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

This study has been completed.
Sponsor:
Collaborator:
Pharma Nord
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00113477
First received: June 8, 2005
Last updated: June 30, 2011
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Statin Therapy
Drug: Q10
Drug: Selen
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Reduction of muscular adverse events

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: May 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113477

Locations
Norway
Lipidklinikken, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Pharma Nord
Investigators
Principal Investigator: Kjetil Retterstøl, MD Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00113477     History of Changes
Other Study ID Numbers: 12004 - versjon 2, 2004-000797-31 (EudraCT), S-04159 (REK Sør), 11250 (NSD), 200500691 (SLV)
Study First Received: June 8, 2005
Last Updated: June 30, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Q10
CoQ10
Coenzyme Q10
selen
selenoprotein
selenoproteins
adverse events
adverse effects
AE
myalgia
muscle
statin therapy
Indication for statin therapy

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014