scholarly journals MIHARI project, a preceding study of MID-NET, adverse event detection database of Ministry Health of Japan—Validation study of the signal detection of adverse events of drugs using export data from EMR and medical claim data

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0255863
Author(s):  
Hiroshi Watanabe ◽  
Kiyoteru Takenouchi ◽  
Michio Kimura
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Medical Records ◽  
Claim Data ◽  
Prescription Data ◽  
Laboratory Examination ◽  
Medical Claim ◽  
Predictive Values ◽  
Medical Claim Data

We studied the effectiveness of the direct data collection from electronic medical records (EMR) when it is used for monitoring adverse drug events and also detection of already known adverse events. In this study, medical claim data and SS-MIX2 standardized storage data were used to identify four diseases (diabetes, dyslipidemia, hyperthyroidism, and acute renal failure) and the validity of the outcome definitions was evaluated by calculating positive predictive values (PPV). The maximum positive predictive value (PPV) for diabetes based on medical claim data was 40.7% and that based on prescription data from SS-MIX2 Standardized Storage was 44.7%. The PPV for dyslipidemia was 50% or higher under either of the conditions. The PPV for hyperthyroidism based on disease name data alone was 20–30%, but exceeded 60% when prescription data was included in the evaluation. Acute renal failure was evaluated using information from medical records in addition to the data. The PPV for acute renal failure based on the data of disease names and laboratory examination results was slightly higher at 53.7% and increased to 80–90% when patients who previously had a high serum creatinine (Cre) level were excluded. When defining a disease, it is important to include the condition specific to the disease; furthermore, it is very useful if laboratory examination results are also included. Therefore, the inclusion of laboratory examination results in the definitions, as in the present study, was considered very useful for the analysis of multi-center SS-MIX2 standardized storage data.

scholarly journals Factors associated with mechanical and systemic adverse events after colonoscopy (France, 2010-2015)

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Laanani ◽  
A Weill ◽  
P O Blotière ◽  
J Pouchot ◽  
F Carbonnel ◽  
...  
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Older Patients ◽  
Public Hospitals ◽  
Serious Adverse Events ◽  
Logistic Regression Models ◽  
Factors Associated ◽  
Increased Risk ◽  
Experienced Endoscopists

Abstract Background More than one million colonoscopies are performed every year in France. They are associated with risks of mechanical and systemic serious adverse events (SAEs) which can be associated with patient, procedure, endoscopist, and facility characteristics. We tried to identify the factors associated with colonic perforation, gastrointestinal bleeding, splenic injury, shock, myocardial infarction, stroke, pulmonary embolism, acute renal failure, and urolithiasis after colonoscopy. Methods We analysed data from the French national claims databases (SNDS). A total of 4,088,799 patients, 30 years or older, undergoing a first screening or diagnostic colonoscopy between 2010 and 2015 were identified. SAE rates were estimated, and risk factors associated with SAEs were identified using multilevel logistic regression models, adjusted for patient, colonoscopy, endoscopist, and facility characteristics. Results Increasing age was associated with an increasing incidence of mechanical and systemic SAEs. Cancer and cardiovascular comorbidities were associated with mechanical SAEs, and a higher number of pre-existing conditions was associated with shock and acute renal failure. Polypectomy, especially of polyps larger than 1 cm, was associated with an increased risk of perforation (OR = 4.1; 95% CI, 3.4-5.0) and bleeding (OR = 13.3; 95% CI, 11.7-15.1). Mechanical SAEs were associated with the endoscopist’s experience, while systemic SAEs were more frequent in public hospitals than in private clinics. Conclusions SAEs related to colonoscopy were more frequent in older patients and in those with comorbidities. Mechanical SAEs were more frequent when colonoscopy was performed by less experienced endoscopists. Systemic SAEs were more frequent in public hospitals, reflecting patient selection processes. The risk of both mechanical and systemic SAEs should be taken into account when deciding to perform colonoscopy, particularly in older patients with multiple pre-existing conditions. Key messages Systemic SAEs are not uncommon after colonoscopy and, together with intestinal SAEs, should be considered when considering the need for colonoscopy. Patients at risk of SAEs should be identified and colonoscopy should be performed by experienced endoscopists in these patients. Less invasive alternatives should also be considered in these patients.

