Increase In Hb Levels Research Articles

Influence of Loop Diuretics on Prevalence of Anemia in Patients with Congestive Heart Failure

Background. It has recently been found that mild-to-moderate anemia is common in patients with congestive heart failure (CHF), occurring in 25% to 80% of patients. Hemodilution is common in patients with CHF but does not frequently recognized because estimation of plasma and red blood cell volumes needs radioisotope techniques. We examined whether a significant increase in Hb levels during treatment with loop diuretics within first days after admission indicates to presence of the hemodilution. Methods.

P086 Once weekly recombinant human erythropoietin treatment for cancer-induced anemia in children with acute lymphoblastic leukemia receiving maintenance chemotherapy: A randomized case-controlled study

Background: Patients receiving chemotherapy for cancer often develop anemia, which can contribute to increased morbidity and reduced quality of life (QOL). Chemotherapy-induced anemia can be successfully treated using recombinant human erythropoietin (rHuEPO). Aim of the study: To demonstrate the effectiveness of once-weekly (QW) rHuEPO dosing to effect improved hemoglobin levels, decreased transfusion use, and improved functional outcomes and QOL in pediatric leukemic patients (ALL) receiving maintenance chemotherapy. Patient and methods: This was a prospective randomized, single-center, open-label, 12-week case-control study of epoetin alfa in pediatric patients with acute lymphoblastic leukemia (ALL) in remission receiving maintenance chemotherapy. Sixty patients were randomly assigned to receive either epoetin alfa (rHuEPO group 1⁄4 30 cases, 17 males and 13 females, age; 6.8 ^ 2.33 years), or no epoetin alfa (control group 1⁄4 30 cases, 16 males and 14 females, age; 6.76 ^ 2.28 years). Both groups were matched as regard age, sex, baseline Hb concentration, remission state, chemotherapy regimen, numbers and amount of blood transfusion, and leukemia state (both were low and standard risk). Epoetin alfa was administered at a dose of 450 IU/kg, once weekly, subcutaneously (s.c.) for 12 consecutive weeks. Endpoints were changes in hematologic and QOL parameters. Results: Among the 30 patients evaluable for hematologic response, the mean increase in Hb from baseline to time of final evaluation was 3.08 ^ 1.48 g/dl ( p , 0.001). An increase in Hb of ^ 2 g/dl, in the absence of blood transfusion, occurred in 70% of patients (21 of 30 patients) who were on the study for ^ 30 days. The overall response rate (Hb increase ^ 2 g/dl or Hb ^ 12 g/dl in the absence of blood transfusion) was 90% (27 of 30 patients). In 30 patients who were evaluable for QOL assessment, epoetin-a therapy was found to significantly (p , 0.001) improve mean cancer linear analog scale (CLAS) scores for energy level, ability to perform daily activity, and overall QOL from baseline to the time of final evaluation. QW epoetin-a was found to be well tolerated. Conclusion: Treatment with QW epoetin-a was found to increase Hb levels, decrease transfusion requirement, and improve functional status and QOL in anemic patients with ALL in maintenance receiving chemotherapy. The once-weekly schedule is convenient, safe, and may reduce the burden on patients, parents, and their caregivers by reducing the number of visits to the clinic.

Low Birth Weight and Normal Birth Weight Newborns of Kolkata, India: Comparison of Some Maternal Risk Factors

This study compared several maternal risk factors of low birth weight (LBW) between 204 normal birth weight (NBW) and 133 LBW newborns from Kolkata, India. Based on their birth weight (BW), newborns were classified as LBW (BW < 2.5 kg) and NBW (BW ≥ 2.5 kg). Results revealed that means for maternal age (MA, p < 0.05), gestational age (GA, p < 0.01), hemoglobin (Hb) concentration (p < 0.05), and per capita daily income (PCDI, p < 0.05) were significantly higher among mothers of NBW. Correlation analyses revealed that MA (r = 0.119, p < 0.05), GA (r = 0.583, p < 0.01), PCDI (r = 0.118, p < 0.05), and Hb (r = 0.138, p < 0.05) were significantly positively correlated with BW; PCDI was also significantly positively correlated (r = 0.142, p < 0.01) with Hb. Stepwise regression analyses with BW as the dependent variable revealed that GA (t = 7.915, p < 0.001) and Hb (t = 2.057, p < 0.05) were the most important predictive variables. The effect of Hb, independent of GA, was statistically significant (change in F = 4.231, p < 0.05). Because GA is not modifiable in pregnant women, there is a need to increase Hb levels among pregnant mothers. Most importantly, appropriately targeted preventive strategies, including iron supplementation, need to be implemented for health promotion.

