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Febuxostat combined with hydration for the prevention of contrast-induced nephropathy in hyperuricemia patients undergoing percutaneous coronary intervention: A CONSORT-compliant randomized controlled trial.
Ma, G, Li, M, Teng, W, He, Z, Zhai, X, Xia, Z
Medicine. 2022;(4):e28683
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Abstract
BACKGROUND To assess the efficacy of febuxostat combined with hydration on contrast-induced nephropathy (CIN) in coronary heart disease patients with hyperuricemia undergoing percutaneous coronary intervention (PCI). METHODS Patients with hyperuricemia who underwent PCI were randomly assigned to 2 groups. The control group was given hydration only, and the febuxostat group received febuxostat 40 mg daily before administration of contrast agent and hydration. The primary endpoint of the study was the incidence of CIN, defined as an increase in baseline serum creatinine concentration by 25% at 2 days after contrast media administration, and variations in the serum levels of creatinine, neutrophil gelatinase-associated lipocalin, uric acid, and estimated glomerular filtration rate were compared. RESULTS A total of 202 patients with hyperuricemia were randomly assigned to either the febuxostat group (n = 100) or the control group (n = 102). The baseline characteristics of the 2 groups were similar. The incidence of CIN was 6.0% (6/100) in the febuxostat group and 14.71% (15/102) in the control group.The levels of neutrophil gelatinase-associated lipocalin at 6-hour and serum creatinine and uric acid at 48-hour in the febuxostat combined hydration group were lower than those in the control group after surgery, and the level of estimated glomerular filtration rate was higher than that in the control group (all P < .05). Multivariate logistic regression analysis revealed that febuxostat was an independent predictor of CIN. CONCLUSION Our study demonstrated that prophylactic treatment with febuxostat combined with hydration can reduce the incidence of CIN in patients with coronary heart disease and hyperuricemia after PCI.
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Empagliflozin and Major Renal Outcomes in Heart Failure.
Packer, M, Butler, J, Zannad, F, Pocock, SJ, Filippatos, G, Ferreira, JP, Brueckmann, M, Jamal, W, Zeller, C, Wanner, C, et al
The New England journal of medicine. 2021;(16):1531-1533
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Clinical Efficacy and Transcriptomic Analysis of Congrong Shujing Granules () in Patients with Parkinson's Disease and Syndrome of Shen (Kidney) Essence Deficiency.
Chen, SY, Xiao, SJ, Lin, YN, Li, XY, Xu, Q, Yang, SS, Huang, LH, Cai, J
Chinese journal of integrative medicine. 2020;(6):412-419
Abstract
OBJECTIVE To evaluate the clinical efficacy and safety of Congrong Shujing Granules ( , CSGs) in treating patients with Parkinson's disease (PD) and Chinese medicine (CM) syndrome of Shen (Kidney) essence deficiency, and to investigate the potential mechanism involving efficacy through a transcriptome sequencing approach. METHODS Eligible PD patients with syndrome of Shen essence defificiency were randomly assigned to a treatment group or a control group by a random number table, and were treated with CSGs combined with Western medicine (WM), or placebo combined with WM, respectively. Both courses of treatment lasted for 12 weeks. The Unifified Parkinson's Disease Rating Scale (UPDRS) score, the PD Question-39 (PDQ-39) score, CM Syndrome Scale score, and drug usage of all patients were evaluated before and after treatment. Safety was evaluated by clinical laboratory tests and electrocardiographs. Blood samples from 6 patients in each group were collected before and after the trial and used for transcriptomic analysis by gene ontology analysis and Kyoto Encyclopedia of Genes and Genomes pathway analysis. Differentially expressed genes were validated using reverse transcription-polymerase chain reaction. RESULTS A total of 86 PD patients were selected from the Third Affifiliated People's Hospital of Fujian University of Traditional Chinese Medicine between January 2017 and December 2017. Finally, 72 patients completed the trial, including 35 in the treatment group and 37 in the control group. When compared with the control group after treatment, patients in the treatment group showed signifificant decreases in UPDRS sub-II score, PDQ-39 score, CM syndrome score, and Levodopa equivalent dose (P<0.05). During the treatment course, no signifificant changes were observed in safety indicators between the two groups (P>0.05). A possible mechanism of clinical effificacy was proposed that involved regulating cell metabolism-related processes and ribosome-related pathways. Treatment with CSGs had shown to affect relevant gene loci for PD, including AIDA, ANKRD36BP2, BCL2A1, BCL2L11, FTH1P2, GCH1, HPRT1, NFE2L2, RMRP, RPS7, TGFBR1, WIPF2, and COX7B. CONCLUSIONS CSGs combined with WM can be used to treat PD patients with CM syndrome of Shen essence defificiency with a good safety. The possible mechanism of action and relevant gene loci were proposed. (Registration No. ChiCTR-IOR-16008394).
