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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113477
Recruitment Status : Completed
First Posted : June 9, 2005
Last Update Posted : July 1, 2011
Pharma Nord
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Statin Therapy Drug: Q10 Drug: Selen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Reduction of muscular adverse events

Secondary Outcome Measures :
  1. Muscular strength measured by SAAT
  2. Correlation between serum Q10 concentration and adverse events
  3. Serum Q10 concentration in comparison to subjects not experiencing AE
  4. The effect of 12 weeks on Lipitor 10 mg x 1 on muscular function and AE

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00113477

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Lipidklinikken, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Pharma Nord
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Principal Investigator: Kjetil Retterstøl, MD Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Layout table for additonal information Identifier: NCT00113477    
Other Study ID Numbers: 12004 - versjon 2
2004-000797-31 (EudraCT)
S-04159 (REK Sør)
11250 (NSD)
200500691 (SLV)
First Posted: June 9, 2005    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: September 2008
Keywords provided by Oslo University Hospital:
Coenzyme Q10
adverse events
adverse effects
statin therapy
Indication for statin therapy