The Safety and the Efficacy of Maintenance Therapy of Recombinant Human Erythropoietin in Patients With Renal Insufficiency

Lim, Victoria S.; Kirchner, Peter T.; Fangman, Jerry; Richmond, John C.; DeGowin, Richard L.

doi:10.1016/s0272-6386(89)80150-7

Cited by 37 publications

(14 citation statements)

References 8 publications

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“…rhEPO treatment has been reported to be useful for improving anemia in predialysis patients with CRF (11,12) without progression to renal failure (17,18). Accumulating evidence suggests that SBI of rhEPO is more effective than i.v.…”

Section: Discussionmentioning

confidence: 99%

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Therapeutic use of continuous subcutaneous infusion of recombinant human erythropoietin in malnourished predialysis anemic patients with diabetic nephropathy

Sohmiya

Kakiba

Kato

1998

European Journal of Endocrinology

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We compared the effect of recombinant human erythropoietin (rhEPO) administration by continuous s.c. infusion (CSI) with that of a weekly bolus s.c. injection (SBI) in five malnourished predialysis anemic patients with diabetic nephropathy. rhEPO was either continuously infused at a flow rate of 6000 IU per week (36 IU/h) (CSI group) or injected s.c. at a dose of 6000 IU once a week (SBI group) for 4 weeks, in a cross-over comparative study with a washout period of 4 weeks. Mean Ϯ S.D. plasma EPO levels increased from a basal value of 18.0 Ϯ 4.9 mIU/ml to a steady state value of 70.5 Ϯ 38.9 mIU/ml 2 weeks after the start of CSI of rhEPO (P < 0.05). Increases in reticulocyte count above the basal value were greater in the CSI group than the SBI group at 3 weeks after the start of treatment (0.94 Ϯ 0.35% vs ¹0.03 Ϯ 0.46%, P < 0.05). Increases in Hb concentration above the basal value were much greater in the CSI group than the SBI group at 4 weeks after the start of treatment (2.56 Ϯ 0.77 g/dl vs 0.28 Ϯ 0.62 g/dl, P < 0.05). These findings suggest that rhEPO administration by CSI is more effective than by SBI for improving anemia in malnourished predialysis patients with diabetic nephropathy.

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Section: Discussionmentioning

confidence: 99%

“…rhEPO therapy has been delivered using a number of different dosages and administration methods in anemic patients with CRF during the predialysis period (10)(11)(12). However, malnourished patients with diabetic nephropathy often show a poor response to EPO administration.…”

Section: Introductionmentioning

confidence: 99%

Therapeutic use of continuous subcutaneous infusion of recombinant human erythropoietin in malnourished predialysis anemic patients with diabetic nephropathy

Sohmiya

Kakiba

Kato

1998

European Journal of Endocrinology

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“…Previous studies have suggested that extended-interval dosing of EPO could treat anemia in CKD patients not on dialysis (15)(16)(17)(18)(19)(20)(21). In a recent randomized, open-label, multicenter study (22), we demonstrated that once-weekly (QW) and every 2 weeks (Q2W) regimens of EPO could be used as potential alternatives to the approved three times weekly dosing for the treatment of anemia in ESA-naïve subjects with stage 3 to 4 CKD (22).…”

mentioning

confidence: 99%

A Randomized Controlled Study Comparing Once-Weekly to Every-2-Week and Every-4-Week Dosing of Epoetin Alfa in CKD Patients with Anemia

