Despite undeniable progress in the reduction of morbidity and mortality of coronary heart
disease (CHD) prevention is a mainstay for medical intervention. The importance of elevated
serum cholesterol for the formation and progress of CHD can be regarded as proved after the
results of the major intervention studies became available. These studies have provided key
evidence for a positive correlation of lipid lowering and decreased mortality. Other studies
in patients with established CHD have shown that stabilization and regression of
atherosclerotic lesions is possible with lowering of cholesterol using a variety of agents.
Different studies have also investigated the long-term effects of lipid lowering strategies
on atherosclerosis by means of coronary angiography and have demonstrated that lipid
reduction reduces progression of atherosclerosis and can promote atherosclerosis regression.
Thus, it has been demonstrated that cholesterol lowering therapy reduces the risk of CHD and
diminishes cardiovascular morbidity and mortality.
Policosanol is a drug that presumably possesses both hypocholesterolemic and antiplatelet
effects. Furthermore there are hints to even more positive effects that influence the
development of atherosclerosis, i.e. inhibition of LDL peroxidation and smooth muscle cell
proliferation.
Previous studies showed efficacy in dose ranges of mostly 5 to 20 mg Policosanol per day. As
nearly all previous studies have been performed in Latin America it cannot be excluded that
either ethnic or nutritional factors contribute to the dose found to be optimal in this
region. This circumstance as well as the requirement to meet the ICH Guideline "Ethnic
Factors in the Acceptability of Foreign Clinical Data" make further studies, i.e. a
dose-finding clinical trial, an efficacy clinical trial in European patients and a long-term
tolerability clinical trial in Caucasian patients necessary.
It is known from more than 60 clinical studies performed so far that Policosanol has an
excellent safety profile. A placebo-controlled design was considered appropriate as patients
with two or more risk factors for the development of cardiovascular events and a LDL of
greater than 190 mg/dl were excluded; the chance of getting an active lipid-lowering agent
during the treatment phase was 80 %.