Analysis of drug-induced hearing loss by using a spontaneous reporting system database
Autoři:
Mizuki Tanaka aff001; Shiori Hasegawa aff001; Satoshi Nakao aff001; Kazuyo Shimada aff001; Ririka Mukai aff001; Kiyoka Matsumoto aff001; Mitsuhiro Nakamura aff001
Působiště autorů:
Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu-shi, Gifu, Japan
aff001
Vyšlo v časopise:
PLoS ONE 14(10)
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pone.0217951
Souhrn
Many drugs can cause hearing loss, leading to sensorineural deafness. The aim of this study was to evaluate the risk of drug-induced hearing loss (DIHL) by using the Japanese Adverse Drug Event Report (JADER) database and to obtain profiles of DIHL onset in clinical settings. We relied on the Medical Dictionary for Regulatory Activities preferred terms and standardized queries, and calculated the reporting odds ratios (RORs). Furthermore, we applied multivariate logistic regression analysis, association rule mining, and time-to-onset analysis using Weibull proportional hazard models. Of 534688 reports recorded in the JADER database from April 2004 to June 2018, adverse event signals were detected for platinum compounds, sulfonamides (plain) (loop diuretics), interferons, ribavirin, other aminoglycosides, papillomavirus vaccines, drugs used in erectile dysfunction, vancomycin, erythromycin, and pancuronium by determining RORs. The RORs of other aminoglycosides, other quaternary ammonium compounds, drugs used in erectile dysfunction, and sulfonamides (plain) were 29.4 (22.4–38.6), 18.5 (11.2–30.6), 15.4 (10.6–22.5), and 12.6 (10.0–16.0), respectively. High lift score was observed for patients with congenital diaphragmatic hernia treated with pancuronium using association rule mining. The median durations (interquartile range) for DIHL due to platinum compounds, sulfonamides (plain), interferons, antivirals for treatment of hepatitis C virus (HCV) infections, other aminoglycosides, carboxamide derivatives, macrolides, and pneumococcal vaccines were 25.5 (7.5–111.3), 80.5 (4.5–143.0), 64.0 (14.0–132.0), 53.0 (9.0–121.0), 11.0 (3.0–26.8), 1.5 (0.3–11.5), 3.5 (1.3–6.8), and 2.0 (1.0–4.5), respectively. Our results demonstrated potential risks associated with several drugs based on their RORs. We recommend to closely monitor patients treated with aminoglycosides for DIHL for at least two weeks. Moreover, individuals receiving platinum compounds, sulfonamides (plain), interferons, and antivirals for HCV infection therapy should be carefully observed for DIHL for at least several months.
Klíčová slova:
Deafness – Erectile dysfunction – Hernia – Interferons – Platinum – Vaccines – Vancomycin – Sulfonamide
Zdroje
1. Cianfrone G, Pentangelo D, Cianfrone F, Mazzei F, Turchetta R, Oriando MP, et al. Pharmacological drugs inducing ototoxicity, vestibular symptoms and tinnitus: a reasoned and updated guide. Eur Rev Med Pharmacol Sci. 2011; 16: 601–636. Available: https://www.ncbi.nlm.nih.gov/pubmed/21796866 [21796866]
2. Lanvers-Kaminsky C, Zehnhoff-Dinnesen AA, Parfitt R, Ciarimboli G. Drug-induced ototoxicity: Mechanisms, Pharmacogenetics, and protective strategies. Clin Pharmacol Ther. 2017; 101: 491–500. https://doi.org/10.1002/cpt.603 [28002638]
3. van Puijenbroek EP, Bate A, Leufkens HG, Lindquist M, Orre R, Egberts AC. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002; 11: 3–10. Available: https://www.ncbi.nlm.nih.gov/pubmed/11998548 [11998548]
4. van Puijenbroek EP, Egberts AC, Heerdink ER, Leufkens HG. Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: an example with diuretics and non-steroidal anti-inflammatory drugs. Eur J Clin Pharmacol. 2000; 56: 733–738. Available: https://www.ncbi.nlm.nih.gov/pubmed/11214785 [11214785]
5. Egberts AC, Meyboom RH, van Puijenbroek EP. Use of measures of disproportionality in pharmacovigilance: three Dutch examples. Drug Saf. 2002; 25: 453–458. Available: https://www.ncbi.nlm.nih.gov/pubmed/12071783 [12071783]
