Showing posts with label Dialysis. Show all posts
Showing posts with label Dialysis. Show all posts

Saturday, December 11, 2010

Public Health: Frequency Of Dialysis Treatment Questioned, Chemotherapy Drug Shortages


Main Category: Medicare / Medicaid / SCHIP
Also Included In: Urology / Nephrology;??Diabetes;??Public Health
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News outlets report on a variety of public health issues.

CQ Health Beat: A new study funded by the National Institutes of Health suggests that receiving dialysis six days a week results in better self-reported patient health than the conventional treatment of three times per week. "Since the brunt of dialysis costs is borne by Medicare, a boost in frequency could mean increased spending by the program, however. ... Might the study eventually lead to increased Medicare outlays for dialysis? Washington, D.C. health policy consultant Alec Vachon says the question isn't easy to answer. 'Our kidneys work 24/7, so it should not be a surprise that more frequent dialysis - beyond standard thrice weekly - is better,' he said. 'But the wild cards are what CMS, patients, or dialysis providers think. Dialysis is already the single largest Medicare line item, and many patients are not keen on even three sessions per week. And would dialysis providers - most of which are for profit - find it attractive to sharply expand capacity even if Medicare would pay for added sessions?'" (Reichard, 11/23).

National Journal: Following a new report Tuesday predicting that nearly half the U.S. population could have diabetes by 2020, researchers estimate "that the diabetes problem will continue to grow without aggressive intervention that primarily focuses on weight management and combating obesity. 'Because diabetes follows a progressive course, often starting with obesity and then moving to prediabetes, there are multiple opportunities to intervene early on and prevent this devastating disease before it's too late,' said Deneen Vojta, senior vice president of the UnitedHealth Center for Health Reform & Modernization (Fung, 11/23).

St. Louis Beacon: The St. Louis Diabetes Coalition is "taking its message out of doctors' offices and to the public" through education seminars in collaboration with Saint Louis University's Center for Outcome Research. "The coalition's programs are free and open to everyone, but the group is especially interested in reaching people who are clueless about how best to handle a disease that's claiming more victims as Americans get less or no exercise and eat more unhealthy foods. ... The coalition's work with SLU's Center for Outcome Research is financed by a $99,000 grant from the St. Louis Community/University Health Research Partnership. Set up in 2009, the partnership focuses on research into diabetes and other health problems" (Joiner, 11/23).

The Associated Press/Boston Globe: "[A]lcohol-related problems are sending nearly 1,000 college-age residents to hospital emergency rooms each year," according to an analysis by the Boston Public Health Commission. "[S]ince 2008, 18- to 22-year-olds have made 40,000 visits to city emergency rooms, and of that number, more than 2 percent were alcohol-related. Commission Executive Director Dr. Barbara Ferrer calls the numbers 'a serious problem and a burden on the health care system'" (11/24).

The Wall Street Journal Health Blog: Amid an "ongoing problem of drug shortages," chemotherapy drugs "are among those most in demand. ... Drug shortages occur for a range of reasons that vary by medication: the unavailability of raw ingredients, FDA enforcement actions that halt production, voluntary recalls, poor inventory ordering, a change in product formulation and even rumors of an impending shortage, which can cause hoarding, according to the Institute for Safe Medication Practices" (Hobson, 11/23).

Charleston, S.C. WCBD: "People eat what is convenient and affordable -- and if it's sodium laden fast food, that's what they'll chow down on. A team of Medical University of South Carolina researchers studied the Chicora Cherokee neighborhood for 6 months. They looked at the impact of the environment on the people who live in the community and on the students attending Burns and Chicora elementary schools in North Charleston. They discovered the lack of affordable, healthy food options in urban communities ironic in a country with an abundance of food. 'We determined that there were only 13 stores within a mile of Chicora Cherokee and of those 13 stores there were "zero" grocery stores', says Amy Painter of MUSCs Center for Communities in Health Partnerships" (Murray, 11/24).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

ⓒ Henry J. Kaiser Family Foundation. All rights reserved.

