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Use of doripenem and risk of seizure and renal impairment in US hospitalized patients: a retrospective cohort study.

ABSTRACT: A large retrospective database study was conducted to assess the incidence rate of treatment-emergent renal impairment/failure, seizure, and hemolytic anemia in doripenem and imipenem intravenous (IV)-exposed patients treated for complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI) in US hospitals.Using the Premier Perspective™ Database (PPD), which maintains hospital discharge records for over 309 million patients, the incidence rate of treatment-emergent renal impairment/failure, seizure, and hemolytic anemia in the doripenem-treated compared with imipenem IV-treated population was examined.The unadjusted doripenem rate ratio (RR) for renal impairment/failure relative to imipenem IV was 1.13 [95% confidence interval (CI) 1.07-1.21; p < 0.0001]. The unadjusted doripenem rate ratio for seizure relative to imipenem IV was 0.74 (95% CI 0.52-1.05; p = 0.07). In the comparative safety analysis, adjusted incidence rates of renal impairment/failure between doripenem-exposed patients and a propensity score-matched comparator cohort of imipenem IV-exposed patients showed no statistically significant difference in cUTI [RR = 1.02; 95% CI 0.93-1.12; p = 0.71] or cIAI (RR = 1.17; 95% CI 1.00-1.36; p = 0.05). Likewise, there was no statistically significant difference in adjusted incidence rates for seizures in doripenem-treated versus matched imipenem-treated patients for cUTI (RR = 0.69; 95% CI 0.41-1.14; p = 0.15) or cIAI (RR = 0.45; 95% CI 0.15-1.41; p = 0.17). No hemolytic anemia events were observed in this study.In this large retrospective cohort study of US hospitalized patients, no statistically significant differences in the adjusted relative rates of renal impairment/failure and seizure were observed between doripenem and a propensity score-matched comparator cohort of imipenem IV patients in the treatment of cUTI and cIAI.

SUBMITTER: Chavers S

PROVIDER: S-EPMC4785857 | biostudies-other | 2016 Apr

REPOSITORIES: biostudies-other

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Use of doripenem and risk of seizure and renal impairment in US hospitalized patients: a retrospective cohort study.

Chavers Scott S Magee Glenn G Baumer Dorothy D Pai Helen H

Therapeutic advances in drug safety 20151214 2

<h4>Objectives</h4>A large retrospective database study was conducted to assess the incidence rate of treatment-emergent renal impairment/failure, seizure, and hemolytic anemia in doripenem and imipenem intravenous (IV)-exposed patients treated for complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI) in US hospitals.<h4>Methods</h4>Using the Premier Perspective™ Database (PPD), which maintains hospital discharge records for over 309 million patients, the in ...[more]

PMID: 27034773

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Project description:BackgroundOutcomes among hospitalized patients with severe vision impairment or blindness have not been extensively explored. This study sought to determine clinical and resource utilization outcomes in patients with severe vision impairment/blindness (SVI/B). Because obesity is very common among those who are hospitalized, we also sought to understand its impact among patients with SVI/B.MethodsWe conducted a retrospective study using the National Inpatient Sample for the year 2017; hospitalized adults with and without SVI/B were compared. In addition, for all patients with SVI/B, we compared those with and without obesity. Multiple logistic regression and linear analysis were used to evaluate mortality, disposition, length of stay, and hospital charges; the analyses were adjusted for multiple variables including age, sex, and race.Results30,420,907 adults were hospitalized, of whom 37,200 had SVI/B. Patients with SVI/B were older (mean age ± SEM: 66.4 ± 0.24 vs. 57.9 ± 0.09 years, p < 0.01), less likely to be female (50 % vs. 57.7 %, p < 0.01), more frequently insured by Medicare (75.7 % vs. 49.2 %, p < 0.01), and had more comorbidities (Charlson comorbidity score ≥ 3: 53.2 % vs. 27.8 %, p < 0.01). Patients with SVI/B had a higher in-hospital mortality rate (3.9 % vs. 2.2 %; p < 0.01), and had lower odds to be discharged home after hospital discharge (adjusted Odds Ratio {aOR} =0.54, [Confidence Interval (CI) 0.51-0.58]; p < 0.01) compared to those without SVI/B. Hospital charges were not significantly different (adjusted Mean Difference {aMD} = $247 CI [-$2,474-2,929]; p = 0.85) but length of stay was longer (aMD = 0.5 days CI [0.3-0.7]; p < 0.01) for those with SVI/B. Patients with vision impariment who were also obese had higher total hospital charges compared to those without obesity (mean difference: $9,821 [CI $1,375-$18,268]; p = 0.02).ConclusionsPatients admitted to American hospitals in 2017 who had SVI/B had worse clinical outcomes and greater resources utilization than those without SVI/B. Hospital-based healthcare providers who understand that those with SVI/B may be at risk for worse outcomes may be optimally positioned to help them to receive the best possible care.

