Use Of Epoetin Alfa Research Articles

Сравнительный фармакоэкономический анализ применения эпоэтина альфа и роксадустата в сочетании с препаратами железа у взрослых пациентов с анемией на фоне хронической болезни почек в условиях системы здравоохранения Российской Федерации

Сравнительный фармакоэкономический анализ применения эпоэтина альфа и роксадустата в сочетании с препаратами железа у взрослых пациентов с анемией на фоне хронической болезни почек в условиях системы здравоохранения Российской Федерации

Эффективность применения эпоэтина альфа у недоношенных детей с массой тела при рождении менее 1500 граммов

Purpose of the research was to evaluate the effect of the administration of epoetin alfa (Eralfon®️) after 8 days of life in very preterm infants with birthweight below 1500 gram and gestational age below 310/7 weeks on the anemia of prematurity, on hemoglobin levels in blood at the age of six months and on retinopathy of prematurity. Materials and methods used: a retrospective study of 105 very preterm infants was conducted at the two perinatal centers, L.A. Vorokhobov Moscow City Clinical Hospital No. 67 of the Moscow Department of Healthcare (Moscow, Russia) and Yaroslavl Oblast Regional Perinatal Center (Yaroslavl, Russia), who were divided into two groups, G1 (56) who did not receive epoetin alpha (EA) at 1 to 2 months of life (the so-called “no EA Group”) and were nursed at the Yaroslavl Oblast Regional Perinatal Center; and G2 (49) who received EA at 1 to 2 months of life (the “EA Group”) and were nursed at the L.A. Vorokhobov Moscow City Clinical Hospital No. 67 of the Moscow Department of Healthcare. In the “EA Group,” there was late (after the 8th day of life) EA administration at a dose of 200 units/kg at once subcutaneously 3 times per week for 6 weeks. Results: hemoglobin levels in peripheral blood on the first day of life had no statistically significant differences. The level of hemoglobin in peripheral blood at the age of 6 months was statistically significantly higher in preterm infants who had received EA at 1 to 2 months of life. The development of the anemia of prematurity was statistically significantly less frequently recorded in the “EA Group:” 40 out of 49 (82.0%) vs. 54 out of 56 (96.0%), p=0.022. Erythrocyte transfusion in the “no EA Group” was performed in 38 out of 56 (67.8%), 25 out of 49 (51.0%) in the “EA group,” p=0.079, OR 0.49 [0.22, 1.08], RR 0.71 [0.47, 1.06]. Children who were in need of high-frequency oscillatory ventilation (HFOV) have not only had statistically significantly more frequent need for erythrocyte transfusion but also statistically significantly more often developed BPD and retinopathy of prematurity at the stage that requires surgical intervention. Conclusion: late EA administration in preterm infants with birthweight below 1500 gram reduces the risk of the development of the anemia of prematurity, increases the level of hemoglobin in peripheral blood at the age of six months old and does not increase the risk for development of retinopathy of prematurity.

Epoetin Alfa: a Creative Way to Treat Anemia

The use of epoetin alfa has been one of the most relevant trends in the past years, therefore, it is important to understand how epoetin alfa differs from other biopharmaceuticals and to summarise the innovative nature of epoetin alfa. This paper aims at why the biopharmaceutical represents innovation in terms of lead-discovery, drug development and fulfilling a previously unmet treatment need. As far as we know, studies on the creativity of epoetin alfa are lacking in the main literature. This paper reveals that the purpose of epoetin alfa’s therapy and current treatment modalities, general principles of the drug discovery process, the creativity in medicinal chemistry & pharmacology of epoetin alfa, choosing the target and sources of compound supply, intellectual property considerations in drug discovery & development, the drawbacks of epoetin alfa and the creativity of epoetin alfa. The contribution of the present research involves that summarising the innovation of epoetin alfa.