Epoetin delta in the management of anaemia in cancer patients

19555 Background: Cancer is often associated with anaemia. Epoetin delta (Shire plc) differs from recombinant erythropoietins as it is produced in a human cell line using gene-activation technology. We report data from a controlled trial of epoetin delta (ED) and an extension study. Methods: Cancer patients with anaemia (haemoglobin [Hb] = 10.5 g/dL) were randomized to 12-weeks’ treatment with ED (150 or 300 IU/kg) or placebo (double blind). Treatment was given subcutaneously, three-times weekly. Patients were included if they were receiving chemotherapy and had at least two cycles remaining when randomized. Primary objective was to demonstrate a difference between ED and placebo in Δ Hb from baseline and the number of patients requiring blood transfusions. Target sample size was 100 patients per arm (99% power for a 1.6 g/dL difference in Δ Hb and a 29% difference in the percentage of patients requiring transfusions). Patients completing the study entered an open-label, 12-week extension in which all initially received ED 150 IU/kg. Dose could be increased to 300 IU/kg if Hb levels were &lt; 12 g/dL after 4 weeks. Results: In total, 313 patients were randomized (100, 103 and 99 to ED 150 and 300 IU/kg, and placebo, respectively). Mean change ± SD in Hb from baseline was 2.47 ± 2.39, 2.46 ± 2.56 and 0.57 ± 1.7 in the ED 150 and 300 IU/kg, and placebo groups respectively (P &lt; 0.0001 for both comparisons). There was no difference in the proportion of patients requiring transfusions (26.0, 21.9 and 26.9%, respectively). In the second study, Hb levels were maintained in those previously on ED and increased in those previously on placebo (2.55 g/dL). In those previously on ED, transfusion requirements were lower. ED was well tolerated. Conclusions: Epoetin delta was effective in increasing Hb levels in patients with anaemia related to cancer and longer treatment was associated with fewer transfusions. No significant financial relationships to disclose.

Preoperative intravenous iron administration corrects anemia and reduces transfusion requirement in women undergoing abdominal hysterectomy

SUMMARYWe prospectively investigated the utility of preoperative intravenous (IV) iron treatment to increase hemoglobin (Hb) levels and reduce the need for transfusion in women with iron deficiency anemia (IDA) or iron deficiency (ID) scheduled for elective abdominal hysterectomy. Seventy‐five women with ID or IDA were enrolled in the study. Women having their surgical procedure at least 1 month after preoperative assessment received IV iron sucrose during 2–4 weeks (IV iron group, n = 31). Women having their surgical procedure a few days after preoperative assessment did not receive IV iron (control group, n = 44). At baseline, there were no differences between the two groups in terms of weight or age, prevalence of anemia, Hb levels or iron laboratory parameters. IV iron sucrose (760 ± 290 mg) increased preoperative Hb (ΔHb: 2.2 ± 1.2 g/dL; P &lt; 0.001) and reduced postoperative transfusion rates when compared with the control group (32%vs. 0%, respectively; P &lt; 0.001). In addition, fewer women from the IV iron group were anemic on postoperative day 21 (23%vs. 68%, respectively; P &lt; 0.01). No life‐threatening iron sucrose adverse effect was observed. Because of the rapid increase in Hb levels, IV iron sucrose administration seems to be an effective approach for treating preoperative anemia and reducing transfusion rates in this female population.

Darbepoetin, effective treatment of anaemia in paediatric patients with chronic renal failure

Darbepoetin alfa (DA) is a unique long-acting treatment for anaemia in patients with chronic renal failure (CRF). This study assessed the mean dose of DA to achieve and maintain haemoglobin (Hb) levels between 11 g/dl and 13 g/dl in CRF children aged 11 years to 18 years. This observational, prospective study was conducted in 39 patients treated with DA. Twenty-nine patients were switched from recombinant human erythropoietin (r-HuEPO), and ten patients were naive to r-HuEPO. Naive patients received initial doses of 0.45 μg/kg of DA. Switched patients received a dose adjusted to the prior dose of r-HuEPO (200 IU r-HuEPO:1 μg DA). Among the switched patients, 79.3% received dialysis. No naive patients underwent dialysis. Overall, 74% of patients showed increased Hb level, with a mean value of 11.6 ± 1.6 g/dl, using a mean DA dose of 0.63 ± 0.48 μg/kg per week, and 66.7% patients reached the target Hb level. Hb increased in naive patients from 9.5 (95% CI: 7.7, 11.4) to 11.7 (95% CI: 10.9, 12.6) g/dl and in switched patients from 11.1 (95% CI: 10.6, 11.5) to 11.5 (95% CI: 10.8, 12.2) g/dl). Higher doses of DA were needed in the “switched” than in the “naive” patients to maintain Hb levels over 11 g/dl, respectively 0.73 (95% CI: 0.54, 0.92) and 0.34 (95% CI: 0.16, 0.52) μg/kg per week. Our results indicate the doses of DA necessary to treat CRF patients aged 11 years to 18 years. DA was an effective treatment to stabilise CRF patients at extended dosing intervals.

