The Medalist Trial: Luspatercept Reduced Transfusion Need in Some Myelodysplastic Syndromes

MedicalResearch.com Interview with:

Dr. Alan List MD President and Chief Executive Officer Moffitt Cancer Center Tampa, FL

Dr. List

Dr. Alan List MD
President and Chief Executive Officer
Moffitt Cancer Center
Tampa, FL

MedicalResearch.com: What is the background for this study?  

Response: In patients with lower risk Myelodysplastic Syndromes (MDS), which accounts for the vast majority of patients with MDS overall, the most common symptomatic cytopenia is anemia. These patients, overtime, become dependent upon red blood cell transfusions and with that, they face a risk of iron loading as well as complications that occur with it. The standard first line therapy that we consider for these patients is erythropoietin-stimulating agents (ESAs). Patients who are transfusion dependent have a low response rate to ESAs, and responses are of short duration. There limited effective limited treatment options for those patients unresponsive or lose response to ESAs.

For years, we’ve known that the transforming growth factor (TGF)-β pathway play an important pathogenetic role in suppressing red cell maturation and cell survival.

Luspatercept is an agent that acts as an erythroid maturation agent by inhibiting the TGF-β signaling pathway by neutralizing a select group of TGF-β superfamily ligands.  Continue reading

Iron Deficiency: The Causes, Detection, and Treatment

spinach-bundlesIron Deficiency: The Causes, Detection, and Treatment

Background:

IDA or iron deficiency anemia is a result of a lack of iron in the human body. This causes a complication of hemoglobin, resulting in the body being unable to obtain enough oxygen. IDA can be caused by a few different occurrences, such as not receiving an adequate level of iron through intake, internal bleeding, or being unable to fully absorb iron into the body. Whatever the cause, research throughout the years has furthered the knowledge available on treatments for IDA, as well as how it can be detected, its symptoms, and how it affects the human body.

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Effects of Delayed Vs Early Umbilical Cord Clamping on Infant Anemia

Ola Andersson, MD, PhD Department of Women’s and Children’s Health Uppsala University, Uppsala, Sweden

MedicalResearch.com Interview with:
Dr. Ola Andersson MD, PhD
Uppsala University,
Uppsala, Sweden

MedicalResearch.com: What is the background for this study?

Response: Anemia affects over 40% of all children under 5 years of age in the world. Anemia can impinge mental and physical performance, and is associated with long-term deterioration in growth and development. Iron deficiency is the reason for anemia in approximately 50% of the children.is. When clamping of the umbilical cord is delayed, ie after 3 minutes, iron deficiency up to 6 months of age can be prevented, but it has not been shown to prevent iron deficiency or anemia in older infants.

At birth, approximately 1/3 of the child’s blood is in the placenta. If clamping of the umbilical cord is done immediately (early cord clamping), the blood will remain in the placenta and go to waste (or can be stored in stem cell banks). If instead clamping is postponed for 3 minutes, most of the blood can flow back to the child as an extra blood transfusion, consisting of about one deciliter (1/2 cup) of blood, equivalent to about 2 liters (half a US gallon) of an adult. A blood donor leaves 0.4-0.5 liters of blood.

Blood contains red blood cells that contain hemoglobin. Hemoglobin carries oxygen to the tissues of the body. Hemoglobin contains a lot of iron, and the extra deciliter of blood may contain iron that corresponds to 3-4 months of the need for an infant.

The World Health Organization (WHO) recommends umbilical cord clamping at 1 minute or later, American College of Obstetricians and Gynecologists (ACOG) recommends umbilical cord clamping at 30-60 seconds or later.

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Novel Oral Iron Formulation Can Correct Anemia in Non-Dialysis CKD

MedicalResearch.com Interview with:

Dr. Glenn M. Chertow, MD Professor Medicine, Nephrology Stanford University School of Medicine

Dr. Glenn M. Chertow

Dr. Glenn M. Chertow, MD
Professor Medicine, Nephrology
Stanford University School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Iron deficiency is common in persons with moderate to advanced (non-dialysis-dependent) chronic kidney disease (CKD), for a variety of reasons. Conventional iron supplements tend to be poorly tolerated and of limited effectiveness. In earlier studies of patients treated with ferric citrate for its effect as a phosphate binder, we saw increases in transferrin saturation and ferritin (markers of iron stores) and hemoglobin and hematocrit (the “blood count”). Therefore, we thought we should test the safety and efficacy of ferric citrate specifically for the treatment of iron deficiency anemia (IDA).