COST-MINIMIZATION ANALYSIS OF USING SHORT AND LONG-ACTING ERYTHROPOESIS-STIMULATING AGENTS FOR CORRECTION OF NEPHROGENIC ANEMIA AGAINST THE BACKGROUND OF SUBSTITUTION THERAPY

Clinical trials conducted in various countries indicate that the use of epoetin alfa in patients with nephrogenic anemia in chronic kidney disease can increase the effectiveness of treatment, reduce the incidence of cardiovascular and infectious complications, and reduce mortality in patients with chronic kidney disease.The aim of the article was to conduct a comparative clinical and economic assessment of the treatment costs of nephrogenic anemia in adult dialysis patients with recombinant human erythropoietins: epoetin alfa, darbepoetin and long-acting methoxy polyethylene glycol – epoetin beta.Materials and methods. The study took into account direct medical costs of nephrogenic anemia pharmacotherapy on the basis of 1 year maintenance therapy according to the following scheme: epoetin alfa – 3 times per week, darbepoetin alfa – once per week, methoxy polyethylene glycol – epoetin beta – once per 2 or 4 weeks. A “costs minimization” analysis was performed for equivalent maintenance epoetins doses for intravenous and subcutaneous administrations. Epoetin alpha equivalents were calculated for an average patient weighing 75 kg by converting a weekly dose of short-acting epoetin (7500 IU) into equivalent doses using dose conversion factors.Results. In the hypothetical cohort of patients under study, epoetin alfa, darbepoetin alfa, and methoxy polyethylene glycol – epoetin beta not differ in effectiveness in achieving target Hb values and in safety. With the equal effectiveness of the investigated drugs, in the studied patients, intravenous epoetin alfa can be less expensive drug therapy relative to the equivalent doses obtained by the calculation: darbepoetin by 14–24% and methoxy polyethylene glycol – epoetin beta by 4–30%. The change-over of patients to the subcutaneous administration makes it possible to decline a weekly dose of epoetin alfa by 20–30% by reducing the frequency of taking the drug to twice a week, and to reduce the cost of drug therapy by a third.Conclusion. Intravenous and subcutaneous administrations of epoetin alfa 2500 IU may be a more economical drug therapy in comparison with the equivalent doses of darbepoetin and methoxy polyethylene glycol – epoetin beta.

Uptake of evidence by physicians: De-adoption of erythropoiesis-stimulating agents after the TREAT trial

BackgroundVariation in de-adoption of ineffective or unsafe treatments is not well-understood. We examined de-adoption of erythropoiesis-stimulating agents (ESA) in anemia treatment among patients with chronic kidney disease (CKD) following new clinical evidence of harm and ineffectiveness (the TREAT trial) and the FDA’s revision of its safety warning.MethodWe used a segmented regression approach to estimate changes in use of epoetin alfa (EPO) and darbepoetin alfa (DPO) in the commercial, Medicare Advantage (MA) and Medicare fee-for-service (FFS) populations. We also examined how changes in both trends and levels of use were associated with physicians’ characteristics.ResultsUse of DPO and EPO declined over the study period. There were no consistent changes in DPO trend across insurance groups, but the level of DPO use decreased right after the FDA revision in all groups. The decline in EPO use trend was faster after the TREAT trial for all groups. Nephrologists were largely more responsive to evidence than primary care physicians. Differences by physician’s gender, and age were not consistent across insurance populations and types of ESA.ConclusionsPhysician specialty has a dominant role in prescribing decision, and that specializations with higher use of treatment (nephrologists) were more responsive to new evidence of unsafety and ineffectiveness.

Prolonged response to recombinant human erythropoietin treatment in patients with myelodysplastic syndrome at a single referral centre in Brazil

OBJECTIVES:To evaluate the effects of epoetin (EPO) alfa treatment on overall survival, event-free survival and response duration in patients with myelodysplastic syndrome (MDS) who were treated at a haematological referral centre in northeastern Brazil.METHODS:This was a retrospective cohort study of 36 patients diagnosed with MDS and treated with EPO alfa at 30,000 to 60,000 IU per week. Clinical data were collected from medical records. The events assessed were non-response to treatment and progression to acute myeloid leukaemia (AML). Statistical analyses were performed using GraphPad Prism 7 and SPSS 24 software.RESULTS:The overall survival of patients who received EPO alfa treatment was 51.64%, with a median of 65 months of treatment, and the overall survival of this group was 100% during the first 24 months. We detected a 43.5-month median event-free survival, with a response rate of 80.5%. We observed responses from 25 to 175 months. Patients with transfusion dependence and those with a high-risk stratification, as determined by the International Prognostic Scoring System (IPSS), the Revised International Prognostic Scoring System (IPSS-R), the WHO classification-based Prognostic Scoring System (WPSS) and the WHO 2016, had a lower event-free survival than other patients.CONCLUSIONS:Despite the wide use of EPO alfa in the treatment of anaemia in patients with MDS, the median response duration is approximately only 24 months. Our data provide encouraging results concerning the benefits of using EPO alfa for the improvement of the quality of life, as patients treated with EPO showed higher overall survival, event-free survival rates and longer response durations than have been previously described in the literature.

