Equations In Patients Research Articles

Predictive correction of serum sodium concentration with formulas derived from the Edelman equation in patients with severe hyponatremia

Severe hyponatremia can cause life-threatening cerebral edema. Treatment comprises rapid elevation of serum sodium concentration; however, overcorrection can result in osmotic demyelination. This study investigated potential factors, including predictive correction based on the Edelman equation, associated with appropriate correction in 221 patients with a serum sodium concentration ≤ 120 mEq/L who were admitted to a hospital in Nagoya, Japan. Appropriate correction was defined as an elevation in serum sodium concentration in the range of 4–10 mEq/L in the first 24 h and within 18 mEq/L in the first 48 h after the start of the correction. Appropriate corrections were made in 132 (59.7%) of the 221 patients. Multivariate analysis revealed that predictive correction with an infusate and fluid loss formula derived from the Edelman equation was associated with appropriate correction of serum sodium concentration (adjusted odds ratio, 7.84; 95% confidence interval, 2.97–20.64). Relative without its use, the predictive equation results in a lower proportion of undercorrection (14.3% vs. 48.0%, respectively) and overcorrection (1.0% vs. 12.2%, respectively). These results suggest that predictive correction of serum sodium concentrations using the formula derived from the Edelman equation can play an essential role in the appropriate management of patients with severe hyponatremia.

Comparison of low-density lipoprotein cholesterol equations in patients with dyslipidaemia receiving cholesterol ester transfer protein inhibition

Abstract Background Low-density lipoprotein (LDL-C) lowering is imperative in cardiovascular disease prevention. Effectively translating the evidence for LDL-C lowering to maximize clinical and public health benefits depends on the availability of accurate LDL-C results from clinical laboratories to guide therapy. Furthermore, prior work has raised the possibility that cholesterol esterase transfer protein (CETP) inhibition could interfere with accurate assessment of LDL-C. Purpose We aimed to compare accuracy of three clinically implemented LDL-C equations in a clinical trial of CETP inhibition. Methods Men and women aged 18–75 years with dyslipidaemia were recruited from 17 sites in the Netherlands and Denmark. Patients were randomly assigned to one of nine groups using various combinations of the CETP inhibitor TA-8995, statin therapy, and placebo. In pooled measurements over 12 weeks, we calculated LDL-C by the Friedewald, Martin/Hopkins, and Sampson equations, and compared values with preparative ultracentrifugation (PUC) LDL-C as the reference measure (also known as “beta quantification”). Based on prior literature and dyslipidaemia guidelines, we examined correct classifications across the LDL-C 1.81 mmol/L cutpoint in the subgroup of patients with triglycerides of 1.69–4.51 mmol/L. Results The analysis included 242 patients contributing 921 observations. The full distributions of differences between LDL-C estimates and PUC are shown in Figure 1. Overall median LDL-C differences between estimates and PUC were small: Friedewald, 0.00 (25th, 75th: −0.10, 0.08) mmol/L; Martin/Hopkins, 0.02 (−0.08, 0.10) mmol/L; and Sampson, 0.05 (−0.03, 0.15) mmol/L. In the subgroup with estimated LDL-C <1.81 mmol/L and triglycerides 1.69–4.51 mmol/L, the Friedewald equation underestimated LDL-C with a median difference versus PUC of −0.25 (−0.33, −0.10) mmol/L, whereas the Martin/Hopkins equation corrected this issue with a median difference of 0.00 (−0.08, 0.10) mmol/L and the Sampson equation showed tendency towards underestimation with a median difference of −0.06 (−0.13, 0.00) mmol/L. In patients with triglyceride levels of 1.69–4.51 mmol/L, Figure 2 shows the proportion of LDL-C levels classified by the equations as < or ≥1.81 mmol/L that were correctly classified when compared with PUC. All three equations showed >95% accuracy when estimated LDL-C levels were ≥1.81 mmol/L. However, the proportion of LDL-C observations <1.81 mmol/L that were correctly classified compared with PUC was 71.4% by Friedewald versus 100.0% by Martin/Hopkins and 93.1% by Sampson. Conclusion In Europeans with dyslipidaemia, our analysis shows improved accuracy in LDL-C when using contemporary LDL-C equations over the Friedewald equation, particularly when using the Martin/Hopkins equation. High levels of accuracy with the Martin/Hopkins equation were seen in individuals treated with CETP inhibition and even in the context of low LDL-C and high triglyceride levels. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Dezima and NewAmsterdam Pharma

