Policosanol (sugarcane wax alcohols) 20 mg/day in Cuban Patients With Grade I Hypertension: A Randomized, Double-Blind, Multicenter Study.
Moura Revueltas Aguero, Amarilys Jimenez Chiquet, Yamile Valdes, Julio César Fernández Travieso, Yenney Reyes Nuñez, Yanay Fernández Dominguez, Evelyn González Pla, Sarahi Mendoza Castaño, Yohani Pérez Guerra, Manuel Delfin Pérez Caballero, Deisy Navarro, Yolanda Cruz Gomez, Meilis Mesa Angarica, Gladys Jiménez Rivero, Carlos Sánchez Texido
Abstract
Open AccessThis study aimed to report the effects of policosanol (20 mg/day) on blood pressure values in Cuban patients with grade I hypertension. A double-blind multicenter trial randomized 400 eligible patients divided into two strata of patients with either prehypertension or grade I hypertension (200 patients each) treated with either placebo or policosanol 20 mg/day (100 patients/group/stratum) for 12 weeks. Having published the results of pre-hypertensive patients, here we report the grade I hypertension stratum (SBP 140-159 mmHg, DBP 90-99 mmHg) results. The primary outcome targeted whether policosanol could achieve significant systolic blood pressure (SBP) reductions ≥10 mmHg versus baseline and significantly different from placebo. Changes in diastolic blood pressure (DBP) and lipid profile variables were secondary outcomes. Safety indicators and adverse events were assessed. Statistical analyses were conducted by Intention to Treat. Both groups were similar at randomization. At study completion, policosanol significantly lowered (p < 0.001) SBP, the primary outcome, by more than 10 mmHg related to baseline and placebo, while also significantly decreasing (p < 0.001) DBP values versus baseline and placebo. Also, more (p < 0.001) policosanol patients reached SBP reductions ≥10 mmHg and DBP reductions ≥5 mmHg versus baseline (74% and 91%, respectively) than placebo patients (12% and 15%, respectively). Policosanol significantly lowered low-density lipoprotein-cholesterol (LDL-C) and total cholesterol, while increasing high-density lipoprotein-cholesterol (HDL-C). It is concluded that oral administration of policosanol 20 mg/day for twelve weeks significantly lowered SBP and DBP in Cuban patients with grade I hypertension, and improved lipid profile variables, being safe and well tolerated. Trial registration: Cuban Public Registry of Clinical Trials identifier: RPCEC00000377; IRB approval number: IRB-120721.