HONOLULU -- Researchers found mixed results with iron chelation for intracerebral hemorrhage (ICH) in the iDEF trial.
The proportion of patients who could achieve modified Rankin Scale (mRS) scores of 0-2 at 90 days was 34.3% with 3 days of deferoxamine mesylate (DFO) infusion and 32.9% with saline as placebo, making iron chelator therapy futile for recovery after ICH, reported Magdy Selim, MD, PhD, of Beth Israel Deaconess Medical Center in Boston, and colleagues.
However, the investigators could not statistically declare complete futility with their 180-day data, Selim said at a late-breaking trial session at the International Stroke Conference here.
"It is futile to conduct a phase III efficacy trial with the anticipation that DFO will result in improved outcomes (mRS 0-2) at 90 days after ICH," he said. "Patients in both groups continued to improve past 90 days -- ICH trials need to have longer follow-up to capture the full extent of recovery."
DFO is supposed to work against iron accumulation in the brain after a brain bleed. The agent binds iron so that it cannot form hydroxyl radicals; also, it induces transcription of heme oxygenase-1 for anti-inflammatory, anti-apoptotic, and blood pressure-lowering effects, according to Selim, who added that it has been available generic since the 1960s for chronic iron overload.
It appeared that patients continued to improve past 3-month follow-up, agreed Brian Silver, MD, of UMass Memorial Medical Center in Worcester, so if the investigators try again, they should consider looking at patients at 6 months or 1 year. Silver's institution participated in the trial although he was not involved with the study.
"There is some signal it may work for some people," he told MedPage Today. "The question is, does this not work or are we not tracking people long enough?"
iDEF was conducted at 40 sites in 294 adults. These were ICH patients scoring ≥6 on the NIH Stroke Scale and >6 on the Glasgow Coma Scale who were functionally independent prior to the bleed.
The trial was another attempt to establish iron chelation therapy in ICH, as the previous HI-DEF study was stopped early in 2013 because of a signal of excess in acute respiratory distress syndrome (ARDS) with continuous DFO infusion over 5 days straight at 62 mg/kg/day.
Selim's group learned their lesson, and iDEF was born with a modified protocol in which the DFO arm had the dose reduced to 32 mg/kg/day of daily infusions for 3 days. Patients at high risk for ARDS were also now excluded.
"Repeated daily infusions of DFO at 32 mg/kg/day for 3 days were well-tolerated, and were not associated with increased serious adverse events, mortality, or pulmonary complications including ARDS," the investigators reported.
iDEF was supported by the NIH/National Institute of Neurology Disorders and Stroke.
Selim and Silver disclosed no relevant relationships with industry.
Iron, chelation : Not a, quick, fix for, brain Bleed Recovery
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