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Completed

NCT Number: NCT00113477

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lipidklinikken, Rikshospitalet

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Q10

Drug

Selen

Drug

Primary outcomes

  1. Reduction of muscular adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Pharma Nord

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 9, 2005
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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