Long-term benefits of policosanol plus low dose of aspirin in the functional recovery of non-cardiogenic ischemic stroke: A randomized, placebo-controlled study
Stroke is one of the main causes of mortality and disability worldwide. Previous studies have demonstrated the benefits of policosanol 20 mg/day (poli 20) + aspirin (AS) 125 mg/day on functional recovery after a non-cardiogenic ischemic stroke (NCIS), but the effects of poli 20 + lower doses of AS have not yet been studied. This randomized, double-blind study investigates the long-term effects of poli 20 + AS 81 mg/day (poli/AS) or placebo + AS 81 mg/day (pla/AS) on functional recovery after an NCIS. Patients who have suffered a recent (≤30 days from stroke onset) NCIS and with a modified Rankin Scale (mRS) score of 2–3 were randomized to receive either poli/AS or pla/AS for 12 months. The primary outcome was whether the frequency of patients in the poli/AS group achieving an mRS score ≤ 1 was higher than that in the pla/AS group. Secondary outcomes included changes in mean mRS and Barthel Index (BI) scores between the poli/AS and pla/AS groups. Effects on lipid profile were collateral outcomes. Of 100 randomized patients, 98 patients completed the study. Missing data from the two remaining patients were handled using single imputation with the last-observation-carried-forward method. Results demonstrated that significantly more poli/AS patients (46/50; 92%) achieved an mRS score ≤ 1 than pla/AS patients (23/50; 46%). Poli/AS significantly reduced the mean mRS score and increased BI score (p < 0.01) compared with baseline and pla/AS. Lipid profile benefits and good tolerability were confirmed. It is demonstrated for the first time that treatment with poli 20 mg/day plus a lower dose of AS (81 mg/day) significantly improved functional recovery following an NCIS compared with pla/AS.
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