The Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy
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|ClinicalTrials.gov Identifier: NCT00113477|
Recruitment Status : Completed
First Posted : June 9, 2005
Last Update Posted : July 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Statin Therapy||Drug: Q10 Drug: Selen||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
- Reduction of muscular adverse events
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00113477
|Oslo, Norway, 0027|
|Principal Investigator:||Kjetil Retterstøl, MD||Lipidklinikken, Rikshospitalet-Radiumhospitalet HF|