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  1. Article: Development of an electronic medical record-based algorithm to identify patients with Stevens-Johnson syndrome and toxic epidermal necrolysis in Japan

    Fukasawa, Toshiki

    http://lobid.org/resources/990155701200206441#!, 14(8):e0221130

    2019  

    Abstract: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), severe drug reactions, are often misdiagnosed due to their rarity and lack of information on differential diagnosis. The objective of the study was to develop an electronic medical ... ...

    Abstract Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), severe drug reactions, are often misdiagnosed due to their rarity and lack of information on differential diagnosis. The objective of the study was to develop an electronic medical record (EMR)-based algorithm to identify patients with SJS/TEN for future application in database studies. From the EMRs of a university hospital, two dermatologists identified all 13 patients with SJS/TEN seen at the Department of Dermatology as the case group. Another 1472 patients who visited the Department of Dermatology were identified using the ICD-10 codes for diseases requiring differentiation from SJS/TEN. One hundred of these patients were then randomly sampled as controls. Based on clinical guidelines for SJS/TEN and the experience of the dermatologists, we tested 128 algorithms based on the use of ICD-10 codes, clinical courses for SJS/TEN, medical encounters for mucocutaneous lesions from SJS/TEN, and items to exclude paraneoplastic pemphigus. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic odds ratio (DOR) of each algorithm were calculated, and the optimal algorithm was defined as that with high PPV and maximal sensitivity and specificity. One algorithm, consisting of a combination of clinical course for SJS/TEN, medical encounters for mucocutaneous lesions from SJS/TEN, and items to exclude paraneoplastic pemphigus, but not ICD-10 codes, showed a sensitivity of 76.9%, specificity of 99.0%, PPV of 40.5%, NPV of 99.8%, and DOR of 330.00. We developed a potentially optimized algorithm for identifying SJS/TEN based on clinical practice records. The almost perfect specificity of this algorithm will prevent bias in estimating relative risks of SJS/TEN in database studies. Considering the small sample size, this algorithm should be further tested in different settings.
    Keywords Antibody therapy ; Algorithms ; Biospy ; Dermatology ; Diagnostic medicine ; Electronic medical records ; Japan ; Lesions
    Language English
    Document type Article
    Database Repository for Life Sciences

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  2. Article ; Online: Timing of Initiation of Xanthine Oxidase Inhibitors Based on Serum Uric Acid Level Does Not Predict Renoprognosis in Patients with Preserved Kidney Function.

    Takayama, Atsushi / Fukasawa, Toshiki / Takeuchi, Masato / Kawakami, Koji

    Metabolic syndrome and related disorders

    2024  Volume 22, Issue 3, Page(s) 222–231

    Abstract: Background: ...

    Abstract Background:
    MeSH term(s) Humans ; Middle Aged ; Aged ; Aged, 80 and over ; Uric Acid ; Xanthine Oxidase ; Hyperuricemia/epidemiology ; Renal Insufficiency, Chronic/diagnosis ; Renal Insufficiency, Chronic/drug therapy ; Glomerular Filtration Rate ; Kidney
    Chemical Substances Uric Acid (268B43MJ25) ; Xanthine Oxidase (EC 1.17.3.2)
    Language English
    Publishing date 2024-01-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2151220-6
    ISSN 1557-8518 ; 1540-4196
    ISSN (online) 1557-8518
    ISSN 1540-4196
    DOI 10.1089/met.2023.0238
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated With Antibiotic Use: A Case-Crossover Study.

    Fukasawa, Toshiki / Urushihara, Hisashi / Takahashi, Hayato / Okura, Takayuki / Kawakami, Koji

    The journal of allergy and clinical immunology. In practice

    2023  Volume 11, Issue 11, Page(s) 3463–3472

    Abstract: Background: Evidence is lacking on the association between antibiotic use and risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in Asians.: Objective: We assessed the risk of SJS/TEN associated with different antibiotic ... ...

