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The use of activated vitamin D and risks of hospitalization for infection and amputation in incident hemodialysis patients in Taiwan: a nationwide population-based cohort study.
Chao, JY, Li, CY, Wang, MC, Kao Yang, YH
BMC nephrology. 2020;(1):331
Abstract
BACKGROUND Hemodialysis patients have a high risk of mortality. The most common causes of death are cardiovascular disease and infection. The potential hazard or benefit associated with vitamin D use and cardiovascular or infection outcome is poorly characterized. METHODS We conducted a retrospective observational cohort study by recruiting 52,757 patients older than 20 years from Taiwan National Health Insurance Research Database (NHIRD) who initiated maintenance hemodialysis between 2001 and 2009. Patients who were prescribed activated vitamin D before the 360th day from hemodialysis initiation were defined as vitamin D users. The primary outcome of interest includes occurrence of acute myocardial infarction (AMI), ischemic stroke, lower limb amputation, and hospitalization for infection, respectively, while death events are treated as competing events. We conducted competing risk analysis using subdistribution hazard regression model to estimate subdistribution hazard ratios (SHRs) in relation to various outcomes. RESULTS During the median follow-up of 1019 days, the vitamin D users had a lower crude mortality rate, lower incidences of AMI, ischemic stroke, amputation, and hospitalization for infection compared with non-users. Taking into consideration competing events of death, vitamin D users were associated with a lower hazard of lower limb amputation (SHR 0.84 [95% CI, 0.74-0.96]) and hospitalization for infection (SHR 0.90 [95% CI, 0.87-0.94]), but not AMI or ischemic stroke, after adjustment for potential confounders. Subgroup analyses and dose response evaluation both showed a consistent association of activated vitamin D treatment with decreased risk of amputation and infection. CONCLUSION The findings suggest that therapeutic activated vitamin D use in hemodialysis patients may be beneficial for decreasing infection events and amputation, of which the latter is a complication of peripheral vascular disease, rather than reducing major atherosclerotic cardiovascular events such as AMI or ischemic stroke.
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Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial.
McGuire, DK, Zinman, B, Inzucchi, SE, Wanner, C, Fitchett, D, Anker, SD, Pocock, S, Kaspers, S, George, JT, von Eynatten, M, et al
The lancet. Diabetes & endocrinology. 2020;(12):949-959
Abstract
BACKGROUND Patients with type 2 diabetes and atherosclerotic cardiovascular disease are at high clinical risk. We assessed the effect of the sodium-glucose co-transporter-2 inhibitor, empagliflozin, on total cardiovascular events and admissions to hospital in the EMPA-REG OUTCOME trial. METHODS The EMPA-REG OUTCOME trial was a randomised, double-blind, non-inferiority trial of patients (aged ≥18 years) with type 2 diabetes and atherosclerotic cardiovascular disease done between August, 2010, and April, 2015. Participants were randomly assigned (1:1:1) to empagliflozin 10 mg or 25 mg, or placebo. The primary outcome was major adverse cardiovascular events: a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction. As prespecified, the effects of pooled empagliflozin versus placebo were assessed on total (first plus recurrent) events of major adverse cardiovascular events, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, and admission to hospital for heart failure. We also did post-hoc analyses on additional cardiovascular and admission to hospital outcomes. We used statistical models that preserve randomisation and account for correlation of recurrent events, including negative binomial regression, as prespecified for the primary analyses. The EMPA-REG OUTCOME trial is registered with ClinicalTrials.gov, NCT01131676, and is closed to accrual. FINDINGS In the EMPA-REG OUTCOME trial, 7020 patients were randomly assigned and treated with empagliflozin 10 mg (n=2345), empagliflozin 25 mg (n=2342), or placebo (n=2333) and followed up for a median of 3·2 years (IQR 2·2 to 3·6) in the pooled empagliflozin group and 3·1 years (2·2 to 3·5) in the placebo group. Analysing total (first plus recurrent) events, empagliflozin versus placebo reduced the risk of major adverse cardiovascular events (rate ratio [RR] 0·78 [95% CI 0·67 to 0·91]; p=0·0020; 12·88 [95% CI 3·74 to 22·02] events prevented per 1000 patient-years); fatal or non-fatal myocardial infarction (0·79 [0·62 to 0·998]; p=0·049; 4·97 [-0·68 to 10·61] events prevented per 1000 patient-years); the composite of fatal or non-fatal myocardial infarction, or coronary revascularisation (0·80 [0·67 to 0·95]; p=0·012; 11·65 [1·25 to 22·05] events prevented per 1000 patient-years); admission to hospital for heart failure (0·58 [0·42 to 0·81]; p=0·0012; 9·67 [3·07 to 16·28] events prevented per 1000 patient-years); and all-cause admission to hospital (0·83 [0·76 to 0·91]; p<0·0001; 50·41 [26·20 to 74·63] events prevented per 1000 patient-years). For outcomes significantly reduced with empagliflozin, risk reductions were numerically larger for total events than for first events. Total fatal or non-fatal stroke was not significantly different between treatment groups (RR 1·10 [95% CI 0·82 to 1·49]; p=0·52). INTERPRETATION Empagliflozin reduced the total burden of cardiovascular complications and all-cause admission to hospital in patients with type 2 diabetes and atherosclerotic cardiovascular disease. FUNDING The Boehringer Ingelheim and Lilly Alliance.