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Sociodemographic and Kidney Disease Correlates of Nutrient Intakes Among Urban African Americans With Uncontrolled Hypertension.
Song, AY, Crews, DC, Ephraim, PL, Han, D, Greer, RC, Boyér, LL, Ameling, J, Gayles, DJ, Sneed, V, Carson, KA, et al
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2019;(5):399-406
Abstract
OBJECTIVE The objective of this study was to determine the association between sociodemographic factors and intakes of 4 nutrients and associations between intakes and markers of kidney disease to identify opportunities to improve outcomes among clinically high-risk African Americans. DESIGN AND METHODS We conducted a cross-sectional study of baseline data from the Achieving Blood Pressure Control Together study, a randomized controlled trial of 159 African Americans (117 females) with uncontrolled hypertension in Baltimore MD. To determine the association between sociodemographic factors and nutrient intakes, we constructed linear and logistic regression models. Using logistic regression, we determined the association between below-median nutrient intakes and kidney disease. Our outcomes of interest were daily intakes of vitamin C, magnesium, dietary fiber, and potassium as estimated by the Block Fruit-Vegetable-Fiber Screener and kidney disease defined as estimated glomerular filtration rate <60 mL/min per 1.73 m2 or urinary albumin-to-creatinine ratio >=30 mg/g. SETTING AND SUBJECTS Baseline data from the Achieving Blood Pressure Control Together study, a randomized controlled trial of 159 African Americans (117 females) with uncontrolled hypertension, were obtained. METHODS To determine the association between sociodemographic factors and nutrient intakes, we constructed linear and logistic regression models. Using logistic regression, we determined the association between below-median nutrient intakes and kidney disease. MAIN OUTCOME MEASURES Our outcomes of interest were daily intakes of vitamin C, magnesium, dietary fiber, and potassium as estimated by the Block Fruit-Vegetable-Fiber Screener and kidney disease defined as estimated glomerular filtration rate <60 mL/min per 1.73 m2 or urinary albumin-to-creatinine ratio ≥30 mg/g. RESULTS Overall, compared to Institute of Medicine recommendations, participants had lower intakes of magnesium, fiber, and potassium but higher vitamin C intakes. For females, sociodemographic factors that significantly associated with lower intake of the 4 nutrients were older age, obesity, lower health numeracy, and lesser educational attainment. For males, none of the sociodemographic factors were significantly associated with nutrient intakes. Below-median intake was significantly associated with albumin-to-creatinine ratio ≥30 (adjusted odds ratio [95% confidence interval]: 3.4 [1.5, 7.8] for vitamin C; 3.6 [1.6, 8.4] for magnesium; 2.9 [1.3, 6.5] for fiber; 3.6 [1.6, 8.4] for potassium), but not with estimated glomerular filtration rate <60. CONCLUSION African Americans with uncontrolled hypertension may have low intakes of important nutrients, which could increase their risk of chronic kidney disease. Tailored dietary interventions for African Americans at high risk for chronic kidney disease may be warranted.
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Empagliflozin reduces cardiovascular events, mortality and renal events in participants with type 2 diabetes after coronary artery bypass graft surgery: subanalysis of the EMPA-REG OUTCOME® randomised trial.