Kidney Function According to Different Equations in Patients Admitted to a Cardiology Unit and Impact on Outcome.

Background: This paper aims to evaluate the concordance between the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and alternative equations and to assess their predictive power for all-cause mortality in unselected patients discharged alive from a cardiology ward. Methods: We retrospectively included patients admitted to our Cardiology Division independently of their diagnosis. The total population was classified according to Kidney Disease: Improving Global Outcomes (KDIGO) categories, as follows: G1 (estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73 m2); G2 (eGFR 89–60 mL/min/1.73 m2); G3a (eGFR 59–45 mL/min/1.73 m2); G3b (eGFR 44–30 mL/min/1.73 m2); G4 (eGFR 29–15 mL/min/1.73 m2); G5 (eGFR <15 mL/min/1.73 m2). Cockcroft-Gault (CG), CG adjusted for body surface area (CG-BSA), Modification of Diet in Renal Disease (MDRD), Berlin Initiative Study (BIS-1), and Full Age Spectrum (FAS) equations were also assessed. Results: A total of 806 patients were included. Good agreement was found between the CKD-EPI formula and CG-BSA, MDRD, BIS-1, and FAS equations. In subjects younger than 65 years or aged ≥85 years, CKD-EPI and MDRD showed the highest agreement (Cohen’s kappa (K) 0.881 and 0.588, respectively) while CG showed the lowest. After a median follow-up of 407 days, overall mortality was 8.2%. The risk of death was higher in lower eGFR classes (G3b HR4.35; 95%CI 1.05–17.80; G4 HR7.13; 95%CI 1.63–31.23; G5 HR25.91; 95%CI 6.63–101.21). The discriminant capability of death prediction tested with ROC curves showed the best results for BIS-1 and FAS equations. Conclusion: In our cohort, the concordance between CKD-EPI and other equations decreased with age, with the MDRD formula showing the best agreement in both younger and older patients. Overall, mortality rates increased with the renal function decreasing. In patients aged ≥75 years, the best discriminant capability for death prediction was found for BIS-1 and FAS equations.

Measure resting energy expenditure and substrate utilization in patients with cirrhosis presenting with acute variceal bleeding

Background and Aims: Baveno-VII recommends early initiation of oral feeding after endoscopic treatment in patients with acute variceal bleeding(AVB). Liver plays important role in energy metabolism(EM). Cirrhotic patients have altered EM leading to malnutrition. There is limited evidence on energy requirement in this scenario, especially in context of systemic fasting preceding endoscopic therapy which these patients often have. The present study assessed resting energy expenditure(REE) and substrate oxidation {respiratory quotient(RQ)} by indirect calorimetry(IC) and measured REE(mREE) was compared with predicted REE(pREE) by existing equations in patients with cirrhosis presenting with AVB.REE was measured as both whole body(WB) y weight(DW) and per kg DW.