scholarly journals Acute Renal Failure in a Patient with Rivaroxaban-Induced Hypersensitivity Syndrome: A Case Report with a Review of the Literature and of Pharmacovigilance Registries

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Gisela Marcelino ◽  
Ould Maouloud Hemett ◽  
Eric Descombes
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Case Reports ◽  
Vitamin K Antagonists ◽  
Clinical Manifestations ◽  
Hypersensitivity Syndrome ◽  
World Health ◽  
Low Grade ◽  
Review Of The Literature

Direct oral anticoagulants (DOACs) are among the most commonly prescribed medications, and DOAC-associated kidney dysfunction may be a problem that is underrecognized by clinicians. We report on the case of an 82-year-old patient who, two weeks after the prescription of rivaroxaban for atrial fibrillation, was hospitalized for a drug-induced hypersensitivity syndrome whose main clinical manifestations were low-grade fever with a petechial rash in the legs and acute renal failure (ARF). Within one week after rivaroxaban withdrawal, the patient’s clinical condition improved and the renal function normalized. In a review of the literature, we only found five case reports of rivaroxaban-related ARF: two patients had tubulo-interstitial nephritis (TIN), two had anticoagulant-related nephropathy (ARN), and the last one had IgA nephropathy. As some recent publications suggest that kidney injury due to anticoagulation drugs may be largely underdiagnosed, we also analyzed the data from the VigiAccess database, the World Health Organization pharmacovigilance program that collects drug-related adverse events from 134 national registries worldwide. Among all the rivaroxaban-associated adverse events reported in VigiAccess since 2006, 4,323 (3.5%) were renal side effects, of which 2,351 (54.3%) were due to unspecified ARF, 363 (8.4%) were due to renal hemorrhage (characteristically associated with ARN), and 24 (0.6%) were due to TIN. We also compared these results with those reported in VigiAccess for other DOACs and vitamin K antagonists. This analysis suggests that the frequency of renal adverse events associated with rivaroxaban and other DOACs may be appreciably higher than what one might currently consider based only on the small number of fully published cases.

scholarly journals Characteristics of heart failure patients incurring high medical costs via matching specific health examination results and medical claim data: a cross-sectional study

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031422
Author(s):  
Yuya Tamaki ◽  
Kana Kazawa ◽  
Hirohito Watanabe ◽  
Tantut Susanto ◽  
Michiko Moriyama
Keyword(s):  
Medical Costs ◽  
Claim Data ◽  
Cross Sectional Study ◽  
Health Examination ◽  
Sectional Study ◽  
Medical Claim ◽  
Cross Sectional ◽  
Pareto Analysis ◽  
Medical Claim Data ◽  
Specific Health

ObjectiveWe describe the characteristics of patients with high medical costs by matching specific annual medical examination results and medical claim data. Clarifying the relationships between examination items and high medical costs allows the screening of high-risk persons.DesignA cross-sectional study.SubjectsSubjects were persons insured by national health insurance in Hiroshima City, Hiroshima Prefecture, from April 2016 to March 2017. To identify true heart failure (HF) patients, the disease name listed in the medical claim data was compared with drugs prescribed for HF, with extraction of only subjects whose comparative data matched.Data collection and analysisThe specific health examination includes a questionnaire on areas such as lifestyle habits, anthropometry, blood pressure, blood tests and urine tests. The percentage of the total medical costs related to the medical care of subjects with HF was described using Pareto analysis. For specific health examination items, we compared the high-cost and low-cost groups. The normality and homoscedasticity of each variable was checked and Student’s t-tests and χ² tests were applied. Finally, multiple logistic regression analysis was used to detect factors in the health examination items related to high medical costs.ResultsPareto analysis showed that 80% of all medical costs were paid by 30% of the HF patient population. The fees for cardiovascular surgery accounted for 54% of the total surgical cost, 64% of which included preventable diseases. Levels of creatinine (Cr) and γ-glutamyl transpeptidase (γ-GTP) and a history of smoking were found to be related to high medical costs.ConclusionAnalysis of specific health examination results for HF patients revealed the association between high medical costs, γ-GTP, Cr, and smoking. These results can thus serve as a reference for screening persons at high risk of HF and help prevent the exacerbation of HF.