Verma, S, Mazer, CD, Fitchett, D, Inzucchi, SE, Pfarr, E, George, JT, Zinman, B
Diabetologia. 2018;(8):1712-1723
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AIMS/HYPOTHESIS After coronary artery bypass graft (CABG) surgery in individuals with type 2 diabetes, there remains a considerable residual cardiovascular risk. In the EMPA-REG OUTCOME® trial in participants with type 2 diabetes and established cardiovascular disease, empagliflozin reduced the risk of cardiovascular death by 38%, all-cause mortality by 32%, hospitalisation for heart failure by 35% and incident or worsening nephropathy by 39% vs placebo when given in addition to standard of care. The aim of this post hoc analysis of the EMPA-REG OUTCOME® trial was to determine the effects of the sodium glucose cotransporter 2 inhibitor empagliflozin on cardiovascular events and mortality in participants with type 2 diabetes and a self-reported history of CABG surgery. METHODS The EMPA-REG OUTCOME® trial was a randomised, double-blind, placebo-controlled trial. Participants with type 2 diabetes and established cardiovascular disease were randomised 1:1:1 to receive placebo, empagliflozin 10 mg or empagliflozin 25 mg, once daily, in addition to standard of care. In subgroups by self-reported history of CABG (yes/no) at baseline, we assessed: cardiovascular death; all-cause mortality; hospitalisation for heart failure; and incident or worsening nephropathy (progression to macroalbuminuria, doubling of serum creatinine, initiation of renal replacement therapy or death due to renal disease). Differences in risk between empagliflozin and placebo were assessed using a Cox proportional hazards model. RESULTS At baseline, 25% (1175/4687) of participants who received empagliflozin and 24% (563/2333) of participants who received placebo had a history of CABG surgery. In participants with a history of CABG surgery, HRs (95% CI) with empagliflozin vs placebo were 0.52 (0.32, 0.84) for cardiovascular mortality, 0.57 (0.39, 0.83) for all-cause mortality, 0.50 (0.32, 0.77) for hospitalisation for heart failure and 0.65 (0.50, 0.84) for incident or worsening nephropathy. Results were consistent between participants with and without a history of CABG surgery (p > 0.05 for treatment by subgroup interactions). CONCLUSIONS/INTERPRETATION In participants with type 2 diabetes and a self-reported history of CABG surgery, treatment with empagliflozin was associated with profound reductions in cardiovascular and all-cause mortality, hospitalisation for heart failure, and incident or worsening nephropathy. These data have important implications for the secondary prevention of cardiovascular events after CABG in individuals with type 2 diabetes. TRIAL REGISTRATION ClinicalTrials.gov NCT01131676.
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Gastro-Intestinal Tolerance and Renal Safety of Protein Oral Nutritional Supplements in Nursing Home Residents: A Randomized Controlled Trial.
Ter Wee, P, Kuhn, M, van der Woude, H, Van De Looverbosch, D, Heyman, H, Mikušová, L, Fouque, D
The journal of nutrition, health & aging. 2016;(9):944-951
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BACKGROUND/OBJECTIVE High protein oral nutritional supplements (ONS) are regularly prescribed to undernourished patients; however usage of these in older adults is being discussed, as their renal function might have declined with age. Therefore, the aim of the current study was to evaluate the effects of 8 week long consumption of high protein ONS on the renal function of nursing home residents in need of supplementation. Furthermore, within the same setup, differences in gastro-intestinal tolerance between a standard and a more concentrated version of an ONS were investigated. DESIGN Randomized, controlled, single-blind, parallel-group, multi-country trial (NTR2565). SETTING Nursing home. PARTICIPANTS 67 nursing home residents in need of ONS (energy-dense, small volume group n=32; standard volume group n=35). INTERVENTION Protein supplementation was provided by either a standard (200ml, 300kcal, 20g protein) or an energy-dense, small volume (125ml, 300kcal, 18g protein) ONS during the 8 week long study. MEASUREMENTS Primary outcome was gastro-intestinal tolerance, assessed by daily stool frequency and consistency, and occurrence and intensity of self-reported gastro-intestinal symptoms. Safety was measured via the occurrence of (serious) adverse events, vital signs, as well as liver- and kidney function monitoring. RESULTS No clinically relevant and, except for flatulence, no statistically significant differences in gastro-intestinal tolerance were observed between groups. No significant difference between groups was found for estimated glomerular filtration rate (eGFR) and urinary albumin/creatinine ratio at baseline and week 8, nor for the changes from baseline. Adverse events and the changes in monitored renal parameters over the study period did not point to a deterioration of renal function. CONCLUSION High protein ONS seems to be well-tolerated and safe; there is no indication that it affects renal function in nursing home residents, including patients with stage 3 chronic kidney disease, under the conditions tested. Results did not suggest a difference in the effect on renal function between standard and energy-dense small volume ONS format.
