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

NCT ID: NCT00113477

Last Updated: 2011-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-12-31

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.

Conditions

Statin Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Q10

Intervention Type: DRUG

Selen

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharma Nord

INDUSTRY

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Kjetil Retterstøl, MD

Role: PRINCIPAL_INVESTIGATOR

Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

Locations

Lipidklinikken, Rikshospitalet

Oslo, Oslo County, Norway

Countries

Norway

Other Identifiers

2004-000797-31 (EudraCT)

Identifier Type: -

Identifier Source: secondary_id

S-04159 (REK Sør)

Identifier Type: -

Identifier Source: secondary_id

11250 (NSD)

Identifier Type: -

Identifier Source: secondary_id

200500691 (SLV)

Identifier Type: -

Identifier Source: secondary_id

12004 - versjon 2

Identifier Type: -

Identifier Source: org_study_id