Comparative Efficacy and Safety Study of Darbepoetin Alfa versus Epoetin Alfa in Management of Anemia Associated with ESRD in Egyptian Hemodialysis Patients

2021 ◽  
Vol 16 ◽  
Author(s):  
Nahla E. El-Ashmawy ◽  
Eman G. Khedr ◽  
Nahla S. Kotb ◽  
Fathi Salem ◽  
Amera O. Ibrahim
Keyword(s):  
Darbepoetin Alfa ◽  
Hemoglobin Concentration ◽  
Treated Group ◽  
Hemodialysis Patients ◽  
Efficacy And Safety ◽  
Epoetin Alfa ◽  
Open Label ◽  
Reactive Protein ◽  
Egyptian Patients ◽  
Serum Crp

Background: Anemia is one of the most common complications of Chronic Kidney Disease (CKD). The vast majority of Egyptian CKD patients are interchangeably treated with Darbepoetin Alfa (DPA) and Epoetin Alfa (EPA) to achieve and maintain target hemoglobin levels. Our study aimed to compare the efficacy and safety of DPA versus EPA for managing anemia amongst Egyptian patients with CKD undergoing dialysis. Methods: A multicenter, open label, randomized, prospective, parallel study was conducted. Patients with CKD undergoing dialysis with Hb level <10 g/dl were enrolled. The primary efficacy endpoint was the change in hemoglobin concentration at the evaluation period (weeks 20-24). Pre-specified adverse events of interest following administration, including blood transfusions requirement, blood pressure and hemoglobin excursions, the relationship between C - Reactive Protein (CRP) and hemoglobin, were assessed. Findings:: Only 98 of 104 enrolled patients completed the study, fifty patients received EPA, and 48 patients received DPA. Our results showed that a significantly higher percentage of patients who achieved target Hb level ≥ 11 g/dL in DPA treated group vs. EPA as well as the meantime to achieve Hb level ≥ 10 g/dL was shorter in DPA treated group. Safety profiles of both treatments were similar. A negative correlation was observed between serum CRP and hemoglobin level in hemodialysis patients. Conclusion: Our study showed that DPA was more effective and well tolerated in achieving and maintaining Hb levels with lower dosing frequency compared to EPA. Furthermore, CRP is recommended to be routinely measured where patients with higher CRP require high ESA doses.

Intraperitoneal Administration of Recombinant Human Erythropoietin

1992 ◽  
Vol 12 (4) ◽  
pp. 378-383 ◽  
Author(s):  
Leon A.M. Frenken ◽  
Dirk G. Struijk ◽  
Peter J.W. Coppens ◽  
Roland G.W.L. Tiggeler ◽  
Raymond T. Krediet ◽  
...  
Keyword(s):  
Recombinant Human Erythropoietin ◽  
Intraperitoneal Administration ◽  
Subcutaneous Administration ◽  
Hemoglobin Concentration ◽  
Treated Group ◽  
Efficacy And Safety ◽  
University Hospitals ◽  
Safe Alternative ◽  
Human Erythropoietin ◽  
Dialysis Solution

Objective To determine the efficacy and safety of intraperitoneal administration of recombinant human erythropoietin (rHuEPO) in continuous ambulatory peritoneal dialysis (CAPD) patients compared to subcutaneous rHuEPO. Design Prospective analysis of an open, nonrandomized investigation. Setting Outpatient CAPD clinics in two university hospitals. Patients Nine adult CAPD patients receiving rHuEPO intraperitoneally and 8 patients receiving rHuEPO sub-cutaneously. Intervention One hundred units of rHuEPO per kilogram of body weight were administered three times a week for 8 weeks or until the target hematocrit of 35% was reached. Thereafter, dosages of rHuEPO were adjusted for response. Intraperitoneal rHuEPO was administered in 1 L of dialysis solution during the night. Measurements Efficacy was assessed by measuring the increase in hemoglobin. Tolerance was assessed by monitoring side effects. Results In the first 8 weeks of treatment hemoglobin concentration increased from 64.5±12.9 glL to 98.3±16.1 g/L (p<0.0005) in the intra peritoneally treated group. In the subcutaneously treated group hemoglobin increased significantlyfaster (p<0.05) from 72.5±4.8 g/L to 119.2±11.3 g/L (p<0.0005) in the same period. Antihypertensive medication had to be increased or instituted in most of the patients in both groups. The incidence of peritonitis in the intraperitoneally treated group was not increased when compared to the pretreatment incidence. Conclusions Subcutaneously administered rHuEPO is superior to intraperitoneally administered rHuEPO with regard to the required dosages. However, the results of this study show that intraperitoneal administration of rHuEPO might be a convenient and safe alternative when subcutaneous administration is undesirable.

