Effect of diabetes on the efficacy and safety of Panax notoginseng saponins in ischemic stroke: a prespecified analysis of the PANDA trial.

BACKGROUND

Diabetes is a risk factor of poor stroke outcomes. A randomized clinical trial has demonstrated that Panax notoginseng saponins (Xuesaitong soft capsules) can improve the functional outcome in ischemic stroke patients. However, it remains uncertain whether comorbid diabetes exerts an influence on the therapeutic outcomes of Xuesaitong.

METHODS

The PANDA (efficacy and safety of Panax notoginseng saponins in the treatment of adults with ischemic stroke in China) trial was a multicenter, randomized, double-blind, placebo-controlled trial comprising 3542 patients. The present prespecified analyses investigated the effect of concomitant use of antidiabetic drugs, a history of diabetes, and baseline fasting blood glucose levels on outcomes in participants randomized to receive Xuesaitong soft capsules versus placebo. The primary outcome was the proportion of patients achieving functional independence.

RESULTS

In the modified intention-to-treat dataset, there were 722 patients with diabetes or treated hyperglycemia during hospitalization (369 in the Xuesaitong group and 353 in the placebo group) and 2244 patients without (1118 in the Xuesaitong group and 1126 in the placebo group). Among patients with diabetes or treated hyperglycemia during hospitalization, the proportion of patients with functional independence at 3 months was 83.20 % (n = 307) in the Xuesaitong group and 79.60 % (n = 281) in the placebo group (odds ratio, 1.27; 95 % confidence intervals [CI], 0.87-1.85; P = 0.215). Regarding patients without diabetes or treated hyperglycemia during hospitalization, the proportion was 91.32 % (n = 1021) in the Xuesaitong group and 83.21 % (n = 937) in the control group (OR, 2.12; 95 % CI, 1.64-2.76; P < 0.001; P for interaction = 0.027). The sensitivity analyses indicated similar significant results.

CONCLUSION

In the PANDA trial, patients without, rather than with, diabetes or treated hyperglycemia during hospitalization received greater benefit from Xuesaitong soft capsules regarding functional independence at 3 months.