Amgen's Commitment To Kidney Disease Underscored At American Society Of Nephrology's 40th Annual Meeting And Scientific Exposition In San Francisco

Main Category: Urology / Nephrology
Article Date: 06 Nov 2007 - 2:00 PDT

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Amgen announced several presentations at the American Society of Nephrology's (ASN) 40th Annual Meeting and Scientific Exposition in San Francisco. Working together with leading clinicians in the field, the company will present a total of 47 abstracts on current topics ranging from hemoglobin variability in patients on dialysis to cost trends in end stage renal disease (ESRD) to the benefit of Sensipar®/Mimpara® (cinacalcet HCI) in treating secondary hyperparathyroidism for patients on dialysis.

"Amgen is committed to advancing the treatment and understanding of kidney disease for the millions of patients around the world who suffer from the disease and the millions more who are at risk for it," said Robert M. Brenner, M.D., executive director, Nephrology Medical Affairs, Amgen "This commitment is evident in the scope and significance of the data we will present this week at ASN."

Key presentations include:

Erythropoietin (EPO) Dose Adjustments and the Effect of Dialysis Facility Hemoglobin (Hb) Variability
(Abstract No. SU-PO548; Poster Session; Sunday, November 4, 2007, 10:00 AM)

This retrospective study used the OutcomesPlus Database of 311,000 dialysis patients to examine facility-level dose adjustment practices, finding that facilities that made the most frequent dose adjustments for erythropoiesis-stimulating agents (ESA) closest to the mean hemoglobin level of their facility had lower hemoglobin variability compared to facilities that adjusted ESA dose when the hemoglobin was furthest from their facility mean hemoglobin.

Short-Term Erythropoiesis Stimulating Agent (ESA) Exposure and Risk of Myocardial Infarction (MI) and Stroke (CVA) in Pre-Dialysis Chronic Kidney Disease (CKD) Patients
(Abstract No. SU-PO1024; Poster Session; Sunday, November 4, 2007, 10:00 AM)

This retrospective analysis of cardiovascular events among CKD patients not on dialysis with anemia did not observe an increased risk for myocardial infarction or stroke among the anemic CKD patients treated with ESAs.

Inflation-adjusted Cost Trends in End Stage Renal Disease (ESRD) Patients Undergoing Dialysis
(Abstract No. SU-FC072; Free Communication; Sunday, November 4, 2007, 4:12 PM)

This actuarial model of Medicare claims data analyzing cost trends for the treatment of ESRD patients on dialysis between 1991 and 2004 revealed that, when adjusted for inflation, reimbursement for dialysis services has decreased significantly.

Mean Outpatient Hemoglobin at Time of Transfusion in Patients with CKD Undergoing Dialysis
(Abstract No. SU-PO532; Poster Session; Sunday, November 4, 2007, 10:00 AM)

This study examined mean hemoglobin levels of patients on dialysis with Medicare as primary payor between 1991 and 2005 specifically looking at the months in which the patient was transfused and the three months before and after transfusion. The study concluded that EPOGEN® (Epoetin alfa) has been successful in reducing transfusions and raising the average hemoglobin within the transfusion month.

Intercurrent Events and Co-morbidities Related to Intra-patient (PT) Hemoglobin (HB) Variability
(Abstract No. SA-PO782; Poster Session; Saturday, November 3, 2007, 10:00 AM)

This analysis examined 522 patients from a multicenter, open-label, randomized conversion trial (rHuEPO to darbepoetin alfa) of CKD patients to assess the relationship between intercurrent events (blood transfusions and hospitalizations) and co-morbidities (diabetes) with intra-patient hemoglobin variability. The findings suggest that intercurrent events and co-morbidities are major factors influencing hemoglobin variability and the ESA type studied does not impact intra-patient hemoglobin variability.

Treatment with Cinacalcet HCI and Concurrent Low-Dose Vitamin D Improved Management of Secondary Hyperparathyroidism (SHPT) Compared with Vitamin D Alone
(Abstract No. SU-FC100; Free Communication; Sunday, November 4, 2007, 5:48 PM)

This open-label, prospective, randomized trial of 173 dialysis patients demonstrated that Sensipar®/Mimpara® plus low dose vitamin D is ana effective combination to help achieve KDOQI goals. KDOQI is a trademark of the National Kidney Foundation , Inc.

About EPOGEN

Amgen launched EPOGEN one of the first biologically derived human therapeutics, into the U.S medical marketplace in 1989 for the treatment of anemia in patients with chronic renal failure on dialysis. EPOGEN is a recombinant protein with the same mechanism of action as endogenous human erythropoietin, a protein produced by the kidneys to stimulate the production of oxygen-transporting red blood cells.

About Aranesp

Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with CRF for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies and in March 2006, the FDA approved every-three-week dosing in these patients.

Aranesp was granted marketing authorization by the European Commission in 2001 for the treatment of anemia associated with chronic renal failure (CRF), in adults and pediatric subjects 11 years of age or older. In 2002, the European Commission approved Aranesp for the treatment of anemia in adult cancer patients receiving chemotherapy with solid tumors. This patient population was subsequently expanded in 2003 to include treatment of symptomatic anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. Approval was granted in 2004 for extended dosing intervals of once-every-three-weeks in the treatment of anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once-per-month Aranesp administration in the treatment of anemia in chronic kidney disease (CKD) patients not on dialysis. In 2006, the Aranesp label was updated to allow CKD patients on dialysis to switch from rHuEPO one to three times a week to Aranesp every two weeks. In 2007, the Aranesp label was updated to allow for treatment of anemia associated with CRF, in all European pediatric patients on dialysis or not on dialysis.

About Sensipar/Mimpara

Approved by the U.S. Food and Drug Administration (FDA) in March 2004, Sensipar® is an oral medication for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic renal failure (CRF) on dialysis and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma. To regulate parathyroid hormone (PTH), Sensipar® acts directly on the parathyroid gland calcium-sensing receptor.

Important US EPOGEN and Aranesp Safety Information Including Boxed WARNINGS
Use the lowest dose of Aranesp® or EPOGEN® that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion.

Aranesp, EPOGEN and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL.

Cancer Patients: Use of ESAs

Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL;

Shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL;

Increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for this population.

Patients receiving ESAs pre-operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving Epoetin alfa who were not receiving prophylactic anticoagulation. Antithrombotic prophylaxis should be strongly considered when Epoetin alfa is used to reduce allogeneic red blood cell transfusions. Aranesp® is not approved for this indication.

Aranesp and EPOGEN are contraindicated in patients with uncontrolled hypertension.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient.

http://www.amgen.com