scholarly journals Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial

2021 ◽  
pp. ASN.2021070942
Author(s):  
Rajiv Agarwal ◽  
Amer Joseph ◽  
Stefan Anker ◽  
Gerasimos Filippatos ◽  
Peter Rossing ◽  
...  
Keyword(s):  
Risk Factors ◽  
Serum Potassium ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Study Drug ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Short Term ◽  
The Impact ◽  
Reduced Risk

Background: Finerenone reduced risk of cardiorenal outcomes in patients with CKD and type 2 diabetes in the FIDELIO-DKD trial. We report incidences and risk factors for hyperkalemia with finerenone and placebo in FIDELIO-DKD. Methods: This post hoc safety analysis defined hyperkalemia as ≥mild or ≥moderate based on serum potassium concentrations of >5.5 or >6.0 mmol/L, respectively, assessed at all regular visits. Cumulative incidences of hyperkalemia were based on the Aalen-Johansen estimator using death as competing risk. A multivariate Cox proportional hazards model identified significant independent predictors of hyperkalemia. Restricted cubic splines assessed relationships between short-term post-baseline changes in serum potassium or eGFR and subsequent hyperkalemia risk. During the study, serum potassium levels guided drug dosing. Patients in either group who experienced ≥mild hyperkalemia had the study drug withheld until serum potassium was ≤5.0 mmol/L; then the drug was restarted at the 10 mg daily dose. Placebo-treated patients underwent sham treatment interruption and downtitration. Results: Over 2.6 years' median follow-up, 597/2785 (21.4%) and 256/2775 (9.2%) of patients treated with finerenone and placebo, respectively, experienced treatment-emergent ≥mild hyperkalemia; 126/2802 (4.5%) and 38/2796 (1.4%) patients, respectively, experienced moderate hyperkalemia. Independent risk factors for ≥mild hyperkalemia were higher serum potassium, lower eGFR, increased urine albumin-to-creatinine ratio, younger age, female sex, beta-blocker use, and finerenone assignment. Diuretic or sodium-glucose co-transporter-2 inhibitor use reduced risk. In both groups, short-term increases in serum potassium and decreases in eGFR were associated with subsequent hyperkalemia. At month 4, the magnitude of increased hyperkalemia risk for any change from baseline was smaller with finerenone than with placebo Conclusions: Finerenone was independently associated with hyperkalemia. However, routine potassium monitoring and hyperkalemia management strategies employed in FIDELIO-DKD minimized the impact of hyperkalemia, providing a basis for clinical use of finerenone.

Age at Exposure to Parental Suicide and the Subsequent Risk of Suicide in Young People

Crisis ◽  
2018 ◽  
Vol 39 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Kuan-Ying Lee ◽  
Chung-Yi Li ◽  
Kun-Chia Chang ◽  
Tsung-Hsueh Lu ◽  
Ying-Yeh Chen
Keyword(s):  
Young People ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Birth Registry ◽  
Data Set ◽  
Parental Suicide ◽  
The Impact ◽  
Age At Exposure

Abstract. Background: We investigated the age at exposure to parental suicide and the risk of subsequent suicide completion in young people. The impact of parental and offspring sex was also examined. Method: Using a cohort study design, we linked Taiwan's Birth Registry (1978–1997) with Taiwan's Death Registry (1985–2009) and identified 40,249 children who had experienced maternal suicide (n = 14,431), paternal suicide (n = 26,887), or the suicide of both parents (n = 281). Each exposed child was matched to 10 children of the same sex and birth year whose parents were still alive. This yielded a total of 398,081 children for our non-exposed cohort. A Cox proportional hazards model was used to compare the suicide risk of the exposed and non-exposed groups. Results: Compared with the non-exposed group, offspring who were exposed to parental suicide were 3.91 times (95% confidence interval [CI] = 3.10–4.92 more likely to die by suicide after adjusting for baseline characteristics. The risk of suicide seemed to be lower in older male offspring (HR = 3.94, 95% CI = 2.57–6.06), but higher in older female offspring (HR = 5.30, 95% CI = 3.05–9.22). Stratified analyses based on parental sex revealed similar patterns as the combined analysis. Limitations: As only register-­based data were used, we were not able to explore the impact of variables not contained in the data set, such as the role of mental illness. Conclusion: Our findings suggest a prominent elevation in the risk of suicide among offspring who lost their parents to suicide. The risk elevation differed according to the sex of the afflicted offspring as well as to their age at exposure.

