title: Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors.
abstract: BACKGROUND
  This study was undertaken to evaluate the efficacy, safety, and tolerability of policosanol, a new cholesterol-lowering drug, in patients with type II hypercholesterolemia and additional coronary risk factors.
  
  
  METHODS
  After 5 weeks of a standard step-1 lipid-lowering diet, 437 patients were randomized to receive, under double-blind conditions, 5 mg policosanol or placebo once a day with the evening meal for 12 weeks and 10 mg policosanol or placebo for the next 12 weeks.
  
  
  RESULTS
  Both groups were similar at randomization. Policosanol (5 and 10 mg/day) significantly reduced (P < .001) serum low-density lipoprotein cholesterol (18.2% and 25.6%, respectively) and cholesterol (13.0% and 17.4%), and it significantly raised (P < .01) high-density lipoprotein cholesterol (15.5% and 28.4%). Triglycerides remained unchanged after the first 12 weeks and lowered significantly (5.2%; P < .01) at study completion. Policosanol was safe and well tolerated, and no drug-related disturbances were observed. Two male patients who received placebo died during the study--one because of a myocardial infarction and the other because of a cardiac arrest that occurred during a surgical intervention. There were 11 serious adverse events (5.1%) in 10 patients who received placebo (4.6%), 7 of which were vascular, compared with no serious adverse events reported in patients receiving policosanol (P < .01).
  
  
  CONCLUSIONS
  Subjects in the group treated with policosanol did not have serious adverse events during the 24-week study. This study shows that policosanol is effective, safe, and well tolerated in patients with hypercholesterolemia and concomitant coronary risk factors.
authors.affiliation: Center of Natural Products, National Center for Scientific Research, Havana City, Cuba.
authors.forename: R
authors.initials: R
authors.lastname: Más
authors.forename: G
authors.initials: G
authors.lastname: Castaño
authors.forename: J
authors.initials: J
authors.lastname: Illnait
authors.forename: L
authors.initials: L
authors.lastname: Fernández
authors.forename: J
authors.initials: J
authors.lastname: Fernández
authors.forename: C
authors.initials: C
authors.lastname: Alemán
authors.forename: V
authors.initials: V
authors.lastname: Pontigas
authors.forename: M
authors.initials: M
authors.lastname: Lescay
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000494:pharmacology*; D003327:Coronary Disease / Q000209:etiology*; D004311:Double-Blind Method; D005233:Fatty Alcohols / Q000494:pharmacology*; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D005233:Fatty Alcohols; D008055:Lipids; C080710:policosanol