With respect to the key findings, more than half (52%) of patients treated with ferric citrate experienced a sizeable (>=1 g/dL) increase in hemoglobin over the 16-week study period compared to fewer than one in five (19%) patients treated with placebo. Rates of adverse events (“side effects”) were similar to placebo; diarrhea in some patients and constipation in others were the most common. There were also favorable effects of ferric citrate on laboratory metrics of bone and mineral metabolism.

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Iron Deficiency Anemia Linked to Hearing Loss

MedicalResearch.com Interview with:
Kathleen Schieffer, BS, PhD Candidate
Biomedical Sciences and Clinical and Translational Science
Clinical and Translational Science Fellow
Hershey, PA 17033

MedicalResearch.com: What is the background for this study?

Response: Hearing loss is common in the United States, with its prevalence increasing with each decade of life. Iron deficiency anemia is a common, reversible condition, associated with negative health outcomes. The inner ear is highly sensitive to ischemic damage and previous animal studies have shown that iron deficiency anemia alters the inner ear physiology. Understanding the association between iron deficiency anemia and hearing loss may open new possibilities for treatment.

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Monoclonal Antibody Crizanlizumab Reduces Sickle Cell Pain Crisis

MedicalResearch.com Interview with:

Kenneth I. Ataga, MD Division of Hematology/Oncology University of North Carolina at Chapel Hill Chapel Hill, NC

Dr. Kenneth I. Ataga

Kenneth I. Ataga, MD
Division of Hematology/Oncology
University of North Carolina at Chapel Hill
Chapel Hill, NC

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The available treatments for acute painful episodes (also referred to as vaso-occlusive crises), the most common complication of sickle cell disease, are limited.

Findings from the Phase II SUSTAIN study showed that crizanlizumab (formerly SelG1) at 5 mg/kg reduced the median rate of sickle cell disease-related pain crises per year by 45.3% vs. placebo in patients with or without concomitant hydroxyurea therapy. In addition, clinically meaningful reductions in the frequency of painful crises were observed regardless of sickle cell disease genotype. 

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Key Barriers To Development of Artificial Red Blood Cells Overcome

MedicalResearch.com Interview with:

Allan Doctor, MD Pediatric Critical Care Medicine Professor of Pediatrics and (Associate) Biochemistry Washington University School of Medicine & Saint Louis Children’s Hospital St. Louis, Missouri

Dr. Allan Doctor

Allan Doctor, MD
Pediatric Critical Care Medicine
Professor of Pediatrics and (Associate) Biochemistry
Washington University School of Medicine &
Saint Louis Children’s Hospital
St. Louis, Missouri

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our research team has developed the first nanoscale artificial cells designed to emulate vital functions of natural red blood cells. If ultimately confirmed safe for use in humans, this nanotechnology-based product, called ‘ErythroMer’, could represent a new and innovative alternative to blood transfusions that would be especially valuable in situations where stored blood is needed, but difficult to obtain or use, such as in pre-hospital or battlefield settings. The artificial cells are designed to be freeze-dried, stored for extended periods at ambient temperatures, and simply reconstituted with water for immediate use.

This year, the National Academy of Sciences estimated that 30,000 civilian trauma deaths/year are preventable and of these, two-thirds arise from hemorrhage in the pre-hospital phase of care. One key goal for our team is to advance treatment for trauma victims or soldiers in austere environments by initiating resuscitation in the field, particularly when transport is prolonged. ErythroMer could be a blood substitute that medics carry in their pack and literally take it out, add water, and inject. There are currently no simple, practical means to bring transfusion to most trauma victims outside of hospitals. Delays in resuscitation significantly impact outcomes; it is our goal to push timely, effective care to field settings.

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Two Different European Strategies Achieve KDIGO Renal Anemia Targets

MedicalResearch.com Interview with:

Dorota Drozdz M.D., Ph.D Jagiellonian University Kraków

Dr. Dorota Drozdz

Dorota Drozdz M.D., Ph.D
Jagiellonian University
Kraków

Response: In Poland and Portugal we use EPO beta for anemia treatment. Our interest was to find differences in clinical patterns taking in consideration that both countries are adherent to KDIGO recommendations an guidelines.

