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Investigations on Differences in Atorvastatin Metabolites Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

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ClinicalTrials.gov Identifier: NCT00414531
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
University of Oslo School of Pharmacy

Study Description
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Brief Summary:
The primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse events, to elucidate whether differences in this ratio might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity.

Condition or disease Intervention/treatment Phase
Myotoxicity of Atorvastatin Treatment Drug: Atorvastatin Phase 4

Detailed Description:

The primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse events, to elucidate whether differences in this ratio might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. If this is shown, measurements of atorvastatin metabolites from patients experiencing muscle adverse events might be a valuable diagnostic tool to diagnose myopathy associated with statin treatment. The primary endpoint cut off level for present myotoxicity has been set to a ratio of p-hydroxyatorvastatin /atorvastatin of 0.15 from the previously performed pilot study (Unpublished data, Herman M et al). Values at or above this ratio will be considered as clinical significant indicia of statin related myopathy.

Secondary objectives include descriptively investigation of drug to metabolite cut off ratio for atorvastatin lactone/atorvastatin. Whether other cut off values, both for p-hydroxyatorvastatin as well as for atorvastatin lactone, give more precise identification of patients that are experiencing statin related myopathy compared to controls will also be investigated.

Explorative objectives of the study are to investigate possible in vitro phenotypic differences in isolated muscle cells from patients experiencing muscle toxicity compared to patients not experiencing muscle toxicity. If there are genetic differences between patients experiencing myotoxicity and those not, this difference is likely to show as phenotypic differences in in vitro studies of isolated muscle cells. If such phenotypic differences are present in vitro possible mechanistic causes will be further investigated.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Investigations on Differences in Atorvastatin Metabolites Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Study Start Date : May 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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Arms and Interventions
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Arm Intervention/treatment
SIM
Patients diagnosed to have or not to have Statin induced Myopathy
 Drug: Atorvastatin
20 to 80 mg per day


Outcome Measures
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Primary Outcome Measures :
  1. ratio of p-hydroxyatorvastatin to atorvastatin vs. myopathy [ Time Frame: march 2009 ]

Secondary Outcome Measures :
  1. ratio of atorvastatin lactone to atorvastatin vs. myopathy [ Time Frame: march 2009 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected atorvastatin induced muscle adverse events.
  • Signed informed consent.
  • 18 years of age or older.
  • Able to donate blood samples.
Contacts and Locations
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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): NCT00414531


Locations
Norway
Rikshospitalet-Radiumhospitalet HF, Lipid clinic
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Study Director: Anders Åsberg, Ph.D. Universtiy of Oslo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier: NCT00414531     History of Changes
Other Study ID Numbers: AVALIP05
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: August 2009

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors