scholarly journals Efficacy and safety of subcutaneous administration of lyophilized powder of alfa-erythropoietin to maintain hemoglobin concentrations among hemodialysis patients

2017 ◽  
Vol Volume 10 ◽  
pp. 275-283
Author(s):  
Bancha Satirapoj ◽  
Rattanawan Dispan ◽  
Ouppatham Supasyndh
2019 ◽  
Vol 52 (7) ◽  
pp. 443-450
Author(s):  
Chie Ogawa ◽  
Ken Tsuchiya ◽  
Kunimi Maeda

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 ◽  
...  

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.


Nanomaterials ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. 802 ◽  
Author(s):  
Yuki Maeda ◽  
Keiichi Motoyama ◽  
Rena Nishiyama ◽  
Taishi Higashi ◽  
Risako Onodera ◽  
...  

Niemann-Pick type C disease (NPC) is a fatal, autosomal recessive disorder, which causes excessive accumulation of free cholesterol in endolysosomes, resulting in progressive hepatomegaly and neurodegeneration. Currently, 2-hydroxypropyl-β-cyclodextrin (HP-β-CyD) is used at a high dose for the treatment of NPC, risking lung toxicity and hearing loss during treatment. One method to reduce the required dose of HP-β-CyD for the treatment of hepatomegaly is to actively deliver β-cyclodextrin (β-CyD) to hepatocytes. Previously, we synthesized lactosyl-β-CyD (Lac-β-CyD) and demonstrated that it lowers cholesterol in NPC model liver cells. In the present study, we studied the efficacy and safety of Lac-β-CyD treatment of hepatomegaly in Npc1−/− mice. After subcutaneous administration, Lac-β-CyD accumulated in the liver and reduced hepatomegaly with greater efficacy than HP-β-CyD. In addition, subcutaneous administration of a very high dose of Lac-β-CyD was less toxic to the lungs than HP-β-CyD. Notably, the accumulation of intracellular free cholesterol in endolysosomes of NPC-like liver cells was significantly lower after administration of Lac-β-CyD than after treatment with HP-β-CyD. In conclusion, these results suggest that Lac-β-CyD is a candidate for the effective treatment of hepatomegaly in NPC.


2018 ◽  
Vol 48 (4) ◽  
pp. 251-259 ◽  
Author(s):  
Jalal Azmandian ◽  
Mohammad Reza Abbasi ◽  
Vahid Pourfarziani ◽  
Amir Ahmad Nasiri ◽  
Shahrzad Ossareh ◽  
...  

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).


2019 ◽  
Vol 34 (4) ◽  
pp. 521-524
Author(s):  
Hugues Michelon ◽  
Marie Tardivel ◽  
Aurélien Dinh ◽  
Jean‐Claude Alvarez ◽  
Elsa Salomon ◽  
...  

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Shenghao Wu ◽  
Cuiping Zheng ◽  
Songyan Chen ◽  
Xiaoping Cai ◽  
Yuejian Shi ◽  
...  

Objective. To investigate the efficacy and safety of the treatment of the newly diagnosed multiple myeloma (MM) patients with the therapy of subcutaneous (subQ) administration of bortezomib and dexamethasone plus thalidomide (VTD) regimen.Methods. A total of 60 newly diagnosed MM patients were analyzed. 30 patients received improved VTD regimen (improved VTD group) with the subQ injection of bortezomib and the other 30 patients received conventional VTD regimen (VTD group).The efficacy and safety of two groups were analyzed retrospectively.Results. The overall remission (OR) after eight cycles of treatment was 73.3% in the VTD group and 76.7% in the improved VTD group (P>0.05). No significant differences in time to 1-year estimate of overall survival (72% versus 75%,P=0.848) and progression-free survival (median 22 months versus 25 months;P=0.725) between two groups. The main toxicities related to therapy were leukopenia, neutropenia, thrombocytopenia, asthenia, fatigue, and renal and urinary disorders. Grade 3 and higher adverse events were significantly less common in the improved VTD group (50%) than VTD group (80%,P=0.015).Conclusions. The improved VTD regimen by changing bortezomib from intravenous administration to subcutaneous injection has noninferior efficacy to standard VTD regimen, with an improved safety profile and reduced adverse events.


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