Correlation between variation in quality of life and change in hemoglobin level after treatment with epoetin alfa 40,000 IU administered once-weekly

Anemia is frequently associated with cancer due to the disease itself and antineoplastic treatments. This open-label, uncontrolled, multi-center study evaluated the effects of once-weekly (qw) epoetin alfa 40,000 IU on hemoglobin (Hb) levels and quality of life (QoL) in anemic patients receiving chemotherapy for solid tumors. A total of 522 patients with Hb level < or =12 g/dL received epoetin alfa 40,000 IU qw subcutaneously for 9-20 weeks to reach and maintain Hb range of 12-14 g/dL. QoL was assessed with the Functional Assessment of Cancer Therapy-Anemia (FACT-An [anemia sub-scale]) and Cancer Linear Analogue Scale (CLAS) at study entry, after two chemotherapy cycles, and at study end. Mean baseline Hb was 10.43 g/dL. Hb increases (g/dL) from baseline after 4, 8, 12 weeks and at study end were 1.07, 1.77, 1.92 and 1.71 g/dL, respectively. Response rates (Hb increase > or =1 and > or =2 g/dL during trial) were 81% and 61%, respectively. Mean increases in the FACT-An score from baseline (mean 55.4) were 3.1 after two chemotherapy cycles and 3.3 at study end; mean increases in the CLAS score from baseline (58.4 mm) were 5.9 mm after two chemotherapy cycles and 6.5 mm at study end. The greatest QoL increase was recorded when patients approached Hb level of 12 g/dL, independent of the baseline Hb level. Hb changes from baseline to trial end were related to corresponding changes in the FACT-An score. A positive correlation was also observed in patients with progressive disease. Adverse events were essentially those associated with chemotherapy. Incidence of thrombovascular events (6.7%) did not differ from the expected standard treatment in cancer patients. Epoetin alfa 40,000 IU qw increased Hb levels and improved or preserved QoL.

A dose exploration, phase I/II study of administration of continuous erythropoietin receptor activator once every 3 weeks in anemic patients with multiple myeloma receiving chemotherapy

Continuous erythropoietin receptor activator (C.E.R.A.) is an innovative agent with unique erythropoietin receptor activity and a prolonged half-life, which has the potential for administration at extended dosing intervals. The objectives of this dose-finding study were to evaluate the hemoglobin (Hb) dose-response, pharmacokinetics, and safety of repeated doses of C.E.R.A. given once every 3 weeks to anemic patients with multiple myeloma (MM) receiving chemotherapy. This was an exploratory two-stage, open-label, parallel-group, multicenter study. Patients received C.E.R.A. doses of 1.0, 2.0, 3.5, 4.2, 5.0, 6.5, or 8.0 mg/kg once every 3 weeks by subcutaneous injection initially for 6 weeks, followed by a 12-week optional extension period. The primary outcome measures were the average Hb level and its change from baseline over the initial 6-week period, based on values of the slope of the linear regression analysis and the area under the curve. Rates of Hb response (defined as an increase in Hb of > or =2 g/dL without transfusion) and blood transfusion were also evaluated. Sixty-four patients entered the study. Dose-related increases in Hb levels were observed during the initial 6-week treatment period for C.E.R.A. doses of 1.0-4.2 mg/kg, with a similar response observed at higher doses. At least 70% of patients receiving 2.0-8.0 mg/kg of C.E.R.A. had Hb responses during the 18-week study. The elimination half-life of C.E.R.A. was found to be long (6.3-9.7 days [151.2-232.8 hours]). All doses were generally well tolerated. Based on its unique, long elimination half-life, C.E.R.A. has been demonstrated to be an effective and well-tolerated treatment of anemia given once every 3 weeks to patients with multiple myeloma receiving chemotherapy.

