CSPC's Three Latest Research Findings of Class 1 New Drug Selected for the World Stroke Congress (WSC) (II)

The 14th World Stroke Congress (WSC) was held in Singapore from October 26-29, 2022, by the World Stroke Organization (WSO).

The three latest research findings of CSPC's class I new drug, Butylphthalide (NBP), for treating acute ischemic stroke, were selected for this Congress.

Today, we will present the second finding.

Paper Information

Title: DL-3-n-Butylphthalide For Acute Ischemic Stroke: An Updated Systematic Review And Meta-Analysis Of Randomized Controlled Trials

Abstract ID: 1915 (P279)

Corresponding author: Wang Deren

Organization: Department of Neurology, West China Hospital, Sichuan University

Background

Butylphthalide (NBP) is a neuroprotective drug widely used in stroke patients in China. A 2010 systematic review showed that NBP was safe and effective in promoting neurological recovery but could not determine whether it could mitigate the risk of long-term death or disability. Since 2010, many randomized controlled trials (RCTs) on NBP have been published, and this study updates the systematic review and meta-analysis of their safety and efficacy data.

Methodology

Electronic databases and reference lists were searched for a comprehensive collection of RCTs comparing patients with or without NBP therapy (including placebo). The methodological quality of RCTs was assessed using the revised Cochrane Risk of Bias Tool 2.0, and the data were meta-analyzed using Review Manager 5.4 software.

Findings

A total of 57 RCTs were included, involving 8,747 patients. 20 study drugs were NBP soft capsules, 29 were NBP injections, and 8 were NBP soft capsules plus sequential injections.

Meta-analysis showed that treatment with NBP was associated with decreased incidence of combined endpoints of death and disability (risk ratio 0.59, 95% CI 0.42 ~ 0.83; 260 patients; 2 studies), death (risk ratio 0.32, 95% CI 0.13 ~ 0.75; 2,287 patients; 10 studies), mRS score (mean difference -0.80, 95% CI -0.88 ~ -0.72; 568 patients; 4 studies); and associated with increased Barthel index (mean difference 11.08, 95% CI 9.10 ~ 13.05; 2,968 patients; 22 studies).

The meta-analysis found that NBP significantly reduced neurological deficits based on NIHSS scores (mean difference -3.39, 95% CI -3.76 ~ -3.03; 7,283 patients; 46 studies) and CCS scores (mean difference -4.16, 95% CI -7.60 ~ -0.73; 543 patients; 4 studies). Adverse events were reported in 31 studies, with increased transaminase (incidence 1.39 ~ 17.53%), rash (0 ~ 1.96%), and gastrointestinal discomfort (1.09 ~ 6.15%) being the most common. No serious adverse events were reported.

Conclusions

This study confirmed that NBP could promote the recovery of activities of daily living of patients with acute ischemic stroke and reduce their neurological deficits and short-term mortality.