    Abstract Background: Evidence is lacking on the association between antibiotic use and risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in Asians.
    Objective: We assessed the risk of SJS/TEN associated with different antibiotic classes in Japanese.
    Methods: We conducted a case-crossover study using a claims database. Firth conditional logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) of SJS/TEN associated with antibiotic use in a 56-day hazard period versus 3 control periods. We created 18 cohorts for each antibiotic class and calculated 56-day cumulative incidence per 100,000 new users. The association between antibiotic class and SJS/TEN was also evaluated in each case using the ALgorithm of Drug causality for Epidermal Necrolysis (ALDEN).
    Results: Our case-crossover study included 170 SJS/TEN cases. Increased ORs were observed for lincomycins (OR, 33.00 [95% CI, 3.74-4332.05]), trimethoprim-sulfamethoxazole (21.20 [6.73-105.98]), penicillins (14.39 [6.95-34.21]), glycopeptides (14.37 [3.17-136.10]), cephalosporins (7.06 [4.25-12.21]), aminoglycosides (6.55 [1.97-26.84]), quinolones (5.98 [3.34-11.20]), fosfomycin (5.40 [1.20-30.97]), carbapenems (5.09 [1.85-15.64]), tetracyclines (4.95 [1.78-15.27]), and macrolides (3.78 [2.13-6.83]). Cumulative incidence of SJS/TEN was 67.4 for trimethoprim-sulfamethoxazole, 86.2 for glycopeptides, and below 10.0 for the others. Despite the high incidence, only 2 cases had a probable causal relationship with glycopeptides.
    Conclusion: Some antibiotic classes, including lincomycins, glycopeptides, aminoglycosides, fosfomycin, and carbapenems, were newly suggested to be associated with risk of SJS/TEN; considered together with the high incidence for trimethoprim-sulfamethoxazole and glycopeptides, these findings warrant caution in clinical practice.
    MeSH term(s) Humans ; Stevens-Johnson Syndrome/epidemiology ; Stevens-Johnson Syndrome/etiology ; Anti-Bacterial Agents/adverse effects ; Cross-Over Studies ; Trimethoprim, Sulfamethoxazole Drug Combination ; Fosfomycin ; Aminoglycosides ; Carbapenems ; Glycopeptides
    Chemical Substances Anti-Bacterial Agents ; Trimethoprim, Sulfamethoxazole Drug Combination (8064-90-2) ; Fosfomycin (2N81MY12TE) ; Aminoglycosides ; Carbapenems ; Glycopeptides
    Language English
    Publishing date 2023-07-17
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2843237-X
    ISSN 2213-2201 ; 2213-2198
    ISSN (online) 2213-2201
    ISSN 2213-2198
    DOI 10.1016/j.jaip.2023.07.012
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Risk of parkinsonism and related movement disorders with gabapentinoids or tramadol: A case-crossover study.

    Ri, Kairi / Fukasawa, Toshiki / Yoshida, Satomi / Takeuchi, Masato / Kawakami, Koji

    Pharmacotherapy

    2023  Volume 43, Issue 2, Page(s) 136–144

    Abstract: Introduction: A safety signal concerning parkinsonism and related movement disorders with gabapentinoids (gabapentin and pregabalin) or tramadol was detected by reviewing individual case reports and data mining in spontaneous report databases. Well- ... ...

