MedicalResearch.com Interview with: Dr. José L. Górriz
Department of Medicine and Nephrology
Valencia Hospital Universitario
Valencia. Spain
MedicalResearch: What is the background for this study? What are the main findings?Dr. Górriz: The background of the study is that several studies have reported on the high prevalence of vascular calcification in chronic kidney disease (CKD) patients not on dialysis. Vascular calcification (VC) has been associated with high cardiovascular mortality in patients on dialysis, but there are no studies in patients in stages before dialysis which analyse the prognostic significance of the presence of Vascular calcification assessed by simple X-ray.
Vascular calcification can occur in both the intima and media of the vessel wall. Intimal calcification is an indicator of atherosclerosis and is associated with ischemic heart disease and medial calcification is associated with arterial stiffness, systolic hypertension, and left ventricular hypertrophy.
Although Vascular calcification can be assessed by various methods, such as ultrasonography, tomography, and arteriography, simple radiology has the advantages of being simple, inexpensive, and commonly applicable in daily clinical practice.
OSERCE 2 is an observational, multicentre and 3-year prospective study performed in 39 Nephrology centres in Spain, which analyzes the presence of Vascular calcification in CKD patients stages 3 and 4 (eGFR between 15-59 ml/min/1,73 m2) and its effect on morbimortality (death, hospitalization and renal progression).
The main findings of the study were that Vascular calcification is highly prevalent in patients with chronic kidney disease, and Vascular calcification assessment using AS independently predicts death and time to hospitalization.
Therefore, it could be a useful index to identify patients with chronic kidney disease at high risk of death and morbidity as previously reported in patients on dialysis.
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MedicalResearch.com Interview with:
Peter Kokkinos, PhD, FAHA, FACSM
Veterans Affairs Medical Center
Professor, Georgetown University School of Medicine
George Washington University School of Medicine and Health Sciences
Director, LIVe Program
Medical Research: What is the background for this study?
Dr. Kokkinos: This is a prospective study and part of a larger cohort, the Veterans Exercise Testing Study (VETS) designed to assess the association between aerobic fitness and the risk of developing Chronic Kidney Disease or CKD. Our cohort included 5,812 middle-aged male Veterans from the Washington, DC Veterans Affairs Medical Center. All participants were CKD-Free prior to entering the study.
Exercise capacity was assessed by a graded exercise test and peak Metabolic Equivalents or METs were determined. Accordingly, we established the following four age-adjusted fitness categories based on Quartiles of peak METs achieved: Least-fit (≤25%; 4.8±0.90 METs; n=1258); Low-fit (25.1%-50%; 6.5±0.96 METs; n=1614); Moderate-fit (50.1%-75%; 7.7±0.91 METs; n=1958), and High-fit (>75%; 9.5±1.0 METs; n=1436).
Multivariable Cox proportional hazard models were used to assess the exercise capacity-CKD association. The models were adjusted for age, BMI, blood pressure, medications, CVD, Risk factors, race, and history of alcoholism. Medical Research: What are the main findings?Dr. Kokkinos: During a median follow-up period of 7.9 years, 1,000 individuals developed CKD. The CKD-fitness association was independent, inverse and graded. The CKD risk was 22% lower for every 1-MET increase in exercise capacity.
When considering fitness categories, CKD risk decreased progressively as fitness status increased. Specifically, when compared to the Least-Fit individuals the risk of developing CKD was 13% 45% and 58% lower for individuals in the Low-Fit; Moderate and High-Fit categories, respectively.
These findings support that higher aerobic fitness lowers the risk of developing CKD. The average exercise capacity necessary to realize these health benefits was just over 6.5 METs (Low-fit). This level of fitness is achievable by many middle-aged and older individuals by daily exercises such as brisk walking. Moderate intensity exercises are effective in improving aerobic fitness regardless of age or comorbidities. Thus, exercise interventions for individuals at risk for CKD and those with preclinical CKD may be implemented to prevent or at least attenuate the rate of developing CKD.
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MedicalResearch.com Interview with:
Prof Vlado Perkovic MBBS PhD FASN FRACP
George Institute for Global Health
University of Sydney
Sydney Australia
Medical Research: What is the background for this study? What are the main findings?
Prof. Perkovic: There has been much discussion about the large number of people with kidney disease around the world- more than 10% of the population in most countries- but the current number of people with kidney failure had not been clearly defined.
