Subcutaneous CERA for the treatment of chronic renal anemia in predialysis patients

Background: We investigated the efficacy, safety and tolerability of once-monthly administration of C.E.R.A. in erythropoiesis stimulating agents (ESAs) naive predialysis patients with CKD for anemia treatmentStudy Design: Single arm, open label study.Methods: A total of 75 patients (mean (SD) age was 52.8 (16.4) years, 76.0% were female) were included in this study conducted between 12 August 2008 and 30 October 2009 in 9 centers across Turkey. The mean change in Hb concentration (g/dL) between baseline (week 0) and the efficacy evaluation period (EEP) was the primary efficacy parameter evaluated in three consecutive periods including a dose titration period (DTP; with initial 1.2 mu g/kg dose of C.E.R.A., subcutaneously, 28 weeks), EEP (8 weeks) and a long-term safety period (16 weeks).Results: Our analysis revealed an improvement in Hb levels from baseline value of 9.4 (0.4) g/dL to time adjusted average level of 11.4 (0.7) g/dL in EEP in the per protocol (PP) population and from 9.3 (0.5) g/dL to 11.1 (1.0) g/dL in intent-to-treat (ITT) population. Mean (SD) change in Hb levels from baseline to EEP was 2.0 (0.7) g/dl in the PP population (primary endpoint) and 1.7 (1.1) g/dL in the ITT population. The percentage of patients whose Hb concentrations remained within the target range of 10.0-12.0 g/dL throughout the EEP was 43.9% (95% CI: 28.5-60.3%) in the PP population and 38.7% (95% CI: 27.6% to 50.6%) in the ITP population. A total of 206 adverse events (AE) were reported in 77.0% of patients with hypertension (20%) as the most frequent AE.Conclusion: Once-monthly subcutaneous C.E.R.A. administration is effective and safe in the treatment of anemia in pre-dialysis patients with CKD, who are not currently treated with ESAs

The assessment of P-wave dispersion and myocardial repolarization parameters in patients with chronic kidney disease

PubMed ID: 29285964OBJECTIVE: The risks of sudden death and cardiac arrhythmia are increased in patients with chronic kidney disease (CKD). Here, we aimed to evaluate the indicators of arrhythmias, such as p-wave dispersion (P-WD), QTc dispersion, Tp-e and Tp-e/QT ratio in patients with CKD stages 3-5 on no renal replacement therapy (RRT).MATERIAL AND METHODS: One-hundred and thirty three patients with CKD stages 3-5 and 32 healthy controls were enrolled into the study. No patients received RRT. QTc dispersion, P-WD and Tp-e interval were measured using electrocardiogram and Tp-e/QT ratio was also calculated.RESULTS: Mean age rates were found similar in patients and controls (60.8?±?14.2 and 61?±?12.9?y, p?=?.937, respectively). Compared patients with controls, P-WD (45.85?±?12.42 vs. 21.17?±?6.6?msec, p?<?.001), QTc-min (366.99?±?42.31 vs. 387.15?±?20.5?msec, p?<?.001), QTc dispersion (71.13?±?27.95 vs. 41.25?±?14.55?msec, p?<?.001), Tp-e maximum (81.04?±?10.34 vs. 75.49?±?10.9?msec, p?<?.001), Tp-e minimum (62.25?±?7.58 vs. 54.8?±?6.72?msec, p?<?.001) and Tp-e/QTc ratio (0.19?±?0.02 vs. 0.18?±?0.01, p?=?.001) were found to be different. QTc-max and Tp-e interval were found to be similar in both groups.CONCLUSION: P-WD and QTc dispersion, Tp-e interval and Tp-e/QTc ratio were found to be increased in with CKD stages 3-5 on no RRT

