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Effects of Policosanol on Older Patients with Hypertension and Type II Hypercholesterolaemia

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Abstract

Objective: This study was conducted to investigate the effects of policosanol administered for 12 months on the lipid profile of older patients with hypertension and type II hypercholesterolaemia and no history of coronary heart disease (CHD) or cerebrovascular disease.

Patients and participants: 589 oldermale and female patientswith hypertension and type II hypercholesterolaemia and no history of CHD or cerebrovascular disease were included.

Methods: This was a prospective, randomised, double-blind, placebo-controlled study in parallel groups treated with policosanol (5 to 10 mg/day) for 1 year. After 6 weeks on a standard step I cholesterol-lowering diet, 589 patients were randomised to policosanol (5mg) or placebo tablets, to be taken once daily for 12 months. The dosage was doubled to 10 mg/day if total cholesterol values were >6.1 mmol/L after 6 months of therapy.

Results: Policosanol significantly (p < 0.00001) lowered serum low-density lipoprotein-cholesterol (LDL-C) [20.5%], total cholesterol (TC) [15.4%], triglycerides (11.9%), LDL-C/high-density lipoprotein-cholesterol (HDL-C) ratio [22.2%] and TC/HDL-C ratio (20.1%), and increased (p < 0.0001) HDL-C (12.7%). The frequency of vascular and all-cause serious adverse events (SAEs) was lower (p < 0.05) in the policosanol recipients (two vascular SAEs, 0.7%; five all-cause SAEs, 1.7%) than in the placebo recipients (six vascular SAEs, 2.0%; 12 all-cause SAEs, 4.1%). Similarly, total adverse events (AEs) were less frequent in the policosanol-treated group (29; 9.8%) compared with the placebo group (52; 17.7%) [p < 0.01]. Three placebo recipients and no policosanol recipients died during the study as a result of myocardial infarction (two patients) and sudden cardiac arrest (one). Policosanol was well tolerated, and no drug-related disturbances in safety indicators were found. Policosanol significantly decreased systolic blood pressure (BP) compared with baseline and placebo, which could be an additional advantage in this population at high coronary risk.

Conclusions: Policosanol administered long term is effective in lowering LDL-C and TC as well as increasing HDL-C levels in older patients with hypertension and type II hypercholesterolaemia without a history of CHD or cerebrovascular disease. In addition, policosanol treatment also shows benefits in the occurrence of SAEs of vascular aetiology, on the general AE profile and the reduction of BP in treated patients compared with baseline.

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Acknowledgements

This trial was supported by a Research Project Grant from the Technical Project Council to the Center of Natural Products from the National Center for Scientific Research, in which other institutions belonging to the Cuban Health System also participated, all of them without specific additional payment. Policosanol was supplied by Laboratorios Dalmer (Havana City, Cuba). This work was approved by the Policosanol in Hypercholesterolemia Associated with Hypertension in the Elderly (PHHE) group.

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Authors and Affiliations

  1. Surgical Medical Research Center, Havana City, Cuba

    Gladys Castaño

  2. Center of Natural Products, National Center for Scientific Research, P.O. Box 6880 or 6990, Cubanacán Havana City, Cuba

    Rosa Más & Julio C. Fernández

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  1. Gladys Castaño
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  2. Rosa Más
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  3. Julio C. Fernández
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  6. Ernesto López
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Correspondence to Rosa Más.

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Castaño, G., Más, R., Fernández, J.C. et al. Effects of Policosanol on Older Patients with Hypertension and Type II Hypercholesterolaemia. Drugs R&D 3, 159–172 (2002). https://doi.org/10.2165/00126839-200203030-00004

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