Association between prenatal exposure to antidepressants and neonatal morbidity: An analysis of real-world data from a nationwide claims database in Japan

Fujioka, Izumi; Ohtsu, Hiroshi; Yonemoto, Naohiro; Sase, Kazuhiro; Murashima, Atsuko

doi:10.1016/j.jad.2022.04.103

Cited by 6 publications

(9 citation statements)

References 48 publications

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“…For example, the specificity of codes for procedures, prescriptions, and devices are high, while code combination is needed to compensate for the ‘tentative diagnosis’ for billing purpose 23. Therefore, we have used our algorithm21 for code combination in JMDC to maximize specificity. We have compared our study design, including patient selection and device use (online supplemental table 2) and the short-term and long-term outcomes (online supplemental table 3) with existing registries in Japan 26–29.…”

Section: Discussionmentioning

confidence: 99%

“…The Japanese claims data contain a ‘tentative disease code’ for billing purposes 22–24. Therefore, to increase specificity, we combined the codes for the diagnosis, prescription, and treatment of hypertension, dyslipidemia, diabetes mellitus, COPD, cerebrovascular disease, renal failure, heart failure, and ischemic heart disease within the same billing month 21. We have defined smoking before the index date based on the smoking history described in previous studies using the JMDC 25…”

Section: Methodsmentioning

confidence: 99%

“…[13][14][15][16][17][18] Recently, a patient-level claims database with an anonymous data-linkage system was developed in Japan and used in various areas of medical research. [19][20][21] In this study, we aimed to examine the relevance of the claims database and evaluate the long-term outcome of EVAR and OAR for the treatment of AAA. 13 15 16…”

Section: What Are the New Findings?mentioning

confidence: 99%

“…Fifth, JMDC is known to have a 'healthy-workers bias'. 21 While the prevalence of AAA is higher in older people, beneficiaries of this claims database JMDC consist of corporate employees and their families aged ≤75 years. Accordingly, age and socioeconomic status may be contributing to lower mortality rates.…”

Section: Limitationsmentioning

confidence: 99%

“…Since there are limitations with registry-based research in vascular medicine,12 health insurance claims have been used as a promising source of RWD with high external validity because there is no reimbursement without billing the payer 13–18. Recently, a patient-level claims database with an anonymous data-linkage system was developed in Japan and used in various areas of medical research 19–21. In this study, we aimed to examine the relevance of the claims database and evaluate the long-term outcome of EVAR and OAR for the treatment of AAA 13 15 16…”

Section: Introductionmentioning

confidence: 99%

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Endovascular versus open repair in patients with abdominal aortic aneurysm: a claims-based data analysis in Japan

Kimura

Ohtsu

Yonemoto

et al. 2022

BMJ Surg Interv Health Technologies

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ObjectivesEndovascular aortic repair (EVAR) evolved through competition with open aortic repair (OAR) as a safe and effective treatment option for appropriately selected patients with abdominal aortic aneurysm (AAA). Although endoleaks are the most common reason for post-EVAR reintervention, compliance with lifelong regular follow-up imaging remains a challenge.DesignRetrospective data analysis.SettingThe Japan Medical Data Center (JMDC), a claims database with anonymous data linkage across hospitals, consists of corporate employees and their families of ≤75 years of age.ParticipantsThe analysis included participants in the JMDC who underwent EVAR or OAR for intact (iAAA) or ruptured (rAAA) AAA. Patients with less than 6 months of records before the aortic repair were excluded.Main outcome measuresOverall survival and reintervention rates.ResultsWe identified 986 cases (837 iAAA and 149 rAAA) from JMDC with first aortic repairs between January 2015 and December 2020. The number of patients, median age (years (IQR)), follow-up (months) and post-procedure CT scan (times per year) were as follows: iAAA (OAR: n=593, 62.0 (57.0–67.0), 26.0, 1.6, EVAR: n=244, 65.0 (31.0–69.0), 17.0, 2.2), rAAA (OAR: n=110, 59.0 (53.0–59.0), 16.0, 2.1, EVAR: n=39, 62.0 (31.0–67.0), 18.0, 2.4). Reintervention rate was significantly higher among EVAR than OAR in rAAA (15.4% vs 8.2%, p=0.04). In iAAA, there were no group difference after 5 years (7.8% vs 11.0%, p=0.28), even though EVAR had initial advantage. There were no differences in mortality rate between EVAR and OAR for either rAAA or iAAA.ConclusionsClaims-based analysis in Japan showed no statistically significant difference in 5-year survival rates of the OAR and EVAR groups. However, the reintervention rate of EVAR in rAAA was significantly higher, suggesting the need for regular post-EVAR follow-up with imaging. Therefore, international collaborations for long-term outcome studies with real-world data are warranted.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: What Are the New Findings?mentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Endovascular versus open repair in patients with abdominal aortic aneurysm: a claims-based data analysis in Japan

