Gene/Protein Disease Symptom Drug Enzyme Compound
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Anaemia is a common occurrence in patients with cancer, resulting in symptoms such as fatigue that have a profound impact on quality of life. Anaemia is also associated with poor treatment outcome and overall survival. Epoetin beta, a recombinant human erythropoietin that has the same structure and function as the endogenous hormone, is an effective and safe treatment of cancer-related anaemia. Various studies in patients with solid tumours have shown that this agent effectively increases haemoglobin levels and reduces the need for emergency blood transfusions regardless of the type of concomitantly administered chemotherapy. Epoetin beta also improves the quality of life of anaemic patients with cancer, decreasing fatigue and improving the ability to perform usual daily activities. In addition, epoetin beta prevents severe anaemia and reduces transfusion requirements in patients with a high-risk of developing anaemia during chemotherapy, such as those receiving platinum-based regimens. A meta-analysis of epoetin beta trials showed that epoetin beta has no negative impact on survival or thrombosis-related survival and may reduce the risk of tumour progression in patients with solid or lymphoid malignancies. Another study has shown epoetin beta to be equally effective when administered once weekly or three times weekly. Therefore, epoetin beta offers an effective, safe and convenient therapy for the management of anaemia in patients with cancer.
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PMID:Epoetin beta therapy in patients with solid tumours. 1616 42

Erythropoietin is a hypoxia-induced hormone that is a major regulator of normal erythropoiesis. Over the last decade, the production of recombinant human erythropoietin has revolutionized the treatment of anemia associated with chronic renal failure, and has led to a greater understanding of anemia pathophysiology and to the elucidation of the interactions of erythropoietin, iron, and erythropoiesis. Anemia has been shown to be independently associated with increased mortality and disease progression. Potential survival benefits associated with correction of anemia have expanded considerably the indications of erythropoietin use in various patient populations and are leading to consideration of earlier, more aggressive treatment of mild to moderate anemia. The results of such treatment are promising in a variety of new clinical settings, including anemia associated with congestive heart failure. Furthermore, the erythropoietin receptor is widely distributed in the cardiovascular system, including endothelial cells, smooth muscle cells and cardiomyocytes and preclinical studies have established erythropoietin to be a pleiotropic cytokine with anti-apoptotic activity and tissue-protective actions in the cardiovascular system, beyond correction of hemoglobin levels. Despite some potential adverse effects, such as hypertension, and the occurrence of erythropoietin resistance, early studies in heart failure patients with anemia suggest that erythropoietin therapy is safe and effective in reducing left ventricular hypertrophy, enhancing exercise performance and increasing ejection fraction. Anemia is found in about one-third of all cases of congestive heart failure (CHF). The most likely common cause is chronic renal insufficiency, which is present in about half of all CHF cases. However, anemia can occur in CHF without renal insufficiency and is likely to be due to excessive cytokine production. The anemia itself can worsen cardiac function, both because it causes cardiac stress through tachycardia and increased stroke volume, and because it can cause a reduced renal blood flow and fluid retention, adding further stress to the heart. Long-standing anemia of any cause can cause left ventricular hypertrophy, which can lead to cardiac cell death through apoptosis and worsen CHF. Therefore, a vicious circle, cardio-renal anemia syndrome, is set up wherein CHF causes anemia, and the anemia causes more CHF and both damage the kidneys worsening the anemia and the CHF further and increasing mortality. There is now evidence that early correction of the CHF anemia with subcutaneous erythropoietin and intravenous iron improves shortness of breath and fatigue, cardiac function, renal function and exercise capacity, reducing the need for hospitalization and improving quality of life. In the present review we discuss the data on current clinical use of erythropoietin in cardiovascular disease, with the main focus on the treatment of congestive heart failure, and summarize the advances and progress made in the understanding of the hematopoietic and pleiotropic effects of erythropoietin in the cardiovascular system.
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PMID:Erythropoietin in heart failure and other cardiovascular diseases: hematopoietic and pleiotropic effects. 1624 29

