scholarly journals A Comparison of the Safety and Efficacy of HX575 (Epoetin Alfa Proposed Biosimilar) with Epoetin Alfa in Patients with End-Stage Renal Disease

2017 ◽  
Vol 46 (5) ◽  
pp. 364-370 ◽  
Author(s):  
Matthew R. Weir ◽  
Pablo E. Pergola ◽  
Rajiv  Agarwal ◽  
Jeffrey C. Fink ◽  
Nelson P. Kopyt ◽  
...  
Keyword(s):  
Renal Disease ◽  
End Stage Renal Disease ◽  
Epoetin Alfa ◽  
Dialysis Patients ◽  
Double Blind ◽  
Evaluation Period ◽  
Absolute Change ◽  
Stage Renal Disease ◽  
End Stage ◽  
Hb Concentration

Background: HX575 (biosimilar epoetin alfa) was approved in Europe in 2007 for the treatment of chronic kidney disease (CKD)-related anemia. This study assessed the clinical equivalence of HX575 with the US-licensed reference epoetin alfa (Epogen®/Procrit®, Amgen/Janssen) following subcutaneous (SC) administration in dialysis patients with CKD-related anemia. Methods: This randomized, double-blind, parallel-group, multicenter study (NCT01693029) was conducted at 49 US clinical sites. Eligible patients were aged ≥18 years, had end-stage renal disease, were on hemodialysis or peritoneal dialysis for ≥6 months (or ≥12 months in the case of a failed kidney transplant), and were receiving treatment with stable SC doses of epoetin alfa. Eligible patients also had mean hemoglobin (Hb) concentration between 9.0 and 11.5 g/dL during the screening period. The primary endpoint was the mean absolute change in Hb concentration between the screening/baseline period (week-4 to week-1) and the evaluation period (weeks 21 to 28). Results: Hb values at the end of the evaluation period and the Hb change from baseline to evaluation period were similar between treatment groups. The estimated difference between groups in mean absolute change in Hb concentration was –0.093 g/dL, with 90% CI (–0.23 to 0.04) entirely within the pre-specified equivalence limits (–0.5 to 0.5 g/dL). The safety profile of each medicine was similar and as expected in dialysis patients, and neither method of treatment led to the development of neutralizing, clinically relevant antibodies. Conclusions: SC HX575 in dialysis patients with renal anemia was therapeutically equivalent to the reference medicine in terms of maintaining stable Hb levels and safety.

scholarly journals Investigation of the Impact of Endodontic Therapy on Survival among Dialysis Patients in Taiwan: A Nationwide Population-Based Cohort Study

2021 ◽  
Vol 18 (1) ◽  
pp. 326
Author(s):  
Chih-Chien Chiu ◽  
Ya-Chieh Chang ◽  
Ren-Yeong Huang ◽  
Jenq-Shyong Chan ◽  
Chi-Hsiang Chung ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Renal Disease ◽  
End Stage Renal Disease ◽  
Root Canal ◽  
Dialysis Patients ◽  
Root Canal Therapy ◽  
Risk Of Death ◽  
Stage Renal Disease ◽  
End Stage

Objectives Dental problems occur widely in patients with chronic kidney disease (CKD) and may increase comorbidities. Root canal therapy (RCT) is a common procedure for advanced decayed caries with pulp inflammation and root canals. However, end-stage renal disease (ESRD) patients are considered to have a higher risk of potentially life-threatening infections after treatment and might fail to receive satisfactory dental care such as RCT. We investigated whether appropriate intervention for dental problems had a potential impact among dialysis patients. Design Men and women who began maintenance dialysis (hemodialysis or peritoneal dialysis) between January 1, 2000, and December 31, 2015, in Taiwan (total 12,454 patients) were enrolled in this study. Participants were followed up from the first reported dialysis date to the date of death or end of dialysis by December 31, 2015. Setting Data collection was conducted in Taiwan. Results A total of 2633 and 9821 patients were classified into the RCT and non-RCT groups, respectively. From the data of Taiwan’s National Health Insurance, a total of 5,092,734 teeth received RCT from 2000 to 2015. Then, a total of 12,454 patients were followed within the 16 years, and 4030 patients passed away. The results showed that members of the non-RCT group (34.93%) had a higher mortality rate than those of the RCT group (22.79%; p = 0.001). The multivariate-adjusted hazard ratio for the risk of death was 0.69 (RCT vs. non-RCT; p = 0.001). Conclusions This study suggested that patients who had received RCT had a relatively lower risk of death among dialysis patients. Infectious diseases had a significant role in mortality among dialysis patients with non-RCT. Appropriate interventions for dental problems may increase survival among dialysis patients. Abbreviations: CKD = chronic kidney disease, ESRD = end-stage renal disease, RCT = root canal therapy.

scholarly journals Dyslipidemia in End Stage Renal Disease: A Study on Dialysis Patients in Bangabandhu Sheikh Mujib Medical University Bangladesh

