Plain language summary
Optimal therapy of heart failure (HF) is a considerable challenge. Standard treatments are administered to block rather than to enhance cellular processes. Coenzyme Q10 (CoQ10) is a powerful lipid-soluble antioxidant. This study is a prospective, randomized, double-blind, placebo-controlled, multi-centre trial of CoQ10 as adjunctive treatment of chronic HF focusing on changes in symptoms, biomarker status, and long-term outcome. A total of 420 patients were randomly assigned to active treatment with CoQ10 (n = 202) or placebo (n = 218). Results show that supplementation with CoQ10 significantly reduced major adverse cardiovascular events and cardiovascular death by 43% and all-cause mortality by 42%. Furthermore, CoQ10 supplementation improved the patients’ symptoms according to the New York Heart Association functional classification after 2 years. Authors conclude that treatment with CoQ10 in addition to standard therapy for patients with moderate to severe HF is safe, well tolerated, and associated with a reduction in symptoms and major adverse cardiovascular events.
Abstract
OBJECTIVES This randomized controlled multicenter trial evaluated coenzyme Q10 (CoQ10) as adjunctive treatment in chronic heart failure (HF). BACKGROUND CoQ10 is an essential cofactor for energy production and is also a powerful antioxidant. A low level of myocardial CoQ10 is related to the severity of HF. Previous randomized controlled trials of CoQ10 in HF were underpowered to address major clinical endpoints. METHODS Patients with moderate to severe HF were randomly assigned in a 2-year prospective trial to either CoQ10 100 mg 3 times daily or placebo, in addition to standard therapy. The primary short-term endpoints at 16 weeks were changes in New York Heart Association (NYHA) functional classification, 6-min walk test, and levels of N-terminal pro-B type natriuretic peptide. The primary long-term endpoint at 2 years was composite major adverse cardiovascular events as determined by a time to first event analysis. RESULTS A total of 420 patients were enrolled. There were no significant changes in short-term endpoints. The primary long-term endpoint was reached by 15% of the patients in the CoQ10 group versus 26% in the placebo group (hazard ratio: 0.50; 95% confidence interval: 0.32 to 0.80; p = 0.003) by intention-to-treat analysis. The following secondary endpoints were significantly lower in the CoQ10 group compared with the placebo group: cardiovascular mortality (9% vs. 16%, p = 0.026), all-cause mortality (10% vs. 18%, p = 0.018), and incidence of hospital stays for HF (p = 0.033). In addition, a significant improvement of NYHA class was found in the CoQ10 group after 2 years (p = 0.028). CONCLUSIONS Long-term CoQ10 treatment of patients with chronic HF is safe, improves symptoms, and reduces major adverse cardiovascular events. (Coenzyme Q10 as adjunctive treatment of chronic heart failure: a randomised, double-blind, multicentre trial with focus on SYMptoms, BIomarker status [Brain-Natriuretic Peptide (BNP)], and long-term Outcome [hospitalisations/mortality]; ISRCTN94506234).
Methodological quality
Jadad score
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5
Allocation concealment
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Yes
