A pharmacological surveillance study of the tolerability of policosanol in the elderly population.

Background: Policosanol is a drug derived from sugar cane wax that has cholesterol-lowering and antiplatelet properties. Randomized, controlled studies are the gold standard for demonstrating drug efficacy, safety, and tolerability, but postmarketing surveillance studies are encouraged for corroborating drug effects. A valid proof of the safety of a drug is a well-documented, good tolerability profile in older individuals, since this population is more prone to drug-related adverse events (AEs).

Comparison of the efficacy and tolerability of policosanol with atorvastatin in elderly patients with type II hypercholesterolaemia.

Background: Hypercholesterolaemia is a risk factor for coronary heart disease (CHD). Clinical studies have shown that lowering elevated serum total cholesterol (TC) levels, and particularly low density lipoprotein-cholesterol (LDL-C) levels, reduces the frequency of coronary morbidity and deaths, whereas high serum levels of high density lipoprotein-cholesterol (HDL-C) protect against CHD. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic dosage range from 5-20 mg/day.

Assessment of the effects of D-003, a new antiplatelet and lipid-lowering compound, in healthy volunteers. A phase I clinical study.

Objective: To investigate the effects of D-003 on the bleeding time (BT) and lipid profile of healthy human volunteers.

Methods: This single-blind, randomised, placebo-controlled, parallel-group study was conducted in healthy volunteers. Step 1 investigated the effects of single doses of D-003 5, 25 or 50 mg on BT in comparison with placebo.