Effect of Iron Supplementation on Haemoglobin Response in Children: Systematic Review of Randomised Controlled Trials

To evaluate the effect of iron supplementation on haemoglobin (Hb) in children through a systematic review of randomised controlled trials. Electronic databases, personal files, hand search of reviews, bibliographies of books, and abstracts and proceedings of international conferences were reviewed. Randomised controlled trials evaluating change in Hb levels with interventions that included oral or parenteral iron supplementation or iron-fortified formula milk or cereals were analysed. A total of 55 trials (56 cohorts) provided relevant information. Publication bias was evident (P < 0.001). The pooled estimate (random-effects model) for change in Hb with iron supplementation (weighted mean difference) was 0.74 g/dL (95% CI, 0.61-0.87; P < 0.001; P < 0.001 for heterogeneity). Lower baseline Hb level, oral medicinal iron supplementation, and malarial nonhyperendemic region were significant predictors of greater Hb response and heterogeneity. Projections suggested that, on average, between 37.9% and 62.3% of baseline anaemia (Hb <11 g/dL) was responsive to iron supplementation among children under 6 years of age; the corresponding range for malarial hyperendemic regions was 5.8% to 31.8%. This systematic review indicates that iron supplementation increases Hb levels in children significantly but modestly. The increase is greater in subjects who are anaemic at the start of the trial and lower in malarial hyperendemic areas and in those consuming iron-fortified food. The projected reductions in prevalence of anaemia with iron supplementation alone highlight the need for additional area-specific interventions, particularly in malaria-prone regions.

Functional iron deficiency in hemodialysis patients with high ferritin

Although functional iron deficiency (FID) may be present in hemodialysis (HD) patients with high serum ferritin levels (>800 ng/mL), current protocols often preclude the use of intravenous (IV) iron in these patients. However, it has not been demonstrated that iron supplementation during erythropoietin therapy is ineffective or unsafe in increasing hemoglobin (Hb) levels in patients with high serum ferritin. This report describes the hematologic efficacy and safety of ferric gluconate (FG) therapy in patients with serum ferritin >800 ng/mL. A retrospective analysis was performed on HD patients at a single California dialysis center from January 1 to December 31, 2003. Patients classified as having high ferritin levels (serum ferritin >800 ng/mL on at least 66% of routine monthly measurements and transferrin saturation [TSAT] <25% on at least 1 occasion) were stratified as follows: patients in Group I were suspected of having FID and received FG > or =250 mg IV over a 3-month period when Hb was <11 g/dL, and patients in Group II were thought not to have FID and received <250 mg FG over a 3-month period. Both groups received standard recombinant human erythropoietin therapy as per the unit's protocol. Of 496 patients, 95 exhibited high ferritin and of these, 39 patients had sufficient data for analysis. Group I patients (n=14) showed a significant increase in Hb levels compared with Group II (n=25). There was no increase in ferritin levels in response to iron administration. No significant differences in hospitalizations or infections were observed between groups. Hemodialysis patients with high ferritin levels may have FID, and IV iron therapy safely improves FID in some patients. A larger randomized trial examining the optimal management of iron administration in HD patients with high ferritin levels is warranted.

Treatment of Anemia of Myelodysplastic Syndromes and Improvements in Cardiac Geometry.

