Ginkgo Diterpene Lactone Meglumine May Improve 90-Day Outcomes in Acute Stroke

Patients with acute ischemic stroke who receive ginkgo diterpene lactone meglumine (GDLM) within 48 hours of onset may have improved outcomes at 90 days, according to study findings published in JAMA Network Open.

The active ingredient in GDLM, ginkgo biloba L, has been shown to have neuroprotective and reparative effects. Researchers conducted a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial (ClinicalTrials.gov Identifier: NCT02526225) to evaluate the safety and efficacy of GDLM compared with placebo in patients with acute ischemic stroke.

A total of 3452 patients were included in the study. Patients eligible for the study were aged 18 to 80, were clinically diagnosed with acute ischemic stroke within 48 hours of onset, had a modified Rankin Scale (mRS) score of 0 or 1 prior to onset, a National Institutes of Health Stroke Scale (NIHSS) score ranging from 4 to 24 after onset, and an upper/lower limb motor deficit score of at least 2.

The researchers randomly assigned patients 1:1 ratio to receive either 25 mg of GDLM once daily in an intravenous infusion or a normal saline infusion once daily for 14 consecutive days. The researchers followed patients up to day 90 after randomization.

The primary endpoint was the proportion of patients with a mRS score of 0 or 1 on day 90. Secondary efficacy endpoints were the proportion of patients with an mRS score of 2 or less on day 90, a decrease in NIHSS score of 4 points or more from baseline to day 7 and day 14, and an increase in NIHSS score between 1 or more points from baseline to day 7.

Safety endpoints include adverse events, serious adverse events within 90 days, and laboratory results from baseline to day 14.

Throughout the trial, 194 and 207 patients were excluded from the GDLM group and placebo group, respectively. 

The researchers found that 50.8% of patients in the GDLM group and 44.1% in the placebo group had an mRS score of 0 or 1 on day 90 (relative risk [RR], 1.15; 95% CI, 1.08-1.24; P <.001).

With respect to the secondary efficacy endpoints, 83.8% of patients in the GDLM group and 69.5% of patients in the placebo group reached a mRS score of 0 to 2 on day 90 (RR, 1.21; 95% CI, 1.16-1.25; P <.001).

In terms of the decrease in NIHSS scores from baseline to day 14 of at least 4 points; 61.3% of the GDLM group experienced a decrease, compared with 50.2% in the placebo group (RR, 1.22; 95% CI, 1.15-1.30; P < .001). Only 3.0% of patients in the GDLM group and 4.6% in the placebo group experienced an increase of at least 1 point in NIHSS score from baseline to day 7 (P =.01).

Although insignificant, the GDLM group and placebo group shared a similar incidence of adverse effects (GDLM group, 17.6% vs placebo group, 17.3%; P =.83) and incidence of severe adverse events (GDLM group, 1.5% vs placebo group, 1.3%; P =.56).

The researchers concluded that, “among patients with AIS [acute ischemic stroke] treated within 48 hours after onset, the 14-day treatment of GDLM could improve the proportion of patients achieving good clinical outcomes at 90 days compared with placebo.”