A Wiecek

Medical University of Silesia in Katowice, Catowice, Silesian Voivodeship, Poland

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Publications (385)949.48 Total impact

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    ABSTRACT: Abstract Background: Studies assessing plasma visfatin/nicotinamide phosphoribosyltransferase (NAMPT) concentrations in chronic kidney disease with the ELISA method are restricted mainly to subjects with end-stage kidney disease. Therefore, little is known about to what extent glomerular filtration rate (GFR) affects the plasma levels of visfatin/NAMPT. The aim of this study was to assess the relations between circulating visfatin/NAMPT levels and estimated GFR (eGFR), independently of potential confounders such as inflammation, nutritional status, and insulin resistance in the elderly population. Methods: The analysis included 3023 elderly subjects (1076 with impaired kidney excretory function - eGFR <60 mL/min/1.73 m2) who were participants of the PolSenior study. Serum insulin, glucose, creatinine, C-reactive protein, interleukin-6, and plasma visfatin/NAMPT concentrations were measured by a highly specific ELISA method. Insulin resistance was assessed on the basis of homeostasis model assessment for insulin resistance, and kidney excretory function was assessed using the full MDRD formula. Results: Similar plasma visfatin/NAMPT levels were found in subjects with eGFR ≥60 and <60 mL/min/1.73 m2 (0.96 ng/mL in both groups), and even in those subjects with eGFR 15-30 mL/min/1.73 m2 (0.83 ng/mL). Additionally, there was no association between plasma visfatin/NAMPT concentrations and eGFR values in models of regression analysis including confounding factors. Conclusions: The results of our study suggest that plasma visfatin/NAMPT levels are not affected by impaired kidney excretory function in elderly subjects.
    Clinical chemistry and laboratory medicine : CCLM / FESCC. 10/2014;
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    ABSTRACT: Patients with chronic kidney failure—defined as a glomerular filtration rate persistently below 15 mL/min per 1·73 m2—have an unacceptably high mortality rate. In developing countries, mortality results primarily from an absence of access to renal replacement therapy. Additionally, cardiovascular and non-cardiovascular mortality are several times higher in patients on dialysis or post-renal transplantation than in the general population. Mortality of patients on renal replacement therapy is affected by a combination of socioeconomic factors, pre-existing medical disorders, renal replacement treatment modalities, and kidney failure itself. Characterisation of the key pathophysiological contributors to increased mortality and cardiorenal risk staging systems are needed for the rational design of clinical trials aimed at decreasing mortality. Policy changes to improve access to renal replacement therapy should be combined with research into low-cost renal replacement therapy and optimum clinical care, which should include multifaceted approaches simultaneously targeting several of the putative contributors to increased mortality.
    05/2014; 383(9931):1831–1843.
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    ABSTRACT: http://ndt.oxfordjournals.org/content/29/suppl_3/iii35.abstract
    05/2014; 29 Suppl 3:iii35-iii36.
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    ABSTRACT: Abstract Background: The cardiotonic steroid marinobufagenin (MBG) is increasingly suggested to be responsible for some of the cardiovascular injury that has been previously attributed to aldosterone. We examined the clinical correlates of circulating MBG concentrations in hypertensive patients and tested the hypothesis that MBG serves as a reliable diagnostic tool for detecting primary aldosteronism (PA). Methods: Plasma MBG concentrations (mean: 0.51 ± 0.25 nmol/l) were measured in the morning fasting samples in 20 patients with PA and 20 essential hypertensive (EH) controls matched for age, sex, body mass index, renal function, urinary sodium and intake of antihypertensive medication (mean age: 51.6 years; 52.2% women). Results: Overall, plasma MBG was directly correlated with plasma aldosterone, aldosterone to active renin ratio (AARR), diastolic blood pressure, mean carotid intima-media thickness, serum sodium, urinary protein to creatinine ratio and inversely with serum potassium levels. Plasma MBG levels were significantly higher in patients with PA compared to EH (mean: 0.68 ± 0.12 versus 0.35 ± 0.24 nmol/l; p < 0.001). ROC analysis yielded a greater AUC for plasma MBG compared to the AARR, PAC and serum potassium levels for detecting PA. Youden's Index analyses yielded the optimal plasma MBG cut-off score for diagnosing PA at > 0.49 nmol/l with specificity and sensitivity values of 0.85 and 0.95, respectively, which were higher than those at the optimum AARR cut-off at > 3.32 ng/dl/µU/ml. Conclusions: In a well-characterized cohort, values of plasma MBG were significantly related to clinical correlates of cardiovascular and renal disease. Plasma MBG emerged as a valuable alternative to the AARR for screening of PA.
