GDLM
Trial question
What is the effect of ginkgo diterpene lactone meglumine in patients with AIS?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 3448
3448 patients (1232 female, 2216 male).
Inclusion criteria: adult patients, aged 18-80 years, with a clinical diagnosis of AIS within 48 hours of onset.
Key exclusion criteria: confirmed encephalitis, brain tumor, brain abscess, or hemorrhagic cerebral infarction; serious disturbance of consciousness; hemorrhagic disease; serious abnormal liver and kidney function; history of mental illness.
Interventions
N=1725 Ginkgo diterpene lactone meglumine (IV infusion of 5 mL/day for 14 consecutive days).
N=1723 placebo (IV infusion of 5 mL/day normal saline for 14 consecutive days).
Primary outcome
Modified Rankin Scale score < 2 at day 90
50.8%
44.1%
50.8 %
38.1 %
25.4 %
12.7 %
0.0 %
Ginkgo diterpene lactone
meglumine
Placebo
Significant
increase ▲
NNT = 14
Significant increase in mRS score < 2 at day 90 (50.8% vs. 44.1%; OR 1.31, 95% CI 1.15 to 1.5).
Secondary outcomes
Significant increase in mRS score of ≤ 2 at day 90 (83.8% vs. 69.5%; OR 2.28, 95% CI 1.93 to 2.68).
No significant difference in reduction in National Institute of Health Stroke Scale score of ≤ -4 at day 7 (27.7% vs. 25%; OR 1.15, 95% CI 0.98 to 1.34).
Significantly greater reduction in National Institute of Health Stroke Scale score of ≤ -4 at day 14 (61.3% vs. 50.2%; OR 1.57, 95% CI 1.37 to 1.81).
Safety outcomes
No significant difference in adverse and severe adverse events.
Conclusion
In adult patients, aged 18-80 years, with a clinical diagnosis of AIS within 48 hours of onset, Ginkgo diterpene lactone meglumine was superior to placebo with respect to mRS score < 2 at day 90.
Reference
Qian Zhang, Anxin Wang, Qin Xu et al. Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2328828.
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