Phase III Open-Label, Randomized Clinical Trial of Epidermal Growth Factor and Growth Hormone Releasing Hexapeptide in Acute Ischemic Stroke.
The study suggests potential benefits of EGF and GHRP-6 in severe-stroke patients, but further research is necessary to confirm these findings.
Where it sits
this study against the rest of the ghrp-6 corpusSummary and findings
This study evaluated the effects of intravenous Epidermal Growth Factor (75µg) and Growth Hormone Releasing Peptide-6 (5mg) in patients with acute ischemic stroke. The trial involved 188 patients, with no differences in primary outcomes but suggested benefits in a subgroup of severe-stroke patients. The findings indicate a need for further research in this specific population.
Abstract
Stroke remains a critical condition. Combined therapy of Epidermal Growth Factor (EGF) and Growth Hormone Releasing Peptide-6 (GHRP6) has shown potential benefits in stroke patients. The present COURAGE-2 study hypothesized that intravenous EGF (75µg) +GHRP6 (5mg) in acute ischemic stroke would result in 20% greater disability improvement at six months, versus standard care.<h4>Methods</h4>A multicenter, randomized, open-label, phase-III trial enrolled patients within 12 hours of symptom onset, and NIHSS score of 5-20. Participants received the combined therapy (n=95; twice daily, 7 days) or standard care (n=93). Primary endpoint was safety and efficacy at 3 and 6 months, measured by modified Rankin Scale (mRS). Secondary endpoints included survival, Barthel Index, and blinded analysis of infarct volume. Sensitivity analyses used a NIHSS≥12 threshold.<h4>Results</h4>Patients were 63.5±11.3 years-old, 110 men, baseline NIHSS score of 9.5 (95%CI: 8.9-10) and mean time to treatment of 7.3±2.8 h. Severe adverse events occurred in 48/188 patients (none treatment-related), with 30/95 in the treated group (OR=1.92; 95%CI: 0.981-3.767). In the intention-to-treat population, no differences were found in mRS, Barthel index nor survival. However, severe-stroke patients (NIHSS≥15, n=27) treated with EGF+GHRP6 showed reduced disability (mRS<sub>6-months</sub>=2.6, 95%CI: 1.3-3.8 vs Control 4.7, 95%CI: 2.6-6; p=0.03), and mortality risk (HR=0.18, 95%CI: 0.03-0.96; p=0.045). In the middle cerebral artery territory, treated patients had greater infarct volume reduction (30 days; p=0.041). Similar outcomes were found using NIHSS≥12 threshold.<h4>Conclusions</h4>The Courage-2 study missed the primary endpoint but suggested potential benefit in moderate-to-severe stroke, warranting further studies targeting this subpopulation.
Background
The study addresses the potential role of Epidermal Growth Factor and GHRP-6 in the treatment of acute ischemic stroke, a condition where timely intervention is critical for patient outcomes. Prior research has suggested that growth factors may play a role in neuroprotection and recovery post-stroke. This trial is significant as it explores these agents in a clinical setting.
Methods
This was a Phase III open-label, randomized clinical trial. The specific population, sample size, dosing regimen, and duration of treatment were not reported in the abstract. Primary and secondary outcome measures were also not detailed.
Results
Not reported in abstract.
Interpretation
Without specific results or effect sizes reported, it is challenging to compare this study to prior literature or to assess the clinical significance of any findings. The lack of detailed results limits the ability to draw conclusions about the efficacy or safety of GHRP-6 in this context. Potential confounds include the open-label design and lack of control group data.
Key findings
- Not reported in abstract.
Limitations
- Not reported in abstract.