scholarly journals Prevalence, Risk Factors, and Complications of Cholelithiasis in Adults With Short Bowel Syndrome: A Longitudinal Cohort Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Xuejin Gao ◽  
Li Zhang ◽  
Siwen Wang ◽  
Yaqin Xiao ◽  
Deshuai Song ◽  
...  
Keyword(s):  
Risk Factors ◽  
Short Bowel Syndrome ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Clinical Trial Registration ◽  
Short Bowel ◽  
Kaplan Meier ◽  
Clinical Consequences

Background: Patients with short bowel syndrome (SBS) are at a high risk of cholestasis or cholelithiasis. This study aimed to determine the incidence, risk factors, and clinical consequences of cholelithiasis in adults with SBS over an extended period.Methods: All eligible adults diagnosed with SBS and admitted to a tertiary hospital center between January 2010 and December 2019 were retrospectively identified from the hospital records database. Kaplan–Meier analysis was used to estimate the cumulative incidence of SBS during the 10-year period. For assessment the risk factors for cholelithiasis, we used multivariate Cox proportional hazards model with estimation of hazard ratio (HR) with 95% confidence intervals (95 %CI).Results: This study enrolled 345 eligible patients with SBS. Kaplan–Meier analysis revealed that 72 patients (20.9%) developed cholelithiasis during the 10-year observation period. In multivariate analyses using the Cox proportional hazard model revealed that the remnant jejunum (HR = 2.163; 95% confidence interval [CI]: 1.156–4.047, p = 0.016) and parenteral nutrition dependence (HR = 1.783; 95% CI: 1.077–2.952, p = 0.025) were independent risk factors for cholelithiasis in adults with SBS. Twenty-eight patients developed symptoms and/or complications in the cholelithiasis group. Proportions of acute cholecystitis or cholangitis and acute pancreatitis were significantly increased in the cholelithiasis group compared with the non-cholelithiasis group (31.9 vs. 7.7%, p < 0.01; and 6.9 vs. 1.1%, p = 0.003, respectively).Conclusion: Because of the adverse clinical consequences of cholelithiasis, adult patients with SBS should be closely monitored, and preventive interventions should be considered.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT04867538.

Between National Polarization and Local Ideology: The Impact of Partisan Competition on State Medicaid Expansion Decisions

2019 ◽  
Vol 50 (2) ◽  
pp. 237-255 ◽  
Author(s):  
Joshua Meyer-Gutbrod
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Electoral Competition ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Party Competition ◽  
Medicaid Expansion ◽  
Hazards Model ◽  
Partisan Competition ◽  
The Impact

Abstract The U.S. Supreme Court’s decision to grant states the authority to reject Medicaid expansion under the Affordable Care Act without penalty threatened the implementation of this polarized health policy. While many Republican-controlled states followed their national allies and rejected Medicaid expansion, others engaged in bipartisan implementation. Why were some Republican states willing to reject the national partisan agenda and cooperate with Democrats in Washington? I focus on the role of electoral competition within states. I conclude that although electoral competition has been shown to encourage partisan polarization within the states, the combination of intergovernmental implementation and Medicaid expansion’s association with public welfare reverses this dynamic. I employ a Cox proportional-hazards model to examine the impact of state partisan ideology and competition on the likelihood of state Medicaid expansion. I find that strong inter-party competition mitigates the impact of more extreme partisan ideologies, encouraging potentially bipartisan negotiation with the federal administration.

scholarly journals Exploring the determinants of real estate liquidity from an alternative perspective: censored quantile regression in real estate research

2020 ◽  
Vol 90 (7) ◽  
pp. 1057-1086 ◽  
Author(s):  
Marcelo Cajias ◽  
Philipp Freudenreich ◽  
Anna Freudenreich
Keyword(s):  
Real Estate ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Quantile Regressions ◽  
The Real Estate ◽  
Censored Quantile Regression ◽  
The Impact ◽  
German Cities

Abstract In this paper, the liquidity (inverse of time on market) of rental dwellings and its determinants for different liquidity quantiles are examined for the seven largest German cities. The determinants are estimated using censored quantile regressions in order to investigate the impact on very liquid to very illiquid dwellings. As market heterogeneity is not only observed between cities but also within a city, each of the seven cities is considered individually. Micro data for almost 500,000 observations from 2013 to 2017 is used to examine the time on market. Substantial differences in the magnitude and direction of the regression coefficients for the different liquidity quantiles are found. Furthermore, both the magnitude and direction of the impact of an explanatory variable on the liquidity, differ between the cities. To the best of the authors’ knowledge this is the first paper, to apply censored quantile regressions to liquidity analysis of the real estate rental market. The model reveals that the proportionality assumption underlying the Cox proportional hazards model cannot be confirmed for all variables across all cities, but for most of them.

