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

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:
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
(Date:6/23/2016)... BEVERLY HILLS, Calif. , June 23, 2016 ... faced the many challenges of the current process. Many of ... option because of the technical difficulties and high laboratory costs ... would have to offer it at such a high cost ... to afford it. Dr. Parsa Zadeh , ...
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... BRAHMS PCT (procalcitonin) assay as a dedicated testing solution ... this clearance, Roche is the first IVD company in ... sepsis risk assessment and management. PCT is ... levels in blood can aid clinicians in assessing the ...
Breaking Medicine Technology:
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... feeding the Frederick area economy by obtaining investment capital for emerging technology companies. ... 2½ years that have already resulted in more than a million dollars of ...
Breaking Medicine News(10 mins):