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Muscle Characteristics Associated With Statin Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00990834
Recruitment Status : Withdrawn (Unable to recruit subjects.)
First Posted : October 7, 2009
Last Update Posted : May 22, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.

Condition or disease Intervention/treatment
Hydroxymethylglutaryl-CoA Reductase Inhibitors Myopathy Drug: simvastatin

Detailed Description:
Statins have been proven to reduce cardiovascular events and mortality in large clinical trials but remain underutilized partly due to the associated myopathy. Severe reactions manifested as rhabdomyolysis are rare but myalgia is commonly noted in clinical practice. The pathophysiology of these events remains obscure. Previous studies suggest that statins block the downstream products (such as cellular signaling molecules) of the mevalonate pathway needed for normal muscle function. Other studies show that statins are associated with gene expressions involved in muscle damage such as atrogin-1. We will quantify these entities pre and post statin therapy to better understand these reactions.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Muscle Characteristics Associated With Statin Therapy
Study Start Date : November 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Statin exposure
Subjects' endpoints will be measured before and after one to eight months of statin exposure.
Drug: simvastatin
simvastatin 80 mg PO daily for one to eight months.
Other Name: Zocor


Outcome Measures

Primary Outcome Measures :
  1. Atrogin-1 expression. [ Time Frame: One to eight months. ]
  2. Intramuscular Ras level. [ Time Frame: One to eight months. ]

Secondary Outcome Measures :
  1. Intramuscular Coenzyme Q10 level. [ Time Frame: One to eight months. ]
  2. Intramuscular mitochondrial to nuclear DNA ratio. [ Time Frame: One to eight months. ]
  3. Intramuscular geranylgeranylpyrophosphate. [ Time Frame: One to eight months. ]
  4. PPAR-gamma coactivator-1-alpha expression. [ Time Frame: One to eight months. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary surgeon's permission.
  • Patient is > 21 years of age.
  • Patient will go through a two phase surgery with the two procedures one to eight months apart.
  • Patient or representative understands the nature of the study.
  • Normal thyroid stimulating hormone (TSH).
  • LDL-cholesterol > 100 mg/dL or highly sensitive C-reactive protein (hsCRP) > 2.0.
  • One of the following risk factors: male > 45 year old or female > 55 year old, smoker, hypertension, first degree family history of coronary artery disease < 55 year old, HDL <40 mg/dL, chronic kidney disease, diabetes mellitus, previous TIA or stroke, previous coronary artery disease.

Exclusion Criteria:

  • Has been on a lipid-lowering medication previously.
  • Severe illness (e.g. trauma or sepsis) more than 24 hours before obtaining the first biopsy.
  • Less than a 10% reduction of LDL after 3 months of therapy (indicative of non-adherence).
  • Contraindications to statins such as liver failure.
  • History of underlying muscle disorder.
  • Taking amiodarone.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00990834


Locations
United States, California
Scripps-Mercy Hospital
San Diego, California, United States, 92103
Sponsors and Collaborators
Scripps Health
Investigators
Principal Investigator: Tam H Truong, MD Scripps Health
Principal Investigator: Paul S Phillips, MD Scripps Health
More Information

Publications:

Responsible Party: Truong, H. Tam, MD, Scripps Mercy Hospital
ClinicalTrials.gov Identifier: NCT00990834     History of Changes
Other Study ID Numbers: MCAST
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by Scripps Health:
Statin
Myopathy
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atrogin-1

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors