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Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.
Bhandari, S, Kalra, PA, Berkowitz, M, Belo, D, Thomsen, LL, Wolf, M
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2021;(1):111-120
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Abstract
BACKGROUND The optimal intravenous (IV) iron would allow safe correction of iron deficiency at a single infusion over a short time. The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease and iron deficiency anaemia. METHODS In this randomized, open-label and multi-centre trial conducted in the USA, patients were randomized 2:1 to a single dose of 1000 mg IIM or iron sucrose (IS) administered as 200 mg IV injections up to five times within a 2-week period. The co-primary endpoints were serious or severe hypersensitivity reactions and change in haemoglobin (Hb) from baseline to Week 8. Secondary endpoints included incidence of composite cardiovascular adverse events (AEs). RESULTS A total of 1538 patients were enrolled (mean estimated glomerular filtration rate 35.5 mL/min/1.73 m2). The co-primary safety objective was met based on no significant difference in the incidence of serious or severe hypersensitivity reactions in the IIM and IS groups [0.3% versus 0%; risk difference: 0.29% (95% confidence interval: -0.19; 0.77; P > 0.05)]. Incidence of composite cardiovascular AEs was significantly lower in the IIM versus IS group (4.1% versus 6.9%; P = 0.025). Compared with IS, IIM led to a more pronounced increase in Hb during the first 4 weeks (P ≤ 0.021), and change in Hb to Week 8 showed non-inferiority, confirming that the co-primary efficacy objective was met. CONCLUSIONS Compared with multiple doses of IS, a single dose of IIM induced a non-inferior 8-week haematological response, comparably low rates of hypersensitivity reactions, and a significantly lower incidence of composite cardiovascular AEs.
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Effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors on renal outcomes in patients with type 2 diabetes mellitus and chronic kidney disease: A protocol for systematic review and meta-analysis.
Yu, B, Dong, C, Hu, Z, Liu, B
Medicine. 2021;(8):e24655
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Abstract
BACKGROUND Many studies have shown the effects of SGLT2 inhibitors on type 2 diabetes, but the effects in patients with type 2 diabetes with chronic kidney disease remains unclear. This study aims to evaluate the effects of SGLT2 inhibitors on renal outcomes in patients with type 2 diabetes mellitus with chronic kidney disease. METHODS We conducted systematic searches of PubMed, Embase, and Cochrane Central Register of Controlled Trials up to April 30, 2020 and included randomized controlled trials of SGLT2 inhibitors in adult type 2 diabetes mellitus (T2DM) patients with chronic kidney disease (CKD) reporting estimated glomerular filtration rate (eGFR) and/or urine albumin/creatinine ratio (UACR) changes and/or acute kidney injury or failure (AKI). Random effects models were adopted to measure the pooled outcomes. RESULTS Nine studies with 8826 participants were included. SGLT2 inhibitors were not associated with a significant change in eGFR (mean difference (MD), -0.75 ml/minutes per 1.73 m2, 95% CI -1.61 to 0.10, P = .09) in type 2 diabetic patients with CKD. UACR reduction after SGLT2 inhibitors was significant in type 2 diabetic patients with CKD (MD -24.27 mg/g, 95% CI -44.46 to -4.09, P = .02). SGLT2 inhibitors associated with AKI in the patients were significant (OR 0.80, 95% CI [0.66 to 0.98], P = .03). CONCLUSION SGLT2 inhibitors had no significant effect on kidney function (eGFR measured) in the pooled analysis. And SGLT2 inhibitors effectively reduced UACR in T2DM with CKD. Besides, SGLT2 inhibitors could reduce the incidence of AKI.
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Current treatment practices for anemia in patients with chronic kidney disease and future opportunities with hypoxia-inducible factor prolyl hydroxylase inhibitors: a narrative review.
Kile, M, Sudchada, P
International urology and nephrology. 2021;(2):283-290
Abstract
To investigate current treatment practices for anemia in patients with chronic kidney disease (CKD), issues surrounding current treatment practices, and the hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) that are currently in clinical trials. Treatment of anemia in patients with CKD has traditionally included iron supplementation and erythropoiesis-stimulating agents (ESAs). However, due to adverse cardiovascular (CV) events and hypo-responsiveness to ESA therapy, new agents are currently in clinical trials to treat anemia in patients with CKD. The HIF-PHIs stimulate erythropoiesis and regulate iron metabolism and are attractive alternatives to iron supplementation and ESAs.
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From the distinctive smell to therapeutic effects: Garlic for cardiovascular, hepatic, gut, diabetes and chronic kidney disease.