We therefore systematically collected information on the number of people with kidney failure around the world and found that 2.6 million people were receiving treatment for kidney failure in 2010, almost 80% of whom were undergoing dialysis while the others had received a kidney transplant. We then noticed very large differences in the number of people receiving treatment in different regions and countries, so used mathematical modeling to calculate the number of people who should be receiving treatment for kidney failure. The results of this analysis suggested there should be between 5 and 10 million people receiving treatment for kidney failure, suggesting that between half and three-quarters of people with kidney failure around the world died without access to dialysis, as a result of the high cost of dialysis treatment that is not affordable for many people around the world. These people are doomed to die of kidney failure, a condition for which we have had an effective treatment for over 50 years. (more…)
MedicalResearch.com Interview with:
Dr. Borja Quiroga MD Ph.D.
Nephrology Unit, Hospital General Universitario Gregorio Marañón
Madrid, Spain
Medical Research: What is the background for this study? What are the main findings?
Dr. Quiroga: Chronic kidney disease patients are at high-risk for the development of cardiovascular events. Although several strategies have been tried for identifying those patients with poorer prognosis, no one has demonstrated by itself being the best one. This could be explained by the fact that several factors are implied in the cardiovascular profile of chronic kidney disease patients.
With this background, in our study we hypothesized if differences in the interarm systolic blood pressure could detect patients with enhanced cardiovascular risk early, and, consequently therapies could be initiated.
Our results provide interesting data on this regard, as we have concluded that an interarm systolic blood pressure difference higher that 10 mmHg is an independent prognosis factor for cardiovascular events. (more…)
MedicalResearch.com Interview with:
Mallika L. Mendu, MD, MBA
Division of Renal Medicine
Brigham and Women’s Hospital, Harvard Medical School
Boston, MA
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Mendu: Chronic kidney disease affects a significant number of adults in the United States, approximately 13%, and is associated with significant morbidity, mortality and cost. We conducted a review of 1487 patients referred for initial evaluation of chronic kidney disease to two academic medical centers in Boston over a 3-year period, and examined how often laboratory and imaging tests were ordered and how often these tests affected diagnosis and/or management. The main finding was that a number of tests (renal ultrasound, paraprotein testing, serologic testing) were commonly ordered despite low diagnostic and management yield. Urine quantification and hemoglobin A1c testing had the highest diagnostic and management yield.
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MedicalResearch.com Interview with:
Alon Eisen, MD
Cardiology Department Rabin Medical Center
Petah Tikva Israel
Research Fellow in Medicine
Brigham and Women's Hospital
MedicalResearch: What is the...
MedicalResearch.com Interview with: Dr. Simonetta Genovesi MD
Department of Health Science
University of Milano-Bicocca, Monza
Italy Nephrology Unit
San Gerardo Hospital, Monza, Italy
MedicalResearch: What is the background for this study? Dr. Genovesi: The prevalence of atrial fibrillation (AF) in patients
with end-stage renal disease (ESRD) on hemodialysis (HD)
is high. The presence of atrial fibrillation increases the risk of
thrombo-embolic stroke in the general population. The
treatment of choice for reducing thrombo-embolic risk in
AF patients is oral anticoagulant therapy (OAT) with
warfarin. However, the use of warfarin in HD patients is
controversial because of the high risk of bleeding and the
fact that it is not demonstrated a clear protection
against the risk of stroke in this population. The purpose
of the study was to prospectively evaluate the effect of
OAT on the risk of mortality, stroke and bleeding in HD
population.
MedicalResearch: What are the main findings? Dr. Genovesi: In our hemodialysis population oral anticoagulant therapy does not increase the risk of total mortality, while antiplatelet agents are associated
with an increased risk of death of about 70%. The
continuous use of warfarin tends to be associated with
improved survival as compared with individuals who
discontinued the medication during the follow-up, but the
incidence of thrombo-embolic events is not different in
OAT subjects as compared with those who do not take it.
Moreover, bleeding events are more frequent in patients
taking warfarin, although the maintenance over time of an
INR in the therapeutic range wards against the risk of
bleeding.
(more…)
MedicalResearch.com Interview with:
Nisha Bansal MD MAS Assistant Professor
Associate Program Director for Research
Kidney Research Institute Division of Nephrology
University of Washington
Medical Research: What is the background for this study? What are the main findings?
Dr. Bansal: We pursued this study to develop a prediction equation for death among elderly patients with chronic kidney disease (CKD), a high-risk patient population that is often difficult to manage given competing risks of end stage renal disease (ESRD) vs. death. In this paper, we developed and validated a simple prediction equation using variables that are readily available to all clinicians.