    Clinical and Experimental Hypertension 04/2014; · 1.28 Impact Factor
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    ABSTRACT: Better biomarkers of CKD reflecting responses to decreased glomerular filtration rate (GFR) are needed. We determined the value of estimated GFR (eGFR) as a threshold for the increase of plasma cFGF23 (C-terminal) and intact fibroblast growth factor-23 (iFGF23) (intact) concentrations in the course of chronic kidney disease (CKD) and compared this eGFR value with values related to increased serum intact parathyroid hormone (iPTH) or phosphorus concentrations in an elderly population. We measured plasma iFGF23, cFGF23, serum phosphorus, calcium, albumin, creatinine, urea, cystatin C, iPTH and vitamin 25-OH-D3 in 3780 population-based study participants aged ≥65 years. Serum phosphorus concentrations hardly increased until mean eGFR reached 47.3 ± 4.7 mL/min/1.73 m(2) but then increased exponentially. Similarly, both iPTH and iFGF23 increased slightly in early CKD but then increased exponentially when eGFR reached 55.0 ± 4.2 mL/min/1.73 m(2) for iPTH and 51.6 ± 5.7 mL/min/1.73 m(2) for iFGF23. The departure point for exponential increases in cFGF23 preceded those for iPTH and iFGF23 and occurred at a mean eGFR of 57.7 ± 7.8 mL/min/1.73 m(2). The prevalence of increased iFGF23 occurred at a remarkably higher eGFR value than that of cFGF23 across the CKD stages. The increase in cFGF23 preceded both the increase in iPTH and iFGF23 as eGFR declined. Increased plasma iFGF23 level did not precede the rise in serum iPTH concentrations and did not occur before stage-3 CKD in elderly persons. However, cFGF23 was not an early marker of CKD in the elderly subjects.
    Nephrology Dialysis Transplantation 04/2014; · 3.37 Impact Factor
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    ABSTRACT: Abstract Background: The assessment of proper hydration status in hemodialysis patients is difficult. None of currently available markers or measures is clinically relevant. Recently, human pre-pro-vasopressin (1-164) split product [copeptin (CPP)] - a new surrogate marker of hydration status - was introduced. The aim of the study was to analyze body weight changes in the early post-transplant period in relation to serum CPP levels before kidney transplantation. Methods: Serum CPP and NT-proBNP concentrations and osmolality were measured in 130 kidney recipients directly prior to transplantation and, additionally, in 78 of them at 14th day post-transplant. Hydration status at transplantation was calculated from the difference in the patient's body weight before transplantation and at the discharge. Results: During the post-transplant hospitalization, the average weight change was -1.6 kg, varying from 10.5 kg loss to weight gain of 5 kg. The overall weight loss was significantly related to pretransplant serum concentration of CPP (r=0.238), but not of NT-proBNP or osmolality. Patients with the lowest initial CPP level (first tertile) had smaller post-transplant weight loss. The early kidney graft function was unrelated to pretransplant CPP. Multivariate regression model revealed that variability of post-transplant weight loss is explained by the number of antihypertensive drugs used prior to transplantation [β=0.213 (0.049-0.377)] and pretransplant CPP values [β=0.233 (0.069-0.397)]. Conclusions: Elevated serum CPP level predicts a rapid weight loss after kidney transplantation and seems to characterize the subgroup of patients with the greatest overhydration. These results suggest the dysregulation of physiological mechanisms of CPP secretion in hemodialysis patients.
    Clinical Chemistry and Laboratory Medicine 04/2014; · 3.01 Impact Factor
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    ABSTRACT: Chronic kidney disease (CKD) is characterized by a gradual endogenous intoxication caused by the progressive accumulation of bioactive compounds that in normal conditions would be excreted and/or metabolized by the kidney. Uremic toxicity now is understood as one of the potential causes for the excess of cardiovascular disease and mortality observed in CKD. An important family of uremic toxins is that of the peptidic middle molecules, with a molecular weight ranging between 500 and 60,000 Da, which makes them, as a consequence, difficult to remove in the process of dialysis unless the dialyzer pore size is large enough. This review provides an overview of the main and best-characterized peptidic middle molecules and their role as potential culprits of the cardiometabolic complications inherent to CKD patients.