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Survey and analysis of the nutritional status in hospitalized patients with malignant gastric tumors and its influence on the quality of life.
Guo, ZQ, Yu, JM, Li, W, Fu, ZM, Lin, Y, Shi, YY, Hu, W, Ba, Y, Li, SY, Li, ZN, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2020;(1):373-380
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Abstract
BACKGROUND/OBJECTIVES The assessment of nutritional status and the quality of life in patients with gastric cancer has become one of the important goals of current clinical treatment. The purpose of this study was to assess the nutritional status in hospitalized gastric cancer patients by using patient-generated subjective global assessment (PG-SGA) and to analyze the influence of nutritional status on the patients' quality of life (QOL). METHODS We reviewed the pathological diagnosis of gastric cancer for 2322 hospitalized patients using PG-SGA to assess their nutritional status and collected data on clinical symptoms, the anthropometric parameters (height, weight, body mass index (BMI), mid-arm circumference (MAC), triceps skin-fold thickness (TSF), and hand-grip strength (HGS). We also collected laboratory data (prealbumin, albumin, hemoglobin) within 48 h after the patient was admitted to the hospital. The 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) was used for QOL assessment in all patients. RESULTS By using PG-SGA, we found 80.4% of the patients were malnourished (score ≥ 4) and 45.1% of the patients required urgent nutritional support (score ≥ 9). In univariate analysis, old age (> 65 years, p < 0.001), female (p = 0.007), residence in a village (p = 0.004), a lower level of education (p < 0.001), and self-paying (p < 0.001) were indicated as risk factors of patients with gastric cancer to be suffering from severe malnutrition. There was a negative correlation between PG-SGA and various nutritional parameters (p < 0.05). The quality of life was significantly different in gastric cancer patients with different nutritional status (p < 0.01). CONCLUSION Malnutrition of hospitalized patients with gastric cancer in China is common and seriously affects the patients' quality of life. The nutritional status should be evaluated in a timely manner and reasonable nutritional intervention should be provided as soon as possible. The PG-SGA was fit for using as a clinical nutrition assessment method, being worthy of clinical application.
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A Risk Score to Predict Admission to the Intensive Care Unit in Patients with COVID-19: the ABC-GOALS score.
Mejía-Vilet, JM, Córdova-Sánchez, BM, Fernández-Camargo, DA, Méndez-Pérez, RA, Morales-Buenrostro, LE, Hernández-Gilsoul, T
Salud publica de Mexico. 2020;(1, ene-feb):1-11
Abstract
OBJECTIVE To develop a score to predict the need for ICU admission in COVID-19. METHODS We assessed patients admitted to a COVID-19 center in Mexico. Patients were segregated into a group that required ICU admission, and a group that never required ICU admission. By logistic regression, we derived predictive models including clinical, laboratory, and imaging findings. The ABC-GOALS was constructed and compared to other scores. RESULTS We included 329 and 240 patients in the development and validation cohorts, respectively. One-hundred-fifteen patients from each cohort required ICU admission. The clinical (ABC-GOALSc), clinical+laboratory (ABC-GOALScl), clinical+laboratory+image (ABC-GOALSclx) models area under the curve were 0.79 (95%CI=0.74-0.83) and 0.77 (95%CI=0.71-0.83), 0.86 (95%CI=0.82-0.90) and 0.87 (95%CI=0.83-0.92), 0.88 (95%CI=0.84-0.92) and 0.86 (95%CI=0.81-0.90), in the development and validation cohorts, respectively. The ABC-GOALScl and ABC-GOALSclx outperformed other COVID-19 and pneumonia predictive scores. CONCLUSION ABC-GOALS is a tool to timely predict the need for admission to ICU in COVID-19.
