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Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

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ClinicalTrials.gov Identifier: NCT01032993
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Catherine Buettner, Beth Israel Deaconess Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Pain
Weakness
Cramps
Myalgia or Myositis Nos
HMG COA Reductase Inhibitor Adverse Reaction
Interventions: Dietary Supplement: Coenzyme Q10
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Persons with a history of statin myalgia were recruited from the greater Boston area using flyers, ads, and announcements to seek volunteers. A history of statin myalgia was defined as having muscle symptoms thought to be due to a statin, with symptoms that began after a statin was started and that persisted for at least 2 weeks while using statin.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Confirmation of statin myalgia was based on completing a statin washout, and statin rechallenge. On washout, improvement of symptoms within 2 months was required to advance. On rechallenge, simvastatin 20 mg daily was given, and only those with return of symptoms within 3 months were randomized. Out of 68 participants enrolled, 39 were randomized.

Reporting Groups
  Description
Coenzyme Q10 The Coenzyme Q10 arm used 600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily for 4 weeks. Active study wafers were ChewQ (ubidecarenone) and were manufactured by Tishcon Corp, (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
Placebo The Placebo arm used placebo wafers taken as three wafers two times daily for 4 weeks. Placebo wafers contained the same excipients as the active wafers, but contained no active CoQ10. The wafers looked and tasted identical to active agent, and were manufactured by the same manufacturer of the active agent, Tishcon Corp (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily

Participant Flow:   Overall Study
    Coenzyme Q10   Placebo
STARTED   19   20 
COMPLETED   19   20 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Coenzyme Q10 CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
Placebo Placebo 2 x daily + Simvastatin 20 mg daily
Total Total of all reporting groups

Baseline Measures
   Coenzyme Q10   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   20   39 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.0  (7.9)   60.1  (11.2)   61.0  (9.7) 
Gender 
[Units: Participants]
Count of Participants
     
Female      14  73.7%      6  30.0%      20  51.3% 
Male      5  26.3%      14  70.0%      19  48.7% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Non-Hispanic White   17   17   34 
Other   2   3   5 
Alcohol Servings/Day 
[Units: Participants]
     
0 to 1   8   8   16 
2 to 4   9   9   18 
5 or more   2   3   5 
Exercise 
[Units: Participants]
     
Moderate/Vigorous   10   8   18 
None/Light   9   12   21 
Diabetes 
[Units: Participants]
     
Yes   5   4   9 
No   14   16   30 
Hypertension 
[Units: Participants]
     
Yes   14   16   30 
No   5   4   9 
Pain (baseline) visual analog scale (0-10) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.4  (2.2)   4.9  (1.9)   4.6  (2.0) 
[1] Pain was rated on a scale from 0 to 10, where 0 =n o pain and 10 = pain as bad as you can imagine


  Outcome Measures

1.  Primary:   Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use   [ Time Frame: 4 weeks ]

2.  Secondary:   Continuation of Statin   [ Time Frame: 4 weeks ]

3.  Secondary:   Percentage of Participants With Improvement in Disability Related to Muscle Pain   [ Time Frame: 4 weeks ]

4.  Secondary:   Percentage of Participants With Adverse Effects   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
100 participants were planned to achieve >50 randomized. However, due to slow recruiting, the CoQ10 and placebo expired and we were unable to obtain more. Therefore only 68 participants were enrolled and ultimately 39 participants were randomized.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Catherine Buettner, MD MPH, Assistant Professor of Medicine
Organization: BIDMC
phone: 617-754-9600
e-mail: cbuettne@bidmc.harvard.edu



Responsible Party: Catherine Buettner, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01032993     History of Changes
Other Study ID Numbers: K23AR055664 ( U.S. NIH Grant/Contract )
K23AR055664 ( U.S. NIH Grant/Contract )
First Submitted: December 15, 2009
First Posted: December 16, 2009
Results First Submitted: October 7, 2016
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017