26 Dec Study Finds Coenzyme Q10 Has No Effect On Statin Myopathy
MedicalResearch.com Interview with:
Beth Taylor, PhD
Director of Exercise Physiology Research
Department of Preventive Cardiology
Hartford Hospital
Hartford, CT 06102
Medical Research: What is the background for this study?
Dr. Taylor: Statins reduce incidence of cardiac events, and thus are extremely effective drugs. However, they may cause muscle side effects such as pain, weakness and soreness (i.e., statin myalgia) in up to 10% of patients. One potential mechanism underlying statin myalgia may be the depletion of Coenzyme Q10, a mitochondrial transport element used in energy production, as statin therapy produces a 30-50% reduction in intramuscular Coenzyme Q10. Seven previous studies to date have produced conflicting results, yet CoQ10 supplementation is used by many patients and recommended by many clinicians despite the absence of definitive results. The purpose of the present study was to assess the effect of CoQ10 on muscle pain, muscle strength and aerobic performance in confirmed myalgics (i.e., patients who tested positive for myalgia during a randomized, double-blinded cross-over trial of statin therapy vs. placebo to confirm myalgia prior to CoQ10 treatment).
Medical Research: What are the main findings?
Dr. Taylor: The first main finding was that after our randomized double-blind cross-over run-in phase, only 35.8% of patients experienced myalgia on simvastatin and did not experience it on placebo, what we term true or confirmed statin myalgia, and 17.5% of patients had no symptoms on simvastatin or placebo which could have been because the dose we selected was too low. However, 29.2% experienced pain on placebo but not on simvastatin and 17.5% experienced pain on both simvastatin and placebo during the confirmation phase.
Secondly, we found that Coenzyme Q10 supplementation had no effect on the incidence and severity of myalgia, time to onset of pain, muscle strength, or aerobic performance. Serum levels of CoQ10 went up, suggesting dosing worked, and LDL-C went down similarly in both groups, suggesting the statin was not compromised. Therefore we did not find an observable effect of CoQ10 on any muscle outcome.
Finally, there were no reductions from baseline in muscle strength or aerobic performance when statins were combined with placebo in our verified statin myalgics. This is notable because while there have been observational reports of decreased muscle strength and aerobic performance in statin myalgics, there have been few rigorous assessments of muscle strength and aerobic performance with statins and myalgia. In our previous study, the The Effect of STatins On Skeletal Muscle Performance (STOMP) trial , we randomized healthy, statin-naïve patients to atorvastatin 80 mg daily or placebo for 6 months, confirming myalgia via a challenge-dechallenge protocol. In that study, we also found no significant differences in the two groups in muscle and exercise performance, and thus the present results confirm those findings.
Medical Research: What should clinicians and patients take away from your report?
Dr. Taylor: Only about a third of patients who reported statin myalgia in the past had verified statin myalgia, demonstrating the difficulty that clinicians face in diagnosing and treating statin-intolerant patients. In addition, CoQ10 supplementation had no beneficial effect on muscle pain, muscle strength, or aerobic exercise capacity. It is likely that one reason for discordant findings in previous trials involving statins, muscle side effects and CoQ10 supplementation is because these trials likely only had 30-50% of patients with true statin myalgia.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Taylor: The low number of confirmed myalgics as well as the lack of predictors that differentiated the myalgics from the non-myalgics demonstrate the difficulty in diagnosing, confirming and treating statin myalgia clinically as well as in researching statin myalgia. This study highlights the need to develop more objective tools to diagnose and differentiate statin myalgia for both clinical and research use. This is critical because statins are life-saving drugs, but real or perceived statin myalgia may diminish their utility for reducing cardiac events.
Citation:
A Randomized Trial of Coenzyme Q10 in Patients with Confirmed Statin Myopathy
Beth A. Taylor, Lindsay Lorson, ,C. Michael White, , Paul D. Thompson,
Available online 17 December 2014
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Last Updated on December 26, 2014 by Marie Benz MD FAAD