PMID- 12099160
OWN - NLM
STAT- MEDLINE
DCOM- 20030103
LR  - 20181025
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 3
IP  - 3
DP  - 2002
TI  - Effects of policosanol on older patients with hypertension and type II 
      hypercholesterolaemia.
PG  - 159-72
AB  - 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 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.
FAU - Castano, Gladys
AU  - Castano G
AD  - Surgical Medical Research Center, Havana City, Cuba.
FAU - Mas, Rosa
AU  - Mas R
FAU - Fernandez, Julio C
AU  - Fernandez JC
FAU - Fernandez, Lilia
AU  - Fernandez L
FAU - Illnait, Jose
AU  - Illnait J
FAU - Lopez, Ernesto
AU  - Lopez E
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - 0 (Fatty Alcohols)
RN  - 0 (Lipids)
RN  - 142583-61-7 (policosanol)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Chi-Square Distribution
MH  - Double-Blind Method
MH  - Fatty Alcohols/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Hyperlipoproteinemia Type II/blood/*drug therapy
MH  - Hypertension/blood/*drug therapy
MH  - Lipids/blood
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
EDAT- 2002/07/09 10:00
MHDA- 2003/01/04 04:00
CRDT- 2002/07/09 10:00
PHST- 2002/07/09 10:00 [pubmed]
PHST- 2003/01/04 04:00 [medline]
PHST- 2002/07/09 10:00 [entrez]
AID - 10.2165/00126839-200203030-00004 [doi]
PST - ppublish
SO  - Drugs R D. 2002;3(3):159-72. doi: 10.2165/00126839-200203030-00004.