Journal of Clinical Trials
Open Access

Long-term effect of policosanol on the functional recovery of non-cardioembolic ischemic stroke patients: A one year study

4^th International Conference on Clinical Trials

September 11-13, 2017 San Antonio, USA

Julio C Fernandez, Eng Dalmer Ruiz, Eng Pablo Reyes, Jose Illnait, Rosa Mas, Sarahi Mendoza, Lilia Fernandez, Meilis Mesa, Hermys Vega and Javier Sanchez

National Center for Scientific Research, Cuba
Surgical Medical Research Centre, India
National Center of Natural Products, USA
Institute of Neurology and Neurosurgery, USA

Posters & Accepted Abstracts: J Clin Trials

Abstract :

Introduction: Stroke is a leading cause of mortality and disability. Policosanol has been effective in brain ischemia models. Clinical studies suggested that policosanol (20 mg/day) + standard aspirin (AS) therapy had benefits versus placebo +AS given for 6 months to patients with recent non-cardioembolic ischemic stroke. The objectives of this study investigate whether policosanol, added to AS therapy within 30 days of stroke onset, is better than placebo + AS for the long-term recovery of noncardioembolic ischemic stroke subjects. Methods: This study was randomized, double-blind, placebo-controlled. Eighty 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 12 months. The primary outcome was mRSs reduction, the secondary outcome the increase of Barthel Index (BI). Low-density lipoprotein-cholesterol (LDL-C) reduction and high-density lipoprotein-cholesterol (HDL-C) increase were collateral outcomes. Results: 80 patients (mean age: 69 years) were randomized. Policosanol/AS decreased significantly mean mRSs from the first interim check-up (1.5 months) (p<0.0001 vs. placebo/AS). The treatment effect did not wear off, even improved, after longterm therapy (p<0.0001 versus placebo/AS). More policosanol/AS (35/40, 87.5%) than placebo/AS (0/30, 0.0%) were achieved mRSsâ�?¤1 (p<0.0001). Policosanol/AS increased significantly BI, lowered LDL-C and increased HDL-C versus placebo/AS, treatments were well tolerated. There were 12 withdrawals three due to fatal adverse events all happened in the placebo/AS groups. Conclusions: Long-term (12 months) administration of policosanol/AS given after suffering non-cardioembolic ischemic stroke was shown to be better than placebo/AS in improving functional outcomes at 3 and 12 months when used among patients with non-cardioembolic ischemic stroke of moderate severity.