- Comparison of the Pharmacokinetic-Pharmacodynamic Relationships of Two Darbepoetin Alfa Formulations in Healthy Male Volunteers. [Journal Article]
- BBioDrugs 2018 Dec 01
- CONCLUSIONS: The test and reference darbepoetin alfa formulations had similar PK, PD, and safety profiles. Thus, it is expected that the two formulations are able to be used interchangeably in clinical settings. ClinicalTrials.gov Identifier: NCT03542916.
- Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan. [Journal Article]
- JAJ Artif Organs 2018 Nov 14
- Recent evidence on maintenance administration of epoetin beta pegol, a continuous erythropoiesis receptor activator (CERA), in dialysis patients shows the clinical benefit of bi-weekly administration...
Recent evidence on maintenance administration of epoetin beta pegol, a continuous erythropoiesis receptor activator (CERA), in dialysis patients shows the clinical benefit of bi-weekly administration (Q2W) in improving hematopoiesis and iron use efficiency. We undertook a single-center observational study of 33 Japanese maintenance dialysis patients, whose anemia had been kept stable through weekly administration (Q1W) of darbepoetin (DA), to evaluate the effectiveness of CERA Q2W switched from DA in maintaining hemoglobin (Hb) levels over a 12-month period. The target Hb level was 10.0-12.0 g/dL. Throughout the 12-month period, the mean Hb was stably maintained at 10.5-10.8 g/dL, 69.7-87.9% of the patients achieving the target Hb level. The mean CERA dose was within the range of 62.9-78.8 µg/2 weeks. The average CERA dose adjustment frequency after switching was low at 0.42-0.67 times/3 months. In both subgroups stratified by the DA dose prior to the switch, Hb levels were kept stable during CERA administration; however, in the low-dose group (10-20 µg/week of DA), the CERA and iron doses decreased over time, whereas in the high-dose group (30-60 µg/week of DA) they remained unchanged. CERA Q2W achieved long-term successful anemia management in Japanese maintenance dialysis patients after switching from DA Q1W. CERA dose was adjusted based on an overall consideration of past changes in Hb levels, erythropoiesis-stimulating agent and iron doses. Subgroup analysis showed the CERA dose in the low-dose group decreased continuously, due possibly to a long-term improvement in iron use efficiency.
- Association of Anemia and Iron Parameters With Mortality Among Patients Undergoing Prevalent Hemodialysis in Taiwan: The AIM - HD Study. [Journal Article]
- JAJ Am Heart Assoc 2018 Aug 07; 7(15):e009206
- Background The Taiwan Health Insurance Bureau has conducted a bundled payment system for hemodialysis reimbursement since 1995. The maximum dose of erythropoiesis-stimulating agents allowed by insura...
Background The Taiwan Health Insurance Bureau has conducted a bundled payment system for hemodialysis reimbursement since 1995. The maximum dose of erythropoiesis-stimulating agents allowed by insurance is capped at 20 000 U of epoetin or 100 μg of darbepoetin alfa per month. Nephrologists have avoided the use of high dosages of erythropoiesis-stimulating agents to achieve a hemoglobin level of 10 to 11 g/dL by iron supplementation. The clinical impact of these policies on patients' outcomes is unknown. The authors aimed to assess the AIM-HD (Association of Anemia, Iron parameters, and Mortality among the prevalent Hemodialysis patients) Study in Taiwan. Methods and Results The AIM-HD study was conducted based on the Taiwan Renal Registry Data System. From 2001 to 2008, the authors enrolled 42 230 patients undergoing hemodialysis who were older than 20 years and had received hemodialysis for more than 12 months. Patient follow-ups occurred until death or December 31, 2008. During a study period of 8 years, 12 653 (30.0%) patients died. After multivariate adjustment, the authors found that a hemoglobin level <10 g/dL was significantly associated with higher risk for all-cause and cardiovascular deaths. Moreover, a serum ferritin level between 300 and 800 ng/mL and transferrin saturation value between 30% and 50% were associated with the lowest all-cause mortality. Conclusions The authors recommend avoiding a low hemoglobin level and maintaining serum ferritin between 300 and 800 ng/mL and transferrin saturation between 30% and 50%, which were associated with lower risks of all-cause mortality among patients undergoing hemodialysis receiving the restricted erythropoiesis-stimulating agent doses but prompt intravenous iron supplementation in Taiwan.
- Investigational use of PEGylated carboxyhemoglobin bovine in a Jehovah's Witness with hemorrhagic shock. [Case Reports]
- TTransfusion 2018; 58(10):2297-2300
- CONCLUSIONS: PCHB was used to stabilize (bridge) a critically ill anemic patient for lifesaving interventions without adverse effects. Additional studies are warranted to explore the drug's safety profile and efficacy in patients declining blood products.
- Safety and effectiveness of long-term use of darbepoetin alfa in non-dialysis patients with chronic kidney disease: a post-marketing surveillance study in Japan. [Journal Article]
- CEClin Exp Nephrol 2018 Sep 04
- CONCLUSIONS: This PMS study showed the safety and effectiveness of long-term use of darbepoetin in a large number of patients. Patients with Hb ≥ 11 g/dL presented fewer composite renal endpoints than those with Hb < 11 g/dL, without an increase in the incidence of cardiovascular-related AEs.
- Pro-gastrin-releasing peptide and outcome in patients with heart failure and anaemia: results from the RED-HF study. [Journal Article]
- EHESC Heart Fail 2018 Aug 25
- CONCLUSIONS: Pro-gastrin-releasing peptide is increased in patients with HF with reduced ejection fraction and anaemia, in particular in patients with poor renal function. However, proGRP adds little as a prognostic marker on top of conventional HF risk factors.
- Protective effects of Tadalafil and darbepoetin against ischemia - reperfusion injury in a rat testicular torsion model. [Journal Article]
- IBInt Braz J Urol 2018 Sep-Oct; 44(5):1005-1013
- CONCLUSIONS: The active substances darbepoetin and tadalafil that were used as a combination had protective effects on both testes and produced out better results in preserving testicular histology. Especially in cases where it is not possible to rescue the torsioned testis, this result was more noticeable in the contralateral testis.
- T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF. [Journal Article]
- CRClin Res Cardiol 2018 Jul 26
- CONCLUSIONS: Leukocyte activation markers sCD163, MIF, sIL-2R, and ALCAM were associated with adverse outcome in patients with HFrEF, but add little as prognostic markers on top of established biochemical risk markers.
- Drugs and Lactation Database (LactMed) [BOOK]
- BOOKNational Library of Medicine (US): Bethesda (MD)
- The excretion of darbepoetin alfa in breastmilk or its effects on breastfed infants have not been studied. However, erythropoietin is a normal component of human milk and darbepoetin is immunological...
The excretion of darbepoetin alfa in breastmilk or its effects on breastfed infants have not been studied. However, erythropoietin is a normal component of human milk and darbepoetin is immunologically and biologically indistinguishable from native erythropoietin. Intravenous darbepoetin has been given safely to newborn infants in doses much larger than those expected to appear in breastmilk. No special precautions are required during breastfeeding.
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- APPLY: A prospective observational study of clinical practice patterns of darbepoetin alfa use in patients with chemotherapy-induced anemia in Romania. [Journal Article]
- MEMOMemo 2018; 11(2):144-151
- CONCLUSIONS: The majority of patients were treated according to national and international recommendations. Guideline adherence was associated with more frequent achievement of Hb targets and lower red blood cell transfusion requirements compared with patients starting anemia treatment with darbepoetin alfa at lower-than-recommended Hb levels.