BACKGROUND: Anemia management in non-dialysis-dependent chronic kidney disease (CKD) patients is associated with cardiovascular and cost benefits, slows decline in renal function, and prevents mortality. Different reviews have focused on evaluating the safety and efficacy of methoxy polyethylene glycol-epoetin beta (MPG-EPO), a continuous erythropoietin receptor activator, in CKD patients regardless of dialysis dependency and others have studied this novel agent exclusively in CKD patients receiving dialysis. AIM OF THE REVIEW: To evaluate the efficacy and tolerability of MPG-EPO compared with other erythropoiesis stimulating agents (in particular darbepoetin alfa) for the treatment of anemia in non-dialysis-dependent CKD patients. METHODS: A systematic review of original studies published mainly in MEDLINE, Cochrane Database, ScienceDirect, ProQuest, clinical trials registries, and Google Scholar was carried out to identify randomized controlled trials (RCTs) comparing MPG-EPO with other erythropoiesis stimulating agents or placebo among patients with anemia of CKD who were not yet receiving dialysis. Data were independently extracted by two reviewers using standardized data abstraction tool. RESULTS: Four trials involving 1,155 patients were included in the review. The changes in hemoglobin level from the baseline reported by the reviewed studies demonstrate that MPG-EPO was clinically non-inferior to darbepoetin alfa. In addition, the studies documented that MPG-EPO-treated patients experienced a lower rate of hemoglobin level above the target range of 12-13 g/dL than darbepoetin-treated patients. The proportion of patients requiring RBC transfusion was higher among patients who received darbepoetin alfa than those who received MPG-EPO. However, the time to hemoglobin response was longer with MPG-EPO than with darbepoetin. Finally, the incidences of serious adverse events were similar between the two therapeutic agents. CONCLUSION: There are currently only few well-designed head-to-head RCTs investigating the efficacy and safety of MPG-EPO compared with other ESAs in non-dialysis-dependent patients. MPG-EPO therapy compared with darbepoetin alfa has demonstrated favorable effects of increasing and maintaining hemoglobin concentrations to recommended target levels. This mini-review is not conclusive due to limited number of studies. Therefore, the beneficial effects and tolerability of MPG-EPO among non-dialysis-dependent CKD patients should be further investigated, given the economic and clinical benefits of managing anemia in this population.
BACKGROUND:Anemia management in non-dialysis-dependent chronic kidney disease (CKD) patients is associated with cardiovascular and cost benefits, slows decline in renal function, and prevents mortality. Different reviews have focused on evaluating the safety and efficacy of methoxy polyethylene glycol-epoetin beta (MPG-EPO), a continuous erythropoietin receptor activator, in CKDpatients regardless of dialysis dependency and others have studied this novel agent exclusively in CKDpatients receiving dialysis. AIM OF THE REVIEW: To evaluate the efficacy and tolerability of MPG-EPO compared with other erythropoiesis stimulating agents (in particular darbepoetin alfa) for the treatment of anemia in non-dialysis-dependent CKDpatients. METHODS: A systematic review of original studies published mainly in MEDLINE, Cochrane Database, ScienceDirect, ProQuest, clinical trials registries, and Google Scholar was carried out to identify randomized controlled trials (RCTs) comparing MPG-EPO with other erythropoiesis stimulating agents or placebo among patients with anemia of CKD who were not yet receiving dialysis. Data were independently extracted by two reviewers using standardized data abstraction tool. RESULTS: Four trials involving 1,155 patients were included in the review. The changes in hemoglobin level from the baseline reported by the reviewed studies demonstrate that MPG-EPO was clinically non-inferior to darbepoetin alfa. In addition, the studies documented that MPG-EPO-treated patients experienced a lower rate of hemoglobin level above the target range of 12-13 g/dL than darbepoetin-treated patients. The proportion of patients requiring RBC transfusion was higher among patients who received darbepoetin alfa than those who received MPG-EPO. However, the time to hemoglobin response was longer with MPG-EPO than with darbepoetin. Finally, the incidences of serious adverse events were similar between the two therapeutic agents. CONCLUSION: There are currently only few well-designed head-to-head RCTs investigating the efficacy and safety of MPG-EPO compared with other ESAs in non-dialysis-dependent patients. MPG-EPO therapy compared with darbepoetin alfa has demonstrated favorable effects of increasing and maintaining hemoglobin concentrations to recommended target levels. This mini-review is not conclusive due to limited number of studies. Therefore, the beneficial effects and tolerability of MPG-EPO among non-dialysis-dependent CKDpatients should be further investigated, given the economic and clinical benefits of managing anemia in this population.
Authors: William McClellan; Stephen L Aronoff; W Kline Bolton; Sally Hood; Daniel L Lorber; K Linda Tang; Thomas F Tse; Brian Wasserman; Marc Leiserowitz Journal: Curr Med Res Opin Date: 2004-09 Impact factor: 2.580
Authors: Nathan W Levin; Steven Fishbane; Francisco Valdés Cañedo; Steven Zeig; George M Nassar; John E Moran; Giuseppe Villa; Ulrich Beyer; Delphine Oguey Journal: Lancet Date: 2007-10-20 Impact factor: 79.321
Authors: Marc A Pfeffer; Emmanuel A Burdmann; Chao-Yin Chen; Mark E Cooper; Dick de Zeeuw; Kai-Uwe Eckardt; Jan M Feyzi; Peter Ivanovich; Reshma Kewalramani; Andrew S Levey; Eldrin F Lewis; Janet B McGill; John J V McMurray; Patrick Parfrey; Hans-Henrik Parving; Giuseppe Remuzzi; Ajay K Singh; Scott D Solomon; Robert Toto Journal: N Engl J Med Date: 2009-10-30 Impact factor: 91.245
Authors: C E Halstenson; M Macres; S A Katz; J R Schnieders; M Watanabe; J T Sobota; P A Abraham Journal: Clin Pharmacol Ther Date: 1991-12 Impact factor: 6.875