September 19, 2008 — Ortho Biotech has announced that preliminary data from an investigator-initiated trial of epoetin alfa in acute ischemic stroke patients show higher mortality among treated patients than those on placebo.
In a statement issued September 17, the company said that patients treated with epoetin alfa within 6 hours of an ischemic stroke died more frequently than those on placebo. "Ortho Biotech has reported this information to the US Food and Drug Administration [FDA] and to European regulatory authorities," the statement notes. "Additional analyses are under way to better understand these preliminary results."
However, the lead investigator of the trial, Hannelore Ehrenreich, MD, from the Max Planck Institute of Experimental Medicine, in Göttingen, Germany, who initiated and designed the study, has said that the Ortho Biotech statement was released prematurely and in her view is an incorrect conclusion, resulting in the FDA being misinformed about the study findings.
"In fact, we have very promising results regarding clinical outcome in ischemic stroke and may ultimately have a treatment that is less dangerous and more beneficial than thrombolysis," Dr. Ehrenreich told Medscape Neurology & Neurosurgery, "The increase in mortality in the intention-to-treat population was limited to patients who received both systemic thrombolytic therapy as well as epoetin alfa."
She said she has already contacted the FDA to try to rectify the situation and is awaiting its response. She plans to submit the study results as soon as possible for publication.
The paper will contain comprehensive and detailed information on efficacy and safety, Dr. Ehrenreich noted.
Asked for some comment on this development, Mark Wolfe, director of public affairs for Ortho Biotech, told Medscape Neurology & Neurosurgery. "We felt it was important to communicate the preliminary results based on all patients who received epoetin alfa," he said. "What we communicated was based on all patients who received 1 or more doses of epoetin alfa. We were not looking at any subgroup analysis or anything like that."
Ortho Biotech is a wholly owned subsidiary of Johnson & Johnson. Epoetin alfa is marketed in the US by Ortho Biotech as Procrit, and as Epogen by Amgen. Outside the US it is marketed by Janssen-Cilag as Eprex/Erypo. None of these products are approved in any country for treatment of patients with acute ischemic stroke.
Ortho Biotech provided funding and the study drug but did not have a role in the study design or conduct, the company statement notes.
Medscape Medical News © 2008 Medscape
Cite this: Susan Jeffrey. Company, Investigator Disagree on Reporting of Epoetin Alfa Trial in Stroke - Medscape - Sep 19, 2008.