Thromboembolic adverse event study of combined estrogen-progestin preparations using Japanese Adverse Drug Event Report database

Hasegawa, Shiori; Matsui, Teruo; Hane, Yuuki; Abe, Junko; Hatahira, Haruna; Motooka, Yumi; Sasaoka, Sayaka; Fukuda, Akiho; Naganuma, Misa; Hirade, Kouseki; Takahashi, Yukiko; Yasutomi, Keita; Nakamura, Mitsuhiro

doi:10.1371/journal.pone.0182045

Cited by 10 publications

(10 citation statements)

References 67 publications

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“…Time-to-onset duration was calculated from the time of the patient's first prescription to the occurrence of the AEs. 7,12 It is necessary to take the correct truncation into account when estimating the time to onset of AEs from SRS data. We chose an analysis period of 730 days after the start date of administration to focus attention on the onset of AEs within 2 years.…”

Section: Statisticsmentioning

confidence: 99%

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Analysis of drug-induced interstitial lung disease using the Japanese Adverse Drug Event Report database

et al. 2020

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Objectives: Drug-induced interstitial lung disease occurs when exposure to a drug causes inflammation and, eventually, fibrosis of the lung interstitium. Drug-induced interstitial lung disease is associated with substantial morbidity and mortality. The aim of this retrospective study was to obtain new information on the time-to-onset profiles of drug-induced interstitial lung disease by consideration of other associated clinical factors using the Japanese Adverse Drug Event Report database. Methods: We identified and analyzed reports of drug-induced interstitial lung disease between 2004 and 2018 from the Japanese Adverse Drug Event Report database. The reporting odds ratio and 95% confidence interval was used to detect the signal for each drug-induced interstitial lung disease incidence. We evaluated the time-to-onset profile of drug-induced interstitial lung disease and used the applied association rule mining technique to uncover undetected relationships, such as possible risk factors. Results: The reporting odds ratios (95% confidence intervals) of drug-induced interstitial lung disease due to temsirolimus, gefitinib, sho-saiko-to, sai-rei-to, osimertinib, amiodarone, alectinib, erlotinib, everolimus, and bicalutamide were 18.3 (15.6–21.3), 17.8 (16.5–19.2), 16.3 (11.8–22.4), 14.5 (11.7–18.2), 12.5 (10.7–14.7), 10.9 (9.9–11.9), 10.6 (8.1–13.9), 9.6 (8.8–10.4), 9.4 (8.7–10.0), and 9.2 (7.9–10.6), respectively. The median durations (day (interquartile range)) for drug-induced interstitial lung disease were as follows: amiodarone (123.0 (27.0–400.5)), methotrexate (145.5 (67.8–475.8)), fluorouracil (86.0 (35.5–181.3)), gemcitabine (53.0 (20.0–83.0)), paclitaxel (52.0 (28.5–77.5)), docetaxel (47.0 (18.8–78.3)), bleomycin (92.0 (38.0–130.5)), oxaliplatin (45.0 (11.0–180.0)), nivolumab (56.0 (21.0–135.0)), gefitinib (24.0 (11.0–55.0)), erlotinib (21.0 (9.0–49.0)), temsirolimus (38.0 (14.0–68.5)), everolimus (56.0 (35.0–90.0)), osimertinib (51.5 (21.0–84.8)), alectinib (78.5 (44.3–145.8)), bicalutamide (50.0 (28.0–147.0)), pegylated interferon-2α (140.0 (75.8–233.0)), sai-rei-to (35.0 (20.0–54.5)), and sho-saiko-to (33.0 (13.5–74.0)) days. Association rule mining suggested that the risk of drug-induced interstitial lung disease was increased by a combination of amiodarone or sho-saiko-to and aging. Conclusion: Our results showed that patients who receive gefitinib or erlotinib should be closely monitored for the development of drug-induced interstitial lung disease within a short duration (4 weeks). In addition, elderly people who receive amiodarone or sho-saiko-to should be carefully monitored for the development of drug-induced interstitial lung disease.

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Section: Statisticsmentioning

confidence: 99%

“…The median duration, quartiles, and the Weibull shape parameters (WSPs) were used to evaluate the time-to-onset data. 7,12 The scale parameter, α, of the Weibull distribution determines the scale of the distribution function. A larger scale value stretches the distribution, whereas a smaller scale value shrinks the data distribution.…”

Section: Statisticsmentioning

confidence: 99%

Analysis of drug-induced interstitial lung disease using the Japanese Adverse Drug Event Report database

et al. 2020

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“…[12][13][14][15][16][17][18][19] Furthermore, association rule mining has been proposed as a new analytical approach for discovering undetected relationships such as the possible risk factors between variables in large databases. [18][19][20][21][22] In this study, we aimed to assess renal impairment (RI) caused by platinum-based compounds by analyzing data from the JADER database. Analyses of the time to onset of RI using the JADER database are rare, and to the best of our knowledge, this is the first study to use association rule mining to detect the association rules between platinum-based compounds and RI.…”

