R. Mas et al., Effects of policosanol on lipid profile and cardiac events in older hypercholesterolaemic patients with coronary disease, CLIN DRUG I, 21(7), 2001, pp. 485-497
Objective: This study was undertaken to investigate the effects of policosa
nol administered for 1 year on the lipid profile and cardiac events of olde
r hypercholesterolaemic patients with coronary heart disease (CHD).
Patients: 280 older patients of both sexes with type II hypercholesterolaem
ia and CHD were included.
Methods: Patients were randomised after 6 weeks of a standard step I choles
terol-lowering diet to treatment with policosanol (5mg) or placebo tablets
once daily for I year. The starting dose was 5 mg/day, which was doubled to
10 mg/day if predefined goals were not reached after 6 months on therapy.
Cardiac events were defined as death from cardiovascular causes [fatal myoc
ardial infarction (MI), sudden cardiac death] and nonfatal Ml, unstable ang
ina pectoris or coronary surgery.
Results: Policosanol significantly (p < 0.00001) lowered serum low-density
lipoprotein-cholesterol (LDL-C) [21.3%], total cholesterol (TC) [15.9%], TC
to high-density lipoprotein-cholesterol (HDL-C) ratio [22.7%] and LDL-C/HD
L-C ratio (26.1%), as well as triglycerides (7.8%, p < 0.001). HDL-C was si
gnificantly increased (18.2%, p < 0.001). The frequency of cardiac events w
as lower (p < 0.001) in policosanol (1 event, 0.7%) than in placebo (11 eve
nts, 7.9%) recipients. Likewise, the frequency of all vascular serious adve
rse events (four events, 2.9%) and all-cause hospitalisations in the polico
sanol group (five events, 3.6%) was lower (p < 0.001) than in the placebo g
roup (15 and 20 events, 10.7 and 14.3%, respectively). No patient died duri
ng the study. Policosanol was well tolerated.
Conclusions: Long-term policosanol is effective in lowering LDL-C and TC an
d in increasing HDL-C levels in older patients with CHD, and also showed be
nefits in the occurrence of cardiac events and overall frequency of serious
adverse events of vascular aetiology.