Introduction: Anemia is a common complication of myelodysplastic syndromes (MDS). Recently, it has been associated with cardiac changes (remodeling) which, in turn, may lead to cardiovascular morbidity and mortality (Oliva et al., Leuk Res, 2005). Hemodynamic factors may lead to gradual cardiac enlargement and left ventricular hypertrophy (LVH) to be expected in such patients at Hb < 10.7 g/dL. Epoetins induce erythroid responses in about 40% of cases so from a pharmoeconomic viewpoint an accurate selection of patients more likely to be responders is recommended. Though increases in Hb levels are correlated with improvements in quality of life (QoL), the effects on cardiac geometry have not been explored. We report preliminary results of a Phase II study in 20 patients with low and intermediate-1 risk MDS and Hb < 11 g/d treated with darbepoetin alfa (DPO)for at least 24 weeks.Patients and Methods: The primary endpoint is the change in cardiac geometry in treated patients. The secondary endpoint is the change in QoL. Patients receive DPO 150 mcg s.c weekly to be increased to 300 mcg weekly in non-responders. Treatment target is Hb=12.0 g/dL. Cardiac geometry is evaluated at baseline, at 24 weeks and at one year by echocardiographic measurements carried out according to the recommendations of the American Society of Echocardiography by an external investigator who is blind to the biochemical results. Left ventricular mass index (LVMI) is calculated according to the Devereux equation and adjusted for body surface area. LVH is defined by a LVMI > 100 g/sqm in women or > 131 g/sqm in men. QoL changes are measured using the QOL-E questionnaire.Results: Patients included in the study are 12M/8F of median age 76 (range 49–84) years. Baseline Hb level was median 9.0 (range 7.5–10.8) g/dL. Five patients were transfusion-dependent. In the 3 patients with baseline Hb > 10.5 g/dL, cardiac geometry was normal in one patient and 2 patients had initial remodelling while, below this cut-off, 10 (59%) had LVH (p=0.038). Fourteen patients received at least 24 weeks of DPO and were evaluated for changes in cardiac geometry. One out of 3 transfusion-dependent patients responded with a decrease in transfusion requirement and 9 out of 11 patients had an erythroid response with at least 1.0 g/dL increase in Hb. Median change in LVMI was −3.5 (range −53.37 to 51.43). Responders had improvements in cardiac geometry (p=0.033): remarkably, of the 4 patients with baseline eccentric hypertrophy, one improved and one completely normalized. At univariate ANOVA analysis, response to treatment was associated with improvements in QOL-E treatment outcome index (p=0.021), specific (p=0.001), fatigue (p=0.02), physical (p=0.028), functional (p=0.022), and general (p=0.048) scores.Conclusions: Our preliminary data suggest that erythroid responses in anemic MDS patients are associated with improvements in cardiac geometry and QoL. The improvement in cardiac remodeling may reduce the risk of cardiac morbidity and mortality. Larger studies are necessary to confirm these results and to evaluate the cost-effectiveness of the treatment strategies for anemia considering the potentials for decreasing cardiovascular risk.

The Use of Recombinant Human Erythropoietin (rHuEpo) after Reduced Intensity Conditioning (RIC) Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation (ASCT) Reduce Red Blood Cell (RBC) Transfusion Requirements.

We previously reported that hemoglobin (Hb) recovery was hastened after RIC ASCT as compared with ASCT after myeloablative conditioning (Transfusion, 44:501–8, 2004). In this setting pretransplant Hb level becomes the major predictive factor for early Hb recovery posttransplant and RBC transfusion (RBCT) requirements. We subsequently reported the efficacy of early rHuEpo administration after RIC ASCT to hasten Hb reconstitution (BMT, 36:901–6, 2005). Here we further confirm the efficacy of early posttransplant administration of rHuEpo after RIC reducing RBC requirements and maintaining high levels of posttransplant Hb in the 2 months following transplant.Forty patients surviving at least 60 days were analyzed. Patients characteristics were as follow: age: 50 (27–64); M/F: 28/12; with myeloid (4), lymphoid (29) or solid (7) malignancies. They received a RIC (Fludarabin (150 mg/m²; Busulfan (8mg/kg) and thymoglobulin (2.5 to 5 mg/kg)) followed with an ASCT (all PBSC) from a HLA identical sibling. Aranesp® (Amgen, France) was started on day 1. The 20 first patients received an infusion of 150 mcg/week while the 20 last patients were subsequently treated with 500 mcg/3 weeks. Aranesp® was administered intravenously when inpatient and subcutaneously when outpatient. Aranesp® administration was sustained until day 60 or when patients reached a Hb level of 140 g/L, whichever occurred first. Overall patients were treated for a median of 7 weeks post transplant. No serious adverse effect or thrombosis episode related to Aranesp® was reported in these patients. This cohort of 40 patients experienced a quicker Hb recovery and lower RBCT requirements than a historical and comparable control group of 27 patients (Day +30 Hb: 114 (94–141) vs. 100 (80–129), p<.0001; patients with 0 or 1 RBCT: 83% vs. 55% (p=.02)). Thirteen of the 40 patients (33%) presented with an Hb level of 120 g/L or more prior to conditioning. Over the first 60 days, these patients received 0 (0–2) RBCT as compared with 1 (0–2) RBCT for patients with a pre-RIC Hb level < 120 g/L (p=.05). On this basis, we hypothesized the interest of increasing Hb level prior to RIC by adequate rHuEpo stimulation. With this perspective, we have treated 13 patients with Aranesp® (500 mcg, SC) 3 weeks prior RIC. Nine of these 13 pts (69%) reached an Hb level of 120 g/L or more on day −7 as compared to 35% in patients not receiving Aranesp ® prior to RIC (p=.04). This indicates that Aranesp® post RIC ASCT is efficient to hasten Hb recovery and decrease RBCTs. In addition, a comprehensive strategy to minimize RBCT in this setting might include pre-transplant stimulation. We will prospectively assess this hypothesis.

