Abstract:Background. Antiplatelet therapy lowers the risk of recurrent stroke. Policosanol, a mixture of 8 high molecular weight sugar cane wax alcohols, has shown to reduce platelet aggregation. Objectives. To investigate whether the therapy with policosanol plus aspirin (AS) could improve the neurological outcome as compared to placebo + AS in patients with a recent ischemic stroke. Methods. Ninety-two (92) patients with a modified Rankin Scale score (mRSs) ≥2 -≤4 after suffering an ischemic stroke within 30 days bef… Show more
“…This double-blind, randomized and controlled study confirms that poli + AS treatment significantly improved stroke functional outcomes in patients who had suffered a recent (≤30 days) moderate to severe ischemic stroke, consistent with the results of a previous double-blind, randomized, controlled study conducted in post-ischemic stroke sufferers [25]. In addition, for the first time, beneficial effects of poli + AS treatment on plasma oxidative variables of these patients were also found.…”
Section: Discussionsupporting
confidence: 89%
“…No patient withdrew from the study, the frequency of AE was low and AE were mild. Systolic blood pressure decreased significantly with poli + AS versus pla + AS, consistent with previous results [23][24][25]. Nevertheless, since no patient had hypotension values and there was a high frequency of study patients with hypertension, this effect could be potentially beneficial, rather than adverse, for stroke recovery.…”
Section: Discussionsupporting
confidence: 89%
“…Also, policosanol has shown protective effects in experimental brain ischemia models [20,21], and long-term administered prevented the progression of carotid-vertebral atherosclerosis in humans [22]. Two open and long-term clinical studies found that the addition of policosanol to aspirin (AS) therapy was associated to very good neurological recovery [23,24], and a further double-blind, placebo-controlled study demonstrated that policosanol + AS treatment improved the neurological recovery and decreased platelet aggregation in patients with recent ischemic stroke [25].In light of this background, this study investigated the effects of the therapy with policosanol 20 mg/day + AS 125 mg/day (poli + AS) on the neurological outcome and plasma oxidative variables in patients who had suffered a recent ischemic stroke as compared to placebo + AS 125 mg/day (pla + AS).…”
Background. Oxidative stress (OS) contributes to brain reperfusion injury after ischemic stroke. Policosanol, a mixture of 8 higher aliphatic sugarcane wax alcohols, has shown to protect against experimental brain ischemia.
Objectives. To investigate the effect of policosanol plus aspirin (AS) therapy on the neurological outcome and plasma oxidative variables in patients post-ischemic strokeMethods. Post-ischemic stroke (≤ 30 days evolution) sufferers with a modified Rankin Scale score (mRSs) ≥2 -≤4 were randomized to placebo or policosanol (20 mg/day) + aspirin (AS) (125 mg/day) (pla + AS) or placebo + AS (pla + AS) for 24 weeks. The primary efficacy variable was to significantly increase the patients with a favourable stroke outcome (mRSs ≤1) versus pla +AS. Plasma oxidative markers (malondialdehyde -MDA-, sulphidril groups -SHG-, total antioxidant capacity -TAC-) were secondary variables.Results. patients (mean age: 64 years) were randomized. No significant changes occurred with pla +AS. After 6 weeks on treatment poli + AS reduced significantly the mean mRSs value (p0.001 vs pla + AS), and this effect was not wear off, but enhanced, throughout the study. More (p0.0001) poli + AS patients (29/31, 93.5%) achieved mRSs values ≤1 at study completion as compared to pla + AS patients (2/30, 6.7%). Also, poli + AS treatment produced significant reductions of plasma MDA and SHG, while increased plasma TAC. Treatments were well tolerated. There were not study withdrawals.
Conclusions. Poli + AS therapy improved the neurological recovery and favourably modified plasma oxidative markers versus pla + AS in patients post-ischemic stroke
“…This double-blind, randomized and controlled study confirms that poli + AS treatment significantly improved stroke functional outcomes in patients who had suffered a recent (≤30 days) moderate to severe ischemic stroke, consistent with the results of a previous double-blind, randomized, controlled study conducted in post-ischemic stroke sufferers [25]. In addition, for the first time, beneficial effects of poli + AS treatment on plasma oxidative variables of these patients were also found.…”
Section: Discussionsupporting
confidence: 89%
“…No patient withdrew from the study, the frequency of AE was low and AE were mild. Systolic blood pressure decreased significantly with poli + AS versus pla + AS, consistent with previous results [23][24][25]. Nevertheless, since no patient had hypotension values and there was a high frequency of study patients with hypertension, this effect could be potentially beneficial, rather than adverse, for stroke recovery.…”
Section: Discussionsupporting
confidence: 89%
“…Also, policosanol has shown protective effects in experimental brain ischemia models [20,21], and long-term administered prevented the progression of carotid-vertebral atherosclerosis in humans [22]. Two open and long-term clinical studies found that the addition of policosanol to aspirin (AS) therapy was associated to very good neurological recovery [23,24], and a further double-blind, placebo-controlled study demonstrated that policosanol + AS treatment improved the neurological recovery and decreased platelet aggregation in patients with recent ischemic stroke [25].In light of this background, this study investigated the effects of the therapy with policosanol 20 mg/day + AS 125 mg/day (poli + AS) on the neurological outcome and plasma oxidative variables in patients who had suffered a recent ischemic stroke as compared to placebo + AS 125 mg/day (pla + AS).…”
Background. Oxidative stress (OS) contributes to brain reperfusion injury after ischemic stroke. Policosanol, a mixture of 8 higher aliphatic sugarcane wax alcohols, has shown to protect against experimental brain ischemia.