    Abstract Introduction: A safety signal concerning parkinsonism and related movement disorders with gabapentinoids (gabapentin and pregabalin) or tramadol was detected by reviewing individual case reports and data mining in spontaneous report databases. Well-designed pharmacoepidemiological studies are needed to assess the signal.
    Objective: This study aimed to investigate the association of exposure to gabapentinoids or tramadol with the risk of parkinsonism and related movement disorders.
    Methods: We conducted a case-crossover study using a Japanese electronic medical records database. Patients with newly diagnosed parkinsonism or related movement disorders between January 1, 2007, and April 14, 2019, were identified. The diagnosis date of outcomes was defined as the index date. We assessed the exposure of each patient to gabapentinoids or tramadol during a 90-day hazard period ending 1 day before the index date and in three 90-day reference periods. Multivariable conditional logistic regression models were employed to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs). To confirm the robustness of the primary findings, we also performed sensitivity analyses using a case-case-time-control design, a different time window for hazard and reference periods, a different definition of outcome, and different number of reference periods.
    Results: A total of 28,972 eligible cases were included in the primary analysis. Exposure to gabapentinoids (aOR, 2.12; 95% CI, 1.73-2.61) and tramadol (aOR, 2.04; 95% CI, 1.57-2.64) was associated with increased risk. Results were consistent across sensitivity analyses.
    Conclusion: Our findings serve as a caution to physicians who prescribe gabapentinoids or tramadol in routine clinical practice.
    MeSH term(s) Humans ; Tramadol/adverse effects ; Cross-Over Studies ; Gabapentin/adverse effects ; Pregabalin/adverse effects ; Parkinsonian Disorders/chemically induced ; Analgesics, Opioid/adverse effects
    Chemical Substances Tramadol (39J1LGJ30J) ; Gabapentin (6CW7F3G59X) ; Pregabalin (55JG375S6M) ; Analgesics, Opioid
    Language English
    Publishing date 2023-01-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 603158-4
    ISSN 1875-9114 ; 0277-0008
    ISSN (online) 1875-9114
    ISSN 0277-0008
    DOI 10.1002/phar.2761
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Cardiovascular Safety of Atomoxetine and Methylphenidate in Patients With Attention-Deficit/Hyperactivity Disorder in Japan: A Self-Controlled Case Series Study.

    Zheng, Yunlong / Fukasawa, Toshiki / Yamaguchi, Fumitaka / Takeuchi, Masato / Kawakami, Koji

    Journal of attention disorders

    2023  Volume 28, Issue 4, Page(s) 439–450

    Abstract: Objective: To investigate the association between atomoxetine or methylphenidate use and arrhythmia, heart failure (HF), stroke, and myocardial infarction (MI) in attention-deficit/hyperactivity disorder (ADHD) patients mainly focused on the people of ... ...

    Abstract Objective: To investigate the association between atomoxetine or methylphenidate use and arrhythmia, heart failure (HF), stroke, and myocardial infarction (MI) in attention-deficit/hyperactivity disorder (ADHD) patients mainly focused on the people of working age.
    Methods: In a self-controlled case series study using a Japanese claims database, we identified events of arrhythmia, HF, stroke, and MI among 15,472 atomoxetine new users and 12,059 methylphenidate new users. Adjusted incidence rate ratios (aIRRs) of outcome events were estimated using multivariable conditional Poisson regression.
    Results: An increased risk of arrhythmia was observed during the first 7 days after the initial atomoxetine exposure (aIRR 6.22, 95% CI [1.90, 20.35]) and in the subsequent exposure (3.23, [1.58, 6.64]). No association was found between methylphenidate exposure and arrhythmia, nor between atomoxetine or methylphenidate exposure and HF. The limited number of stroke and MI cases prevented thorough analysis.
    Conclusions: Clinicians should consider monitoring for arrhythmia after patients initiating or re-initiating atomoxetine.
    MeSH term(s) Humans ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Attention Deficit Disorder with Hyperactivity/epidemiology ; Attention Deficit Disorder with Hyperactivity/chemically induced ; Methylphenidate/adverse effects ; Atomoxetine Hydrochloride/adverse effects ; Japan/epidemiology ; Central Nervous System Stimulants/adverse effects ; Arrhythmias, Cardiac/chemically induced ; Arrhythmias, Cardiac/drug therapy ; Stroke/chemically induced ; Stroke/drug therapy ; Adrenergic Uptake Inhibitors/adverse effects
    Chemical Substances Methylphenidate (207ZZ9QZ49) ; Atomoxetine Hydrochloride (57WVB6I2W0) ; Central Nervous System Stimulants ; Adrenergic Uptake Inhibitors
    Language English
    Publishing date 2023-12-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2004350-8
    ISSN 1557-1246 ; 1087-0547
    ISSN (online) 1557-1246
    ISSN 1087-0547
    DOI 10.1177/10870547231214993
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Comparative effectiveness and safety of edoxaban, rivaroxaban, and apixaban in patients with venous thromboembolism: A cohort study.