scholarly journals Efficacy and safety of bimekizumab as add-on therapy for rheumatoid arthritis in patients with inadequate response to certolizumab pegol: a proof-of-concept study

2019 ◽  
Vol 78 (8) ◽  
pp. 1033-1040 ◽  
Author(s):  
Sophie Glatt ◽  
Peter C Taylor ◽  
Iain B McInnes ◽  
Georg Schett ◽  
Robert Landewé ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Certolizumab Pegol ◽  
Inadequate Response ◽  
Proof Of Concept ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Reactive Protein ◽  
Dual Inhibition

ObjectiveEvaluate the efficacy and safety of dual neutralisation of interleukin (IL)-17A and IL-17F with bimekizumab, a monoclonal IgG1 antibody, in addition to certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) and inadequate response (IR) to certolizumab pegol.MethodsDuring this phase 2a, double-blind, proof-of-concept (PoC) study (NCT02430909), patients with moderate-to-severe RA received open-label CZP 400 mg at Weeks 0, 2 and 4, and 200 mg at Week 6. Patients with IR at Week 8 (Disease Activity Score 28-joint count C-reactive protein (DAS28(CRP))>3.2) were randomised 2:1 to CZP (200 mg every 2 weeks (Q2W)) plus bimekizumab (240 mg loading dose then 120 mg Q2W) or CZP plus placebo. The primary efficacy and safety variables were change in DAS28(CRP) between Weeks 8 and 20 and incidence of treatment-emergent adverse events (TEAEs).ResultsOf 159 patients enrolled, 79 had IR at Week 8 and were randomised to CZP plus bimekizumab (n=52) or CZP plus placebo (n=27). At Week 20, there was a greater reduction in DAS28(CRP) in the CZP-IR plus bimekizumab group compared with the CZP-IR plus placebo group (99.4% posterior probability). The most frequent TEAEs were infections and infestations (CZP plus bimekizumab, 50.0% (26/52); CZP plus placebo, 22.2% (6/27)).ConclusionsPoC was confirmed based on the rapid decrease in disease activity achieved with 12 weeks of CZP plus bimekizumab. No unexpected or new safety signals were identified when neutralising IL-17A and IL-17F in patients with RA concomitantly treated with CZP, but the rate of TEAEs was higher with dual inhibition.

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

2018 ◽  
Vol 48 (4) ◽  
pp. 251-259 ◽  
Author(s):  
Jalal Azmandian ◽  
Mohammad Reza Abbasi ◽  
Vahid Pourfarziani ◽  
Amir Ahmad Nasiri ◽  
Shahrzad Ossareh ◽  
...  
Keyword(s):  
Body Weight ◽  
Hemodialysis Patients ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Epoetin Alfa ◽  
Double Blind ◽  
Epoetin Beta ◽  
Significant Difference ◽  
The Mean ◽  
Stage Renal Disease

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).

Alpha Lipoic Acid Reduces Symptoms and Inflammation Biomarkers in Patients with Chronic Hemorrhoidal Illness

2018 ◽  
Vol 88 (5-6) ◽  
pp. 281-290
Author(s):  
Marizela Šabanović ◽  
Midhat Jašić ◽  
Amer Odobašić ◽  
Emilija Spaseska Aleksovska ◽  
Suzana Pavljašević ◽  
...  
Keyword(s):  
Lipoic Acid ◽  
Hemorrhoidal Disease ◽  
Control Group ◽  
Alpha Lipoic Acid ◽  
Open Label ◽  
Double Blind ◽  
Treatment Regimens ◽  
Reactive Protein ◽  
Number Of Patients ◽  
Serum Crp