(1) Current treatments for anaemia in patients receiving cancer chemotherapy include blood transfusion and epoetin alfa and beta. These epoetins correct anaemia in 40% to 65% of patients and reduce the number of patients who require transfusions during the second and third months of treatment by 12-35% in absolute terms. (2) Darbepoetin alfa is slightly more glycosylated than epoetin alfa and beta. It is no more effective than these two drugs in chronic renal failure. Darbepoetin alfa is now approved for the treatment of anaemia in patients who are receiving chemotherapy for non myeloid malignancies. (3) Two placebo-controlled dose-finding studies and two placebo-controlled trials involving nearly 1000 patients in total have shown that darbepoetin alfa decreases the number of transfused patients by 17-25% in absolute terms, and that it probably reduces fatigue. However, one-quarter of patients receiving darbepoetin were nonetheless transfused. (4) In the absence of reliable comparisons, there is no firm evidence that darbepoetin alfa is more effective than other epoetins. (5) According to relatively imprecise company reports, darbepoetin alfa increased the risk of thromboembolic events during clinical trials (6% versus 3%), including pulmonary embolism (1.3% versus 0%); the company also states that darbepoetin alfa does not increase the risk of arterial hypertension, a classical effect of epoetin that is mentioned in the summary of product characteristics (SPC). Placebo-controlled trials and dose-finding studies show no impact on the outcome of cancer, but follow-up is limited and a negative effect cannot be ruled out. The company states that no cases of erythroblastopenia have occurred among more than 70 000 treated patients. (6) According to the SPC, darbepoetin alfa can be given once a week. However, the optimal epoetin dosing schedule is unknown. Epoetin therapy takes several weeks to correct anaemia, whereas transfusion is immediately effective. (7) In practice, darbepoetin alfa seems a little easier to administer than epoetin alfa or beta, but the advantages and disadvantages of these drugs as compared with blood transfusion are not entirely clear.
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PMID:Darbepoetin alfa: new indication/new dosage. No proven advantage in chemotherapy-induced anaemia. 1628 72

Patients with cancer-related anemia have an inadequate Epo response that is further impaired by cancer treatments such as chemotherapy. Significant number of studies have demonstrated that treatment of anemia in cancer patients using recombinant human EPO(rHuEPO, epoetin alfa) significantly increases hemoglobin(Hb) levels,reduces transfusion requirements,and improves quality of life,particularly by relieving fatigue. However,the findings of several studies have raised the possibility of an adverse effect of thromboembolism. The American Society of Clinical Oncology and the American Society of Hematology developed an evidence-based clinical practice guideline for the use of epoetin in patients with cancer. In cancer patients, the risk of bleeding depends not only on the platelet count, but also on the underlying disease, in accordance with coagulation defects. The cause of thrombocytopenia must be established prior to platelet transfusion since platelet transfusions may be relatively contraindicated in certain conditions e. g., heparin-induced thrombocytopenia(HIT), and thrombotic thrombocytopenic purpura/hemolytic uremic syndrome(TTP/HUS).
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PMID:[Approaches to anemia, thrombocytopenia, and DIC in cancer patients]. 1641 Jun 90