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The effects of resistance exercise and oral nutritional supplementation during hemodialysis on indicators of nutritional status and quality of life.
Martin-Alemañy, G, Valdez-Ortiz, R, Olvera-Soto, G, Gomez-Guerrero, I, Aguire-Esquivel, G, Cantu-Quintanilla, G, Lopez-Alvarenga, JC, Miranda-Alatriste, P, Espinosa-Cuevas, A
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2016;(10):1712-20
Abstract
BACKGROUND Protein-energy wasting (PEW) is common in patients undergoing hemodialysis (HD). Studies have assessed the positive effect of oral nutritional supplementation (ONS) or resistance exercise (RE) on nutritional status (NS) markers in patients undergoing HD. METHODS The aim of this study was to assess the effect of ONS and RE on NS and the quality of life (QOL) of 36 patients undergoing HD. In a randomized clinical trial, patients were divided into the following two groups: a control group (ONS) that received a can of ONS during their HD sessions and an intervention group (ONS + RE) that received a can of ONS and underwent a 40-min session of RE during their HD sessions. Both interventions lasted 12 weeks. The patients' anthropometric, biochemical, dietetic and bioelectrical impedance measurements as well as their QOL, evaluated using the Kidney Disease Quality of Life Short Form, were recorded. RESULTS At baseline, 55.5% of patients presented with PEW according to International Society of Renal Nutrition and Metabolism criteria (20 patients). We found statistically significant changes from baseline in both groups, such as increases in body weight, body mass index, midarm circumference, midarm muscle circumference, triceps skinfold thickness, fat mass percentage, handgrip strength, phase angle and serum albumin. A decrease in the prevalence of PEW was observed in both groups at the end of the intervention. A delta comparison between groups showed no statistically significant differences in the anthropometric and biochemical parameters. No significant improvement was observed in QOL and body composition measured by bioimpedance vector analysis. Dietary energy and protein intake increased significantly during the study period for all patients. CONCLUSION Oral nutritional supplementation during HD improves NS. The addition of RE during HD does not seem to augment the acute anabolic effects of intradialytic ONS on NS.
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Low-Iodine-Load and Low-Tube-Voltage CT Angiographic Imaging of the Kidney by Using Bolus Tracking with Saline Flushing.
Kanematsu, M, Goshima, S, Kawai, N, Kondo, H, Miyoshi, T, Watanabe, H, Noda, Y, Tanahashi, Y, Bae, KT
Radiology. 2015;(3):832-40
Abstract
PURPOSE To prospectively determine the feasibility of low-iodine-load and low-tube-voltage computed tomographic (CT) angiographic imaging of the kidney and to evaluate the opacification and image quality compared with moderate-iodine-load and high-iodine-load techniques. MATERIALS AND METHODS Institutional review board approval and written informed consent was obtained. One hundred thirteen consecutive patients randomly underwent three protocols for dual-phase renal CT angiographic imaging: high-iodine-load (600 mg iodine per kilogram of body weight at 120 kVp); moderate-iodine-load (400 mg iodine per kilogram of body weight at 80 kVp); and low-iodine-load (contrast agent injection initially prepared at 400 mg iodine per kilogram of body weight but stopped immediately after bolus-tracking trigger at 80 kVp) scanning. CT numbers of vessels and kidneys were measured. CT numbers and signal-to-noise ratio (SNR) were compared with one-way analysis of variance and posthoc Tukey-Kramer test and depiction of vessels and image noise, with Kruskal-Wallis test and pair-wise Mann-Whitney test with Bonferroni correction. RESULTS Mean iodine weight administered was significantly reduced in order of low- (16.4 g), moderate- (23.5 g), and high-iodine-load (33.7 g) protocols (P < .001). Mean CT numbers of abdominal aorta, renal artery, and renal cortex in first phase were significantly lower with high-iodine-load protocol (308, 274, and 132 HU, respectively) than with moderate- (347, 334, and 156 HU, respectively; P = .001-.006) or low-iodine-load (362, 316, and 161 HU, respectively; P = .001-.003) protocol. Mean CT number of renal vein in second phase was significantly lower with low-iodine-load protocol (223 HU) than with moderate- (299 HU; P < .001) or high-iodine-load (258 HU; P = .020). Mean SNR of renal medulla in second phase was significantly lower (P = .019) with moderate-iodine-load protocol (mean SNR, 7.2) than with high-iodine-load protocol (mean SNR, 10.0). No significant difference in image quality grades was found between high-iodine-load (mean grade, 2.6-2.9), moderate-iodine-load (mean grade, 2.6-3.0), and low-iodine-load (mean grade, 2.6-2.9) protocols (P = .018-.31). CONCLUSION Combined application of low-iodine-load, bolus tracking with saline flushing, and low-tube-voltage scanning is feasible and resulted in substantial reduction of iodine dose for renal CT angiographic imaging without compromising image quality.
