Cut off-to-Head Studies Show Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Once a Week.
UNKNOWN ORLEANS — Amgen Inc. (Nasdaq:AMGN), the world’s largest biotechnology company, today presented ultimate results from an analysis of three identical leadership-to-head trials showing that Aranesp(R) (darbepoetin alfa) dosed at times every two weeks provided similar results as epoetin alfa dosed sometimes every week in boosting hemoglobin and reducing the need on blood transfusions in cancer patients with chemotherapy-induced anemia. The results were presented by the study’s lead investigator, Lee Schwartzberg, M.D., medical director of The West Clinic, Memphis, Tenn., at the 40th Annual American Club of Clinical Oncology (ASCO) congress. (Abstract #8063)
“These are the maiden clinical details from head-to-head comparisons that show the comparability of Aranesp dosed every two weeks versus epoetin alfa dosed once a week,” said Dr. Schwartzberg. “These results are important as the data implies that less repeated dosing with Aranesp may make increased resolute convenience without compromising effectiveness.”
The analysis includes data on 312 patients across the three studies with mamma, non-paltry cell lung cancer, and gynecological cancer who were randomized to receive either Aranesp 200 mcg every two weeks or epoetin alfa 40,000 U every week. Whether treated with Aranesp or epoetin alfa, patients in this study achieved objective hemoglobin of greater than or equal to 11 g/dL and had alike resemble transfusion rates.
The results were analyzed based upon the acquirement and maintenance of butt hemoglobin threshold (greater than or even to 11 g/dL) and range (11-13 g/dL, which is based on the ASH/ASCO and Governmental Inclusive Cancer Network (NCCN) guidelines for cancer and treatment-akin anemia).
Patients in both arms of the studies achieved and maintained hemoglobin levels of 11-13 g/dL. The median time to reach the target hemoglobin knock down was five weeks in the Aranesp group and four weeks in the epoetin alfa group. After achieving the goal hemoglobin direct, 81 percent of patients in the Aranesp agglomeration remained in the target assortment compared to 75 percent in the epoetin alfa bunch.
Aranesp allows patients to reach therapeutic goals while providing the convenience of less frequent dosing. Results of a patient satisfaction questionnaire certainty to swatting participants demonstrate that medical visits for anemia treatment incur a clinically sententious burden on patients and caregivers. Patients fork out on usually two hours traveling to and from their oncologist’s thing and two hours at the office receiving treatment. In addition, the scanning shows that the majority of patients would prefer to assign time with family and friends.
“These survey results celebrate that cancer patients and their caregivers allot a noteworthy amount of time for cancer treatments resulting in more anon a punctually away from family, friends and work,” said Dr. Schwartzberg. “Our results assume that patients and caregivers can extras from every two week dosing of Aranesp, which can be produced end in less travelling and less time in the physician’s aegis. It is a win-win job for everyone.”
The edition and archetype of adverse events were compare favourably with between the two treatment groups and were in accord with the adverse event capitalize on to save this citizenry of anemic cancer patients receiving Aranesp.
There Aranesp
Aranesp(R) was approved by the U.S. Food and Drug Dispensation (FDA) in July 2002 for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. The FDA approved Aranesp in September 2001 for the treatment of anemia associated with long-standing renal incompetent, also known as long-standing kidney disease, to go to patients on dialysis and patients not on dialysis.
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the discovery of recombinant erythropoietin, epoetin alfa, which is currently marketed in the U.S. by Amgen as EPOGEN(R)(i) and by Ortho Biotech Products, LP, as Procrit(R)(ii). Building on this heritage, Amgen developed Aranesp, which contains two additional sialic acid-containing carbohydrate chains than the epoetin alfa molecule resulting in more activity with the added further of less-many supplying.
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may snowball the chance of thrombotic and other acute events; dose reductions are recommended if the hemoglobin increase exceeds 1.0 g/dL in any two-week period. The most commonly reported side effects in Aranesp trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.
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Aranesp prescribing information can be accessed by calling 800-772-6436 or by logging onto http://www.aranesp.com.
(i)EPOGEN(R) is a registered trademark of Amgen Inc.
(ii)Procrit(R) is a registered trademark of Ortho Biotech
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