Pèrgola¹,

Gartenberg²,

Fu³

et al. 2010

Clinical Journal of the American Society of Nephrology

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Background and objectives: Extended-interval dosing of epoetin alfa (EPO) is commonly used to treat anemia in patients with chronic kidney disease (CKD).This study aimed to demonstrate that EPO dosed every 2 weeks (Q2W) and every 4 weeks (Q4W) was noninferior to once-weekly (QW) dosing.Design, setting, participants, & measurements: 430 anemic subjects with stage 3 to 4 CKD receiving a stable QW dose of EPO were randomized 1:1:2 to QW, Q2W, and Q4W dosing for 36 weeks. Hemoglobin (Hb) was measured weekly, and the dose of EPO was adjusted to maintain an Hb level of 11.0 to 11.9 g/dl. The primary endpoint was change in Hb from baseline to the average of the last 12 weeks of treatment.Results: Both the Q2W and Q4W dosing groups were noninferior to the QW group. The estimated difference of the mean change in Hb between Q2W and QW was ؊0.03 g/dl; and between Q4W and QW was ؊0.09 g/dl. From weeks 13 to 37, the mean percentage of weeks per subject with Hb 10.0 to 11.9 g/dl, inclusive, was 81% for QW, 81% for Q2W, and 75% for Q4W. Death occurred, respectively, in 4%, 3%, and 4%; thromboembolic vascular events occurred in 3%, 5%, and 3%; and serious adverse events occurred in 22%, 26%, and 26% of subjects.Conclusions: Q2W and Q4W EPO dosing maintained Hb levels in subjects with stage 3 to 4 CKD. Deaths, thromboembolic vascular events, and serious adverse events were comparable across the dosing groups.

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“…This reflects the life span (up to 120 d) of the red blood cells produced in response to ESA administration. In support of this concept, several studies in patients with CKD have reported that epoetin alfa administered (subcutaneously) up to every 4 wk can achieve and maintain Hb levels within a specified target range (15)(16)(17)(18)(19)(20)(21). In clinical practice, physicians often use once-weekly (QW) and biweekly (Q2W) dosing intervals in this patient population.…”

mentioning

confidence: 99%

A Randomized Controlled Study of Weekly and Biweekly Dosing of Epoetin Alfa in CKD Patients With Anemia

Pèrgola

Gartenberg

et al. 2009

Clinical Journal of the American Society of Nephrology

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Background and objectives: In clinical practice, physicians often use once-weekly (QW) and biweekly (Q2W) dosing of epoetin alfa to treat anemia in patients with chronic kidney disease (CKD). Although the literature supports this practice, previous studies were limited by short treatment duration, lack of randomization, or absence of the approved three times per week (TIW) dosing arm. This randomized trial evaluated extended dosing regimens of epoetin alfa, comparing QW and Q2W to TIW dosing in anemic CKD subjects. The primary objective was to show that treatment with epoetin alfa at QW and Q2W intervals was not inferior to TIW dosing.Design, setting, participants, & measurements: 375 subjects with stage 3 to 4 CKD were randomized equally to the three groups and treated for 44 wk; to explore the impact of changing from TIW to QW administration on hemoglobin (Hb) control and adverse events, subjects on TIW switched to QW after 22 wk. The Hb was measured weekly, and the dose of epoetin alfa was adjusted to achieve and maintain an Hb level of 11.0 to 11.9 g/dl.Results: Both the QW and Q2W regimens met the primary efficacy endpoint. More subjects in the TIW group than in the QW and Q2W groups exceeded the Hb ceiling. Adverse events were similar across treatment groups and consistent with the morbidities of CKD patients.Conclusions: Administration of epoetin alfa at QW and Q2W intervals are potential alternatives to TIW dosing for the treatment of anemia in stage 3 to 4 CKD subjects.

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The Safety and the Efficacy of Maintenance Therapy of Recombinant Human Erythropoietin in Patients With Renal Insufficiency

Cited by 37 publications

References 8 publications

Therapeutic use of continuous subcutaneous infusion of recombinant human erythropoietin in malnourished predialysis anemic patients with diabetic nephropathy

Therapeutic use of continuous subcutaneous infusion of recombinant human erythropoietin in malnourished predialysis anemic patients with diabetic nephropathy

A Randomized Controlled Study Comparing Once-Weekly to Every-2-Week and Every-4-Week Dosing of Epoetin Alfa in CKD Patients with Anemia

A Randomized Controlled Study of Weekly and Biweekly Dosing of Epoetin Alfa in CKD Patients With Anemia

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