Section: Introductionmentioning

confidence: 99%

Analysis of adverse events of renal impairment related to platinum-based compounds using the Japanese Adverse Drug Event Report database

et al. 2018

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Objectives:Platinum compounds cause several adverse events, such as nephrotoxicity, gastrointestinal toxicity, myelosuppression, ototoxicity, and neurotoxicity. We evaluated the incidence of renal impairment as adverse events are related to the administration of platinum compounds using the Japanese Adverse Drug Event Report database.Methods:We analyzed adverse events associated with the use of platinum compounds reported from April 2004 to November 2016. The reporting odds ratio at 95% confidence interval was used to detect the signal for each renal impairment incidence. We evaluated the time-to-onset profile of renal impairment and assessed the hazard type using Weibull shape parameter and used the applied association rule mining technique to discover undetected relationships such as possible risk factor.Results:In total, 430,587 reports in the Japanese Adverse Drug Event Report database were analyzed. The reporting odds ratios (95% confidence interval) for renal impairment resulting from the use of cisplatin, oxaliplatin, carboplatin, and nedaplatin were 2.7 (2.5–3.0), 0.6 (0.5–0.7), 0.8 (0.7–1.0), and 1.3 (0.8–2.1), respectively. The lower limit of the reporting odds ratio (95% confidence interval) for cisplatin was >1. The median (lower–upper quartile) onset time of renal impairment following the use of platinum-based compounds was 6.0–8.0 days. The Weibull shape parameter β and 95% confidence interval upper limit of oxaliplatin were <1. In the association rule mining, the score of lift for patients who were treated with cisplatin and co-administered furosemide, loxoprofen, or pemetrexed was high. Similarly, the scores for patients with hypertension or diabetes mellitus were high.Conclusion:Our findings suggest a potential risk of renal impairment during cisplatin use in real-world setting. The present findings demonstrate that the incidence of renal impairment following cisplatin use should be closely monitored when patients are hypertensive or diabetic, or when they are co-administered furosemide, loxoprofen, or pemetrexed. In addition, healthcare professionals should closely assess a patient’s background prior to treatment.

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“…27,29) The usefulness of the Weibull distribution for profiling the time-to-onset of ADEs has been reported. 11,12,[30][31][32] To the best of our knowledge, no time-to-onset analysis of respiratory depression for opioids in cancer patients has been done using SRSs. The aim of the time-to-onset analysis was to obtain new information and compare the risks and onset profiles of respiratory depression for opioids in the real world.…”

Section: Discussionmentioning

confidence: 99%

“…SRS, such as the JADER database, is subject to various biases, including overreporting, under-reporting, missing data, the exclusion of healthy individuals, the lack of a denominator, and confounding factors. [11][12][13][14][30][31][32] Because of these limitations, disproportionality measures (ROR) do not allow for risk quantification. Rather, RORs provides a rough indication of signal strength and are only relevant to the hypothesis.…”

Section: Discussionmentioning

confidence: 99%

Analyses of Respiratory Depression Associated with Opioids in Cancer Patients Based on the Japanese Adverse Drug Event Report Database

Sugawara

Uchida

Suzuki

et al. 2019

Biological & Pharmaceutical Bulletin

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Opioid-induced respiratory depression is a potentially life-threatening adverse drug event. The purpose of this study was to evaluate the incidence of respiratory depression using the Japanese Adverse Drug Event Report (JADER) Database to obtain data to promote proper use of opioids. The JADER database from April 2004 to March 2017 was obtained from the Pharmaceuticals and Medical Devices Agency. We calculated the reporting odds ratios (RORs) of suspected opioids (morphine, fentanyl, oxycodone, tapentadol, methadone, tramadol, pentazocine, buprenorphine, and codeine phosphate hydrate), analyzed the daily dose at first appearance and the time-to-onset profile, and assessed the hazard type using the Weibull shape parameter. ROR analysis detected adverse event signals for all opioids. Morphine showed a large ROR value with statistical significance in elderly (≥70 years old) patients. The median daily doses of oral morphine and oxycodone for inducing respiratory depression were comparably low (30 mg/d as oral morphine equivalent dose), while that of transdermal fentanyl was 120 mg/d (oral morphine equivalent dose). On time-to-onset analysis using the Weibull distribution, those opioids were classified as the early failure type. The median time-to-onset of oral morphine, oral oxycodone and transdermal fentanyl was 5.5, 11 and 12.5 d, respectively, and almost 50% of cases were reported within 30 d. Taken together, our results suggest that it is important to monitor patients carefully for at least the first one week to one month, even if opioids are administered at a relatively low dose, especially in elderly patients administered morphine.

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Thromboembolic adverse event study of combined estrogen-progestin preparations using Japanese Adverse Drug Event Report database

Cited by 10 publications

References 67 publications

Analysis of drug-induced interstitial lung disease using the Japanese Adverse Drug Event Report database

Analysis of drug-induced interstitial lung disease using the Japanese Adverse Drug Event Report database

Analysis of adverse events of renal impairment related to platinum-based compounds using the Japanese Adverse Drug Event Report database

Analyses of Respiratory Depression Associated with Opioids in Cancer Patients Based on the Japanese Adverse Drug Event Report Database

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