    Fukasawa, Toshiki / Seki, Tomotsugu / Nakashima, Masayuki / Kawakami, Koji

    Journal of thrombosis and haemostasis : JTH

    2022  Volume 20, Issue 9, Page(s) 2083–2097

    Abstract: Background: Although several studies have compared the effectiveness and safety of rivaroxaban and apixaban in patients with venous thromboembolism (VTE), direct comparison of these drugs with edoxaban is lacking.: Objective: We compared the ... ...

    Abstract Background: Although several studies have compared the effectiveness and safety of rivaroxaban and apixaban in patients with venous thromboembolism (VTE), direct comparison of these drugs with edoxaban is lacking.
    Objective: We compared the effectiveness and safety of edoxaban, rivaroxaban, and apixaban in patients with VTE.
    Patients/methods: In this retrospective cohort study using a Japanese hospital administrative database, we identified three mutually exclusive groups of patients with VTE beginning treatment with edoxaban, rivaroxaban, or apixaban. Primary effectiveness outcome was recurrent VTE, and principal safety outcome was a composite of intracranial hemorrhage and gastrointestinal bleeding. Subjects were followed for up to 180 days. Baseline characteristics among groups were balanced using propensity score matching weights.
    Results: Three thousand three hundred sixty-nine edoxaban, 1592 rivaroxaban, and 1998 apixaban initiators were identified. There were no significant differences among the three drugs in the prevention of recurrent VTE (adjusted incidence rate ratio [aIRR], 0.77; 95% confidence interval [CI], 0.45-1.30 for edoxaban vs. rivaroxaban; aIRR, 0.92; 95% CI, 0.54-1.56 for edoxaban vs. apixaban; and aIRR, 1.20; 95% CI, 0.69-2.10 for rivaroxaban vs. apixaban), or in the risk of intracranial hemorrhage or gastrointestinal bleeding (aIRR, 1.57, 95% CI, 0.85-2.90 for edoxaban vs. rivaroxaban; aIRR, 1.30, 95% CI, 0.76-2.23 for edoxaban vs. apixaban; and aIRR, 0.83, 95% CI, 0.42-1.64 for rivaroxaban vs. apixaban).
    Conclusions: In routine care, edoxaban, rivaroxaban, and apixaban appear to have similar effectiveness and safety in the treatment of VTE.
    MeSH term(s) Anticoagulants/therapeutic use ; Cohort Studies ; Gastrointestinal Hemorrhage/chemically induced ; Gastrointestinal Hemorrhage/diagnosis ; Humans ; Intracranial Hemorrhages/chemically induced ; Intracranial Hemorrhages/drug therapy ; Pyrazoles ; Pyridines ; Pyridones/adverse effects ; Retrospective Studies ; Rivaroxaban/adverse effects ; Thiazoles ; Venous Thromboembolism/diagnosis ; Venous Thromboembolism/drug therapy ; Venous Thromboembolism/prevention & control
    Chemical Substances Anticoagulants ; Pyrazoles ; Pyridines ; Pyridones ; Thiazoles ; apixaban (3Z9Y7UWC1J) ; Rivaroxaban (9NDF7JZ4M3) ; edoxaban (NDU3J18APO)
    Language English
    Publishing date 2022-07-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 2112661-6
    ISSN 1538-7836 ; 1538-7933
    ISSN (online) 1538-7836
    ISSN 1538-7933
    DOI 10.1111/jth.15799
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Adherence to and persistence with lacosamide, perampanel, lamotrigine, and levetiracetam in adult patients with focal epilepsy in Japan: A descriptive cohort study using a claims database