Managing severe anemia when the patient is a Jehovahʼs Witness: Explaining to patients who cannot accept major blood fractions how available therapies are produced can help them decide which therapies do not violate their religious beliefs.

Managing severe anemia when the patient is a Jehovahʼs Witness: Explaining to patients who cannot accept major blood fractions how available therapies are produced can help them decide which therapies do not violate their religious beliefs.

Dose of Erythropoiesis-Stimulating Agents and Adverse Outcomes in CKD: A Metaregression Analysis

Targeting higher hemoglobin levels with erythropoiesis-stimulating agents (ESAs) to treat the anemia of chronic kidney disease (CKD) is associated with increased cardiovascular risk. Metaregression analysis examining the association of ESA dose with adverse outcomes independent of target or achieved hemoglobin level. Patients with anemia of CKD irrespective of dialysis status. We searched MEDLINE (inception to August 2010) and bibliographies of published meta-analyses and selected randomized controlled trials assessing the efficacy of ESAs for the treatment of anemia in adults with CKD, with a minimum 3-month duration. Two authors independently screened citations and extracted relevant data. Individual study arms were treated as cohorts and constituted the unit of analysis. ESA dose standardized to a weekly epoetin alfa equivalent, and hemoglobin levels. All-cause and cardiovascular mortality, cardiovascular events, kidney disease progression, or transfusion requirement. 31 trials (12,956 patients) met the criteria. All-cause mortality was associated with higher (per epoetin alfa-equivalent 10,000-U/wk increment) first-3-month mean ESA dose (incidence rate ratio [IRR], 1.42; 95% CI, 1.10-1.83) and higher total-study-period mean ESA dose (IRR, 1.09; 95% CI, 1.02-1.18). First-3-month ESA dose remained significant after adjusting for first-3-month mean hemoglobin level (IRR, 1.48; 95% CI, 1.02-2.14), as did total-study-period mean ESA dose adjusting for target hemoglobin level (IRR, 1.41; 95% CI, 1.08-1.82). Parameter estimates between ESA dose and cardiovascular mortality were similar in magnitude and direction, but not statistically significant. Higher total-study-period mean ESA dose also was associated with increased rate of hypertension, stroke, and thrombotic events, including dialysis vascular access-related thrombotic events. Use of study-level aggregated data; use of epoetin alfa-equivalent doses; lack of adjustment for confounders. In patients with CKD, higher ESA dose might be associated with all-cause mortality and cardiovascular complications independent of hemoglobin level.

Economic analysis of epoetin alfa in critically ill trauma patients

Recent randomized control trials (RCTs) suggest that epoetin alfa reduces mortality in critically ill trauma patients; however, epoetin alfa is also costly and associated with adverse events. This study evaluates the cost-effectiveness of epoetin alfa in surgical trauma patients in an intensive care unit setting. We constructed a decision analytic model to compare adjunctive use of epoetin alfa with standard care in trauma patients from the perspective of a Canadian payer. Baseline risks of events, relative efficacy, and resource use were obtained from RCTs and observational studies. One-way and probabilistic sensitivity analyses were conducted and longer time horizons explored through Markov models. Epoetin alfa was associated with a cost per quality-adjusted life year (QALY) gained of $89,958 compared with standard care at 1 year. One-way sensitivity analyses indicated that results were sensitive to plausible ranges of mortality risk, risk of thrombosis, relative risk of mortality, relative risk of thrombosis, and quality of life estimates. Cost-effectiveness acceptability curves generated from probabilistic sensitivity analysis indicated that the probability that epoetin alfa would be considered attractive ranged from 0% to 85% over a willingness-to-pay range of $25,000 to $120,000/QALY. Consideration of lifetime time horizons reduced the cost per QALY gained to $7,203, but results were sensitive to the effect of epoetin alfa on mortality. Although the cost per QALY gained with epoetin alfa use may fall into an acceptable range, there is significant uncertainty about its true cost-effectiveness. If data regarding long-term efficacy and safety are confirmed in future trials, epoetin alfa could potentially be cost-effective in this population. Economic analysis, level I.