    Seminars in Nephrology 01/2014; · 2.83 Impact Factor
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    ABSTRACT: Background. Age-related decrease in bone marrow erythropoietic capacity is often accompanied by the telomere length shortening in peripheral white blood cells. However, limited and conflicting data hamper the conclusive opinion regarding this relationship. Therefore, the aim of this study was to assess an association between telomere length and peripheral blood cell count parameters in the Polish elderly population. Material and Methods. The substudy included 1573 of 4981 subjects aged 65 years or over, participants of the population-based PolSenior study. High-molecular-weight DNA was isolated from blood mononuclear cells. Telomere length (TL) was measured by QRT-PCR as abundance of telomere template versus a single gene copy encoding acidic ribosomal phosphoprotein P0. Results. Only white blood count (WBC) was significantly different in TL tertile subgroups in all subjects (P = 0.02) and in men (P = 0.01), but not in women. Merely in men significant but weak positive correlations were found between TL and WBC (r = 0.11, P < 0.05) and RBC (r = 0.08, P < 0.05). The multiple regression analysis models confirmed a weak, independent contribution of TL to both RBC and WBC. Conclusions. In the elderly, telomere shortening limits hematopoiesis capacity to a very limited extent.
    The Scientific World Journal 12/2013; 2013:153608. · 1.73 Impact Factor
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    ABSTRACT: Patients on haemodialysis (HD) exhibit increased cardiovascular mortality associated with accelerated vascular calcification (VC). VC is influenced by inhibitors such as matrix Gla protein (MGP), a protein activated in the presence of vitamin K. HD patients exhibit marked vitamin K deficiency, and supplementation with vitamin K reduces inactive MGP levels in these patients. The VitaVasK trial analyses whether vitamin K1 supplementation affects the progression of coronary and aortic calcification in HD patients. VitaVasK is a prospective, randomized, parallel group, multicentre trial (EudraCT No.: 2010-021264-14) that will include 348 HD patients in an open-label, two-arm design. After baseline multi-slice computed tomography (MSCT) of the heart and thoracic aorta, patients with a coronary calcification volume score of at least 100 will be randomized to continue on standard care or to receive additional supplementation with 5 mg vitamin K1 orally thrice weekly. Treatment duration will be 18 months, and MSCT scans will be repeated after 12 and 18 months. Primary end points are the progression of thoracic aortic and coronary artery calcification (calculated as absolute changes in the volume scores at the 18-month MSCT versus the baseline MSCT). Secondary end points comprise changes in Agatston score, mitral and aortic valve calcification as well as major adverse cardiovascular events (MACE) and all-cause mortality. VitaVask also aims to record MACE and all-cause mortality in the follow-up period at 3 and 5 years after treatment initiation. This trial may lead to the identification of an inexpensive and safe treatment or prophylaxis of VC in HD patients.
    Nephrology Dialysis Transplantation 11/2013; · 3.37 Impact Factor
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    ABSTRACT: Rapidly progressing ageing of worldwide populations is likely to increase the occurrence of chronic kidney disease (CKD) in the next decades. However, until now little is known about the prevalence of CKD in the Polish elderly population. The aim of this study was to assess the prevalence of CKD and its relation to socioeconomic conditions in the Polish elderly population. A glomerular filtration rate estimated (eGFR) according to the CKD-EPI formula and urine albumin/creatinine ratio were determined in 3797 out of 4979 randomly selected elderly subjects from the national survey study PolSenior. Additionally, some socioeconomic factors related to the prevalence of CKD were also analysed. The prevalence of CKD in the Polish elderly population was 29.4%. Only 3.2% of elderly subjects with CKD were aware of the disease. CKD was more frequent among urban dwellers, non-smokers, alcohol abstinents and those with low physical activity. Decreased eGFR was more frequent among less educated women, better educated men, blue collar female workers and white collar male workers. Increased albuminuria was associated with low physical activity. (i) CKD affects almost one-third of the elderly Polish population. (ii) In Poland elderly subjects with CKD are usually unaware of their kidney disease. (iii) In Polish elderly population, CKD is more frequently present among urban residents, non-smokers, abstainers and less physically active people. (iv) Only in women is higher educational status related to the lower risk of CKD.