    Chen, Siming / Fukasawa, Toshiki / Ikeda, Akio / Takeuchi, Masato / Shimotake, Akihiro / Yoshida, Satomi / Kawakami, Kōji

    Heliyon. 2023 Apr., v. 9, no. 4 p.e15017-

    2023  

    Abstract: We evaluated adherence to and 1-year persistence of two third-generation anti-seizure medications (ASMs), lacosamide and perampanel, in adult patients with focal epilepsy, compared with lamotrigine and levetiracetam. A cohort study was conducted using a ... ...

    Abstract We evaluated adherence to and 1-year persistence of two third-generation anti-seizure medications (ASMs), lacosamide and perampanel, in adult patients with focal epilepsy, compared with lamotrigine and levetiracetam. A cohort study was conducted using a Japanese health insurance claims database (JMDC Inc.). We identified patients with adult-onset focal epilepsy who initiated any of the four ASMs between August 31, 2016, and October 31, 2019. Patients were further classified into ASM-naïve patients initiating any of the four ASMs as first-line treatment, and ASM-experienced patients initiating any of the four ASMs as second- or later-line treatment. Outcomes included adherence (proportion of days covered [PDC], defined as the total number of days covered by ASMs divided by the total number of days in the follow-up period) and 1-year persistence for the four ASMs. We identified 141 lacosamide, 75 perampanel, 80 lamotrigine, and 530 levetiracetam initiators. Among these, the proportion of ASM-naïve patients was highest in the levetiracetam group (60.8%), followed by the lamotrigine (25.0%), lacosamide (20.6%), and perampanel groups (1.3%). Mean PDC (standard deviation) was similar across the four groups, at 0.95 (0.08) for lacosamide, 0.93 (0.12) for perampanel, 0.92 (0.10) for lamotrigine and 0.94 (0.11) for levetiracetam. The proportion of patients persisting with treatment for 1 year was highest in the lacosamide group (73.0%), followed by the levetiracetam (58.3%), lamotrigine (57.5%), and perampanel groups (54.7%). In ASM-naïve patients, adherence and 1-year persistence were almost identical in the lacosamide, lamotrigine, and levetiracetam groups. Results for ASM-experienced patients did not significantly differ from those of all patients. With regard to adherence and 1-year persistence, lacosamide may be equal to or better than lamotrigine and levetiracetam, especially in patients with experienced ASM, while perampanel may be comparable to lamotrigine and levetiracetam in patients with experienced ASM.
    Keywords Japan ; adults ; cohort studies ; databases ; epilepsy ; health insurance ; standard deviation ; Pharmacoepidemiology ; Proportion of days covered ; Real-world evidence ; Third-generation anti-seizure medication
    Language English
    Dates of publication 2023-04
    Publishing place Elsevier Ltd
    Document type Article ; Online
    Note Use and reproduction
    ZDB-ID 2835763-2
    ISSN 2405-8440
    ISSN 2405-8440
    DOI 10.1016/j.heliyon.2023.e15017
    Database NAL-Catalogue (AGRICOLA)

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  8. Article: Adherence to and persistence with lacosamide, perampanel, lamotrigine, and levetiracetam in adult patients with focal epilepsy in Japan: A descriptive cohort study using a claims database.

    Chen, Siming / Fukasawa, Toshiki / Ikeda, Akio / Takeuchi, Masato / Shimotake, Akihiro / Yoshida, Satomi / Kawakami, Koji

    Heliyon

    2023  Volume 9, Issue 4, Page(s) e15017

    Abstract: Objective: We evaluated adherence to and 1-year persistence of two third-generation anti-seizure medications (ASMs), lacosamide and perampanel, in adult patients with focal epilepsy, compared with lamotrigine and levetiracetam.: Methods: A cohort ... ...

