As if kickback allegations weren't enough, Amgen got hit over the weekend with a new study that raises questions about Aranesp safety. In a paper published online Friday evening by the New England Journal of Medicine, Boston researchers concluded that Aranesp worked no better than placebo to reduce deaths or cardiovascular problems in patients with type 2 diabetes and kidney disease. Rather, the study showed, Aranesp patients were almost twice as likely to have strokes as placebo patients were.
It's the first study to track the death and serious complications in patients using Aranesp--part of a class of anemia meds that also includes Amgen's Epogen and Johnson & Johnson's Procrit--versus those on placebo, the Boston Globe reports. "The risks of the therapy were bigger than we thought, namely stroke, and the benefits were less than we thought, in quality of life," Dr. Marc Pfeffer, a cardiologist at Brigham and Women's Hospital who led the international study group, told the Globe.
Here are the numbers: Of the 4,000 patients in the study, about 5 percent of those who took Aranesp had strokes, compared with about half that rate in placebo patients. In 188 Aranesp patients with a history of cancer, 60 died, compared with 37 deaths in the 160 placebo patients with cancer history. The risk of stroke in patients using drugs like Aranesp has been recognized before, but in a statement Amgen said that this study observed a risk of "higher magnitude."
Amgen said that it has shared the study results with drug regulators and that the risks are likely to be included in Aranesp labeling "once discussions are complete." As you know, FDA and other regulators have been intensely tracking the safety of Aranesp and its sister meds over the last couple of years, and payers such as Medicare have limited dosing of the meds in an attempt to avoid some of the more serious side effects.