Trial Outcomes & Findings for Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms (NCT NCT01032993)
NCT ID: NCT01032993
Last Updated: 2017-01-23
Results Overview
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
COMPLETED
PHASE2/PHASE3
68 participants
4 weeks
2017-01-23
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Baseline characteristics by cohort
| Measure |
Coenzyme Q10
n=19 Participants
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
|
Placebo
n=20 Participants
Placebo 2 x daily + Simvastatin 20 mg daily
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Gender
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Alcohol Servings/Day
0 to 1
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Alcohol Servings/Day
2 to 4
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Alcohol Servings/Day
5 or more
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Exercise
Moderate/Vigorous
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Exercise
None/Light
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Diabetes
Yes
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Diabetes
No
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Hypertension
Yes
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Hypertension
No
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Pain (baseline) visual analog scale (0-10)
|
4.4 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksClinically 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
Outcome measures
| Measure |
Coenzyme Q10
n=19 Participants
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
|
Placebo
n=20 Participants
Placebo 2 x daily + Simvastatin 20 mg daily
|
|---|---|---|
|
Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use
|
53 % of participants with pain reduction
|
65 % of participants with pain reduction
|
SECONDARY outcome
Timeframe: 4 weeksAdherence 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.
Outcome measures
| Measure |
Coenzyme Q10
n=19 Participants
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
|
Placebo
n=20 Participants
Placebo 2 x daily + Simvastatin 20 mg daily
|
|---|---|---|
|
Continuation of Statin
Adherent with Statin at 4 wks
|
17 participants
|
18 participants
|
|
Continuation of Statin
Not Adherent with Statin at 4 wks
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 4 weeksDisability improvement was based on patient report of improvement they felt was meaningful to them
Outcome measures
| Measure |
Coenzyme Q10
n=19 Participants
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
|
Placebo
n=20 Participants
Placebo 2 x daily + Simvastatin 20 mg daily
|
|---|---|---|
|
Percentage of Participants With Improvement in Disability Related to Muscle Pain
|
36 % reporting improved function
|
40 % reporting improved function
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Coenzyme Q10
n=19 Participants
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
|
Placebo
n=20 Participants
Placebo 2 x daily + Simvastatin 20 mg daily
|
|---|---|---|
|
Percentage of Participants With Adverse Effects
Nausea/dyspepsia
|
21 % of participants reporting
|
10 % of participants reporting
|
|
Percentage of Participants With Adverse Effects
Fatigue
|
10 % of participants reporting
|
10 % of participants reporting
|
Adverse Events
Coenzyme Q10
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Coenzyme Q10
n=19 participants at risk
CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
|
Placebo
n=20 participants at risk
Placebo 2 x daily + Simvastatin 20 mg daily
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/dyspepsia
|
21.1%
4/19 • Number of events 4 • 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.
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.
|
10.0%
2/20 • Number of events 2 • 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.
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.
|
|
General disorders
Fatigue
|
10.5%
2/19 • Number of events 2 • 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.
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.
|
10.0%
2/20 • Number of events 2 • 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.
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.
|
Additional Information
Catherine Buettner, MD MPH, Assistant Professor of Medicine
BIDMC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place