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MedicalResearch.com Interview with:
Laura Plantinga, PhD Assistant Professor
Division of Renal Medicine, Department of Medicine
Emory University School of Medicine
Atlanta, GA 30322
Medical Research: What is the background for this study? What are the main findings?
Dr. Plantinga: Quality of care for end-stage renal disease (ESRD), which is treated with dialysis or kidney transplantation, is a high priority for the U.S. healthcare system, given universal coverage of these services. However, quality of ESRD care remains relatively unexplored in lupus patients, who have multiple providers and may have greater access to care. We found that, overall, nearly three-quarters of U.S. ESRD patients with lupus had pre-ESRD nephrology care and about 20% of lupus patients on dialysis were waitlisted for kidney transplant per year; however, fewer than one-quarter of those who started on dialysis had a permanent vascular access in place, which is associated with better outcomes than a temporary catheter. Furthermore, patients who were black or Hispanic were nearly a third less likely to have pre-ESRD care and were also less likely to be placed on the kidney transplant waitlist in the first year of dialysis than white patients. Having Medicaid or no insurance at the start of ESRD were both associated with lower likelihood of quality ESRD care by all measures, despite universal Medicare coverage after the start of ESRD. While there was geographic variation in quality of ESRD care, patterns were not consistent across quality measures.
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MedicalResearch.com Interview with:
Elmi Muller, M.B., Ch.B., M.Med.
University of Cape Town–Surgery
Groote Schuur Hospital Observatory Cape Town
Cape Town, South AfricaMedical Research: What is the background for this study?
Dr. Muller: South Africa currently offers dialysis and transplantation as a treatment option for patients with End Stage Renal Disease (ESRD). However, dialysis is not freely available to everyone, but severely limited and only available to a selected group of patients. This means that patients get assessed when they present with ESRD and they only get accepted onto a dialysis programme if they fulfill certain criteria. These criteria are criteria to assess the patient’s medical fitness in general as well as social criteria to assess whether the patient will be compliant with follow-up. In most state hospitals, patients will only be accepted onto a dialysis program if they are also fit to receive a transplant in the long run. The idea is that dialysis programs should naturally feed into transplant programs. Therefore a patient who is not a suitable transplant candidate will normally be turned down for dialysis.
In 2008, when the HIV positive-to-positive program started, patients with ESRD and HIV would be turned down for dialysis. The reason was that they were seen as unfit for transplantation and therefore not suitable dialysis patients. This meant that anybody with HIV and ESRD was doomed to die. This situation remained unchallenged for a number of years, especially as the rollout of antiretroviral therapy was quite slow in the state sector.
Because of very high HIV rates in the country, more and more HIV positive brain-dead donors presented to the Groote Schuur Hospital Transplant team. These donors were mostly braindead people who were worked up for organ donation (after consent was obtained from the family) and who then turned out to be HIV positive. In 2008 it made sense to try and marry this supply of donors with the group of HIV positive patients without any treatment options in the country.
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MedicalResearch.com Interview with:
W. H .Wilson Tang, M.D., F.A.C.C., F.A.H.A.
Professor in Medicine, Cleveland Clinic Lerner College of Medicine
Cleveland Clinic, Cleveland, OH 44195.
Medical Research: What is the background for this study? What are the main findings?
Dr. Tang: Our group has previously demonstrated that TMAO is linked to future cardiac risks in both humans and in animal models. We now show that long-term exposure to higher levels of TMAO promotes renal functional impairment and fibrosis in animal studies. We also show that in humans, as the kidneys lose function, TMAO isn’t eliminated as easily, and their blood levels further rise, thereby increasing cardiovascular and kidney disease risks further. This newly discovered TMAO link offers further insight into the relationship between cardiovascular disease and chronic kidney disease.
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Medical Research Interview
Dr Gomez-Puerta MD, PhD, MPH
Division of Rheumatology, Immunology, and Allergy; Brigham and Women's Hospital, Harvard Medical School, Boston, MAMedicalResearch: What is the background for this study? What are the main findings? Dr. Gomez-Puerta: Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology which can cause multiorgan system damage and which disproportionately affects women and non- Caucasian minorities. Up to 60% of SLE patients develop renal disease, lupus nephritis (LN), and of these, approximately one fifth progress to end-stage renal disease (ESRD). The risk of cardiovascular (CV) events and mortality is higher in patients with ESRD and in particular in patients suffering SLE. However, information about CV outcomes and mortality is limited in patients with LN associated ESRD.