Cost-effectiveness of Treating Chronic Anemia with Epoetin Alfa among Hemodialysis Patients in the United States

ObjectivesThe objectives of this analysis were to assess health and economic consequences of targeting hemoglobin (Hb) levels around 10-11g/dL relative to 9-10g/dL using an economic model and to explore the impact of different assumptions on cost-effectiveness. Study DesignClinical and economic impact of treating anemia in the US hemodialysis population to target Hb levels of 10-11g/dL and 9-10g/dL was assessed using a Markov model. A sensitivity analysis assessed the effects of varying assumptions on the model. ResultsOur cost-effectiveness analysis suggests that maintaining Hb 10-11g/dL would result in average reductions of 0.51 hospitalizations and increases of 0.09 quality-adjusted life years per patient, with hospitalization cost offsets of $15,340 over 5 years when compared with Hb of 9-10g/dL. Over the lifetime of the patient, cost-effectiveness improved with hospitalization cost offsets of $21,450 and increases of 0.12 quality-adjusted life years. Sensitivity analysis of individual parameters showed that mortality, hospitalization, health preference, and time horizon of the model had the most influence on cost-effectiveness. ConclusionsOur analysis suggests that epoetin alfa use targeting Hb levels of 10-11g/dL relative to 9-10g/dL may result in better patient outcomes and lower costs. The sensitivity analysis highlighted how assumptions affected cost-effectiveness conclusions; the appropriateness of these assumptions will remain uncertain until new research in today’s dialysis population examining the effects of targeting to lower Hb levels is conducted.

An Open-Label, Randomized, Parallel-Group Study of Perioperative Epoetin Alfa Versus Standard of Care for Blood Conservation in Major Elective Spinal Surgery

Prospective, open-label, randomized, parallel-group study at 80 centers. To demonstrate there is no clinically important additional risk for deep vein thrombosis with perioperative use of epoetin alfa versus standard of care in spine surgery without prophylactic anticoagulation. Trials of epoetin alfa in orthopedic surgery that demonstrated no additional risk of thrombovascular events included perioperative pharmacologic anticoagulation. Subjects received epoetin alfa 600 U/kg subcutaneously once weekly starting 3 weeks before spinal surgery plus standard of care for blood conservation, or standard of care alone. Perioperative anticoagulation therapy was not permitted; mechanical deep vein thrombosis prophylaxis was allowed. Doppler imaging for deep vein thrombosis was done on postoperative day 4 (or day of discharge), or for suspected deep vein thrombosis. Deep vein thrombosis was diagnosed by Doppler result or adverse event report. The criterion for no additional risk of deep vein thrombosis was a 1-sided 97.5% upper confidence limit < or =4% between groups. Of the 680 subjects analyzed (340 in each treatment group), 16 (4.7%) in the epoetin alfa group and 7 (2.1%) in the standard of care group had a diagnosis of deep vein thrombosis either by Doppler or by adverse event report with normal Doppler. The between-group difference was 2.6% (97.5% upper confidence limit, 5.4%). Deep vein thrombosis confirmed by Doppler (4.1% vs. 2.1%), other clinically relevant thrombovascular events (1.5% vs. 0.9%), and all adverse events combined (76.5% vs. 73.2%) occurred with similar frequency in the 2 treatment groups. This study documented a higher incidence of deep vein thrombosis and similar rates of other clinically relevant thrombovascular events with epoetin alfa versus standard of care for blood conservation in subjects who did not receive prophylactic anticoagulation before spinal surgery. Antithrombotic prophylaxis should be considered when erythropoietin is used in the surgical setting.

