Phase III Open-Label, Randomized Clinical Trial of Epidermal Growth Factor and Growth Hormone Releasing Hexapeptide in Acute Ischemic Stroke.
Francisco Hernández-Bernal, Nelvys Subirós-Martínez, Juan H Gutiérrez-Ronquillo et al.
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In 30 seconds
The COURAGE-2 study was a multicenter, randomized, open-label phase III trial assessing the efficacy of intravenous Epidermal Growth Factor (75µg) and Growth Hormone Releasing Peptide-6 (5mg) in patients with acute ischemic stroke. While the primary endpoint was not met, severe-stroke patients (NIHSS≥15) showed significant disability reduction (mRS 2.6 vs 4.7, p=0.03) and lower mortality risk (HR=0.18, p=0.045).
Key findings
- No differences in mRS, Barthel index, or survival in the overall population.
- Severe-stroke patients treated with EGF+GHRP6 had a mRS of 2.6 compared to 4.7 in controls (p=0.03).
- Mortality risk in treated severe-stroke patients was significantly lower (HR=0.18, p=0.045).
- Greater infarct volume reduction was observed in treated patients at 30 days (p=0.041).
Why it matters
This study highlights the potential for targeted therapies in severe acute ischemic stroke, suggesting that specific patient subgroups may benefit from combined treatment approaches, which could influence future clinical strategies.