- |||||||||| Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
Acute Kidney Injury after Cardiac Surgery Is Associated with Increased Iron Deficiency Anemia Risk () - Dec 7, 2024 - Abstract #ASH2024ASH_9735; The increased 12-month risk of IDA and repeat cardiac surgery was mitigated with ESA treatment within 3 months with no increase in acute MI. Postoperative ESA use may protect against AKI-associated anemia without increased adverse events, representing an opportunity to improve health outcomes.
- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
Risks and Harms to Physicians Reporting Hematologic Adverse Drug Reactions (ADRs) to Health Authorities () - Dec 7, 2024 - Abstract #ASH2024ASH_9597; ADR findings resulted in drug removal (n = 7; Vioxx, Avandia, Bextra, Celebrex, Trasylol, Phenyl propanolamine, Hydroxy-ethyl starch), revised indications (n = 2) (Procrit, Aranesp 2007, 2008, 2010)) or 10-year delay in FDA-approval (n = 1) (Fereprox)...Pharmaceutical companies paid $600,000 (Fereprox) to $5.8 billion (Vioxx) in fines and settlements.Discussion : Twelve physicians experienced severe threats and/or harms after reporting hematologic-associated ADRs to Health Authorities and/or in major publications. We suggest physicians not sign secrecy agreements that might jeopardize public safety (as currently established by almost all US medical universities) and should partner with independent drug safety monitoring boards (DSMBs) on ADR evaluations to monitor safety concerns of drugs and medical devices.
- |||||||||| Epogen (epoetin alfa) / Amgen
Trial completion date: Pharmacological Countermeasures for High Altitude (clinicaltrials.gov) - Dec 4, 2024 P4, N=18, Active, not recruiting, Further studies are needed to establish optimal dosing schedules, and whether treatment can be discontinued safely in stable patients. Trial completion date: Dec 2024 --> Mar 2025
- |||||||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Combining ESA and Luspatercept in Non-RS MDS Patients Having Failed ESA - Results of the Phase 1-2 Part a of the GFM Combola Study (Ballroom 20AB (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_2200; Based on a TITE-BOIN-ET design, Epoetin alfa was administered weekly at dose concentrations ranging from 30 000UI to 60 000 UI...All patients had resistance to ESA and 7 had also received Revlimid (n=3), IDH inhibitors (n=2), Thalidomide (n=1), AZA (n=1)...Based on the results of this Phase 1 study, the dosing schedule Luspatercept 1.75 mg/kg/21d and EPO 60 000 UI/w, that balanced clinical efficacy and safety profile was selected as the RP2D. This regimen is being compared to Luspatercept 1.75 mg/kg/21d in the ongoing randomized Phase 2 study.
- |||||||||| Epogen (epoetin alfa) / Amgen
Trial completion date: Pharmacological Countermeasures for High Altitude (clinicaltrials.gov) - Nov 4, 2024 P4, N=18, Active, not recruiting, These data support luspatercept as the treatment of choice in TD ESA-naive pts with lower-risk MDS. Trial completion date: Sep 2024 --> Dec 2024
- |||||||||| hydroxyurea / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date: ACHiEvE-SCD: Hydroxyurea and EPO in Sickle Cell Disease (clinicaltrials.gov) - Sep 25, 2024 P1/2, N=17, Active, not recruiting, Not yet recruiting --> Withdrawn | N=86 --> 0 Recruiting --> Active, not recruiting | Trial completion date: Aug 2025 --> Mar 2025 | Trial primary completion date: May 2025 --> Dec 2024
- |||||||||| Epogen (epoetin alfa) / Amgen
Acute Tubular Necrosis (ATN) after Hemopure in a Patient with Sickle Cell Disease (SCD) (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_3348; She was given Epogen 20,000 IU daily and was diuresed with robust urinary response (3L/24hr)...Renal side effects include hypertension attributed to heme scavenging of endothelial nitric oxide, and nephrotoxicity possibly from renal oxidative stress and vasoconstriction. This case seeks to contribute to the growing body of literature on the safety and risks associated with HBOCs.
- |||||||||| chlorpromazine / Generic mfg.
A RARE CASE OF CHLORPROMAZINE-INDUCED IMMUNE HEMOLYTIC ANEMIA (Convention Center Exhibit Hall: Poster Area 2) - Sep 19, 2024 - Abstract #CHEST2024CHEST_7313; The hematologist was consulted immediately, and the patient received one dose of IV Epoetin alfa 20000 units, one dose of IV Venofer 200 mg and she was also started on IV methylprednisolone 80 mg...The patient's home medications included Chlorpromazine, Divalproex, and Fluoxetine...He was discharged to home with prednisone and divalproex...Cephalosporins, nonsteroidal anti-inflammatory agents, levofloxacin, oxaliplatin, and teicoplanin have been reported to cause IHA... Chlorpromazine is a widely used drug in psychiatry and physicians should be aware of this rare adverse event of hemolytic anemia.