P45 Clinical impact and QoL in older colon cancer patients after chemotherapy

P45 Clinical impact and QoL in older colon cancer patients after chemotherapy

Epoetin alfa reduces blood transfusion requirements in patients with intertrochanteric fracture

Purpose The purpose of this study is to identify the potential benefits or complications from the use of epoetin alfa in patients with intertrochanteric fracture. Materials and Methods Seventy-nine patients who sustained an intertrochanteric fracture were divided into 2 groups. One group received 10 daily doses of 20 000 IU of epoetin alfa beginning from the day of trauma, whereas the control group received placebo. Results We found a statistically significant difference in the required units of allogenic blood used between the 2 groups ( P = .034). The group that received epoetin alfa also showed an elevation of hematocrit and hemoglobin values, which was statistically significant at the seventh postoperative day ( P = .019 and .015, respectively) compared to the control group. No complications were evident during our study. Conclusions Patients with intertrochanteric fractures seem to benefit from the use of epoetin alfa because it is safe and reduces the need for blood transfusions.

Prevention of anaemia by early intervention with once weekly epoetin alfa during chemotherapy

This study compared the effects of early intervention with standard use of epoetin alfa on haemoglobin (Hb) levels and transfusion requirements in cancer patients receiving chemotherapy. Patients with Hb>10 and ⩽12g/dL were randomised 1:1 to epoetin alfa (40,000 IU, subcutaneously, once weekly), initiated within 7d of the start of the first on-study chemotherapy cycle (defined as early intervention) versus epoetin alfa when Hb⩽10g/dL (defined as standard therapy). Increases in Hb values were significantly higher with early intervention compared to standard therapy from week 6 to 10 (P⩽0.05) and approached significance at week 15/16 (P=0.0531). Although the percentage of patients receiving blood transfusions was similar in both groups, the amount of blood transfused was almost twice as high in the standard epoetin alfa group (n.s.). Early intervention with epoetin alfa was well tolerated and overall survival did not differ significantly between groups. Initiation of epoetin alfa at the onset of chemotherapy and Hb<12g/dL improves Hb levels significantly versus standard therapy.

Erythropoietic agents for anemia of critical illness

Evidence regarding the cost-effective use of and benefits associated with epoetin alfa in treating anemia of critically ill patients is assessed. Anemia of critical illness is a leading cause of inadequate oxygen delivery that affects almost all patients in the intensive care unit setting after day 3. Red blood cell transfusions are commonly used to correct anemia of critical illness, but they are also associated with risks including hemolytic reactions and viral transmission. The latest evidence suggests that when a strict transfusion protocol is implemented, epoetin alfa does not decrease the transfusion requirements of critically ill patients. In the absence of a strict transfusion protocol, an average of 5.1 doses of epoetin, at a cost of $2154, is required to avoid one transfusion. Evidence is accumulating that epoetin may reduce mortality rates in trauma patients. However, important questions remain regarding the magnitude and mechanism of the potential benefit and if the benefit outweighs the risk of thromboembolism. Therefore, the reduction in transfusion-related adverse events is the only clinical outcome benefit that is well-supported by current evidence. However, the known risk of transfusion-related adverse events is low; approximately 29,000 patients would need to be treated to avoid a serious transfusion-related event. Treating these patients would cost over $25 million, and it would take over 100 years to prevent one serious event in a unit admitting 20 epoetin-eligible patients per month. Published data suggest a prohibitive cost associated with epoetin alfa use in critically ill patients given that the only well-supported clinical benefit of this treatment is the avoidance of transfusion-related adverse events. Continued research is necessary to clarify if there is a net clinical benefit of epoetin use (especially in trauma patients) and to develop optimal blood management strategies.

Investigation of Epoetin alfa (EPO) 80,000 Units (U) Every 4 Weeks (Q4W) vs. 40,000 U Every 2 Weeks (Q2W) in Patients with Cancer Not Receiving Chemotherapy (CT) or Radiation Therapy (RT): Final Results.