Once-weekly epoetin beta (30,000 IU) in anemic patients with lung cancer receiving chemotherapy

Anemia occurs frequently in patients with lung cancer receiving chemotherapy and has a negative impact on quality of life (QoL). Erythropoietic proteins effectively increase hemoglobin (Hb) levels, reduce transfusion requirements and improve QoL in anemic patients with a range of malignancies. This prospective, observational study evaluated epoetin beta 30,000 IU once weekly in patients with lung cancer in a real-life, clinical-practice setting. Forty patients (72.5% with NSCLC and 27.5% with SCLC) were treated with epoetin beta during any cycle of chemotherapy when Hb decreased to <12 g/dL. Hb levels were assessed at regular intervals and transfusion needs were monitored throughout the study. In total, 72.5% of patients required epoetin treatment by the second cycle of chemotherapy. Epoetin beta treatment duration ranged from 1 to >9 (median 4) weeks. Mean (+/-S.D.) baseline Hb was 10.4+/-1.2 g/dL. Epoetin beta was associated with a rapid increase in Hb levels, with a mean increase of 1.3 g/dL by week 4. Most patients (95%) remained transfusion-free throughout the study. Epoetin beta was well tolerated. This early intervention strategy with epoetin beta 30,000 IU once weekly is an effective and well-tolerated therapy for anemia in patients with lung cancer.

An induction dose of epoetin α of 40 000 IU daily for three consecutive days increases and maintains hemoglobin levels in anemic cancer patients undergoing chemotherapy

Background: This pilot study was conducted to evaluate the feasibility, activity, and safety of an induction dose of epoetin α in cancer patients with moderate or severe anemia who were receiving chemotherapy.Patients and methods: Thirty patients with solid tumors and hemoglobin (Hb) levels <11.0 g/dl were enrolled. Patients received single s.c. injections of epoetin α, 40000 IU for three consecutive days, and were then observed for the following 30 days. The primary efficacy variable was the response rate (Hb increase ≥1 g/dl) at day 15. Secondary efficacy variables included the proportion of patients given blood transfusions between baseline and the end of study, the duration of response (Hb level ≥1 g/dl), and ability to maintain the planned chemotherapy dose (dose intensity).Results: At day 15, 23 of 30 (77%) patients had achieved increases in Hb levels of at least 1 g/dl. The mean Hb increase in responders was 2.0 g/dl [95% confidence interval (CI) = 1.7–2.3 g/dl]. The Hb increase was 2.3±0.7 g/dl in responders with baseline Hb levels <9.5 g/dl (median Hb value), and 1.7±0.6 g/dl in those with higher Hb levels (P = 0.012). The median duration of response was 6.1 weeks (95% CI = 1.6–10.6 weeks). Hematologic parameters were not significantly changed in nonresponders. Multivariate analysis detected no significant differences in Hb increase at day 15 on the basis of age, sex, weight, baseline Hb levels, type or stage of tumor, or treatment with platinum-based chemotherapy. No serious adverse event related to epoetin α treatment was observed.Conclusions: We conclude that a higher initial dosing of epoetin α appears to be an efficient schedule for treating anemia in cancer patients undergoing chemotherapy, conferring higher response rates than those seen with standard doses. Further evaluation of these and other epoetin α dosage regimens is warranted.

Efek suplementasi kombinasi zat besi, vitamin C, dan asam folat terhadap peningkatan kadar hemoglobin dan kapasitas VO2 maks pada atlet sepak bola divisi utama dan satu nasional di Daerah Istimewa Yogyakarta

Background: Excessive endurance exercise of football players may break their blood cells and decrease the level of haemoglobin (Hb). These will influence the aerobic capacity (VO2 max) and make the need for iron (Fe) of an athlete more than that of common people.Objective: To know the influence of Fe, vitamin C (ascorbic acid), and folic acid combined supplementation to the increase of VO2 max capacity of the national main and first division club football players in Daerah Istimewa Yogyakarta.Method: The study was RCT (Randomized Controlled Trial) experimental with a completely randomized design plan. The subjects were football players of Perserikatan Sepak Bola Indonesia Mataram (PSIM), Perserikatan Sepak Bola Sleman (PSS), and Perserikatan Sepak Bola Bantul (PERSIBA). They were then divided into two groups: treatment group and control group, each of them consisted of 35 players. Treatment group were given combined supplement capsules of 100 mg Fe, 100 mg vitamin C, and 2 mg folic acid three times a week for eight weeks, while the control group were given the placebo capsules. Before and after supplementation, their Hb and VO2 max were measured. However, the physical exercises were done based on the schedule, programmed by the clubs.Results: Combined supplementation of Fe, vitamin C, and folic acid could increase Hb level significantly (p=0.008), but there was no significant difference of VO2 max capacity between treatment group and control group (p=0.062). However, there was significant correlation between the increase of Hb level and VO max capacity (r=0.712; p&lt;0.001).Conclusion: Combined supplementation of Fe, vitamin C, and folic acid led to the increase of Hb level of main and first division clubs football players in Daerah Istimewa Yogyakarta, but could not influence their VO2 max capacity.

