Low Response to Anemia Fighting Drug Could Mean Higher Death Risk

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Patients with chronic conditions that cause anemia, such as kidney disease and diabetes, taking the drug darbepoetin alpha, sold under the brand name Aranesp, could face a higher chance of heart disease and death. The findings suggest keeping iron levels on the low side, rather than giving higher doses of Aranesp to patients, could save lives.

Poor response to anti-anemia drug produced higher rates of cardiovascular events and death

Patient who had a poor initial response to darbepoetin alpha ultimately had higher rates of cardiovascular events that included stroke, heart attack, heart failure and death.

The drug that treats anemia that affects about 1 million diabetics and kidney failure patients in the United States was also linked to higher rates of death from cancer, found in the study titled "Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT)."

The findings were a surprise because the drug is used to treat anemia. The study showed fewer patients being treated needed blood transfusions, but was no better than placebo for improving kidney disease and cardiovascular disease outcomes.

Patients receiving Aranesp that stimulates the production of red blood cells by mimicking the action of a natural hormone in the body called erythropoietin had twice the incidence of stroke, also found in the study.

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The TREAT trial included 4,038 patients with type 2 diabetes, anemia and kidney damage, but not on dialysis - 1,872 received injections of darbepoetin alpha, and 1,889 received placebo injections.

Those given the anemia drug also received extra injections to boost hemoglobin to 13 grams per deciliter. Others, whose hemoglobin fell below 9g/dl, were given "rescue" injections.

Researchers divided the study participants into two groups - those who responded early to the anti-anemia drug and those whose hemoglobin levels remained low despite receiving the drug.

Dr. Robert Toto, professor of internal medicine and clinical sciences and a senior author of the study, which appeared in the New England Journal of Medicine, says it may be that patients were in poorer health to begin with, but the findings could also mean poor treatment response to Aranesp does raise the risk of death.

He says, "For instance, if a person’s hemoglobin level doesn’t improve within one or two months of anti-anemia treatment, it may be better to stop the drug and seek alternative treatment. A state of mild anemia might pose less cardiovascular risk in such a case than continuing or escalating the dose in an attempt to reach a normal hemoglobin level."

The study doesn't prove the anti-anemia drug darbepoetin alpha caused deaths, but the suggestion from the study could lead to new directions for treating anemia in patients with diabetes, kidney failure and anemia.

N Engl J Med 2010; 363:1146-1155

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