- |||||||||| Epogen (epoetin alfa) / Amgen
Iron Overload: A Case of Hidden Hemochromatosis (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3556; Patient was recommended to switch from IV iron to Epogen therapy, and discharged with outpatient follow-up, which were not pursued...While, the diagnosis of acquired hemochromatosis typically requires a TSAT > 45% alongside elevated ferritin levels, prior literature has shown these values to not be the most reliable indicator of hepatic iron stores. Chelation is typically initiated prophylactically in patients receiving over 10 units of blood, but was delayed in our patient with acquired hemochromatosis, underscoring the need for physician vigilance and timely intervention in these cases.
- |||||||||| Epogen (epoetin alfa) / Amgen
Journal: Evaluation of serum ferritin level and hepatitis b and hepatitis c viral infection in chronic hemodialysis patients. (Pubmed Central) - Aug 4, 2024 The study aimed to assess serum ferritin levels and their connection to Epoetin alfa resistance, along with exploring the link between hepatitis C virus, iron overload, and the prevalence of hepatitis C and B infections in chronic HD patients...Excessive blood transfusions can lead to iron overload and inhibit erythropoiesis. Maintaining HB at 110-120 g/l improves quality of life and reduces anemia-related risks.
- |||||||||| Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Vafseo (vadadustat) / Akebia Therap
New P3 trial: VOICE: Vafseo Outcomes In-Center Experience (clinicaltrials.gov) - Jul 24, 2024 P3, N=2200, Not yet recruiting,
- |||||||||| Epogen (epoetin alfa) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date: Pharmacological Countermeasures for High Altitude (clinicaltrials.gov) - Jul 16, 2024 P4, N=18, Active, not recruiting, Some studies have postulated the use of bivalirudin to prevent HIT but further research is needed to investigate this approach. Recruiting --> Active, not recruiting | Trial completion date: Aug 2022 --> Sep 2024 | Trial primary completion date: Aug 2022 --> Sep 2023
- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
Clinical, Retrospective data, Journal: The effect of erythropoiesis?stimulating agents on lung cancer patients: a meta?analysis. (Pubmed Central) - Jul 5, 2024 There was no statistically significant difference between the two groups in the incidence of adverse reactions (RR 0.98, 95% CI 0.95-1.00, P?=?0.10). In conclusion, ESAs does not increase the mortality of lung cancer patients or may reduce the risk of death, and can reduce the need for blood transfusion, although ESA can increase the incidence of thrombotic vascular adverse events.Registration PROSPERO CRD42023463582.
- |||||||||| AND017 / Hangzhou Andao Pharma
Trial completion, Enrollment change: A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (clinicaltrials.gov) - Jun 27, 2024 P2, N=175, Completed, In conclusion, ESAs does not increase the mortality of lung cancer patients or may reduce the risk of death, and can reduce the need for blood transfusion, although ESA can increase the incidence of thrombotic vascular adverse events.Registration PROSPERO CRD42023463582. Active, not recruiting --> Completed | N=120 --> 175
- |||||||||| Epogen (epoetin alfa) / Amgen
Trial completion, Trial completion date, Trial primary completion date, Adverse events: PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns (clinicaltrials.gov) - Jun 4, 2024 P3, N=313, Completed, Future studies with a longer follow-up are needed to confirm these findings. Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Apr 2024 | Trial primary completion date: Mar 2023 --> Nov 2023
- |||||||||| Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Jesduvroq (daprodustat) / GSK, Kyowa Kirin
Journal: Daprodustat (Jesduvroq) for anemia of chronic kidney disease. (Pubmed Central) - Mar 2, 2024 In hemodialysis Egyptian patients, Aranesp with extended dosing intervals proved to be more effective in achieving target Hb with comparable adverse effect profiles, a substantial cost-saving strategy, and offered time-saving advantages for medical staff workload compared to Eprex. No abstract available
- |||||||||| Epogen (epoetin alfa) / Amgen
Supporting a Pediatric Jehovah's Witness Patient on a Ventricular Assist Device to Transplantation (Board #40; Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1768; Postoperatively, in the ICU, she experienced significant bleeding (hemoglobin drop from 12.9 to 5.7 g/dL) with hemodynamic compromise requiring chest exploration and tranexamic acid...To promote count recovery, iron supplementation and Epoetin alfa were started...Stimulation of erythropoiesis pre-operatively along with aggressive blood sparing intra-operative strategies may entirely eliminate the need for transfusions. Generalized adoption of these blood sparing techniques would likely be beneficial to all patients undergoing complex cardiac surgeries.
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