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Journal of Analytical & Bioanalytical Techniques | ISSN: 2155-9872 | Volume 9
World HPLC, Separation Techniques & Pharmacovigilance
World Analytical Chemistry & Mass Spectrometry
18
th
International Conference on
August 29-30, 2018 | Toronto, Canada
&
Concomitant use of policosanol and antiplatelet drugs in older patients
Julio C Fernandez
1
, Jose Illnait, Lilia Fernandez, Rosa Mas, Sarahi Mendoza, Rafael Gamez, Luis E Lopez
2
and
Meilis Mesa
1
National Centre for Scientific Research, Cuba
2
Surgical Medical Research Centre, Cuba
Introduction:
Policosanol is a cholesterol-lowering drug with antiplatelet action. Policosanol effects have been investigated in
clinical trials and post-marketing surveillance, its efficacy and safety are demonstrated. Policosanol has resulted very safely,
even when administered to special populations with high consumption of concomitant drugs, without demonstration of drug-
related Adverse Events (AE). Accordingly, the potential risk of Drug-Drug Interaction (DDI) with policosanol appears to be
low. DDI generally comes from pharmacokinetic or/and pharmacodynamic actions. Experimental data show that DDI with
policosanol derived from pharmacokinetic interactions is not very probable. Nevertheless, DDI based on pharmacological
interactions needs to be investigated. Antiplatelet drugs are widely used in middle-aged and geriatric populations mainly to
prevent recurrent coronary or cerebrovascular events. Experimental and small clinical studies have shown that policosanol
enhances the antiplatelet effects of aspirin in an additive manner. Hence, the interest to study putative DDI between policosanol
and antiplatelet drugs in a population sensitive to drug-related effects, as the elderly, is supported.
Objective:
The objective of the present analysis as a part of a prevention study, we investigatedwhether policosanol administered
to older individuals taking antiplatelet drugs supposes concern regarding a potential risk for adverse drug-drug interactions.
Methods:
We randomized 1470 elderly patients at high coronary risk to policosanol 5 mg/day or placebo for 3 years. For this
analysis, the records of all patients (334) taking antiplatelet drugs were included. The analysis was by intention-to-treat.
Results:
After one year, policosanol decreased significantly Low-Density Lipoprotein-Cholesterol (LDL-C) (21.0%), total
cholesterol (16.9%) and triglycerides (19.6%), while raisedHigh-Density Lipoprotein-Cholesterol (HDL-C) (6.2%). Policosanol
effects were maintained, even improved, during the follow-up. At study completion policosanol lowered LDL-C (34.3 %),
total cholesterol (23.9%), triglycerides (22.2%) and raised HDL-C (14.5%). Sixty patients (41 placebo, 19 policosanol, p<0.01)
withdrew from the study, 33 (23 placebo, 10 policosanol) (p<0.01) due to some adverse event, all serious. Policosanol did not
impair safety indicators and did not increase any adverse event with respect to placebo.
Conclusions:
The policosanol can be administered to older patients taking antiplatelet drugs without risk of relevant adverse
drug-drug interactions.
Biography
Julio Cesar Fernandez Travieso is a Senior Investigator in Clinical Trials Unit, National Centre for Scientific Research, Havana, Cuba. He has completed his BSc in
Pharmaceutical Sciences from Havana University, Cuba 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 and Palmex.
julio.fernandez@cnic.cuJulio C Fernandez et al., J Anal Bioanal Tech 2018, Volume 9
DOI: 10.4172/2155-9872-C1-028