Drugs ease anemia in kidney disease
Study: Larger doses of two medicines can control condition
LOS ANGELES, Nov. 17 Larger doses of two drugs can successfully control anemia in chronic kidney disease patients when given as infrequently as once a month, according to research from the companies selling the drugs.
This is the first trial showing that if you take people that reach target hemoglobin levels, they can be maintained with monthly dosing.
DR. ROBERT BRENNER
director, global development, Amgen AMGEN, THE WORLDS largest biotechnology company, Sunday said a six-month study of Aranesp, a longer-lasting version of its blockbuster drug Epogen, showed it controlled anemia in 85 percent of kidney disease patients not on dialysis when given just once a month.
The study was presented at a meeting of the American Society of Nephrology in San Diego.
The 86 patients who completed the trial had already been successfully treated with every-other-week injections of the drug. The dose was doubled under the once-monthly regimen.
Side effects included high blood pressure, swelling, fatigue and upper respiratory infection.
This is the first trial showing that if you take people that reach target hemoglobin levels, they can be maintained with monthly dosing,said Dr. Robert Brenner, director of global development at Amgen.
Brenner said Amgen is studying whether to pursue formal U.S. Food and Drug Administration approval for monthly Aranesp, which is currently approved for weekly and every-other-week regimens.
In other research presented at the conference, Johnson & Johnson said its anemia drug Procrit maintained hemoglobin levels in 80 percent of non-dialysis patients dosed once monthly at four times the typical weekly dose during a four-month trial.
Interim results from the multidose study of 185 patients showed weekly Procrit worked in 96 percent of patients and in 92 percent of enrollees given the drug every other week, but it controlled anemia in just 71 percent of patients treated once every three weeks.
Procrit is labeled for administration two or three times a week.
Patients did very well ... We also did not see any difference in quality of life with extended dosing,said Dr. Sarbani Bhaduri, associate director of clinical affairs, nephrology, at the J&J unit that markets Procrit.
She said the results are comparableto the Amgen trial, but are based on a larger number of patients a total of 550 when the study concludes.
Side effects were comparable to those seen with typical Procrit usage, including a higher rate of infections, Bhaduri said.
J&J also said a retrospective study of 225 patients who received extended dosing of Procrit over more than 10 months showed that as the dosing interval was extended in some patients to less often than once a month the total dose used per four-week period decreased and hemoglobin increased.
Amgen,s Aranesp is approved by the FDA for use as infrequently as every other week for anemia in chronic kidney disease as well as in certain cancer patients. Procrit, licensed by Amgen to J&J many years ago, is sold in the United States for the same markets.
Both drugs are bioengineered forms of a human protein that stimulates production of red blood cells.
Next month, early data from an Amgen-sponsored study comparing Aranesp to Procrit in the oncology setting is scheduled to be unveiled at a