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Anti-hypertensive strategies in patients with MEtabolic parameters, DIabetes mellitus and/or NephropAthy (the M E D I N A study).
Spinar, J, Vitovec, J, Soucek, M
Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia. 2014;(3):412-21
Abstract
AIMS: The primary questions asked by the MEDINA (MEtabolic parameters, DIabetes mellitus and NephropAthy) study are: 1) Do angiotensin converting enzyme inhibitors (ACE-I) have any advantages over angiotensin receptor blockers (ARB)? 2) Should the other drug for combination be a diuretic or a calcium-channel blocker (CCB)? 3) How are the risks reduced by the co administration of a statin? METHODS A total of 439 hypertensive patients with metabolic syndrome and/or diabetes mellitus were randomized to 2 groups: group 1--ramipril (ACE-I) or perindopril and group 2--losartan (ARB). Hydrochlorothiazide (diuretic) or amlodipine (CCB) were added to both groups. As a third step, a statin was added. RESULTS Blood pressure decreased 24.1/13.3 mmHg in the ACE inhibitor group and 25.9/13.5 in the losartan group. The difference was insignificant. Adding either hydrochlorothiazide or amlodipin was equally effective. There were no significant differences on metabolic parameters in the trial arms. Cholesterol level decreased by 0.95 mmol/L in the ACE-I group and 1.02 mmol/L in the ARB group (ns). CONCLUSION MEDINA has so far confirmed the equivalence of ACE-I and ARB in hypertension treatment. Adding either diuretic or CCB was equally effective. Our data support the current recommendations on adding a statin to reduce cardiovascular risk.
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Safety of enhanced renin-angiotensin-aldosterone system inhibition with aliskiren in nondiabetic patients with chronic kidney disease.
Lizakowski, S, Tylicki, L, Rutkowski, P, Renke, M, Sulikowska, B, Heleniak, Z, Donderski, R, Bednarski, R, Przybylska, M, Manitius, J, et al
Polskie Archiwum Medycyny Wewnetrznej. 2013;(5):221-7
Abstract
INTRODUCTION Various methods of combination renin-angiotensin-aldosterone system blockade help achieve more potent antiproteinuric effects, but may be associated with higher risk of side effects. Therapies involving direct renin inhibitor, aliskiren, may promote renal fibrosis by stimulating (pro)renin receptor due to increased renin levels. OBJECTIVES The aim of the study was to compare the effects of combination treatment with angiotensin receptor blockers, telmisartan (80 mg/d) and aliskiren (300 mg/d) with those of combination treatment with 80 mg/d telmisartan and mineralocorticoid receptor blocker (50 mg/d eplerenone) and telmisartan (160 mg/d) alone on the urinary excretion of transforming growth factor β1 (TGF‑β1), renal function, and serum potassium levels. PATIENTS AND METHODS A randomized open-label controlled cross-over study was performed in 18 white patients (7 women and 11 men; mean age, 42.4 ±1.9 years) with proteinuric nondiabetic chronic kidney disease and estimated glomerular filtration rate of 85.2 ±4.6 ml/min. RESULTS The urinary excretion of TGF‑β1 was stable despite a significant increase in plasma renin levels after treatment with telmisartan and aliskiren. There were no differences in renal function and serum potassium levels between the compared treatments. Moreover, there were no episodes of hypotension or acute renal impairment. CONCLUSIONS Combination therapy with telmisartan and aliskiren may be safe in young nondiabetic patients with normal renal function at low vascular risk. This treatment may be an alternative for a subset of patients in whom standard RAA system blockade is ineffective.