Abstract 9368: Concordance of LDL-Cholesterol Levels Between the Friedewald, Martin/Hopkins, and Sampson Equations in Patients With Atherosclerotic Cardiovascular Disease

Introduction: Accurate estimation of low-density lipoprotein cholesterol (LDL-C) is important for cardiovascular risk assessment and guiding cholesterol-lowering therapy. Different methods currently exist to estimate LDL-C. There is limited data in patients with atherosclerotic cardiovascular disease (ASCVD) in prior studies. Objectives: To assess concordance of estimated LDL-C using the Friedewald, Martin/Hopkins, and Sampson equations. Methods: We performed a retrospective analysis of electronic health record data from a large multistate healthcare system. Patients with ASCVD and triglycerides (TG) &lt;400 mg/dL between October 1, 2015 and June 30, 2019 were included. LDL-C was estimated using the Friedewald equation (with a fixed TG to very LDL-C [VLDL-C] ratio of 5:1), Martin/Hopkins equation (with a flexible ratio), and Sampson equation (with estimation of VLDL-C by multiple least squares regression). Pairwise comparisons were performed, with patients categorized as concordant if the LDL-C was &lt;70 mg/dL using both equations and discordant if the LDL-C was &lt;70 mg/dL for the reference equation and ≥70 mg/dL for the comparator. Results: The study included 146,106 patients with ASCVD (median age 68 years, 56% male, and 91% White). Discordance rates were 15% for the Friedewald vs Martin/Hopkins comparison, 9% for the Friedewald vs Sampson comparison, and 7% for the Sampson vs Martin/Hopkins comparison. Estimated LDL-C was lower for the Friedewald and Sampson equations compared to the Martin/Hopkins equation. Discordance was more pronounced at lower LDL-C cut points and in those with TG ≥150 mg/dL. Conclusions: Important differences in estimated LDL-C exist between the three equations, particularly among those with TG ≥150 mg/dL. These results in ASCVD patients, synthesized with prior evidence, raise concern that reliance upon the Friedewald and Sampson equations may result in underestimation and thus, undertreatment of LDL-C in those at increased risk.

Comparison of Methods to Estimate Low-Density Lipoprotein Cholesterol in Patients With High Triglyceride Levels

Low-density lipoprotein cholesterol (LDL-C) is typically estimated with the Friedewald or Martin/Hopkins equation; however, if triglyceride levels are 400 mg/dL or greater, laboratories reflexively perform direct LDL-C (dLDL-C) measurement. The use of direct chemical LDL-C assays and estimation of LDL-C via the National Institutes of Health Sampson equation are not well validated, and data on the accuracy of LDL-C estimation at higher triglyceride levels are limited. To compare an extended Martin/Hopkins equation for triglyceride values of 400 to 799 mg/dL with the Friedewald and Sampson equations. This cross-sectional study evaluated consecutive patients at clinical sites across the US with patient lipid distributions representative of the US population in the Very Large Database of Lipids from January 1, 2006, to December 31, 2015, with triglyceride levels of 400 to 799 mg/dL. Data analysis was performed from November 9, 2020, to March 23, 2021. Accuracy in LDL-C classification according to guideline-based categories and absolute errors between estimated LDL-C and dLDL-C levels. Patients were randomly assigned 2:1 to derivation and validation data sets. Levels of dLDL-C were measured by vertical spin-density gradient ultracentrifugation. The LDL-C levels were estimated using the Friedewald method, with a fixed ratio of triglycerides to very low-density lipoprotein cholesterol (VLDL-C ratio of 5:1), extended Martin/Hopkins equation with a flexible ratio, and Sampson equation with VLDL-C estimation by multiple least-squares regression. A total of 111 939 patients (mean [SD] age, 52 [13] years; 65.0% male) with triglyceride levels of 400 to 799 mg/dL were included, representing 2.2% of 5 081 680 patients in the database. Across all individual guideline LDL-C classes (<40, 40-69, 70-99, 100-129, 130-159, 160-189, and ≥190), estimation of LDL-C by the extended Martin/Hopkins equation was most accurate (62.1%) compared with the Friedewald (19.3%) and Sampson (40.4%) equations. In classifying LDL-C levels less than 70 mg/dL across all triglyceride strata, the extended Martin/Hopkins equation was most accurate (67.3%) compared with Friedewald (5.1%) and Sampson (26.4%) equations. In addition, for classifying LDL-C levels less than 40 mg/dL across all triglyceride strata, the extended Martin/Hopkins equation was most accurate (57.2%) compared with the Friedewald (4.3%) and Sampson (14.4%) equations. However, considerable underclassification of LDL-C occurred. The magnitude of error between the Martin/Hopkins equation estimation and dLDL-C was also smaller: at LDL-C levels less than 40 mg/dL, 2.7% of patients had 30 mg/dL or greater differences between dLDL-C and estimated LDL-C using the Martin/Hopkins equation compared with the Friedewald (92.5%) and Sampson (38.7%) equations. In this cross-sectional study, the extended Martin/Hopkins equation offered greater LDL-C accuracy compared with the Friedewald and Sampson equations in patients with triglyceride levels of 400 to 799 mg/dL. However, regardless of method used, caution is advised with LDL-C estimation in this triglyceride range.

