scholarly journals Effect of tofogliflozin on arterial stiffness in patients with type 2 diabetes: prespecified sub-analysis of the prospective, randomized, open-label, parallel-group comparative UTOPIA trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Naoto Katakami ◽  
◽  
Tomoya Mita ◽  
Hidenori Yoshii ◽  
Toshihiko Shiraiwa ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Conventional Treatment ◽  
Mixed Effects ◽  
Mixed Effects Models ◽  
Open Label ◽  
Parallel Group ◽  
History Of

Abstract Background Tofogliflozin, an SGLT2 inhibitor, is associated with favorable metabolic effects, including improved glycemic control and serum lipid profile and decreased body weight, visceral adipose tissue, and blood pressure (BP). This study evaluated the effects of tofogliflozin on the brachial-ankle pulse wave velocity (baPWV) in patients with type 2 diabetes (T2DM) without a history of apparent cardiovascular disease. Methods The using tofogliflozin for possible better intervention against atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. As one of the prespecified secondary outcomes, changes in baPWV over 104 weeks were evaluated in 154 individuals (80 in the tofogliflozin group and 74 in the conventional treatment group) who completed baPWV measurement at baseline. Results In a mixed-effects model, the progression in the right, left, and mean baPWV over 104 weeks was significantly attenuated with tofogliflozin compared to that with conventional treatment (– 109.3 [– 184.3, – 34.3] (mean change [95% CI] cm/s, p = 0.005; – 98.3 [– 172.6, – 24.1] cm/s, p = 0.010; – 104.7 [– 177.0, – 32.4] cm/s, p = 0.005, respectively). Similar findings were obtained even after adjusting the mixed-effects models for traditional cardiovascular risk factors, including body mass index (BMI), glycated hemoglobin (HbA1c), total cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, systolic blood pressure (SBP), hypertension, smoking, and/or administration of drugs, including hypoglycemic agents, antihypertensive agents, statins, and anti-platelets, at baseline. The findings of the analysis of covariance (ANCOVA) models, which included the treatment group, baseline baPWV, and traditional cardiovascular risk factors, resembled those generated by the mixed-effects models. Conclusions Tofogliflozin significantly inhibited the increased baPWV in patients with T2DM without a history of apparent cardiovascular disease, suggesting that tofogliflozin suppressed the progression of arterial stiffness. Trial Registration UMIN000017607. Registered 18 May 2015. (https://www.umin.ac.jp/icdr/index.html)

The Use of Theory of Linear Mixed-Effects Models to Detect Fraudulent Erasures at an Aggregate Level

2021 ◽  
pp. 001316442199489
Author(s):  
Luyao Peng ◽  
Sandip Sinharay
Keyword(s):  
Type I Error ◽  
Real Data ◽  
Mixed Effects ◽  
Error Rates ◽  
Mixed Effects Models ◽  
Type I ◽  
Aggregate Level ◽  
Linear Mixed Effects Models ◽  
Linear Mixed Effects ◽  
Best Linear Unbiased

Wollack et al. (2015) suggested the erasure detection index (EDI) for detecting fraudulent erasures for individual examinees. Wollack and Eckerly (2017) and Sinharay (2018) extended the index of Wollack et al. (2015) to suggest three EDIs for detecting fraudulent erasures at the aggregate or group level. This article follows up on the research of Wollack and Eckerly (2017) and Sinharay (2018) and suggests a new aggregate-level EDI by incorporating the empirical best linear unbiased predictor from the literature of linear mixed-effects models (e.g., McCulloch et al., 2008). A simulation study shows that the new EDI has larger power than the indices of Wollack and Eckerly (2017) and Sinharay (2018). In addition, the new index has satisfactory Type I error rates. A real data example is also included.

scholarly journals ALLY in fighting COVID-19: magnitude of albumin decline and lymphopenia (ALLY) predict progression to critical disease

2021 ◽  
pp. jim-2020-001525
Author(s):  
Johanna S van Zyl ◽  
Amit Alam ◽  
Joost Felius ◽  
Ronnie M Youssef ◽  
Dipesh Bhakta ◽  
...  
Keyword(s):  
Medical Records ◽  
Resource Planning ◽  
Mixed Effects ◽  
Mixed Effects Models ◽  
Disease Course ◽  
Risk Models ◽  
Simple Tool ◽  
Laboratory Results ◽  
Risk Of Disease ◽  
Critical Patients

The global severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic leading to coronavirus disease 2019 (COVID-19) is straining hospitals. Judicious resource allocation is paramount but difficult due to the unpredictable disease course. Once hospitalized, discerning which patients may progress to critical disease would be valuable for resource planning. Medical records were reviewed for consecutive hospitalized patients with COVID-19 in a large healthcare system in Texas. The main outcome was progression to critical disease within 10 days from admission. Albumin trends from admission to 7 days were analyzed using mixed-effects models, and progression to critical disease was modeled by multivariable logistic regression of laboratory results. Risk models were evaluated in an independent group. Of 153 non-critical patients, 28 (18%) progressed to critical disease. The rate of decrease in mean baseline-corrected (Δ) albumin was −0.08 g/dL/day (95% CI −0.11 to −0.04; p<0.001) or four times faster, in those who progressed compared with those who did not progress. A model of Δ albumin combined with lymphocyte percentage predicting progression to critical disease was validated in 60 separate patients (sensitivity, 0.70; specificity, 0.74). ALLY (delta albumin and lymphocyte percentage) is a simple tool to identify patients with COVID-19 at higher risk of disease progression when: (1) a 0.9 g/dL or greater albumin drop from baseline within 5 days of admission or (2) baseline lymphocyte of ≤10% is observed. The ALLY tool identified >70% of hospitalized cases that progressed to critical COVID-19 disease. We recommend prospectively tracking albumin. This is a globally applicable tool for all healthcare systems.

scholarly journals Serum syndecan-1 reflects organ dysfunction in critically ill patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Keiko Suzuki ◽  
Hideshi Okada ◽  
Kazuyuki Sumi ◽  
Hiroyuki Tomita ◽  
Ryo Kobayashi ◽  
...  
Keyword(s):  
Risk Factor ◽  
Critically Ill ◽  
Organ Dysfunction ◽  
Critically Ill Patients ◽  
Repeated Measures ◽  
Significant Risk ◽  
Mixed Effects ◽  
Mixed Effects Models ◽  
Endothelial Glycocalyx ◽  
Outcome Variable

AbstractSyndecan-1 (SDC-1) is found in the endothelial glycocalyx and shed into the blood during systemic inflammatory conditions. We investigated organ dysfunction associated with changing serum SDC-1 levels for early detection of organ dysfunction in critically ill patients. To evaluate the effect of SDC-1 on laboratory parameters measured the day after SDC-1 measurement with consideration for repeated measures, linear mixed effects models were constructed with each parameter as an outcome variable. A total of 94 patients were enrolled, and 831 samples were obtained. Analysis using mixed effects models for repeated measures with adjustment for age and sex showed that serum SDC-1 levels measured the day before significantly affected several outcomes, including aspartate aminotransferase (AST), alanine transaminase (ALT), creatinine (CRE), blood urea nitrogen (BUN), antithrombin III, fibrin degradation products, and D-dimer. Moreover, serum SDC-1 levels of the prior day significantly modified the effect between time and several outcomes, including AST, ALT, CRE, and BUN. Additionally, increasing serum SDC-1 level was a significant risk factor for mortality. Serum SDC-1 may be a useful biomarker for daily monitoring to detect early signs of kidney, liver and coagulation system dysfunction, and may be an important risk factor for mortality in critically ill patients.

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