Quality of life in male hemodialysis patients - Role of erectile dysfunction

Background: Health-related quality of life (QOL) is affected in hemodialysis patients (HD). A number of factors such as age, anemia, and comorbidity had been implicated in decreased QOL. Erectile dysfunction (ED) is a frequent and potentially treatable complication in HD patients. In this cross-sectional study, we aimed to evaluate the possible relation between the QOL and ED in HD patients. Patients and Methods: Among the 511 chronic HD patients dialyzed in 11 outpatient HD centers, 148 male patients (mean age: 46 +/- 9 years) were included. The mean time on dialysis was 41 +/- 35 months (range: 3-203 months). Biochemical parameters such as BUN, creatinine, hemoglobin, serum albumin and Kt/V were measured. The QOL of the patients were measured with the short form of Medical Outcomes Study (SF-36), physical component scores (PCS) and mental component scores (MCS) were calculated. The ED was evaluated by the International Index of Erectile Function (IIEF). Results: One hundred and four of the 148 patients (70%) had ED. Hemoglobin levels were correlated with PCS (r = 0.197, p = 0.02) and MCS (r = 0.20, p = 0.019). Patients with ED had lower scores in nearly all the components related to PCS and MCS as compared to patients without ED. IIEF score was correlated with PCS (r = 0.369, p < 0.001) and MCS (r = 0.308, p < 0.001). In linear regression analysis, IIEF score and hemoglobin levels were the independent variables that predicted both PCM and MCS. Conclusion: ED, a frequent complication in HD patients, was related to QOL together with anemia. Successful treatment of ED and anemia may lead to improvement in QOL in HD patients. Copyright (C) 2004 S. Karger AG, Basel

Ambulatory blood pressure monitoring in haemodialysis and continuous ambulatory peritoneal dialysis (CAPD) patients

The aim of this study was to compare the results of the 44-h ambulatory blood pressure monitoring (ABPM) data between haemodialysis (HDp) and CAPD patients and to investigate the relation of circadian rhythm in blood pressure (BP) with development of left ventricular hypertrophy. Twenty-two HDp (11 male, 11 female, mean age: 50 +/- 17 years) and 24 CAPDp (11 male, 13 female, mean age: 47 +/- 15 years) were included. Echocardiographic measurements and ABPM were performed in all study groups. ABPM of the first and second days were analysed separately and compared with CAPDp. Left ventricular hypertrophy was detected in 17 of the 22 HDp (77%) and 17 of the 24 CAPDp (71%). There was no significant differences between HD and CAPDp in respect to 44-h, daytime and night-time systolic and diastolic BP values. Although the course of BP in CAPDp was stable during the 44-h period, systolic and diastolic BP levels on the second day were significantly higher than those of on the first day in HDp (P < 0.001 for both). Daytime systolic and diastolic BP levels on the first day in HD group were recorded lower than those of the CAPD group. On the second day, night-time BP readings (both systolic and diastolic BP) were measured significantly higher in the HD group compared with the CAPD group. Twenty-one of the 24 (88%) CAPD patients were dippers, whereas only four of the 22 (18%) HDp were dippers (P < 0.001). Dipper patients had significantly lower left ventricular mass index (LVMI) than nondipper patients (131 +/- 29 g/m(2) vs 153 +/- 40 g/m(2), P = 0.03). In 44-h ABPM, there were no differences in daytime and night-time systolic and diastolic blood pressures between HD and CAPD patients. Non-dipper patients had increased LVMI as compared with dipper patients. Abnormalities in circadian rhythm of the blood pressure might be one of the implicated factors for development of left ventricular hypertrophy

Lower erythropoietin and iron supplementation are required in hemodialysis patients with hepatitis C virus infection

