A randomized trial of coenzyme Q10 in patients with statin myopathy: Rationale and study design

Abstract

Background Statins are the most commonly prescribed and effective medications for reducing low-density lipoprotein levels. Some patients experience myopathic symptoms during statin treatment. The etiology is not known, but depletion of mevalonate pathway metabolites, including coenzyme Q10 (CoQ10), has been suggested. CoQ10 supplementation has been recommended to patients who experience myalgic symptoms despite a lack of conclusive evidence supporting its utility. Objective The Co-Enzyme Q10 in Statin Myopathy study is designed to examine the effect of CoQ10 supplementation on the extent and intensity of muscle pain during treatment with simvastatin. Methods We will recruit patients with a documented history of myalgia during statin treatment. The presence of statin-related myalgia will be confirmed in a crossover run-in trial during which presence and absence of symptoms will be documented during statin and placebo treatment, respectively. Individuals with myalgic symptoms while on statin but not placebo will be randomized to receive simvastatin 20 mg daily plus either 600 mg daily of CoQ10 or placebo. Muscle pain intensity will be documented during weekly phone calls using the Brief Pain Inventory (Short Form) (BPI-SF). Treatment will continue for 8 weeks or until muscle symptoms are reported continuously for one week or become intolerable, and then subjects will crossover to the alternative treatment (CoQ10 or placebo). Results This study is an ongoing clinical trial. Conclusions This study will determine the utility of CoQ10 for reducing pain intensity in myalgic patients and will provide guidance for clinicians treating patients with hypercholesterolemia who are intolerant to statins.

An assessment by the Statin Muscle Safety Task Force: 2014 update

“…Thus, it is not clear whether their myalgic symptoms could be reliably reproduced in the context of the study design. In the ongoing Co-Enzyme Q10 in Statin Myopathy study, 69 authors will examine the effect of CoQ10 supplementation on the extent and intensity of muscle pain during treatment with simvastatin by recruiting 135 patients with a documented history of myalgia during statin treatment. The presence of statin-related myalgia will be tested in a crossover run-in trial design during, which the presence and absence of symptoms will be documented during statin and placebo treatment, respectively.…”

Statin myopathy: the fly in the ointment for the prevention of cardiovascular disease in the 21st century?

“…The CEQ10 group had a decrease in SAM symptoms, but not related to the level of CEQ10. The groups were not well matched at baseline and there was no between group comparison, only within Parker [67] 8 all statins. A careful history and examination is undertaken to identify possible risk factors and alternative diagnoses (anxiety and depression or fibromyalgia, inflammatory rheumatic conditions and neurological conditions and risk factors, including rb12 and carnatine deficiencies, recent trauma or infections, alcohol abuse, drug interactions, chronic kidney disease).…”

The Role of Coenzyme Q10 Supplementation with Statin Drug Use and Chronic Diseases

“…Correspondingly, it is crucial that clinicians understand that statins block the HMG-CoA reductase, thus reducing the levels of Coq10 producing consequences beyond musclerelated adverse events. A randomized trial of Coq10 in patients with statin myopathy demonstrated that Coq10 reduced the pain intensity in muscle pain, myalgia patients; showing Coq10 supplementation is a useful clinical practice strategy [17].…”

“…Six randomized controlled trials and nine observational studies reported that statins reduce plasma and serum Coq10 levels by 16-54% and Coq10 deficiency was identified as a strong mortality predictor in chronic heart failure [14][15][16][17][18]. Also, statins may unmask presymptomatic neuromuscular disorders, thus, elevated serum creatine kinase (CK) levels and adverse muscle events should be monitoring after discontinuation of statins [19].…”