Abstract. Background: Oral dietary supplementation is becoming increasingly popular as an addition to classical approaches for the prevention and treatment of hemorrhoidal disease. Aim: To examine the effect of orally administrated alpha lipoic acid (ALA), known for its antioxidant and anti-inflammatory properties, in the treatment of patients with permanent symptoms of hemorrhoidal disease. Methods: Patients with second- and third-degree hemorrhoids (n = 100) were enrolled into a randomized, open label, single-center trial. The study group (n = 50) was treated with 200 mg of orally administered ALA once a day during the 12-week period, the control group (n = 50) did not receive any treatment. Results: There were no significant differences in demographics, diagnosis, or exposure to major risk factors between the study and placebo group at baseline. ALA significantly improved subjective efficacy variables, such as pain and discomfort (p < 0.01) as well as objective signs of the disease, such as bleeding (p < 0.01), in comparison to the control group. Furthermore, the 3-month treatment significantly reduced the number of patients with positive C-reactive protein (CRP) value (serum CRP > 5 mg/L) from 18% before to only 2% after the treatment (χ2 = 4.65; p < 0.01). Average leukocyte count has also been significantly reduced in the treatment group (p < 0.01) from 7.29 × 109/L before to 6.18 × 109/L after treatment. Conclusions: The obtained results indicate that ALA is effective in the treatment of second- and third-degree hemorrhoids. Larger, double-blind controlled trials are needed to confirm the results and to investigate optimal treatment regimens.

Efficacy and Safety of Every‐2‐Week Darbepoetin Alfa in Patients with Anemia of Cancer: A Controlled, Randomized, Open‐Label Phase II Trial

2007 ◽  
Vol 12 (6) ◽  
pp. 727-737 ◽  
Author(s):  
Veena Charu ◽  
Chandra P. Belani ◽  
Ahmad N. Gill ◽  
Mukesh Bhatt ◽  
Dianne Tomita ◽  
...  
Keyword(s):  
Phase Ii ◽  
Darbepoetin Alfa ◽  
Phase Ii Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Phase

scholarly journals Dalbavancin for the Treatment of Osteomyelitis in Adult Patients: A Randomized Clinical Trial of Efficacy and Safety

2018 ◽  
Vol 6 (1) ◽  
Author(s):  
Urania Rappo ◽  
Sailaja Puttagunta ◽  
Vadym Shevchenko ◽  
Alena Shevchenko ◽  
Alena Jandourek ◽  
...  
Keyword(s):  
Clinical Response ◽  
Dose Regimen ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Standard Of Care ◽  
First Episode ◽  
Efficacy And Safety ◽  
Open Label ◽  
Reactive Protein ◽  
Radiologic Findings

Abstract Background Osteomyelitis is a challenging infection that can involve 4–6 weeks of intravenous (IV) antibiotics. Dalbavancin, approved for acute bacterial skin and skin structure infections, has potent activity against gram-positive pathogens. This study assessed the efficacy and safety of dalbavancin as a 2-dose regimen for osteomyelitis. Methods This study was a randomized, open-label, comparator-controlled trial in adults with a first episode of osteomyelitis defined by clinical symptoms, radiologic findings, and elevated C-reactive protein. Patients were randomized 7:1 to dalbavancin (1500 mg IV on days 1 and 8) or standard of care (SOC) for osteomyelitis (oral or IV) per investigator judgment for 4–6 weeks. The primary endpoint was clinical response at day 42, defined as recovery without need for additional antibiotics in the clinically evaluable (CE) population. Clinical response was also assessed at day 21, 6 months, and 1 year. Results Eighty patients were randomized to dalbavancin (n = 70) or SOC (n = 10). All had baseline debridement; Staphylococcus aureus was the most common pathogen (60% of patients). Clinical cure at day 42 was seen in 65/67 (97%) and 7/8 (88%) patients in the dalbavancin group and SOC group in the CE population, respectively. Clinical response was similar in the dalbavancin group at day 21 (94%), 6 months, and 1 year (96%). Treatment-emergent adverse events occurred in 10 patients in the dalbavancin group; no patient discontinued treatment due to an adverse event. Conclusions A 2-dose regimen of weekly dalbavancin is effective and well tolerated for the treatment of osteomyelitis in adults. Clinical Trials Registration NCT02685033.

Clinical Outcomes Associated with Conversion from Epoetin alfa to Darbepoetin alfa in Hospitalized Hemodialysis Patients

2006 ◽  
Vol 26 (6) ◽  
pp. 571-578 ◽  
Author(s):  
Erdal Sarac ◽  
Anand Chikyarappa ◽  
Brian Sabol ◽  
David Gemmel ◽  
Denise Globe ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Darbepoetin Alfa ◽  
Hemodialysis Patients ◽  
Epoetin Alfa
Sign in / Sign up

Export Citation Format

Share Document