Recent investigational studies have explored the use of epoetin alfa for the treatment of cancer-related anemia in patients not receiving CT or RT. Previous studies in this patient population showed that EPO was effective in treating anemia at regimens of 40,000 U weekly, 60,000 U Q2W, and 80,000 U every 3 weeks. Because these patients do not experience the myelosuppressive effects of CT or RT, a lower cumulative dose of EPO may be efficacious. The current pilot study was designed to investigate two novel dosing regimens in this population. Based on recent safety concerns from studies with another ESA in cancer patients not receiving CT or RT, enrollment in this study was stopped prematurely. This prospective, randomized, open-label, multi-center study was to enroll 100 patients with an active non-myeloid malignancy, baseline (BL) hemoglobin (Hb) level ≤11 g/dL, and not receiving or planning to receive CT or RT during the course of the study. Non-cytotoxic antineoplastic therapy was allowed. Patients were randomized 1:1 to receive EPO subcutaneously either 80,000 U Q4W (maximum 13-week treatment period) or 40,000 U Q2W (maximum 15-week treatment period). Hb levels were obtained weekly in all patients. EPO was held for Hb level >13 g/dL; dose was reduced for Hb >12 g/dL or Hb increase >1 g/dL in any 2-week period. The primary efficacy endpoint was hematopoietic response (HR), defined as a ≥1 g/dL rise in Hb from BL. Enrollment was stopped at 60 patients (safety population; 29 Q4W, 31 Q2W). All received at least a partial planned cumulative dose of study drug. BL characteristics were similar: % female, 59% Q4W and 61% Q2W; mean age, 73 years Q4W and 71 years Q2W; ECOG 0–1 83% Q4W and 96% Q2W; mean BL Hb, 10.3 g/dL Q4W and 9.9 g/dL Q2W. Prostate was the most common tumor site in both the Q4W (n=6, 21%) and Q2W (n=10, 32%) groups. Efficacy was analyzed in 59 (28 Q4W, 31 Q2W) patients who also had at least one post-BL Hb value (mITT population). HR was achieved in 25 patients (89.3%; 95% CI 71.8, 97.7) in the Q4W group and 28 patients (90.3%; 95% CI 74.2, 98.0) in the Q2W group. The median time to achieve HR was 14 days in the Q4W group and 20 days in the Q2W group. Packed red blood cell transfusion rates for the period Day 29 through end of study were 10.7% (n=3) among Q4W patients and 3.2% (n=1) among Q2W patients. Fewer Q4W (n=20, 69%) vs. Q2W (n=27, 87%) patients required an EPO dose reduction or dose hold. Four patients in each group experienced a serious adverse event unrelated to study drug. No clinically relevant TVEs were reported among Q4W patients, while 2 events (myocardial ischemia and deep vein thrombosis) were reported in a single patient in the Q2W group. Two deaths (both attributed to disease progression) were reported in the Q2W treatment group. The two novel dosing regimens investigated in this study (80,000 U Q4W and 40,000 U Q2W) produced comparable efficacy (with approximately 90% response to either dose regimen) and safety outcomes. Although this study reinforces the dosing flexibility of epoetin alfa with dosing intervals of up to 4 weeks, current labeling warns against the use of ESAs in these types of patients with active malignant disease receiving neither CT or RT.