Prognostic value of glomerular function estimated by Cockcroft-Gault creatinine clearance, MDRD-4, CKD-EPI and European Kidney Function Consortium equations in patients with acute coronary syndromes

BackgroundIt remains unknown which equation used to assess the glomerular function is better for risk stratification in patients with acute coronary syndrome (ACS). MethodsThis study included 3985 patients with ACS. Glomerular function was assessed using 4 equations: the Cockcroft-Gault creatinine clearance (C-GCrCl), Modification of Diet in Renal Disease-4 (MDRD-4), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and European Kidney Function Consortium (EKFC) equations. The primary outcome was one-year all-cause mortality. ResultsFor each 30 ml/min decrement, the adjusted hazard ratio [HR] with 95% confidence interval [CI] for one-year mortality was 1.67 [1.27–2.25] for C-GCrCl, 1.45 [1.16–1.81] for MDRD-4, 1.76 [1.35–2.30] for CKD-EPI and 1.94 [1.44–2.63] for EKFC equation. Area under the receiver operating characteristic curve (AUC) for one-year mortality was 0.748 [0.709–0.788] for C-GCrCl, 0.670 [0.621–0.718] for estimated glomerular filtration rate (eGFR) calculated by MDRD-4 equation, 0.725 [0.684–0.765] for eGFR calculated by CKD-EPI equation and 0.741 [0.703–0.779] for eGFR calculated by EKFC equation (P = 0.342 for C-GCrCl, vs. EKFC equation and P ≤ 0.009 for all other AUC comparisons). ConclusionsIn patients with ACS, C-GCrCl and EKFC equations showed a similar discriminatory power regarding prediction of one-year mortality. Both equations were better than MDRD-4 and CKD-EPI equations for risk discrimination for mortality.Clinical Trial Registration: NCT01944800.

Novel equation for estimating resting energy expenditure in patients with chronic kidney disease

In chronic kidney disease (CKD), determining energy expenditure is the precondition for recommending energy intake in nutrition management. We aimed to develop and validate a resting energy expenditure (REE) equation for patients with CKD. This cross-sectional study enrolled 300 patients with CKD (stages 3-5) according to inclusion and exclusion criteria. Stepwise linear regression analysis was used to derive a new REE equation (eREE-CKD) according to actual REE (aREE) measured using indirect calorimetry in the development dataset. The eREE-CKD value was then validated with aREE in the validation dataset and compared with values from existing equations obtained in general populations, namely, the Harris-Benedict, Mifflin, WHO, and Schofield equations in terms of bias, precision, and accuracy. The eREE-CKD equation: eREE-CKD (kcal) = (1 if male; 0 if female) × 106.0 - [1 if diabetes mellitus (DM); 0 if non-DM] × 51.6 - 4.7 × age (y) + 13.1 × weight (kg) + 645.5 (R2= 0.779).The bias, precision, and accuracy (percentage of estimates that differed >20% from the measured REE) of the eREE-CKD equation were -0.4 (IQR: -29.8, 23.8) kcal, 98.4 (IQR: 79.5, 116.6) kcal, and 5.4%, respectively with indirect calorimetry as the reference method. Both bias and precision of the eREE-CKD were significantly better than the Harris-Benedict, WHO, and Schofield equations (P<0.001) and similar to the Mifflin equation (P=0.125 for bias and 0.268 for precision). Accuracy of the eREE-CKD was significantly better than the Harris-Benedict, WHO, Mifflin, and Schofield equations (P<0.001). Bias, precision, and accuracy of the eREE-CKD equation were consistent when applied to subgroups categorized according to high-sensitivity C-reactive protein concentrations and CKD stages, respectively. The eREE-CKD equation using age, sex, weight, and DM data could serve as a reliable tool for estimating REE in patients with CKD. This trial was registered at clinicaltrials.gov as NCT03377413.

