Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis

No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient’s data for survival including two clinical trials (BETA and ALFAE) was performed. Results: In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, p = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo (p = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21–0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, p = 0.02). Conclusions: Repeated doses of albumin might be beneficial for patient’s survival as an add-on therapy after an HE episode, but an adequately powered trial is needed

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Three-stage Gamma Knife treatment for metastatic brain tumors larger than 10 cm3: a 2-institute study including re-analyses of earlier results using competing risk analysis

Journal of Neurosurgery ◽

10.3171/2018.7.gks181392 ◽

2018 ◽

Vol 129 (Suppl1) ◽

pp. 77-85 ◽

Cited By ~ 5

Author(s):

Masaaki Yamamoto ◽

Yoshinori Higuchi ◽

Toru Serizawa ◽

Takuya Kawabe ◽

Osamu Nagano ◽

...

Keyword(s):

Risk Analysis ◽

Brain Metastases ◽

Gamma Knife ◽

Survival Rates ◽

Competing Risk ◽

Published Data ◽

Competing Risk Analysis ◽

Survival Times ◽

Actuarial Survival ◽

Peripheral Dose

OBJECTIVEThe results of 3-stage Gamma Knife treatment (3-st-GK-Tx) for relatively large brain metastases have previously been reported for a series of patients in Chiba, Japan (referred to in this study as the C-series). In the current study, the authors reappraised, using a competing risk analysis, the efficacy and safety of 3-st-GK-Tx by comparing their experience with that of the C-series.METHODSThis was a retrospective cohort study. Among 1767 patients undergoing GK radiosurgery for brain metastases at Mito Gamma House during the 2005–2015 period, 78 (34 female, 44 male; mean age 65 years, range 35–86 years) whose largest tumor was > 10 cm3, treated with 3-st-GK-Tx, were studied (referred to in this study as the M-series). The target volumes were covered with a 50% isodose gradient and irradiated with a peripheral dose of 10 Gy at each procedure. The interval between procedures was 2 weeks. Because competing risk analysis had not been employed in the published C-series, the authors reanalyzed the previously published data using this method.RESULTSThe overall median survival time after 3-st-GK-Tx was 8.3 months (95% CI 5.6–12.0 months) in the M-series and 8.6 months (95% CI 5.5–10.6 months) in the C-series (p = 0.41). Actuarial survival rates at the 6th and 12th post–3-st-GK-Tx months were, respectively, 55.1% and 35.2% in the M-series and 62.5% and 26.4% in the C-series (HR 1.175, 95% CI 0.790–1.728, p = 0.42). Cumulative incidences at the 12th post–3-st-GK-Tx, determined by competing risk analyses, of neurological deterioration (14.2% in C-series vs 12.8% in M-series), neurological death (7.2% vs 7.7%), local recurrence (4.8% vs 6.2%), repeat SRS (25.9% vs 18.0%), and SRS-related complications (2.3% vs 5.1%) did not differ significantly between the 2 series.CONCLUSIONSThere were no significant differences in post–3-st-GK-Tx results between the 2 series in terms of overall survival times, neurological death, maintained neurological status, local control, repeat SRS, and SRS-related complications. The previously published results (C-series) are considered to be validated by the M-series results.

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Waitlist Mortality and Posttransplant Outcomes in African Americans with Autoimmune Liver Diseases

Journal of Transplantation ◽

10.1155/2021/6692049 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

John Paul Nsubuga ◽

Daniela Goyes ◽

Hirsh D. Trivedi ◽

Esli Medina-Morales ◽

Vilas Patwardhan ◽

...

Keyword(s):

African Americans ◽

Risk Analysis ◽

Liver Transplant ◽

Graft Survival ◽

Liver Diseases ◽

Cox Regression ◽

Survival Rates ◽

Competing Risk ◽

Competing Risk Analysis ◽

Autoimmune Liver Diseases

Background. Liver transplantation is indicated in end-stage liver disease due to autoimmune diseases. The liver allocation system can be affected by disparities such as decreased liver transplant referrals for racial minorities, especially African Americans that negatively impact the pre- and posttransplant outcomes. Aim. To determine differences in waitlist survival and posttransplant graft survival rates between African American and Caucasian patients with autoimmune liver diseases. Study. The United Network for Organ Sharing database was used to identify all patients with autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis who underwent liver transplant from 1988 to 2019. We compared waitlist survival and posttransplant graft survival between Caucasians and African Americans using Kaplan–Meier curves and Cox regression models. We also evaluated the cumulative incidence of death or delisting for deterioration and posttransplant incidence of death and retransplantation using competing risk analysis. Results. African Americans were more likely to be removed from the waitlist for death or clinical deterioration (subdistribution hazard ratio (SHR) 1.26, 95% CI 1–1.58, P = 0.046 ) using competing risk analysis. On multivariate Cox regression analysis, there was no difference in posttransplant graft survival among the two groups (hazard ratio (HR) 1.10, 95% CI 0.98–1.23, P = 0.081 ). Conclusions. Despite the current efforts to reduce racial disparities, we found that African Americans are more likely to die on the waitlist for liver transplant and are less likely to be transplanted, with no differences in graft survival rates. The persistence of healthcare disparities continues to negatively impact African Americans.

