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Darbepoetin alfa

Antonino Mafodda, D Giuffrida, A Prestifilippo, D Azzarello, R Giannicola, M Mare, R Maisano
PURPOSE: Erythropoiesis-stimulating agents (ESAs) are often used in treatment of patients with chemotherapy-induced anemia. Many studies have demonstrated an improved hemoglobin (Hb) response when ESA is combined with intravenous iron supplementation and a higher effectiveness of intravenous iron over traditional oral iron formulations. A new formulation of oral sucrosomial iron featuring an increased bioavailability compared to traditional oral formulations has recently become available and could provide a valid alternative to those by intravenous (IV) route...
April 9, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
E H Fiocchi, L D Cowgill, D C Brown, J E Markovich, S Tucker, M A Labato, M B Callan
BACKGROUND: Darbepoetin alfa (darbepoetin) is an erythropoiesis-stimulating agent used for the treatment of anemia secondary to chronic kidney disease (CKD) in dogs, but reports describing response are lacking. HYPOTHESIS/OBJECTIVES: To evaluate the effectiveness of darbepoetin in dogs with anemia secondary to CKD, dosing protocols, and adverse events. ANIMALS: Thirty-three client-owned dogs with naturally occurring CKD, including 26 with comorbidities...
March 2017: Journal of Veterinary Internal Medicine
Marina Urena, Maria Del Trigo, Omar Abdul-Jawad Altisent, Francisco Campelo-Prada, Ander Regueiro, Robert DeLarochellière, Daniel Doyle, Siamak Mohammadi, Jean-Michel Paradis, François Dagenais, Eric Dumont, Rishi Puri, Vincent Laroche, Josep Rodés-Cabau
AIMS: The aim of this study was to evaluate, in anemic patients, the efficacy of erythropoietin (EPO) in reducing red-cell (RC) transfusion rates post-TAVI. METHODS AND RESULTS: This was a randomized double-blind trial. Patients with severe symptomatic aortic stenosis and concomitant anemia with an indication for TAVI were randomized (1:1) to receive 2 weight-based doses of EPO (darbepoetin alfa) + iron or placebo at days 10 (±4 days) and 1 (±1 day) pre- TAVI...
January 10, 2017: EuroIntervention
Joerg Seckinger, Wilfried Dschietzig, Gerd Leimenstoll, Peter M Rob, Martin K Kuhlmann, Wolfgang Pommer, Uwe Fraass, Eberhard Ritz, Vedat Schwenger
BACKGROUND: The physical-functional and social-emotional health as well as survival of the elderly (≥75 years of age) haemodialysis patient is commonly thought to be poor. In a prospective, multicentre, non-interventional, observational study, the morbidity, mortality and quality of life (QoL) in this patient group were examined and compared with a younger cohort. METHODS: In 92 German dialysis centres, 2507 prevalent patients 19-98 years of age on haemodialysis for a median of 19...
December 2016: Clinical Kidney Journal
Tadashi Yoshida, Matsuhiko Hayashi
Anemia in chronic kidney disease (CKD) is a risk factor for cardiovascular diseases and is treated by long-acting erythropoiesis-stimulating agents (ESA). Although results of previous studies showed that the hemoglobin level could not be maintained at initiation of dialysis in CKD patients treated with recombinant human erythropoietin, it remains undetermined if long-acting ESA are effective to prevent the progression of anemia at initiation of dialysis. In the present study, hemoglobin levels in 40 CKD patients treated with darbepoetin alfa (DA) and 15 CKD patients treated with a continuous erythropoietin receptor activator (CERA) were retrospectively compared during the 6 months period prior to initiation of dialysis...
December 19, 2016: Keio Journal of Medicine
S Fouad
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Fatma Al Raisi, Issa Al Salmi, Pramod Kamble, Muna Al Shehri, Faissal A M Shaheen
The anemia of chronic kidney disease (CKD) is a common comorbidity seen in kidney diseases. It is also associated with increased cardiovascular morbidity and mortality and diminished quality of life. Often, patients with CKD of different stages require erythropoiesis-stimulating agents (ESAs) to maintain their hemoglobin (Hb) within the target range. Darbepoetin alfa is a newer ESA with a longer half-life than recombinant human erythropoietin (EPO). The objective of this study is to assess the efficacy and safety profile of twice-monthly (Q2W) and once a month (1QM) darbepoetin alfa in CKD patients, not on dialysis...