Comparison of creatinine, cystatin, CKD-EPI cystatin C, CKD-EPI creatinine and MDRD equations in estimating glomerular filtration rate in patients with nephrotic syndrome

Objective: It’s recommended to use equations such as Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) by using creatinine level in estimating glomerular filtration rate (GFR). Here, we aimed to compare serum cystatin-C (Cys-C) and Cys-C based equations with creatinine and creatinine based equations in patients with chronic kidney disease (CKD) and nephrotic syndrome (NS).

An Ultrasound Model to Predict the Short-Term Effects of Endovascular Stent Placement in the Treatment of Carotid Artery Stenosis.

Purpose: The present study aimed to explore the predictive ability of an ultrasound linear regression equation in patients undergoing endovascular stent placement (ESP) to treat carotid artery stenosis-induced ischemic stroke.Methods: Pearson's correlation coefficient of actual improvement rate (IR) and 10 preoperative ultrasound indices in the carotid arteries of 64 patients who underwent ESP were retrospectively analyzed. A predictive ultrasound model for the fitted IR after ESP was established.Results: Of the 10 preoperative ultrasound indices, peak systolic velocity (PSV) at stenosis was strongly correlated with postoperative actual IR (r = 0.622; P < 0.01). The unstable plaque index (UPI; r = 0.447), peak eccentricity ratio (r = 0.431), and plaque stiffness index (β; r = 0.512) moderately correlated with actual IR (P < 0.01). Furthermore, the resistance index (r = 0.325) and the dilation coefficient (r = 0.311) weakly correlated with actual IR (P < 0.05). There was no significant correlation between actual IR and the number of unstable plaques, area narrowing, pulsatility index, and compliance coefficient. In combination, morphological, hemodynamic, and physiological ultrasound indices can predict 62.39% of neurological deficits after ESP: fitted IR = 0.9816 – 0.1293β + 0.0504UPI – 0.1137PSV.Conclusion: Certain carotid ultrasound indices correlate with ESP outcomes. The multi-index predictive model can be used to evaluate the effects of ESP before surgery.

Cost-effectiveness analysis of empagliflozin versus sitagliptin as second-line therapy for treatment in patients with type 2 diabetes in the United States.

AimTo estimate the cost‐effectiveness of sequential addition of empagliflozin versus sitagliptin after metformin in patients with type 2 diabetes (T2D) with or without cardiovascular disease (CVD) from the perspective of the US healthcare payer.MethodsAn individual simulation model predicted lifetime diabetes‐related complications, using UKPDS‐OM2 equations in patients without CVD, and EMPA‐REG OUTCOME equations in patients with CVD. Additional US‐based sources informed inputs for population characteristics, adverse events, non‐CV death, treatment escalation, quality of life and costs. Costs and quality‐adjusted life‐years (QALYs) were discounted 3.0% annually.ResultsThe incremental cost‐effectiveness ratio (ICER) for second‐line empagliflozin versus sitagliptin in the overall T2D population was $6967/QALY. Empagliflozin led to longer CVD‐free survival (0.07 years) and an 11% reduction in CV death in patients with CVD compared with sitagliptin. Empagliflozin resulted in greater benefits with greater costs in patients with versus without baseline CVD, yielding ICERs of $3589/QALY versus $12 577/QALY, respectively. Results were consistent across a range of deterministic and probabilistic sensitivity analyses and scenarios.ConclusionCompared with sitagliptin, empagliflozin was cost‐effective (at $50 000/QALY US threshold) as a second‐line treatment to metformin for T2D patients with or without CVD in the United States. Our findings lend additional support for more widespread adoption of guidelines by healthcare decision‐makers for T2D treatment.

