Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study

To determine the effects of policosanol on the cholesterol profile.

The primary objectives of this study are to determine the changes in the lipid profile [LDL-C, HDL-C, triglycerides, total cholesterol] and the emerging risk factor, Lp(a), when policosanol is added to statin therapy. Additionally, one more primary objective is to evaluate the safety of the combination regimen.

Inclusion Criteria:

• LDL > 100
• Male or Non-Pregnant Female. Women must be surgically sterile or postmenopausal and not using hormone replacement therapy (HRT) or using a stable, consistent HRT dose with intentions to continue therapy throughout the course of the study
• Mentally competent to understand study rationale and protocol
• Speak and read English
• Currently receiving low to moderate dose statin therapy with plans to continue to the same dose for at least 8 weeks. Low to moderate dose statins include the following daily doses: atorvastatin ≤20 mg, fluvastatin ≤40 mg, lovastatin ≤40 mg, pravastatin ≤40 mg, rosuvastatin ≤10 mg, simvastatin ≤ 40 mg

Exclusion Criteria:

• LDL < 100
• Sensitivity to policosanol
• Currently taking a high-dose statin or other lipid-lowering agents (i.e. high-dose niacin formulations [>500mg/day], bile-acid sequestrants, ezetimibe, fibrates and high-dose Omega-3 fish oils [>900mg of combined EPA/DHA daily])
• Currently taking medications which have the potential to interact with policosanol (i.e. warfarin, high-dose aspirin)
• Active liver disease or ALT level 2.5 times the upper limit of normal
• Chronic disease involving hepatic, renal or coronary artery disease
• Currently experiencing "flu-like" symptoms
• Currently experiencing any form of acute physical injury
• Acute psychiatric disorders
• Immuno-compromised state
• Currently taking systemic steroidal drugs
• Currently pregnant or lactating
• Females of childbearing potential
• Dependence on alcohol or illicit drugs
• Participation in any other clinical trial within the last 30 days
• Displays s/s of acute systemic infection (oral temperature >100°F, WBC>12x10³/µL)