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BY OUR PHARMA CORRESPONDENT
8 September, 2005: Late-stage studies to evaluate the effect of anemia treatment with darbepoetin alfa on morbidity and mortality in patients with heart failure, has been begun by Amgen.
The randomized, placebo-controlled, double-blind, multicenter trials will be conducted at different geographical locations, Amgen announced in a press release.
Numerous epidemiological studies have consistently demonstrated that lower hemoglobin values, reflecting a condition known as anemia, are associated with increased hospitalizations and mortality in heart failure patients. "These studies have generated a very strong hypothesis that if you raise hemoglobin values with darbepoetin alfa, you can improve outcomes in this patient population. This landmark trial will test this important hypothesis, the release noted.
The Executive Committee for this phase 3 trial will be co-chaired by Karl Swedberg, professor of Medicine at Sahlgrenska University Hospital/Ostra-Goteborg University in Sweden.
According to the American Heart Association, approximately five million Americans and over four million Europeans suffer from heart failure. Over twenty three million suffer from heart failure worldwide. Heart failure is the leading cause of hospitalization for people over the age of 65 years and causes almost one million hospitalizations each year. This condition results in decreased oxygen delivery to the body due to a poorly functioning heart. Anemia reduces the oxygen content of the blood. When both heart failure and anemia occur together, oxygen delivery is further hampered, leading to a worsened condition for the patient. Although anemia is a common condition in heart failure patients, physicians caring for them have typically overlooked anemia in the absence of definitive studies suggesting that it should be treated.
Results from Amgen's phase 2 pilot studies of anemia in heart failure patients will be released in early 2006. More information about Amgen's Phase 3 trial in heart failure is available at www.amgentrials.com.
Darbepoetin alfa (Aranesp) is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the development of a recombinant erythropoietin, epoetin alfa, which is currently marketed in the U.S. by Amgen as Epogen (Epoetin alfa) and by Ortho Biotech Products, LP, as Procrit (Epoetin alfa.) 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 benefit of less-frequent administration.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, the drug was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies.
Aranesp is contraindicated in patients with uncontrolled hypertension and patients with known hypersensitivity to the active substance or any of the excipients. Erythropoietic therapies may increase the risk of thrombotic and other serious 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 the trials were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.
The drug dosage should be adjusted for each patient to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Doses must be individualized to ensure that hemoglobin is maintained at an appropriate level for each patient.
A biotechnology pioneer since 1980, Amgen develops treatments to fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses.
BY OUR PHARMA CORRESPONDENT
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