Policosanol (sugarcane wax alcohols) 20 mg/day in Cuban Patients With Grade I Hypertension: A Randomized, Double-Blind, Multicenter Study

IF 2.5 3区医学 Q2 PERIPHERAL VASCULAR DISEASE

Journal of Clinical Hypertension Pub Date : 2025-10-01 DOI:10.1111/jch.70126

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, and the Family's Doctors of the Polyclinical Centres of Plaza Municipality

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Abstract

This 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.

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糖醇（甘蔗蜡醇）20毫克/天对古巴I级高血压患者的治疗：一项随机、双盲、多中心研究

本研究旨在报道胆甾醇（20mg /天）对古巴I级高血压患者血压值的影响。一项双盲多中心试验将400例符合条件的患者随机分为两组，分别为高血压前期和I级高血压患者（每组200例），分别接受安慰剂或20 mg/天的胆甾醇治疗（100例/组/层），为期12周。在发表了高血压前期患者的结果后，我们报告了I级高血压层（收缩压140-159 mmHg，舒张压90-99 mmHg）的结果。该研究的主要终点是，与基线相比，乙醇是否能显著降低收缩压(SBP)≥10 mmHg，并与安慰剂有显著差异。舒张压（DBP）和脂质谱变量的变化是次要结果。评估安全指标和不良事件。采用Intention to Treat进行统计分析。两组在随机分组时相似。在研究结束时，与基线和安慰剂相比，胆甾醇显著降低（p < 0.001）收缩压（主要结局）超过10 mmHg，同时与基线和安慰剂相比，也显著降低（p < 0.001）舒张压值。此外，与基线相比，更多的（p < 0.001） policyosanol患者达到收缩压降低≥10 mmHg和舒张压降低≥5 mmHg（分别为74%和91%），而安慰剂患者（分别为12%和15%）。低密度脂蛋白-胆固醇（LDL-C）和总胆固醇显著降低，高密度脂蛋白-胆固醇（HDL-C）显著升高。结论：口服糖皮质醇20mg /天，连续12周可显著降低古巴I级高血压患者的收缩压和舒张压，改善血脂指标，安全且耐受性良好。试验注册：古巴临床试验公共注册中心标识符：RPCEC00000377；IRB批准号：IRB-120721。

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来源期刊

Journal of Clinical Hypertension PERIPHERAL VASCULAR DISEASE-

CiteScore

5.80

自引率

7.10%

发文量

191

审稿时长

4-8 weeks

期刊介绍： The Journal of Clinical Hypertension is a peer-reviewed, monthly publication that serves internists, cardiologists, nephrologists, endocrinologists, hypertension specialists, primary care practitioners, pharmacists and all professionals interested in hypertension by providing objective, up-to-date information and practical recommendations on the full range of clinical aspects of hypertension. Commentaries and columns by experts in the field provide further insights into our original research articles as well as on major articles published elsewhere. Major guidelines for the management of hypertension are also an important feature of the Journal. Through its partnership with the World Hypertension League, JCH will include a new focus on hypertension and public health, including major policy issues, that features research and reviews related to disease characteristics and management at the population level.