Early treatment with statins did not reduce disability in patients with ischemic stroke compared with delayed treatment, according to results from the Administration of Statin on Acute Ischemic Stroke Patient (ASSORT; Clinicaltrials.gov identifier: NCT02549846) trial presented at the 2017 International Stroke Conference in Houston, Texas.
The ASSORT investigators conducted a multicenter open-label trial in 13 hospitals in Japan. Patients were eligible for inclusion if they had been diagnosed with dyslipidemia or had low-density lipoprotein cholesterol (LDL-C) levels less than or equal to 100 mg/dL and were hospitalized within 24 hours after cerebral infarction onset. A total of 257 patients were randomly assigned to receive statins within 24 hours (n = 131) or on the seventh day of hospitalization (n = 126).
The primary end point was disability as assessed by modified Rankin Scale (mRS) at 90 days. Secondary end points included changes in National Institutes of Health Stroke Scale/Score (NIHSS) from hospital admission through day 8, changes in LDL-C from admission until 21 days or discharge, and major adverse cardiovascular or cerebrovascular events (MACCE) until 90 days. Safety end points were also recorded (death and any adverse events until 90 days after randomization).
At 90 days, the mRS in each group was as follows: mRS 0, 28 (21.4%) in the early statin group vs 27 (21.4%) in the delayed group; mRS 1, 42 (32.1%) in the early group vs 32 (25.4%) in the delayed group; mRS 2, 21 (16%) in the early group vs 25 (19.8%) in the delayed group; mRS 3, 17 (13%) in the early group vs 20 (15.9%) in the delayed group; mRS 4, 13 (9.9%) in the early group vs 13 (10.3%) in the delayed group; mRS 5, 2 (1.5%) in the early group vs 0 (0%) in the delayed group; and mRS 6, 2 (1.5%) in the early group vs 1 (0.8%) in the delayed group (P =.70 for all).
In terms of secondary end points, both treatment groups saw –1 change in NIHSS from baseline through day 7 (P =.40), a similar change in LDL-C (–65.0 vs –51.0 mg/dL in the early and delayed groups, respectively; P =.001), and new ischemic stroke occurred in 9 patients (6.9%) in the early group vs 5 patients (4%) in the delayed group (P =.41).
A total of 32 adverse events occurred in the early statin group compared with 22 in the delayed statin group (P =.22). In addition, 2 patients died in the early statin group compared with 1 in the delayed statin group.
Although there were no significant differences between these 2 treatment groups, the investigators suggested that a higher statin dose might be more effective for stroke prevention.
Disclosures: Dr Yoshimura reports receiving financial support from Sionogi Pharmaceutical Co, Takeda, Bristol-Myers Squibb, Mitsubishi Tanabe Pharmaceuticals, Sanofi, Boehringer-Ingelheim, Otsuka Pharmaceutical, Bayer, and Pfizer. Dr Daimon reports receiving financial support from Astellas Pharma, Eisai, Terumo, Ono, Daiichi-Sankyo, Chugai Pharmaceuticals, Ajinomoto, and Shizuoka Organization for Creation of Industries Pharma Valley Center. Drs Takashima and Kimura are employees of Shionogi & Co., Ltd. Dr Morimoto reports receiving financial support from AstraZeneca, Daiichi-Sankyo, Pfizer, and Boston Scientific.
Yoshimura S, Uchida K, Daimon T, et al. Randomized controlled trial of early vs delayed statin therapy in patients with acute ischemic stroke. LB 17. Presented at: the 2017 International Stroke Conference. February 22-24, 2017; Houston, TX.