We observed important variation in cardiovascular outcomes and mortality by race and ethnicity among lupus nephritis related ESRD patients. After adjusting for multiple demographic and clinical factors and accounting for the competing risk of kidney transplantation and loss to follow-up, our results illustrate for the first time that Asian (vs. White) and Hispanic (vs. non-Hispanic) lupus nephritis related ESRD patients have lower mortality risks.
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MedicalResearch.com Interview with:
Suma Prakash MD, MSc, FRCPC
Department of Medicine, Division of Nephrology
Case Western Reserve University
MetroHealth Medical Center Cleveland, Ohio
Medical Research: What is the background for this study? What are the main findings?
Dr. Prakash: Patients with advanced chronic kidney disease are often faced with difficult decisions of having to choose between options to replace their kidney function. Many patients may not be ready to make treatment decisions since most people don’t want to need a chronic medical treatment.
The behavioural stage of change model originally used to help people with smoking cessation has been used to help patients make decisions about self-care with diabetes and undergo cancer screening. It has not been studied in patients with chronic kidney disease. As patients progress through the stages, they are more ready to make decisions. Focusing on better understanding the decision making process from patients’ perspectives allows us as medical professionals to help patients make timely decision about their options.
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MedicalResearch.com Interview with:
David K. Packham, M.B., B.S., M.D
Royal Melbourne Hospital
Melbourne Renal Research Group VIC 3073, Australia,
Medical Research: What is the background for this study? What are the main findings?
Dr. Packham: ZS-9 represents a new mechanism of action for addressing hyperkalemia. Unlike traditional nonspecific organic polymer cationexchangers, ZS-9 is a non-absorbed, inorganic crystalline potassium-selective cation exchanger that traps excess potassium in the gastrointestinal tract. It has been evaluated in three prospective, randomized, double-blind, placebo-controlled studies with over 1100 patients to date, representing the largest ever clinical development program for hyperkalemia.
ZS-003 was the first of two pivotal Phase 3 studies that evaluated the safety and efficacy of ZS-9 in patients with hyperkalemia. In ZS-003, treatment of patients with an oral suspension of ZS-9 (2.5, 5, or 10 grams, three times a day) resulted in statistically significant and clinically meaningful reductions in serum potassium, compared with placebo, during the “acute phase” (first 48 hours), with 99 percent of patients achieving normal potassium levels with the highest 10 gram dose. During the next 12 days of the trial (the “maintenance phase”), ZS-9 (5 or 10 grams) given once daily could maintain the corrected potassium levels achieved during the acute phase. In contrast, patients who were randomized back to placebo after achieving normal potassium reverted back to hyperkalemia. The tolerability profile has been favorable, with adverse event rates from ZS-9 similar to that of placebo. (more…)
MedicalResearch.com Interview with:
Professeur Sidney Chocron
Chef de Service Chirurgie Thoracique et Cardio-Vasculaire
CHU de Besançon - Hôpital Jean Minjoz
BESANCON Cedex
Medical Research: What is the background for this study? What are the main findings?Prof. Chocron: Acute kidney injury (AKI) is one of the most frequent complications after cardiac surgery.There is a time delay between the onset of renal impairment and the resulting telltale increase in blood creatinine levels.
Recent studies have underlined the promising properties of Neutrophil Gelatinase-Associated Lipocalin (NGAL). NGAL values early after surgery could predict the duration and severity of Acute Kidney Injury. In addition, NGAL can independently predict deteriorating renal function and could therefore be useful even in the context of pre-existing renal failure.
We aimed to assess the predictive ability of plasma NGAL levels to identify deteriorations in renal function after cardiac surgery in patients with pre-existing renal failure.
Medical Research: What are the main findings?
Prof. Chocron: One hundred sixty six patients with pre-operative renal failure i.e pre-operative creatinine clearance ≤60 mL/min/1.73m2 according to the Cockcroft Gault formula, were included in the study.
The threshold NGAL values at 6 hours after operation, as determined by ROC curve analysis was 155 ng/mL with a sensitivity of 79% and a specificity of 58%.
By multivariate analysis at 6 hours, a history of hypertension (OR=3.2 [1.2 - 8.9]), occurrence of at least 1 post-operative complication (OR=4.5 [1.3 - 15]), and an NGAL value above 155 ng/mL (OR=7.1 [2.7 - 18]) were shown to be independent predictors of the occurrence of post-operative AKI.
