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:12/5/2016)... , Dec. 5, 2016  Balloon catheter is ... which is inserted into the femoral artery in the ... arm to treat constricted blood vessels. These products are ... to atherosclerosis – deposition of lipid substances in the ... catheter market is projected to expand at a CAGR ...
(Date:12/5/2016)... , Dec. 5, 2016  Zimmer Biomet Holdings, Inc. ... that, pursuant to its previously-announced cash tender offers ... the table below (collectively, the "Notes"), approximately $2.6 billion ... tendered and not validly withdrawn on or prior ... time, today, December 5, 2016 (the "Early ...
(Date:12/5/2016)... LONDON , Dec. 5 2016 ... 2022 Summary GlobalData,s new report, "United ... provides key market data on the United Kingdom ... in millions of US dollars, volume (in units) ... Optical Coherence Tomography (OCT), Retinal Ultrasound Imaging Systems, ...
Breaking Medicine Technology:
(Date:12/5/2016)... ... 2016 , ... What: Shriners Hospitals for Children, with the help of Dimension ... using a video monitor and web-enabled camera. Santa visits with children through Dimension Data’s ... Christmas Wonderland, which is where the video connection to the North Pole will stream. ...
(Date:12/5/2016)... ... December 05, 2016 , ... "FCPX Overlay Glare is a tool ... effect without heavy rendering or complicated compositing," said Christina Austin - CEO of Pixel ... an organic spectrum of lights that simulates the look of a glare. Just ...
(Date:12/5/2016)... ... December 05, 2016 , ... ... Surgery, is excited to announce the arrival of the newest Sciton laser in ... the ability to use tunable non-ablative and ablative wavelengths for exceptional results. Outperforming ...
(Date:12/5/2016)... ... December 05, 2016 , ... The Avamere Family of Companies ... Avamere Transitional Care of Puget Sound ; located at 630 S Pearl Street, ... provide patients recovering from illness or injury with intensive skilled nursing and rehabilitation ...
(Date:12/5/2016)... ... ... For many years, Andrew G. Zubinas has accumulated over 130 ... the Lithuanian language and its poetry inspired him in writing “ Forest ... all aspects of a living, breathing forest where nothing ever stays the same. His ...
Breaking Medicine News(10 mins):