6. Nakao S, Hatahira H, Sasaoka S, Hasegawa S, Motooka Y, Ueda N, et al. Evaluation of Drug-Induced Photosensitivity Using the Japanese Adverse Drug Event Report (JADER) Database. Biol Pharm Bull. 2017; 40: 2158–2165. https://doi.org/10.1248/bpb.b17-00561 [29199239]
7. Harpaz R, Chase HS, Friedman C. Mining multi-item drug adverse effect associations in spontaneous reporting systems. BMC Bioinformatics. 2010; 11 Suppl 9: S7. https://doi.org/10.1186/1471-2105-11-S9-S7 [21044365]
8. Yildirim P. Association Patterns in Open Data to Explore Ciprofloxacin Adverse Events. Appl Clin Inform. 2015; 6: 728–747. https://doi.org/10.4338/ACI-2015-06-RA-0076 [26763627]
9. Hatahira H, Abe J, Hane Y, Matsui T, Sasaoka S, Motooka Y, et al. Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases. J Pharm Health Care Sci. 2017; 3: 19. https://doi.org/10.1186/s40780-017-0088-5 [28729910]
10. Sauzet O, Carvajal A, Escudero A, Molokhia M, Cornelius VR. Illustration of the weibull shape parameter signal detection tool using electronic healthcare record data. Drug Saf. 2013; 36: 995–1006. https://doi.org/10.1007/s40264-013-0061-7 [23673816]
11. Nakamura M, Umetsu R, Abe J, Matsui T, Ueda N, Kato Y, et al. Analysis of the time-to-onset of osteonecrosis of jaw with bisphosphonate treatment using the data from a spontaneous reporting system of adverse drug events. J Pharm Health Care Sci. 2015; 1: 34. https://doi.org/10.1186/s40780-015-0035-2 [26819745]
12. Abe J, Umetsu R, Mataki K, Kato Y, Ueda N, Nakayama Y, et al. Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database. J Pharm Health Care Sci. 2016; 2: 14. https://doi.org/10.1186/s40780-016-0048-5 [27330825]
13. Sasaoka S, Matsui T, Hane Y, Abe J, Ueda N, Motooka Y, et al. Time-to-Onset Analysis of Drug-Induced Long QT Syndrome Based on a Spontaneous Reporting System for Adverse Drug Events. PLoS One. 2016; 8: e0164309. https://doi.org/10.1371/journal.pone.0164309 [27723808]
14. Poluzzi E, Raschi E, Piccinni C, De Ponti F. Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS). InTech. 2012. pp. 265–302. https://doi.org/10.5772/50095
15. Suzuki Y, Suzuki H, Umetsu R, Uranishi H, Abe J, Nishibata Y, et al. Analysis of the Interaction between Clopidogrel, Aspirin, and Proton Pump Inhibitors Using the FDA Adverse Event Reporting System Database. Biol Pharm Bull. 2015; 38: 680–686. https://doi.org/10.1248/bpb.b14-00191 [25947914]
16. Takeyama M, Sai K, Imatoh T, Segawa K, Hirasawa N, Saito Y. Influence of Japanese Regulatory Action on Denosumab-Related Hypocalcemia Using Japanese Adverse Drug Event Report Database. Biol Pharm Bull. 2017; 40: 1447–1453. https://doi.org/10.1248/bpb.b17-00266 [28867727]
17. Abe J, Umetsu R, Uranishi H, Suzuki H, Nishibata Y, Kato Y, et al. Analysis of polypharmacy effects in older patients using Japanese Adverse Drug Event Report database. PLoS One. 2017; 12: e0190102. https://doi.org/10.1371/journal.pone.0190102 [29267348]
18. Zhu A-, Li J, Leong T-. Automated knowledge extraction for decision model construction: a data mining approach. AMIA Annu Symp Proc. 2003: 758–762. Available: https://www.ncbi.nlm.nih.gov/pubmed/14728275 [14728275]
19. Hahsler M, Grün B, Hornik K. A computational environment for mining association rules and frequent item sets. J Stat Soft. 2005; 14: 15. Available: https://www.jstatsoft.org/article/view/v014i15
20. Brock PR, Knight KR, Freyer DR, Campbell KC, Steyger PS, Blakley BW, et al. Platinum-induced ototoxicity in children: a consensus review on mechanisms, predisposition, and protection, including a new International Society of Pediatric Oncology Boston ototoxicity scale. J Clin Oncol. 2012; 30: 2408–2417. https://doi.org/10.1200/JCO.2011.39.1110 [22547603]
21. Sheth S, Mukherjea D, Rybak LP, Ramkumar V. Mechanisms of Cisplatin-Induced Ototoxicity and Otoprotection. Front Cell Neurosci. 2017; 11: 338. https://doi.org/10.3389/fncel.2017.00338 [29163050]