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MedicalResearch.com Interview with:
James Flory MD, MSCEDivision of Endocrinology and Department of Healthcare Policy and Research
Weill Cornell Medical College, NY NYMedical Research: What is the background for this study? What are the main findings?
Dr. Flory: Metformin is the first-line drug for type 2 diabetes, with much better evidence for safety and improved clinical outcomes than any alternative. The one major safety concern about metformin is the fear that it can cause lactic acidosis, which led to a Food and Drug Administration black box warning against using metformin in patients with even a modest degree of renal impairment. These fears and warnings were based on serious problems with an older drug in the same class, not on experiences with metformin itself, and over the past 20 years it has become clear that the risk of lactic acidosis with metformin is extremely low, and that this warning against the use of the drug in mild renal failure is overly strict. (Dr. Lipska and colleagues published a superb review of this issue a few years back: Diabetes Care June 2011 vol. 34 no. 6 1431-1437)
This is important from a public health perspective because so many patients with diabetes have mild to moderate kidney disease, and we were concerned that the FDA warning was preventing the use of metformin in these patients. Our study was intended to estimate how many patients who would benefit from metformin are not taking it because they have mild kidney disease.
We found that rates of metformin use are much lower in patients with mild kidney disease – just the population where the FDA warning discourages use, but modern data show that metformin is safe. In all, at least 1 million patients with type 2 diabetes who would benefit from metformin appear not to be taking it because clinicians are following the FDA warning and being too conservative.(more…)
MedicalResearch.com Interview with:
Alison G Abraham PhD
Associate Scientist
Department of Epidemiology
Johns Hopkins Bloomberg School of Public Health
Medical Research: What was the motivation for this study?Dr. Abraham: HIV-infected individuals are at higher risk for kidney dysfunction compared to the general population. Prior to effective antiretroviral therapy, very aggressive forms of kidney disease were described primarily among black HIV-infected individuals. While effective therapy and increasing viral suppression rates have made HIV-associated nephropathy rare, some of these same drugs have nephrotoxic effects. In addition, the reduction in AIDS and mortality has led to HIV-infected individuals living long enough to experience age-related chronic diseases, which are also risk factors for kidney disease and end-stage renal disease. Thus we wanted to know how these competing forces were affecting end-stage renal disease risk in the well-treated HIV-infected North American population over time. Are we seeing more ESRD as a result of nephrotoxic drugs and chronic disease, or less ESRD as a result of better viral suppression and large reductions in HIV-associated nephropathy?
Medical Research: What are the main findings?Dr. Abraham: We found that end stage renal disease rates have been steadily falling over the past 10 years coincident with notable improvements in viral suppression prevalence. However a large racial discrepancy in ESRD risk has persisted even though HIV-associated nephropathy cases are now rare. While ESRD cases among blacks in our study tended to have higher viral loads and lower CD4 counts compared to non-black ESRD cases, suggesting less effective HIV treatment, we found that the racial discrepancy in ESRD risk persisted even among the well-suppressed subset, i.e. those who had undetectable viral loads for 90% of their follow-up time.
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MedicalResearch.com Interview with:
Florentina E. Sileanu BS
Center for Critical Care Nephrology and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center
Departments of Critical Care Medicine and Department of Biostatistics,
University of Pittsburgh Graduate School of Public Health and
Dr. John A. Kellum, MD, MCCM
Professor of Medicine, Bioengineering and Clinical & Translational Science
Vice Chair for Research Center for Critical Care Nephrology,
University of Pittsburgh School of Medicine
Pittsburgh, PA
Medical Research: What is the background for this study? What are the main findings?
Response: Acute Kidney Injury (AKI) affects millions of Americans each year resulting in increased short and long-term complications including need for dialysis and death. Many trials recruiting subjects at risk for AKI have focused on those with other (e.g. cardiovascular and respiratory) organ failures because these patients are at highest for AKI. However, patients without these conditions might not be at low-risk for AKI. We explored whether Acute Kidney Injury occurring as a single organ failure or occurring before other organ failures would be associated with the same outcomes as in sicker patients. Using a large, academic medical center database, with records from July 2000 through October 2008, we identified a "low-risk" cohort as patients without cardiovascular and respiratory organ failures defined as not receiving vasopressor support or mechanical ventilation within the first 24 hours of ICU admission. We were able to show that low-risk patients have a substantial likelihood of developing AKI and that the relative impact on mortality of AKI is actually greater for low-risk patients (OR, 2.99; 95% 2.62-3.41) than for high-risk patients (OR, 1.19; 95% 1.09-1.3).
