만성 신장질환에서 Conventional Erythropoiesisstimulating Agent(ESA)s에서 Methoxy Polyethylene Glycol Epoetin-beta(MPGEPO)로 전환 시빈혈 개선 효과 분석 = Anemia Improvement in Chronic Kidney Disease Associated with Switch from Erythropoiesis-stimulating Agents to Methoxy Polyethylene Glycol Epoetin-beta

다국어 초록 (Multilingual Abstract)

Background : Anemia is a common complication in patients with chronic kidney disease(CKD). Untreated anemia increases morbidity and mortality related to cardiovascular disease.
Treatment of anemia commonly utilizes erythropoiesis-stimulating agents (ESAs). Conventional ESAslike epoetin have short half-lives, which necessitate frequent dosing (weekly or biweekly). Methoxypolyethylene glycol epoetin-beta (MPGEPO) is a recently developed ESA that can be administeredmonthly. This study evaluated the effect on anemia and potential side effects of anemia treatmentinvolving a single agent switch to MPGEPO from conventional ESAs.
Methods : Study subjects were 41 patients who received MPGEPO at Seoul National University Hospital from September 2009 to September 2012. Patents were switched from epoetin-beta (n=24) ordarbepopetin-alfa (n=17). To evaluate the efficacy and potential side effects, hemoglobin (Hb) levelswere monitored 3 months before and after conversion. Efficacy was the percentage of patients whoseone-month average Hb level increased more than 1 g/dl. Potential side effects, such as high bloodpressure, were assessed by the percentage of patients whose Hb level was < 12 g/dl. Costs of treatmentwere calculated as one-month upper limit of insurance cost and ratio of patients who remainedon the initial dose.
Results : Hb level improvement was evident in 5 of 24 (20.8%) patients treated with epoetin-beta, 10of 24 (41.6%) patients after switching to MPGEPO, 7 of 17 (41.1%) patients treated with darbepoetinalfa,and 12 of 17 (70.6%) patients after switching to MPGEPO. Potential side effects in the samerespective order of treatment were evident in 9 of 24 (38%), 7 of 24 (29%), 5 of 17 (29%), and 7 of 17(41%) patients. One-month upper limit of insurance cost was increased 1.5- and 1.4- fold afterswitching to MPGEPO from epoetin-beta and darbepoetin-alfa, respectively, compared to beforeswitch. The number of patients who remained on the initial dose was also increased after switchingto MPGEPO.
Conclusions : Conversion from conventional ESAs to MPGEPO increased the Hb level and reduceddosing frequency. But drug switching did not reduce the frequency of potential side effects andincreased drug costs. Drug selection must consider the state of patents, weighing the advantages anddisadvantages of each drug.

참고문헌 (Reference)

1 Allen R. Nissenson, "Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients" 40 (40): 110-, 2002

2 Macdougall, I. C., "Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients" 10 (10): 2392-2395, 1999

3 "KDOQI Clinical Practice Guidelines, Clinical Practice Recommendations for Anemia in Chronic Kidney Disease" 47 (47): 2006

4 Canaud B., "Intravenous (IV) CERA (continuous erythropoietin receptor activator) administered once every 2 weeks maintains stable haemoglobin(Hb) levels in patients with chronic kidney disease on dialysis" 2006

5 Saueressig U., "Healthcare Resource Utilization for Anemia Management; Current Practice with Erythropoiesis-Stimulating Agents, the Impact of Converting to Once-Monthly C.E.R.A" 26 : 537-546, 2008

6 Stead RB1, "Evaluation of the safety, pharmacodynamics of Hematide, a novel erythropoietic agent, in a phase 1, double-blind, placebo controlled dose-escalation study in healthy volunteers" 108 : 1830-1834, 2006

7 Frank J. Papatheofanis, "Dosing patterns, hematologic outcomes,, cost of erythropoietic agents in predialysis chronic kidney disease patients with anemia" 22 (22): 837-, 2006

8 Egrie J.C., "Development, characterization of novel erythropoiesis stimulating protein (NESP)" 84 : S3-, 2001

9 Sing A.K., "Correction of anemia with epoetin alfa in chronic kidney disease" 355 : 2085-2098, 2006