22. Gatell JM, Ferran F, Araujo V, Bonet M, Soriano E, Traserra J, et al. Univariate and multivariate analyses of risk factors predisposing to auditory toxicity in patients receiving aminoglycosides. Antimicrob Agents Chemother. 1987; 31: 1383–1387. Available: https://www.ncbi.nlm.nih.gov/pubmed/3674849 [3674849]
23. Xie J, Talaska AE, Schacht J. New developments in aminoglycoside therapy and ototoxicity. Hear Res. 2011; 281: 28–37. https://doi.org/10.1016/j.heares.2011.05.008 [21640178]
24. Ikeda K, Oshima T, Hidaka H, Takasaka T. Molecular and clinical implications of loop diuretic ototoxicity. Hear Res. 1997; 107: 1–8. Available: https://www.ncbi.nlm.nih.gov/pubmed/9165341 [9165341]
25. Bruniera FR, Ferreira FM, Saviolli LR, Bacci MR, Feder D, da Luz Gonçalves Pedreira M, et al. The use of vancomycin with its therapeutic and adverse effects: a review. Eur Rev Med Pharmacol Sci. 2015; 19: 694–700. Available: https://www.ncbi.nlm.nih.gov/pubmed/25753888 [25753888]
26. Jiang M, Karasawa T, Steyger PS. Aminoglycoside-Induced Cochleotoxicity: A Review. Front Cell Neurosci. 2017; 11: 308. https://doi.org/10.3389/fncel.2017.00308 [29062271]
27. Kanda Y, Shigeno K, Kinoshita N, Nakao K, Yano M, Matsuo H. Sudden hearing loss associated with interferon. Lancet. 1994; 343: 1134–1135. Available: https://www.ncbi.nlm.nih.gov/pubmed/7910234 [7910234]
28. Tunca A, Erbayrak M, Aytaç S, Türkay C. Axonal neuropathy and hearing loss associated with alpha interferon treatment in chronic hepatitis B: a case report. Turk J Gastroenterol. 2004; 15: 97–99. Available: https://www.ncbi.nlm.nih.gov/pubmed/15334319 [15334319]
29. Formann E, Stauber R, Denk DM, Jessner W, Zollner G, Munda-Steindl P, et al. Sudden hearing loss in patients with chronic hepatitis C treated with pegylated interferon/ribavirin. Am J Gastroenterol. 2004; 99: 873–877. Available: https://www.ncbi.nlm.nih.gov/pubmed/15128353 [15128353]
30. Elloumi H, Houissa F, Hadj NB, Gargouri D, Romani M, Kharrat J, et al. Sudden hearing loss associated with peginterferon and ribavirin combination therapy during hepatitis C treatment. World J Gastroenterol. 2007; 13: 5411–5412. Available: https://www.ncbi.nlm.nih.gov/pubmed/17879419 [17879419]
31. Maddox PT, Saunders J, Chandrasekhar SS. Sudden hearing loss from PDE-5 inhibitors: A possible cellular stress etiology. Laryngoscope. 2009; 119: 1586–1589. https://doi.org/10.1002/lary.20511 [19507217]
32. McGwin G Jr. Phosphodiesterase type 5 inhibitor use and hearing impairment. Arch Otolaryngol Head Neck Surg. 2010; 136: 488–492. https://doi.org/10.1001/archoto.2010.51 [20479381]
33. Khan AS, Sheikh Z, Khan S, Dwivedi R, Benjamin E. Viagra deafness—sensorineural hearing loss and phosphodiesterase-5 inhibitors. Laryngoscope. 2011; 121: 1049–1054. https://doi.org/10.1002/lary.21450 [21520123]
34. Brummett RE, Fox KE. Vancomycin- and erythromycin-induced hearing loss in humans. Antimicrob Agents Chemother. 1989; 33: 791–796. Available: https://www.ncbi.nlm.nih.gov/pubmed/2669623 [2669623]
35. Cheung PY, Tyebkhan JM, Peliowski A, Ainsworth W, Robertson CM. Prolonged use of pancuronium bromide and sensorineural hearing loss in childhood survivors of congenital diaphragmatic hernia. J Pediatr. 1999; 135: 233–239. Available: https://www.ncbi.nlm.nih.gov/pubmed/10431119 [10431119]
36. Masumoto K, Nagata K, Uesugi T, Yamada T, Taguchi T. Risk factors for sensorineural hearing loss in survivors with severe congenital diaphragmatic hernia. Eur J Pediatr. 2007; 166: 607–612. Available: https://www.ncbi.nlm.nih.gov/pubmed/17043841 [17043841]
37. Robertson CM, Tyebkhan JM, Peliowski A, Etches PC, Cheung PY. Ototoxic drugs and sensorineural hearing loss following severe neonatal respiratory failure. Acta Paediatr. 2006; 95: 214–223. Available: https://www.ncbi.nlm.nih.gov/pubmed/16449030 [16449030]