We found that in both countries the mean hemoglobin (Hb) level and percentage of patients in target Hb level (10-12 g/dl on ESA treatment) are the same, but the approaches were different – in Poland the ESA dose was statistically lower than in Portugal and iron dose was statistically higher than in Portugal. Most other lab tests results were similar. Future secondary outcomes analysis should answer the question, which method is safer.

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No Iron Benefit To Mother From Eating Placenta

MedicalResearch.com Interview with:

Daniel C Benyshek, PhD Professor, Department of Anthropology Adjunct Professor, UNLV School of Medicine Co-Director, Metabolism, Anthropometry and Nutrition Lab UNLV

Dr. Daniel C Benyshek

Daniel C Benyshek, PhD
Professor, Department of Anthropology
Adjunct Professor, UNLV School of Medicine
Co-Director, Metabolism, Anthropometry and Nutrition Lab
University of Nevada, Las Vegas

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Maternal placentophagy is ubiquitous among nearly all terrestrial mammals, but is rare to non-existent among humans in the historic and cross-cultural records. Recently, however, human maternal placentophagy has emerged as a popular trend among a small but growing number of women in many industrialized countries. Most women engaging in the practice today consume their processed placenta in capsule form, taken daily, over several weeks postpartum. While human maternal placentophagy advocates claim many maternal health benefits from the practice, including improved postpartum mood, increased breast-milk production, and improved energy, among others, no carefully designed, placebo-controlled studies have evaluated these claims.

Our randomized, double-blind, placebo-controlled pilot study (N=23) investigated some of these claims. Our study found that the postpartum iron status of participants who consumed their own encapsulated placenta (based on the three week daily intake recommendation of one prominent placenta encapsulation service), was no different from those women who consumed the same amount of beef placebo.

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Minimally Invasive Gene Editing Cured Thalassemia in Mice

MedicalResearch.com Interview with:

Peter M. Glazer, MD, PhD Robert E. Hunter Professor of Therapeutic Radiology and Professor of Genetics; Chair, Department of Therapeutic Radiology Yale University

Dr. Peter M. Glazer

Peter M. Glazer, MD, PhD
Robert E. Hunter Professor of Therapeutic Radiology and Professor of Genetics; Chair, Department of Therapeutic Radiology
Yale University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is generally recognized that gene editing in blood stem cells could provide a strategy for treatment of inherited disorders such as sickle cell disease and thalassaemia. Recent excitement has focused on CRISPR/Cas9 technology because of it is so easy to use. However, the CRISPR approach introduces an active DNA cutting enzyme into cells, which can lead to off-target cuts in the genome. As an alternative, we have pursued triplex-forming peptide nucleic acids (PNAs) designed to bind site-specifically to genomic DNA via strand invasion and formation of PNA/DNA/PNA triplexes. PNAs consist of a charge-neutral peptide-like backbone and nucleobases enabling hybridization with DNA with high affinity. PNA/DNA/PNA triplexes recruit the cell’s own DNA repair machinery to initiate site-specific editing of the genome when single-stranded ‘donor DNAs’ are co-delivered as templates containing the desired sequence modification.

We found that triplex-forming PNAs substituted at the gamma position yielded high levels of gene editing in blood stem cells in a mouse model of human β-thalassaemia. Injection of thalassemic mice with nanoparticles containing gamma PNAs and donor DNAs ameliorated the disease phenotype, with sustained elevation of blood hemoglobin levels into the normal range and up to 7% β-globin gene correction in stem cells, with extremely low off-target effects. We conclude that the combination of nanoparticle delivery and next generation PNAs may offer a minimally invasive treatment for genetic disorders of the blood that can be achieved safely and simply by intravenous administration.

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IV Iron Postoperatively May Reduce Infections, Transfusions and Length of Hospital Stay

MedicalResearch.com Interview with:
Alhossain A. Khalafallah, Clinical Professor
Menzies Institute for Medical Research,
University of Tasmania, Australia
Consultant Haematologist
Launceston General Hospital
Australia

MedicalResearch.com: What is the background for this study?