The agreement between resting energy expenditure predictive equations in patients with breast cancer

The agreement between resting energy expenditure predictive equations in patients with breast cancer

Prediction of Morphological Lesions Using Various Glomerular Filtration Rate Equations in Patients with Primary Glomerulonephritis

Prediction of Morphological Lesions Using Various Glomerular Filtration Rate Equations in Patients with Primary Glomerulonephritis

Validation of Natriuretic Response Prediction Equation in Patients with Acute Decompensated Heart Failure

Introduction The majority of acute decompensated heart failure (ADHF) admissions are driven by congestion. Sodium is the primary pathophysiologic driver of volume retention, with water passively following. However, monitoring sodium output in routine clinical practice is challenging. We previously created a model, the natriuretic response prediction equation (NRPE), to predict total sodium excretion following an IV dose of loop diuretic. The NRPE requires only a spot urine sodium and creatinine obtained 2 hours following diuretic administration (Figure 1). The objective of this study was to externally validate the NRPE. Hypothesis NRPE will accurately predict 6 hour post loop diuretic sodium output. Methods A total of 638 urine collections from 409 patients hospitalized with ADHF undergoing intravenous loop diuretic therapy were included. Intensively supervised urine collections were performed, and urine spot samples were taken at 2 hours after loop diuretic administration. A poor natriuretic response was defined as a sodium output of 150 mmol within this 6-hour period. Results The median IV furosemide equivalent dose was 80 mg (40-160), resulting in a cumulative 6-hour sodium output of 85 mmol (50-143) and urine output of 960 mL (640-1410). Poor natriuretic response was observed in 25% of the urine collections, averaging a cumulative sodium output of 29±13 mmol. Suboptimal and excellent responses were seen in 57% and 21% of the visits. The NRPE accurately predicted poor, suboptimal, and excellent natriuretic response, with an AUC of 0.92, 0.90, and 0.90, respectively (p Conclusions The NRPE, using only a 2 hour post diuretic spot urine sample, is a rapid and highly accurate method to monitor natriuretic response in ADHF patients.

Accuracy of the MedGem® portable indirect calorimeter for measuring resting energy expenditure in adults with class II or III obesity

The accuracy of some portable indirect calorimeters in estimating resting energy expenditure (REE) - and hence energy recommendations - among pre-bariatric patients is unknown. Our objective was to assess the accuracy of the MedGem® among individuals with class II or III obesity awaiting bariatric surgery. Male and female adults who were awaiting bariatric surgery were recruited to this cross-sectional study. MedGem-derived oxygen consumption (O2) and REE were compared to O2 and REE from a metabolic cart. REE was also calculated using several common equations to assess the clinical utility of this portable tool. Body composition was assessed by dual energy X-Ray absorptiometry. Paired t-test and Bland-Altman analysis (expressed as bias [average difference] and limits of agreement [bias±2 standard deviations]) evaluated O2 and REE accuracy. Twenty-six individuals were included (34±9 years old; n = 20, 76.9% female), with the majority (n=15, 57.7%) having class II obesity. Neither O2 (MedGem: 283±63 vs. metabolic cart: 293±64ml/min, p=0.114) nor REE (MedGem: 1963±437 vs. metabolic cart: 2047±440kcal/day, p=0.057) were different between devices. Body composition did not relate to bias. The MedGem had wide limits of agreement for REE (-504 to 336kcal/day), which was similar to predictive equations. Although REE from the MedGem was not different than REE from the metabolic cart, individual-level accuracy was poor and similar to predictive equations in patients with class II or III obesity. Nonetheless, efficacy of repeated assessments during weight loss warrant future investigation.

