Efficacy of Diterpene Ginkgolides Meglumine injection in elderly patients with ischemic stroke: A post hoc analysis of a randomized controlled trial

Abstract

BackgroundElderly patients with ischemic stroke (IS) have worse functional outcomes and poorer quality of life after suffering a stroke than younger patients. The identification of effective agents is critical to optimizing the therapy of IS in elderly patients. PurposeTo examine the efficacy of diterpene ginkgolides meglumine injection (DGMI) vs. Ginaton in treating patients with IS, across different age subgroups. MethodsEfficacy was determined through the post hoc analysis of a randomized controlled study, which had a cohort of 998 patients with IS. Participants were pooled and grouped by age (elderly [aged ≥ 65 yr] vs. non-elderly [aged < 65 yr]). The primary efficacy outcome was the proportion of patients with modified Rankin Scale (mRS) score ranging from 0 to 1 at 90 d. The secondary outcomes were neurological deficit (tested using the National Institutes of Health Stroke Scale [NIHSS] score) and quality of life (tested using the EuroQol-5 Dimension [EQ-5D] and EQ visual analog scale [EQ-VAS] questionnaires). ResultsThere were 399 (40%) patients in the elderly group (average age = 69.8±3.3 yr) and 599 (60%) patients in the non-elderly group (average age = 55.8±6.8 yr). The randomized treatment groups had similar baseline characteristics. For the elderly group, 174 (94%) of the 185 participants in the DGMI group and 169 (79%) of the 214 participants in the Ginaton group achieved the main outcome of a mRS score of 0–1 after three months (odds ratio [OR] = 0.87 [95% confidence interval [CI] = 0.81–0.93], p<0.001). For the non-elderly group, 301 (96%) of the 314 participants in the DGMI group and 237 (83%) of the 214 participants in the Ginaton group achieved the main outcome of a mRS score of 0–1 after three months (OR = 0.88 [95% CI = 0.84–0.92], p<0.001). The overall mean EQ-5D index score and EQ-VAS of the DGMI group were higher than that of the Ginaton group for elderly patients. After controlling other covariates including treatments, gender, weight, height and medical history, the results of mRS score, NIHSS score, EQ-5D index score, and EQ-VAS based on generalized linear model were similar to those of the single covariate analysis. ConclusionsDGMI demonstrated a superior efficacy to Ginaton for patients with IS in both elderly and non-elderly ages.