38. Agrawal Y, Platz EA, Niparko JK. Prevalence of hearing loss and differences by demographic characteristics among US adults: data from the National Health and Nutrition Examination Survey, 1999–2004. Arch Intern Med. 2008; 168: 1522–1530. https://doi.org/10.1001/archinte.168.14.1522 [18663164]
39. Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing loss prevalence and risk factors among older adults in the United States. J Gerontol A Biol Sci Med Sci. 2011; 66: 582–590. https://doi.org/10.1093/gerona/glr002 [21357188]
40. Umetsu R, Abe J, Ueda N, Kato Y, Matsui T, Nakayama Y, et al. Association between Selective Serotonin Reuptake Inhibitor Therapy and Suicidality: Analysis of U.S. Food and Drug Administration Adverse Event Reporting System Data. Biol Pharm Bull. 2015; 38: 1689–1699. https://doi.org/10.1248/bpb.b15-00243 [26521821]
41. Ozawa K, Hineno A, Kinoshita T, Ishihara S, Ikeda SI. Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan. Drug Saf. 2017; 40: 1219–1229. https://doi.org/10.1007/s40264-017-0574-6 [28744844]
42. Dawes P, Emsley R, Cruickshanks KJ, Moore DR, Fortnum H, Edmondson-Jones M, et al. Hearing loss and cognition: the role of hearing AIDS, social isolation and depression. PLoS One. 2015; 10: e0119616. https://doi.org/10.1371/journal.pone.0119616 [25760329]
43. Castiglione A, Benatti A, Velardita C, Favaro D, Padoan E, Severi D, et al. Aging, Cognitive Decline and Hearing Loss: Effects of Auditory Rehabilitation and Training with Hearing Aids and Cochlear Implants on Cognitive Function and Depression among Older Adults. Audiol Neurootol. 2016; 21 Suppl 1: 21–28. Available: https://www.ncbi.nlm.nih.gov/pubmed/27806352 [27806352]
44. Au A, Stuyt JG, Chen D, Alagramam K. Ups and downs of Viagra: revisiting ototoxicity in the mouse model. PLoS One. 2013; 8: e79226. https://doi.org/10.1371/journal.pone.0079226 [24244454]
45. Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994; 151: 54–61. Available: https://www.ncbi.nlm.nih.gov/pubmed/8254833 [8254833]
46. Morini F, Capolupo I, Masi R, Ronchetti MP, Locatelli M, Corchia C, et al. Hearing impairment in congenital diaphragmatic hernia: the inaudible and noiseless foot of time. J Pediatr Surg. 2008; 43: 380–384. https://doi.org/10.1016/j.jpedsurg.2007.10.048 [18280294]
47. Norén GN, Orre R, Bate A, Edwards IR. Duplicate detection in adverse drug reaction surveillance. Data Min Knowl Discov. 2007; 14: 305–328. https://doi.org/10.1007/s10618-006-0052-8
48. Cohen BE, Durstenfeld A, Roehm PC. Viral causes of hearing loss: a review for hearing health professionals. Trends Hear. 2014; 18. https://doi.org/10.1177/2331216514541361 [25080364]
49. Kobel M, Le Prell CG, Liu J, Hawks JW, Bao J. Noise-induced cochlear synaptopathy: Past findings and future studies. Hear Res. 2017; 349: 148–154. https://doi.org/10.1016/j.heares.2016.12.008 [28007526]
Článek vyšel v časopise
PLOS One
2019 Číslo 10
- S diagnostikou Parkinsonovy nemoci může nově pomoci AI nástroj pro hodnocení mrkacího reflexu
- Je libo čepici místo mozkového implantátu?
- Pomůže v budoucnu s triáží na pohotovostech umělá inteligence?
- AI může chirurgům poskytnout cenná data i zpětnou vazbu v reálném čase
- Nová metoda odlišení nádorové tkáně může zpřesnit resekci glioblastomů
Nejčtenější v tomto čísle
- Correction: Low dose naltrexone: Effects on medication in rheumatoid and seropositive arthritis. A nationwide register-based controlled quasi-experimental before-after study
- Combining CDK4/6 inhibitors ribociclib and palbociclib with cytotoxic agents does not enhance cytotoxicity
- Experimentally validated simulation of coronary stents considering different dogboning ratios and asymmetric stent positioning
- Risk factors associated with IgA vasculitis with nephritis (Henoch–Schönlein purpura nephritis) progressing to unfavorable outcomes: A meta-analysis
Zvyšte si kvalifikaci online z pohodlí domova
Všechny kurzy