Response: There are limited data regarding the effect of postoperative anemia on patient’s outcomes. The issue of postoperative anemia was noticeably to affect a large cohort of patients world-wide.

This study was aiming at comparing the new approach with a single ferric carboxymaltose infusion versus standard or routine usual care for management of postoperative anemia.

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Anemia Increases Mortality From Stroke

MedicalResearch.com Interview with:
Raphae Barlas M.A
3rd year MBChB student
The Institute of Applied Health Sciences
Aberdeen

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Anemia and stroke are both common conditions. While previous studies have found an association between anemia on admission and increased mortality in stroke patients, this was not consistent throughout the literature. We aimed to comprehensively assess this association by conducting our own observational study, consisting of 8000 patients from UK regional stroke registry data. We then aggregated our findings into a systematic review and meta-analysis of the existing literature for a total study population of approximately 30,000 patients.

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IV Iron Administered Post-Op May Improve Surgical Outcomes

MedicalResearch.com Interview with:
Clinical Professor Alhossain A.Khalafallah
Menzies Institute for Medical Research,
University of Tasmania, Australia
Consultant Haematologist
Senior Staff Specialist
Launceston General Hospital,
Australia

MedicalResearch.com: What is the background for this study?

Response:
1. Iron deficiency is one of the most common nutritional deficiencies worldwide, affecting up to one third of the population worldwide.
2. Prevalence of anaemia in orthopaedic surgery ranges between 10-20% with the main cause of anaemia identified as nutritional deficiency.
3. New intravenous iron preparations have been developed at a higher purchase price than oral iron. Iron carboxymaltose, as one example, remains underutilised in the treatment of perioperative anaemia.
4. To our knowledge, this study is the first to compare the efficacy, safety and long term effect on iron stores and length of hospital stay in the postoperative anaemia setting.

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Iron Deficiency Common In Heart Failure Patients and Linked To Worse Outcomes

MedicalResearch.com Interview with:

John G. F. Cleland, MD, FRCP, FESC Department of Cardiology Hull York Medical School, University of Hull, Castle Hill Hospital, Kingston-Upon-Hull National Heart and Lung Institute Royal Brompton and Harefield Hospitals Imperial College London, United Kingdom

Dr. John Cleland

John G. F. Cleland, MD, FRCP, FESC
Department of Cardiology
Hull York Medical School, University of Hull, Castle Hill Hospital, Kingston-Upon-Hull
National Heart and Lung Institute
Royal Brompton and Harefield Hospitals Imperial College
London, United Kingdom

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This analysis shows that iron deficiency is very common in patients with heart failure and often leads to anaemia and that the prevalence of both iron deficiency and anaemia are highly sensitivity to the criteria used to define them. The World Health Organization defines anaemia as a haemoglobin concentration of <13g/dL in men and <12g/dL in women but doctors should realise this is the lower limit of normal and haemoglobin concentrations should ideally be about 2g/dL higher than this. A man with a haemoglobin of 12g/dL is quite severely anaemic. This study suggest that iron deficiency is common when haemoglobin drops below 14g/dL for men and 13g/dL for women.

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Sickle Cell Anemia: Discontinuing Blood Exchange After Transition to Adulthood Linked with Increased Mortality

MedicalResearch.com Interview with:

Samir K. Ballas MD FACP Emeritus Professor of Medicine and Pediatrics Department of Medicine/Cardeza Foundation for Hematologic Research Thomas Jefferson University Philadelphia, PA

Dr. Samir Ballas

Samir K. Ballas MD FACP
Emeritus Professor of Medicine and Pediatrics
Department of Medicine/Cardeza Foundation for Hematologic Research
Thomas Jefferson University
Philadelphia, PA

Medicalresearch.com: What is the background for this study?

Dr. Ballas: Previous studies have shown that the incidence of overt stroke is about 11% in children with sickle cell anemia by ages 2 – 20 years. Untreated stokes recur periodically with increasing severity and mortality. Transfusion therapy has been documented to decrease the frequency and morbidity of stroke in children by 90%. Accordingly, children who develop overt stroke are treated with chronic blood exchange transfusion to prevent the recurrence of additional strokes. When children reach the age of 18-20 years their medical care is transitioned to adult programs. This transition process is associated with several issues one of which is the discontinuation of chronic blood exchange transfusion in patients with history of overt stokes partly due to logistic considerations and partly due to lack of research in strokes in adult patients and the complications of chronic blood transfusion .

