The effect of intravenous ginkgolide on clinical improvement of patients with acute ischemic stroke

Aims: To compare the efficacy of ginkgolide in the treatment of Chinese patients with ischemic stroke between pre-marketing and post-marketing studies. Methods: This is a re-analysis of a pre-marketing (phase II/III, multicenter, double-blind, parallel-controlled; February 2005 to September 2005) and post-marketing (phase IV, multicenter, open, single-arm registration; April 2013 to June 2014) studies. The intervention groups received intravenous ginkgolide (10 mL daily, 14 days). Primary outcome was an improvement of National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) scores after 14 days. Results: In pre- and post-marketing studies, NIHSS and mRS scores all improved, compared to that of baseline (P < 0.001) in acute phase. Those factors significantly associated with oNIHSS after 14 days of therapy with ginkgolide were grouping (pre-marketing vs. post-marketing; OR 2.169, 95%CI = 1.462-3.216, P < 0.001), male (OR = 1.532, 95%CI = 1.152-2.037, P = 0.003), enrollment within 30 days after onset (OR = 1.915, 95%CI = 1.452-2.526, P < 0.001) and NIHSS score more than 8 points at baseline (OR = 15.140, 95%CI = 11.436-20.045, P < 0.001) after adjustment. Ginkgolide had a greater effect on patients in a relatively acute phase (time of onset to enrollment <= 30 days) and moderate-severe stroke (baseline NIHSS>8 points). Incidences of adverse reactions in the pre-marketing and post-marketing studies were 0.46% and 5.28%, respectively (P < 0.001). Conclusion: Intravenous ginkgolide may improve the outcome of acute ischemic stroke. Differences in effect between pre-marketing and post-marketing studies may be associated with gender, time of onset to enrollment and severity of stroke.