Cholesterol-Lowering Effects of Policosanol
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 %.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Placebo-Controlled, Randomised, Double-Blind, Multi-Centre Clinical Trial on Dose-Dependent Cholesterol-Lowering Effects of Policosanol in Patients With Hypercholesterolaemia With 10 to 80 Mg Policosanol for 12 Weeks|
- Decrease in LDL cholesterol
- Changes in other lipoproteins
|Study Start Date:||September 2000|
|Estimated Study Completion Date:||July 2001|
Visit 1: Informed consent, Inclusion and exclusion criteria, medical history, concomitant diseases and medication, physical examination, vital signs, lipid profile, safety lab, urine analysis, 12-lead EKG. Diet counseling.
Run-in phase six weeks. Visit 2 and 3 (5 and 6 weeks after visit 1): Baseline lipids. Visit 4: Baseline lipid sample, start treatment. Randomization to one of five groups, placebo, 10 mg, 20 mg, 40 mg, or 80 mg policosanol.
Visit 5 and 6 (6 and 12 weeks after visit 4): Lipid sample. Safety lab.