    Abstract Objective: We evaluated adherence to and 1-year persistence of two third-generation anti-seizure medications (ASMs), lacosamide and perampanel, in adult patients with focal epilepsy, compared with lamotrigine and levetiracetam.
    Methods: A cohort study was conducted using a Japanese health insurance claims database (JMDC Inc.). We identified patients with adult-onset focal epilepsy who initiated any of the four ASMs between August 31, 2016, and October 31, 2019. Patients were further classified into ASM-naïve patients initiating any of the four ASMs as first-line treatment, and ASM-experienced patients initiating any of the four ASMs as second- or later-line treatment. Outcomes included adherence (proportion of days covered [PDC], defined as the total number of days covered by ASMs divided by the total number of days in the follow-up period) and 1-year persistence for the four ASMs.
    Results: We identified 141 lacosamide, 75 perampanel, 80 lamotrigine, and 530 levetiracetam initiators. Among these, the proportion of ASM-naïve patients was highest in the levetiracetam group (60.8%), followed by the lamotrigine (25.0%), lacosamide (20.6%), and perampanel groups (1.3%). Mean PDC (standard deviation) was similar across the four groups, at 0.95 (0.08) for lacosamide, 0.93 (0.12) for perampanel, 0.92 (0.10) for lamotrigine and 0.94 (0.11) for levetiracetam. The proportion of patients persisting with treatment for 1 year was highest in the lacosamide group (73.0%), followed by the levetiracetam (58.3%), lamotrigine (57.5%), and perampanel groups (54.7%). In ASM-naïve patients, adherence and 1-year persistence were almost identical in the lacosamide, lamotrigine, and levetiracetam groups. Results for ASM-experienced patients did not significantly differ from those of all patients.
    Significance: With regard to adherence and 1-year persistence, lacosamide may be equal to or better than lamotrigine and levetiracetam, especially in patients with experienced ASM, while perampanel may be comparable to lamotrigine and levetiracetam in patients with experienced ASM.
    Language English
    Publishing date 2023-03-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 2835763-2
    ISSN 2405-8440
    ISSN 2405-8440
    DOI 10.1016/j.heliyon.2023.e15017
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Frequency and determinants of serum calcium monitoring during eldecalcitol therapy in patients with osteoporosis.

    Ri, Kairi / Fukasawa, Toshiki / Masuda, Soichiro / Tanaka, Shiro / Takeuchi, Masato / Yoshida, Satomi / Kawakami, Koji

    Journal of bone and mineral metabolism

    2023  Volume 41, Issue 6, Page(s) 890–900

    Abstract: Introduction: Eldecalcitol (ELD) is an active vitamin D: Materials and methods: This was a descriptive cohort study using a Japanese electronic medical records database. We identified osteoporosis patients who initiated treatment with ELD or other ... ...

    Abstract Introduction: Eldecalcitol (ELD) is an active vitamin D
    Materials and methods: This was a descriptive cohort study using a Japanese electronic medical records database. We identified osteoporosis patients who initiated treatment with ELD or other AVDs (alfacalcidol and calcitriol) between April 1, 2011 and September 10, 2021. The index date for cohort entry was the first prescription date of ELD or other AVDs. The frequency of serum calcium monitoring was evaluated every 6 months. Determinants of serum calcium monitoring were identified using multivariable logistic regression models. We also calculated the incidence of hypercalcemia and the frequency of serum calcium monitoring within 6 months before hypercalcemia.
    Results: We identified 12,671 ELD users and 7867 other AVD users. Within 6 months after cohort entry, 45.9% of ELD users and 58.7% of other AVD users underwent serum calcium monitoring. Female sex, no use of systemic corticosteroids, moderate-to-good renal function, treatment in smaller hospitals, and treatment in orthopedic surgery departments were associated with a lower likelihood of receiving serum calcium monitoring during ELD therapy. The incidence of hypercalcemia among ELD users was 6.36 per 100 person-years, with 20.6% of cases not receiving serum calcium monitoring before hypercalcemia.
    Conclusion: Our findings suggest that serum calcium monitoring is not given adequate attention during ELD therapy in routine clinical practice.
    MeSH term(s) Humans ; Female ; Calcium ; Hypercalcemia/drug therapy ; Hypercalcemia/chemically induced ; Cohort Studies ; Bone Density ; Vitamin D ; Osteoporosis/drug therapy ; Osteoporosis/chemically induced
    Chemical Substances eldecalcitol (I2JP8UE90H) ; Calcium (SY7Q814VUP) ; Vitamin D (1406-16-2)
    Language English
    Publishing date 2023-10-28
    Publishing country Japan
    Document type Journal Article
    ZDB-ID 1295123-7
    ISSN 1435-5604 ; 0914-8779
    ISSN (online) 1435-5604
    ISSN 0914-8779
    DOI 10.1007/s00774-023-01470-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Clinical Characteristics and Outcomes of Patients With Venous Thromboembolism Receiving Edoxaban in the Real World.