In a large, 16-week, prospective study of 2,964 anemic patients with various cancers undergoing chemotherapy, once-weekly subcutaneous administration of 40,000 U of epoetin alfa,with potential escalation to 60,000 U, increased hemoglobin (Hgb) levels, decreased transfusion requirements, and improved quality of life (QOL) as assessed using the Linear Analog Scale Assessment (LASA) for energy, activity, and overall QOL and the Functional Assessment in Cancer Therapy-Anemia (FACT-An) QOL instrument. A retrospective subset analysis conducted in 244 colorectal cancer patients enrolled in the study showed statistically significant improvements from baseline to final readings in LASA energy, activity, and overall QOL and FACT-An Anemia Symptoms and Fatigue subscale scores (P < 0.02). Moreover, patients who achieved larger improvements in Hgb levels also demonstrated greater percentage improvements in QOL over baseline measurements. Mean Hgb levels increased by 1.2 g/dL after 4 weeks of treatment and by 1.6 g/dL by study end, independent of red blood cell transfusion within 28 days prior to the Hgb assessment. Hematopoietic response (Hgb level > or = 12 g/dL and/or increase in Hgb level > or = 2 g/dL, independent of transfusion) was observed in 61% of patients (139/229). Additionally, the proportion of patients receiving transfusions decreased from 17% at baseline to 4% during the final month of therapy. Epoetin alfa was well tolerated, with no evidence of unexpected adverse events. Except for significantly higher QOL scores at baseline, results for the cohort of colorectal cancer patients were similar to those for patients with other cancer types in the main study population.
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PMID:Clinical benefits of once-weekly epoetin alfa in anemic patients with colorectal cancer receiving chemotherapy. 1672 48

The aim of the 18 months follow up study was to assess the frequency of anemia during IFN/RBV therapy in patients with chronic hepatitis C; to manage anemia either with recombinant human erythropoietin (rHuEPO)--epoetin alpha or with RBV dose reduction and to compare the rate of SVR in patients with RBV dose reduction and with administration of epoetin alpha. Study enrolled 61 patients with chronic active hepatitis C aged 33-61 years. All patients had HCV genotype 1b. Out of them 41 were male and 20 female. Anemia (Hb <10 or >2 g/dL Hgb drop from baseline) developed in 41 patients out of 61 (67,21%) during the therapy. These 41 patients were randomized into two groups: 21 patients who received 40 000 IU epoetin alpha weekly (I group) and 20 patients in whom for managing anemia we used standard of care (SOC) or RBV dose reductions from 1000/1200 to 800/600 mg (II group). In all 21 patients of the I group the Hb level normalized without reduction of RBV dose. In this group of patients SVR at 6 months after completion of full course of treatment was achieved in 17 (66%) patients. Improvement of quality of life (QOL) was observed in all 21 patients. Out of 20 patients of II group with standard of care (SOC) 5 patients developed symptomatic anemia with fatigue and dyspnoea; RBV was stopped temporarily. In 15 patients RBV dose was reduced from 1200 mg to 600 mg for correction of anemia. In this group of patients SVR at 6 months after treatment completion was achieved in 7 (25%) patients. Lower RBV doses yield a lower treatment response in patients with HCV genotype 1. In anemic HCV-infected patients on RBV/PEG-IFN therapy, EPO maintains RBV dose and significantly improves anemia and QOL. EPO has the potential to improve adherence rate, which may in turn improve SVR.
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PMID:Ifn/Rbv treatment induced anemia and its correction with epoetin alpha in patients with hepatitis C. 1698 Jul 47

Anaemia has a high incidence in cancer patients, especially when it is a consequence of myelosuppressive treatments. The incidence and prevalence of this condition is influenced by the type and extension of the tumour, type and intensity of the myelosuppressive treatment that patients receive, and previous surgery or intercurrent infections. Clinical manifestations of anaemia, overlapped by tumour symptomatology, depend on haemoglobin (Hb) levels; these manifestations cause impairment of the functional capacity, as well as a negative impact on the quality of life (QOL) of cancer patients as a consequence. Erythropoietin treatment for anaemia has been established as optimal for correcting Hb levels. Its impact on patients' QOL has been evaluated in numerous randomised prospective studies by the use of diverse types of erythropoietin and administration modes. The three types of erythropoietin, alpha, beta and darbepoetin alpha, have shown a clear efficacy in all haematological parameters. This positive effect is related with significant improvements in the QOL of patients, especially those patients undergoing myelosuppressive treatments, and with regard to specific scales of fatigue and anaemia.
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PMID:Impact of erythropoietin treatment on the quality of life of oncologic patients. 1797 25