    Nephrology Dialysis Transplantation 10/2013; · 3.37 Impact Factor
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    ABSTRACT: Epidemiological studies have highlighted the role of arterial stiffness as a risk factor for development of cardiovascular (CV) diseases. Moreover, aortic stiffness has been shown to be a significant predictive factor of all-cause and CV mortality in different populations including patients with end-stage renal disease. Pulse-wave velocity (PWV) is the most widely used technique to assess arterial stiffness. Although PWV can be measured on any artery or between any arterial sites, only carotid-to-femoral PWV, representing stiffness of the aorta and iliofemoral axes, has been shown to have predictive value for morbidity and mortality. The several available commercial devices differ according to the type of signal (pressure, distension, flow) or by recording both sites simultaneously or using ECG synchronization. It is also possible to directly measure arterial diameter changes during the cardiac cycle and link them to local pulse-pressure changes, which provides the pressure-diameter relationship and stress-strain relationship if arterial wall thickness is also measured. These techniques are based on high-precision vascular echo tracking or magnetic resonance imaging and applanation tonometry. This paper summarizes the basic principles of arterial haemodynamics and various methodologies to assess stiffness and the latest consensus recommendations for clinical applications.
    Nephrology Dialysis Transplantation 09/2013; · 3.37 Impact Factor
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    ABSTRACT: Developing guidelines on a subject as broad as hypertension is difficult, especially when the guidance relates to hypertension in the chronic kidney disease (CKD) population. The Kidney Disease: Improving Global Outcomes Guideline Development Group has applied a rigorous methodology in reviewing all available evidence, and their recommendations are consistent with the evidence-based approach. As a result, the European Renal Best Practice endorses most of its recommendations. However, the Work Group feels that some additional advice could help clinicians in daily practice: (i) individualization of treatment should be taken into account, especially (cardiovascular) co-morbidities, age, gender and race; (ii) side-effects, such as postural dizziness should be monitored closely, particularly in elderly, diabetics and patients with arterial stiffness; (iii) the importance of salt restriction should not be neglected; (iv) although angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor blocker (ARBs) remain a cornerstone in the management of hypertension, and especially cardiovascular protection, in some particular situations such as in advanced CKD and in patients without proteinuria, their role is less well defined; (v) as most CKD patients need more than one antihypertensive drug to achieve blood pressure control, the specific (renal) (dis)advantages of other classes than ACE-I or ARB should be taken into account.
    Nephrology Dialysis Transplantation 09/2013; · 3.37 Impact Factor
  • Piotr Kuczera, Marcin Adamczak, Andrzej Wiecek
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    ABSTRACT: Recent clinical studies suggest that fibroblast growth factor 23 (FGF23) is important in the pathogenesis of calcium-phosphate abnormalities in patients with chronic kidney disease and that increased plasma FGF23 concentration is a cardiovascular risk factor in these patients. The aim of this prospective, single-arm, open-label clinical study was to assess the influence of 6-month cinacalcet treatment on plasma FGF23 concentration in haemodialysed patients with secondary hyperparathyroidism (sHPT). In 58 haemodialysed patients with sHPT (parathormone PTH > 300 ng/l), serum PTH, FGF23, calcium and phosphate concentrations were assessed before the first dose of cinacalcet and after 3 and 6 months of treatment. Serum PTH concentration decreased significantly after 3 and 6 months of treatment, and the mean serum calcium and phosphate concentrations remained stable during the treatment period. Plasma FGF23 concentration (geometric mean with 95% confidence index) decreased after 3 and 6 months of treatment from 354 (261-481) ng/l to 295 (204-428) ng/l; P = 0·099 and to 183 (117-285) ng/l; P = 0·015, respectively. FGF23 concentration decreased in 52% of patients. In multivariate regression analysis, plasma FGF23 concentration changes were explained by the changes in serum phosphate, but not by serum PTH or calcium changes or by the dose of cinacalcet. 1. Cinacalcet treatment decreases plasma FGF23 concentration in haemodialysed patients with secondary hyperparathyroidism. 2. The decrease in plasma FGF23 concentration seems to be related to the decrease in serum phosphate concentration.
