Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 89
Updated:4/21/2016
Start Date:March 2005
End Date:August 2006

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Evaluation of Plant Sterol and Placebo on Low-density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy.

The purpose of this study is to see if combination therapy with a "statin" medication and
two additional agents that work differently than "statin" medications can further lower the
so-called "bad cholesterol." One therapy is a prescription drug approved by the Food and
Drug Administration to treat high cholesterol (Welchol). The other therapy is Minute Maid
Heart Wise orange juice. This study juice is available in supermarkets and contains plant
sterols that have been shown to lower cholesterol.

Coronary heart disease (CHD) is the primary cause of morbidity and mortality in the United
States. Lowering LDL cholesterol in both patients with and without CHD reduces coronary
events and death. Statin medications are the primary mechanism of lowering LDL cholesterol,
but some patients do not reach their goal LDL with maximum tolerated statin doses and must
utilize combination therapy to further lower cholesterol. Additionally, some patients prefer
to utilize "natural" mechanisms to lower cholesterol. This prospective, double-blinded,
randomized study will compare plant sterol (natural cholesterol treatment) with placebo in
patients treated with combination statin and colesevelam therapy.

Inclusion Criteria:

- Diagnosis of high cholesterol being treated with a statin

- LDL cholesterol greater than 100

- Ability to swallow large tablets

Exclusion Criteria:

- Diabetes

- Use of other medications to treat high cholesterol

- History of liver disease
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