KYAMC Journal ◽  
2020 ◽  
Vol 11 (3) ◽  
pp. 113-117
Author(s):  
Salahuddin Feroz ◽  
Shah Md Zakir Hossain ◽  
Rafi Nazrul Islam ◽  
Amir Mohammad Kaiser ◽  
Miliva Mozaffor ◽  
...  
Keyword(s):  
Renal Disease ◽  
End Stage Renal Disease ◽  
Hdl Cholesterol ◽  
Dialysis Patients ◽  
Ckd Stage ◽  
Group A ◽  
Group B ◽  
Stage Renal Disease ◽  
End Stage ◽  
Medical University

Background: Dyslipidemia contributes to the high cardiovascular risk in end stage renal disease (ESRD) or in dialysis patients; however, it remains an underestimated problem. Objective: To see the extent of dyslipidemia in patients of end stage renal disease i.e. chronic kidney disease (CKD) stage 5 who underwent hemodialysis or peritoneal dialysis procedure. Materials and Methods: This cross-sectional study was conducted from September 2016 to March 2018 Bangabandhu Sheikh Mujib Medical University (BSMMU) on 55 CKD (stage 5) patients where 31 in hemodialysis (HD) (group A) and 24 in continuous ambulatory peritoneal dialysis (CAPD) (group B). Serum lipid profile was estimated in both groups by using the standard laboratory technique. Results: Dialysis adequacy (Kt/V) was found 1.46 for HD patients (group A) and 1.81 for CAPD patients (group B).All serum lipids were higher in amount in CAPD patients than HD patients-total cholesterol (222.3±24.2 mg/dl vs. 198.9±28.4 mg/dl; p<0.05), triglycerides (179.6±24.7 mg/dl vs. 176.6±24.4 mg/dl; p<0.05), HDL cholesterol (40.8±3.90 mg/dl vs. 38.5±4.95 mg/dl; p>0.05) and LDL cholesterol (145.5±22.1 mg/dl vs. 123.2±26.5 mg/dl; p<0.05). Besides, dyslipidemia was more evident in CAPD patients than HD patients, as per raised serum total cholesterol (83.33% vs. 70.97%), raised triglycerides (95.83% vs. 83.87%), raised LDL (100% vs. 77.42%) and lowering of HDL cholesterol (87.5% vs. 80.65%) were found more in group B in comparison to group A. Conclusion: Dyslipidemic risk factors are highly evident in dialysis patients and the extent of dyslipidemia is observed more in CAPD than HD patients. KYAMC Journal Vol. 11, No.-3, October 2020, Page 113-117

Role of vitamin D in oxidative stress modulation in end‐stage renal disease patients: A double‐blind randomized clinical trial

2020 ◽  
Vol 24 (3) ◽  
pp. 367-373
Author(s):  
Leila Malekmakan ◽  
Zeinab Karimi ◽  
Afshin Mansourian ◽  
Maryam Pakfetrat ◽  
Jamshid Roozbeh ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Clinical Trial ◽  
Vitamin D ◽  
Renal Disease ◽  
Randomized Clinical Trial ◽  
End Stage Renal Disease ◽  
Double Blind ◽  
Stage Renal Disease ◽  
End Stage

Incidence and risk factors for HPV-associated cancers in women with end-stage renal disease

2020 ◽  
Vol 68 (5) ◽  
pp. 1002-1010
Author(s):  
Joan Han ◽  
Jennifer L Waller ◽  
Rhonda E Colombo ◽  
Vanessa Spearman ◽  
Lufei Young ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cervical Cancer ◽  
General Population ◽  
Renal Disease ◽  
End Stage Renal Disease ◽  
Dialysis Patients ◽  
Herpes Infection ◽  
Factors Associated ◽  
Stage Renal Disease ◽  
End Stage

Human papillomavirus (HPV) causes the majority of cervical, anal/rectal, and oropharyngeal cancers in women. End-stage renal disease (ESRD) is also associated with an increased risk of malignancy, but the incidence of and risk factors for HPV-associated cancers in US dialysis patients are not defined. We queried the US Renal Data System for women with HPV-associated cancers and assessed for incidence of cancer diagnosis and association of risk factors. From 2005 to 2011, a total of 1032 female patients with ESRD had 1040 HPV-associated cancer diagnoses. Patients had a mean age of 65 years, were mostly white (63%), and on hemodialysis (92%). Cervical cancer (54%) was the most common, followed by anal/rectal (34%), and oropharyngeal (12%). The incidence of HPV-associated cancers in patients with ESRD increased yearly, with up to a 16-fold increased incidence compared with the general population. Major risk factors associated with the development of any HPV-associated cancer included smoking (adjusted relative risk=1.89), alcohol use (1.87), HIV (2.21), and herpes infection (2.02). Smoking, HIV, and herpes infection were prominent risk factors for cervical cancer. The incidence of HPV-associated cancers in women with ESRD is rising annually and is overall higher than in women of the general population. Tobacco use is a universal risk factor. For cervical cancer, the presence of HIV and herpes are important comorbidities. Recognizing risk factors associated with these cancers may improve diagnosis and facilitate survival. The role of HPV vaccination in at-risk dialysis patients remains to be defined but warrants further study.

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