CoEnzyme Q10 in Statin Myopathy

NCT01140308 | Unknown DMC

• 1 other identifier: 1RC1AT005836-01
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Statins (such as simvastatin or Zocor) are the most effective and widely prescribed medications to lower cholesterol levels and reduce the frequency of heart attacks, cardiac deaths and strokes. Unfortunately, statins can cause muscle discomfort or pain called "myalgia" in patients treated with these drugs. These symptoms often cause patients who need these medications to stop taking the drug. The cause of statin muscle pain is not known, but it is thought that a reduction of a vitamin-like substance called Coenzyme Q10 (CoQ10) during statin treatment may play a role. CoQ10 is a vitamin like substance and is not a drug approved and regulated by the Food and Drug Administration (FDA). This study will look at the effects of CoQ10 supplements on individuals who develop muscle symptoms while on simvastatin. The investigators hope to test the hypothesis that CoQ10 supplementation compared to placebo in patients with documented statin myalgia reduces the intensity of pain during statin treatment.

Conditions

Statin Myopathy

Keywords

Statin Myopathy; CoEnzyme Q10; CoQ10; Statin Myalgia

Outcome Measures

Primary Outcomes (1)

• To test the hypothesis that CoQ10 supplementation compared to placebo in patients with documented statin myalgia reduces the intensity of pain during statin treatment.

  Increasing pain tolerability is a key clinical measure. We selected 8 weeks of therapy for the simvastatin vs placebo and CoQ10 vs placebo sections of the study because in the largest clinical study, the median time toonset of mylagia in statin naïve subjects was 1 month (4) and statin rechallenge typically reproduces symptoms more rapidly(3). Consequently, most subjects with true statin myalgia will have clearly developed symptoms at or before 8 weeks, the point at which study procedures are completed, allowing us to accurately assess the impact of CoQ10 on muscle pain intensity.

  We selected 8 weeks of therapy .

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Simvastatin 20mg + Placebo

Drug: Placebo

Co Q10

ACTIVE COMPARATOR

Simvastatin 20mg + CoQ10

Drug: CoEnzyme Q10

Interventions

CoEnzyme Q10 DRUG

Randomization to Treatment: Simvastatin 20mg + 600 mg CoQ10 (pill) Load Subjects for 2 weeks on Treatment (CoQ10) Eight weeks of Treatment

Also known as: CoQ10, Ubiquinone, Q10, CoQ, Q, Ubidecarenone

Co Q10

Placebo DRUG

Randomization to Treatment: Simvastatin 20mg + Placebo 600mg Load Subjects for 2 weeks on Treatment Eight weeks of treatment

Also known as: Sugar pill

Sugar Pill

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will not exclude patients with diagnosed CAD, peripheral vascular disease or diabetes since these patients warrant aggressive lipid treatment, and would benefit from any intervention that increases their tolerance of statins. We do not consider it inappropriate or unethical to place such patients on placebo during the simvastatin vs placebo phase because these patients will have previously been documented to be intolerant of statins. All patients will be maintained on lipid lowering diets during the study.
• Race - We will seek to recruit Caucasians, Hispanics and African American in accordance with their distributions in the study communities.
• CoQ10 Use - Subjects previously using supplemental CoQ10 must discontinue this supplementation for two months prior to entering the study.
• Diet - All subjects will be instructed in a standard lipid lowering diet and asked to maintain this throughout the 6 months of the study.

You may not qualify if:

• Subjects will be excluded if they have had cancer within 5 years of entry, have hepatic disease (ALT \> 2 times normal) or renal disease (creatinine \> 2 mg/L) since these patients may require more careful monitoring during the study and would be best managed in a totally clinical setting.
• Subjects presently treated with other medications known to alter statin metabolism (3)
• Subjects who cannot discontinue other lipid-lowering medications
• Subjects with hypo or hyper thyroidism defined as a TSH \> 5 or \<0.01 IU/L since these conditions are known to be associated with statin intolerance and muscle weakness, respectively
• Subjects with hepatic dysfunction evidenced by a baseline alanine aminotransferase (ALT) level \> 2 UNL
• Subjects with renal dysfunction defined as a baseline creatinine \> 2mg/dl;
• Subjects with physical disabilities prohibiting the strength and exercise performance measurements
• Subjects who regularly use corticosteroids or other drugs known to affects skeletal muscle metabolism or regularly have intramuscular injections that will affect CK levels.
• Women of child-bearing potential who do not use an effective birth-control technique.

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Related Publications (2)

• Taylor BA, Lorson L, White CM, Thompson PD. Low vitamin D does not predict statin associated muscle symptoms but is associated with transient increases in muscle damage and pain. Atherosclerosis. 2017 Jan;256:100-104. doi: 10.1016/j.atherosclerosis.2016.11.011. Epub 2016 Nov 12.

  PMID: 27993387 DERIVED

• Taylor BA, Lorson L, White CM, Thompson PD. A randomized trial of coenzyme Q10 in patients with confirmed statin myopathy. Atherosclerosis. 2015 Feb;238(2):329-35. doi: 10.1016/j.atherosclerosis.2014.12.016. Epub 2014 Dec 17.

  PMID: 25545331 DERIVED

MeSH Terms

Interventions

coenzyme Q10; Ubiquinone; Tuberculin; Sugars

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes; Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Carbohydrates

Study Officials

• Paul D Thompson, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 9, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

US (1)