The FDA ( Food and Drug Administration ) has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of Epoetin alfa to treat acute ischemic stroke. The drug used in this investigational study was Eprex.
Eprex is a member of the class of erythropoiesis stimulating agents ( ESAs ) that are approved by the FDA for use in the treatment of certain patients with anemia.
Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received Epoetin alfa compared to patients who received the placebo ( 16% versus 9% ).
Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage occurring among approximately 4% of patients who received Epoetin alfa compared to 1% of patients in the placebo group.
Treatment of anemia was not a goal of the trial and most patients were not anemic.
This clinical trial was a double-blind, placebo-controlled, multicenter investigation in 522 adult patients with an MRI-confirmed ischemic stroke in the area of the middle cerebral artery. Patients were randomized to either receive treatment with a placebo or Epoetin alfa administered as an intravenous dose of 40,000 units daily for three days.
rtPA ( recombinant tissue-type plasminogen activator ), a medication used to help dissolve blood clots, and often used for acute strokes, was also used when clinically indicated.
The goal of this clinical trial was to determine whether a relatively high dose of Epoetin alfa ( 40,000 units daily ) administered for three days would improve the functional outcome.
The clinical trial utilized doses of Epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product.
The FDA is aware of other clinical trials using Epoetin alfa for potential neuroprotective effects ( improving the functional outcomes of patients after stroke ).
The finding of increased mortality in patients receiving Epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.
Source: FDA, 2008
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