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MedicalResearch.com Interview with:
Madhav Swaminathan, MBBS, MD, FASE, FAHA
Associate Professor with Tenure
Clinical Director, Division of Cardiothoracic Anesthesiology & Critical Care Medicine Department of Anesthesiology
Duke University Health System Durham, NC 27710
Medical Research: What is the background for this study? What are the main findings?Dr. Swaminathan: The background is the need for salvage therapies for acute kidney injury (AKI,) which is a common complication in hospitalized patients. It is particularly a problem in the postoperative period after cardiac surgery. Preventive strategies have not worked well for decades. Hence the focus on strategies that target kidney recovery. Mesenchymal stem cells have been shown to be useful in enhancing kidney recovery in pre-clinical trials. We therefore hypothesized that administration of human Mesenchymal stem cells (AC607, Allocure Inc, Burlington, MA) to patients with established post-cardiac surgery AKI would result in a shorter time to kidney recovery. We conducted a phase 2, double blinded, placebo controlled, randomized clinical trial to test our hypothesis. Unfortunately we could not confirm the hypothesis and there were no significant differences in time to kidney recovery among patients that received AC607 versus placebo in 156 randomized cardiac surgery subjects.
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MedicalResearch.com Interview with:
Anders Nissen Bonde MBs
Department of Cardiology
Copenhagen University Hospital Gentofte,
Gentofte, DenmarkMedical Research: What is the background for this study? What are the main findings?Response: Patients with severe chronic kidney disease have been excluded from
randomized trials of antithrombotic therapy in atrial fibrillation.They
represent a very fragile group as they are both at increased risk of
stroke/thromboembolism and major bleedings, and previous observational
studies have had conflicting conclusions regarding the safety and benefits
of the treatment. A previous study from our department reported both
increased risk of bleeding and reduced risk of stroke with warfarin.
We wanted to assess the net clinical benefit of aspirin and warfarin in
these patients, balancing stroke and major bleeding associated with the
treatment.
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MedicalResearch.com Interview with:
Dr. Julia Lewis, MD, Lead Investigator
Nephrologist and Professor of Medicine
Vanderbilt University Medical Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Lewis: The 48-week Open Label Extension (OLE) study for Auryxia™ (ferric citrate) was conducted to determine long term safety following the Phase 3 52-week active-control period. The study also evaluated changes in serum phosphorus, transferrin saturation (TSAT), serum ferritin, hemoglobin, hematocrit and additional parameters, as well as intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) usage.
In the OLE study, Auryxia demonstrated long-term safety in dialysis-dependent chronic kidney disease (CKD) patients. The results were consistent with those seen in the published pivotal Phase 3 trial.
The study demonstrated that the adverse events (AE’s) profile of Auryxia was similar to that seen in the Phase 3 52-week active-control period. AEs occurred in 142 patients treated with Auryxia. They were primarily non-serious gastrointestinal (GI) - related AE’s, including diarrhea, nausea, vomiting and constipation. Serious adverse events occurred in 75 patients, though none were related to Auryxia. In addition, there were no clinically or statistically significant differences in liver enzymes or aluminum levels observed from baseline to the end of the 48 weeks.
Similar to the original trial, we witnessed excellent phosphorus control with the drug, along with an increase and then a plateau in serum ferritin and TSAT levels with Auryxia. The plateauing of serum ferritin and TSAT further supports iron absorption is highly regulated by the gastrointestinal track as seen in the 52-week active control period. This suggests that the body absorbs iron as needed for effective erythropoiesis.
Additionally, iron store increases from ferric citrate resulted in, by the end of the extension study, 85% of subjects not using any IV iron.
We presented this data at the 2014 American Society of Nephrology Meeting. The abstract can be found online at www.asn-online.org.
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MedicalResearch.com Interview with:
Thomas Weichhart, PhD
Associate Professor, Medical University of Vienna
Institute of Medical Genetics Vienna Austria
Medical Research:What is the background for this study? Dr. Weichhart: Impairment of high-density lipoprotein (HDL) function has been associated with cardiovascular events in patients with kidney failure on hemodialysis. The protein composition of HDLs is altered in these patients presumably compromising the cardioprotective effects of HDLs. In an earlier study we found that two proteins in particular, namely Serum Amyloid A (SAA) and Surfactant Protein B (SP-B), are significantly raised in the HDL of dialysis patients, and these also contribute towards HDL losing its protective effect. In the current study we have now developed an novel test that can quickly and directly measure the SAA and SP-B bound to HDL.
