title: Effects of policosanol on older patients with hypertension and type II hypercholesterolaemia.
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.
  
  
  METHODS
  589 older male and female patients with 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 (5 mg) 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 recipents 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.
authors.affiliation: Surgical Medical Research Center, Havana City, Cuba.
authors.forename: Gladys
authors.initials: G
authors.lastname: Castaño
authors.forename: Rosa
authors.initials: R
authors.lastname: Más
authors.forename: Julio C
authors.initials: JC
authors.lastname: Fernández
authors.forename: Lilia
authors.initials: L
authors.lastname: Fernández
authors.forename: José
authors.initials: J
authors.lastname: Illnait
authors.forename: Ernesto
authors.initials: E
authors.lastname: López
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005233:Fatty Alcohols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006938:Hyperlipoproteinemia Type II / Q000097:blood / Q000188:drug therapy*; D006973:Hypertension / Q000097:blood / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D005233:Fatty Alcohols; D008055:Lipids; C080710:policosanol