Navigation Links
Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
Date:9/12/2007

September 11, 2007

WASHINGTON, Sept. 12 /PRNewswire-USNewswire/ -- The following is a statement by KCP Chairman Dr. Edward Jones:

Yesterday's FDA Advisory Committee meeting underscores the many considerations that must be factored in to policymaking related to anemia treatment in patients suffering from chronic kidney disease. The kidney community salutes FDA for working with scientists, practicing nephrologists, and other members of the medical community to achieve a consensus on hemoglobin and dosing levels for erythropoietin-stimulating agents (ESAs) based on different patient populations. The community is unified in its belief that patient quality of care and quality of life must be taken into account as physicians treat anemia in kidney patients. Patients with chronic kidney disease and those on dialysis depend on ESAs to stimulate red blood cell production in their bodies.

Anemia-management drugs have been well demonstrated to improve quality of life for kidney patients and provide significant medical benefits. Unlike patients with cancer, patients with chronic kidney disease are permanently affected by anemia, which in turn affects their ability to engage in day-to- day activities that non-patients take for granted -- caring for their families, holding a job, and going to school. Without ESA therapy, ESRD patients may develop hemoglobin levels that are dangerously low. Before ESAs were available, blood transfusions were required in most kidney patients. Transfused patients often suffered from heart failure, iron overload, and other chronic problems.

Several studies have demonstrated improvement in the morbidity and mortality of patients with kidney disease and kidney failure by the appropriate management of their anemia. After extensive review of the results of six new studies, a National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) work group updated its Clinical Practice Guideline on Anemia this month and recommended that ESA therapy in dialysis and non- dialysis CKD patients should target hemoglobin levels in the range of 11 to 12 g/dL. These guidelines are scientifically based.

The FDA panel members reaffirmed current dosing practices and voted against limiting the upper threshold of hemoglobin levels to 11. Additionally, the FDA made it clear that the label instructions were never intended to result in EPO doses being withheld if a patient's hemoglobin level exceeded 12. Further, the committee stressed the need for small incremental dose adjustments of ESAs in an effort to minimize hemoglobin variation around the target. Dr. Ellis Unger specifically raised this as he emphasized the importance of focusing on best practices and the importance of minimizing the rate of rise and rate of fall in hemoglobin. The community urges CMS to consider these findings as they implement the Erythropoietin Monitoring Policy (EMP) used to treat anemia in ESRD patients.

The complexities of ESA dosing were readily apparent during yesterday's Advisory Commission's discussion, and we appreciate the panel's thoughtful consideration of the impact its decision will have on patients.

KCP is a nationwide alliance of representatives from the entire kidney care community, including patients and their advocates, nephrologists, nurses, dialysis care providers, and manufacturers who have joined together to improve the quality of care and quality of life for individuals suffering from kidney disease and kidney failure.


'/>"/>
SOURCE Kidney Care Partners
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Lupus Foundation of America Statement on Results for Clinical Study of CellCept Released by Aspreva Pharmaceutical Company
2. Obama Statement on Bush Veto of Stem Cell Bill
3. Statement by Philip Home Chairman of the RECORD Study Steering Committee and Professor of Diabetes Medicine at Newcastle University in England
4. New Position Statement from The North American Menopause Society Addresses Use of Local Estrogen for Treatment of Vaginal Atrophy in Postmenopausal Women
5. Response Genetics Announces Publication of a Phase III Clinical Trial Demonstrating That Low Levels of ERCC-1 Help to Predict Likelihood of Response to Cisplatin-Based Therapy in Lung Cancer
6. TMC125 Showed Significant Virologic Response at Week 24 in Treatment-Experienced HIV Patients With NNRTI Resistance in Phase 3 Trials
7. Trexima (Sumatriptan/Naproxen Sodium) Demonstrated Migraine-Free Response Across Multiple Attacks
8. Cervarix, the GSK Cervical Cancer Candidate Vaccine, Provides Sustained Immune Response in 100 Percent of Women up to 55 Years of Age
9. Data Demonstrated Metastatic Melanoma Response to Investigational Immunotherapy Ipilimumab
10. Ontak (denileukin diftitox) Achieves 49.1% Overall Response Rate in Phase III Trial of Cutaneous T-Cell Lymphoma (CTCL)
11. Introgen Reports Updated Phase 2 Advexin Data Correlating Improved Survival, Tumor Responses and Predictive p53 Biomarker
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
(Date:6/24/2016)... 2016  Collagen Matrix, Inc., ("Collagen Matrix") the ... of collagen and mineral based medical devices for ... Bill Messer has joined the company as ... the growing portfolio of oral surgery, neurosurgery, orthopaedic ... joins the Collagen Matrix executive team as an ...
(Date:6/24/2016)... -- Dublin ... the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global market ... its applications in various applications. The report deals with ... main industries: pharmaceutical and biotechnology, food and beverage, and ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand ... project," said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s ... within Final Cut Pro X . Simply select a ProHand generator and drag ...
(Date:6/25/2016)... ... ... Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and Mental ... exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took place ... BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive an ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
Breaking Medicine News(10 mins):