Revueltas Moura, Jimenez Chiquet Amarilys, Valdes Yamile, Fernández Julio C, Reyes Yenney, Fernández Yanay, González Evelyn, Mendoza Sarahi, Pérez Yohani, Pérez Manuel Delfin, Navarro Deisy, Cruz Yolanda, Mesa Meilis, Jiménez Gladys, Sánchez Carlos
Department of Epidemiology, National Institute of Hygiene, Epidemiology and Microbiology, Havana, Cuba.
Calixto García Hospital, Havana, Cuba.
J Clin Hypertens (Greenwich). 2025 Apr;27(4):e14948. doi: 10.1111/jch.14948.
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.
高血压是最常见的可改变的心血管危险因素。聚多卡醇具有调节血脂和有益的血管多效性作用。此前一些古巴的试验发现，聚多卡醇可降低高胆固醇血症患者的血压。最近在亚洲高血压前期受试者中也发现了类似结果。本研究的目的是报告每天20毫克聚多卡醇对古巴高血压前期患者血压的影响。一项双盲多中心试验将400名符合条件的患者随机分为两个各含200名患者的组（高血压前期和1级高血压），分别接受安慰剂或每天20毫克聚多卡醇治疗（每组/每层100名患者），为期12周。主要结局是确定聚多卡醇与安慰剂相比是否能使收缩压（SBP）显著降低≥10毫米汞柱。舒张压（DBP）和血脂谱的变化为次要结局。评估了安全性指标和不良事件（AE）。采用意向性分析（ITT）进行统计分析。在此我们报告高血压前期组（SBP 120 - 139毫米汞柱，DBP 80 - 89毫米汞柱）的结果。随机分组时两组相似。在研究结束时，与基线和安慰剂相比，聚多卡醇显著降低了（p < 0.001）SBP和DBP值。此外，与安慰剂组患者（分别为7%和22%）相比，更多（p < 0.0001）服用聚多卡醇的患者（44%）达到SBP降低≥10毫米汞柱且DBP降低≥5毫米汞柱（分别为44%和61%）。聚多卡醇显著降低了低密度脂蛋白胆固醇（LDL-C）和总胆固醇（TC），并升高了高密度脂蛋白胆固醇（HDL-C）。聚多卡醇耐受性良好。9名患者（4.5%）中断试验，均非因不良事件。4名患者（3名服用安慰剂，1名服用聚多卡醇）报告了不良事件。结论是，给古巴高血压前期患者每天服用20毫克聚多卡醇，持续12周，可降低SBP和DBP，并使血脂谱产生有益变化，且耐受性良好。
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