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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
Enrollment 68
Recruitment Details 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 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.
Arm/Group Title Coenzyme Q10 Placebo
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 19 20
Completed 19 20
Not Completed 0 0
Arm/Group Title Coenzyme Q10 Placebo Total
Hide Arm/Group Description CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily Placebo 2 x daily + Simvastatin 20 mg daily Total of all reporting groups
Overall Number of Baseline Participants 19 20 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 39 participants
62.0  (7.9) 60.1  (11.2) 61.0  (9.7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Female
14
  73.7%
6
  30.0%
20
  51.3%
Male
5
  26.3%
14
  70.0%
19
  48.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Non-Hispanic White 17 17 34
Other 2 3 5
Alcohol Servings/Day  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
0 to 1 8 8 16
2 to 4 9 9 18
5 or more 2 3 5
Exercise  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Moderate/Vigorous 10 8 18
None/Light 9 12 21
Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Yes 5 4 9
No 14 16 30
Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Yes 14 16 30
No 5 4 9
Pain (baseline) visual analog scale (0-10)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 20 participants 39 participants
4.4  (2.2) 4.9  (1.9) 4.6  (2.0)
[1]
Measure Description: Pain was rated on a scale from 0 to 10, where 0 =n o pain and 10 = pain as bad as you can imagine
1.Primary Outcome
Title Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use
Hide Description Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coenzyme Q10 Placebo
Hide Arm/Group Description:
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
Placebo 2 x daily + Simvastatin 20 mg daily
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: % of participants with pain reduction
53 65
2.Secondary Outcome
Title Continuation of Statin
Hide Description Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coenzyme Q10 Placebo
Hide Arm/Group Description:
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
Placebo 2 x daily + Simvastatin 20 mg daily
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: participants
Adherent with Statin at 4 wks 17 18
Not Adherent with Statin at 4 wks 2 2
3.Secondary Outcome
Title Percentage of Participants With Improvement in Disability Related to Muscle Pain
Hide Description Disability improvement was based on patient report of improvement they felt was meaningful to them
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coenzyme Q10 Placebo
Hide Arm/Group Description:
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
Placebo 2 x daily + Simvastatin 20 mg daily
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: % reporting improved function
36 40
4.Secondary Outcome
Title Percentage of Participants With Adverse Effects
Hide Description serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 serious adverse events occurred during the study that were judged unrelated to the study: specifically, 3 participants were hospitalized prior to randomization, 1 for pneumonia; 1 for a back injury; and 1 for a mental health condition. All recovered. There were no SAE during the randomization period. Non serious AEs are listed below.
Arm/Group Title Coenzyme Q10 Placebo
Hide Arm/Group Description:
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
Placebo 2 x daily + Simvastatin 20 mg daily
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: % of participants reporting
Nausea/dyspepsia 21 10
Fatigue 10 10
Time Frame Serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.
Adverse Event Reporting Description 3 serious adverse events occurred during the study that were judged unrelated to the study agent. Specifically, 3 participants were hospitalized prior to randomization: 1 for pneumonia; 1 for a back injury; and 1 for a mental health condition. All recovered. There were no SAE during the randomization period. Non serious AEs are listed below.
 
Arm/Group Title Coenzyme Q10 Placebo
Hide Arm/Group Description CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily Placebo 2 x daily + Simvastatin 20 mg daily
All-Cause Mortality
Coenzyme Q10 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Coenzyme Q10 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coenzyme Q10 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/19 (21.05%)      2/20 (10.00%)    
Gastrointestinal disorders     
Nausea/dyspepsia   4/19 (21.05%)  4 2/20 (10.00%)  2
General disorders     
Fatigue   2/19 (10.53%)  2 2/20 (10.00%)  2
Indicates events were collected by systematic assessment
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.
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
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