Red Yeast Rice and Phytosterols In Statin Intolerance

Hyperlipidemia Clinical Trial

Official title:

Red Yeast Rice and Phytosterols Versus Red Yeast Rice and Placebo for the Treatment of Hyperlipidemia in Patients With Statin Intolerance: A Multi-Center Randomized Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897975
• Other study ID #: FWA00005390 Chestnut HillHC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 11, 2009
• Last updated: July 14, 2011
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2009
• Source: Chestnut Hill Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Red yeast rice may be useful to lower cholesterol, especially in a population of patients who cannot tolerate traditional therapy with statins.

The addition of an over-the-counter phytosterol to red yeast rice may offer additional lipid lowering benefits when compared to red yeast rice alone.

These supplements will be given to all participants. Up to one-half will enroll in a lifestyle intervention program called Change of Heart and will be compared to patients who do not participate in the program. The study will last one year.

Description:

Although recent studies have shown that red yeast rice is an effective therapy in the treatment of hyperlipidemia, additional supplements may be required to lower cholesterol to levels that have been associated with decreased coronary events. Specifically a target has been to lower low-density lipoprotein-C (LDL-C) to levels below 100 mg/dl. Red yeast rice has been found to be effective in lowering cholesterol in the context of the Change of Heart Program, where participants are encouraged to make significant lifestyle changes. This has been documented in two recent trials that we have published in the past year in the Mayo Clinic Proceedings (July 2008) and The Annals of Internal Medicine (in press). Clinically, we have found it necessary to add a phytosterol supplement to red yeast rice to lower LDL-C levels below 100 mg/dl. There has been a great deal of interest in phytosterols in both the lay and medical press in the past several years. This over the counter supplement lowers cholesterol by acting in the intestine to decrease the absorption of cholesterol. As it is not absorbed, there have not been any reports of significant side effects. The purpose of this study is to examine the lipid lowering effects of red yeast rice with and without adding a phytosterol. Some participants will attend the Change of Heart Program and take these supplements. Another group of participants will take the same supplements, with their usual medical care, but not enroll in the Change of Heart Program. The study will last one year, and participants will have been intolerant of statins in the past.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Men and women age > 21

• LDL > 100 and physician suggestion to take statin

• Subject complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy

• Having stopped a statin drug for personal reasons and not willing to restart this medication

• Refusal to take a statin as prescribed by personal physician

• CPK < 400

• Not taking any cholesterol lowering medication, red yeast rice extract or a phytosterol product for at least 1 month prior to initiation of trial

• Ability to exercise without physical restrictions

• Ability to attend 12 week consecutive Change of Heart lifestyle education sessions

• Liver function studies normal at baseline

• Subject willing to remain off the dietary supplement CoQ10 for duration of trial

• TSH must be normal

Exclusion Criteria:

• A history of muscle damage (CPK > 400 IU) on statin therapy

• Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year

• Known intolerance to one of the study drugs

• Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease

• Uncontrolled hypertension (defined as SBP > 180 mmHg or DBP > 100 mmHg

• Heart attack, bypass surgery, or angioplasty/stent within 1 year of study

• Triglyceride level more than 400 mg/dl

• Underlying musculoskeletal disorder preventing muscle testing

• Taking other medicines including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• red yeast rice
600 mg 3 capsules bid

Drug:
• phytosterol
phytosterol 450 mg 2 tabs bid with food

Behavioral:
• therapeutic lifestyle program
TLC - 12 weeks

Drug:
• placebo
placebo

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Chestnut Hill Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Chestnut Hill Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol levels		one year
Secondary	myalgia compared to prior statin usage		one year
Secondary	other lipoprotein levels		one year
Secondary	weight loss in TLC program vs. baseline		one year