Annatto-derived GG for Statin-associated Myopathy

(GG-statin Trial)

Overseen By Chwan-Li (Leslie) Shen, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Texas Tech University Health Sciences Center

Must be taking: Statins

Must not be taking: CoQ10, Steroids

Disqualifiers: Malignancy, Neurological, Psychiatric, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

95 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you have not taken CoQ10 or steroid medications one month before starting the study.

What makes Annatto-derived GG unique for treating statin-associated myopathy?

Annatto-derived GG (Geranylgeraniol) is unique because it is derived from a natural source and may help address statin-associated myopathy by potentially replenishing compounds like dolichol and CoQ10, which are linked to muscle health and may be depleted by statins. This approach differs from other treatments that focus on lipid-lowering or antioxidant effects. ^{1 2 3 4 5}

Research Team

Chwan-Li (Leslie) Shen, PhD

Principal Investigator

Texas Tech Health Science Center

Eligibility Criteria

This trial is for people over 40 who started having muscle pain after beginning or increasing the dosage of statin medication. It's not for pregnant or breastfeeding women, those with genetic muscle metabolism disorders, recent steroid or CoQ10 supplement use, cancer patients, or individuals with major neurological or psychiatric issues.

Inclusion Criteria

You are taking statin medication and experiencing muscle pain with or without other symptoms.

You are taking a statin and recently started having muscle pain within the last 90 days.

You must be at least 40 years old, regardless of whether you are male or female.

Exclusion Criteria

You have a genetic disorder that affects your muscles and nerves.

Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions

Had steroid medication one month before starting the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive annatto-derived geranylgeraniol (GG) or placebo for 3 months to assess effects on statin-associated muscle symptoms

12 weeks

Baseline visit, monthly check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months

3 months

2 visits (in-person)

Treatment Details

Interventions

• High GG
• Low GG
• Placebo

Trial Overview The study tests if a supplement called annatto-derived geranylgeraniol (GG) can help with muscle pain caused by statins. Participants will receive either a placebo, low dose GG, or high dose GG for three months to see which helps more.

Participant Groups

Group I: High GG Active Control 1 Intervention

HIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner

Group II: Low GG Active Control 1 Intervention

LOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner

Group III: Placebo Placebo Group 1 Intervention

Placebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

Findings from Research

In a pilot study involving 14 patients with statin-induced myopathy, the combination of conifer-tree needle polyprenols and CoQ10 was found to be generally safe, with no significant changes in safety parameters, although one patient had to discontinue due to liver enzyme elevations.

Significant improvements in muscle pain and weakness were observed, with some patients reporting complete resolution of symptoms, suggesting potential efficacy that warrants further investigation in larger controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy. Latkovskis, G., Saripo, V., Sokolova, E., et al.[2019]

In a study of 354 patients reporting muscle-related issues from statin therapy, 85% were found to have probable or definite drug adverse effects, with common symptoms including muscle pain (93%), fatigue (88%), and weakness (85%).

Higher potency statins, particularly atorvastatin, were associated with a significantly higher incidence of muscle-related adverse effects compared to lower potency statins, suggesting that switching to lower potency options or discontinuing statins may help alleviate these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statin-associated muscle-related adverse effects: a case series of 354 patients. Cham, S., Evans, MA., Denenberg, JO., et al.[2022]

A 3-month treatment with atorvastatin at various dosages (10, 40, and 80 mg/day) did not impact maximal muscle performance during exercises, indicating that overall muscle strength was maintained.

However, atorvastatin was associated with reduced muscle excitability and adaptation to fatigue, particularly in muscles with more slow-oxidative fibers, and this was linked to a decreased potassium release after exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of long-term atorvastatin treatment on the electrophysiological and mechanical functions of muscle. Delliaux, S., Steinberg, JG., Lesavre, N., et al.[2019]

Cholesfytol®, a dietary supplement combining red yeast rice and olive extract, significantly reduced LDL cholesterol by 23.3% and total cholesterol by 17.5% in a study of 642 hypercholesterolemic patients over 2 months, demonstrating its efficacy as an alternative to statins.

The treatment was well-tolerated, with only 13 patients reporting minor side effects, and it did not induce new-onset statin-associated muscle symptoms (SAMS), making it a safe option for patients with a history of SAMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a combination of red yeast rice and olive extract in hypercholesterolemic patients with and without statin-associated myalgia. Tshongo Muhindo, C., Ahn, SA., Rousseau, MF., et al.[2018]

Statins are effective lipid-lowering drugs widely used to prevent cardiovascular diseases, but they can cause muscular side effects that lead to poor patient compliance and potential discontinuation of treatment.

This review is the first to combine laboratory and clinical findings on statin-induced myotoxicity, aiming to clarify the mechanisms behind these adverse effects and improve safety measures to prevent severe complications like rhabdomyolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational insight into statin-induced muscle toxicity: from cell culture to clinical studies. Taha, DA., De Moor, CH., Barrett, DA., et al.[2014]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Statin-associated muscle-related adverse effects: a case series of 354 patients. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Effect of long-term atorvastatin treatment on the electrophysiological and mechanical functions of muscle. [2019]

4. Scotland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a combination of red yeast rice and olive extract in hypercholesterolemic patients with and without statin-associated myalgia. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Translational insight into statin-induced muscle toxicity: from cell culture to clinical studies. [2014]