Efficacy and Safety of Policosanol (Sugarcane Wax Alcohols) 20 mg/Day in Cuban Prehypertensive Patients: A Randomized, Double-Blind, Multicentre Study

Abstract

Hypertension is the most common modifiable cardiovascular risk factor. Policosanol exhibits lipid-modifying and beneficial vascular pleiotropic effects. Some previous Cuban trials found that policosanol lowered blood pressure in hypercholesterolemic patients. Similar results were found recently in prehypertensive Asian subjects. The aim of this study was to report the effects of 20 mg/day of policosanol on blood pressure in Cuban patients with prehypertension. A double-blind multicenter trial randomized 400 eligible patients into two strata of 200 patients each (prehypertension and Grade 1 hypertension), treated with placebo or 20 mg/day of policosanol (100 patients/group/stratum) for 12 weeks. The primary outcome was to determine whether policosanol could achieve significant systolic blood pressure (SBP) reductions ≥10 mmHg versus placebo. Changes in diastolic blood pressure (DBP) and lipid profile were secondary outcomes. Safety indicators and adverse events (AE) were assessed. Statistical analyses were conducted by intention-to-treat (ITT). Here we report the results of the prehypertension stratum (SBP 120–139 mmHg, DBP 80–89 mmHg). Both groups were similar at randomization. At study completion, policosanol significantly lowered (p < 0.001) SBP and DBP values versus baseline and placebo. Also, more (p < 0.0001) policosanol patients (44%) reached SBP reductions ≥10 mmHg and DBP reductions ≥5 mmHg versus baseline (44% and 61%, respectively) than placebo patients (7% and 22%, respectively). Policosanol significantly lowered low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) and increased low-density lipoprotein cholesterol (HDL-C). Policosanol was well tolerated. Nine patients (4.5%) discontinued the trial, none because of AE. Four patients (3 placebo, 1 policosanol) reported AE. It is concluded that policosanol 20 mg/day given for 12 weeks to Cuban patients with prehypertension lowered SBP and DBP and produced beneficial changes in the lipid profile, being well tolerated.