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

This study has been completed.
Sponsor:
Collaborator:
Pharma Nord
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00113477
First received: June 8, 2005
Last updated: June 30, 2011
Last verified: September 2008

June 8, 2005
June 30, 2011
May 2005
December 2007   (final data collection date for primary outcome measure)
Reduction of muscular adverse events
Same as current
Complete list of historical versions of study NCT00113477 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Statin Therapy
  • Drug: Q10
  • Drug: Selen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00113477
12004 - versjon 2, 2004-000797-31 (EudraCT), S-04159 (REK Sør), 11250 (NSD), 200500691 (SLV)
Not Provided
Not Provided
Oslo University Hospital
Pharma Nord
Principal Investigator: Kjetil Retterstøl, MD Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Oslo University Hospital
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP