BRIDGEWATER, N.J., Sept 22, 2005 /PRNewswire via COMTEX/ -- A study published in the September 2005 issue of The Oncologist demonstrated that PROCRIT® (Epoetin alfa) increased hemoglobin -- or red blood cell -- levels more than Aranesp® (darbepoetin alfa) in patients with cancer and anemia caused by chemotherapy. In fact, within four weeks of initiating therapy, 47 percent of patients treated with PROCRIT achieved the primary endpoint of the study, an increase in hemoglobin of one gram or more per deciliter of blood (g/dL), compared to 33 percent of patients who were treated with Aranesp.
Both therapies are approved to treat anemia caused by chemotherapy in patients with most types of cancer by increasing hemoglobin levels and reducing the need for transfusions. Hemoglobin levels are the main measure doctors use to assess red blood cells and anemia. This study is the first designed specifically to compare the products in regard to improvement of hemoglobin levels at the doses most commonly used by physicians.
These final results are from a prospective, randomized, open-label, multi-center study that compared the efficacy of PROCRIT and Aranesp in the treatment of chemotherapy-related anemia. Enrollment in the study was stopped when a planned interim statistical analysis of the first 305 patients to complete four weeks of therapy showed that the average increase in hemoglobin was significantly higher for patients who were treated with PROCRIT, compared to patients who were treated with Aranesp, and that there was no need to continue enrolling patients.
"Anemia is a debilitating side effect of chemotherapy. Raising hemoglobin levels has been shown to improve symptoms associated with the condition," said Dr. Roger Waltzman, Assistant Professor, Department of Medicine, Section of Medical Oncology and Section of Palliative Medicine, Saint Vincent's Hospital, New York, NY. "The results demonstrated that PROCRIT can provide patients with effective treatment to manage anemia from chemotherapy."
The endpoints of this study included hemoglobin response, transfusions and safety. A total of 358 adult patients with cancer and chemotherapy-related anemia were enrolled and treated in the study. The most common tumor types were breast and lung. All enrolled patients had baseline hemoglobin levels of 11 g/dL or less, were scheduled to receive chemotherapy for 12 weeks or more, and had no anemia therapy for the past three months. Patients were randomized to receive PROCRIT 40,000 U weekly or Aranesp 200 mcg subcutaneously every two weeks, the most commonly used doses in clinical practice, for up to 16 weeks. The dosing regimen of 40,000 U weekly for PROCRIT in this clinical setting is an approved dose in the product labeling.
Patients who were treated with PROCRIT demonstrated better results in terms of raising hemoglobin levels than patients who were treated with Aranesp. When starting study treatment, the average hemoglobin level was 10.2 g/dL in the PROCRIT treatment group and 10.1 g/dL in the Aranesp group. Hemoglobin increases after four weeks of treatment were 0.7 g/dL for patients who were treated with PROCRIT and 0.3 g/dL for patients who were treated with Aranesp. Further hemoglobin increases for PROCRIT and Aranesp, respectively, were 1.0 g/dL and 0.5 g/dL after eight weeks and 1.3 g/dL and 0.7 g/dL after 12 weeks.
Patients treated with PROCRIT also were transfused with fewer units of red blood cells during the study. The patients treated with PROCRIT who needed a transfusion received an average of 2.5 units of red blood cells, while patients treated with Aranesp who needed a transfusion received an average of 3.9 units of red blood cells, a statistically significant difference. In addition, from week 5 of the study until its conclusion, 13 percent of patients treated with PROCRIT received transfusions, compared to 18 percent of patients treated with Aranesp. This difference, however, did not achieve statistical significance. Both agents demonstrated similar safety profiles. Ortho Biotech Clinical Affairs, L.L.C. supported the study. Dr. Roger Waltzman is a consultant to Ortho Biotech Products, L.P.
Anemia is a side effect experienced by more than two-thirds of cancer patients undergoing chemotherapy. This potentially life-threatening condition occurs when the body does not have enough red blood cells, which carry oxygen. Oxygen acts like fuel for the body, providing energy for muscles and organs to work. Common symptoms of anemia include extreme fatigue, shortness of breath, dizziness, decreased ability to concentrate and sleeplessness.
PROCRIT (Epoetin alfa) stimulates red blood cell production and has an amino acid sequence identical to the body's naturally occurring erythropoietin, which is produced in healthy kidneys. When more red blood cells are produced, more oxygen is carried through the body, which may increase energy levels. It has been used in more than two million people across four indications and is indicated to treat chemotherapy-related anemia in patients with most types of cancer.
PROCRIT is available by prescription only and is injected by doctors or nurses. PROCRIT is not for patients with uncontrolled high blood pressure. High blood pressure has been noted rarely in cancer patients treated with PROCRIT, and blood pressure should be monitored carefully. Drugs like PROCRIT may increase the risk of blood clots. In studies, the most common side effects included fever, diarrhea, nausea, vomiting, edema, shortness of breath, tingling and upper respiratory infection.
For full U.S. prescribing information and additional information on PROCRIT and anemia, please refer to the attached package insert or visit http://www.procrit.com/oncology/index.html.
About Ortho Biotech Products, L.P.
In 1990, Ortho Biotech Products, L.P. was established in Raritan, N.J. Since that time, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative healthcare products that enhance the quality of patients' lives. Ortho Biotech, located in Bridgewater, N.J., is an established market leader in Epoetin alfa therapy for anemia management across multiple indications.
SOURCE Ortho Biotech Products, L.P.
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