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Journal of Analytical & Bioanalytical Techniques | ISSN: 2155-9872 | Volume 9
World HPLC, Separation Techniques & Pharmacovigilance
World Analytical Chemistry & Mass Spectrometry
18th International Conference on
August 29-30, 2018 | Toronto, Canada
&
Effects of policosanol in older patients consuming nitrates vasodilators
Julio C Fernandez1, Jose Illnait, Lilia Fernandez, Sarahi Mendoza, Rafael Gamez, Rosa Mas, Luis E Lopez2, Juan A Gutierrez and Meilis Mesa
1National Centre for Scientific Research, Cuba
2 Surgical Medical Research Centre, Cuba
Introduction: Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The efficacy and safety of
policosanol have been investigated in clinical studies and post-marketing surveillance. Policosanol is very safe and no drug-
related Adverse Events (AE) have been demonstrated, even in population subsets with high consumption of concomitant
therapy, indicating that the potential risk of Drug-Drug Interaction (DDI) for policosanol is low. Vasodilators are used in
geriatric populations mainly to treat congestive heart failure and acute decompensating of heart failure, although associatedwith
other anti-hypertensive are also used to manage arterial hypertension. Vasodilators, however, have a considerable risk of drug-
related toxicity, the most frequent symptoms being those derived from excessive vasodilation and hypotension, such as nausea,
vomiting, loss of consciousness and reflex tachycardia. Vasodilators show important DDI derive from pharmacodynamic
interactions with several drugs, those associated with the concomitant use of other vasodilators and diuretics being the most
relevant. Considering such facts, the interest to study putative DDI between policosanol and vasodilators is supported.
Objective: To investigate whether policosanol administered to older patients consuming vasodilators induces any specific
disturbance on safety indicators and/or increase the frequency or severity of AE in such patients.
Methods: This report was based in the analysis of the records of all patients (185) taking nitrates vasodilators included in a
prevention study in the elderly randomized to policosanol 5 mg/d or placebo for 3 years. The analysis was by Intention-to-treat.
Results: Baseline characteristicswerewell balanced inboth groups. After one year on treatment, policosanol lowered significantly
Low-Density Lipoprotein-Cholesterol (LDL-C) (20.9%), Total Cholesterol (TC) (15.9%) and triglycerides (19.3%), whereas
raised High-Density Lipoprotein-Cholesterol (HDL-C) (8.3%). Policosanol effects persisted, even increased, during the 3 years
treatment. At the end of the study, policosanol reduced LDL-C (35.0%), TC (25.0%), triglycerides (19.3%) and raised HDL-C
(16.7%). Of 185 randomized patients taking vasodilators, 44 (23.8%) withdrew from the trial. The frequency of withdrawals
in placebo (31/95; 32.6%) was greater (p<0.01) than in the policosanol group (13/90; 14.4%). Overall, 26/185 (14.1%) patients
discontinued due to some AE: 23 placebo (24.2%) and 3 policosanol patients (3.0%) (p<0.01). Policosanol did not impair safety
indicators compared with placebo but induced additional decreases in systolic pressure compared with placebo. The frequency
of policosanol patients experiencing Serious Adverse Events (SAE) (3/90; 3.3%) was lower (p<0.01) than in the respective
placebo (23/95; 24.2%). Likewise, the frequency of policosanol patients who experienced some mild or moderate AE during
the study (10/90; 11.1%) was lower (p<0.05) than in matched placebo (28/95; 29.5%).
Conclusions: Policosanol was well tolerated in older subjects with high coronary risk-taking vasodilators, not impairing safety
indicators or increasing any AE respect to placebo. Policosanol, however, produced additional decreases of arterial pressure
and reduced the frequency of SAE compared with placebo. Cholesterol-lowering efficacy of policosanol was persistent and
consistent with that expected. These results indicate that policosanol can be administered to older patients taking vasodilators
without risk of relevant adverse DDI.
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 C Fernandez et al., J Anal Bioanal Tech 2018, Volume 9
DOI: 10.4172/2155-9872-C1-028