Ribeiro, M, Alvarenga, L, Cardozo, LFMF, Chermut, TR, Sequeira, J, de Souza Gouveia Moreira, L, Teixeira, KTR, Shiels, PG, Stenvinkel, P, Mafra, D
Clinical nutrition (Edinburgh, Scotland). 2021;(7):4807-4819
Abstract
Garlic, a member of the Allium family, widely used in cooking for many centuries, displays well described antioxidant and anti-inflammatory properties, as a result of its constituent organosulfur compounds, such as alliin, allicin, ajoene S-allyl-cysteine, diallyl sulfide and diallyl disulfide, among others. Although garlic has demonstrated beneficial effects in cardiovascular disease, diabetes, and cancer, its efficacy as a therapeutic intervention in chronic kidney disease remains to be proven. This review thus focuses on the potential benefits of garlic as a treatment option in chronic kidney disease. and its ability to mitigate associated cardiovascular complications and gut dysbiosis.
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Translation of Nutrient Level Recommendations to Control Serum Phosphate Into Food-Based Advice.
Byrne, FN, Gillman, B, Kiely, M, Bowles, M, Connolly, P, Earlie, J, Murphy, J, Rennick, T, Reilly, EO, Shiely, F, et al
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2021;(1):43-48
Abstract
The control of hyperphosphatemia is key to the management of chronic kidney disease mineral and bone disorder. Dietary restriction of phosphorus is essential to control hyperphosphatemia. Guidelines for chronic kidney disease and end-stage kidney disease generally provide high-level guidance on whether a nutrient should be restricted e.g, restrict dietary phosphorus. Dietitians translate such guidance into nutrient-based strategies and finally into food-based practical dietary advice for patients to follow. The practical aspects of dietary advice are not well described in the literature, neither are the challenges of concurrently altering 1 nutrient e.g., phosphorus while continuing to restrict others e.g., potassium, while maintaining overall nutritional adequacy and quality of life. In this article, we describe how we translated updated nutrient level recommendations into practical dietary advice to be delivered at the bedside.
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Effects of canagliflozin on cardiovascular, renal, and safety outcomes in participants with type 2 diabetes and chronic kidney disease according to history of heart failure: Results from the CREDENCE trial.
Sarraju, A, Li, J, Cannon, CP, Chang, TI, Agarwal, R, Bakris, G, Charytan, DM, de Zeeuw, D, Greene, T, Heerspink, HJL, et al
American heart journal. 2021;:141-148
Abstract
We aimed to assess the efficacy and safety of canagliflozin in patients with type 2 diabetes and nephropathy according to prior history of heart failure in the Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation (CREDENCE) trial. We found that participants with a prior history of heart failure at baseline (15%) were more likely to be older, female, white, have a history of atherosclerotic cardiovascular disease, and use diuretics and beta blockers (all P < .001), and that, compared with placebo, canagliflozin safely reduced renal and cardiovascular events with consistent effects in patients with and without a prior history of heart failure (all efficacy P interaction >.150). These results support the efficacy and safety of canagliflozin in patients with type 2 diabetes and nephropathy regardless of prior history of heart failure.
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Sotagliflozin Reduces HF Events in T2DM Regardless of Baseline Characteristics, Including HF, CKD and LVEF.
Zhao, LM, Ding, LL, Zhan, ZL, Qiu, M
Cardiovascular drugs and therapy. 2021;(5):1077-1078
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Nutrition in Chronic Kidney Disease-The Role of Proteins and Specific Diets.
Apetrii, M, Timofte, D, Voroneanu, L, Covic, A
Nutrients. 2021;(3)
Abstract
Chronic kidney disease (CKD) is a global public health burden, needing comprehensive management for preventing and delaying the progression to advanced CKD. The role of nutritional therapy as a strategy to slow CKD progression and uremia has been recommended for more than a century. Although a consistent body of evidence suggest a benefit of protein restriction therapy, patients' adherence and compliance have to be considered when prescribing nutritional therapy in advanced CKD patients. Therefore, these prescriptions need to be individualized since some patients may prefer to enjoy their food without restriction, despite knowing the potential importance of dietary therapy in reducing uremic manifestations, maintaining protein-energy status.
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Prediction of microalbuminuria from proteinuria in chronic kidney disease due to non-diabetic lifestyle-related diseases: comparison with diabetes.
