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The Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy

A Single-Centre, Randomised Double-Blind Placebo-Controlled Study to Measure the Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00113477
Enrollment
40
Registered
2005-06-09
Start date
2005-05-31
Completion date
2007-12-31
Last updated
2011-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Statin Therapy

Keywords

Q10, CoQ10, Coenzyme Q10, selen, selenoprotein, selenoproteins, adverse events, adverse effects, AE, myalgia, muscle, statin therapy, Indication for statin therapy

Brief summary

The purpose of this study is to determine whether supplements of Q10 and Selen are effective in reducing muscular adverse events (AE) in statin therapy.

Detailed description

Statins inhibit the synthesis of cholesterol by inhibiting the enzyme HMG-CoA reductase. The reduction of intracellular cholesterol leads to an increase in the number of LDL-receptors, and subsequent increased uptake and metabolism of LDL in the liver. Several large clinical trials have shown that the use of statins decreases morbidity and mortality in patients with risk factors for atherosclerotic disease. Unfortunately, 5% of statin users experience adverse events (mainly gastrointestinal \[GI\] and muscular). Statins inhibit not only cholesterol synthesis, but also synthesis of other substances in the mevalonate pathway. Among these other substances are Q10 and selenoproteins. It is well known that serum Q10 levels decrease during statin therapy, and that Q10 supplement inhibits this decrease. One study has shown reduction of Q10 in blood-platelets during statin therapy. Q10 is an important element in the mitochondrial respiratory chain. Depletion of Q10 leads to a reduction of high energy phosphates, anaerobe metabolism and mitochondrial dysfunction. This is suggested to be the cause of muscular adverse events in statin therapy. There are several reports of individuals relieved from muscular adverse effects after Q10 supplement, but no randomized, placebo controlled studies have been conducted. Symptoms of selenoprotein deficiency are very similar to adverse events seen in statin therapy, but no clinical trials have been conducted to evaluate the effect of selen supplement on adverse effects of statin therapy.

Interventions

DRUGQ10
DRUGSelen

Sponsors

Pharma Nord
CollaboratorINDUSTRY
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Men and women 18 - 75 years old * Indication for statin * Previous history of muscular AE on statin therapy.

Exclusion criteria

* If female, be of non-childbearing potential, i.e., post-menopausal (defined as \>12 months since last menstrual period) or surgically sterilised, or using adequate barrier contraception if of childbearing potential. * Previously serious muscular AE * Patients taking drugs interacting with statins, and where these drugs cannot be stopped. * Allergy against selen * Liver or kidney failure

Design outcomes

Primary

MeasureTime frame
Reduction of muscular adverse events

Secondary

MeasureTime frame
Muscular strength measured by SAAT
Correlation between serum Q10 concentration and adverse events
Serum Q10 concentration in comparison to subjects not experiencing AE
The effect of 12 weeks on Lipitor 10 mg x 1 on muscular function and AE

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026