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Mortality and Hospitalizations among Sickle Cell Disease Patients with End-Stage Kidney Disease Initiating Dialysis.
Olaniran, KO, Eneanya, ND, Zhao, SH, Ofsthun, NJ, Maddux, FW, Thadhani, RI, Dalrymple, LS, Nigwekar, SU
American journal of nephrology. 2020;(12):995-1003
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BACKGROUND Sickle cell disease (SCD) is the most common inherited hematological disorder and a well-described risk factor for end-stage kidney disease (ESKD). Mortality and hospitalizations among patients with SCD who develop ESKD remain understudied. Furthermore, prior studies focused only on SCD patients where ESKD was caused by SCD. We aimed to describe mortality and hospitalization risk in all SCD patients initiating dialysis and explore risk factors for mortality and hospitalization. METHODS We performed a national observational cohort study of African American ESKD patients initiating dialysis (2000-2014) in facilities affiliated with a large dialysis provider. SCD was identified by diagnosis codes and matched to a reference population (non-SCD) by age, sex, dialysis initiation year, and geographic region of care. Sensitivity analyses were conducted by restricting to patients where SCD was recorded as the cause of ESKD. RESULTS We identified 504 SCD patients (mean age: 47 ± 14 years; 48% females) and 1,425 reference patients (mean age: 46 ± 14 years; 49% females). The median follow-up was 2.4 (IQR 1.0-4.5) years. Compared to the reference, SCD was associated with higher mortality risk (hazard ratio 1.66; 95% confidence interval [CI]: 1.36-2.03) and higher hospitalization rates (incidence rate ratio 2.12; 95% CI: 1.88-2.38) in multivariable analyses. Exploratory multivariable mortality risk models showed the largest mortality risk attenuation with the addition of time-varying hemoglobin and high-dose erythropoietin, but the association of SCD with mortality remained significant. Sensitivity analyses (restricted to ESKD caused by SCD) also showed significant associations between SCD and mortality and hospitalizations, but with larger effect estimates. High-dose erythropoietin was associated with the highest risk for mortality and hospitalization in SCD. CONCLUSIONS Among ESKD patients, SCD is associated with a higher risk for mortality and hospitalization, particularly in patients where SCD is identified as the cause of ESKD.
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Sodium-Glucose Cotransporter-2 Inhibitors in Heart Failure: A Meta-Analysis of Randomized Clinical Trials.
Kumar, K, Kheiri, B, Simpson, TF, Osman, M, Rahmouni, H
The American journal of medicine. 2020;(11):e625-e630
Abstract
BACKGROUND We aimed to conduct this study with the goal of further clarifying the role of sodium-glucose cotransporter-2 inhibitors (SGLT2i) in patients with preexisting heart failure with reduced ejection fraction with or without diabetes and to leverage increased sample size and power to evaluate clinically important secondary safety and efficacy outcomes. METHODS This meta-analysis was completed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The primary outcome was a composite of cardiovascular death or heart failure hospitalization. Secondary outcomes included the individual components of the primary outcome; major adverse cardiovascular events (defined as a composite of cardiovascular death, myocardial infarction, stroke), any death, myocardial infarction, or stroke, along with adverse events such as volume depletion, acute kidney injury, adverse events leading to drug discontinuation, amputation, and severe hypoglycemia. Other outcomes included the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score and changes in N-terminal pro-hormone BNP (NT-proBNP). Pooled hazard ratios (HRs) and 95% confidence intervals (CIs) for dichotomous variables and weighted difference (MD) and 95% CI for continuous variables. RESULTS Compared with placebo, SGLT2i use was associated with a significant reduction of cardiovascular death or heart failure hospitalization (HR = 0.74; 95% CI = 0.66-0.82; P <0.01), heart failure hospitalization (HR = 0.69; 95% CI = 0.57-0.84; P <0.01), cardiovascular death (HR = 0.79; 95% CI = 0.68-0.92; P <0.01), and any death (HR = 0.80; 95% CI = 0.70-0.92; P <0.01). CONCLUSIONS SGLT2i was associated with a decreased risk of clinically relevant cardiovascular death, heart failure hospitalization, and heart failure symptoms with similar rates of adverse events.