Background: Chronic hepatitis C virus (HCV) infection is a common infectious agent in chronic hemodialysis (HD) patients. In this prospective case-control study, we aimed to investigate the influence of chronic HCV infection on erythropoietin (EPO) and iron requirement in HD patients. Patients and methods: 49 HD patients (24 male, 25 female, mean age 47 +/- 15 years) were included. The mean time spent on dialysis was 39 +/- 38 months, and follow-up time was 1 year for this study. Biochemical analyses and complete blood counts together with iron status of the patients (transferrin saturation and serum ferritin levels) were measured monthly. Highly sensitive C-reactive protein (hs-CRP) levels were measured within 3-month intervals. Endogenous EPO levels were measured by enzyme-linked immunoassay 2 weeks after cessation of EPO treatment. Results: Eleven of the HD patients (22%) were anti-HCV(+). There was no difference in age, sex, time on dialysis, distribution of primary renal diseases, predialytic BUN, Kt/V, albumin and i-PTH levels between HCV(+) and (-) patients. Anti-HCV-positive patients required significantly lower weekly doses of EPO (87 +/- 25 IU/kg vs 129 +/- 11 IU/kg, p = 0.042) and iron (16.8 +/- 12.2 mg vs 32.6 +/- 16.1 mg, p = 0.02) replacement than anti-HCV(-) group; hs-CRP levels were similar between study groups. Serum endogenous EPO levels were significantly higher in HCV(+) patients than HCV(-) HD patients (9.43 +/- 6.47 mU/ml vs 3.59 +/- 2.08 mU/ml, p = 0.008). Conclusion: Anti-HCV(+) HD patients had higher serum EPO levels and required less EPO and iron replacement as compared to anti-HCV(-) patients. Because of the changes in iron metabolism, iron treatment should be carefully administered in HD patients with HCV

The association of peritoneal transport properties with 24-hour blood pressure levels in CAPD patients

Objectives: We aimed to investigate the effects of peritoneal transport characteristics on blood pressure (BP) parameters, measured by 24-hour ambulatory blood pressure monitoring (ABPM), and on the development of left ventricular hypertrophy (LVH) in continuous ambulatory peritoneal dialysis (CAPD) patients

Erectile dysfunction and the effects of sildenafil treatment in patients on haemodialysis and continuous ambulatory peritoneal dialysis

Background. Sexual dysfunction, including erectile dysfunction, is common in patients with uraemia. Despite successful treatment of male sexual dysfunction with sildenafil in non-uraemic population, its efficacy in dialysis patients is unknown. Patients and methods. In this study, 35 male HD patients (mean age 48±12 years) and 15 male CAPD patients (mean age 44±12 years) were included. In the baseline period, haemoglobin, serum urea, and albumin, Kt/V, several hormonal parameters, Beck depression scale, and penile Doppler blood flow, (peak systolic velocity after intracavernous papaverine administration) were measured. The international index of erectile function (IIEF) form was used to evaluate erectile dysfunction. Sildenafil was given to patients with erectile dysfunction at a dose of 50-100 mg/day twice a week. Results. The percentage of erectile dysfunction was similar between patients on HD (71%) and those on CAPD (80%). Patients with erectile dysfunction were significantly older and had lower free-testosterone serum levels and penile blood flow than those without. In linear regression analysis for baseline IIEF score, penile blood flow was the only independent variable associated with erectile dysfunction. IIEF score increased to a similar extent after sildenafil treatment in both HD patients (from 8.10±5.54 to 21.70±9.61, P < 0.001) and CAPD patients (from 9.90±3.87 to 21.60±10.18, P = 0.011). Changes in IIEF scores after sildenafil treatment were associated with baseline penile blood flow as an independent variable by linear regression analysis. Adverse events observed during sildenafil treatment were dyspepsia in two patients and headache in one patient. Conclusion. The rate of erectile dysfunction is high in dialysis patients. Penile blood flow is the most important factor for predicting both the development of erectile dysfunction and the response to sildenafil therapy in such patients. Oral sildenafil is an effective, reliable, well-tolerated treatment for uraemic patients with erectile dysfunction

