Red Yeast Rice and Phytosterols In Statin Intolerance

This study has been completed.
Sponsor:
Information provided by:
Chestnut Hill Health System
ClinicalTrials.gov Identifier:
NCT00897975
First received: May 11, 2009
Last updated: July 14, 2011
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Dietary Supplement: red yeast rice
Drug: phytosterol
Behavioral: therapeutic lifestyle program
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chestnut Hill Health System:

Primary Outcome Measures:
  • LDL cholesterol levels [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • myalgia compared to prior statin usage [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • other lipoprotein levels [ Time Frame: one year ] [ Designated as safety issue: No ]
  • weight loss in TLC program vs. baseline [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: red yeast rice (RYR) plus phytosterol
arm will take red yeast rice and phytosterol supplement
Dietary Supplement: red yeast rice
600 mg 3 capsules bid
Drug: phytosterol
phytosterol 450 mg 2 tabs bid with food
Placebo Comparator: red yeast rice plus placebo Dietary Supplement: red yeast rice
600 mg 3 capsules bid
Drug: placebo
placebo
Active Comparator: TLC plus red yeast rice plus placebo
subjects attend 12 week therapeutic lifestyle program and take above supplement
Dietary Supplement: red yeast rice
600 mg 3 capsules bid
Behavioral: therapeutic lifestyle program
TLC - 12 weeks
Drug: placebo
placebo
Experimental: TLC plus RYR plus phytosterol
Therapeutic lifestyle program for 12 weeks plus red yeast rice plus phytosterol
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897975

Locations
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States
Chestnut Hill Hospital
Philadelphia, Pennsylvania, United States, 19118
Sponsors and Collaborators
Chestnut Hill Health System
Investigators
Principal Investigator: David J Becker, MD Chestnut Hill Heathcare
  More Information

No publications provided by Chestnut Hill Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Becker, MD, Chestnut Hill Hospital
ClinicalTrials.gov Identifier: NCT00897975     History of Changes
Other Study ID Numbers: FWA00005390 Chestnut HillHC
Study First Received: May 11, 2009
Last Updated: July 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Chestnut Hill Health System:
statin associated myalgias
hyperlipidemia
red yeast rice
phytosterols
therapeutic lifestyle changes
compliance

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Red yeast rice
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014