Prediction of Spirometric Indices Using Forced Oscillometric Indices in Patients with Asthma, COPD, and Interstitial Lung Disease.

Background and ObjectiveSpirometry is sometimes difficult to perform in elderly patients and patients with cognitive impairment. Forced oscillometry (FOT) is a simple, noninvasive technique used for measuring respiratory impedance. The aim of this study was to develop regression equations to estimate vital capacity (VC), forced vital capacity (FVC), and forced expiratory volume in 1 s (FEV1.0) on the basis of FOT indices and to evaluate the accuracy of these equations in patients with asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (ILD).Materials and MethodsWe retrospectively included data on 683 consecutive patients with asthma (388), COPD (128), or ILD (167) in this study. We generated regression equations for VC, FVC, and FEV1.0 by multivariate linear regression analysis and used them to estimate the corresponding values. We determined whether the estimated data reflected spirometric indices.ResultsActual and estimated VC, FVC, and FEV1.0 values showed significant correlations (all r > 0.8 and P < 0.001) in all groups. Biases between the actual data and estimated data for VC, FVC, and FEV1.0 in the asthma group were −0.073 L, −0.069 L, and 0.017 L, respectively. The corresponding values were −0.064 L, 0.027 L, and 0.069 L, respectively, in the COPD group and −0.040 L, −0.071 L, and −0.002 L, respectively, in the ILD group. The estimated data in the present study did not completely correspond to the actual data. In addition, sensitivity for an FEV1.0/FVC ratio of <0.7 and the diagnostic accuracy for the classification of COPD grade using estimated data were low.ConclusionThese results suggest that our method is not highly accurate. Further studies are needed to generate more accurate regression equations for estimating spirometric indices based on FOT measurements.