Medicalresearch.com: What are the main findings?

Dr. Ballas: The major finding of the study is that the discontinuation of chronic blood exchange after transition to adult programs is associated with increased mortality. All the patients who discontinued blood transfusion died within 3-5 years after transition whereas patients who continued having blood exchange transfusion survived to a mean age of 36 years at the time of writing this study.
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Should Dose of EPO in CKD Be Individualized For Patient’s Quality of Life?

MedicalResearch.com Interview with:
Dr. Navdeep Tangri
Attending physician and Assistant Professor in the Division of Nephrology
Department of Medicine and the Department of Community Health Sciences
University of Manitoba

and Dr. David Collister 
Seven Oaks General Hospital Renal Program
Winnipeg, Manitoba Canada. 

Medical Research: What is the background for this study? What are the main findings?

Response: Anemia is common in chronic kidney disease (CKD) including dialysis and its treatment with erythopoetin stimulating agents (ESAs) reduces the need for blood transfusions and has varying effects on morbidity and mortality. The optimal hemoglobin (HGB) targets for treating anemia in CKD are controversial with safety concerns around the normalization of hemoglobin levels due to an increase in cardiovascular (CV) events. The effects of ESAs on health related quality of life (HRQOL) are unclear with individualization o fhemoglobin targets being controversial as clinicians and patients attempt to balance perceived HRQOL benefits with cardiovascular risk.

We performed an updated meta-analysis of randomized controlled trials (RCTs) that evaluated the treatment of anemia in CKD with ESAs that targeted higher versus lower hemoglobin targets using validated HRQOL metrics including SF-36 and KDQ. We included 17 studies and found that higher hemoglobin targets compared to lower HGB targets did result in a statistically significant difference in HRQOL and thus did not improve HRQOL beyond a clinically meaningful threshold. Any change in HRQOL was further attenuated in dialysis subgroups.

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Stored Blood For Transfusions Works As Well As Fresh Blood

Dr. Walter H. Dzik MD Associate Pathologist, Massachusetts General Hospital Associate Professor of Pathology Harvard Medical Schoo

Dr. Walter Dzik

MedicalResearch.com Interview with:
Dr. Walter H. Dzik MD
Associate Pathologist, Massachusetts General Hospital
Associate Professor of Pathology
Harvard Medical School

Medical Research: What is the background for this study? What are the main findings?

Dr. Dzik: Millions of Red Blood Cell transfusions are given each year.  To maintain adequate blood inventories worldwide, Red Blood Cell units are stored under refrigerated conditions.  Previous animal and laboratory research has highlighted the fact that red cells undergo biochemical, morphologic, and biophysical changes during prolonged refrigerated blood storage.    Researchers and clnicians have questioned whether the changes that occur during storage would impair the ability of transfused Red Cells to delivery oxygen to tissues.

Our study was a randomized controlled trial conducted in patients with extreme anemia and insufficient global tissue oxygenation.    We randomly assigned children with severe anemia and lactic acidosis to receive Red Blood Cells stored 1-10 days versus Red Blood Cells stored 25-35 days.   We measured the recovery from lactic acidosis in response to transfusion in the two groups.   We also measured cerebral tissue oxygenation using a non-invasive tissue oximeter.    We found that the proportion of patients who achieved reversal of lactic acidosis was the same in the two RBC storage-duration groups.   The rate of decline of lactic acidosis was also equal.   There was also no difference in cerebral oxygenation, resolution of acidosis, correction of vital signs, clinical recovery, survival and 30-day followup.   
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FDA Study Compares Anaphylactic Risk of IV Iron Products

Cunlin Wang, MD, PhD Division of Epidemiology I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration

Dr. Wang

MedicalResearch.com Interview with:
Cunlin Wang, MD, PhD
Division of Epidemiology I,
Office of Surveillance and Epidemiology,
Center for Drug Evaluation and Research
US Food and Drug Administration

