Red Yeast Rice and Phytosterols In Statin Intolerance

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.

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