    Yamashita, Yugo / Fukasawa, Toshiki / Takeda, Chikashi / Takeuchi, Masato / Ono, Koh / Kawakami, Koji

    Circulation journal : official journal of the Japanese Circulation Society

    2023  Volume 88, Issue 3, Page(s) 371–379

    Abstract: Background: The effectiveness and safety of edoxaban for venous thromboembolism (VTE) in unselected real-world patients have not been fully evaluated.Methods and Results: In the Japanese nationwide administrative database, we identified 6,262 VTE ... ...

    Abstract Background: The effectiveness and safety of edoxaban for venous thromboembolism (VTE) in unselected real-world patients have not been fully evaluated.Methods and Results: In the Japanese nationwide administrative database, we identified 6,262 VTE patients in whom edoxaban was initiated; these patients were divided into 3 groups based on their index doses: 15 mg/day (n=235), 30 mg/day (n=4,532), and 60 mg/day (n=1,495). We evaluated patient characteristics, recurrent VTEs, and a composite endpoint of intracranial hemorrhage (ICH) and gastrointestinal (GI) bleeding. Patient characteristics among the 15-, 30-, and 60-mg edoxaban groups varied widely regarding several aspects, including age (mean 81.0, 76.2, and 65.0 years, respectively) and body weight (mean 49.5, 51.8, and 70.3 kg, respectively). At 180 days, the cumulative incidence of recurrent VTEs in the 15-, 30-, and 60-mg edoxaban groups was 4.4%, 2.6%, and 1.8%, respectively, whereas that of ICH or GI bleeding was 7.3%, 5.4%, and 3.3%, respectively. Subgroup analyses showed that the cumulative incidence of ICH or GI bleeding in patients in the 15-mg edoxaban group was 3.6% for patients aged ≥80 years, 8.4% for those with a body weight <60 kg, and 31.3% for those with renal dysfunction.
    Conclusions: Only a minority of patients with VTEs received a super low dose (15 mg) of edoxaban, and these patients may be at higher risk of bleeding as well as VTE recurrence.
    MeSH term(s) Humans ; Venous Thromboembolism/drug therapy ; Venous Thromboembolism/epidemiology ; Pyridines/adverse effects ; Gastrointestinal Hemorrhage/chemically induced ; Intracranial Hemorrhages/chemically induced ; Body Weight ; Anticoagulants/adverse effects ; Factor Xa Inhibitors/adverse effects ; Thiazoles
    Chemical Substances edoxaban (NDU3J18APO) ; Pyridines ; Anticoagulants ; Factor Xa Inhibitors ; Thiazoles
    Language English
    Publishing date 2023-12-23
    Publishing country Japan
    Document type Journal Article
    ZDB-ID 2068090-9
    ISSN 1347-4820 ; 1346-9843
    ISSN (online) 1347-4820
    ISSN 1346-9843
    DOI 10.1253/circj.CJ-23-0818
    Database MEDical Literature Analysis and Retrieval System OnLINE

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