Efficacy and Safety of Epoetin Alfa in Critically Ill Patients

Anemia, which is common in the critically ill, is often treated with red-cell transfusions, which are associated with poor clinical outcomes. We hypothesized that therapy with recombinant human erythropoietin (epoetin alfa) might reduce the need for red-cell transfusions. In this prospective, randomized, placebo-controlled trial, we enrolled 1460 medical, surgical, or trauma patients between 48 and 96 hours after admission to the intensive care unit. Epoetin alfa (40,000 U) or placebo was administered weekly, for a maximum of 3 weeks; patients were followed for 140 days. The primary end point was the percentage of patients who received a red-cell transfusion. Secondary end points were the number of red-cell units transfused, mortality, and the change in hemoglobin concentration from baseline. As compared with the use of placebo, epoetin alfa therapy did not result in a decrease in either the number of patients who received a red-cell transfusion (relative risk for the epoetin alfa group vs. the placebo group, 0.95; 95% confidence interval [CI], 0.85 to 1.06) or the mean (+/-SD) number of red-cell units transfused (4.5+/-4.6 units in the epoetin alfa group and 4.3+/-4.8 units in the placebo group, P=0.42). However, the hemoglobin concentration at day 29 increased more in the epoetin alfa group than in the placebo group (1.6+/-2.0 g per deciliter vs. 1.2+/-1.8 g per deciliter, P<0.001). Mortality tended to be lower at day 29 among patients receiving epoetin alfa (adjusted hazard ratio, 0.79; 95% CI, 0.56 to 1.10); this effect was also seen in prespecified analyses in those with a diagnosis of trauma (adjusted hazard ratio, 0.37; 95% CI, 0.19 to 0.72). A similar pattern was seen at day 140 (adjusted hazard ratio, 0.86; 95% CI, 0.65 to 1.13), particularly in those with trauma (adjusted hazard ratio, 0.40; 95% CI, 0.23 to 0.69). As compared with placebo, epoetin alfa was associated with a significant increase in the incidence of thrombotic events (hazard ratio, 1.41; 95% CI, 1.06 to 1.86). The use of epoetin alfa does not reduce the incidence of red-cell transfusion among critically ill patients, but it may reduce mortality in patients with trauma. Treatment with epoetin alfa is associated with an increase in the incidence of thrombotic events. (ClinicalTrials.gov number, NCT00091910 [ClinicalTrials.gov].).

Effect of preprinted order form on epoetin alfa prescribing

The effect of a required preprinted order form on the prescribing of epoetin alfa was evaluated. An initial drug-use evaluation (DUE) was conducted in January 2004 to determine how closely prescribing guidelines for epoetin alfa were being followed. A preprinted order form was then developed and approved by the medical staff, with use required for all adult epoetin alfa orders. A follow-up DUE was conducted in January 2006 to assess the effects of the preprinted order form on prescribing patterns. Expenditures for epoetin alfa for 12 months before and after implementation of the preprinted order form were also calculated. Data for 45 and 44 patients were reviewed for the initial and follow-up DUEs, respectively. Smaller doses were ordered at more frequent intervals and epoetin alfa was prescribed more often by nephrologists and less frequently by surgeons and critical care intensivists after implementation of the preprinted order form. Use of epoetin alfa according to hospital guidelines improved from 44% to 73% (p = 0.0089). Significantly more patients' ferritin and transferrin saturation values were measured postimplementation of the order form (p = 0.0176). In addition, the annual expense for epoetin alfa was reduced by $151,042, a 36% reduction from baseline. Implementation of a required preprinted order form increased the frequency of appropriate prescribing of epoetin alfa in a community teaching hospital.

Use of Hematopoietic Growth Factors as Adjuvant Therapy for Anemia and Neutropenia in the Treatment of Hepatitis C

To review the hematologic adverse effects of hepatitis C virus (HCV) therapy and adjuvant treatment with epoetin alfa and granulocyte colony-stimulating factor (ie, filgrastim). Medical literature indexed in MEDLINE (1966-January 2007) and EMBASE (1980-January 2007) was searched, and published conference abstracts were reviewed. Peer-reviewed articles and relevant conference abstracts regarding the use of epoetin alfa and granulocyte colony-stimulating factor were reviewed. Ribavirin induces a dose-dependent hemolytic anemia. Studies using epoetin alfa 40 000 units subcutaneously once weekly have demonstrated efficacy in maintaining hemoglobin, ribavirin dose, and quality of life scores, but clear benefit shown with sustained virologic response (SVR) is lacking. The hemoglobin threshold for initiation of epoetin alfa used in studies may not adequately reflect values used in clinical practice. Treatment-related neutropenia is caused primarily by interferon or peginterferon. Few studies have investigated the impact of granulocyte or granulocyte-macrophage colony-stimulating factor derivatives on neutropenia. Results of dose maintenance evaluation vary, and studies reporting data on SVR showed no effect from growth factor therapy. The frequency of bacterial infections was not reported. The role and benefit of hematopoietic growth factors in HCV therapy have not been conclusively determined to date. However, the possibility of a benefit to individual patients seen on an outpatient basis remains, and an individualized treatment approach is recommended.

EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update

EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update