A randomized trial of coenzyme Q10 in patients with confirmed Statin Myopathy

Abstract

Background Coenzyme Q10 (CoQ10) supplementation is the most popular therapy for statin myalgia among both physicians and patients despite limited and conflicting evidence of its efficacy. Objective This study examined the effect of coenzyme Q10 (CoQ10) supplementation on simvastatin-associated muscle pain, muscle strength and aerobic performance in patients with confirmed statin myalgia. Methods Statin myalgia was confirmed in 120 patients with prior symptoms of statin myalgia using an 8-week randomized, double-blind crossover trial of simvastatin 20 mg/d and placebo. Forty-one subjects developed muscle pain with simvastatin but not with placebo and were randomized to simvastatin 20 mg/d combined with CoQ10 (600 mg/d ubiquinol) or placebo for 8 weeks. Muscle pain (Brief Pain Inventory [BPI]), time to pain onset, arm and leg muscle strength, and maximal oxygen uptake (VO2max) were measured before and after each treatment. Results Serum CoQ10 increased from 1.3±0.4 to 5.2±2.3 mcg/mL with simvastatin and CoQ10, but did not increase with simvastatin and placebo (1.3±0.3 to 0.8±0.2) (p<0.05). BPI pain severity and interference scores increased with simvastatin therapy (both p<0.01), irrespective of CoQ10 assignment (p=0.53 and 0.56). There were no changes in muscle strength or VO2max with simvastatin with or without CoQ10 (all p>0.10). Marginally more subjects reported pain with CoQ10 (14 of 20 vs 7 of 18; p=0.05). There was no difference in time to pain onset in the CoQ10 (3.0±2.0 weeks) vs. placebo (2.4±2.1 wks) groups (p=0.55). A similar lack of CoQ10 effect was observed in 24 subjects who were then crossed over to the alternative treatment. Conclusions Only 36% of patients complaining of statin myalgia develop symptoms during a randomized, double-blind crossover of statin vs placebo. CoQ10 supplementation does not reduce muscle pain in patients with statin myalgia. Trial Registration NCT01140308; www.clinicaltrials.gov

Interpretation of the evidence for the efficacy and safety of statin therapy

“…In a similar cross-over trial among 120 patients with a history of muscle complaints who were randomized to simvastatin 20 mg daily then placebo or placebo then simvastatin, muscle pain was reported by 36% of the patients when on simvastatin but not on placebo versus 29% of them when on placebo but not on simvastatin. 251,252 These results indicate that, even among highly selected patients who have repeatedly attributed intolerable symptoms to statin therapy, some of the reported musclerelated intolerance may be due to the statin but most of it is not. In summary, given the 0.3% absolute excess of muscle problems based on more than 10,000 reported cases in meta-analyses of randomized trials during 3-5 years of treatment (webtable), 247 the excess rate of symptomatic muscle pain and other muscle-related problems due to statin therapy would appear to be no more than about 10-20 cases annually per 10,000 treated individuals, with only about 1 of those cases associated with substantial elevations in CK concentrations (i.e.…”

Coenzyme Q10 remarkably improves the bio-energetic function of rat liver mitochondria treated with statins

“…A clinical study showed that coenzyme Q10 supplementation might decrease some degree of muscles pain associated with statin (Caso et al, 2007). While a more recent randomized trial study has failed to establish any significant benefits of CoQ10 supplementation in terms of reduction of statin-induced pain in patients (Taylor et al, 2015). In our study the mitochondria from rat liver was used.…”

Statin Therapy as Primary Prevention in Exercising Adults: Best Evidence for Avoiding Myalgia

“…30 It is involved in electron transport in mitochondria, and deficiency could impair mitochondrial energy metabolism in muscle, 31 although evidence of this is conflicting. 32 Interference in this pathway can also destabilize muscle membranes during activity.…”