November 2016: Saudi Journal of Kidney Diseases and Transplantation
Ralph V Boccia, David H Henry, Laura Belton, Chet Bohac, Hassan H Ghazal
Data on efficacy and safety of darbepoetin alfa (DA) administered at hemoglobin (Hb) ≤10 g/dL are limited. In this analysis, we examined DA's efficacy and safety in patients with Stage IV cancers and chemotherapy-induced anemia (CIA) initiated on DA at Hb ≤10 g/dL. Data for patients with Stage IV cancers and CIA and who initiated DA at Hb ≤10 g/dL were extracted from three phase 3 trials identified in a central database of Amgen-sponsored DA studies in CIA. Efficacy outcomes were assessed by achievement of Hb increases of ≥1 g/dL and ≥2 g/dL and red blood cell (RBC) or whole blood transfusion requirements...
December 2016: Cancer Medicine
Masato Okano, Mitsuhiko Sato, Shinji Kageyama
Human erythropoietin (EPO) and recombinant human EPO (rEPO) are approximately 30-kDa glycosylated proteins comprising 165 amino acids. Darbepoetin alfa (NESP) is a glycosylated protein encompassing five changes in the amino acid sequence of human EPO, which contains two extra sugar chains. NESP is under patent protection in the USA until May 2024 and in Europe until July 2016, which suggests that the number of NESP biosimilars might substantially increase. The detailed characterisation of biosimilar products are required to ensure the identity and purity of the biosimilar products in terms of safety and efficacy for patients...
November 2016: Drug Testing and Analysis
Pere Gascón, Rajnish Nagarkar, Martin Šmakal, Kostas Syrigos, Carlos H Barrios, Jesús Cárdenas Sánchez, Li Zhang, David H Henry, Alex Fleishman, Cisio De Oliveira Brandao
No abstract text is available yet for this article.
October 2016: Journal of Thoracic Oncology
Anvarsadat Kianmehr, Abdolkarim Mahrooz, Morteza Oladnabi, Yaghoub Safdari, Javad Ansari, Kamal Veisi, Mehdi Evazalipour, Hamid Shahbazmohammadi, Eskandar Omidinia
Darbepoetin alfa is a biopharmaceutical glycoprotein that stimulates erythropoiesis and is used to treat anemia, which associated with renal failure and cancer chemotherapy. We herein describe the structural characterization of recombinant darbepoetin alfa produced by Leishmania tarentolae T7-TR host. The DNA expression cassette was integrated into the L. tarentolae genome through homologous recombination. Transformed clones were selected by antibiotic resistance, diagnostic PCRs, and protein expression analysis...
September 2016: Molecular Biotechnology
G Kourlaba, I Boletis, D Goumenos, C Iatrou, V Papagiannopoulou, G Tritaki, N Maniadakis
No abstract text is available yet for this article.
November 2014: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Jan-Christoph Galle, Janet Addison, Michael G Suranyi, Kathleen Claes, Salvatore Di Giulio, Alain Guerin, Hans Herlitz, István Kiss, Mourad Farouk, Nick Manamley, Gerhard Wirnsberger, Christopher Winearls
BACKGROUND: Extended dosing of the erythropoiesis-stimulating agent (ESA) darbepoetin alfa (DA) once biweekly or monthly reduces anaemia treatment burden. This observational study assessed outcomes and dosing patterns in patients with chronic kidney disease not on dialysis (CKD-NoD) commencing extended dosing of DA. METHODS: Adult CKD-NoD patients starting extended dosing of DA in Europe or Australia in June 2006 or later were followed up until December 2012. Outcomes included haemoglobin (Hb) concentration, ESA dosing, mortality rates and receipt of dialysis and renal transplantation...
December 2016: Nephrology, Dialysis, Transplantation
Daniele Marcelli, Inga Bayh, José I Merello, Pedro Ponce, Alex Heaton, Fatih Kircelli, Charles Chazot, Attilio Di Benedetto, Cristina Marelli, Erzsebet Ladanyi, Miroslaw Kroczak, Stefano Stuard, Aileen Grassmann, Laura Scatizzi, Katharina Brand, Bernard Canaud
Hyporesponsiveness to erythropoiesis-stimulating agent therapy in dialysis patients is poorly understood. Some studies report an improvement in the erythropoiesis-stimulating agent resistance index (ERI) with hemodiafiltration (HDF) versus high-flux hemodialysis (HD). We explored ERI dynamics in 38,340 incident HDF and HD patients treated in 22 countries over a 7-year period. Groups were matched by propensity score at baseline (6 months after dialysis initiation). The follow-up period (mean of 1.31 years) was stratified into 1 month intervals with delta analyses performed for key ERI-related parameters...