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Wang:  IV Iron has been known for its risk of anaphylactic reaction, but there has been little research on the comparative safety of individual IV Iron products from a large population-based study. This study included 688,183 new users of IV iron not on dialysis from the U.S. Medicare program over a ten-year span (January 2003 to December 2013). The main findings of the study are:  the risk for anaphylaxis at first exposure was higher for iron dextran than non-dextran IV iron products combined (iron sucrose, gluconate and ferumoxytol).  When individual IV Iron products were compared, the data suggested that iron dextran has the highest risk of anaphylaxis and Iron sucrose has the lowest risk, estimated both at the first time exposure and after cumulative exposures.  The low and high molecular weight dextran products could not be individually identified during most of study period. However,  from January 2006 through March 2008, during which the use of two dextran products could be distinguished, there was very low use of high molecular weight dextran (Dexferrum@). This suggested that the study results likely represent the risk of the low molecular weight dextran (Infed@).

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IV Iron in Hospitalized Hemodialysis Patients Not Linked With Worsening Infections

Dr. Julie H. Ishida MD San Francisco Veterans Affairs Medical Center Nephrology Section San Francisco, CAMedicalResearch.com Interview with:
Dr. Julie H. Ishida MD
San Francisco Veterans Affairs Medical Center
Nephrology Section
San Francisco, CA

Medical Research: What is the background for this study? What are the main findings?

Dr. Ishida: Intravenous iron is important in the treatment of anemia of end-stage renal disease, but it is biologically plausible that iron may increase infection risk. While results from epidemiologic studies evaluating the association between intravenous iron and infection in hemodialysis patients have been conflicting, guidelines for the treatment of anemia of chronic kidney disease have recommended caution in prescribing, avoidance and withholding of intravenous iron in the setting of active infection. However, no data specifically support the recommendation to withhold intravenous iron during active infection.

Our study observed that among hemodialysis patients hospitalized for bacterial infection who had been receiving intravenous iron as an outpatient, continued receipt of intravenous iron was not associated with higher all-cause mortality, readmission for infection, or longer hospital stay.

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Biomarker May Predict Cancers Grow With Anemia Drug

Anil K. Sood, M.D

Dr. Anil Sood

MedicalResearch.com Interview with:
Anil K. Sood, M.D.
Professor of Gynecologic Oncology and Reproductive Medicine
The University of Texas MD Anderson Cancer Center

Medical Research: What is the background for this study? What are the main findings?

Dr. Sood: Erythropoietin is an important drug for managing anemia, but concerns have surfaced that it might promote cancer growth. The data with the conventional epo-receptor were not convincing with regard to an explanation for why tumor growth might increase. Therefore, we considered whether there could be an alternative receptor to explain these findings. We carried out a systematic search and identified EphB4 as the alternative receptor that explained the increased tumor growth in response to epo.

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Serum Phosphorus Level May Be a Biomarker For Anemia

MedicalResearch.com Interview with:
Lac Tran, MD
Division of Nephrology and Hypertension
Kaiser Permanente Los Angeles Medical Center
Los Angeles, CA

Medical Research: What is the background for this study? What are the main findings?

Dr. Tran: Abnormal serum phosphorus levels have been associated with adverse cardiovascular outcomes and progression to renal failure.  Given phosphorus’s important biological roles in cellular replication and bone mineral metabolism, we sought to investigate the association between phosphorus levels and anemia in normal kidney function and early chronic kidney disease.

Our study is a population-based study among a large racially/ethnically diverse population within the Kaiser Permanente Southern California health system.
Among 155, 974 individuals, 4.1% had moderate anemia and 12.9% had mild anemia.  We found that phosphorus levels greater than 3.5 mg/dL and less than 2.0 mg/dL showed a greater likelihood for moderate anemia.  Every 0.5 mg/dL phosphorus level increase demonstrated a 16% greater likelihood for moderate anemia.  The highest phosphorus tertile of our population had a 26% greater likelihood for anemia compared to the middle tertile.  We also found that female sex, Asian race, diabetes, low albumin, and low iron saturation were risk factors for anemia.

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Iron Deficiency Anemia May Complicate Diagnosis of Diabetes

MedicalResearch.com Interview with:
Emma English PhD

Lecturer in Healthcare Science and Academic Lead for Clinical Biochemistry
University of Nottingham, School of Medicine
Royal Derby Hospital, UK

MedicalResearch: What is the background for this study? What are the main findings?

