Researchers question anemia drug benefits

Performs no better than placebo in trial

By Elizabeth Cooney
Globe Correspondent / October 31, 2009

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A drug commonly prescribed to treat anemia in patients with both type 2 diabetes and kidney disease worked no better than a placebo in reducing deaths or cardiovascular problems it was thought to prevent, according to a paper published online last night. Instead, people who took the drug, Aranesp, were almost twice as likely to have strokes as patients given a dummy pill.

The study, led by Boston researchers, is the first trial to compare this class of anemia drugs with a placebo in the ability to prevent death and serious complications - even though the drugs have been in use for decades.

“The risks of the therapy were bigger than we thought, namely stroke, and the benefits were less than we thought, in quality of life,’’ said Dr. Marc Pfeffer, a cardiologist at Brigham and Women’s Hospital who led an international group studying Aranesp, which raises red blood cell levels.

Patients with type 2 diabetes and kidney disease often become anemic, and heart and kidney problems can be accelerated by anemia, so doctors have long prescribed Aranesp (darbepoetin alfa) and similar drugs believing that treating the anemia would improve patient’s prognosis. The study confirmed that patients taking Aranesp required fewer blood transfusions and suffered less fatigue, but other hoped-for outcomes were not seen.

Dr. Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice said the findings reinforce a crucial message in medicine.

“This current study is an important reminder of how important it is not to assume the treatments work, but to prove them,’’ said Woloshin, who was not involved in the study. Aranesp, made by California-based Amgen, was approved by the Food and Drug Administration in 2001 for use in kidney patients, but a similar drug also made by Amgen has been prescribed for 20 years.

The study results were released hours after attorneys general from Massachusetts and 14 other states sued Amgen in federal court in Boston alleging that the company offered kickbacks to doctors to boost sales of Aranesp. The states, which joined a former company sales representative who earlier filed a whistle-blower suit under seal, allege that Amgen provided doctors excess amounts of the drug in product vials, and encouraged them to bill insurers, including state Medicaid programs and Medicare, for the free Aranesp. Amgen issued a statement, saying, “We believe that the allegations are without merit, and we look forward to the opportunity to examine these matters with the states before the Court.’’

Pfeffer’s study, published by The New England Journal of Medicine, randomly assigned more than 4,000 patients - none of whom was on dialysis - to receive Aranesp or a placebo. This study design is considered the gold standard of drug trials. It found that patients who took the drug were just as likely as patients taking a placebo to have a heart attack, develop congestive heart failure, progress to end-stage renal disease and need dialysis, or die.

In the Aranesp group, almost twice as many patients had strokes: 101 who took the drug, compared with 53 who didn’t. A spokesman for Amgen, which sponsored the trial, said the landmark study answered important questions about Aranesp. “We hoped that we could do more for patients beyond reducing the need for transfusion and in fact improve cardiovascular disease,’’ said Dr. Preston Klassen, executive medical director of global development at Amgen.

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