    Clinical Endocrinology 09/2013; · 3.40 Impact Factor
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    ABSTRACT: Patients with chronic kidney disease (CKD) are at a particularly high risk for cardiovascular disease. Vascular calcification (VC) is considered a cardiovascular risk marker, so in CKD patients screening for the presence of VC is suggested in current guidelines. VC is the result of both passive and active processes that involve a variety of proteins and factors. In the CKD population, numerous studies have identified circulating biomarkers potentially responsible for VC and have evaluated their link with this process. This narrative review, and an accompanying analysis performed on the Amiens CKD database, focuses on selected VC biomarkers-namely phosphate, fibroblast growth factor 23 (FGF23), osteopontin (OPN), osteoprotegerin (OPG), matrix Gla protein and fetuin A-all of which have been implicated as major players in VC in experimental studies in vitro or in animal models. None of the VC biomarkers considered in this review have qualified as a reliable predictor of meaningful clinical events or as a valid indicator of the risk of having VC. In the analysis based on the Amiens-CKD database, no biomarker outperformed age and the classical risk factors as a predictor of VC either in the aorta or in the coronaries. Well-designed clinical trials are now urgently needed to test the potential value of these biomarkers as a guide for interventions targeting VC.
    Nephrology Dialysis Transplantation 09/2013; · 3.37 Impact Factor
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    ABSTRACT: Increased intrarenal resistance index (RI) has been associated with decreased long-term allograft and patient survival in kidney transplant recipients. Taking into account the potential role of endothelial dysfunction, systemic inflammation, arteriosclerotic lesions, and left ventricle remodeling, we performed a cross-sectional study that aimed to evaluate extrarenal factors that may have influence on kidney graft RI in a large cohort of stable kidney transplant recipients. One hundred seventy-four kidney transplant recipients were enrolled into the study. Mean time after transplantation was 8.4±1.8 years. Echocardiography, carotid ultrasound (intima-media thickness), pulse wave velocity, and Doppler examination of kidney graft were performed. The inflammatory markers, adhesion molecules, and plasma N-terminal prohormone of brain natriuretic peptide concentrations were also measured. Patients were divided into quartile subgroups based on RI value (Q1: RI≤0.68, Q2: RI=0.69-0.72, Q3: RI=0.73-0.76, and Q4: RI≥0.77). The analyzed subgroups were comparable with respect to demographics (except age) and anthropometric parameters as well as comorbidities. The values of age, serum phosphate, pulse wave velocity, left ventricular mass (LVM), and LVM index (LVMI) increased in subsequent RI quartile subgroups. The strongest correlation was found between RI and age, LVM, LVMI, and plasma parathormone concentration and was negative with estimated glomerular filtration rate. In backward stepwise multivariate regression analysis, the RI variability was explained by age, LVMI, and serum phosphate concentration. Arterial stiffness and left ventricular hypertrophy may significantly influence the intrarenal vascular resistance measured using Doppler sonography in stable kidney transplant recipients.
    Transplantation 07/2013; · 3.78 Impact Factor
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    ABSTRACT: BACKGROUND: The brain natriuretic peptides (BNP, NT-proBNP ) are useful diagnostic markers of heart failure (HF), as exemplified by the ESC Heart Failure guidelines. The PolSenior project was an epidemiological study carried out to examine medical, psychological and socioeconomic aspects of aging in Poland. The aim of this study is an epidemiological description of HF based on elderly population from the PolSenior Study, stratified by NT-pro-BNP concentration values. MATERIAL AND METHODS: The research sample included 4979 respondents (2567 males and 2412 females) split into six equally sized age groups of elderly individuals. The study consisted of three visits performed by trained nurses and included a questionnaire survey, comprehensive geriatric assessment and blood and urine sampling with more than 50 biochemical parameters measured. Serum NT-pro- BNP was measured by electrochemiluminescence method (ECLIA). RESULTS: The prevalence of chronic kidney disease (CKD) (77.8%) and atrial fibrilattion (39.5%), number of hospitalizations (23.7%) and number of patients treated with HF drugs were highest in NTproBNP>2000 pg/ml group and least frequent in NT-proBNP <400 pg/ml group. Obese patients had significantly more frequently NT-proBNP values <400pg/ml (73.0%) and less frequently NT-proBNP values >2000 pg/ml (2.8%). Age over 70 years and male gender were associated with the increased NT-pro-BNP (>400 pg/ml) (OR 1.41; CI 1.20-1.65 for male gender). CONCLUSIONS: We conclude that CKD and atrial fibrillation are associated with the occurrence of increased NT-pro-BNP, the surrogate for HF in elderly population. On contrary, overweight or obesity are associated with lower prevalence of HF in elderly.
