IV adrenomedullin shows favorable safety profile within 24 hours of acute ischemic stroke

Key takeaways:

• The study included 60 older adults with acute ischemic stroke given IV adrenomedullin.
• Good and favorable outcomes in the treatment group were comparable with placebo at 90 days.

Intravenous adrenomedullin given to individuals within 24 hours of acute ischemic stroke was found to be safe at 90 days, according to a presentation from the International Stroke Conference.

“Adrenomedullin has strong anti-inflammatory and angiogenic properties, which have been reported to ameliorate the consequences of ischemic stroke in several animal models,” Takeshi Yoshimoto, MD, a neurologist at the National Cerebral and Cardiovascular Center in Japan, and colleagues wrote.

Yoshimoto and colleagues sought to examine safety and tolerability of IV adrenomedullin within 24 hours of acute non-cardioembolic ischemic stroke onset in adults within a phase 2 clinical trial.

The AdrenoMedullin For Ischemic Stroke study was a randomized, double-blind, trial that included 60 participants (median age 75 years; 35% female) who recorded a baseline NIH Stroke Scale (NIHSS) score of 1 or higher (median score of 3) and were randomly allocated to the intermittent IV AM (I-AM group of 30 g/kg in total for 7 days; n = 20) or placebo

(n = 10) in the first cohort and a combination of continuous (the first 3 days) and intermittent (following 4 days) IV AM (C/I-AM group of 56 g/kg in total for 7 days; n = 20) or placebo (n = 10) in the second cohort.

The primary endpoint for the study was treatment-related serious adverse events, with secondary efficacy endpoints of favorable outcomes as measured by modified Rankin Scale [mRS] score of 0 to 2 at 90 days) and good outcomes (mRS 0 to 3 at 90 days).

According to results, the primary endpoint did not occur in all groups.

Among the secondary efficacy endpoints, researchers found rates of favorable outcome (75% vs. 68.9%; aOR = 1.45; 95% CI: 0.32-6.53) and good outcome (90% vs. 73.7%; aOR = 3.86; 95% CI: 0.67-22.11) in the I-AM group were not statistically different from those given placebo.

Similarly, rates of good outcomes in the C/I-AM group were not different with those in the placebo group (85% vs. 73.7%, aOR = 1.56; 95% CI: 0.72-3.39).

“Treatment with IV AM within 24 hours of AIS onset is safe,” Yoshimoto and colleagues concluded. “Intermittent IV AM may contribute to improved AIS prognosis. The efficacy and safety of AM will need confirmation in the next phase of clinical trials.”