Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients.

BACKGROUND: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. METHODS: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10-12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. RESULTS: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10-12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. CONCLUSION: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).

Comparison of half-dose and full-dose triple therapy regimens for Helicobacter pylori eradication in patients with end-stage renal disease.

AIM: The aim of this study was to compare the half-dose and full-dose triple therapy regimens for Helicobacter pylori (Hp) eradication in patients with end-stage renal disease. BACKGROUND: H. Pylori is one the most important causes of dyspepsia in patients with end-stage renal disease (ESRD). PATIENTS AND METHODS: Sixty-six patients with ESRD were enrolled in the study with Hp infection and peptic disease with a need of Hp eradication. Patients were randomly assigned to full-dose (A=35 patients) or half-dose group (B=31 patients). Patients received clarithromycin 500 mg, amoxicillin 1000 mg and omeprazole 20 mg twice daily in group A and clarithromycin 250 mg and amoxicillin 500 mg twice daily and omeprazole 20 mg once daily in group B for two weeks. Patients provided stool samples 4 weeks of completing study to assess the success of Hp eradication by Hp-specific stool antigen. Finally, the rate of eradication and complications were compared between two groups. RESULTS: The successful Hp eradication was achieved in 26 patients (74%) in group A and in 22 patients (74%) in group B. The difference between 2 groups was not statistically significant (p=0.973) (per protocol analysis). CONCLUSION: Half-dose triple-therapy with clarithromycin, amoxicillin and omeprazole is as effective as full-dose triple-therapy to eradicate the Hp in patients with ESRD. According to lower toxicity level, complications and cost in half-dose regimen in this subset of patients, this protocol is advised.

Incidence of chronic kidney disease and its risk factors, results of over 10 year follow up in an Iranian cohort.

To examine, the predictors of incident chronic kidney disease (CKD) in a community-based cohort of Middle East population, during a mean follow-up of 9.9 years. In a sample of 3313 non-CKD Iranian adults ≥20 years the estimated glomerular filtration rate (eGFR) was calculated at baseline and at three year intervals during three consecutive phases. The eGFR <60 mL/min/1.73 m2 was defined as CKD. Multivariate Logistic regression analysis was used to determine the independent variables associated with incident CKD. The incidence density rates of CKD were 285.3 and 132.6 per 10,000 person-year, among women and men, respectively. Female gender per se was associated with higher risk of CKD, compared with males. Among women, age, eGFR, known diabetes, being single or divorced/widowed, hypertension (marginally significant) and current smoking were independent risk factors for CKD; however the intermediate degree of education and family history of diabetes decreased the risk by 40% (P<0.05). Among male subjects, independent predictors of developing CKD included aging and hypertension (with significantly higher risk than in women, P for interaction<0.05), eGFR, new diagnosed diabetes, high normal blood pressure; abdominal obesity decreased the risk of CKD about 30% which was marginally significant. In the Iranian population,>2% of individuals develops CKD each year. Our findings confirmed that sex- specific risk predictors should be considered in primary prevention for incident CKD.

Acute effects of hemodialysis on pulmonary function in patients with end-stage renal disease.

INTRODUCTION: Despite many beneficial effects, hemodialysis may cause pulmonary dysfunction. On the other hand, patients with end-stage renal disease are potentially prone to lung edema and respiratory dysfunction. This study was conducted to evaluate the alterations of pulmonary function indicators after hemodialysis, measured by spirometry. MATERIALS AND METHODS: A total of 26 patients on hemodialysis for at least 3 months were studied. They were all older than 18 years old. None of the patients was a current or recent smoker, and none of them had a history of respiratory diseases, current or recent respiratory infections, musculoskeletal disorders, or tuberculosis. All of the patients underwent the spirometry test before and after a 4-hour hemodialysis session, and the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), vital capacity (VC), and FEV1/FVC ratio were measured. RESULTS: After hemodialysis, the FVC significantly increased (P = .02), while no significant improvement in the FEV1, VC, and FEV1/FVC ratio were observed. Gender was related to the changes in VC, with better results in women (P < .001). There was no association between the changes in spirometry parameters and age, body mass index, cause of kidney failure, type of anion used for hemodialysis, and weight changes. CONCLUSIONS: According to our results, pulmonary function, especially the FVC, improves after a session of hemodialysis.

Comparison of overall obesity and abdominal adiposity in predicting chronic kidney disease incidence among adults.

OBJECTIVE: Epidemiological data on the association between different aspects of adiposity and the risk for chronic kidney disease (CKD) in a cohort are limited. We compared the independent power of waist circumference (WC), waist-to-hip ratio (WHR), and body mass index (BMI) in predicting CKD in a large cohort of adults. DESIGN: This was a population-based cohort study. SETTING, PARTICIPANTS, AND MEASUREMENTS: A representative sample of 3107 subjects (1309 men and 1798 women), aged over 20 years, and free of CKD at baseline, was followed for 7 years. METHODS: We estimated glomerular filtration rate (GFR) by using the abbreviated equation from the Modification of Diet in Renal Disease Study, and defined CKD as an estimated GFR of less than 60 mL/min/1.73 m(2). Adjusted relative hazards of CKD were modeled using Cox proportional hazards regression, including BMI, WC, and WHR as risk factors. RESULTS: During the 7-year follow-up (median of 2183 days), 13.5% of participants (n = 419) developed CKD. The WC was positively related to risk of CKD, after multivariable adjustment for age, sex, smoking, menopause, physical activity, blood pressure, prevalent and incident diabetes, and change in WC during study period: Hazard ratios for CKD incidence were 1.00 (reference), 1.60 (95% CI: 1.06, 2.42), 1.86 (0.95 CI: 1.21, 2.85), and 1.88 (0.95 CI: 1.17, 3.01) for WC categories 1 to 4, respectively (P for trend < .02). The WHR was not independently associated with CKD. The rate of GFR decline (measured in mL/min/1.73 m(2)/year) was associated with baseline waist categories: regression coefficient for 1 SD increase in WC = -0.18 (0.95 CI:-0.28, -0.07). Based on Harrell's measure of concordance statistics, baseline WC was a better predictor of CKD than WHR (P < .05) and BMI (P < .05). CONCLUSIONS: Abdominal adiposity measured with WC, irrespective of general adiposity, is a more important determinant of CKD risk in adults than are WHR and BMI.