    Experimental gerontology 06/2013; · 3.34 Impact Factor
  • A Kolonko, J Chudek, A Wiecek
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    ABSTRACT: BACKGROUND: It is generally accepted that kidneys procured from female donors may not perform optimally in male recipients, mostly due to their smaller size and nephron underdosing. Nowadays, conflicting results have been published regarding the detrimental effect of H-Y incompatibility on the long-term prognosis of male kidneys transplanted into female recipient. The aim of this study was an analysis of the impact of donor-recipient gender matching on early function and survival of grafts among a relatively homogenous cohort of kidney recipients. METHODS: We analyzed 477 consecutive first kidney transplants from deceased donors with longer than 3-month survival. Highly sensitized recipients and those with graft losses attributed to noncompliance were excluded from the study. Early kidney graft function was defined based on serum creatinine (Scr) concentrations at postoperative day 3 and the need for dialysis: immediate graft factors (IGF; Scr < 3mg/dL), slow graft function (Scr > 3mg/dL and no dialysis) or delayed graft function (DGF; dialysis in the first posttransplant week). RESULTS: The lowest 10.7% incidence of IGF was observed among male recipients of female kidneys (F-M). For female donor, the relative risk for IGF in female recipient was 3.13 (1.35-7.26) than in male recipient. The frequencies of DGF were similar. During the 5-year follow-up, 54 grafts were lost. The risk for loss was significantly higher in the F-M group: 19.6% vs 8.8% in the three other combined groups (odds ratio = 2.54; 95 confidence interval (1.41-4.59); P = .002). CONCLUSIONS: Transplantation of the female kidney to a male recipient impairs early kidney graft function increasing the risk of graft loss over a 5-year follow-up. This phenomenon seems to be related to nephron underdosing.
    Transplantation Proceedings 05/2013; 45(4):1639-1643. · 0.95 Impact Factor
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    ABSTRACT: Aim/Background: Experimental and clinical studies revealed contradictory data concerning the influence of renin-angiotensin-aldosterone (RAA) system activation on visfatin release. The aim of the present study was the assessment of the effect of dietary sodium restriction with RAA system activation on visfatin level in hypertensive and normotensive patients with visceral obesity. Methods: The study included 24 hypertensive patients with visceral obesity (12 women) and 22 normotensive subjects with visceral obesity (11 women) constituting the control group. Plasma renin activity, plasma insulin, aldosterone and visfatin levels were determined twice, on normal-salt diet after 6-8 h in recumbent position and the second time after 3 days of dietary sodium restriction and upright position for 2 h. Dietary compliance was controlled by 24 h natriuresis measurement. Results: Hypertensive patients had significantly higher plasma visfatin level than the control group [11.0 (8.5-13.5) vs. 6.8 (6.0-7.6) ng/ml, p=0.003]. Dietary sodium restriction and upright position caused significant increase in PRA and plasma aldosterone level in both groups. While, plasma visfatin level remained unaffected. In the combined group plasma visfatin levels correlated with BMI (r=0.398), waist circumference (r=0.391), glucose (r=0.328), insulin (r=0.663), HOMA-IR (r=0.698), triglycerides (r=0.500) and CRP (r=0.546) but not with percentage of fat mass, percentage of trunk fat, and blood pressure values. Conclusions: 1) Increased plasma visfatin concentration may play a significant role in the pathogenesis of hypertension in patients with visceral obesity. 2) RAA system activation by dietary sodium restriction and upright position has no effect on plasma visfatin levels in subjects with visceral obesity.