Anemia has a high prevalence and incidence in patients with cancer and is associated with a range of symptoms, including fatigue, which affect the vast majority patients receiving chemotherapy exerting a considerable impact on patients' quality of life. The development of the erythropoiesis-stimulating agent epoetin represented a major step forward in the treatment of chemotherapy-related anemia, providing an effective and safe alternative to red blood cell transfusions. The subsequently introduced epoetin analogue, darbepoetin alpha, with a prolonged serum half-life, allowed for extended dosing intervals and less frequent administration. Recently published large prospective trials provided the oncology community with new important information on the use of currently available erythropoietic agents to improve anemia in patients suffering from cancer. However, it is also clear from recent reports that scrutiny on the safe use of these drugs is still required.
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PMID:Darbepoetin alpha coming of age. 1821 54

Patients with breast cancer treated with adjuvant chemotherapy experience not only fatigue and menopausal symptoms but also documented cognitive dysfunction and reduced capacity to carry out activities of daily living. The role of epoetin alfa in improving cognition and functional capacity was assessed in a large randomized trial through patient self-reported outcomes. Patients with breast cancer (N = 354, adjuvant and metastatic) undergoing chemotherapy were randomized in a 1:1 ratio to receive epoetin alfa (40,000 IU once weekly) or the standard of care (SOC). Change in patient-reported Health Utilities Index Mark 3 (HUI3) from baseline to week 12 was compared between the epoetin alfa and SOC groups. In addition, correlations between the disease-nonspecific HUI3 utility scale and the cancer-specific quality of life instrument Functional Assessment of Cancer Therapy-Anemia (FACT-An) and Fatigue subscales were assessed. Epoetin alfa treatment significantly improved HUI3 scores compared with patients receiving SOC (P = 0.036). Three subscales within HUI3 were also significantly better for epoetin alfa-treated patients (emotion, P = 0.048; ambulation, P = 0.048; and cognition, P = 0.02). Moreover, a strong correlation (P = 0.0001) exists between the disease-nonspecific utility scale HUI3 and the disease-specific FACT-An and FACT-Fatigue scales in terms of overall scores and score changes. The findings of the study demonstrate for the first time in patients with breast cancer that epoetin alfa significantly enhances functional well-being, which translates into significantly better utility scores. In addition, epoetin alfa also significantly improved cognitive function of women undergoing chemotherapy, and this could have an important impact on their lives from a societal perspective.
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PMID:Weekly administration of epoetin alfa improves cognition and quality of life in patients with breast cancer receiving chemotherapy. 1862 59

Anemia is common in patients with hematologic malignancies, occurring in up to 70% of patients; it is associated with debilitating fatigue and weakness that negatively affect the ability of patients to conduct daily activities and cope with cancer. The severity of anemia in this population is dependent on the specific malignancy diagnosed, extent of disease, and the type and duration of chemotherapy received. Despite the well-known adverse consequences of anemia in patients with cancer, nearly half of patients with hematologic malignancies do not receive treatment for anemia. Clinical trials have demonstrated that treatment with erythropoietic agents (ie, epoetin alfa, epoetin beta, and darbepoetin alfa) in anemic patients with hematologic malignancies significantly increases hemoglobin (Hb) and reduces transfusion requirements. In addition, there is growing evidence to support the role of these agents in alleviating anemia-related symptoms and improving quality of life (QOL). Clinical practice guidelines issued by the National Comprehensive Cancer Network recommend erythropoietic therapy for patients receiving chemotherapy who have a Hb level </= 11 g/dL and symptoms or risk factors related to anemia. However, several trials of epoetin alfa therapy in patients with solid tumors or hematologic malignancies and mild-to-moderate anemia (Hb levels >/= 8 g/dL to </= 12 g/dL) receiving chemotherapy have demonstrated a positive effect on hematologic and QOL outcomes. Final results from a recent clinical trial evaluating the effects of earlier treatment with epoetin alfa on hematologic outcomes, QOL, health care resource utilization, and work/productivity in patients with mild anemia will provide further information on the most appropriate strategy for anemia treatment in this population.
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PMID:Treatment of anemia with erythropoietic agents in patients with hematologic malignancies. 1862 76


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