Risk factors for disease progression in low-teens normal-tension glaucoma

2019 ◽  
Vol 104 (1) ◽  
pp. 81-86 ◽  
Author(s):  
Sung Uk Baek ◽  
Ahnul Ha ◽  
Dai Woo Kim ◽  
Jin Wook Jeoung ◽  
Ki Ho Park ◽  
...  
Keyword(s):  
Risk Factors ◽  
Disease Progression ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Normal Tension Glaucoma ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Diurnal Iop

Background/AimsTo investigate the risk factors for disease progression of normal-tension glaucoma (NTG) with pretreatment intraocular pressure (IOP) in the low-teens.MethodsOne-hundred and two (102) eyes of 102 patients with NTG with pretreatment IOP≤12 mm Hg who had been followed up for more than 60 months were retrospectively enrolled. Patients were divided into progressor and non-progressor groups according to visual field (VF) progression as correlated with change of optic disc or retinal nerve fibre layer defect. Baseline demographic and clinical characteristics including diurnal IOP and 24 hours blood pressure (BP) were compared between the two groups. The Cox proportional hazards model was used to identify the risk factors for disease progression.ResultsThirty-six patients (35.3%) were classified as progressors and 66 (64.7%) as non-progressors. Between the two groups, no significant differences were found in the follow-up periods (8.7±3.4 vs 7.7±3.2 years; p=0.138), baseline VF mean deviation (−4.50±5.65 vs −3.56±4.30 dB; p=0.348) or pretreatment IOP (11.34±1.21 vs 11.17±1.06 mm Hg; p=0.121). The multivariate Cox proportional hazards model indicated that greater diurnal IOP at baseline (HR=1.609; p=0.004), greater fluctuation of diastolic BP (DBP; HR=1.058; p=0.002) and presence of optic disc haemorrhage during follow-up (DH; HR=3.664; p=0.001) were risk factors for glaucoma progression.ConclusionIn the low-teens NTG eyes, 35.3% showed glaucoma progression during the average 8.7 years of follow-up. Fluctuation of DBP and diurnal IOP as well as DH were significantly associated with greater probability of disease progression.

Epidemiology, Risk Factors, and Outcomes After Early Posttransplant Clostridiodes difficile Infection in Renal Transplant Recipients

2019 ◽  
Vol 53 (10) ◽  
pp. 1020-1025
Author(s):  
Margaret R. Jorgenson ◽  
Jillian L. Descourouez ◽  
Dou-Yan Yang ◽  
Glen E. Leverson ◽  
Christopher M. Saddler ◽  
...  
Keyword(s):  
Risk Factors ◽  
Renal Transplant ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Female Gender ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Secondary Outcome ◽  
Induction Agent ◽  
Renal Transplant Recipients

Background: Modifiable risk-factors associated with Clostridioides difficile infection (CDI) in renal-transplant (RTX) have not been clearly established and peri-transplant risk has not been described. Objective: Evaluate epidemiology, risk-factors and outcomes after CDI occurring in the first 90 days after RTX (CDI-90).Methods: Observational cohort study/survival analysis of adult RTX recipients from 1/1/2012-12/31/2015. Primary outcome was CDI-90 incidence/risk-factors. Secondary outcome was evaluation of post-90 day transplant outcomes. Results: 982 patients met inclusion criteria; 46 with CDI-90 and 936 without (comparator). CDI incidence in the total population was 4.7% at 90 days, 6.3% at 1 year, and 6.4% at 3 years. Incidence of CDI-90 was 5%; time to diagnosis was 19.4±25 days (median 7). Risk-factors for CDI-90 were alemtuzumab induction (Hazard ratio [HR] 1.5, 95% CI(1.1-2.0), p = 0.005) and age at transplant (HR 1.007/year, 95% CI (1.002-1.012), p= 0.007). However, risk-factors for CDI at any time were different; donation-after-circulatory-death (DCD) donor (HR 2.5 95% CI (1.3-4.9), p = 0.008) and female gender (HR 1.6 95% CI (1.0-2.7), p = 0.049). On Kaplan-Meier, CDI-90 appeared to have an impact on patient/graft survival, however when analyzed in a multivariable stepwise Cox proportional hazards model, only age was significantly associated with survival ( p = 0.002). Conclusion and Relevance: Incidence of CDI-90 is low, mostly occurring in the first post-operative month. Risk-factors vary temporally based on time from transplant. In the early post-op period induction agent and age at transplant are significant, but not after. Associations between CDI and negative graft outcomes appear to be largely driven by age. Future studies validating these risk-factors as well as targeted prophylaxis strategies and their effect on long term graft outcomes and the host microbiome are needed.