    Kidney and Blood Pressure Research 04/2013; 37(2-3):124-131. · 1.60 Impact Factor
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    ABSTRACT: Peginesatide, a synthetic peptide-based erythropoiesis-stimulating agent (ESA), is a potential therapy for anemia in patients with advanced chronic kidney disease. We conducted two randomized, controlled, open-label studies (EMERALD 1 and EMERALD 2) involving patients undergoing hemodialysis. Cardiovascular safety was evaluated by analysis of an adjudicated composite safety end point--death from any cause, stroke, myocardial infarction, or serious adverse events of congestive heart failure, unstable angina, or arrhythmia--with the use of pooled data from the two EMERALD studies and two studies involving patients not undergoing dialysis. In the EMERALD studies, 1608 patients received peginesatide once monthly or continued to receive epoetin one to three times a week, with the doses adjusted as necessary to maintain a hemoglobin level between 10.0 and 12.0 g per deciliter for 52 weeks or more. The primary efficacy end point was the mean change from the baseline hemoglobin level to the mean level during the evaluation period; noninferiority was established if the lower limit of the two-sided 95% confidence interval was -1.0 g per deciliter or higher in the comparison of peginesatide with epoetin. The aim of evaluating the composite safety end point in the pooled cohort was to exclude a hazard ratio with peginesatide relative to the comparator ESA of more than 1.3. In an analysis involving 693 patients from EMERALD 1 and 725 from EMERALD 2, peginesatide was noninferior to epoetin in maintaining hemoglobin levels (mean between-group difference, -0.15 g per deciliter; 95% confidence interval [CI], -0.30 to -0.01 in EMERALD 1; and 0.10 g per deciliter; 95% CI, -0.05 to 0.26 in EMERALD 2). The hazard ratio for the composite safety end point was 1.06 (95% CI, 0.89 to 1.26) with peginesatide relative to the comparator ESA in the four pooled studies (2591 patients) and 0.95 (95% CI, 0.77 to 1.17) in the EMERALD studies. The proportions of patients with adverse and serious adverse events were similar in the treatment groups in the EMERALD studies. The cardiovascular safety of peginesatide was similar to that of the comparator ESA in the pooled cohort. Peginesatide, administered monthly, was as effective as epoetin, administered one to three times per week, in maintaining hemoglobin levels in patients undergoing hemodialysis. (Funded by Affymax and Takeda Pharmaceutical; ClinicalTrials.gov numbers, NCT00597753 [EMERALD 1], NCT00597584 [EMERALD 2], NCT00598273 [PEARL 1], and NCT00598442 [PEARL 2].).
    New England Journal of Medicine 01/2013; 368(4):307-19. · 54.42 Impact Factor
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    New England Journal of Medicine 01/2013; 368(4):307-19. · 54.42 Impact Factor

Publication Stats

3k Citations
949.48 Total Impact Points

Institutions

  • 1998–2014
    • Medical University of Silesia in Katowice
      • Department of Nephrology, Endocrinology and Metabolic Diseases
      Catowice, Silesian Voivodeship, Poland
  • 2012
    • National Research Council
      • Institute of Clinical Physiology IFC
      Roma, Latium, Italy
  • 2011
    • Universidad Autónoma de Madrid
      Madrid, Madrid, Spain
  • 2008–2010
    • Śląskie Centrum Chorób Serca
      • Department of Cardiac Surgery and Transplantology
      Hindenburg, Silesian Voivodeship, Poland
    • Medical University of Gdansk
      • Department of Nephrology, Transplantology and Internal Medicine
      Gdańsk, Pomeranian Voivodeship, Poland
    • Azienda Ospedaliera della Provincia di Lecco
      Lecco, Lombardy, Italy
  • 2006–2010
    • Central Clinical Hospital of the Ministry of Interior in Warsaw
      Warszawa, Masovian Voivodeship, Poland
    • Cardinal Wyszynski National Institute of Cardiology
      Warszawa, Masovian Voivodeship, Poland
  • 2009
    • Ghent University
      • Department of Internal Medicine
      Gent, VLG, Belgium
  • 1994–2009
    • Silesian University of Technology
      Gleiwitz, Silesian Voivodeship, Poland
  • 2007
    • Medical University of Warsaw
      • Klinika Immunologii, Transplantologii i Chorób Wewnętrznych
      Warsaw, Masovian Voivodeship, Poland
  • 1995–2005
    • University of Silesia in Katowice
      Catowice, Silesian Voivodeship, Poland
  • 2000
    • Poznan University of Medical Sciences
      • Department of Nephrology Transplantology and Internal Medicine
      Posen, Greater Poland Voivodeship, Poland
  • 1988–1989
    • Heidelberg University
      Tiffin, Ohio, United States