Dr. English: HbA1c is widely used for monitoring glycaemic control in people with diabetes as there is clear evidence that lowering HbA1c values leads to reductions in the rates of diabetes complications. Recently the World Health Organization and the American Diabetes Association have both advocated the use of HbA1c for the diagnosis of Type 2 diabetes at a value of ≥48 mmol/mol (6.5%). Whilst there are many advantages to the use of HbA1c as a diagnostic tool there are equally some significant limitations to its use. A widely cited confounder is anaemia, however to what extent and which types of anaemia affect HbA1c results was not clearly understood. When HbA1c was introduced as a diagnostic test in England we received many queries from healthcare professionals asking questions such as ‘at what level of anaemia should I not use HbA1c?’ and ‘should I routinely screen patients for anaemia when using HbA1c? And if so, what test should I use?’. In order to answer these questions we conducted a systematic review of the literature to determine what was known on this subject.

Our findings, presented in Diabetologia, suggest that iron deficiency and iron deficiency anaemia may lead to a spuriously elevated HbA1c level, thus may lead a false positive diagnosis of diabetes. However, non-iron deficiency anaemias can lead to an artificially lower HbA1c and may lead to a false negative result where a diagnosis of diabetes would be missed. There is no clear evidence to suggest at what levels anaemia can give rise to these effects on HbA1c value and also there does not appear to be a single ideal test for identifying patients where this could be an issue.

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Low Dose Vitamin C May Improve Iron Deficiency in Dialysis Patients

MedicalResearch.com Interview with:
Dr. Tanjim Sultana MD
Department of Nephrology
Lenox Hill Hospital New York

Medical Research: What is the background for this study? What are the main findings?

Response: Almost all dialysis patients are anemic. One quarter of patients requiring High dose Epogen have functional iron deficiency, which means they have adequate iron store but unable to utilize it. Vitamin C has been shown to mobilize iron from their storage and making it available to use in red blood cell production. Prior studies showed intravenous high dose vitamin C could increase hemoglobin levels and decrease epogen requirement. In our study we used daily low dose oral vitamin C in functional iron deficient patients to achieve the same goals. Patients taking daily low dose vitamin C for 3 months had significant decrease in their epogen dose compared to the control group.

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Chronic Kidney Disease Patients Receiving Less ESA Therapy For Anemia

MedicalResearch.com Interview with:
Dennis J. Cotter
President
Medical Technology and Practice Patterns Institute, Inc.
Bethesda, MD 20816

Medical Research: What are the main findings of the study?

Answer: This is the first study to document anemia management practice patterns among predialysis CKD patients before and after publication of TREAT. Using a retrospective observational design based on a large US health plan database with over 1.2 million claims for predialysis CKD stage 3 and 4 patients, we report 4 main study findings.

1) For CKD stage 3 patients, the proportion prescribed ESA therapy declined from 17% pre-TREAT to 11% post-TREAT (a 38% decline) and for CKD stage 4 patients, from 34% to 27% (a 22% decline).

2) Prescribing of ESA therapy was declining even before TREAT, but the decline accelerated in the post-TREAT period.

3) ESA prescribing declined after TREAT regardless of anemia status; among patients with hemoglobin <10 g/dL, only 25% of stage 3 and 33% of stage 4 CKD were prescribed ESAs two years after TREAT, a notable 50% decline.

4) After adjusting for all covariates, the probability of prescribing ESAs was 35% less during a two year period after vs. before TREAT publication.
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Dialysis Patients: A Standardized Transfusion Ratio to Evaluate Anemia Management

MedicalResearch.com Interview with:
David T. Gilbertson, Ph.D.
Chronic Disease Research Group
Center for Observational Research, Amgen, Inc, Thousand Oaks, CA

MedicalResearch: What were the main findings of the study?

Dr. Gilbertson: Since transfusion avoidance is important in patients receiving maintenance hemodialysis, development of a measure of red blood cell transfusion use to assess dialysis facility anemia management is reasonable. Because dialysis facility size varies widely, calculation of a standardized transfusion ratio (STfR) using standard methods is possible, but these methods result in significant instability in estimates for small dialysis facilities. Use of more advanced statistical methods results in standardized transfusion ratio estimates that are considerably more stable and more consistently precise across dialysis facilities of all sizes.
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