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Incidence of Hospitalization for Heart Failure Relative to Major Atherosclerotic Events in Type 2 Diabetes: A Meta-analysis of Cardiovascular Outcomes Trials.
Sacre, JW, Magliano, DJ, Shaw, JE
Diabetes care. 2020;(10):2614-2623
Abstract
BACKGROUND Emerging evidence points to heart failure as being a common first presentation of cardiovascular (CV) disease in type 2 diabetes. PURPOSE The purpose of this study was to determine whether hospitalization for heart failure (HHF) occurs more or less frequently than major adverse CV events (MACE) in people with type 2 diabetes. DATA SOURCES Placebo arms of CV outcomes trials in type 2 diabetes were included. STUDY SELECTION Sixteen CV outcomes trials were selected, including five dipeptidyl peptidase 4 inhibitor trials, seven glucagon-like peptide 1 receptor agonist trials, and four sodium-glucose cotransporter 2 inhibitor trials. DATA EXTRACTION We extracted incidence rates of HHF, myocardial infarction (MI), stroke, and the composite outcomes of CV death or HHF and MACE (CV death, nonfatal MI, or nonfatal stroke). DATA SYNTHESIS In two trials enriched with people with chronic kidney disease, HHF was more common than both MI and stroke. Among the remaining 14 trials, HHF was less frequent than MI in 13 (93%), with this difference being significant in 8 (57%); however, HHF surpassed stroke in all but 1 study (93%; significant in 7 studies [50%]). Heterogeneity among trials was moderate/high (I 2 >50%) and partly explained by HHF/MI correlating with age and previous MI history (P < 0.05). In seven trials that reported events stratified by presence/absence of preexisting CV disease, ratios of HHF/MI and HHF/stroke were similar between groups. LIMITATIONS Enrichment of trial populations with those at high risk of CV events limits generalizability. CONCLUSIONS Although less frequent than MI, HHF is a common event in type 2 diabetes, both in those with and those without prior CV disease.
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Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes.
Cannon, CP, Pratley, R, Dagogo-Jack, S, Mancuso, J, Huyck, S, Masiukiewicz, U, Charbonnel, B, Frederich, R, Gallo, S, Cosentino, F, et al
The New England journal of medicine. 2020;(15):1425-1435
Abstract
BACKGROUND The cardiovascular effects of ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, have not been established. METHODS In a multicenter, double-blind trial, we randomly assigned patients with type 2 diabetes and atherosclerotic cardiovascular disease to receive 5 mg or 15 mg of ertugliflozin or placebo once daily. With the data from the two ertugliflozin dose groups pooled for analysis, the primary objective was to show the noninferiority of ertugliflozin to placebo with respect to the primary outcome, major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). The noninferiority margin was 1.3 (upper boundary of a 95.6% confidence interval for the hazard ratio [ertugliflozin vs. placebo] for major adverse cardiovascular events). The first key secondary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure. RESULTS A total of 8246 patients underwent randomization and were followed for a mean of 3.5 years. Among 8238 patients who received at least one dose of ertugliflozin or placebo, a major adverse cardiovascular event occurred in 653 of 5493 patients (11.9%) in the ertugliflozin group and in 327 of 2745 patients (11.9%) in the placebo group (hazard ratio, 0.97; 95.6% confidence interval [CI], 0.85 to 1.11; P<0.001 for noninferiority). Death from cardiovascular causes or hospitalization for heart failure occurred in 444 of 5499 patients (8.1%) in the ertugliflozin group and in 250 of 2747 patients (9.1%) in the placebo group (hazard ratio, 0.88; 95.8% CI, 0.75 to 1.03; P = 0.11 for superiority). The hazard ratio for death from cardiovascular causes was 0.92 (95.8% CI, 0.77 to 1.11), and the hazard ratio for death from renal causes, renal replacement therapy, or doubling of the serum creatinine level was 0.81 (95.8% CI, 0.63 to 1.04). Amputations were performed in 54 patients (2.0%) who received the 5-mg dose of ertugliflozin and in 57 patients (2.1%) who received the 15-mg dose, as compared with 45 patients (1.6%) who received placebo. CONCLUSIONS Among patients with type 2 diabetes and atherosclerotic cardiovascular disease, ertugliflozin was noninferior to placebo with respect to major adverse cardiovascular events. (Funded by Merck Sharp & Dohme and Pfizer; VERTIS CV ClinicalTrials.gov number, NCT01986881.).
