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

Statin Therapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113477
• Other study ID #: 12004 - versjon 2
• Secondary ID: 2004-000797-31 (
• Status: Completed
• Phase: Phase 4
• First received: June 8, 2005
• Last updated: June 30, 2011
• Start date: May 2005
• Est. completion date: December 2007

Study information

• Verified date: September 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Statin Therapy

Intervention

Drug:
• Q10

• Selen

Locations

Country	Name	City	State
Norway	Lipidklinikken, Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Pharma Nord

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of muscular adverse events
Secondary	Muscular strength measured by SAAT
Secondary	Correlation between serum Q10 concentration and adverse events
Secondary	Serum Q10 concentration in comparison to subjects not experiencing AE
Secondary	The effect of 12 weeks on Lipitor 10 mg x 1 on muscular function and AE