International Research Journal of Pharmacy and Medical Sciences ISSN (Online): 2581-3277 28 Julio César Fernández-Travieso, Javier Sánchez-López, José Illnait- Ferrer, Lilia Fernández-Dorta, and Sarahí Mendoza-Castaño, “A Preliminary Retrospective Analysis of the Effects of Policosanol on Ischemic Stroke Patients,” International Research Journal of Pharmacy and Medical Sciences (IRJPMS), Volume 2, Issue 3, pp. 28-34, 2019. A Preliminary Retrospective Analysis of the Effects of Policosanol on Ischemic Stroke Patients Julio César Fernández-Travieso 1 , Javier Sánchez-López 2 , José Illnait- Ferrer 1 , Lilia Fernández-Dorta 1 , Sarahí Mendoza-Castaño 1 1 National Centre for Scientific Research, Havana, Cuba 2 Institute of Neurology and Neurosurgery, Havana, Cuba Abstract— Introduction: Stroke is one of the leading causes of mortality and disability. Clinical studies conducted in patients with a recent ischemic stroke and treated with policosanol (20 mg/day) + standard aspirin (AS) (125 mg/day) therapy have shown benefits versus placebo + AS to patients with recent ischemic stroke. The objective of the present paper is to a preliminary retrospective analysis of the policosanol treatment effects in the patients included in ischemic stroke recovery trials. Methods: This report analysed the records of all patients included in four ischemic stroke recovery studies. Patients with a modified Rankin Scale score (mRSs) 2 to 4 were randomized, within 30 days of onset, to policosanol+AS or placebo+AS, for 6 and 12 months. The primary outcome was mRSs reduction. Decreases on low-density lipoprotein-cholesterol (LDL-C), total cholesterol and increases on high-density lipoprotein-cholesterol (HDL-C) were secondary outcomes. Results: Two hundred and seventy one patients (mean age: 67 years) were included in the analysis. At the six months more policosanol+AS (117/136, 86 %) than placebo+AS patients (10/135, 7.3 %) achieved mRSs goals. In correspondence, at the 12 months of the study more policosanol+AS (50/59, 84.7 %) than placebo+AS patients (5/59, 8.5 %) achieved mRSs goals. Treatment with policosanol+AS significantly decreased mean mRSs from the first interim check-up. The treatment effect did not wear off, even improved, after 6 and 12 months therapy when the net decrease versus placebo+AS was 56 % and 70.8 %, respectively. In addition, policosanol+AS reduced significantly LDL-C (21.6 %) and total cholesterol (12.5 %), and increased HDL-C (6.3 %). Treatments were safe and well tolerated. Eight patients reported serious adverse events (6 placebo+AS, 2 policosanol+AS) and other 13 patients (8 placebo+AS, 5 policosanol+AS) reported moderate or mild adverse events. Conclusions: The preliminary retrospective analysis of the effects of policosanol+AS on ischemic stroke patients indicate that this treatment for 6 and 12 months proved to be more effective than the placebo+AS treatment in the functional recovery of these patients. Keywords— Aspirin, policosanol, ischemic stroke, recovery, modified Rankin Scale score. I. INTRODUCTION schemic stroke is the second leading cause of death worldwide as well as the leading cause of long-term disability. 1,2 About half of stroke survivors remain with physical or cognitive impairment that severely affect their physical and social functions. Also, stroke implies a high cost to patients, families and health systems. 3 Stroke occurs when blood flow to the brain is interrupted, without oxygen-rich blood, brain cells die. Most strokes (87 % of cases) are classified as ischemic (a clot or a mass blocks a blood vessel, cutting off blood flow to a part of the brain). 1 It is important to identify risk factors and sources of stroke in order to take steps towards preventing stroke. Primary prevention addresses all measures for avoiding a stroke or transient ischemic attack. Secondary prevention addresses all measures for avoiding recurrences after a first transient ischemic attack or stroke manifestation, which is becoming more frequent in an increasingly ageing population. 4-6 Control of modifiable ischemic stroke risk factors, such as hypertension, diabetes, dyslipidemia, cigarette smoking and obesity are key measures to prevent recurrent strokes. 6 Aspirin (AS) remains the gold standard of antiplatelet therapy for stroke recovery and prevention, and several studies and meta-analyses support the merits of antiplatelet drugs in stroke prevention by lowering platelet function, which reduces thrombotic complications of atherosclerosis. 7-10 Reduction of low-density lipoprotein-cholesterol (LDL-C) levels has been shown to be relevant not only for stroke prevention, 11,12 but also for improving functional outcomes after stroke, a key matter for reducing the disability after stroke. 13-15 Policosanol, a mixture of 8 high molecular weight sugarcane wax alcohols, has shown protective effects in experimental brain ischemia, 16-18 and clinical studies have found coherent results. 19-25 In light of these facts, a preliminary retrospective analysis was undertaken to verify whether policosanol added to AS within 30 days of stroke onset, is better than placebo + AS for the six and 12 months recovery of ischemic stroke patients included. II. MATERIALS AND METHODS The present analysis includes the data of all patients included in ischemic stroke recovery studies. Studies Design Patients who suffered recent ischemic stroke (≤ 30 days before recruitment) and gave their informed written consent enrolled at external visits of the Institute of Neurology and Neurosurgery (Havana, Cuba). The independent Ethics Committee approved the studies protocols and the studies were registered in the Cuban Public Registry of Clinical Studies. I