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MedicalResearch.com Interview with:
Giovanni Landoni, M.D.
Head of Research,Department of Anesthesiology and Intensive Care
Associate Professor at Università Vita-Salute San Raffaele, Milan
Medical Research: What is the background for this study?Dr. Landoni:The prevention and treatment of acute kidney injury after cardiac surgery is a major therapeutic goal, but no effective agents have yet been identified. Meta-analyses suggested that fenoldopam might be effective.
Medical Research: What are the main findings?Dr. Landoni: We found that in cardiac surgery patients with early acute kidney injury (defined as a ≥50% increase of serum creatinine from baseline or oliguria for ≥6 hours), fenoldopam had no impact on the need for renal replacement therapy or 30-day mortality, while increasing the rate of hypotension.
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MedicalResearch.com Interview with: Prof. Francesca Mallamaci
Professor of Nephrology
Head of the Hypertension Unit at the Department of Nephro-Urology, CNR-IBIM Research on Clinical Epidemiology and Pathophysiology of Renal Diseases and Hypertension, Reggio Calabria, Italy
Medical Research: What is the background for this study? What are the main findings?Dr. Mallamaci: It is well known that physical activity is beneficial both in normal individuals and in patients with heart failure which represent a high risk category of patients. We have scanty information about physical activity in dialysis patients. So the aim of our study was to test the effectiveness of a low-intensity, easy to implement, home exercise program on physical performance in about 300 dialysis patients in a multicenter, randomized, controlled clinical trial (EXCITE, ClinicalTrials.gov NCT01255969). What we found in our study was that dialysis patients who performed exercise improved their physical performance and this was documented by 2 well known and validated performance tests such as the Six Minute Walking Test and the Sit-to-stand-to sit test. We found also that after 2 year follow-up dialysis patients who were in the active exercise arm had a lower rate of hospitalization and a trend to a better survival, compared to dialysis patients in the control arm of the study. (more…)
MedicalResearch.com Interview with:with
Stuart M. Sprague, DO, FACP, FASN, FNKF
Chairperson, Division of Nephrology and Hypertension
NorthShore University HealthSystem
Evanston, Illinois 60201
Medical Research: Congratulations, Dr. Sprague, on your presentation of another successful phase 3 clinical trial program at the recently concluded Annual Meeting of the American Society of Nephrology. Your presentation unveiled a new vitamin D repletion therapy that effectively controls secondary hyperparathyroidism in chronic kidney disease. Can you give us a little background for the presented studies?
Dr. Sprague: Thanks! Vitamin D insufficiency is a big problem in chronic kidney decease (or CKD): it afflicts more than 20 million adults in the United States who have stages 1 through 4 CKD. Its prevalence increases with CKD severity and it drives secondary hyperparathyroidism. The studies which I presented evaluated a novel therapy to treat secondary hyperparathyroidism (SHPT) arising from vitamin D insufficiency in patients diagnosed with stage 3 or 4 CKD. This new therapy is a modified-release formulation of calcifediol.
Medical Research: Can you tell us more about vitamin D insufficiency? Dr. Sprague: Vitamin D insufficiency is a condition in which the body has low vitamin D stores. It is characterized by inadequate blood levels of the vitamin D, known as 25-hydroxyvitamin D. An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases. Vitamin D insufficiency has also been associated with increased mortality in CKD.
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MedicalResearch.com Interview with:
Anu Wadhwa, M.D.
Assistant Professor of Medicine
Division of Nephrology and Hypertension
Loyola University Medical Center/ Hines VA Hospital
Maywood, IL-60153
Medical Research: What is the background for this study?Dr. Wadhwa: Patients with end stage renal disease rely on dialysis treatments to survive. Hence this population is very vulnerable during emergencies or disaster situations. We believe that patient education on an individual level is the cornerstone of a successful disaster plan. In this quality improvement study, we assessed disaster preparedness in our dialysis patients and evaluated multidisciplinary approach to disseminate this information. Multidisciplinary team of physicians, nurses, dieticians and social workers reviewed preparedness-relevant topics with the patients. Patients were provided purple cards (created by KCER) with emergency information to carry with them at all times. A simple yes/no questionnaire asking disaster preparedness relevant questions was given to the patients before and after this education was provided. Disaster preparedness was defined as perceived preparedness (survey question) and a positive response to at least three key questions-having a plan they have had discussed with a family member or dialysis unit, knowledge of backup dialysis facility and familiarity with emergency diet plan.
