanol. J Pharm Sci. 1979;68:1358-1366.
Navid A, Ng DM, Wong SE, Lightstone FC. Application of a physiologically based pharmacokinetic model to study theophylline metabolism and its interactions with ciprofloxacin and caffeine. CPT Pharmacometrics Syst Pharmacol. 2016;5:74-81.
Sarkar MA, Hunt C, Guzelian PS, Karnes HT. Characterization of human liver cytochromes P-450 involved in theophylline metabolism. Drug Metab Dispos. 1992;20:31-37.
Orlando R, Padrini R, Perazzi M, De Martin S, Piccoli P, Palatini P. Liver dysfunction markedly decreases the inhibition of cytochrome P450 1A2-mediated theophylline metabolism by fluvoxamine. Clin Pharmacol Ther. 2006;79:489-499.
Yao C, Kunze KL, Kharasch ED, et al. Fluvoxamine-theophylline interaction: gap between in vitro and in vivo inhibition constants toward cytochrome P4501A2. Clin Pharmacol Ther. 2001;70:415-424.
Maeda K, Hisaka A, Ito K, et al. Classification of drugs for evaluating drug interaction in drug development and clinical management. Drug Metab Pharmacokinet. 2021;41:100414.
Ohnishi A, Kato M, Kojima J, Ushiama H, Yoneko M, Kawai H. Differential pharmacokinetics of theophylline in elderly patients. Drugs Aging. 2003;20:71-84.
Tanikawa K, Matsumoto Y, Matsuzaki T, et al. Population pharmacokinetic analysis of theophylline: relationship between serum concentrations and clinical effects in therapeutic drug monitoring. Yakugaku Zasshi. 1999;119:861-867.
Sakaeda T, Tamon A, Kadoyama K, Okuno Y. Data mining of the public version of the FDA adverse event reporting system. Int J Med Sci. 2013;10:796-803.
Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy. 2004;24:743-749.