Project description:Introduction: MicroRNAs (miRNAs) are small, non-coding RNA molecules involved in post-transcriptional gene regulation and have recently been shown to play a role in cancer metastasis. In solid tumors, especially breast cancer, alterations in miRNA expression contribute to cancer pathogenesis, including metastasis. Considering the emerging role of miRNAs in metastasis, the identification of predictive markers is necessary to further understanding of stage-specific breast cancer development. This is a retrospective analysis that aimed to identify molecular biomarkers related to distant breast cancer metastasis development.<br><br>Methods: A retrospective case cohort study was performed in 64 breast cancer patients treated during the period from 1998-2001. The case group (n=29) consisted of patients with a poor prognosis who presented with breast cancer recurrence or metastasis during follow up. The control group (n=35) consisted of a random sample of patients with a good prognosis who did not develop breast cancer recurrence or metastasis. These patient groups were stratified according to TNM clinical stage (CS) I, II and III, and the main clinical features of the patients were homogeneous. miRNA profiling was performed using formalin-fixed, paraffin-embedded tumors. Biomarkers related to metastatic potential were identified independent of clinical stage, and a cutoff point was selected based on the optimal sensitivity and specificity (ROC curve). Finally, a hazard risk analysis of these biomarkers was performed to evaluate their relation to metastatic potential. <br><br>Results: miRNA expression profiling identified several miRNAs that were either specific and shared across all clinical stages (p?0.05). Among these, we identified miRNAs previously associated with cell motility (let-7 family), cell proliferation and invasion (hsa-miR-16 and has-miR-205) and distant metastasis (hsa-miR-21). In addition, hsa-miR-494 and hsa-miR-21 were up-regulated in metastatic cases of CSI and II. Furthermore, the combination of the 3 miRNAs identified for CSII (hsa-miR-494, hsa-miR-183 and hsa-miR-21) was significant and were a more effective risk marker compared to the single miRNAs. <br><br>Conclusions: Women with metastatic breast cancer, especially CSII, presented up-regulated levels of miR-183, miR-494 and miR-21, which were associated with a poor prognosis. These miRNAs therefore represent new risk biomarkers of breast cancer metastasis and may be useful for future targeted therapies.

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Project description:BackgroundThe novel coronavirus SARS-CoV-2 and its associated disease, COVID-19, have caused worldwide disruption, leading countries to take drastic measures to address the progression of the disease. As SARS-CoV-2 continues to spread, hospitals are struggling to allocate resources to patients who are most at risk. In this context, it has become important to develop models that can accurately predict the severity of infection of hospitalized patients to help guide triage, planning, and resource allocation.ObjectiveThe aim of this study was to develop accurate models to predict the mortality of hospitalized patients with COVID-19 using basic demographics and easily obtainable laboratory data.MethodsWe performed a retrospective study of 375 hospitalized patients with COVID-19 in Wuhan, China. The patients were randomly split into derivation and validation cohorts. Regularized logistic regression and support vector machine classifiers were trained on the derivation cohort, and accuracy metrics (F1 scores) were computed on the validation cohort. Two types of models were developed: the first type used laboratory findings from the entire length of the patient's hospital stay, and the second type used laboratory findings that were obtained no later than 12 hours after admission. The models were further validated on a multicenter external cohort of 542 patients.ResultsOf the 375 patients with COVID-19, 174 (46.4%) died of the infection. The study cohort was composed of 224/375 men (59.7%) and 151/375 women (40.3%), with a mean age of 58.83 years (SD 16.46). The models developed using data from throughout the patients' length of stay demonstrated accuracies as high as 97%, whereas the models with admission laboratory variables possessed accuracies of up to 93%. The latter models predicted patient outcomes an average of 11.5 days in advance. Key variables such as lactate dehydrogenase, high-sensitivity C-reactive protein, and percentage of lymphocytes in the blood were indicated by the models. In line with previous studies, age was also found to be an important variable in predicting mortality. In particular, the mean age of patients who survived COVID-19 infection (50.23 years, SD 15.02) was significantly lower than the mean age of patients who died of the infection (68.75 years, SD 11.83; P<.001).ConclusionsMachine learning models can be successfully employed to accurately predict outcomes of patients with COVID-19. Our models achieved high accuracies and could predict outcomes more than one week in advance; this promising result suggests that these models can be highly useful for resource allocation in hospitals.

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Use of doripenem and risk of seizure and renal impairment in US hospitalized patients: a retrospective cohort study.

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Use of doripenem and risk of seizure and renal impairment in US hospitalized patients: a retrospective cohort study.

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