Objectives. To investigate the effect of policosanol plus aspirin (AS) therapy on the neurological outcome and plasma oxidative variables in patients post-ischemic strokeMethods. Post-ischemic stroke (≤ 30 days evolution) sufferers with a modified Rankin Scale score (mRSs) ≥2 -≤4 were randomized to placebo or policosanol (20 mg/day) + aspirin (AS) (125 mg/day) (pla + AS) or placebo + AS (pla + AS) for 24 weeks. The primary efficacy variable was to significantly increase the patients with a favourable stroke outcome (mRSs ≤1) versus pla +AS. Plasma oxidative markers (malondialdehyde -MDA-, sulphidril groups -SHG-, total antioxidant capacity -TAC-) were secondary variables.Results. patients (mean age: 64 years) were randomized. No significant changes occurred with pla +AS. After 6 weeks on treatment poli + AS reduced significantly the mean mRSs value (p0.001 vs pla + AS), and this effect was not wear off, but enhanced, throughout the study. More (p0.0001) poli + AS patients (29/31, 93.5%) achieved mRSs values ≤1 at study completion as compared to pla + AS patients (2/30, 6.7%). Also, poli + AS treatment produced significant reductions of plasma MDA and SHG, while increased plasma TAC. Treatments were well tolerated. There were not study withdrawals.
Conclusions. Poli + AS therapy improved the neurological recovery and favourably modified plasma oxidative markers versus pla + AS in patients post-ischemic stroke
“…The results of this study were encouraging as the CNS neurological score improved significantly and progressively over the 5 years study period of all the patients involved in the study, only one suffered a new stroke (1.8%), four (7.3%) experienced a new TIA, and fifty patients (90.9%) did not experience a new vascular event. No patient died during the trial and no other serious adverse effects occurred [48].…”
Section: Open Studiesmentioning
confidence: 92%
“…Given this result, a 60 months follow-up study was designed for 55 patients who suffered an ischemic stroke with a prior history of TIA, after hospital discharge. In this study, the neurological evolution of the patients was evaluated with the aim of demonstrating the usefulness of treatment with policosanol (20 mg/ day) plus aspirin (125 mg/day) [48].…”
Stroke is among the leading causes of mortality and disability; therefore, it constitutes a relevant health problem. Cuban policosanol presents lipid-lowering, antiplatelet, antioxidant and vascular endothelium protective properties, all of which give it a comprehensive anti-atherosclerotic effect. This review is aimed to show, analyze and discuss the main preclinical and clinical evidence of the effects of Cuban policosanol on ischemic stroke. Preclinical studies evidenced the anti-ischemic effects of preventive and therapeutic oral treatment with Cuban policosanol in Mongolian gerbils with cerebral ischemia induced by unilateral and permanent ligation of a carotid artery, and in global cerebral ischemia induced by bilateral clamping and recirculation of both carotids; being similar or superior to other anti-ischemic agents. Also, combination therapy with aspirin produced greater anti-stroke efficacy compared with aspirin monotherapy, but being similar to policosanol plus atorvastatin combination. This anti-stroke effect was associated to a serum thromboxane A2 (TxA2) concentrations reduction and prostacyclin (PgI2) increase, leading to a favorable TxA2/PgI2 balance, and also to the malondialdehyde (MDA) and sulfhydryl groups (SHG, lipid peroxidation and protein oxidation markers, respectively) reduction. Cuban policosanol combined with aspirin (standard therapy) improved and benefited patients with prior ischemic stroke in terms of functional and neurological outcomes, in open-label studies and in randomized, double-blind, controlled studies. These beneficial effects on stroke patients were associated with antioxidant and antiplatelet effects of policosanol. Also, the combinations of Cuban policosanol plus aspirin and atorvastatin plus aspirin compared in a clinical study significantly and similarly improved the neurological recovery of patients with ischemic stroke. Cuban policosanol was safe and well tolerated, with no serious adverse events occurring during the trials. In conclusion, Cuban policosanol is a safe and effective natural drug for ischemic stroke treatment, which is supported by preclinical and clinical evidences.
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