Phase 3
Completed N=39
Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Postoperative Pain · Weakness · Cramps · Myalgia or Myositis Nos
Source: ClinicalTrials.gov NCT01032993 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use — 53; 65 % of participants with pain reduction
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use |
53; 65 | — |
| SECONDARY Continuation of Statin |
17; 18; 2; 2 | — |
| SECONDARY Percentage of Participants With Improvement in Disability Related to Muscle Pain |
36; 40 | — |
| SECONDARY Percentage of Participants With Adverse Effects |
21; 10; 10; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a history of muscle symptoms (such as aches, pains, cramps and/or weakness) while taking a statin drug that persisted for at least 2 weeks on a statin
Exclusion Criteria
- Plasma creatine kinase levels > 3 times the upper normal limit
- Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) > 2 times the upper normal limit
- Pregnancy or breastfeeding (a contraindication for statin use)
- Severe renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min/1.73 m2
- Bleeding disorder, current use of warfarin, an international normalized ratio (INR) greater than 1.5, or a platelet count less than 100,000 mm3
- Contraindication to strength testing, including myocardial infarction, unstable angina, or revascularization procedure within the past six weeks, a history of brain aneurysm or stroke
- Chest or abdominal surgery within the past six weeks
- Severe persistent pain related to other causes
- Unable to complete self-administered questionnaires, or unable to read or converse in English
Data sourced from ClinicalTrials.gov (NCT01032993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.