scholarly journals Relative risks of adverse events among older adults receiving opioids versus NSAIDs after hospital discharge: A nationwide cohort study

PLoS Medicine ◽  
2021 ◽  
Vol 18 (9) ◽  
pp. e1003804
Author(s):  
Shoshana J. Herzig ◽  
Timothy S. Anderson ◽  
Yoojin Jung ◽  
Long Ngo ◽  
Dae H. Kim ◽  
...  
Keyword(s):  
Older Adults ◽  
Renal Failure ◽  
Acute Renal Failure ◽  
Cohort Study ◽  
Adverse Events ◽  
Hospital Discharge ◽  
Healthcare Utilization ◽  
Colonic Motility ◽  
Post Discharge ◽  
Propensity Matching

Background Although analgesics are initiated on hospital discharge in millions of adults each year, studies quantifying the risks of opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) among older adults during this transition are limited. We sought to determine the incidence and risk of post-discharge adverse events among older adults with an opioid claim in the week after hospital discharge, compared to those with NSAID claims only. Methods and findings We performed a retrospective cohort study using a national sample of Medicare beneficiaries age 65 and older, hospitalized in the United States hospitals in 2016. We excluded beneficiaries admitted from or discharged to a facility. We derived a propensity score that included over 100 factors potentially related to the choice of analgesic, including demographics, diagnoses, surgeries, and medication coadministrations. Using 3:1 propensity matching, beneficiaries with an opioid claim in the week after hospital discharge (with or without NSAID claims) were matched to beneficiaries with an NSAID claim only. Primary outcomes included death, healthcare utilization (emergency department [ED] visits and rehospitalization), and a composite of known adverse effects of opioids or NSAIDs (fall/fracture, delirium, nausea/vomiting, complications of slowed colonic motility, acute renal failure, and gastritis/duodenitis) within 30 days of discharge. After 3:1 propensity matching, there were 13,385 beneficiaries in the opioid cohort and 4,677 in the NSAID cohort (mean age: 74 years, 57% female). Beneficiaries receiving opioids had a higher incidence of death (1.8% versus 1.1%; RR 1.7 [1.3 to 2.3], p < 0.001, number needed to harm [NNH] 125), healthcare utilization (19.0% versus 17.4%; RR 1.1 [1.02 to 1.2], p = 0.02, NNH 59), and any potential adverse effect (25.2% versus 21.3%; RR 1.2 [1.1 to 1.3], p < 0.001, NNH 26), compared to those with an NSAID claim only. Specifically, they had higher relative risk of fall/fracture (4.5% versus 3.4%; RR 1.3 [1.1 to 1.6], p = 0.002), nausea/vomiting (9.2% versus 7.3%; RR 1.3 [1.1 to 1.4], p < 0.001), and slowed colonic motility (8.0% versus 6.2%; RR 1.3 [1.1 to 1.4], p < 0.001). Risks of delirium, acute renal failure, and gastritis/duodenitis did not differ between groups. The main limitation of our study is the observational nature of the data and possibility of residual confounding. Conclusions Older adults filling an opioid prescription in the week after hospital discharge were at higher risk for mortality and other post-discharge adverse outcomes compared to those filling an NSAID prescription only.

Clinical Outcomes in Patients with ADAMTS13-Deficient Thrombotic Thrombocytopenic Purpura (TTP) Who Received Platelet Transfusions (PT).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1302-1302
Author(s):  
Karen K. Swisher ◽  
Johanna A. Kremer Hovinga ◽  
Bernhard Lämmle ◽  
Deirdra R. Terrell ◽  
Sara K. Vesely ◽  
...  
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Case Reports ◽  
Invasive Procedure ◽  
Venous Catheter ◽  
Neurological Complications ◽  
First Episode ◽  
Adamts13 Activity ◽  
Microvascular Thrombosis