The Epidemiology of Hemoglobin Levels in Patients With Type 2 Diabetes

Anemia is a common finding in patients with diabetes, for whom it constitutes an additional burden. The aim of this study is to clarify the natural history of anemia in patients with type 2 diabetes and describe factors that predict a decrease in hemoglobin (Hb) levels. A 5-year prospective cohort study was designed as a follow-up of 503 individuals with type 2 diabetes in a single diabetes clinic. In addition to standard management, a full blood count was obtained at each routine visit. No intervention was undertaken to modify Hb levels. At baseline, 12% of patients had anemia, and an additional 13% developed anemia during follow-up. Overall Hb levels decreased by -0.07 +/- 0.01 g/dL/y, suggesting that anemia is the end point of a process that begins more than 10 years previously with the initiation of vascular damage. The greatest decreases in Hb levels were seen in patients with macroalbuminuria, renal impairment, or established macrovascular disease at baseline (all P < 0.01). In patients with microvascular disease, decreasing Hb levels tracked with decreasing glomerular filtration rates (GFRs). Patients with an estimated GFR greater than 90 mL/min/1.73 m2 (>1.5 mL/s) or normoalbuminuria had stable Hb levels during the 5-year follow-up. In patients with anemia in our cohort who were managed conservatively, Hb levels decreased by 0.09 +/- 0.03 g/dL/y. This decrease was associated with HbA1c levels, but not renal function. This study defines the natural history of Hb levels in patients with type 2 diabetes. Early identification of anemia may be achieved by means of annual or biannual screening in high-risk groups with nephropathy, advanced age, or macrovascular disease. These data are important for developing a rational response to the prevention and management of anemia.

Relationship between hemoglobin level and quality of life in anemic patients with chronic kidney disease receiving epoetin alfa

ABSTRACTObjectives: To evaluate the relationship between hemoglobin (Hb) level and quality of life (QOL) in anemic patients with non-dialysis chronic kidney disease receiving epoetin alfa.Patients and methods: A post-hoc analysis using data from a multicenter, open-label, prospective study of epoetin alfa for anemia in patients with chronic kidney disease not on dialysis was conducted. The relationship between Hb and QOL was analyzed using correlation and longitudinal analyses, the latter adjusting for sample selection bias. The Linear Analog Scale Assessment (LASA) and the Kidney Disease Questionnaire (KDQ) subscales were used to measure QOL. The impact of an incremental 1 g/dL increase in Hb level on LASA and KDQ scores was determined using an incremental analysis.Results: A total of 1183 and 1044 patients formed the study populations for the LASA and KDQ analyses, respectively. There was a positive and significant relationship between Hb levels and QOL ( p < 0.05). Using non-linear regression analysis, we characterized the sigmoid-shape of the relationship between Hb levels and QOL scores. Hemoglobin change was a statistically significant determinant of QOL improvement for both LASA and KDQ scales ( p < 0.05). The model predicted that, based on a 2 unit change in Hb, the greatest incremental QOL improvement per unit of Hb increase occurred when Hb was in the range of 11 to 12 g/dL.Conclusions: This study demonstrates that, beyond the well-known relationship between Hb increases and QOL improvements, the maximal incremental gain in QOL occurred when Hb reached 11 to 12 g/dL. This suggests that treating anemic patients with non-dialysis chronic kidney disease until their Hb level reaches 12 g/dL will result in the greatest QOL improvement per Hb unit increase. The analyses were conducted based on an open-label study of epoetin alfa and could be further validated using a randomized, controlled trial, comparing incremental gains in QOL associated with treatment initiation at varying levels of Hb across arms.

