CHICAGO (Reuters) - Aggressive treatment with blockbuster anemia drugs may offer the best approach for kidney dialysis patients with severe anemia, U.S. researchers said on Tuesday.
But aggressive treatment only made things worse for patients in the final stages of kidney disease with mild anemia, they reported in the Journal of the American Medical Association.
The findings may help guide regulators as they weigh new restrictions on erythropoiesis-stimulating agents or ESAs, such as Amgen Inc"s Epogen.
ESAs are used by 95 percent of patients with chronic kidney disease.
"Eliminating coverage or severely restricting marketability of ESAs might mean pouring out the baby with the bath water," Dr. Wolfgang Winkelmayer of Stanford University School of Medicine in California said in a statement.
Earlier this month, U.S. regulators said health providers who treat cancer patients with ESAs will need to be trained in their use and document that they have informed patients of the risks, under guidelines approved by U.S. regulators.
Cancer patients with anemia often initially respond well to ESAs, but the drugs can cause tumors to grow faster and shorten patients" lives.
The new requirements, which take effect March 24, apply to Amgen Inc"s Epogen and Aranesp, as well as Johnson Johnson"s Procrit.
Sales of the drugs -- which are genetically engineered forms of a protein that boosts production of red blood cells -- have fallen sharply since a late 2006 study by JJ showed a higher risk of death and cardiovascular complications for aggressively treated patients.
For the study in end-stage kidney disease patients, Winkelmayer and colleagues evaluated different treatment approaches used on 4,500 patients at dialysis centers throughout the United States.
They divided patients according to the aggressiveness of treatment used and the severity of their anemia.
"Our study for the first time showed that with very aggressive treatment in those patients (with the most severe anemia), there was an association with better outcomes," Winkelmayer, who conducted the research while at Harvard Medical School, said in a telephone interview.
Winkelmayer said his findings suggest at least for some chronic kidney disease patients on dialysis, aggressive treatment is best.
ESAs are the most expensive drugs used by dialysis patients reimbursed by the federal Medicare insurance program, costing the agency nearly $2 billion a year.
(Editing by Sandra Maler)
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