Abstract Case reports describe neurological complications, acute renal failure and death in patients with TTP following PT; these observations have led to recommendations to avoid PT. The Oklahoma TTP-HUS Registry enrolled 254 consecutive patients with their first episode of clinically diagnosed TTP from 11-13-1995 (the date of our initial ADAMTS13 measurement) to 12-31-2006 for whom plasma exchange treatment (PEX) was requested; ADAMTS13 activity was measured in 235 (93%) patients immediately before their first PEX; 44 (19%) patients had ADAMTS13 activity <10%. To avoid selection bias, the 19 patients without ADAMTS13 measurements were also included; 9 died before a sample was obtained. We excluded 11 of the 63 patients because of alternative etiologies or subsequent diagnoses (drug-associated TTP-HUS (5), sepsis (4), cancer (1), post-BMT (1)). The initial episodes of 52 patients were analyzed (42 with ADAMTS13 <10%; 10 not measured). 26 (50%) patients received PT; 23 (88%) only before the first PEX. 13 patients had 1 PT; 9 had 2–3, and 4 had 4–14. 17 (65%) patients received PT for an indication such as central venous catheter placement or hemorrhage, 5 (19%) only because of thrombocytopenia, and 4 (15%) had multiple PT for both reasons. Patients PT (n=26) No PT (n=26) P *median; **seizure, stroke, coma, focal abnormalities anytime during the course; †most abnormal values at diagnosis ± 7 days, median; §defined by ↑ Cr ≥ 0.5 mg/dL x 2 days or Cr ≥4.0 and dialysis. Age* (years) 40 41 0.649 Female (%) 69% 88% 0.090 Race (% black) 35% 38% 0.773 Severe neurologic abnormalities** 46% 50% 0.789 Platelet count† (/μL) 11,000 13,000 0.058 Hematocrit† (%) 21 22 0.339 LDH† (U/L) 1639 1226 0.045 Creatinine† (mg/dL) 1.3 1.0 0.156 Acute renal failure§ 8% 4% 1.000 Death (30 days) 27% 12% 0.159 There were no clinically important differences between the groups of patients who did or did not receive PT. 22 of 26 (85%) patients who received PT had no adverse events in <24 hours. Although there was no difference in the overall occurrence of severe neurologic abnormalities, 2 patients who received PT had new neurologic events <24 hours after a PT (stroke, seizure). Patients who received PT had a higher but not significantly different mortality. 7 patients who received PT died; 3 died 9, 12, and 72 hours after PT; autopsies were performed in 2 of these 3 patients documenting systemic microvascular thrombosis; another patient died 6 hours after PT from intrathoracic hemorrhage due to subclavian line placement. The other 3 patients died 14, 18, and 18 days after PT from S. epidermidis sepsis, respiratory failure, and stroke. 3 patients who had not received PT died; 2 died immediately after diagnosis before PEX could begin; autopsies in both documented systemic microvascular thrombosis. 1 patient died of enterococcal sepsis 11 days after diagnosis. Conclusions: PT are commonly given to patients with TTP, most often before the diagnosis is established and PEX is begun. Although PT may be followed by severe complications or death, the relation of PT to these adverse events is uncertain. It is prudent to avoid PT in patients with TTP; however in patients with overt hemorrhage or who require a high risk invasive procedure, PT may be appropriate supportive care.

Safety and Preliminary Efficacy Results of a Phase I First-in-Human Study of the Novel Notch-1 Targeting Antibody Brontictuzumab (OMP-52M51) Administered Intravenously to Patients with Hematologic Malignancies

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5108-5108 ◽  
Author(s):  
Carla Casulo ◽  
Jia Ruan ◽  
Nam H. Dang ◽  
Lia Gore ◽  
Catherine Diefenbach ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Research Funding ◽  
Cell Lymphoma ◽  
Hematologic Malignancies ◽  
Employment Equity ◽  
Activating Mutations ◽  
Equity Ownership