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Serum potassium level on hospital arrival and survival after out-of-hospital cardiac arrest: The CRITICAL study in Osaka, Japan.
Shida, H, Matsuyama, T, Iwami, T, Okabayashi, S, Yamada, T, Hayakawa, K, Yoshiya, K, Irisawa, T, Noguchi, K, Nishimura, T, et al
European heart journal. Acute cardiovascular care. 2020;(4_suppl):S175-S183
Abstract
BACKGROUND Little is known about the association between serum potassium level on hospital arrival and neurological outcome after out-of-hospital cardiac arrest (OHCA). We investigated whether the serum potassium level on hospital arrival had prognostic indications for patients with OHCA. METHODS This prospective, multicenter observational study conducted in Osaka, Japan (CRITICAL study) enrolled consecutive patients with OHCA transported to 14 participating institutions from 2012 to 2016. We included adult patients aged ⩾18 years with OHCA of cardiac origin who achieved return of spontaneous circulation and whose serum potassium level on hospital arrival was available. Based on the serum potassium level, patients were divided into four quartiles: Q1 (K ⩽3.8 mEq/L), Q2 (3.8< K⩽4.5 mEq/L), Q3 (4.5< K⩽5.6 mEq/L) and Q4 (K >5.6 mEq/L). The primary outcome was one-month survival with favorable neurological outcome, defined as cerebral performance category scale 1 or 2. RESULTS A total of 9822 patients were registered, and 1516 of these were eligible for analyses. The highest proportion of favorable neurological outcome was 44.8% (189/422) in Q1 group, followed by 30.3% (103/340), 11.7% (44/375) and 4.5% (17/379) in the Q2, Q3 and Q4 groups, respectively (p<0.001). In the multivariable analysis, the proportion of favorable neurological outcome decreased as the serum potassium level increased (p<0.001). CONCLUSIONS High serum potassium level was significantly and dose-dependently associated with poor neurological outcome. Serum potassium on hospital arrival would be one of the effective prognostic indications for OHCA achieving return of spontaneous circulation.
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Meta-Analysis Evaluating the Effects of Renin-Angiotensin-Aldosterone System Blockade on Outcomes of Heart Failure With Preserved Ejection Fraction.
Kuno, T, Ueyama, H, Fujisaki, T, Briasouli, A, Takagi, H, Briasoulis, A
The American journal of cardiology. 2020;(8):1187-1193
Abstract
Clinical trials of renin-angiotensin-aldosterone system (RAAS) antagonists in heart failure with preserved ejection fraction (HFpEF) have suggested neutral results and treatment is focused on associated symptoms and comorbidities. MEDLINE and EMBASE were searched through October 2019 for randomized controlled studies investigating the effects of different RAAS antagonists in patients with HFpEF. The main outcomes were all-cause mortality, trial defined cardiovascular mortality, and heart failure (HF) hospitalizations. To compare different RAAS antagonists, a random-effects restricted-maximum-likelihood network meta-analysis based on a frequentist framework for indirect and mixed comparisons was used. We used p scores to rank best treatments per outcome. Our search identified 5 eligible clinical trials (PEP-CHF, perindopril; CHARM-preserved, candesartan; I-PRESERVE, irbesartan; TOPCAT, spironolactone; PARAGON-HF, sacubitril-valsartan and valsartan) enrolling a total 10,523 on RAAS antagonists and 6,259 controls. We did not identify any statistical difference in all-cause and cardiovascular mortality among RAAS antagonists and placebo. The combination of sacubitril-valsartan was associated with significantly decreased HF hospitalization risk compared with controls (odds ratio 0.73, 95% confidence interval 0.61 to 0.87) and angiotensin II receptor blockers (odds ratio 0.80, 95% confidence interval 0.71 to 0.91), without heterogeneity among studies (I2 = 0). Angiotensin receptor neprilysin inhibitor (ARNI) ranked better than other RAAS antagonists for HF hospitalizations (p value 0.9). In conclusion, RAAS antagonists do not affect mortality but the combination of sacubitril-valsartan is associated with lower HF hospitalizations in HFpEF patients.