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allied
academies
Cell Science, Stem Cell Research &
Pharmacological Regenerative Medicine
November 29-30, 2017 | Atlanta, USA
Annual Congress on
Adv cel sci tissue cul 2017 | Volume 1 Issue 2
Long-term effect of policosanol on the functional recovery of non-cardioembolic ischemic stroke
patients: A one year study
Julio C Fernández
1
, Javier Sánchez
3
, José Illnait
2
, Rosa Mas
1
, Sarahí Mendoza
1
, Lilia Fernández
1
, Meilis Mesa
2
, Hermys Vega
2
, Pablo Reyes
4
and
Dalmer
Ruiz
4
1
Center of Natural Products, Cuba
2
Medical Surgical Research Centre, Cuba
3
Institute of Neurology and Neurosurgery, Cuba
4
National Center for Scientific Research, Cuba
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 non-cardioembolic 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 is
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:
Eighty 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 long-termtherapy (p<0.0001 versus placebo/
AS). More policosanol/AS (35/40, 87.5%) than placebo/
AS (0/30, 0.0%) achieved mRSs ≤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.
Speaker Biography
Julio C Fernández is a Senior Investigator in Clinical Trials Unit, National Centre for
Scientific Research, Havana city, Cuba. He has completed his BSc in Pharmaceutical
Sciences from Havana University Cube in 1996. He was awarded with PhD in
Pharmaceutical Sciences in 2003. He has published more than 130 publications and
presented more than 100 papers in various scientific events. His research interest
mainly focuses on clinical trials phase I-IV of different natural products: Policosanol,
Abexol, Prevenox, Palmex.
e:
itsme.sunandini@gmail.com