Efficacy and safety of anisodine hydrobromide injection in acute ischemic stroke-a multicenter real-world...

To evaluate the efficacy and safety of anisodine hydrobromide injection in patients with acute ischemic stroke in a real-world clinical setting.

Multicenter, real-world observational cohort study conducted from April 2018 to December 2021 with 90-day follow-up. Multivariable logistic regression and inverse probability of treatment weighting (IPTW) were applied.

A total of 4,179 patients aged ≥18 years with acute ischemic stroke admitted within 30 days of onset were included; 2,120 received anisodine hydrobromide and 2,059 received best medical treatment.

Intravenous anisodine hydrobromide injection administered as part of routine clinical care.

The primary outcome was unfavorable functional outcome (modified Rankin Scale [mRS] 3-6) at 90 days. Secondary outcomes included overall mRS distribution, changes in National Institutes of Health Stroke Scale (NIHSS) scores, hemorrhagic transformation, and 90-day mortality or recurrent stroke.

Unfavorable functional outcome occurred in 14.3% (282/2,120) of the anisodine group versus 20.6% (396/2059) of controls (adjusted OR, 0.63; 95% CI, 0.53-0.74). IPTW analysis confirmed the result (OR, 0.64; 95% CI, 0.51-0.80). The anisodine group had a more favorable mRS distribution (OR, 0.68; 95% CI, 0.61-0.77) and greater NIHSS improvement (mean ΔNIHSS difference = -0.61; 95% CI, -0.79 to -0.43). Hemorrhagic transformation, mortality, and recurrent stroke did not differ significantly between groups.

In this large multicenter cohort conducted in China, anisodine hydrobromide showed a potential association with improved 90-day functional outcomes, with no clear increase in adverse events among patients with acute ischemic stroke.

https://www.chictr.org.cn/, identifier ChiCTR1900027517.