Sleep quality, depression, and quality of life in elderly hemodialysis patients

Kultigin Turkmen,1 Fatih Mehmet Erdur,1 Ibrahim Guney,2 Abduzhappar Gaipov,1 Faruk Turgut,3 Lutfullah Altintepe,2 Mustafa Saglam,1 Halil Zeki Tonbul,1 Emaad M Abdel-Rahman41Division of Nephrology, Meram School of Medicine, Necmettin Erbakan University, Meram, Konya, Turkey; 2Division of Nephrology, Meram Research and Training Hospital, Meram, Konya, Turkey; 3Division of Nephrology, Iskenderun State Hospital, Iskenderun, Hatay, Turkey; 4Division of Nephrology, University of Virginia Health System, Charlottesville, VA, USAObjective: Both the incidence and the prevalence of end-stage renal disease (ESRD) in elderly patients are increasing worldwide. Elderly ESRD patients have been found to be more prone to depression than the general population. There are many studies that have addressed the relationship between sleep quality (SQ), depression, and health related quality of life (HRQoL) in ESRD patients, but previous studies have not confirmed the association in elderly hemodialysis (HD) patients. Therefore, the aim of the present study was to demonstrate this relationship in elderly HD patients.Patients and methods: Sixty-three elderly HD patients (32 females and 31 males aged between 65 and 89 years) were included in this cross-sectional study. A modified Post-Sleep Inventory (PSI), the Medical Outcomes Study 36-item short form health survey, and the Beck Depression Inventory (BDI) were applied.Results: The prevalence of poor sleepers (those with a PSI total sleep score [PSI-4 score] of 4 or higher) was 71% (45/63), and the prevalence of depression was 25% (16/63). Of the 45 poor sleepers, 15 had depression, defined as a BDI score of 17 or higher. Poor sleepers had a significantly higher rate of diabetes mellitus (P = 0.03), significantly higher total BDI scores, and lower Physical Component Scale scores (ie, lower HRQoL) than good sleepers. The PSI-4 score correlated negatively with Physical Component Scale (r = &amp;minus;0.500, P &amp;lt; 0.001) and Mental Component Scale scores (r = &amp;minus;0.527, P &amp;lt; 0.001) and it correlated positively with the BDI score (r = 0.606, P &amp;lt; 0.001). In multivariate analysis, independent variables of PSI-4 score were BDI score (beta value [&amp;beta;] = 0.350, P &amp;lt; 0.001), Mental Component Scale score (&amp;beta; = &amp;minus;0.291, P &amp;lt; 0.001), and age (&amp;beta; = 0.114, P = 0.035).Conclusion: Poor SQ is a very common issue and is associated with both depression and lower HRQoL in elderly HD patients.Keywords: health-related quality of life, end-stage renal disease, poor sleep quality, Post-Sleep Inventory, Beck Depression Inventor

Treatment with antidepressive drugs improved quality of life in chronic hemodialysis patients

Background: Despite some improvements in dialysis therapies, depression still remains an important problem in chronic hemodialysis (HD) patients. In this study, we aimed to investigate the association of depression and its treatment with quality of life (QOL) in HD patients. Patients and methods: 97 HD patients (52 male, 45 female, mean age 55 16 years) were enrolled. All patients had been dialyzed for more than 6 months. In order to evaluate QOL of the patients, a short form of Medical Outcomes Study (SF-36) was used. Depression was assessed by using Beck Depression Inventory (BDI). Patients who had BDI score >= 15 were diagnosed as to have depression. Patients with depression received antidepressive treatment (sertralin HCl, 50 mg/day) for an 8-week period. After 8-week antidepressive treatment, all biochemical analysis, SF-36 and BDI were performed again. Results: 40 patients (20 male, 20 female, mean age 56 +/- 14 years) had depression. All parameters related to QOL were significantly decreased in patients with depression as compared to patients without depression. Severity of depression was correlated with QOL parameters. After 8 weeks of treatment, as parallel to changes in BDI, QOL parameters improved in patients with depression. Conclusion: Decrease in QOL, associated with depression and antidepressive treatment, improves QOL in HD patients. Hemodialysis patients should be followed-up closely for presence of depression. Treatment of depression with antidepressive drug regimen would lead to relieve the symptoms related to depression,and improvement of QOL in these patients. Antidepressive treatment should be required more often than we prescribe in routine clinical practice now