Early intervention with epoetin beta prevents severe anaemia in patients with solid tumours receiving platinum-based chemotherapy: results of the NeoPrevent study

Anaemia is common during platinum-based chemotherapy. This study aimed to evaluate the efficacy and safety of epoetin beta in the prevention of severe anaemia in patients with solid tumours receiving concomitant platinum therapy. In this open-label, single-arm study, patients (n = 255) with solid tumours and haemoglobin (Hb) levels </= 13 g/dl (men) or </= 12 g/dl (women) received epoetin beta 450 IU/kg ( approximately 30,000 IU) weekly until 4 weeks after their last platinum-based chemotherapy cycle. An anaemia prevention response [defined as patients with a Hb response (increase in Hb level > 1 g/dl from baseline) plus patients whose Hb levels remained +/- 1 g/dl of baseline throughout the study] was observed in 234 patients (92%). Response to epoetin beta was rapid. Of the 159 patients achieving a Hb response, 139 (87%) had Hb levels > 1 g/dl of baseline within 4 weeks of treatment initiation. Mean Hb levels had improved from 10.8 +/- 1.0 g/dl at baseline to 12.2 +/- 1.8 g/dl by the final visit. Quality of life measured by linear analogue scale assessment significantly (P < 0.01) improved in patients achieving a Hb response (n = 159). Epoetin beta effectively prevents anaemia in most patients with solid tumours receiving concurrent platinum-based chemotherapy.

Anemia as a Predictor of Cardiovascular Events in Patients with Elevated Serum Creatinine

Patients with anemia and patients with chronic kidney disease have elevated risks for cardiovascular disease. Available studies have been too small to provide details about the relationship or to provide for extensive covariate control. In a large insurance database with linked laboratory values, records of women with serum creatinine >1.2 mg/dl and men with serum creatinine >1.4 mg/dl, identified from July 2000 through June 2003, were sought, and the insurance claims searches for hospitalizations that were associated with myocardial infarction, coronary revascularization, unstable angina, stroke, or congestive heart failure. New onset of dialysis also was sought. Multivariate Poisson regression was used to estimate rate ratios for these events at various hemoglobin (Hb) levels, with adjustment for patient characteristics and previous event history. Among 88,657 patients with high serum creatinine, the risk for hospitalization with myocardial infarction was two to five times higher in anemic (Hb <12 g/dl) patients than in people with Hb from 12.0 to 12.9 g/dl. A similar but less dramatic pattern of higher incidence of coronary revascularization was observed with lower Hb levels. Risks for hospitalization with congestive heart failure declined regularly with increasing Hb levels from a doubling of risk at Hb <10 g/dl to a 61% decrease at 15 g/dl, both relative to 12.0 to 12.9 g/dl. The risk for progression to dialysis was only slightly elevated (7 to 34%) in anemic patients. Anemia raises the risk for cardiovascular disease in patients with elevated serum creatinine.

Efficacy and safety of epoetin beta 30,000 IU once weekly in patients with solid tumors and chemotherapy-induced anemia

18620 Background: Anemia is common in patients receiving chemotherapy, causing a multitude of symptoms which have a major impact on quality of life (QoL). Epoetin beta rapidly increases hemoglobin (Hb) levels and improves QoL in anemic patients with a variety of tumors. In patients with lymphoid malignancies, once-weekly epoetin beta 30,000 IU has comparable efficacy to the three-times weekly 10,000 IU regimen (Cazzola et al. Br J Haematol 2003; 122: 386–393). Methods: This was a randomized, double-blind, dose-finding study assessing the efficacy and safety of once-weekly epoetin beta in patients with solid tumors receiving chemotherapy. Adult patients with anemia (Hb levels &lt;11 g/dl) were randomized to receive epoetin beta 30,000 IU or 20,000 IU once weekly for 12 weeks. All patients received oral iron supplementation. Hb levels, transfusion need and QoL (Functional Assessment of Cancer Therapy-fatigue subscale score [FACT-fatigue]) were assessed at regular intervals. Results: Fifty patients were randomized; 30 patients received epoetin beta 30,000 IU once weekly and 20 received 20,000 IU once weekly. Mean (± SD) increase in Hb from baseline to week 12 was 1.75 ± 2.15 g/dl in the 30,000 IU group (p = 0.008 vs baseline) and 1.04 ± 1.75 g/dl in the 20,000 IU group (p = non-significant). Hb response (increase in Hb level ≥2 g/dl from baseline) was observed in 78.3% of patients receiving epoetin beta 30,000 IU and 66.7% receiving epoetin beta 20,000 IU. Improvements in FACT-fatigue were significantly (p &lt; 0.001) correlated with increases in Hb level. Transfusion use was low during the study in both groups. Both epoetin beta regimens were well tolerated and there were no dose-dependent adverse events. Conclusion: Epoetin beta 30,000 IU once weekly is an effective and well-tolerated treatment of anemia in patients with solid tumors. No significant financial relationships to disclose.