ASSORT: Timing of statin therapy does not affect physical disability in patients with acute ischemic stroke

According to a presentation at the International Stroke Conference, among patients with less severe acute ischemic stroke and preexisting dyslipidemia, there was no significant difference between early or delayed statin therapy in terms of alleviating dependence at 90 days after onset.

“Some observational studies have shown statin use at the acute phase of ischemic stroke was beneficial for clinical outcome, but no randomized control trial is available so far,” Shinichi Yoshimura, MD, PhD, from Hyogo College of Medicine in Nisinomiya City, Japan, said in a presentation. “We conducted a multicenter [randomized controlled trial] to determine the efficacy of early statin treatment compared to delayed statin therapy to alleviate physical disability at 90 days after acute ischemic stroke.”

To assess whether immediate statin therapy after acute ischemic stroke improved the 90-day neurological function compared with delayed therapy, the researchers enrolled 270 patients in the ASSORT trial, a multicenter, open-label, randomized controlled trial in patients with less severe acute ischemic stroke.

Patients (mean age, 70 years; 65% men) were randomly assigned to early or delayed doses of a high-intensity statin: atorvastatin 20 mg per day, pitavastatin 4 mg per day or rosuvastatin 5 mg per day.

Patients were included in the study if they experienced stroke (not transient ischemic attack or cardiogenic stroke) and had hypercholesterolemia or underwent treatment for hypercholesterolemia at the time of registration.

The primary endpoint was patient disability, as measured by the modified Rankin Scale at 90 days.

Secondary endpoints for the trial were changes in NIH Stroke Scale score through the seventh day of the trial, changes in LDL from admission to 21 days or discharge and adverse CV or cerebrovascular events up to 90 days.

According to the researchers, the distribution of modified Rankin Scale scores at 90 days was similar in each group (P = .7; adjusted common OR = 0.84; 95% CI, 0.53-1.3).

There was no significant difference in the secondary endpoints with the exception of LDL from baseline through the 21^st day or discharge, which was –65 mg/dL in the early group and –51 mg/dL in the delayed group (P = .001).

There were no significant differences between the groups in the safety endpoints of death, any adverse events, progression of symptoms, musculoskeletal adverse events and increase in creatinine kinase. – by Dave Quaile

Reference:

Yoshimura S, et al. LB17. Presented at: International Stroke Conference; Feb. 22-24, 2017; Houston.

Disclosure: The study was supported by Shionogi Co. Ltd. Yoshimura reports receiving research grants from Bristol-Myers/Squibb, Shionogi Co. Ltd., Takeda and Terumo and honoraria from Bayer, Boehringer Ingelheim, Bristol-Myers/Squibb, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Otsuka Pharmaceutical, Pfizer and Sanofi.