Abstract Background: The Notch pathway plays a key role in embryonic development and regulation of stem and progenitor cells, and is implicated in human cancer. Notch1 (N1) signaling is activated by various mechanisms including N1 activating mutations in certain hematologic tumors such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B cell lymphoma (DLBCL). Brontictuzumab (BRON) is a humanized IgG2 antibody that inhibits the signaling function of N1. As such, BRON is a novel anti-cancer agent that inhibits tumor growth through direct actions on tumor cells, including cancer stem cells, and tumor angiogenesis. Materials and methods: A phase I dose escalation and expansion study was initiated in patients (pts) with previously treated CLL, MCL, DLBCL, anaplastic large cell lymphoma (ALCL), transformed mycosis fungoides (TMF), Sezary Syndrome (SS), T-cell acute lymphoblastic leukemia (T-ALL), or other hematologic malignancies with known N1 activating mutation. BRON was administered intravenously to study safety, pharmacokinetics (PK), pharmacodynamics, preliminary efficacy, and to determine the maximum tolerated dose (MTD). Clinical trial information: NCT01778439. Results: Twenty-four pts were enrolled and 23 pts have been treated in 4 dose escalation cohorts at doses of 0.25 mg/kg every 4 weeks (Q4W), 0.5 mg/kg Q4W, 1 mg/kg Q4W, and 1 mg/kg every 2 weeks (Q2W). Tumor types included DLBCL (6 pts), CLL (5 pts), TMF (5 pts), MCL (4 pts), and one each with T-ALL, T-cell prolymphocytic leukemia (T-PLL), and follicular lymphoma (FL). Two pts experienced dose-limiting toxicity (DLTs) adverse events at the 1.0 mg/kg Q2W dose cohort: one pt had gr 5 acute renal failure in the setting of tumor lysis (1 mg/kg Q2W) and 1 pt had gr 3 diarrhea and gr3 acute on chronic renal failure (1 mg/kg Q2W). The most frequent treatment-related adverse events (AE) of any grade were: diarrhea (22%), fatigue (17%), anemia (13%), abdominal pain (9%), nausea (9%), vomiting (9%), peripheral edema (9%), increased bilirubin (9%), decreased appetite (9%), hypokalemia (9%), and acute renal failure (9%). One pt with TMF had partial response to treatment, after receiving 1 mg/kg Q2W. Two additional pts had stable disease as best overall response (1 with MCL, and 1 with TMF). Five of the 24 pts had N1 mutations that were predicted to be deleterious and 3 pts had unknown N1 mutation status. Of the 5 patients with N1 mutations, 3 had classical frame shift mutations in the N1 PEST domain and are validated to be activating mutations and 2 had mutations in EGF-like domain where the mutation significance is unknown. Of the three patients with known N1 activating mutations, 1 pt was treated at 0.25 mg/kg Q4W and had progressive disease at first assessment, 1 pt never received study drug, and 1 pt treated at 1 mg/kg Q2W had stable disease as best response and was on study 101 days. Conclusions: BRON is generally well tolerated and had moderate anti-tumor activity. Diarrhea is the primary toxicity of this antibody. The MTD has not been established. Updated efficacy, safety, N1 intracellular domain expression status, and PK results will be presented. Disclosures Casulo: Infinity: Consultancy, Honoraria; Celgene: Research Funding. Dang:Pharmacyclics LLC, an AbbVie Company: Research Funding; Seattle Genetics: Research Funding; Novartis: Honoraria; Eisai: Research Funding; Valor: Research Funding; Oncomed Pharmaceuticals Inc: Research Funding. Diefenbach:Gillead: Equity Ownership; BMS: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Merck: Consultancy, Research Funding. Porcu:miRagen: Other: Investigator in a clinical trial; celgene: Other: Investigator in a clinical trial; Innate Pharma: Other: Investigator in a clinical trial; Millenium: Other: investigator in a clinical trial. Faoro:OncoMed Pharmaceuticals: Employment, Equity Ownership. Dupont:OncoMed Pharmaceuticals: Employment, Equity Ownership. Kapoun:OncoMed Pharmaceuticals: Employment, Equity Ownership. Wang:OncoMed Pharmaceuticals: Employment, Equity Ownership. McGuire:OncoMed Pharmaceuticals: Employment, Equity Ownership. Flinn:Janssen: Research Funding; Gilead Sciences: Research Funding; Pharmacyclics LLC, an AbbVie Company: Research Funding; ARIAD: Research Funding; RainTree Oncology Services: Equity Ownership.

Sign in / Sign up

Export Citation Format

Share Document