Treatment of patients presenting with acute ischemic stroke (AIS) with a 14-day course of ginkgo diterpene lactone meglumine (GDLM) significantly improves 90-day clinical outcomes in comparison with placebo, a new study finds. These data were reported by Quian Zhang, MD, of the Capital Medical University, Beijing, and colleagues, in a manuscript published online Monday in JAMA Network Open. Various processes are involved in the development of AIS, such as excitotoxicity, oxidative and nitrosative stress, cell apoptosis and widespread inflammation. Neuroprotective mechanisms have been suggested as potential management options for patients with AIS. GDLM is helpful in maintaining the blood brain barrier, reducing brain edemas, improving energy metabolism and other neuroprotective cascades. GDLM has the potential to be therapeutic in treating AIS. The purpose of this multicenter, randomized, double-blind, placebo-controlled, parallel-group study—which occurred between Feb. 1, 2016 and May 1, 2018 at 100 centers in China—was to determine the safety and outcomes of GDLM treatment in patients who have AIS. A total of 3,448 (median age=63 years, 35.7% women) patients were diagnosed with AIS symptoms within 48 hours of onset and had a modified Rankin Scale (mRS) score of 0 or 1 before symptom onset as well as a National Institutes of Health Stroke Scale (NIHSS) score between 4 and 24. The mRS scale ranges from 0 (zero symptoms or completely recovered) to 6 (death), and measures stroke disability. The NIHSS measures the amount of impairment stroke has caused, and ranges from 0-42; the greater the severity of impairment, the higher the score. Data from the study were analyzed between January 2019 and December 2022. Patients were randomized into two groups: receiving GDLM (n=1,725, median age=63, 37.1% female) or placebo (n=1,723, median age=63, 34.4% female) once per day by intravenous infusion. Thrombolysis and thrombectomy were not allowed to be administered during the treatment process. The primary outcome of this study was the number of patients who had an mRS of 0 or 1 on day 90 post-randomization. Adverse events and serious adverse events were included in the safety outcomes. The primary outcome was observed in 877 patients in the GDLM group at day 90, and 759 patients in the placebo group (risk difference=6.79%, 95% confidence interval [CI]=1.15-1.50; relative risk=1.15, 95% CI=1.08-1.24; p<0.001). The two groups experienced similar rates of adverse events (GDLM n=303 versus placebo n=298; risk difference=0.27%, 95% CI: -2.26% to 2.80%; odds ratio=1.02; 95% CI=0.85-1.21; relative risk=1.02, 95% CI=0.88-1.17; p=0.83). The investigators highlighted a few limitations in this study. First, the results may not be generalizable to ethnic groups outside those with Han Chinese ethnicity because of the study location. Second, intravenous thrombolysis and mechanical thrombectomy were not used to treat the ischemic stroke patients, and further research into the efficacy of GDLM is necessary in this area. Overall, this trial demonstrated how GDLM might improve clinical outcomes in patients with AIS who were treated within 48 hours after symptom onset, compared with patients who were treated with placebo. Source: Zhang Q, Wang A, Xu Q, et al. Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug. 14. (Article in Press) Image Credit: www.danildesign.com – stock.adobe.com