P0222KIDNEY EFFECTS IN THE MOXIE TRIAL: A STUDY OF OMAVELOXOLONE IN PATIENTS WITH FRIEDRICH'S ATAXIA

Abstract Background and Aims Omaveloxolone, an Nrf2 activator, is an investigational drug that targets targets inflammation and mitochondrial dysfunction, metabolic, and bioenergetic pathways. Omaveloxolone is an analog of bardoxolone, methyl which has been shown to improve kidney function in multiple studies of chronic kidney diseases. The MOXIe Part 2 trial investigated omaveloxolone in patients with Friedreich’s ataxia (FA), a rare and serious hereditary disease caused by mitochondrial dysfunction that affects multiple organ systems resulting in ataxia, cardiomyopathy, and reduced lifespan. The study met its primary efficacy endpoint, and omaveloxolone improved neurological function, as assessed by the modified Friedreich’s ataxia rating scale (mFARS). We report the effect of omaveloxolone on kidney function in this patient population. Method The MOXIe trial (NCT02255435) was an international, multi-center, double-blind, placebo-controlled, randomized trial that enrolled 103 patients between 16 and 40 years of age with genetically confirmed FA. Patients were randomized 1:1 to receive either omaveloxolone 150 mg or placebo administered once daily for 48 weeks. The trial included 24 patients that were younger than 18 years of age. Baseline eGFR for the overall patient population receiving placebo or omaveloxolone was 109.2 ± 21.7 and 113.4 ± 14.7 mL/min/1.73 m2, respectively. Baseline eGFR for the pediatric population receiving placebo or omaveloxolone was 99.1 ± 33.7 and 106.3 ± 15.6 mL/min/1.73 m2, respectively. Serum creatinine was collected at baseline, Weeks 4, 12, 18, 24, 36 and 48 on-treatment and 4-weeks off-treatment at Week 52. Glomerular filtration rate was estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation for patients ≥ 18 years of age. For patients &amp;lt;18 years of age, the Bedside Schwartz equation was used to calculate eGFR. Results In placebo patients, mean (SD) eGFR decreased by 4.4 ± 11.0 mL/min/1.73 m2 from baseline whereas patients receiving omaveloxolone had an average increase of +7.0 ± 10.7 mL/min/1.73 m2 from baseline after 48 weeks, resulting in a difference of 11.4 mL/min/1.73 m2 between treatment groups. At Week 52, mean eGFR was -4.2 ± 10.9 mL/min/1.73 m2 relative to baseline in placebo patients and remained +0.9 ± 10.8 mL/min/1.73 m2 above baseline in omaveloxolone patients after 4-weeks off-treatment. In pediatric patients randomized to placebo, at week 48 eGFR decreased by -11.3 ± 14.3 mL/min/1.73 m2 whereas patients receiving omaveloxolone had an average increase of +5.5 ± 14.5 mL/min/1.73 m2 from baseline, resulting in a difference of 16.8 mL/min/1.73 m2 between treatment groups. Conclusion Patients with FA randomized to placebo in the MOXIe trial had eGFR declines over 48 weeks that were similar to rates of decline observed in the most rapidly progressing forms of chronic kidney disease. The rapid kidney function decline in FA reflects the multi-system nature of the disease whereby mitochondrial dysfunction, and associated chronic inflammation, affects not only the central nervous system but also the heart and possibly the kidney. In contrast to placebo, treatment with omaveloxolone improved eGFR in patients with FA and the effects were sustained through one year of treatment. The durability of eGFR improvements are consistent with those observed with its analog, bardoxolone methyl, in clinical trials for various forms of CKD.

Prognostic Value of Cystatin C-Derived Estimated Glomerular Filtration Rate in Patients with Acute Heart Failure

Background: Renal function is closely related to cardiac function and an important prognostic marker in heart failure. Objective: We aimed to test the prognostic value of cystatin C (cysC)-derived estimated glomerular filtration rates (eGFR) in comparison with eGFRs from creatinine solely based equations in patients with acute heart failure (AHF). Methods: This study included 262 patients (65.8 ± 14.9 years old, 126 male) with AHF. Prognostic value of the eGFRs, from cysC-based equations chronic kidney disease epidemiology collaboration (CKD-EPI-cysC and CKD-EPI-creatinine [cr]-cysC equations) were compared with eGFRs calculated from serum creatinine levels only (Modification of Diet in Renal Disease [MDRD]-4 and CKD-EPI-cr equations). Prognosis was evaluated with the composite of all-cause mortality and hospitalization for heart failure within 1 year. Results: During the follow-up period (mean follow-up period, 264.0 ± 136.1 days), 67 (25.6%) events occurred. Estimated GFR using CKD-EPI-cysC was the best for predicting 1-year outcome using receiver operating characteristic curve analysis (area under curve 0.585, 0.607, 0.669, and 0.652 for eGFRs from MDRD-4, CKD-EPI-cr, CKD-EPI-cysC, and CKD-EPI-cr-cysC respectively). The Kaplan-Meier survival curve analysis showed that only the eGFRs classification from the equations based on cysC significantly predicted 1-year outcome in patients with AHF. Conclusions: Estimated GFRs calculated with cysC predicted the prognosis more accurately in patients with AHF than the eGFRs from creatinine only equations.

Routine Assessment of Patient Index Data 3 (RAPID3) alone is insufficient to monitor disease activity in rheumatoid arthritis in clinical practice

ObjectiveTo test the longitudinal association between patient-reported outcome, Routine Assessment of Patient Index Data 3 (RAPID3) and the Disease Activity Score in 28 joints that includes the erythrocyte sedimentation rate...

Resting metabolic rate: comparison between indirect calorimetry with predictive equations in patients submitted to bariatric surgery

Abstract.