Ogi, M, Seto, T, Wakabayashi, Y
Clinical and experimental nephrology. 2021;(7):727-750
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Abstract
BACKGROUND To suppress increases in kidney failure and cardiovascular disease due to lifestyle-related diseases other than diabetes, early intervention is desirable. We examined whether microalbuminuria could be predicted from proteinuria. METHODS The participants consisted of adults who exhibited a urinary protein-to-creatinine ratio (uPCR) of < 0.5 g/gCr and an eGFR of ≥ 15 ml/min/1.73 m2 in their spot urine at their first examination for lifestyle-related disease. Urine was tested three times for each case, with microalbuminuria defined as a urinary albumin-to-creatinine ratio (uACR) of 30-299 mg/gCr, at least twice on three measurements. Youden's Index was used as an index of the cut-off value (CO) according to the ROC curve. RESULTS A single uPCR was useful for differentiating normoalbuminuria and micro- and macroalbuminuria in patients with non-diabetic lifestyle-related diseases. Regarding the GFR categories, the CO of the second uPCR was 0.09 g/gCr (AUC 0.89, sensitivity 0.76, specificity 0.89) in G1-4 (n = 197) and 0.07 g/gCr (AUC 0.92, sensitivity 0.85, specificity 0.88) in G1-3a (n = 125). Using the sum of two or three uPCR measurements was more useful than a single uPCR for differentiating microalbuminuria in non-diabetic lifestyle disease [CO, 0.16 g/gCr (AUC 0.91, sensitivity 0.85, specificity 0.87) and 0.23 g/gCr (AUC 0.92, sensitivity 0.88, specificity 0.84), respectively]. CONCLUSION Microalbuminuria in Japanese individuals with non-diabetic lifestyle-related diseases can be predicted from the uPCR, wherein the CO of the uPCR that differentiates normoalbuminuria and micro- and macroalbuminuria was 0.07 g/gCr for G1-3a, while that in G3b-4 was 0.09 g/gCr.
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Chlorthalidone for Hypertension in Advanced Chronic Kidney Disease.
Agarwal, R, Sinha, AD, Cramer, AE, Balmes-Fenwick, M, Dickinson, JH, Ouyang, F, Tu, W
The New England journal of medicine. 2021;(27):2507-2519
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Abstract
BACKGROUND Little evidence has been available to support the use of thiazide diuretics to treat hypertension in patients with advanced chronic kidney disease. METHODS We randomly assigned patients with stage 4 chronic kidney disease and poorly controlled hypertension, as confirmed by 24-hour ambulatory blood-pressure monitoring, in a 1:1 ratio to receive chlorthalidone at an initial dose of 12.5 mg per day, with increases every 4 weeks if needed to a maximum dose of 50 mg per day, or placebo; randomization was stratified according to previous use of loop diuretics. The primary outcome was the change in 24-hour ambulatory systolic blood pressure from baseline to 12 weeks. Secondary outcomes were the change from baseline to 12 weeks in the urinary albumin-to-creatinine ratio, N-terminal pro-B-type natriuretic peptide level, plasma renin and aldosterone levels, and total body volume. Safety was also assessed. RESULTS A total of 160 patients underwent randomization, of whom 121 (76%) had diabetes mellitus and 96 (60%) were receiving loop diuretics. At baseline, the mean (±SD) estimated glomerular filtration rate was 23.2±4.2 ml per minute per 1.73 m2 of body-surface area and the mean number of antihypertensive medications prescribed was 3.4±1.4. At randomization, the mean 24-hour ambulatory systolic blood pressure was 142.6±8.1 mm Hg in the chlorthalidone group and 140.1±8.1 mm Hg in the placebo group and the mean 24-hour ambulatory diastolic blood pressure was 74.6±10.1 mm Hg and 72.8±9.3 mm Hg, respectively. The adjusted change in 24-hour systolic blood pressure from baseline to 12 weeks was -11.0 mm Hg (95% confidence interval [CI], -13.9 to -8.1) in the chlorthalidone group and -0.5 mm Hg (95% CI, -3.5 to 2.5) in the placebo group. The between-group difference was -10.5 mm Hg (95% CI, -14.6 to -6.4) (P<0.001). The percent change in the urinary albumin-to-creatinine ratio from baseline to 12 weeks was lower in the chlorthalidone group than in the placebo group by 50 percentage points (95% CI, 37 to 60). Hypokalemia, reversible increases in serum creatinine level, hyperglycemia, dizziness, and hyperuricemia occurred more frequently in the chlorthalidone group than in the placebo group. CONCLUSIONS Among patients with advanced chronic kidney disease and poorly controlled hypertension, chlorthalidone therapy improved blood-pressure control at 12 weeks as compared with placebo. (Funded by the National Heart, Lung, and Blood Institute and the Indiana Institute of Medical Research; CLICK ClinicalTrials.gov number, NCT02841280.).