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MedicalResearch.com Interview with:Anthony Bleyer, Jr.
Wake Forest University Class of 2015, Economics
President, Club Sports Union
Senior Captain, Wake Forest Men's Ultimate
Medical Research: What is the background for this study? What are the main findings?Response: There are over 100,000 individuals waiting for a kidney transplant, but each year only approximately 6,000 individuals have living donors who donate them a kidney; the rest of the individuals must remain on dialysis until they receive a kidney from an individual who has died and is a kidney donor. A major limiting factor for kidney donation is that many individuals are not healthy enough to donate a kidney because they have excessive obesity, diabetes mellitus, blood pressure that is too high, or they have other health conditions. While it was known that obesity, hypertension, and other health conditions are contraindications to kidney transplant, there was no data about what percentage of the US population would be able to donate a kidney. To study this, we (a team of kidney doctors and researchers at Wake Forest School of Medicine, Winston-Salem, NC) analyzed data from the National Health and Nutrition Survey. This study is a population-based sample that is representative of the US population.
Based on data from this study, we determined that 55.2% of the U.S. population would not have met eligibility criteria for kidney donation, often due to preventable health conditions. 19.2% of the population would have been unable to donate due to hypertension, 15% due to obesity, 11.6% due to excessive alcohol intake, and 11.5% due to diabetes. 60.1% of individuals with an adjusted family household income (AFHI) <$35,000 did not meet eligibility criteria vs. 49.3% for an AFHI > $100,000. If one considers non-US citizenship and a family income below the poverty threshold as exclusion criteria, 68.5% of the US population would be unable to donate.
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MedicalResearch.com Interview with:Naoka Murakami MD PhD
Mount Sinai Beth Israel Department of Medicine
Medical Research: What is the background of the study? What are the main findings? Dr. Murakami: Dialysis patients live in a complex sociomedical situation and are highly dependent on technologies to sustain their lives; such as transportation, electricity and water for the dialysis apparatus. Interruption of this infrastructure by a natural disaster can result in devastating outcomes.
During triage of patients arriving at Mount Sinai Beth Israel in the immediate aftermath of hurricane Sandy, we observed that many dialysis patients did not know about their medications, their comorbid conditions nor their dialysis prescriptions. Therefore we conducted a cross-sectional follow-up study of 357 hemodialysis patients in five dialysis units in lower Manhattan, New York. Using checklists prepared by the National Kidney Foundation and the Department of Homeland Security, we found that 26.3% subjects missed dialysis sessions and 66.1% received dialysis at non-regular dialysis unit(s). We observed that the distribution of a “Dialysis emergency packet” significantly improved retention of medical records at home. Analysis showed that dialysis-specific preparedness, racial ethnicity (non-African American, Hispanic or Caucasian), reception of dialysis in affiliated units, and older age, were associated with a significant reduction in missed dialyses.
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MedicalResearch.com Interview with:
Ning Tan, MD, PHD
Senior Consultant Cardiologist. Department of Cardiology
Guangdong Cardiovascular Institute
Guangdong General Hospital
Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
Medical Research: What are the main findings of the study?Dr. Tan: In this study, we evaluated whether Low density lipoprotein cholesterol (LDL-C) is an independent risk factor of contrast-induced acute kidney injury (CI-AKI) in patients undergoing percutaneous coronary intervention (PCI). We prospectively enrolled 3236 consecutive patients undergoing PCI in our hospital and demonstrated that LDL-C is significantly and independently associated with CI-AKI in patients undergoing PCI.
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MedicalResearch.com Interview with: Dr Jelena Kornej
Department of Electrophysiology
Heart Center Leipzig Leipzig Germany;
Medical Research: What are the main findings of the study?Dr. Komej: Both atrial fibrillation (AF) and renal impairment are known to coexist and associated with increased morbidity and mortality. However, there is only limited data on changes of renal function after AF catheter ablation and predictors thereof. This is the largest study analyzing the effects of atrial fibrillation catheter ablation on renal function and changes thereof in a contemporary population during mid-term follow-up. We found that lower baseline eGFR was associated with higher CHADS2and CHA2DS2-VASc scores and that both scores were independently associated with eGFR changes after atrial fibrillation catheter ablation as were atrial fibrillation recurrences.
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