Updated from Nov. 16
Certain uses of anemia drugs like
Johnson & Johnson's
Procrit could pose a greater risk of heart problems and death than previously expected, according to recent research data.
The drugs, known generically as epoetin alfa, are approved to treat low hemoglobin levels associated with anemia in some patients with chronic kidney disease. Low hemoglobin can lead to extreme weakness and fatigue, as well as a heightened risk of developing other diseases.
However, when used in one study of patients with chronic kidney disease to achieve a higher hemoglobin level than the target range approved by the Food and Drug Administration, treatment didn't lead to an improvement in quality of life. That led trial investigators to question the benefits of aggressive adminstration of the drug. The research was published in Thursday's
New England Journal of Medicine
"We believe that the use of a high-target hemoglobin level provides no cost-benefit for either patients or payers in this population, even before considering risk," according to Dr. Ajay Singh, a professor of medicine at Harvard Medical School and lead author of the study.
"Several studies have demonstrated that the correction of anemia in patients with chronic kidney disease improves the quality of life and exercise tolerance while reducing the need for transfusion," he continued. "However ... there remains much uncertainty about the validity of various assessments of the quality of life in published studies."
Among patients with hemoglobin levels of 17.5%, the higher level, Singh found that 125 of 715 experienced serious events including heart attacks, hospitalization for congestive heart failure without dialysis, stroke without improvement in the quality of life, and death. At the lower hemoglobin level, 97 of more than 700 patients experienced those episodes.
Researchers say the trial results confirm that an improvement in hemoglobin levels is better than treatment intended to fully restore normal levels, supporting the current approvals suggesting that readings are improved but not normalized. Drug companies aren't allowed to market medications for unapproved uses.
The study was supported by J&J companies Ortho Biotech and Johnson & Johnson Pharmaceutical Research and Development. Singh received grant support, consulting and lecture fees from, and has served on the advisory boards of, Ortho Biotech, Amgen and
In a separate trial conducted over three years, researchers found that completely correcting anemia didn't affect the likelihood of a first cardiovascular event. General health and physical function became much better with normal hemoglobin levels. At the same time, there was no significant difference in the incidence of adverse events between people with low hemoglobin and those with normal readings. Hypertensive episodes and headaches were more prevalent among patients with normal hemoglobin levels.
Dr. Tilman Drueke, lead investigator of the second trial, has received consulting and lecture fees from Hoffmann-La Roche. He has also gotten consulting fees, lecture fees and grant support from Amgen and