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| ID | Type | Description | Link |
|---|---|---|---|
| K23AR055664 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced by some individuals who use statin medications.
This study will recruit individuals who have had muscle symptoms while using a statin. During the first part of the study, volunteers will be given a statin medication to see if their muscle symptoms return. Those who experience muscle symptoms on this statin rechallenge will be invited to continue in the second part of the trial, in which participants will be randomly assigned to receive either CoQ10 or a placebo (sugar pill) to take with statin medication. We hypothesize that those who receive CoQ10 will experience an improvement in their muscle symptoms compared to those who receive placebo, and, secondarily, that those who receive CoQ10 will be more likely to continue taking the statin medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coenzyme Q10 | Active Comparator | 600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily. Study wafers: ChewQ (Tishcon Corp, Westbury, NY) are chewable wafers each containing 100 mg of Coenzyme Q10 (ubidecarenone USP). All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study. |
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| Placebo | Placebo Comparator | Placebo was manufactured by the manufacturer of ChewQ, Tishcon Corp (Westbury, NY), included the same excipients, but no active CoQ10, and looked and tasted identical to active agent. All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme Q10 | Dietary Supplement | 300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use | 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Continuation of Statin | 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. | 4 weeks |
| Percentage of Participants With Improvement in Disability Related to Muscle Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Buettner, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
No consent for sharing IPD from trial participants was obtained when this clinical trial began
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Coenzyme Q10 | CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily |
| BG001 | Placebo | Placebo 2 x daily + Simvastatin 20 mg daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use | 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 | Posted | Number | % of participants with pain reduction | 4 weeks |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coenzyme Q10 | CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/dyspepsia | Gastrointestinal disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Buettner, MD MPH, Assistant Professor of Medicine | BIDMC | 617-754-9600 | cbuettne@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001247 | Asthenia |
| D009120 | Muscle Cramp |
| D063806 | Myalgia |
| D018979 | Myositis, Inclusion Body |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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| Placebo | Other | Placebo (three chewable tablets) 2 times daily for 4 weeks |
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Disability improvement was based on patient report of improvement they felt was meaningful to them |
| 4 weeks |
| Percentage of Participants With Adverse Effects | 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. | 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Alcohol Servings/Day | Number | participants |
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| Exercise | Number | participants |
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| Diabetes | Number | participants |
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| Hypertension | Number | participants |
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| Pain (baseline) visual analog scale (0-10) | Pain was rated on a scale from 0 to 10, where 0 =n o pain and 10 = pain as bad as you can imagine | Mean | Standard Deviation | units on a scale |
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| Units |
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| Counts |
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| Participants |
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| Secondary | Continuation of Statin | 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. | Posted | Number | participants | 4 weeks |
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| Secondary | Percentage of Participants With Improvement in Disability Related to Muscle Pain | Disability improvement was based on patient report of improvement they felt was meaningful to them | Posted | Number | % reporting improved function | 4 weeks |
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| Secondary | Percentage of Participants With Adverse Effects | 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: 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. | Posted | Number | % of participants reporting | 4 weeks |
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| 0 |
| 19 |
| 4 |
| 19 |
| EG001 | Placebo | Placebo 2 x daily + Simvastatin 20 mg daily | 0 | 20 | 2 | 20 |
| Fatigue | General disorders | Systematic Assessment |
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| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D059352 | Musculoskeletal Pain |
| D009220 | Myositis |
| D010335 | Pathologic Processes |