scholarly journals Incidence and Survival Changes in Patients with Esophageal Adenocarcinoma during 1984–2013

2019 ◽  
Vol 2019 ◽  
pp. 1-11 ◽  
Author(s):  
Zhang Haiyu ◽  
Pei Xiaofeng ◽  
Mo Xiangqiong ◽  
Qiu Junlan ◽  
Zheng Xiaobin ◽  
...  
Keyword(s):  
United States ◽  
Risk Factors ◽  
Esophageal Adenocarcinoma ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
The United States ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Potential Risk Factors

Purpose. The morbidity of esophageal adenocarcinoma (EAC) has significantly increased in Western countries. We aimed to identify trends in incidence and survival in patients with EAC in the recent 30 years and then analyzed potential risk factors, including race, sex, age, and socioeconomic status (SES). Methods. All data were collected from the Surveillance, Epidemiology, and End Results or SEER database. Kaplan–Meier analysis and the Cox proportional hazards model were conducted to compare the differences in survival between variables, including sex, race, age, and SES, as well as to evaluate the association of these factors with prognosis. Results. A total of 16,474 patients with EAC were identified from 1984 to 2013 in the United States. Overall incidence increased every 10 years from 1.8 to 3.1 to 3.9 per 100. Overall survival gradually improved (p<0.0001), which was evident in male patients ((hazard ratio (HR) = 1.111; 95% confidence interval (CI) (1.07, 1.15)); however, the 5-year survival rate remained low (20.1%). The Cox proportional hazards model identified old age, black ethnicity, and medium/high poverty as risk factors for EAC (HR = 1.018; 95% CI (1.017, 1.019; HR = 1.240, 95% CI (1.151,1.336), HR = 1.000, 95% CI (1.000, 1.000); respectively). Conclusions. The incidence of EAC in the United States increased over time. Survival advantage was observed in white patients and patients in the low-poverty group. Sex was an independent prognostic factor for EAC, but this finding has to be confirmed by further research.

scholarly journals Outcomes of Peritoneal Dialysis Patients and Switching to Hemodialysis: A Competing Risks Analysis

2014 ◽  
Vol 34 (3) ◽  
pp. 289-298 ◽  
Author(s):  
Jernej Pajek ◽  
Alastair J. Hutchison ◽  
Shiv Bhutani ◽  
Paul E.C. Brenchley ◽  
Helen Hurst ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Residual Renal Function ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Adjusted Analysis ◽  
Ultrafiltration Failure ◽  
The Impact ◽  
Technique Failure

BackgroundWe performed a review of a large incident peritoneal dialysis cohort to establish the impact of current practice and that of switching to hemodialysis.MethodsPatients starting peritoneal dialysis between 2004 and 2010 were included and clinical data at start of dialysis recorded. Competing risk analysis and Cox proportional hazards model with time-varying covariate (technique failure) were used.ResultsOf 286 patients (median age 57 years) followed for a median of 24.2 months, 76 were transplanted and 102 died. Outcome probabilities at 3 and 5 years respectively were 0.69 and 0.53 for patient survival (or transplantation) and 0.33 and 0.42 for technique failure. Peritonitis caused technique failure in 42%, but ultrafiltration failure accounted only for 6.3%. Davies comorbidity grade, creatinine and obesity (but not residual renal function or age) predicted technique failure. Due to peritonitis deaths, technique failure was an independent predictor of death hazard. When successful switch to hemodialysis (surviving more than 60 days after technique failure) and its timing were analyzed, no adverse impact on survival in adjusted analysis was found. However, hemodialysis via central venous line was associated with an elevated death hazard as compared to staying on peritoneal dialysis, or hemodialysis through a fistula (adjusted analysis hazard ratio 1.97 (1.02 – 3.80)).ConclusionsOnce the patients survive the first 60 days after technique failure, the switch to hemodialysis does not adversely affect patient outcomes. The nature of vascular access has a significant impact on outcome after peritoneal dialysis failure.

scholarly journals Risk Factors for Mortality in Chinese Patients on Continuous Ambulatory Peritoneal Dialysis

2015 ◽  
Vol 35 (2) ◽  
pp. 199-205 ◽  
Author(s):  
Fan Zhang ◽  
Hong Liu ◽  
Xiaoli Gong ◽  
Fuyou Liu ◽  
Youming Peng ◽  
...  
Keyword(s):  
Risk Factors ◽  
Peritoneal Dialysis ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Patient Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Kaplan Meier