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Nitazoxanide versus Rifaximin in Preventing the Recurrence of Hepatic Encephalopathy: A Randomized Double Blind Controlled Trial

Journal of Hepato-Biliary-Pancreatic Sciences ◽

10.1002/jhbp.947 ◽

2021 ◽

Author(s):

Khadija A.M. Glal ◽

Sherief M. Abd‐Elsalam ◽

Tarek M. Mostafa

Keyword(s):

Hepatic Encephalopathy ◽

Controlled Trial ◽

Double Blind

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Bayesian competing risk analysis: An application to nasopharyngeal carcinoma patients data

Computational and Systems Oncology ◽

10.1002/cso2.1006 ◽

2020 ◽

Vol 1 (1) ◽

Author(s):

Rakesh Kumar Saroj ◽

K. Narasimha Murthy ◽

Mukesh Kumar ◽

Atanu Bhattacharjee ◽

Kamalesh Kumar Patel

Keyword(s):

Nasopharyngeal Carcinoma ◽

Risk Analysis ◽

Competing Risk ◽

Competing Risk Analysis

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Self-employment duration during the COVID-19 pandemic: A competing risk analysis

Journal of Business Venturing Insights ◽

10.1016/j.jbvi.2021.e00241 ◽

2021 ◽

pp. e00241

Author(s):

Jasper Grashuis

Keyword(s):

Risk Analysis ◽

Competing Risk ◽

Competing Risk Analysis ◽

Self Employment ◽

Employment Duration

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Standard and competing risk analysis of the effect of albuminuria on cardiovascular and cancer mortality in patients with type 2 diabetes mellitus

Diagnostic and Prognostic Research ◽

10.1186/s41512-018-0035-4 ◽

2018 ◽

Vol 2 (1) ◽

Cited By ~ 7

Author(s):

Benjamin G. Feakins ◽

Emily C. McFadden ◽

Andrew J. Farmer ◽

Richard J. Stevens

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Risk Analysis ◽

Cancer Mortality ◽

Competing Risk ◽

Competing Risk Analysis

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Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

10.21203/rs.3.rs-16499/v2 ◽

2020 ◽

Author(s):

Jun Ni ◽

Huisheng Chen ◽

Guofang Chen ◽

Yong Ji ◽

Fei Yi ◽

...

Keyword(s):

Ischemic Stroke ◽

Thrombolytic Therapy ◽

Acute Ischemic Stroke ◽

Barthel Index ◽

Controlled Trial ◽

Survival Rates ◽

Control Group ◽

Efficacy And Safety ◽

Clinical Trial Registry ◽

Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

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A Scoring System For Predicting Hepatocellular Carcinoma Risk In Alcoholic Cirrhosis: A Competing Risk Analysis

10.21203/rs.3.rs-970975/v1 ◽

2021 ◽

Author(s):

Kyunghan Lee ◽

Gwang Hyeon Choi ◽

Eun Sun Jang ◽

Sook-Hyang Jeong ◽

Jin–Wook Kim

Keyword(s):

Hepatocellular Carcinoma ◽

Risk Analysis ◽

Viral Hepatitis ◽

Validation Cohort ◽

Alcoholic Cirrhosis ◽

Competing Risk ◽

Competing Risk Analysis ◽

Hazards Model ◽

B Virus

Abstract Background & Aims: The role of hepatocellular carcinoma (HCC) surveillance is being questioned in alcoholic cirrhosis because of the relative low HCC risk. Comorbid viral hepatitis may synergistically increase the HCC risk in alcoholic cirrhosis. This study aimed to assess the risk and predictors of HCC in patients with alcoholic cirrhosis by using competing risk analysis in an area with intermediate prevalence for hepatitis B virus.Methods: A total of 965 patients with alcoholic cirrhosis were recruited at a university-affiliated hospital in Korea and randomly assigned to either the derivation (n=643) and validation (n=322) cohort. Subdistribution hazards model of Fine and Gray was used with deaths and liver transplantation treated as competing risks. Death records were confirmed from Korean government databases. A nomogram was developed to calculate the Alcohol-associated Liver Cancer Estimation (ALICE) score.Results: Markers for viral hepatitis were positive in 21.0 % and 25.8 % of patients in derivation and validation cohort, respectively. The cumulative incidence of HCC was 13.5 and 14.9 % at 10 years for derivation and validation cohort, respectively. Age, positivity for viral hepatitis markers, alpha-fetoprotein level, and platelet count were identified as independent predictors of HCC and incorporated in the ALICE score, which discriminated low, intermediate, and high risk for HCC in alcoholic cirrhosis at the cut-off of 120 and 180. Conclusions: HCC risk can be stratified by using clinical parameters including viral markers in alcoholic cirrhosis in an area where the prevalence of viral hepatitis is substantial.

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