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Wednesday, November 3, 2010

Kidney Patients Not On Dialysis, FDA Advisers Recommend Continuation Of Aranesp (Darbepoetin Alfa)


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Main Category: Urology / Nephrology
Also Included In: Blood / Hematology;??Regulatory Affairs / Drug Approvals;??Diabetes
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An FDA Advisory Committee has recommended the continued use of Aranesp (Darbepoetin alfa), a synthetic form of erythropoietin used to treat anemia in patients with mild to moderate chronic (long-term) kidney disease. Although the Advisory Committee's recommendations are not binding, the FDA usually goes along with what their members say. The Committee voted 15 in favor with 1 abstention not to withdraw the medication. They had met after studies involving 4,000 participants showed that the risk of stroke for those taking Aranesp was equal to those on a placebo. The Advisers also voted on whether use should be limited to rescue therapy for individuals with extremely low levels of iron - they voted 9 to 5 that there should not be this limit.

Safety concerns have affected the sales of Aranesp since 2006. The medication is also used for treating patients with anemia caused by cancer chemotherapy. Treating kidney patients not on dialysis accounts for $600 million's worth of Arenesp's annual sales.

Reshma Kewalramani, M.D., FASN, executive director, Global Development at Amgen, the makers and marketers of Aranesp, said:

This Advisory Committee meeting is a valuable forum for the FDA, Amgen and the nephrology community to review the results from TREAT, which further inform use of ESAs in patients with chronic renal failure who are not on dialysis. We look forward to sharing our analyses of TREAT and describing proposed label changes that will help guide nephrologists in focusing their use of ESA therapy on patients most likely to benefit.

TREAT is the largest study of erythropoiesis-stimulating agent (ESA) use in patients with chronic renal failure. It is a double-blind, randomized, placebo-controlled Phase III study of individuals with moderate kidney dysfunction (not on dialysis), with moderate anemia as well as diabetes Type 2, and were treated to a hemoglobin target of 13 g/dL, a higher level than recommended in the current approved ESA label, Amgen informs.

The trial's endpoints of all-cause mortality reduction or cardiovascular morbidity reduction were not met, the study also showed a higher risk of stroke in the Aranesp group of patients.

Amgen stresses that the cardiovascular risks have been included in the boxed warning of the FDA-approved ESA labels since 2007. Amgen adds that since December 2009, the warnings have been strengthened to include the specific stroke risk.

Amgen proposes that ESA labels be altered, limiting treatment to those most likely to benefit - patients with significant anemia who have a high risk for transfusion and for whom avoiding transfusion is clinically important, including individuals for whom preserving kidney transplant eligibility is important. For patients with chronic renal failure who are receiving dialysis (not studied in TREAT) the benefits are clear and unchanged, the company adds.

Robert Toto, M.D., University of Texas Southwestern Medical Center, said:
The nephrology community has, and will continue to gain, significant understanding about the treatment of anemia in patients with chronic kidney disease not on dialysis from this large and rigorously designed and conducted clinical trial. First and foremost, TREAT has informed us that the risks of treatment may outweigh the benefits for some patients with chronic kidney disease and anemia who are not on dialysis. However, ESAs remain an important therapeutic option for patients on dialysis, where the benefits are clear, and for certain patients not on dialysis; specifically those with significant anemia in whom blood transfusion avoidance is important, especially to preserve eligibility for kidney transplantation, the preferred treatment option for patients with failing kidneys.

Over 26 million Americans are affected by chronic kidney disease, which invariably leads to progressive kidney damage and impaired kidney function. Chronic kidney disease is most commonly caused by diabetes Type 2 or hypertension (high blood pressure). When a person with chronic kidney disease develops kidney failure there are two options for staying alive - regular long-term dialysis or a kidney transplant. A common complication of chronic kidney disease is anemia, which may occur during the disease's early stages. As kidney function gets worse anemia becomes more common.

Aranesp was approved in both the USA and the European Union in 2001 for the treatment of anemia linked to chronic renal failure for patients not on dialysis as well as those on dialysis. In 2008 the European Commission updated Aranesp use also for chronic renal failure patients with symptomatic anemia.

The FDA approved Aranesp in 2002 for anemia treatment caused by chemotherapy in individuals with nonmyeloid malignancies. In 2002 the European Commission approved Aranesp treatment for anemia caused by concomitantly administered chemotherapy in patients with non-haematological malignancies. In 2003 its use was extended in Europe to include non-myeloid malignancies in patients receiving chemotherapy.

Sources: FDA, Amgen

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

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