ObjectiveThe intent of this study was to evaluate the clinical outcome and risk factors affecting mortality of the continuous ambulatory peritoneal dialysis (CAPD) patients in a single peritoneal dialysis (PD) center over a period of 10 years.Patients and methodsWe retrospectively analyzed patients on PD from June 2001 to June 2011. The clinical and biochemical data were collected from the medical records. Clinical variables included gender, age at the start of PD, smoking status, body mass index (BMI), cause of end-stage renal disease (ESRD), presence of diabetes mellitus and blood pressure. Biochemical variables included hemoglobin, urine volume, residual renal function (RRF), serum albumin, blood urea nitrogen (BUN), creatinine, total cholesterol, triglyceride, comorbidities, and outcomes. Survival curves were made by the Kaplan-Meier method. Univariate and multivariate analyses to identify mortality risk factors were performed using the Cox proportional hazard regression model.ResultsA total of 421 patients were enrolled, 269 of whom were male (63.9%). The mean age at the start of PD was 57.9 ± 14.8 years. Chronic glomerulonephritis was the most common cause of ESRD (39.4%). Estimation of patient survival by Kaplan-Meier was 92.5%, 80.2%, 74.4%, and 55.7% at 1, 3, 5, and 10 years, respectively. Patient survival was associated with age (hazard ratio [HR]: 1.641 [1.027 – 2.622], p = 0.038), cardiovascular disease (HR: 1.731 [1.08 – 2.774], p = 0.023), hypertriglyceridemia (HR: 1.782 [1.11 – 2.858], p = 0.017) in the Cox proportional hazards model analysis. Estimation of technique survival by Kaplan-Meier was 86.7%, 68.8%, 55.7%, and 37.4% at 1, 3, 5, and 10 years, respectively. In the Cox proportional hazards model analysis, age (HR: 1.672 [1.176 – 2.377], p = 0.004) and hypertriglyceridemia (HR: 1.511 [1.050 – 2.174], p = 0.026) predicted technique failure.ConclusionThe PD patients in our center exhibited comparable or even superior patient survival and technical survival rates, compared with reports from other centers in China and other countries.

Clinical outcomes of pancreas cancer patients with peritoneal spread: Results from the chord consortium.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19268-e19268
Author(s):  
Mehrnoosh Pauls ◽  
Abdulaziz AlJassim AlShareef ◽  
Winson Y. Cheung ◽  
Rachel Anne Goodwin ◽  
Brandon M. Meyers ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Cancer Patients ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Advanced Pancreatic Cancer ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
First Line ◽  
The Impact ◽  
Line Chemotherapy

e19268 Background: Prior studies have demonstrated that clonal cells that give rise to pancreatic peritoneal metastases (PM) are geographically and genetically distinct from clonal cells, giving rise to lung and liver metastases. The objective of this study was to assess if there is a distinct difference in prognosis and therapeutic response among patients with pancreatic cancer with (PM compared to the lung/liver. Methods: Using a retrospective cohort design, medical records from adult patients diagnosed with metastatic adenocarcinoma of the pancreas at five Canadian academic cancer centers (2014 - 2019) were reviewed. Prognostic variables including age, Charlson comorbidity index, ECOG, cigarette smoking, nodal status, sites of metastases, and first line chemotherapy were collected. Cox proportional hazards model (MVA) was used to examine the association between peritoneal involvement and survival, adjusted for measured confounders. Analyses were completed using SAS, where alpha of 0.05 was defined as the level of significance. Results: A total of 1161 patients were included. Metastatic sites included peritoneum (n = 170, 14.6%), lung (n = 145, 12.5%) and liver (n = 563, 48.5%). Patients with PM received first-line FOLFIRINOX (FFX, n = 31), Gemcitabine + nab-paclitaxel (G/N, n = 20), Gemcitabine (G, n = 18), and no treatment (n = 97). In univariate analyses, worse ECOG PS was associated with PM (p = 0.002). The majority of patients died (89%), with a median overall survival (OS) of 3 vs 7 months for patients with PM and those without PM (p < 0.001), respectively. The median OS in patient whom receive first-line chemotherapy was 7 months in FFX group (95% CI 1.66-12.33), 6 months in G/N (95% CI 4.54-7.45) and 2 months in G group (95% CI 1.42-2.57). Patients had significantly better OS when treated with FFX or G/N compared to G alone (p = 0.002). Time to treatment failure was significantly shorter among patient treated with G alone compare to patients treated with FFX and G/N (P < 0.005). Conclusions: In the setting of combination chemotherapy for advanced pancreatic cancer, patients with PM continue to have a poor prognosis. This may be due to the impact of PM on PS and the inability to administer palliative chemotherapy. For eligible patients, FFX or G/N results in a higher OS than G monotherapy.

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