July 2016: Kidney International
Shang-Chih Liao, Cheng-Chieh Hung, Chien-Te Lee, Chih-Hsiung Lee, Chin-Chan Lee, Chun-Liang Lin, Chiao-Yin Sun, Ben-Chung Cheng, Chih-Chao Yang, Chien-Hsing Wu, Jin-Bor Chen
This multicenter study was designed to assess the hemoglobin (Hb) stability and conversion ratio of the switch from epoetin beta to darbepoetin alfa in Taiwanese hemodialysis (HD) patients. A total of 135 HD patients were enrolled and randomized with intravenous darbepoetin alfa or epoetin beta. The study duration was 24 weeks. Equivalent doses and conversion ratios were assessed with respect to Hb stratification: low Hb (≥8.0 g/dL to ≤10.0 g/dL) and high Hb (>10.0 g/dL to ≤11.0 g/dL). The results showed stable Hb levels in the study period...
August 2016: Therapeutic Apheresis and Dialysis
Carlo Barbieri, Elena Bolzoni, Flavio Mari, Isabella Cattinelli, Francesco Bellocchio, José D Martin, Claudia Amato, Andrea Stopper, Emanuele Gatti, Iain C Macdougall, Stefano Stuard, Bernard Canaud
Anemia management, based on erythropoiesis stimulating agents (ESA) and iron supplementation, has become an increasingly challenging problem in hemodialysis patients. Maintaining hemodialysis patients within narrow hemoglobin targets, preventing cycling outside target, and reducing ESA dosing to prevent adverse outcomes requires considerable attention from caregivers. Anticipation of the long-term response (i.e. at 3 months) to the ESA/iron therapy would be of fundamental importance for planning a successful treatment strategy...
2016: PloS One
Robin K Ohls, Daniel C Cannon, John Phillips, Arvind Caprihan, Shrena Patel, Sarah Winter, Michael Steffen, Ronald A Yeo, Richard Campbell, Susan Wiedmeier, Shawna Baker, Sean Gonzales, Jean Lowe
BACKGROUND: We previously reported improved neurodevelopmental outcomes at 2 years among infants treated with the erythropoiesis-stimulating agents (ESAs) darbepoetin alfa (darbepoetin) or erythropoietin. Here we characterize 4-year outcomes. METHODS: Former preterm infants randomly assigned to receive darbepoetin (10 μg/kg, once per week), erythropoietin (400 U/kg, 3 times/week), or placebo through 35 weeks' postconceptual age were evaluated at 3.5 to 4 years of age...
March 2016: Pediatrics
Jean-Loup Mouysset, Beata Freier, Joan van den Bosch, Charles Briac Levaché, Alain Bols, Hans Werner Tessen, Laura Belton, G Chet Bohac, Jan-Henrik Terwey, Giuseppe Tonini
PURPOSE: To assess hemoglobin (Hb) outcomes and fatigue-related quality-of-life (QoL) (electronic assessment) in patients with solid tumors and symptomatic chemotherapy-induced anemia receiving cytotoxic chemotherapy and darbepoetin alfa (DA) or another erythropoiesis-stimulating agent according to European indication. METHODS: eAQUA was a Phase IV prospective observational study. The primary outcome (assessed in the primary analysis set [PAS]: patients receiving one or more DA dose who had baseline and week 9 assessments for Hb and QoL) was the proportion of patients receiving DA having both Hb increases ≥1 g/dL and improved QoL between baseline and week 9...
2016: Cancer Management and Research
Robert Pirker, Michael Hedenus, Johan Vansteenkiste, Enrique Hernandez, Laura Belton, Jan-Henrik Terwey
PURPOSE: Limited data are available to describe the effectiveness of darbepoetin alfa (DA) in terms of hemoglobin (Hb) and transfusion outcomes when initiated at Hb ≤10 g/dL (the threshold specified in the summary of prescribing characteristics). We assessed DA, initiated according to current labeling (Hb ≤10 g/dL), in chemotherapy-induced anemia (CIA). METHODS: Data for patients with cancer and CIA who initiated DA at Hb ≤10 g/dL were extracted from a database of Amgen-sponsored trials...
January 1, 2016: Clinical Therapeutics
Chiharu Ito, Tetsu Akimoto, Yoshiyuki Morishita, Hisashi Yamamoto, Manabu Ogura, Tomoyuki Yamazaki, Atsushi Miki, Sumiko Homma, Eiji Kusano, Yasushi Asano, Daisuke Nagata
BACKGROUND: Erythropoiesis-stimulating agents (ESAs) are the mainstay of treatment for renal anemia in chronic kidney disease (CKD) patients. However, the difference in hematopoietic effect between darbepoetin alfa (DA) and continuous erythropoiesis receptor activator (CERA) has remained unclear in non-dialysis CKD patients. Another purpose of this study was to analyze the red blood cells indices under treatment with these two ESAs in ESA-naïve CKD patients. METHODS: This study was designed as a multicenter retrospective observational investigation, and included 61 patients receiving DA (group DA) and 36 patients receiving CERA (group CERA) for at least six months...
2015: Nihon Jinzo Gakkai Shi
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