Kimura

Ohtsu

Yonemoto

et al. 2022

BMJ Surg Interv Health Technologies

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Directions for perinatal pharmacoepidemiology studies in Japan

Obara

2024

Congenital Anomalies

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The efforts of the Japan Drug Information Institute in Pregnancy (JDIIP) established at the National Center for Child Health and Development, Toranomon Hospital, and more than 50 support medical institutions are unique in Japan and play an essential role (https:// www.ncchd.go.jp/kusuri/). The role of the JDIIP is particularly important in terms of information dissemination, education, and the work of revising the drug package insert, and it must continue to play an important role. From this perspective, it would be meaningful to publish review papers on the activities of the JDIIP and the use of consultation cases and to disseminate information about their activities.

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Cardiotoxicity of adjuvant chemotherapy with trastuzumab: a Japanese claim-based data analysis

et al. 2022

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ObjectiveAdjuvant chemotherapy with trastuzumab improves the postoperative life expectancy of women with early-stage breast cancer. Although trastuzumab is reportedly cardiotoxic, quantification based on real-world evidence is lacking. Therefore, in this study, we aimed to analyse trastuzumab cardiotoxicity using a nationwide claim-based database.MethodsIn this retrospective study, we used data from a nationwide claims database (Japan Medical Data Center, Tokyo, Japan) under the universal healthcare system. Women with breast cancer who underwent initial surgery were included. Patients with recurrent or advanced-stage breast cancer, with a history of heart failure, receiving neoadjuvant chemotherapy or a preoperative history of less than 6 months were excluded. Propensity score (PS) was calculated using logistic regression based on age, cardiovascular risk factors, radiotherapy and concomitant anthracyclines (AC).ResultsWe identified 12 060 eligible patients (mean age 50.8±8.56 years) between January 2010 and December 2019. After 1:2 PS matching (trastuzumab users, TZ, n=1005; non-users, NT, n=2010), Cox proportional hazards model analysis showed that the rate of heart failure development within 18 months postoperative was significantly higher in the TZ group than in the NT group (adjusted HR 2.28, 95% CI 1.38 to 3.77). Baseline cardiac evaluation in the combined AC/TZ cases was 27.2% preoperative, 66.0% pre-AC and 86.6% pre-TZ, respectively.ConclusionTrastuzumab cardiotoxicity remained relevant in the claim-based analysis adjusted for AC effects. Further collaborative studies in cardio-oncology with real-world data are warranted to improve the rate of baseline cardiovascular risk assessment in patients with cancer scheduled for cardiotoxic cancer treatment.

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Association between prenatal exposure to antidepressants and neonatal morbidity: An analysis of real-world data from a nationwide claims database in Japan

Cited by 6 publications

References 48 publications

Endovascular versus open repair in patients with abdominal aortic aneurysm: a claims-based data analysis in Japan

Endovascular versus open repair in patients with abdominal aortic aneurysm: a claims-based data analysis in Japan

Directions for perinatal pharmacoepidemiology studies in Japan

Cardiotoxicity of adjuvant chemotherapy with trastuzumab: a Japanese claim-based data analysis

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