Clinical trial NCT00113477: The Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Statin Therapy
Keywords: Q10
CoQ10
Coenzyme Q10
selen
selenoprotein
selenoproteins
adverse events
adverse effects
AE
myalgia
muscle
statin therapy
Indication for statin therapy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Pharma Nord
First posted: 2005-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of muscular adverse events
Secondary outcomes:
measure: Muscular strength measured by SAAT
measure: Correlation between serum Q10 concentration and adverse events
measure: Serum Q10 concentration in comparison to subjects not experiencing AE
measure: The effect of 12 weeks on Lipitor 10 mg x 1 on muscular function and AE
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lipidklinikken, Rikshospitalet
Study officials:
affiliation: Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
name: Kjetil Retterstøl, MD
role: PRINCIPAL_INVESTIGATOR
References: